<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:29871.wais]
A BILL TO AMEND TITLE 35, UNITED STATES CODE, TO CONFORM CERTAIN FILING
PROVISIONS WITHIN THE PATENT AND TRADEMARK OFFICE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON COURTS, THE INTERNET,
AND INTELLECTUAL PROPERTY
OF THE
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
ON
H.R. 5120
__________
SEPTEMBER 14, 2006
__________
Serial No. 109-150
__________
Printed for the use of the Committee on the Judiciary
Available via the World Wide Web: http://judiciary.house.gov
_____
U.S. GOVERNMENT PRINTING OFFICE
29-871 PDF WASHINGTON : 2006
_________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government
Printing Office Internet: bookstore.gpo.gov Phone: toll free
(866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250 Mail:
Stop SSOP, Washington, DC 20402-0001
COMMITTEE ON THE JUDICIARY
F. JAMES SENSENBRENNER, Jr., Wisconsin, Chairman
HENRY J. HYDE, Illinois JOHN CONYERS, Jr., Michigan
HOWARD COBLE, North Carolina HOWARD L. BERMAN, California
LAMAR SMITH, Texas RICK BOUCHER, Virginia
ELTON GALLEGLY, California JERROLD NADLER, New York
BOB GOODLATTE, Virginia ROBERT C. SCOTT, Virginia
STEVE CHABOT, Ohio MELVIN L. WATT, North Carolina
DANIEL E. LUNGREN, California ZOE LOFGREN, California
WILLIAM L. JENKINS, Tennessee SHEILA JACKSON LEE, Texas
CHRIS CANNON, Utah MAXINE WATERS, California
SPENCER BACHUS, Alabama MARTIN T. MEEHAN, Massachusetts
BOB INGLIS, South Carolina WILLIAM D. DELAHUNT, Massachusetts
JOHN N. HOSTETTLER, Indiana ROBERT WEXLER, Florida
MARK GREEN, Wisconsin ANTHONY D. WEINER, New York
RIC KELLER, Florida ADAM B. SCHIFF, California
DARRELL ISSA, California LINDA T. SANCHEZ, California
JEFF FLAKE, Arizona CHRIS VAN HOLLEN, Maryland
MIKE PENCE, Indiana DEBBIE WASSERMAN SCHULTZ, Florida
J. RANDY FORBES, Virginia
STEVE KING, Iowa
TOM FEENEY, Florida
TRENT FRANKS, Arizona
LOUIE GOHMERT, Texas
Philip G. Kiko, General Counsel-Chief of Staff
Perry H. Apelbaum, Minority Chief Counsel
------
Subcommittee on Courts, the Internet, and Intellectual Property
LAMAR SMITH, Texas, Chairman
HENRY J. HYDE, Illinois HOWARD L. BERMAN, California
ELTON GALLEGLY, California JOHN CONYERS, Jr., Michigan
BOB GOODLATTE, Virginia RICK BOUCHER, Virginia
WILLIAM L. JENKINS, Tennessee ZOE LOFGREN, California
SPENCER BACHUS, Alabama MAXINE WATERS, California
BOB INGLIS, South Carolina MARTIN T. MEEHAN, Massachusetts
RIC KELLER, Florida ROBERT WEXLER, Florida
DARRELL ISSA, California ANTHONY D. WEINER, New York
CHRIS CANNON, Utah ADAM B. SCHIFF, California
MIKE PENCE, Indiana LINDA T. SANCHEZ, California
J. RANDY FORBES, Virginia
Blaine Merritt, Chief Counsel
David Whitney, Counsel
Joe Keeley, Counsel
Ryan Visco, Counsel
Shanna Winters, Minority Counsel
C O N T E N T S
----------
SEPTEMBER 14, 2006
OPENING STATEMENT
Page
The Honorable Lamar Smith, a Representative in Congress from the
State of Texas, and Chairman, Subcommittee on Courts, the
Internet, and Intellectual Property............................ 1
The Honorable John Conyers, Jr., a Representative in Congress
from the State of Michigan, and Member, Subcommittee on Courts,
the Internet, and Intellectual Property........................ 2
The Honorable Howard L. Berman, a Representative in Congress from
the State of California, and Ranking Member, Subcommittee on
Courts, the Internet, and Intellectual Property................ 3
The Honorable William L. Jenkins, a Representative in Congress
from the State of Tennessee, and Member, Subcommittee on
Courts, the Internet, and Intellectual Property................ 4
WITNESSES
The Honorable Jon W. Dudas, Undersecretary of Commerce for
Intellectual Property, Director of the U.S. Patent and
Trademark Office
Oral Testimony................................................. 6
Prepared Statement............................................. 7
Mr. Clive Meanwell, Chief Executive Officer, The Medicines
Company
Oral Testimony................................................. 8
Prepared Statement............................................. 10
Ms. Kathleen D. Jaeger, President and Chief Executive Officer,
Generic Pharmaceutical Association
Oral Testimony................................................. 14
Prepared Statement............................................. 16
Mr. John R. Thomas, Professor of Law, Georgetown University Law
Center
Oral Testimony................................................. 25
Prepared Statement............................................. 27
APPENDIX
Material Submitted for the Hearing Record
Statement of the Honorable Howard Berman, a Representative in
Congress from the State of California, and Ranking Member,
Subcommittee on Courts, the Internet, and Intellectual Property 49
Statement of the Honorable Elton Gallegly, a Representative in
Congress from the State of California, and Member, Subcommittee
on Courts, the Internet, and Intellectual Property............. 49
A letter to the Honorable Jonathan W. Dudas, Under Secretary for
Intellectual Property and Director, U.S. Patent and Trademark
Office (USPTO) from the Honorable Lamar Smith, a Representative
in Congress from the State of Texas, and Chairman, Subcommittee
on Courts, the Internet, and Intellectual Property, and the
Honorable Howard Berman, a Representative in Congress from the
State of California, and Ranking Member, Subcommittee on
Courts, the Internet, and Intellectual Property................ 51
A letter to the Honorable Lamar Smith, a Represetative in
Congress from the State of Texas, and Chairman, Subcommittee on
Courts, the Internet, and Intellectual Property in response to
a letter requesting the United States Patent and Trademark
Office (USPTO) analysis and assessment of H.R. 5120............ 59
A letter to the Honorable Jon W. Dudas, Under Secretary for
Intellectual Property and Director, U.S. Patent and Trademark
Office (USPTO) from Jane A. Axelrad, Associate Director for
Policy, Center from Drug Evaluation and Research, Department of
Health & Human Services in regard to the March 24, 2003 letter
from Karin Ferriter requesting FDA's assistance in preparing a
response to a request for reconsideration in the application
for patent term extension for U.S. Patent No. 5, 196, 404 filed
by The Medicines Company....................................... 61
A paper on Critical Actions That Relate to The Medicines Company
Application for patent Term Extension for U.S. Patent 5, 196,
404............................................................ 64
Requested submission from the Honorable William Jenkins, a
Representative in Congress from the State of Tennessee; Letters
from leading medical practitioners and consumer groups......... 65
Letter from Lawrence Goffney..................................... 79
Testimony from Thomas Schatz, President, Citizens Against
Government Waste............................................... 85
A BILL TO AMEND TITLE 35, UNITED STATES CODE, TO CONFORM CERTAIN FILING
PROVISIONS WITHIN THE PATENT AND TRADEMARK OFFICE
----------
THURSDAY, SEPTEMBER 14, 2006
House of Representatives,
Subcommittee on Courts, the Internet,
and Intellectual Property,
Committee on the Judiciary,
Washington, DC.
The Subcommittee met, pursuant to notice, at 11:14 a.m., in
Room 2141, Rayburn House Office Building, the Honorable Lamar
Smith (Chairman of the Subcommittee) presiding.
Mr. Smith. The Subcommittee on Courts, the Internet, and
Intellectual Property will come to order.
I am going to recognize myself for an opening statement,
then the Ranking Member of the full Judiciary Committee, Mr.
Conyers, as well as Mr. Berman and as well as Mr. Jenkins, the
author of the legislation on which we are having the hearing
today.
Thank you all for your interest. And we will proceed and
then get to questions for our panelists as soon as we can.
I will recognize myself for an opening statement.
Today we begin an examination of H.R. 5120, a bill to amend
title 35 of United States Code to conform certain filing
provisions within the Patent and Trademark Office.
This is an important hearing on a serious subject, and I
look forward to the testimony of our witnesses.
It is the tradition of our Subcommittee to ensure all
stakeholders have an opportunity to be heard and have their
concerns placed on the record. This is a critical step to take
before we begin to consider what further steps, if any, may be
appropriate.
H.R. 5120 is a highly unusual bill. Its enactment will
single out a specific company and their legal counsel for
special consideration. I believe the proponents of the
legislation have the burden to establish that a change in
public law is necessary. At the same time, I want to compliment
the company for its commitment to the regular legislative
process.
And I appreciate Dr. Meanwell's willingness to respond to
tough questions in a public forum, which I believe is necessary
to assist the Members of the Subcommittee in understanding the
circumstances that led this company and their counsel to this
point.
Their view is that the law is inflexible and, in their
words, should be conformed to other provisions of the patent
code that permit parties who have failed to meet statutory
deadlines to be granted an extension. Further, they believe the
public interest in spurring innovation and promoting public
health is best served by providing for the retroactive
application of such a change in the law in their case.
Not unexpectedly, there are countervailing arguments.
Opponents of this measure maintain there is no good reason the
law requires amendment. They note that since this provision was
first enacted more than two decades ago, only three of more
than 700 applications have ever been denied in any part for
having missed the 60-day filing deadline.
Further, they assert there is substantial precedent in the
Patent Act to support the view that no relief should be granted
when certain statutory deadlines are not met and that relief
should extend only to circumstances where it is objectively
demonstrated that the failure to file was unavoidable rather
than merely unintentional. In other words, they believe the
proposed change would actually make this deadline inconsistent
with other precedents in the Patent Act. This is just a preview
of the various arguments that the Subcommittee Members will
soon hear and need to weigh for themselves.
That concludes my opening remarks. And the gentleman from
Michigan, Mr. Conyers, is recognized for his.
Mr. Conyers. I thank you, Chairman Smith. And I join you in
welcoming all the witnesses: the Honorable Jon Dudas, a very
dear friend of ours, Dr. Meanwell, and President Jaeger of
Generic Pharmaceutical Association, and Professor Thomas.
I wanted you to know as I head for the floor on a judiciary
bill that is currently up for consideration that the proposal
before us, legislation that would permit the Patent and
Trademark Office to consider late applications for an extended
term of patent protection or marketing exclusivity, currently
if a patent owner files for an extension even 1 day late, then
the PTO has no discretion to consider it.
I understand that The Medicines Company faced this problem
directly in 2002 when it sought patent term extension for its
heart drug, Angiomax. If it was granted, the extension would
have permitted the company to exclude competition to Angiomax
for a longer period.
The application for additional patent protection was due 60
days after the Food and Drug Administration approved the drug.
But the application was filed on the 61st day. Because it has
no discretion to review late filings, the PTO summarily
rejected its consideration.
Before us today is a proposal that would allow the PTO to
consider the application. Contrary to how it has been
portrayed, it would not automatically extend the term of
exclusivity or automatically prevent competitors from entering
the market. And in that regard, the bill appears equitable.
And I look forward to returning to continue the discussion
with these very able witnesses that are before us.
And I thank you for your courtesy, Chairman Smith.
Mr. Smith. Would the gentleman from Michigan yield to the
gentleman from California, Mr. Berman, for his opening
statement as well?
Mr. Conyers. Absolutely.
Mr. Berman. Thank you, Mr. Chairman.
And thank you, Mr. Ranking Member, for yielding.
I appreciate scheduling this hearing on a bill giving the
USPTO additional discretion to extend certain patent deadlines.
While similar measures, bills that have specifically extended
the Angiomax patent, have been attached to legislative vehicles
in the past, I am glad that this issue is finally being
reviewed by the Committee with jurisdiction over patent
matters. It is important that this Subcommittee be able to
analyze the impact of any changes this bill may make on the
patent system.
