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Intellectual Property and Genomics
Overview
Patenting genetic discoveries has proven controversial over the past several
years. There are now patents associated with around a quarter of the genes in
the human genome. Patents are extremely valuable to those developing products
based on genetic discoveries. They are issued to encourage innovation, and provide
protection to allow those investing in genetic research the opportunity to maximize
the profit from their investment.
However, when patents limit the use of basic
genetic information, they threaten to inhibit or limit biomedical research.
There are concerns that the large number of patents associated with the human
genome will limit the integration of personalized medicine into health care either because of
restrictive patents or prohibitive costs. The so-called "thicket of patents"
therefore has the potential to inhibit the translation of genetic discoveries
into health care benefits.
Central to the debate over the patenting of genetic discoveries is the question
of what criteria should determine whether a discovery is patentable. Are genes
part of our collective heritage that should not be patentable at all? Alternatively,
if genetic discoveries are patentable, how should a legitimate discovery be
defined? Should the isolation and purification of genes from their natural state
be a sufficient basis for a patent, or should the applicant be required to demonstrate
a use for the discovery?
The United States Patent and Trademark Office (USPTO), the agency that issues
patents in the United States, has developed guidelines on the patenting of genetic discoveries.
The current guidelines state that identification of a gene's sequence alone
is not patentable, but that a gene isolated from its natural state may be patentable
if the applicants can demonstrate "specific, substantial and credible utility"
for the discovery. See: United States Patent and Trademark Office Utility Examination
Guidelines (2001) [uspto.gov]  .
Since its inception, the Human Genome Project and its planners emphasized that
in order to reap its maximum benefit, new DNA sequence should be freely available
in the public domain. Thus, all sequence information acquired during the Human
Genome Project was immediately deposited into databases that can be accessed
via the World Wide Web. However, patents on some gene sequences and other types
of information derived from genetic sequences have been granted.
Due to concerns that gene patents were being granted too liberally, then-National
Institutes of Health (NIH) director Harold Varmus and National Human Genome
Research Institute (NHGRI) director Francis Collins wrote to the U.S. Patent
and Trademark Office (USPTO), the agency that issues patents in the United States,
urging them to implement stricter criteria for biotechnology patents. In part
as a result of this letter, in January 2001, the USPTO revised its guidelines
on DNA sequence and sequence-derived intellectual property and raised the bar
on genetic utility standards.
The 2001 revision improved the guidelines, but there is still concern that
the standards are not rigorous enough. New issues have emerged surrounding the
possibility of patents on newer types of genomic data, such as "haplotypes",
protein structures, and expression array data. As with genes, if these genetic
data are patented, the fees and potential reach-through restrictions may inhibit
biomedical researchers from conducting additional research with these foundational
tools.
The NHGRI, in partnership with other organizations, is actively working on these issues of patent and licensing policy, in hope of maintaining the level of access to basic genomic data that will ultimately benefit researchers, care providers and patients. The NHGRI, in partnership with other NIH institutes, funded the National Academy of Sciences report Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health [nationalacademies.org], completed in 2006. More recently, NHGRI Director Francis Collins was invited to meet with patent examiners to present information about genome-wide association studies (GWAS) and the types of data that will be generated from these studies. The examiners are interested in potential uses of GWAS data to help inform the patent examination process. The NIH also is working with the USPTO to develop procedures to facilitate data sharing with the USPTO.
Pending Legislation
The bipartisan, bicameral Patent Reform Act of 2007 was introduced by House Judiciary Committee on Courts, the Internet, and Intellectual Property Chairman Howard Berman (D-CA) and Senate Judiciary Committee Chairman Patrick Leahy (D-VT). The House version (H.R.1908) was passed in the House in September. The Senate version (S.1145) of the bill has passed committee, and a vote is expected later in the fall. The core bill aims to improve patent quality and overhaul the system for awarding patents and for awarding damages for patent infringement. The bill also changes the U.S. patent system to a first-inventor-to-file priority (currently, the priority is first-to-invent). Opponents object to the provisions that would make it easier to challenge patents after they are granted and would limit damages according to a patent's contribution to the overall value of a product. In response to the passage of H.R.1908, the White House issued a Statement of Administrative Policy (SAP) [whitehouse.gov] opposing the bill's provisions regarding damages apportionment.
Separate from considerations of specific legislation, the House Judiciary Committee's Subcommittee on Courts, the Internet and Intellectual Property held a hearing on the topic of gene patents on October 30, 2007, entitled "Stifling or Stimulating - The Role of Gene Patents in Research and Genetic Testing" [digitalcommons.umaryland.edu]
NHGRI Interest in Intellectual Property
Balancing Intellectual Property Rights with Research Needs: A Report from
the National Academy of Sciences
On November 17, The National Academy of Sciences' (NAS) Committee on Intellectual
Property Rights in Genomic and Protein Research and Innovation released its
report Balancing Intellectual Property Rights with Research Needs: A Report from
the National Academy of Sciences. The report
was funded by the National Institutes of Health (NIH).
This well-crafted report identifies some of the most pressing issues regarding
use of intellectual property in the life sciences, lays out these issues clearly
and recommends actions to a variety of stakeholders. Many of the report's recommendations
endorse the current NIH policies regarding intellectual property and data release.
The NIH will focus on responding to these recommendations.
Other Concerns and Activities
Report and Policies
Last Updated: September 9, 2008
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