United States: Chilling Assault On Personalized Medicine

An unusual collection of plaintiffs came together to recently file a significant lawsuit and now a summary judgment motion clarifying their position, in which the plaintiffs make an assault against patents claiming genetic lifesaving tests (see Association for Molecular Pathology v. U.S. Patent & Trademark Office (09-cv-04515 S.D.N.Y. 2009)). Plaintiffs allege that patent claims of a group of eight patents directed to in vitro diagnostic tests are unconstitutional under the First Amendment and Article 1, Section 8, Clause 8 of the U.S. Constitution. This unusual group of plaintiffs¹ consists of six associations, eight academicians involved in cancer research, a breast cancer support group, a nonprofit public interest organization, and six breast cancer patients that cannot afford to pay for BRCA genetic testing. At issue is whether isolated DNA sequences and methods of diagnosing or detecting abnormalities in such sequences are patent-eligible subject matter.

The importance of this issue can be seen by the fact that 16 organizations that have already filed amicus briefs at the Federal District Court level all in support of plaintiffs' position seeking to invalidate the underlying patents. To date, no amicus brief has been filed in support of defendants' position. Absent extensions, defendants' opposition to the summary judgment motion is due on September 10, 2009, and amicus briefs in support of defendants' position should be filed by no later than September 23, 2009.

In their summary judgment motion, and arguably queuing up the issues for appeal, plaintiffs first argue that the First Amendment prevents the government from limiting thought and knowledge and that the underlying patents directly violate this limitation. According to plaintiffs, claims of five of the patents involve looking at one or more sequences and reaching some conclusion about the genes. As such, they assert that these claims are unconstitutional. Plaintiffs further allege that a genetic sequence is biological information itself and that a claim over genes themselves—whether in the natural or wild-type form or mutated forms—is a claim to the informational content thereby being a limit on pure information.

Plaintiffs also argue that the underlying patents impede rather than promote the progress of science in violation of Article 1, Section 8, Clause 8 of the U.S. Constitution. This section of the U.S. Constitution gives Congress the authority "to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive Right to their respective Writings and Discoveries." Plaintiffs purport to have evidence that the patent claims were not necessary for the BRCA1 and BRCA2 genes to have been identified and sequenced, or to induce physicians to sequence and analyze them. Instead, plaintiffs offer evidence for what they claim impedes research and clinical development of and quality assurance of genetic testing for BRCA1 and BRCA2 genes. Based on this argument, plaintiffs conclude that the patented claims are unconstitutional.

Defendants' response to this summary judgment motion is due September 10, 2009. Whether isolated DNA sequences should be patentable subject matter has been widely debated. This lawsuit certainly brings the debate front and center, and a negative result could have a chilling effect on personalized medicine. Should the plaintiffs be successful in their case, the BRCA patents would be held invalid. Additionally, success by plaintiffs in this case could significantly increase the risk that other patents claiming in vitro diagnostic tests in the same fashion as the BRCA patents would be deemed indirectly invalid. If plaintiffs' arguments are defeated, however, those in favor of patent protection for isolated DNA sequences and related in vitro diagnostic tests will have a significant legal decision on which to rely for future research and product development investment.

Background

In the lawsuit, the plaintiffs target the BRCA genetic tests developed by Myriad Genetics. The BRCA genes (i.e., BRCA1 and BRCA2) are known as tumor suppressors. Certain mutations to the BRCA genes increase the risk of developing breast and ovarian cancers. For instance, approximately 5-10% of women who develop breast cancer are likely to have a mutation in the BRCA genes. Women with one of these significant gene mutations have an approximately 40-85% lifetime risk of developing breast cancer. Inherited mutations on the BRCA genes also increase the risk of ovarian cancer.

Eight issued U.S. patents cover the BRCA genetic test. Myriad Genetics is co-owner but not the sole owner of each of these eight patents. Myriad shares ownership of some of these patents with the University of Utah Research Foundation, the U.S. Secretary of Health and Human Services, Centre de Rechèrche du Chul, the Tokyo Cancer Institute, Endo Rechèrche, Inc. of Quebec, HSC Research & Development Limited Partnership of Toronto, and the Trustees of the University of Pennsylvania. Myriad is the exclusive licensee of the other owners' interest in the eight patents.

The lawsuit was brought against Myriad Genetics, the U.S. Patent and Trademark Office, and the Directors of the University of Utah Research Foundation. Notably, the plaintiffs decided not to join as defendants the U.S. Secretary of Health and Human Services, Endo Rechèrche, Inc., HSC Research and Development, and the Trustees of the University of Pennsylvania. Defendants filed several motions to dismiss challenging the standing of plaintiffs to bring this suit.

Issues Being Addressed

In the complaint, the plaintiffs allege the following causes of action:

Plaintiffs request that the court declare the claims of the underlying patents invalid and/or unenforceable, enjoin defendants from taking any actions to enforce the claims of these patents, and grant plaintiffs attorneys' fees and costs.

Importance of this Case

The motion for summary judgment highlights the constitutional issues/challenge to the patents. If companies cannot patent in vitro diagnostic tests, it may be difficult for these companies to keep competitors from also selling their test. If so, how will investors be able to recoup their investments? Why would investors want to invest in the development of in vitro diagnostic tests in the future? The unwanted side effect could be a chilling effect or a sudden halt to the development of personalized medicine.

Should in vitro diagnostic companies not be able to patent isolated DNA sequences for the targets of their tests, then their ability to prevent entry by competitors and to recoup their investment could be severely affected. As a result, investments in in vitro diagnostic development may significantly decrease, and the promise of the new era of personalized medicine may be unreachable. If defendants prevail, on the other hand, a clear message will be sent and strong legal precedent developed on which companies can rely for future patent protection on products produced from often costly research and development.

Footnotes

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