Patents are a cornerstone of innovation. The Constitution
provides a limited period of time of protection in order to
promote innovation. Therefore, the patent process provides the
exclusive right for an invention for 17 to 20 years generating
incentives for an inventor to continue to create after which
the invention becomes available for public use.
There is a delicate balance here: providing enough of an
incentive to the inventor to spend the time, energy and money
to create new inventions and on the other hand, the value of
allowing the invention to be used by the public enabling others
to develop new products or provide similar products for lower
cost. Therefore, when considering the effect of allowing the
PTO discretion to extend certain patent deadlines there is a
natural tension between providing the flexibility to extend the
deadline and maintaining a hard date for specific types of
filings.
While providing greater elasticity may prevent Draconian
results, does that come at the expense of stability in the
market? There are to be other instances--there appears to be
other instances where the PTO has discretion to extend
deadlines. But the situation in this bill is designed to
address is not one of those sections. Why? Is there something
different about this type of filing that the PTO should not
have discretion in this case?
Unfortunately, the PTO, I am sorry to say, Jon, hasn't
provided much guidance in its response to the letter from the
Chairman and myself about the policy questions posed by this
bill. So I look forward to this hearing to hear the witnesses
discuss the policy implications of this bill on the patent
system and possibly on Hatch-Waxman.
Just to conclude, originally this legislation began as an
effort to address one particular late filing of one patent.
There has been no demonstrated need or request from any other
patent owners, as far as I know, to provide discretion to the
PTO for these types of filings. Moreover, from the way the bill
has been written, it is clear this bill would affect the late
filing of a particular company, which occurred about over 4
years ago. Some have even suggested that the better alternative
to this bill is a private bill.
However, this bill and this particular circumstance does
raise some questions about why there are inconsistencies in the
discretion afforded to the PTO to determine when filings are
timely. I look forward to this opportunity to explore those
issues.
I yield back, Mr. Chairman.
Mr. Smith. Thank you, Mr. Berman.
The gentleman from Tennessee, Mr. Jenkins, is recognized
for an opening statement.
Mr. Jenkins. Thank you, Chairman Smith, for holding this
hearing.
And thank you, Mr. Berman, for your participation. I look
forward to the views of our witnesses, like you, sir. And I am
grateful for their appearance this morning.
H.R. 5120 has drawn bipartisan sponsorship from 23 of our
colleagues, including three Members of the full Judiciary
Committee: Mr. Hyde, Mr. Delahunt, and Mr. Meehan. I introduced
this measure because I believe it is both good patent policy
and sound health care policy. It corrects an inequity in the
patent law and will encourage important innovation in medical
research, precisely the purpose that Congress sought to
accomplish in enacting the Hatch-Waxman Act.
In the course of this hearing, I hope that you will hear
several examples of relief that is available for late payments,
late filings and deficient filings. By enacting H.R. 5120 we
are continuing to promote the basic purpose of Hatch-Waxman,
and we are strengthening Hatch-Waxman. It is important to do
this so that our nation will continue to lead the way in
medical research and so that patients will not be denied
promising new, innovative developments.
Mr. Chairman, I am submitting letters from leading medical
practitioners and consumer groups, including a letter from the
Cleveland Clinic, the University of California at Los Angeles,
and the Emory Health Care Center in Atlanta, Georgia, from
across our country endorsing H.R. 5120 to include in the
Committee report.
Their credentials and their views are impressive. They
emphasize the health care advantages of this measure,
particularly its effect on opening up new avenues of medical
research to prevent and treat strokes.
Mr. Chairman, I would like to ask unanimous consent to
introduce these letters and that they be made a part of the
record.
Mr. Smith. Okay. Without objection, those letters will be
made a part of the record.
[The letters follow in the Appendix]
Mr. Jenkins. Thank you.
H.R. 5120 is a narrowly tailored bill. It simply confers
discretion on the patent office to consider an unintentionally
late filed patent term restoration application submitted to the
patent office within 5 days of the 60-day deadline in current
law. It does not confer any substantive rights on any applicant
but merely allows the applicant to present the facts
surrounding the late filing to the patent office.
The director of the patent office then has 30 days to rule
on the petition. Honest mistakes should not cause irreparable
hardship for innovators or patients. A few days unintentional
late filing mistake at the patent office should not be a cause
for blocking promising medical research that could lead to
important health care advances.
Mr. Chairman, I appreciate all the efforts you and the
Subcommittee have invested in preparing for this hearing. I
hope that we can move as quickly as possible through the
Committee process and proceed with the enactment of H.R. 5120.
Thank you.
Mr. Smith. Thank you, Mr. Jenkins.
And, without objection, other Members' opening statements
will be made a part of the record, as well as a statement by
Representative Elton Gallegly, a letter from Lawrence Goffney
and testimony by Thomas Schatz, president of Citizens Against
Government Waste.
Mr. Smith. Before I introduce our witnesses, I would like
to ask you all to stand and be sworn in.
[Witnesses sworn.]
Thank you. Please be seated.
Our first witness is Jon Dudas, who is the Undersecretary
for Intellectual Property and Director of the United States
Patent and Trademark Office. Mr. Dudas is the lead policy
adviser to the Secretary of Commerce, the President of the
United States and Administration agencies on intellectual
property matters.
As Director of the USPTO, he is responsible for
administering the laws that relate to the issuance of patents
and trademarks and day-to-day management of the agency's $1.7
billion budget and 8,000 employees.
Prior to joining the Administration, Mr. Dudas served 6
years as Counsel to this Subcommittee and as Staff Director and
Deputy General Counsel to the Committee on the Judiciary. Mr.
Dudas is a summa cum laude graduate of the University of
Illinois where he earned a bachelor of science in finance. He
is an honors law graduate from the University of Chicago.
Our second witness is Clive Meanwell, who is the Chairman
and Chief Executive Officer of The Medicines Company, a
pharmaceutical company based in Parsippany, New Jersey that
specializes in acute care hospital medicines. In 1996, Dr.
Meanwell co-founded TMC to develop medicines for specialized
patient populations.
TMC's only product is marketed under the name Angiomax and
is used to prevent blood clots in patients from cardiovascular
disease. Dr. Meanwell oversaw the acquisition, development and
successful regulatory review of Angiomax, which culminated with
the Food and Drug Administration's approval in 2000. Dr.
Meanwell holds both an M.D. and a Ph.D. from the University of
Birmingham in the United Kingdom.
Our next witness is Kathleen D. Jaeger, who has served as
the President and CEO of the Generic Pharmaceutical Association
since 2002. Before joining that organization, Ms. Jaeger was a
partner in the Washington office of several law firms where she
developed a specialty in food and drug practice. In addition to
earning her J.D. from Catholic University Law School, Ms.
Jaeger also has a bachelor of science in pharmacy and a minor
in chemistry, which she earned at the University of Rhode
Island.
Our final witness is John R. Thomas, who is a professor of
law at the Georgetown University Law Center. Professor Thomas
formerly served as an associate or visiting professor on the
faculties of George Washington University, Cornell Law School
and the University of Tokyo. Professor Thomas has written
extensively on intellectual property law co-authoring both a
patent law case book and a one-volume treatise on intellectual
property.
Welcome to you all.
As you know, we have your entire written statements, which,
without objection, will be made a part of the record. But
please limit your testimony to 5 minutes.
And, Mr. Dudas, we will begin with you.
TESTIMONY OF JON DUDAS, UNDERSECRETARY OF COMMERCE FOR
INTELLECTUAL PROPERTY, DIRECTOR OF THE U.S. PATENT AND
TRADEMARK OFFICE
Mr. Dudas. Thank you, Mr. Chairman, Ranking Member Berman,
Congressman Jenkins and Congressmen Meehan and Delahunt, for
inviting me to testify today on H.R. 5120.
This bill would amend patent law to permit the USPTO to
consider certain late-filed applications for patent extension
under Hatch-Waxman if such applications are filed no later than
5 days after the current 60-day time period and applicants file
a petition showing that the delay was unintentional.
Mr. Chairman, the USPTO does not at this point have a
position on this bill. Certainly, there could be some benefits
and at least one direct beneficiary of providing the
flexibility proposed in the bill. But there are also benefits
to maintaining a certainty inherent in the current law.
While we have a sense of the potential impact on the
possible direct beneficiary to this legislation and while we
know very well our own abilities to enforce the law, we do not
yet have a full sense of the impact on other interested
parties. Therefore, I commend you for holding this hearing to
help determine the potential impact and to otherwise examine
the possible merits and limitations of this proposal.
Although I am unable to give you a clear reading of support
or opposition, I would like to share with you a number of
observations that may be helpful to the Subcommittee as it
reviews the bill.
First, this type of legislation is not without precedent.
As indicated in my written statement, current patent and
trademark law provides the USPTO with discretionary authority
to accept late-filed submissions in a number of situations.
Also, while we currently do not believe the legislation
requires additional restrictions or limitations in order to
ensure a neutral application if enacted, further review of the
issue may be helpful as the legislative process continues.
In terms of application, we are aware of one current
application for patent term extension that would immediately
benefit from enactment of the bill. You will be hearing from
the owner of that patent shortly. But our review of the over
700 applications for patent term extensions filed since 1984
indicates that one other application filed 5 days late may have
benefited from this bill if it had been in effect.
So after a review of 700 applications since 1984, there are
a total of four patent term extension requests that were over
60 days, two that were within 65 days but older than 60 days
and one that is currently pending.
I should note that it is not unprecedented for newly
enacted patent legislation to apply to issued patents and
pending applications. But prospective or retrospective
discretionary authority as proposed in this bill should involve
a careful balancing of all relevant interests involved. Again,
we are pleased that the Subcommittee is reviewing input with an
eye toward that balancing.
Mr. Chairman, if granted the authority proposed in the
bill, I would not foresee any implementation problems at the
USPTO. The USPTO would, of course, follow the policies
reflected in our administration of areas currently subject to
discretionary review of delayed filings.
Mr. Chairman, in closing I want to thank you, Ranking
Member Berman, and the Members of this Subcommittee for your
continuing and strong support for the USPTO operations and for
your efforts to maintain and improve our system of intellectual
property protection and enforcement. And I look forward to
answering your questions.
[The prepared statement of Mr. Dudas follows:]
Prepared Statement of the Honorable Jon W. Dudas
Chairman Smith, Ranking Member Berman, and Members of the
Subcommittee:
Thank you for inviting me to testify today on H.R. 5120, a bill
``to amend title 35, United States Code, to conform certain filing
provisions within the Patent and Trademark Office.''
The bill would amend patent law to permit the USPTO to consider
certain late-filed applications for patent extension under section 156
of title 35 if such applications are filed not later than five days
after the current 60-day time period and the applicants file a petition
that shows that the delay in filing the application was unintentional.
Mr. Chairman, as indicated in our recent letters to you and Ranking
Member Berman, the United States Patent and Trademark Office (USPTO)
does not at this time have a position on this proposed legislation.
While there could be some benefits, and at least one direct
beneficiary, of providing the type of additional flexibility provided
by the proposal, there are also benefits to maintaining the certainty
inherent in the current law in this area.
While we have a sense of the potential impacts on the possible
direct beneficiary to this legislation, we do not yet have a full sense
of the impact on others in the invention, manufacturing, consumer, and
intellectual property communities.
Accordingly, we commend you for holding this hearing to help
determine the potential impact on all interested parties and to
otherwise examine the possible merits and limitations of the proposal.
I am pleased to share with you a number of our observations that
may be helpful as the Subcommittee reviews the bill.
precedent
This type of legislation is not without precedent. Currently,
patent laws provide the USPTO with discretionary authority to accept
late-filed submissions in a number of situations, including: payment of
maintenance fees (35 USC Sec. 41(c)(1)); abandonment of applications
(35 USC Sec. 133); and payment of issue fees (35 USC Sec. 151). The
trademark laws have similar language, for example, regarding timely
filing of a verified statement of use (15 USC Sec. 1051(d)(4)) and
abandonment of an application for failure to reply or amend (15 USC
Sec. 1062(b)).
