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FDA
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June 12, 2003
What does the FDA rule change accomplish?
How many 30 month stays are currently allowed and how will this change?
What is FDA's estimate of the savings to consumers from the final rule?
How was $35 billion in savings estimated?
What types of patents must be submitted now and what will change under the final rule?
How will FDA be able to determine if the appropriate patents have been filed?
How long does an NDA applicant have to submit patent information to FDA?
Will the generic drug applicant have to do anything different under the final rule?
Will there be more than one 30-month stay available to an innovator?
How would the Final Rule have impacted the other drugs in the FTC Report, if it had been in effect?
What is the effective date of the final rule?
What does the FDA rule change accomplish?
The final rule will provide the American health care consumer with faster access to high quality, low-cost generic drugs while maintaining legitimate incentives for innovative new drug development. FDA estimates that the final rule will result in savings to consumers of $35 billion over 10 years.
Specifically, the final rule
How many 30 month stays are currently allowed and how will this change?
Under FDA's traditional interpretation, multiple and overlapping 30-month stays can be imposed with respect to each ANDA or 505(b)(2) application. Under the final rule a maximum of one 30-month stay per ANDA or 505(b)(2) application would be allowed. Once that stay expires, or there is a court decision in the innovator patent suit against that applicant finding the patent invalid or not infringed, the application could be approved (if otherwise approvable).
What is FDA's estimate of the savings to consumers from the final rule?
FDA estimates that consumers will save approximately $35 billion over ten years.
How was $35 billion in savings estimated?
FDA calculated a one-year impact based on recent experience with multiple stays and what consumers would have saved, had the subsequent stays not existed. FDA then used actuarial projections of prescription drug expenditures to extend the estimate out ten years.
What types of patents must be submitted now and what will change under the final rule?
Patents that must be submitted under current practice in conjunction with an NDA are drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method of use patents that claim the drug that is the subject of the NDA. Process (or manufacturing) patents may not be submitted to FDA. The patent must claim a pending or approved drug product or its approved use, and support a patent infringement claim.
Under the final rule, the NDA applicant would have to submit information on each patent that claims the drug product (active ingredient), drug substance (formulation/ composition) or a method of using the drug that is the subject of the NDA, amendment, or supplement and with respect to which a claim of patent infringement could reasonably be asserted. The submission will not be considered complete, if the questions on the declaration forms related to the patent being submitted, are not answered.
Information on patents claiming packaging, patents claiming metabolites, and patents claiming intermediates must not be submitted. Information on process patents must not be submitted. Product-by-process patents are a type of product patent. A product-by-process patent claims a product by using or listing process steps to wholly or partially define the claimed product. The final rule requires the submission of product-by-process patent information where the product claimed is novel.
The final rule requires information concerning certain polymorph patents to be submitted if they claim the same active ingredient as the approved product. The polymorph patents must be submitted if the NDA holder has test data demonstrating that the drug product containing the polymorph will perform the same as the drug product described in the NDA. The information on polymorph patents must not be submitted if the NDA holder does not have the test data demonstrating that the drug product containing the polymorph will perform the same as the drug product described in the NDA.
The final rule clarifies that information on patents on unapproved methods of use must not be submitted. Patent information submitted claiming approved methods of use must identify each individual claim and the corresponding use or indication in the approved drug labeling. We also require the NDA holder to provide the information on the approved method of use to be published in the Orange Book as the "use code"
How will FDA be able to determine if the appropriate patents have been filed?
The final rule includes declaration forms (FDA Forms 3542 and 3542a) that consolidate all of the patent information that must be submitted. Most of the information can be provided through "check-off" statements. These declarations will provide much more information on the nature of the patent being submitted. The detailed declaration forms will assist the NDA holder or patent owner in submitting only information on eligible patents. The forms will also help FDA to quickly review the information to determine if the patent is eligible for submission from the "face" of the declaration without having to assess and evaluate the patent contents.
How long does an NDA applicant have to submit patent information to FDA?