Similarly, while we currently do not believe the legislation
requires additional restrictions or limitations in order to ensure
neutral application if enacted, further exploration of the issue may be
informative as the legislative process continues.
previous applicants that would benefit from enactment
We are aware of one current application for patent term extension
that would immediately benefit from enactment of the bill. That
application is related to patent number 5,196,404 owned by the company
represented at the table here today. More generally, a review of our
records indicates that, of the over 700 applications for patent term
extension filed since 1984, three other applications were not granted
due, at least in part, to timeliness issues. One of these applications
was filed within 65 days of the ``approval date,'' and thus may have
been eligible for a petition to have the delay excused, if the proposed
provision had been in effect.
prospective vs. retrospective
It is not unprecedented for newly enacted patent legislation to
apply to issued patents and pending applications. That fact noted,
prospective or retrospective discretionary authority, as proposed in
the bill, would have to involve a careful balancing of all relevant
interests involved. We are unable to make a particular recommendation
in this regard because we are unaware of any substantive input by
interested parties, other than the 404 patent owner.
exercise of discretion
With respect to the circumstances under which we would expect to
exercise discretion under this bill, we believe it is premature to
attempt to list or identify particular examples at this point. We
would, of course, if granted the subject authority, be likely to follow
the policies reflected in the administration of areas currently subject
to discretionary review of delayed filings.
patent reform
Although our survey of patent term extension applications reveals
few issues related to timeliness, this legislation would be of use to
at least one current applicant and could be utilized by future
applicants who miss the patent term extension application deadline due
to unintentional delay. As noted above, the discretionary authority
contemplated by H.R. 5120 is similar to other deadline-extending
provisions in patent law.
As indicated in testimony before your Subcommittee in April, the
USPTO supports enactment of two patent proposals pending before the
Subcommittee that are widely supported throughout the intellectual
property community, namely, a post-grant review procedure and a new
procedure for submission of prior art. We continue to review other
proposals before the Subcommittee.
Thank you.
Mr. Smith. Thank you, Mr. Dudas.
Dr. Meanwell.
TESTIMONY OF CLIVE MEANWELL, CHIEF EXECUTIVE OFFICER, THE
MEDICINES COMPANY
Mr. Meanwell. Thank you, Mr. Chairman and Members of the
Committee. I am pleased to be here and appreciate the
Committee's invitation to testify. My name is Clive Meanwell. I
come before you today both as a physician and as the chairman
and CEO of The Medicines Company, a young company devoted to
developing medicines for acutely ill patients.
The subject of today's hearing may seem dry and technical,
but, as you know, it is actually about ensuring the potential
to save lives and reduce health care costs. Our company serves
as a poster child for why this legislation is needed. Relying
on incentives in the patent law, we spent more than $200
million developing Angiomax, an intravenous blood thinner that
has proven to be effective and safe for patients while actually
saving hospitals an average of $400 per use compared with more
established therapies.
Once FDA approved Angiomax, we applied for patent term
restoration to recover time lost while seeking approval. The
60-day deadline was mistaken for a 2-month limit, and the
application was filed 1 day late. Unlike most other patent
provisions, current law gives the PTO no discretion to accept a
late filing. So our application was denied.
This drastic penalty took away 4\1/2\ years of patent
rights we had earned and cut off our ability to invest tens of
millions of dollars more in research to confirm promising new
uses of Angiomax in open heart surgery and stroke.
Mr. Chairman, this is a good bill for three principle
reasons.
First, the existing deadline provision imposes hugely
disproportionate penalty like having your home repossessed when
you are a day late with the last mortgage payment. Deadlines
are important, but most patent law provisions like Federal
court rules recognize that human beings make mistakes and that
catastrophic consequences should not flow from them.
Second, this legislation is consistent with most patent
laws and regulations, which allow minor mistakes to be excused.
Third, the bill could benefit millions of seriously ill
patients. Only companies with a period of exclusivity can make
the large-scale investments necessary to develop new uses of
the drug beyond the scope of its initial FDA approval.
Some critics suggest this bill will disrupt the decision
making process of generic manufacturers who pursue their own
applications on relatively tight timelines. I am on the board
of a company that sells generics, and I know how important
these tight timelines are. But they have nothing to do with the
patent term restoration--with when patent term restoration
applications are filed. The only dates really important to a
generic firm are the date of FDA approval and the date a patent
expires.
Similarly, the claim that this bill might interfere with
settled expectations is a fallacy. There are no settled
expectations 60 days after a drug has been approved, nor would
the time added by this bill, a maximum of 35 days, have the
slightest impact on a generic's business plans. It is the
pioneers' settled expectations that get blown to bits if its
patent rights are lost over a minor filing error.
It is also suggested that since the filing of Hatch-Waxman
application triggers an elaborate sequence for calculating the
registration period--the restoration period, ensuring that this
triggering event happens in a seasonable manner is somehow
important. But calculating the restoration term typically takes
3 years after the application is filed. So the few extra days
this bill could add at the start of the process are just
trivial.
This bill will not--and let me repeat that--will not upset
the delicate balance that Hatch-Waxman strikes between
innovators and generics. In fact, it preserves the balance.
Generics retain all their rights. And the patent owners get
nothing more than the restoration period that they already
earned under Hatch-Waxman. Without this bill, however, an
innovator who makes an unintentional filing mistake loses what
Congress intended to provide: an opportunity to recover time
lost during FDA approval.
I just don't believe that Congress intended to throw this
careful balance overboard in the event that an innovator trips
on their way to the patent office. Some say this is a single
company bill. But that is a red herring. This bill would fix a
legal pothole for all other patent holders and could
potentially help millions of patients who will benefit from new
drugs and new uses of drugs.
In summary, this bill enhances the fundamental bargain
struck by Hatch-Waxman. It removes a Draconian penalty for
minor error. It is consistent with current law. And it will
potentially improve the lives of millions of needy patients.
Thank you very much.
[The prepared statement of Mr. Meanwell follows:]
Prepared Statement of Clive Meanwell
Thank you Mr. Chairman and Members of the Committee.
My name is Clive Meanwell, and I am the Chairman and Chief
Executive Officer of The Medicines Company, a young pharmaceutical
company based in New Jersey where we develop acute care medicines for
hospital patients, a small segment of the market often considered
unattractive by big drug companies. I am also a doctor. And I am
pleased to be here and appreciate the Committee's invitation to
testify.
Mr. Chairman, the subject of today's hearing--filing deadlines for
certain patent applications--might seem like a dry and technical one,
but it is actually about creating the potential to save lives. It is
about amending a provision of the Hatch-Waxman Act that, if left
unchanged, will right now kill the further development of a drug that
is helping thousands of heart disease patients every month and has the
promise to help hundreds of thousands more patients with life-
threatening cardiovascular conditions, including stroke victims. Beyond
our case, if the provision is left unchanged, it will also put at risk
the development of other drugs that will save lives in the future.
The purpose of this hearing, at least as I see it, is to weigh the
distinct benefit of the proposed filing amendment against whatever
benefit there may be to retaining the existing, inflexible provision.
In my view, what H.R. 5120 does, in a nutshell, is to preserve the
fundamentally sound bargain Congress struck in the Hatch-Waxman Act
between encouraging innovation and bringing generic drugs to market. In
preserving Hatch-Waxman's incentive to develop new drugs and new uses
for drugs--without curtailing provisions that benefit generic
manufacturers--this bill also stands solidly on the side of patients.
background
To date, The Medicines Company's only marketed product is a new
blood thinning drug called Angiomax. The FDA has already approved
Angiomax for use in angioplasty--a procedure often used to treat
coronary artery disease, including heart attacks. Catheters, inflatable
balloons, and stents are used to open up a coronary artery that is
narrowed or blocked by arteriosclerosis or blood clots. Approximately
one million angioplasties are performed each year in the United States,
and in this setting Angiomax has been shown effective and safe, and is
also associated with a significant reduction in bleeding complications
compared to other treatments. More than 250,000 patients benefited from
Angiomax last year alone. These positive results have been seen in both
clinical trials and real-world use, in many different groups of
patients, from diverse ethnic backgrounds, with a range of risk factors
and a variety of life-threatening coronary artery disease states. And
Angiomax--a product of high technology research--is particularly useful
for people who cannot tolerate heparin, an extract of pig intestines
discovered in 1916, that until the last decade was the only injectable
anticoagulant available.
In addition to its established effectiveness in coronary
angioplasty, Angiomax may also have important uses in patients
undergoing cardiac surgery, those with pre-heart attacks and those with
strokes. Each of these conditions represents enormous public health
problems in the United States today. Coronary artery disease and stroke
combine to kill well over a half million Americans each year--more than
the deaths caused by all cancers combined, and therefore by far the
leading cause of death in this country. The initial promise of Angiomax
in these new research areas is exciting. For example, results of an
Angiomax pilot trial in open heart surgery were reported in the Annals
of Thoracic Surgery in 2004, where an expert commentator stated,
``bivalirudin [i.e., Angiomax] could be the `holy grail' eagerly sought
by cardiac surgeons and anesthesiologists (and hematologists). . . .''
Ann. Thorac. Surg. 2004; 77:925-31. In another example, early studies
involving carotid artery stenting--a procedure used to unblock the
arteries in the neck that can throw off blood clots to the brain--have
shown that Angiomax can reduce the risks of bleeding and effectively
prevent embolic strokes during this delicate life-saving procedure.
We have already committed, and hope to continue committing,
substantial resources to research and development of these significant
new uses for Angiomax. And that brings me to the point of my testimony
today.
Our company serves, I am sorry to say, as a poster child for why
this bill is needed.
In developing Angiomax, we did what research-based biotech and
pharmaceutical companies regularly do in responding to the incentives
of the U.S. patent system: we spent large amounts of time and money to
bring a new product to market. In total, development of Angiomax for
angioplasty took eight years and cost more than $200 million. We
anticipate that the clinical trials needed to establish the safety and
effectiveness of Angiomax in patients for cardiac surgery and for
stroke will take at least 4 more years and cost tens of millions of
dollars. These investments are not viable without the patent
exclusivity provided by the Hatch-Waxman Act.
As you know, the U.S. patent law framework--including Hatch-
Waxman--is designed to provide incentives for the investment of such
time and money. Hatch-Waxman, of course, enables research-based
pharmaceutical companies to recoup some of the time spent in the FDA
approval process so that the patent exclusivity period is not unfairly
curtailed. Often, it is the possibility of qualifying for Hatch-Waxman
patent term restoration that provides innovators with the incentive to
invest in drugs that no one else wants to develop. Moreover, once such
restoration has been granted, innovators have added incentive to pursue
further research on drugs to broaden their approved use, an important
step in the development process, since it is not unusual for FDA to
grant a narrow approval in the first instance.
The FDA approved Angiomax for the narrow initial use in coronary
angioplasty on December 15, 2000. Under the Hatch-Waxman formula, we
calculated that we were entitled to a restoration period of
approximately 4\1/2\ years. We quickly set about preparing our
application for patent restoration, completing a first draft of the
100-plus page application package by the first week of January 2001 and
then working steadily along with our counsel on further drafts. But
then human error intervened. The current filing provision of Hatch-
Waxman requires an application to be filed within 60 days of FDA's
approval of the drug in question. Unfortunately, the 60-day requirement
was evidently mistaken for a two-month requirement, and our patent
restoration application was filed on February 14, 2001, within a two-
month window, but one day late for the actual 60-day deadline. Unlike
other filing provisions of the patent laws, this provision of Hatch-
Waxman does not allow for any discretion to accept late applications,
no matter the reason and no matter how close to the actual deadline.
So, the Patent and Trademark Office denied the petition as untimely. We
filed a motion for reconsideration which is still pending, but the PTO
lacks the authority to grant it.
So, because of an inadvertent administrative error, The Medicines
Company--and the patients who could be helped by Angiomax--are facing a
drastic and disproportionate penalty. The basis for a $200 million
investment that powered development of a life-saving drug in coronary
angioplasty has been completely cut out from under us. And our hope of
extending the benefit of Angiomax into critically important new areas
is in tatters. Without patent restoration, our patent will expire in
2010, not nearly enough time to make possible the investment of years
and tens of millions of dollars needed to confirm the efficacy of
Angiomax in treating stroke and serious heart disease to the
satisfaction of ourselves, the FDA and medical practitioners. And
others who make accidental filing mistakes in the future, may face a
similar predicament.
Making the consequences of a minor mistake so catastrophic, both to
a patent owner and the public, simply cannot be good or wise public
policy.
h.r. 5120-weighing the benefits
H.R. 5120 is a modest bill that would correct this unduly harsh
result for us and for any other innovators who make the same mistake.
The bill would not give a patent owner anything other than what it has
already earned under the Hatch-Waxman system--a credit for the portion
of a patent term effectively lost while seeking FDA approval. The bill
would not, by its own terms, grant patent term restoration. It would
simply give the PTO authority to accept an application that was filed
late on account of an unintentional error.
Mr. Chairman, I think a reasoned analysis of the potential costs
and benefits of this legislation argues powerfully in its favor. Let me
begin with the benefits of modifying the existing deadline provision.
First, the effect of the existing provision is like having your
home repossessed for making your mortgage payment a day late_a
completely disproportionate punishment for a minor, administrative
mistake. As a matter of wise public policy, this does not make sense.
Years of highly valuable, hard earned patent rights--in our case more
than a third of our total patent period--should not be forfeited on
account of a minor clerical error.
Second, this legislation is entirely consistent with typical patent
law and practice and supports the purpose of Hatch-Waxman. Recognizing
the obvious importance of patent rights and the national interest in
promoting pharmaceutical innovation, the great majority of relevant
patent laws and regulations actually do give the PTO discretion to
excuse inadvertent mistakes. For example: if an applicant files an
incomplete application for patent term restoration, the PTO can grant
up to two extra months to correct the errors in the application. This
is not an isolated example. There are more than 30 such examples where
the PTO has the authority to excuse errors that could otherwise deprive
an applicant of its rights. We have submitted a memorandum detailing
these examples to the Committee. Thus, the rigid statutory 60-day
deadline, allowing PTO no discretion to excuse an inadvertent error is,
in fact, an anomaly, which this bill would rightly correct. Moreover,
by preventing the automatic forfeit of years of patent protection for
minor clerical errors, the bill supports an important purpose of the
Hatch-Waxman system--to make sure patent owners have an opportunity to
recover the portion of their exclusivity period that would otherwise be
lost while awaiting FDA approval.
Third, this bill would potentially benefit millions of seriously
ill patients. Only a company that can assure itself of a significant
period of exclusivity will take the risks and make the substantial
investment necessary to obtain the approval of new uses of a drug
beyond the scope of its initial FDA approval. In our case, no generic
manufacturer would do what we are prepared to do--invest years and tens
of millions of dollars to test promising new uses of Angiomax for heart
disease and stroke--because the manufacturer would have no financial
incentive to do so. If the initial promise we have seen for such
applications is realized, Angiomax could potentially provide vital help
to hundreds of thousands of seriously ill patients. And what is true
for us will be true for others in the future. So this is an important,
potentially life-saving bill for patients.
Now, I understand that concerns have also been raised about this
bill, but they do not, individually or together, begin to measure up to
the bill's substantial benefits.
Settled expectations/certainty. First, it has been said that H.R.
5120 might interfere with settled expectations about when a drug would
come off patent, and that there are legitimate benefits to maintaining
the certainty inherent in current law. In principle, there are of
course benefits to certainty in laws. But the interest of ``settled
expectations'' is more effectively served by this bill than by the
status quo.
The fact that a patent owner might get an additional 5 days to file
a patent restoration application, and that the PTO could take 30 days
to decide whether to grant this additional time, will not have the
slightest impact on the business plans a generic manufacturer has or
has not made to enter a new market. The truth is that neither generics
manufacturers nor anyone else can know what the duration of a possible
patent term restoration period might be until the proposed patent term
extension is published for public comment, often years after the
application is filed. That is the first notice that a generic
manufacturer is likely to rely on in terms of its own planning, and
this bill would have no impact on the content or timing of such notice.
I am very sympathetic to the value of generics companies in our
healthcare system--indeed I sit on the board of directors of one, and I
am proud of what we do there. But the claimed disturbance to certainty
and settled expectations entailed in H.R. 5120 would not even amount to
a ripple upon the water for a generic firm.
By contrast, the settled business expectations that are obliterated
are those of a patent holder that devises its business and investment
strategy in reliance on the opportunity for Hatch-Waxman restoration,
if those rights are lost on account of a minor filing error.
The delicate balance. Second, some have said that enacting this
bill would upset the delicate balance in Hatch-Waxman between (a)
spurring innovation by assuring that a patent holder retains its
exclusivity rights despite the years it takes to get FDA approval, and
(b) allowing generic manufacturers to produce cheaper drugs. I'm
neither a lawyer nor a legislator, but it seems to me that the
``balance'' argument cuts in favor of H.R. 5120, not against it.
The Hatch-Waxman balance was premised, as I understand it, on the
following five elements: first, a generic manufacturer can study a drug
during the patent term without infringing the patent; second, a generic
manufacturer can rely upon the investment and testing done by the
innovator, rather than incurring the time and expense required to test
the drug itself; third, a generic manufacturer who files an ANDA
(Abbreviated New Drug Application) successfully challenging an existing
patent is eligible for a six-month period of marketing exclusivity; and
fourth, generic manufacturers benefit from the five-year limit on the
patent restoration term and the 14-year cap on the overall patent term;
while, fifth, the innovator is provided an incentive--through the grant
of patent term restoration--to undertake the risk, expense, and delay
of drug testing and FDA approval.
Under H.R. 5120, this balance is fully preserved. Generic
manufacturers would retain all of the benefits I just described--study
during patent term, benefiting from others' R&D investments, ANDA
opportunity, and limited patent terms--and the innovator would retain
its benefit of term restoration in exchange for conducting clinical
testing. Without this bill, however, an innovator who makes a minor,
inadvertent filing error loses its entire Hatch-Waxman benefit--the
opportunity to seek the patent term restoration that was already
earned.
I simply cannot believe that, as Congress constructed this careful
balance, it meant to throw it overboard in the event that the innovator
tripped on the way to the Patent Office. That was manifestly not part
of the bargain Congress intended to strike.
Deadlines. Third, some say simply that 60 days means 60 days, full
stop. I understand the importance of deadlines, and I understand that
penalties are an important way to enforce deadlines. But, the problem
here is that the punishment does not remotely fit the crime. As I have
noted, the PTO has extensive discretion to extend deadlines in most
situations encountered in patent examinations. And I understand that a
similar rule applies in federal civil litigation, where the relevant
rule (6(b)) gives judges broad discretion to extend a deadline or
permit a filing ``where the failure to act was the result of excusable
neglect.'' The flexibility found in the patent law and the rules of
civil procedure is built on a fundamental and simple recognition--that
people are human and sometimes make inadvertent mistakes, and thus
draconian consequences ought not to flow from such errors. An argument
that comes down to the claim that a rule is a rule and should not be
changed no matter how inappropriate its effect seems to me unworthy of
this great legislative body. The PTO, of course, cannot change such a
rule in a statute, but Congress can if it concludes, as a matter of
policy, that a wise amendment is available. I think H.R. 5120
constitutes just such an amendment.
Single company. Fourth, the notion that this is just a bill to help
one company is a red herring. Of course, our company would potentially
be helped by the bill, since the PTO would then have the discretion to
accept our filing and consider our application on the merits if it so
chose. But, as the PTO has noted, others in the past have had
timeliness problems with regard to Hatch-Waxman filings, and, because
people will always make mistakes, others will have this problem in the
future. Our company is the one that has stumbled, inadvertently, into
this legal pothole. But that does not change the reality that the
pothole ought to be fixed. Most laws passed by Congress benefit some
companies and disadvantage others--that is just a fact of life. If
there is any difference here, it is that most of the beneficiaries of
this law will be found in the future and no one is likely to be
disadvantaged.
Going to court. Finally, some have said to me that we should just
file a lawsuit rather than advocating an amendment to Hatch-Waxman. But
that course of action would fail in fundamental ways that I care about
a great deal. First, there is a bona fide public policy problem here.
This really is not just one company's concern. The immense
disproportion between a relatively trivial mistake and the enormous
consequences that flow from it is just not right--not for us and not
for any other companies that follow in our wake.
In addition, I care deeply about pursuing the promise of Angiomax
to heart and stroke applications, which as I have explained, we will
not be able to do absent patent term restoration. As I said at the
outset, I am not just a businessman, I am also a doctor. I have made a
lifelong commitment to improve patient care, and I would hate to let
that promise go unexplored. Money that we might recover in a lawsuit
would be useful to the company, but it would not save a single life. So
that is not the answer to this problem even for us, much less for
future patent owners.
conclusion
In summary, this is a small but important piece of legislation. I
think the answer to the question I posed at the start of my of my
testimony--whether the benefits of the bill outweigh the benefits of
the status quo--is clear. H.R. 5120 would provide palpable benefits
both to innovators and to patients in a manner that is fully consistent
with patent law and practice. The only harms identified--a negligible
effect on certainty and the loss of an unintended, unplanned and
unearned windfall for generic manufacturers--in my judgment are
definitively outweighed by those benefits.
Mr. Chairman, I have been impressed by the thorough and diligent
manner in which this Subcommittee has carried on its work. I hope that,
with a single-minded focus on the public interest, the Subcommittee
will see fit to move the bill forward toward ultimate enactment.
Thank you very much and I look forward to your questions.
Mr. Smith. Thank you, Dr. Meanwell.
Ms. Jaeger.
TESTIMONY OF KATHLEEN JAEGER, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, GENERIC PHARMACEUTICAL ASSOCIATION
Ms. Jaeger. Chairman Smith, Ranking Member Berman and
Members of this Committee, my name is Kathleen Jaeger, and I am
the president and CEO of the Generic Pharmaceutical
Association. On behalf of GPhA and our 130 members, I want to
thank you for convening this hearing and allowing GPhA to
express its views on H.R. 5120.
Mr. Chairman and Members of this Committee, what we are
essentially discussing here this morning is playing by the
rules and whether Congress is willing to turn its back on the
rules because one company decided it just didn't want to play
by those rules.
The fact is that Congress established specific criteria in
both title 1 and title 2 of the Hatch-Waxman amendments on how
brand and generic pharmaceutical companies should operate when
in the Hatch-Waxman system, including how and when a brand
company could apply for a patent term extension, or a PTE.
Congress worked hard to ensure that they established a
system that addressed two competing yet equally important
goals: encouraging innovation and expediting the public's
access to more affordable generic medicine. The system was
designed to foster both goals, and a process was put in place
that hundreds of companies have been following since 1984.
As with any system, the Hatch-Waxman system is replete with
rules and deadlines. And they need to be followed to achieve
these important public health goals. In the case of The
Medicines Company, it simply chose not to follow the rules that
says there is a deadline for submitting the PTE application.
And now it is asking for a change of the rules because it
didn't follow them.
Mr. Chairman, that is simply not the way the system works.
We all know the rules, and we all know that if we don't play by
them we could be benched, we could be penalized or lose an
extraordinary opportunity.
Congress cannot create a system where if a company misses a
deadline it can come running to Congress to fix it. If that was
the case, I daresay this Committee would have an even busier
hearing calendar than it does now.
For example, several brand companies have lost the
opportunity to secure a 30-month automatic stay under title 1
of Hatch-Waxman because the brand companies failed to file a
lawsuit against a generic patent challenger within the
statutory mandated 45-day deadline.