The final rule requires submission of information upon NDA or supplement filing and upon approval. The patent information is published after FDA approves the NDA. If the patent information is submitted after NDA approval, publication of the information is required within 30 days. For patents issued by the Patent and Trademark Office after NDA approval, the applicant has 30 days after issuance in which to submit the patent information to the FDA to have it considered as timely filed. If a declaration form for a newly issued patent is submitted within 30 days of patent issuance and is incomplete or otherwise improperly filled out, the new rule permits 15 days for modification of a declaration forms after we notify the applicant of any problems with the submission. Patents submitted to FDA beyond the timeframe are not considered timely filed patents. ANDA and 505(b)(2) applicants are not required to certify to an untimely-filed patent if their application was submitted before the patent information was listed.
Will the generic drug applicant have to do anything different under the final rule?
It depends. Under current law, if an applicant wants to market its generic or 505(b)(2) drug before a listed patent expires, it must file what is called a "paragraph IV" certification stating the patent is invalid or will not be infringed by the generic drug. The applicant must notify the NDA holder and the patent owner that it is seeking approval for a generic or 505(b)(2) drug and describe why the patent is invalid or will not be infringed by the proposed drug product. The applicant currently has to file additional certifications and notifications, with the possibility of new 30-month stays, if new patents are submitted and listed in the Orange Book for the brand name drug.
Under the final rule, if an ANDA or 505(b)(2) applicant has filed a "paragraph IV" certification, given notice, and there has been one full opportunity for a 30-month stay, no additional notice has to be provided by that applicant for any subsequent paragraph IV certification. There will be no possibility of another 30-month stay. A full opportunity for a 30-month stay means that the statutory 45-day time period, after notice of a paragraph IV certification, has expired or a patent infringement lawsuit on the related patent has been filed.
Will there be more than one 30-month stay available to an innovator?
The single 30-month stay is per ANDA or 505(b)(2) application. It is possible that an innovator could obtain more than one 30-month stay -- but not on a single application. The 30-month stays are on each ANDA, and there may be multiple ANDA applicants for one listed drug product.
Under the final rule, what happens if an ANDA applicant files a paragraph III certification and right before that patent expires the innovator submits a patent and it is listed in the Orange Book -- will the generic approval be delayed?
An ANDA applicant must always file a certification to a patent listed in the Orange Book or if it is a use patent they have the option to submit a statement that they are not claiming that use. If there has been no previous paragraph IV certification, or no full opportunity for a 30-month stay, notice must be given to the NDA holder and patent owner when the first paragraph IV certification is filed. After notice, there will be the required 45-day period during which a patent infringement suit can be filed. If suit is filed, one 30-month stay per that application would result and the approval of a generic or 505(b)(2) application would be delayed.
Why do you allow patent information to be submitted for listing in the Orange Book, after NDA approval, and even after an ANDA has been filed?
We believe it is important to encourage innovation by drug companies on approved drugs. The statute contemplates that all patent information will not be submitted with an NDA filing or on approval. If the patent meets the specific requirements for submission and listing there is no legitimate reason to deny it. We are confident that inappropriate patents will not be submitted thus reducing delays in approval of generic and 505(b)(2) applications.
Can you give examples of patents you think must be submitted even after an ANDA or 505(b)(2) application has been filed?
Without identifying specific patents, any patents meeting the requirements including such innovations as improved purity of the active ingredient, safer dosing regime, and, new indication for which a supplement was approved but the patent was not issued until after application approval.
The FTC Report noted a number of drugs for which generic competition has been delayed by multiple 30-month stays. One of the drugs noted with the most delays is Paxil -- for which there is still no generic competition. Will the final rule speed approval of a generic for Paxil?
It is certainly possible. When the rule is effective patent information submitted for any additional later-issued patents and listed in the Orange Book will not result in automatic 30-month stays for those generic applications that already have been subject to such stays. For already listed patents, including patents listed for Paxil, the rule will not apply retroactively. At this time, approval of a generic version of Paxil depends on the pending litigation, current applicable 30-month stays and the ability of a company to market when it receives approval.
How would the Final Rule have impacted the other drugs in the FTC Report, if it had been in effect?
Here are two examples to illustrate what might have happened:
What is the effective date of the final rule?
The final rule will be effective 60 days after the date of publication date of June 18, 2003 thus the effective date will be August 19, 2003 for patent submission. The compliance date will be six months after date of publication, specifically December 18, 2003, of the final rule for the submission of polymorph patent information for which the NDA has test data demonstrating that the drug product containing the polymorph will perform the same as the drug product described in the NDA.
More Information on FDA's Generic Drugs Final Rule and Initiative