Likewise on our side of the industry, a generic company is
eligible for 180 days of generic exclusivity provided that
among other things, the company is the first to file a generic
application with FDA that contains a paragraph four patent
challenge. If another company files 1 day after the first
generic company filed its application, that subsequent firm
gets nothing because those are the rules.
If Congress approves this legislation, rules go out the
window. You would basically be saying that the deadlines don't
mean anything. Under this legislation, the PTO would be given a
discretion to accept a P.T. application filed up to 5 days
after expiration of statutory deadline. And by its terms, this
bill would have the practical effect of automatically extending
a deadline to 65 days.
This extension not only undermines the intent of Congress,
it ultimately delays the ability of more affordable generic
drugs to be brought to consumers. And this Committee needs to
ask itself what happens when some other company misses the new
deadline and files on day 66. Do we extend the deadline again?
And what are the consequences to the health care system when
several of the Hatch-Waxman system deadlines get extended and
the system unravels?
Now, this legislation has been labeled, ``Sorry I am Late,
the Dog Ate My Homework Act,'' by Citizens Against Government
Waste. While this label is quite amusing, there is nothing
funny about the consequences of this legislation. It isn't as
simple as saying my dog ate my homework.
This is a major change in the law with enormous negative
implications, a change that would offset the delicate balance
Congress created under the Hatch-Waxman Act between the brand
and generic pharmaceutical companies. That balance has
stimulated pharmaceutical innovation while ensuring that
consumers are able to receive safe, effective and affordable
medicines in a timely manner.
In the end, statutory deadlines have meaning. They have
consequences. Allowing 5 extra days to file a patent term
extension application renders that deadline meaningless and
treats certain patentees differently than everyone else who
respects statutory deadlines. And all to the benefit of one
company who by its own inactions failed to file a simple form
within the statutory timeframe.
Mr. Chairman and Members of this Committee, we thank you
for giving GPHA the opportunity to present our concerns about
this legislation. This legislation opens a Pandora's Box that
simply should not be opened because one company didn't get its
paperwork done on time. Thank you.
[The prepared statement of Ms. Jaeger follows:]
Prepared Statement of Kathleen Jaeger
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Mr. Smith. Thank you, Ms. Jaeger.
Professor Thomas.
TESTIMONY OF JOHN THOMAS, PROFESSOR OF LAW, GEORGETOWN
UNIVERSITY LAW CENTER
Mr. Thomas. Thank you, Mr. Chairman and other distinguished
Members of the Subcommittee. I am pleased to testify today on
my personal behalf. My views are my own rather than those of
Georgetown University or other institutions with which I am
affiliated.
The Hatch-Waxman Act represents an effort to refine within
the pharmaceutical industry the central problem of any
intellectual property regime: encouraging the labors that lead
to innovation on one hand and disseminating the fruits of those
labors on the other. Thus the Hatch-Waxman Act created an
expedited generic marketing approval protocol, but also called
for term extensions for patents on approved drugs.
Patent term extension is unquestionably a fundamental part
of the Hatch-Waxman Act, a statute that for all its perceived
flaws has been highly successful in both encouraging the
generic drug industry and promoting the discovery and
development of new drugs by brand name firms.
As the Committee considers modifications to the 60-day
period provided by section 156, the term extension statute, a
few basic subjects and points may be worthy of review.
First, the Federal circuit has long interpreted the 60-day
deadline strictly. Its 1989 decision in Unimed v. Quigg held
that an NDA holder was not entitled to patent term extension
even though it filed promptly after having the drug cleared by
the Drug Enforcement Administration.
It held that, in fact, the date for term extension
calculation was the FDA approval date, which had occurred more
than a year before. It is a 17-year-old case, and I simply know
of no other circumstance during that period in which anyone has
come to Congress requesting a term extension.
Second, U.S. PTO regulations already provide some
flexibility in meeting the deadline standards. And so, there is
already some ability for NDA holders to follow an expedited
application that can then be filled out.
Third, term extension determinations do not entail merely a
ministerial calculation. The filing of an application for term
extension potentially triggers a fairly elaborate proceeding
potentially involving the USPTO, Secretary of Health and Human
Services, Secretary of Agriculture, the patent proprietor and
third hearings--third parties. There may even be an informal
hearing to discuss qualifications for the term extension.
And that somewhat distinguishes this case from other sorts
of deadlines that the USPTO deals with, for example, responding
to an office action. So ensuring that these deadlines are met
promptly would arguably serve important administrative goals.
Finally, it is true that some deadlines of the USPTO can be
waived or extended. Though, of course, many of those extensions
entail third party rights, for example, user rights in favor of
those who may have a reliance interest on the expiration of
diminution of patent rights.
As you know, the Patent Reform Act of 2005 retains the 1-
year deadline. Anyone who discloses an invention more than a
year before filing forfeits their patent rights. And that is a
provision that can work very hard against independent inventors
and small firms.
The Hatch-Waxman Act is replete with deadlines that impose
even tighter timeframes. A brand name firm has to file a patent
infringement suit within 45 days of receipt of notice of a
paragraph four ANDA, otherwise it loses its entitlement to a 3-
month stay by the FDA.
On the generic side, a paragraph four ANDA applicant who
files 1 day after another such applicant potentially loses its
entitlement to a 180-day period of generic exclusivity. So
there already are a lot of tight deadlines and even shorter
deadlines in the Hatch-Waxman Act.
Now, in view of those principles, allow me to offer a few
observations.
First, one question is the extent of the problem. How many
times has this occurred? Is this a recurring issue or one that
we think might change?
Second, what is the standard for the USPTO to resolve
whether there ought to be an extension or not? The statute
right now says the delay in--or the bill says that whether the
delay in filing the application is unintentional.
I am sort of reminded of Aristotle and the Nicomedian
ethics. No one can suffer injustice voluntarily because no one
can wish to be harmed, Aristotle says. Well, if that is so,
what does this mean? Is this an automatic 5-day deadline for
everyone? If that is so, better just to change the period to 61
days, 65 days or something else.
If, in fact, the USPTO is supposed to do a malpractice
style inquiry, I would suggest this is not a situation where
the USPTO is well suited. And it ought to retain its core
responsibilities.
There are a lot of other section 156 issues that seem to me
to be more compelling. For example, the applicability of patent
term extension to combination therapies. And the Committee may
wish to consider that.
Thank you again for the opportunity to submit this
testimony. I would be delighted to answer any questions.
[The prepared statement of Mr. Thomas follows:]
Prepared Statement of John R. Thomas
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Mr. Smith. Thank you. Thank you, Professor Thomas.
And let me say this is the first panel where every witness
has kept within their 5-minute limit. So that is appreciated.
It is appreciated in part because we have a Judiciary Committee
bill on the House floor right now. We are actually trying to
expedite this hearing.
Mr. Dudas, let me direct my first question to you. The PTO
has had under consideration for 4 years now a request by The
Medicines Company for reconsideration. You have also said that
the statute is clear and you have your hands tied. Why is it
that the PTO has not acted in 4 years on the request by The
Medicines Company?
Mr. Dudas. Thank you. We have acted within 4 years, and I
will explain.
This is a rather administrative procedure back and forth
between the USPTO and other agencies, the FDA and Department of
Agriculture. But that question came up in my mind as well. How
many of these do we have that are over 4 years old? How long
does this process take?
I talked to the woman who is in charge of this process. The
average time period is a little bit over 3 years. It is a
series of back and forths with the FDA and the Department of
Agriculture. We now have 30 cases. I have a list of them that I
had compiled--30 cases where they are active over 4 years old.
The second question is, well, do we want things to be
active for 4 years. We are very careful in every case measuring
everything at the USPTO to make certain we protect rights.
Mr. Smith. And you are just as careful in issuing patents
as well, right?
Mr. Dudas. Absolutely, absolutely. And so, the answer to
that is basically both referred to it here. These are patent
term extensions. The date that really matters is when the
patent term originally expires. So you look at this case. It is
the year 2010, 2015, et cetera.
Mr. Smith. Yes, right.
Mr. Dudas. So the back and forth--certainly, if we get
close to that time period we accelerate the process.
Mr. Smith. Okay. Thank you, Mr. Dudas.
Mr. Dudas. Sure.
Mr. Smith. Dr. Meanwell, this is a particularly litigious
society that we have today. I am sure there are any number of
plaintiff's attorneys who would be happy to file a malpractice
suit, contingency fee or not, on your behalf. Why haven't you
simply resorted to those means and filed a malpractice suit?
Mr. Meanwell. Mr. Chairman, a lawsuit won't solve this
problem. We will still be left with the underlying pothole in
the law. I think there is a real policy problem to solve here.
Of course, I would like the money. The money would be
useful to help me build my company. But it wouldn't save a
single life. I don't think at this stage that a lawsuit is
going to move any of us forward. Certainly, it is not going to
move forward the well-being of any patient.
So for us, at this point, we would rather come here and
debate the merits of fixing this hole in the law than suing our
law firm.
Mr. Smith. Okay. Thank you, Dr. Meanwell.
Ms. Jaeger, you said in your written and opening statement
that severe harm would be caused to both consumers and
taxpayers if this legislation were to be passed. That is in
distinction to what Dr. Meanwell has said where he said that
actually consumers would be benefited by having an extension to
the patent.
You made that assertion. Can you support it with evidence
that consumers and taxpayers would be harmed by passing this
legislation?
Ms. Jaeger. Absolutely, Mr. Chairman.
There are two issues here. The first one is the broader
piece on harm having to do with the statutory framework of
Hatch-Waxman. As I said in my testimony, the Hatch-Waxman
system is a very complex system. And it is based on an
intellectual property-based generic approval system. In that
system, there are numerous rules and deadlines.
We were very concerned that with respect to this particular
issue we start moving deadlines, they start to be very clouded.
We do not, well, actually we will not have a system. The system
will totally unravel to the detriment of the generic industry
and to consumers. These deadlines need to be met, and they need
to be there for the administration of the orderly conduct of
all parties in the system.
Mr. Smith. Right. But wouldn't consumers be benefited by
the continuing research and development of additional benefits
that might accrue from this particular type of drug? And would
that be halted by The Medicines Company not getting their
extension or reconsideration?
Ms. Jaeger. I think the broader issue is that the rules
need to be followed is more imperative to consumers. Again, we
have had situations where other deadlines in the Hatch-Waxman
system have been missed by brand companies even by 1 day. Yet
they did not get the benefit and the opportunity of that other
provision.
And again, it goes to the benefit of consumers and ensuring
that everyone plays by the rules. And in this instance, what we
are talking about also, getting down to more of a specific
issue, is we do have a situation where the patent will expire
in 2010.
Our members do a lot of research and development many years
prior to bringing a generic to the marketplace. They rely on
that information that has been posted. They are relying on the
information that the PTE extension has been rejected. They have
made business decisions on reliance on that decision.
Mr. Smith. Okay. Thank you, Ms. Jaeger.
Professor Thomas, would you respond to two issues that I
brought up so far, that being the possibility of and the
advisement of filing a malpractice suit? And second of all,
whether you think real harm is being done to consumers if we do
not grant discretion to the patent holder.
Mr. Thomas. Yes, sir. The malpractice suit is part of
patent practice. As someone who used to spend his time
prosecuting patent applications, my experience was the
docketing clerk was the most important colleague I had. And he
would come and tell me, ``Look, you have got a deadline up
here, and it is irremediable.''
And so, any first-year associate at a patent law firm is
advised about this in no uncertain terms. And you can read the
law books. They are full of malpractice cases where regrettably
deadlines have been missed. So that has traditionally been the
method of compensation for those who have missed deadlines.
Alternatively, shareholder suits against company management----
Mr. Smith. And what about harm?
Mr. Thomas. Harm to patients?
Mr. Smith. Harm to consumers if extension is not granted.
Mr. Thomas. Well, we are deciding here, I guess,
essentially is wealth transfer between patient populations that
will pay lower prices for generic versions of drugs versus, you
know, surplus that would go to the firm due to its super-
competitive profits that are based on a patent. Harm to
patients, it is hard to say. We have already got this
medication in hand.
But the patent law is about incentives. We have got the
patent in hand. The question is how The Medicines Company
chooses to use its resources and whether, in fact, it is the
best actor to further develop this medication.
Mr. Smith. Okay. Thank you, Professor Thomas.
The gentleman from California, Mr. Berman, is recognized
for his questions.
Mr. Berman. Well, thank you, Mr. Chairman. I guess I have a
set of questions for Dr. Meanwell and Ms. Jaeger.
Ms. Jaeger, I thought maybe your testimony went a little
far in saying that the company chose not to meet the deadline.
My guess is they don't feel they chose not to meet the
deadline. Somebody screwed up big time. Maybe somebody at the
company screwed up by not watching who was in charge of not
screwing up. And bad things happened. And this is clearly a
case.
But the central public policy point from not the company's
well-being or the shareholders' well-being--but, Dr. Meanwell,
when you came a long time ago, I think it was, to my office,
you made the point, which you have repeated here, that not
having what was your settled expectation regarding the delays
caused by the FDA and added on to your patent term is going to
keep you from investing the funds to do the trials and the
research in the trials to find where you think there are
beneficial uses from this drug or some slight variation of this
drug and that you believe that that is the real harm to the
public in a way that you see, apart from your own interests,
your company's interests, your shareholders' interests, that a
new use of this drug will be precluded.
And I guess what I am asking is you originally developed
Angiomax based on raising funds to do the research and trial
runs for the blood thinning use that it is now used for. Why
can't you do that same process for the new uses of this
particular drug, even though I recognize a huge amount of
revenue, if nothing changes, is going to be lost to you by not
having what was your settled expectation of exclusivity?
And maybe, because my time might run out, let me just ask
Ms. Jaeger very specifically. Apart from all the generalized
talk, what generic drug company thought that this patent term
would expire 4, 4\1/2\ years earlier than you would have
normally assumed and has made an investment based on what
didn't happen on the 60th day to produce an alternative that is
going to end up in a lower cost drug?
I would like you to be specific about your members that you
sort of generalized have made investments based on their, what
you claim to be, their settled expectation of when this thing
would come on the market, especially given that at least for,
it seems like, years, but maybe it is only two since there has
been a great deal of public discussion about this issue that
would unsettle anyone's expectations about anything.
So those are my two questions.
Mr. Meanwell. Thank you for the question. Indeed, there has
been quite a lot of public disclosure about this. It is not so
much the loss of money and revenue, Mr. Berman. It is the loss
of time that is the critical component in research here.
By not having the extension that we had expected, I cannot
launch the kind of programs that are required today to prove
that this drug, to my satisfaction, to the satisfaction of the
FDA, to the satisfaction of doctors and their patients, will
meet the needs of patients with, for example, stroke or
undergoing open heart surgery. I need several years to do that
in.
It was our plan that we would follow--and this is not
unusual for hospital products--the initial research program
with the FDA.
Mr. Berman. Explain that to me.
Mr. Meanwell. Yes, sir.
Mr. Berman. Why does the fact that the patent will expire
in 2010 if nothing is done have anything to do with the time
needed to run the clinical tests to determine if there are
other uses?
Mr. Meanwell. Because, sir, if I start the trials today--
and some of them have preliminarily started--and then we held
it, I would have 2, 3, 4 years to do it, 1 year to get it
through the FDA and, at that point, would happily hand over
those indications to my colleagues in the generic industry. I
would not benefit from them at all. And I simply don't have
time to get them done.
Mr. Berman. Don't you need a patent for new uses of----
Mr. Meanwell. No, sir. But I need an FDA approval in order
to promote those new uses, and I don't have that today. I need
to work hard to get a new indication for the drug beyond its
existing use. And I don't have time to do that unless the
patent term is restored, which, of course, is what under Hatch-
Waxman we believe we had earned in the normal way.
So our expectations were to get that. We set our programs
up sequentially. We now cannot pursue that research in what
looked like very promising new indications in important
illnesses.
Mr. Berman. Thank you. I have to say, I think it is me, but
I am not fully understanding why. But just to get my second
question answered----
Ms. Jaeger. May I just add, Ranking Member Berman,
regarding that issue, is that a number of companies, a lot of
brand companies, do actually pursue their brand products to
subsequent clinical trials and do get new indications of use.
When they do bring those indications of use, and the Food and
Drug Administration does approve those new indications of use,
they will get 3 years of exclusivity under the Hatch-Waxman
system.
At the same time, there are also generally speaking, on
average, there are also some patents that also will be issued
protecting that particular product for that new indication of
use. Generally speaking, there will be new I.P. protection for
those new indications of use as they bring those products to
the marketplace.
As to your question, I cannot sit here and tell you
specifically one company, or if there are 10 companies in our
industry. Unfortunately, our pipelines, our companies'
pipelines, are proprietary information.
What I can tell you is what they do utilize for business
decisions and that is the CEOs and their R&D teams are looking
at what we call the Orange Book, which is a publication by FDA
that puts forth all the products as approved by FDA, the market
exclusivity that is generated that protects the brand company,
the 5 years to 3 years, as well as all patents that the brand
company claimed this particular--that claim to protect this
particular product and that are eligible for listing in that
system. We look at those patents based upon that information,
we then turn around and make business decisions on what
products we will start our R&D investment on.
A 2010 product is something our companies are considering
and have been considering for many years. That is something
they are now looking at and will bring a product through the
appropriate R&D process and do the necessary application
process to have something ready to go when that, when that
patent expires in 2010.
Mr. Berman. --perhaps 10 generic drug companies are
spending money on research in developing this generic product
in the hope that one of those 10--each one of those 10 will be
the first guy to file that thing and get the 180 days
exclusivity? That seems like high-risk ventures.
Ms. Jaeger. No, there is two different issues here in
Hatch-Waxman. What happens is there is a patent challenge
process. And what the patent challenge process is, that
Congress, in their wisdom, basically said the brand companies
are to file all patents they deem that claim that particular
drug product with FDA.
If there is a patent that gets filed with the Food and Drug
Administration that a generic company believes is either filed
wrongly, or it is frivolous, or it is questionable, meaning
that they believe their product will be outside the scope of
that patent, then they will file a paragraph four challenge,
which means they are challenging the patent. And then we go
into a very complicated Hatch-Waxman patent challenge process.
However, if a generic company looks at a patent and believes it
is valid, it may not challenge it.
What the companies are going to do then is under the
statute file a paragraph three patent certification, which
basically says to the Food and Drug Administration, we will not
be seeking approval until that patent expires. But indeed,
these companies are looking at the patents. They are looking at
the market, and they are making determinations many years prior
to the patent expiring.
As you imagine, our generic companies want to get FDA
approval the day the relevant patent expires. So they are going
to back in at least 2 years of FDA review of a generic
application, which is 2008.
Their application has to be in by 2008. We are in 2006 now.
That means a lot of R&D work has to be done now or could have
been done last year as well.
So our systems are, we back in from where patent expiration
and the market exclusivity periods will expire. We back in at
least 2 years for FDA review of a generic application. And then
we back in our R&D schedules.
Mr. Smith. Thank you, Mr. Berman.
The gentleman from Tennessee, Mr. Jenkins, is recognized
for his questions.
Mr. Jenkins. Thank you, Mr. Chairman.
Mr. Dudas, you mentioned several instances in which relief
can be given for the late payment of fees, late filings or
deficient filings. I have been told that there may be as many
as 30 instances under our patent law in which this is the case.
Is that a pretty accurate number of cases where relief can be
given for late filings?
Mr. Dudas. We have not compiled each and every one of them,
but that seems very much a reasonable estimate of how many
there are.
Mr. Jenkins. Now, well, let me ask Ms. Jaeger.
Ms. Jaeger, you have been in law school much more recently
than I have. But my memory is--and I am sure you will correct
me if I misspeak--but in England, there was a court known as
the keeper of the king's conscience. What was it, exchequer
came to us in our country as the chancellory system. And it was
basically a system where there was no laches adequate remedy at
law. And it brought with it the doctrine of--now, I am not
recommending that be applied in this instance.
But I would ask you with the prospect of this particular
medicine--and it has not been denied, and there is ample
medical evidence that the prospects for it in the treatment of
strokes and heart disease are very promising.
So I would ask you, what is wrong with 30 instances under
our patent laws where relief can be given, what is wrong with
us departing from the rigidity that you stick with and going to
a more humane situation where we can go ahead, this company can
spend those tens of millions of dollars that they spoke about
and get on with the prospect of benefiting?
You know, some of us--and you may feel this way when you
get older, but some of us have family backgrounds that kind of
indicate that we need to be on the lookout for strokes coming
on one of these days. And millions and millions of Americans
would welcome any prospect to have their prospects for the
future improved.
So what is wrong with us departing from rigidity? We
already have flexibility in the law in, I say, at least 30
instances. So what is wrong with us departing and seizing this
opportunity that we have? We seize too few in this country in
advancing genuine and good. We seize many, but there are many
that we miss.
What is wrong with us departing from rigidity and going to
a more humane system? Would you not, would you not be an
advocate of a--and perhaps we are the keeper in this instance
of the king's conscience. And so, would you fault us then if we
went to a more humane system?
Ms. Jaeger. To that question I have three points. And I
think the first point is, it is quite important that with
respect to the PTE filing deadline, it is truly consistent with
other substantive statutory provisions that establish deadlines
for patentees seeking to expand the scope or lengthen the term
of the patent.
For example, a patentee seeking to enlarge the scope of the
claims in the original patent by invoking PTO's reissuance
proceedings must apply within 2 years from the grant of the
original patent. Likewise, a patentee seeking to claim priority
to the date of an early filed foreign patent must file with the
U.S. within 12 months of the earliest day on such foreign
application was filed. And these governing statutes do not
allow PTO to extend those deadlines much like the PTE
applications.
And then, too, these statutes don't have what we call
equitable tolling provisions. Now, GPHA is not supporting nor
endorsing the concept of moving forward an equitable tolling
statute for this particular situation. But even assuming that
there was an equitable tolling statute here, this situation
would not rise to that level.
Unfortunately, it is an administrative error. An
administrative error would not rise to a level of inequitable
conduct, in an equitable tolling statute, much like that for
the Federal circuit, and there we are talking about the Federal
rules of civil procedures, which state a failure to take the
proper steps at the proper time not in consequence of the
party's own carelessness, inattention or willful disregard of
the process of the court but in consequence of some unexpected
or unavoidable hindrance or accident or reliance on the care of
his counsel or a promise made by an adverse party. In that
situation, we apply just a general equitable tolling statute or
this particular civil rule of procedure.
Under either scenario, this situation doesn't rise to that
level. And therefore, redress was not appropriate. We do
believe--my third point is that redress should not be found
here with respect to a retroactive amendment, but that there
are other recourses that the company can pursue outside this
Committee.
Mr. Smith. Thank you, Mr. Jenkins.
The gentleman from Massachusetts, Mr. Meehan?
Mr. Meehan. Thank you, Mr. Chairman.
And to the Ranking Member, thank you very much for putting
this hearing together. I think we all can agree that somebody
didn't file a form on time, whether it is incompetently or--I
doubt they intentionally didn't file it. And I can only assume
that whoever failed to file is somewhere in an unemployment
line somewhere.
I am interested--because we all agree it wasn't filed on
time. And we could go on and on about that, although I am--it
is interesting how when we have a Conference Committee how we
reach these magical numbers, whether it be 50 or 60 or 45. I
can assure you it is usually the House wants one number, the
Senate wants another, and we split the difference in the
middle.
But in any event, I think it would be important, Dr.
Meanwell, just for the record, that you could talk about the
public health benefits of this drug and what it means for the
future. Because I really haven't heard it for the record here.
And if you could do that.
Mr. Meanwell. Yes, I will do that. I would like to also add
something I said to Mr. Berman, which I missed in my attempt to
be brief. But let me first get to the point of the drug.
This is an intravenous blood thinner. It is a very unique,
high-technology product. It is one which has proven in heart
procedures called angioplasty to be highly effective and to
substantially reduce the risk of bleeding among these patients.
Typically patients today are receiving a mix of powerful blood
thinners in a hospital intravenously. And the big risk is
bleeding. And the other big risk is having a heart attack. And
then there is a minor risk, if you wish, of dying.
This drug has reduced all of those: bleeding, dying and
heart attacks relative to the alternative therapy, which in
this case is heparin, which is a 60-year-old product made of
pig intestines and which has a lot of side effects, most
notably, bleeding and allergies. We have basically knocked out
all of those issues.
Now, we found in the course of our research in coronary
angioplasty that doctors started to try to experiment with the
drug in stroke and cardiac surgery. One report from a doctor
described this drug as--and I quote, and I am willing to put
this into the record--``the holy grail of drugs for cardiac
surgery in patients who are allergic to heparin.''
We cannot complete that research right now because we don't
have the money, the time, the incentive that Hatch-Waxman
originally saw we would and which we expected to get but for
our error in filing.
As far as stroke is concerned, it is one of the biggest
causes of death in Americans today. It affects all ethnic
groups, particularly African-Americans, as we know. It is a
deadly disease, of course, and something that really needs to
be worked on. We have shown that this drug in preliminary
trials can enable the positioning of the carotid stents, stents
in the neck to prevent stroke better than any other product
that is currently out there. Most experts believe this is a
drug that should be developed extensively in that situation.
Mr. Meehan. Thank you.
Secretary Dudas, I want to make sure that I understand the
current law correctly. As I understand it, an application which
contains a number of technical errors submitted on time within
the 60 days can be returned to the applicant who has a number
of months to correct these mistakes. But a perfectly filed and
complete patent resolution application mistakenly filed 1 day
late--and I have been counting how many days have--how many
months have 30 days and how many have 31, which apparently is
part of the problem. Do you know quickly how many have 30 days?
Mr. Dudas. I have to count it on my hand.
Mr. Meehan. Right. But I am interested is that case. In
other words, in other words, if you file an application with
mistakes on time, can you make corrections?
Mr. Dudas. Yes, you can.
Mr. Meehan. How does that work?
Mr. Dudas. Well, there is a variety of different instances.
Mr. Meehan. So, in other words, so even if somebody files
with mistakes, as long as they file within the 60 days, they
will get a period of months to correct those mistakes?
Mr. Dudas. There is an opportunity to correct mistakes in
some cases with applications and also in other areas in the
office, yes.
Mr. Meehan. Do you, do you believe that PTO can waive the
60-day filing requirement on its own inherent authority? Or is
it your belief that an extension must be legislated through a
measure such as H.R. 5120?
Mr. Dudas. It is our belief that it would have to be
legislated.
Mr. Meehan. Do you agree with the discretionary authority
in 5120? Do you agree that it is similar to other deadline-
extending provisions presently in patent law? And if so,
approximate--well, I think the question was asked. But you said
maybe 30. But you agree that there is already discretionary
authority with other deadlines?
Mr. Dudas. There is definitely discretionary authority with
some other deadlines. And this is not in some way that we find
to be fundamentally inconsistent with some of the other
deadlines.
Mr. Meehan. Okay. So there are other deadlines that it is
okay, this discretion that you guys have? There are other
mistakes that are filed that somebody has a period of months to
correct. Would you agree with the description of H.R. 5120 that
the bill simply gives the PTO the discretion to review a patent
term restoration application filed a few days late to determine
whether that filing was delayed intentionally? Would you agree?
Mr. Dudas. I think that is correct, as I read it. It would
depend on what--and I am not familiar with the legal standard
of unintentional. And we have folks in our office that could
determine, whether or not it would be automatic. But the bill
on its face says discretion to determine whether it is
unintentional.
Mr. Meehan. Would you agree that the legislation doesn't by
itself add any additional patent term restoration?
Mr. Dudas. The bill itself does not add any patent term
restoration.
Mr. Meehan. Finally, some people have characterized this
bill as automatically extending--I heard some of the witnesses
say that it automatically extends the 60-day filing deadline by
5 days. Do you agree with that?
Mr. Dudas. I think the only way that would be true is if
the term unintentional--no, it can't be that, because if
someone did it intentionally it wouldn't be automatic, either.
So I think a lot depends on the standard of unintentional. But,
no, there is at least that standard there.
Mr. Meehan. And I read it, and I share Mr. Berman's
feeling. I read the material from you, the letter from you. One
thing I think we can be clear is the PTO doesn't have any
reason to oppose this legislation. Is that correct?
Mr. Dudas. From a PTO perspective, an administrative
perspective and an ability to carry it out, no, we don't have a
reason to oppose.
Mr. Meehan. Thank you, Mr. Chairman.
Mr. Smith. Okay. Thank you, Mr. Meehan.
I am going to ask, Mr. Dudas, you another question and in
doing so, give other witnesses, if they so desire, an
opportunity to answer the question as well. And what I am
trying to do here in asking a question about precedent is to
find out exactly what the facts are, and be a little bit more
specific when we talk about those precedents.
I have a list in front of me which may or may not be
entirely comprehensive of all the instances where discretion
has been allowed in the case of unintentional mistakes. And so
far as I can see from this list in front of me, which, as I
say, may not be completely extensive, is that in all the
instances where discretion has been allowed in the case of
unintentional mistakes that deal with the statute as opposed to
PTO rules generally fall into two categories: discretion being
allowed in the case of late fees and discretion being allowed
in the case of failure to reference earlier applications.
Clearly, discretion in those instances don't rise to the
level of significance of discretion in the case of extending a
patent. Do you know of any instance where there would be a
precedent directly on point where discretion would be allowed
in the case of an unintentional mistake dealing with the
approval of a patent and dealing with discretion being allowed
in the case of the statute as opposed to PTO rules?
Mr. Dudas. I am not aware of that, but I would give the
following caveat that we have in our deputy office of
operations and policy within Patent and Trademark Office--I
would like to follow-up----
Mr. Smith. Okay. It would probably be useful to the
Committee to realize two things. One, most of the discretion
that is being given is of relatively minor infractions or
deadlines dealing with PTO rules, not the statute. And if you
have any case in point, I think that would be helpful. But
there is precedent perhaps on both sides. I just haven't seen
the precedent yet on the side of extending a patent.
Dr. Meanwell, do you have any examples you could give? And
then we will ask Ms. Jaeger and Professor Thomas.
Mr. Meanwell. I would like to say that the hard and fast
deadlines that we have reviewed--and I am no patent attorney,
so I am----
Mr. Smith. Neither am I.
Mr. Meanwell. The ones that seek to expand the scope of a
patent, the breadth of the intellectual property, are indeed
often hard and fast. I know at least of three. In fact, they
were mentioned earlier, I think, 102-B, 251 and 119-A are the
things related to establishing a patent, either here or in
foreign territories. But actually, that is establishing new
grounds for a patent. That is establishing the breadth of a
patent.
Here we are talking about the time life of a patent. We are
not talking about the breadth of the patent in any way. The
breadth of the Angiomax patent will remain exactly the same.
And one of the things I should have said to Mr. Berman is
that that means that we are not looking for a new patent to do
what we are doing. We are hoping to use this one as long as we
need. And we will need to invest $100 million to do so. So we
obviously would like to recoup that with exclusivity
thereafter. So just to clarify.
But there are certainly situations where expanded the scope
of a patent is hard and fast. But this is a procedural
situation, in my opinion, not expanding the scope of the patent
in any way. And by the way, the revision here would not in any
way give us a single day more on our term than would be
normally envisioned under Hatch-Waxman. And, you know, frankly
for such a Draconian penalty to be hammered out for the sake of
this dumb mistake, we feel would be, would be inequitable.
Mr. Smith. Okay. Thank you, Dr. Meanwell.
Ms. Jaeger or Professor Thomas, any precedents to cite or
examples to give?
Mr. Thomas. Mr. Chairman, I believe the most apt analogy
would be with respect to maintenance fees, which may well be
the first element on the chart you have referenced. As you
know, the patent 20-year term is not automatic. You have to pay
periodic annuities essentially to the patent office to retain
the term and the 3 and-a-half, 7 and-a-half and 11 and-a-half
years from the date of issuance. Some of those deadlines aren't
met, so there are provisions for coming in late and asking for
your patent to be maintained in a sense, sort of a term
extension.
Mr. Smith. You are right. Okay.
Mr. Thomas. However, and those applications are entertained
by the U.S. PTO. However, if there is a late maintenance fee
accepted, that gives some right with respect to third parties
that are rather vaguely defined by the statute, for example,
something that would be akin to the first inventor Defense Act,
which you are considering modifying to encompass all sorts of
inventions, not just----
Mr. Smith. Okay. Thank you, Professor Thomas.
Mr. Thomas. You are welcome.
Mr. Smith. Ms. Jaeger?
Ms. Jaeger. I just want to reiterate for the record, I know
we see three particular situations where patentees are seeking
to expand the scope or lengthen the term that do not, do not
have any discretion for PTO. And, of course, that is the----
Mr. Berman. Expand the scope.
Ms. Jaeger. Expand the scope of patent with a reissuance
proceeding or a PTE, which is extending the length of the
patent as well as, of course, you know, the foreign early filed
foreign patent provision as well.
Mr. Smith. Okay, okay. Thank you, Ms. Jaeger.
Let me explain to the panelists that I have to leave for
another engagement. I am going to ask the gentleman from
Tennessee to chair the rest of the hearing. And thank you all
again for being here.
Mr. Jenkins. [Presiding.] Mr. Berman, were you finished?
I am sorry. Go ahead.
Mr. Berman. I was just interrupting somebody else.
Actually, now I understand, Dr. Meanwell, you are not
seeking a new patent. You will need to get FDA approval for the
new uses. You won't need to get a new patent. And it makes a
heck of a difference whether it expires in 2010 or 2014 whether
you have some exclusive period for marketing this drug that FDA
would have approved for additional uses. Okay. I have got it.
It is not about a new patent.
Professor Thomas, you made a point in your initial
testimony. I forget exactly how you put it, but a policy reason
perhaps to not provide discretion in this provision is because
it implicates not just the patent office, but the Secretary of
HHS and the head of FDA and the Secretary of Agriculture. And I
don't know what other agencies you mentioned.
But realistically, what is the difference if under the
limited nature of this extension in terms--I am trying to
understand why is that a policy argument against doing it when
in the limited nature of the relief proposed in this
legislation.
Mr. Thomas. It is a good point. It is only 5 days. But it
does create a lot of reliance interest upon other actors. And
that is something that is not as commonly the case with other
missed PTO deadlines. So in short, there are a host of actors
out there that have to engage in a fair amount of steps.
Another distinction that may be salient to you--and again,
let me first once more acknowledge you are right about the 5
days. It is only 5 days from that perspective. But there are
any number of other deadlines that if missed are irremediable
under the Patent Act. And again, they often impact small
entities that are not sophisticated players in the patent
system. They have long been a part of our law. That really----
Mr. Berman. That are not, that are not----
Mr. Thomas. That cannot be correctable. And that is really
not the case here. Right? We are really talking about very
sophisticated actors that are well-advised. And that may be why
this is not a situation that has recurred.
One of my colleagues at Georgetown often uses the phrase
``big boys'' that I don't like because of its gender
implications. But nonetheless, do we need in a sense really a
protection statute for sophisticated actors who have just been
gifted with a watershed event for their firm, FDA marketing
approval?
Mr. Berman. Well, no, look, one cannot help but avoid the
notion that in life there are a lot of deadlines that every day
because some little person or company or whatever missed them
and opportunity was lost or harm was done and, I mean, you
can't, you can't but avoid thinking at this. And at the same
time, it is hard to avoid thinking about the enormity of, you
know--I mean, there is a disproportional aspect of what has
happened here, too, on the other side in terms of just nature
of mistake versus money lost. So I guess that is part of the
consideration.
Ms. Jaeger, my last question--in the context of, somewhere
companies in your association, unknown to you because of the
proprietary interests may have spent money, and in some cases
considerable money, thinking that notwithstanding all the
hullabaloo in 2010 this thing is coming out there and we want
to be ready to fill that void with a lower cost consumer
benefit therefore protection.
Are there situations--somebody mentioned in the context of
some other statute the maintenance fees. In the context of
things, are compensation for money spent in reliance on
something that Congress subsequently changed--is there any
precedent for those kinds of arrangements?
Ms. Jaeger. Well, I think when we are looking at this
retroactively--we are looking at this retroactive bill. And in
so doing, the job, I think, of everyone here is to sort of do
the analysis of weighing the benefits and the risks.
And here, yes, absolutely, the benefit would inure to The
Medicines Company and would provide them with 5 additional
years of market exclusivity in the United States. It is adding
to their patent that they have today, which expires in 2010. It
is not taking away their patent. It is just going to extend the
terms of that particular patent and give them this
extraordinary benefit.
At the same time, the burden that would be placed on our
industry would be that we relied upon the 2010 patent
expiration date. We went through and did some performance
research and development, which costs money from our industry
side.
At the same time, we also have a downstream effect of the
others in the health care distribution channel, which are the
insurers and the PBMs and the consumers, that have relied upon
that date as well for forecasting and in trying to figure out
what health insurance premiums will be in 2010 and the like. So
this does have a negative implication downstream in the health
care distribution channels.
At the same time, among the broader issue, we are just very
concerned about the many, many deadlines in Hatch-Waxman. And,
you know, we say, we all hope to move the deadline to, 65 days.
When we get to another situation when someone comes in at 67,
68, are we going to move it again? And then do we move the 45-
day window? And does that move----
Mr. Berman. We are very good at saying it is this time
only, never again until----
Ms. Jaeger. And we think it is a Pandora's Box that doesn't
need to be opened, sir.
Mr. Berman. Just in closing, Mr. Chairman, as I heard Dr.
Meanwell describe the drug, I realized that this fit perfectly
with what happened to my father, who died from an allergic
reaction to heparin during a heart surgery where he had to have
a blood thinner at that time. This is 16 years ago or
something. Not from the heart surgery, not from the heart
attack, but from not having--so I could personally testify
there is something valuable about what you have produced here.
And I yield back.
Mr. Jenkins. Professor Thomas, let me go back to the
flexibility that you spoke about with respect to the payment of
fees for continuation. If that flexibility was not in the law,
then this patent continuation would be just as dead as any of
the other instances that could kill its continued life. Isn't
that true? If we had the same rigidity in the law with respect
to the payment of those fees that we have, let us say, in this
instance, then that would put an end to that patent and its
continuation just as surely.
Mr. Thomas. Sir, I don't know all the facts of the case. I
am not aware of how long the patent has been extant and whether
they have paid maintenance fees or not. So in good faith I
can't answer that, sir.
Mr. Jenkins. Well, let me ask it not on a comparative
basis, but just on the basis of if the law was different and
said you had to pay these fees on time, you couldn't pay them a
day late, then your continuation would be just as dead, would
it not? It would be dead.
Mr. Thomas. That is right, if the maintenance fees were
paid late, right.
Mr. Jenkins. Okay.
Mr. Meehan, do you have any questions, sir?
Mr. Meehan. Mr. Chairman, I just want to point out on this
issue of unintentional error in standards that are, that are
used by the PTO, there is a letter in the record from Lawrence
Goffney that specifically says that the agency is extremely
familiar with the unintentional error standard that is being
proposed in H.R. 2150. Indeed, this is a standard most commonly
used by the PTO in determining whether to accept late filings
under the statutory provisions. And I would refer that to
Members of the Committee.
Just one more thing that I want to ask Ms. Jaeger. So you
can't provide us with a company that is ready to develop this
drug or has had an investment or anything of that nature?
Ms. Jaeger. No, sir, not at this time I cannot because,
again, our companies' pipelines are proprietary. As you can
imagine, they are fierce competitors. And so, it is not
something they are about to disclose, what products they are or
are not going to bring to the market in a few years.
Mr. Meehan. Right. And that is basically for some of us--
the question is, you know, what is the future going to be of
this particular drug and the advances that have been made?
It is my understanding that clinical data demonstrates that
up to 23,000 transfusions could be saved if these results move
forward, more than 1 million of these performed each year,
these procedures. So from my perspective, that is why we are
balancing interests here.
We are balancing a lawyer at a firm who messed up with what
the public health effect would be in the end. And for me, that
is a significant thing that we should weigh.
So I thank the Chairman. I just want to point out those
unintentional error standards into the record.
Mr. Jenkins. Thank you, Mr. Meehan.
Does any other Member of the Committee have any additional
questions?
Mr. Berman?
Mr. Berman. No.
Mr. Jenkins. Any?
Well, the Chairman has already complimented this panel of
witnesses. And let me add to that and say that your remarks
were very informative. Your answers were very direct and
cogent, and we certainly appreciate that.
I think that this Committee has learned quite a bit today.
I hope that we can use it to the benefit of the people across
the United States of America. It is a difficult situation.
And, Ms. Jaeger, let me say I have the utmost respect for
you and what your association members are doing. We shouldn't
let it pass without saying that your members provide a really
valuable service to millions and millions of Americans.
As I understand it, Dr. Meanwell is also on the board of
directors of a generic company. Was that brought out? Is that
true?
Mr. Meanwell. Yes, I am, sir. I am on the board of a
company that sells generics. I absolutely agree with your
remarks.
Mr. Jenkins. All right. Well, thank you very much for
coming.
And the Committee will be adjourned.
[Whereupon, at 12:35 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
Material Submitted for the Hearing Record
Statement of the Honorable Howard Berman, a Representative in Congress
from the State of California, and Ranking Member, Subcommittee on
Courts, the Internet, and Intellectual Property
Mr. Chairman,
Thank you for scheduling this hearing on a bill giving the USPTO
additional discretion to extend certain patent deadlines. While similar
measures (bills that have specifically extended the Angiomax patent)
have been attached to legislative vehicles in the past, I am glad that
this issue is finally being reviewed by the committee with jurisdiction
over patent matters. It is important that this Subcommittee be able to
analyze the impact of any changes this bill may make on the patent
system.
Patents are the cornerstone of innovation. The Constitution
provides for a limited period of time of protection in order to promote
innovation. Therefore, the patent process provides the exclusive right
for an invention (for 17 to 20 years) generating incentives for an
inventor to continue to create after which the invention becomes
available for public use. There is a delicate balance of - on the one
hand- providing enough of an incentive to the inventor to spend the
time, energy and money to create new inventions - and on the other- the
value of allowing the invention to be used by the public enabling
others to develop new products or provide similar products for lower
cost.
Therefore, when considering the effect of allowing the PTO
discretion to extend certain patent deadlines, there is a natural
tension between providing the flexibility to extend a deadline and
maintaining a hard date for specific types of filings. While providing
greater elasticity may prevent seemingly draconian results does it come
at the expense of stability in the market? There appear to be other
instances where the PTO has discretion to extend deadlines but the
situation this bill is designed to address is not among them. WHY? Is
there something different about this type of filing that the PTO should
NOT have discretion in this case?
Unfortunately, the PTO has not provided much guidance in its
response to the (letter from the Chairman and myself about the) policy
questions posed by this bill. I look forward to hearing from the other
witnesses to discuss the policy implications of this bill on the patent
system and possibly Hatch-Waxman.
Originally this legislation began as an effort to address one
particular late filing, of one patent - there has been no demonstrated
need nor request from any other patent owners to provide discretion to
the PTO for these type of filings. Moreover, from the way the bill has
been written it is clear that this bill would effect the late filing of
a particular company which occurred over 4 years ago. Some have even
suggested that the better alternative to this bill is a private bill.
However, this bill and this particular circumstance does raise some
questions about why there are inconsistencies in the discretion
afforded to the PTO to determine when filings are timely. As such I
look forward to further exploring the issues.
__________
Statement of the Honorable Elton Gallegly, a Representative in Congress
from the State of California, and Member, Subcommittee on Courts, the
Internet, and Intellectual Property
Mr. Chairman, I would like to begin by thanking you for holding
this hearing on H.R. 5120. I appreciate your interest in this important
issue. I would also like to commend Congressman Jenkins for the
introduction of this legislation.
H.R. 5120, which I strongly support, deals with what seems to be a
narrow issue in our nation's patent law, namely the question of patent
term restoration applications submitted to the Patent and Trademark
Office. However, although the change to the law is relatively minor,
the passage of this legislation would both provide greater fairness to
patent holders and encourage innovation by companies in the medical
research field and in other industries.
H.R. 5120 would amend the Hatch-Waxman Act to provide the U.S.
Patent and Trademark Office with modest discretion to accept late-filed
patent term restoration applications. In a recent letter to the
Subcommittee, the Director of the Patent and Trademark office confirmed
that under current law the PTO already enjoys discretion in numerous
instances to accept late-filed applications. However, Congress has not
given the PTO similar discretion to accept late-filed patent
restoration applications.
This strikes me, and other cosponsors of H.R. 5120, as an
unfortunate and undeserved inconsistency in our patent law.
Mr. Chairman, failure to allow an innovator that has earned patent
term restoration to qualify merely because of a clerical or other
unintentional error discourages innovation and ultimately harms
patients who rely on research into new medicines. We must keep in mind
that for a company to qualify for patent term restoration, it must
already have successfully completed an incredibly rigorous drug testing
and development regime, ultimately obtaining FDA approval of its drug.
The Hatch-Waxman Act offers patent term restoration as an incentive for
innovators to invest their time, effort, and resources in this arduous
drug development and approval process.
I can think of no area in the patent law where permitting
discretion on the part of the PTO too accept late-filed applications is
more important that in the case of patent restoration applications.
Yet, this is one area where Congress has not granted the PTO such
discretion. It is imperative that we correct this situation by the
passage of H.R. 5120.
I understand that some oppose H.R. 5120, arguing that giving the
PTO any discretion will somehow disadvantage generic manufacturers.
In my view, the Hatch-Waxman Act provides generic manufacturers
with clear, enumerated benefits. However, Congress never intended one
of those benefits to be the ability to take advantage of unintentional
clerical errors, thereby gaining years of marketing time at the expense
of innovative companies that have satisfied all of the many processes
required by Hatch-Waxman.
Mr. Chairman, I want to thank you again for holding this hearing
today.
A letter to the Honorable Jonathan W. Dudas, Under Secretary for
Intellectual Property and Director, U.S. Patent and Trademark Office
(USPTO) from the Honorable Lamar Smith, a Representative in Congress
from the State of Texas and Chairman, Subcommittee on Courts, the
Internet, and Intellectual Property, and the Honorable Howard Berman, a
Representative in Congress from the State of California, and Ranking
Member, Subcommittee on Courts, the Internet, and Intellectual Property
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
A letter to the Honorable Lamar Smith, a Represetative in Congress from
the State of Texas, and Chairman, Subcommittee on Courts, the Internet,
and Intellectual Property, in response to a letter requesting the
United States Patent and Trademark Office (USPTO) analysis and
assessment of H.R. 5120
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
A letter to the Honorable Jon W. Dudas, Under Secretary for
Intellectual Property and Director, U.S. Patent and Trademark Office
(USPTO) from Jane A. Axelrad, Associate Director for Policy, Center
from Drug Evaluation and Research, Department of Health & Human
Services in regard to the March 24, 2003 letter from Karin Ferriter
requesting FDA's assistance in preparing a response to a request for
reconsideration in the application for patent term extension for U.S.
Patent No. 5, 196, 404 filed by The Medicines Company
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
A paper on Critical Actions That Relate to The Medicines Company
Application for patent Term Extension for U.S. Patent 5, 196, 404
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Requested submission from the Honorable William Jenkins, a
Representative in Congress from the State of Tennessee; Letters from
leading medical practitioners and consumer groups
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Letter from Lawrence Goffney
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Testimony from Thomas Schatz, President,
Citizens Against Government Waste
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
<all>