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BRCA1/2 patents ruled invalid in PUBPAT/ACLU lawsuit

3/29/10 From PUBPAT: Judge Robert Sweet issued his opinion holding all of the challenged patents invalid. (1) The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed on 5/12/09, in the U.S.District Court SDNY in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.

The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes. The ruling follows a lawsuit brought by a group of patients and scientists represented by PUBPAT and ACLU who charged that the challenged patents are illegal and restrict both scientific research and patients' access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are products of nature….Because the PUBPAT/ACLU lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes….
A few comments about the lawsuit:
- Christopher A. Hansen, an attorney with the ACLU, told the judge at the hearing: They uncovered a law of nature. It is very much to their credit. But uncovering a law of nature is not creating an invention.
Brian M. Poissant, defendants' lawyer, (Jones Day) argued at the hearing: This is not nature's handiwork. This is an invention of man. Once the gene is isolated, it is transformed chemically. Myriad's probes and primers are like guided missiles. They go along this very long strand of DNA and they know where to stop. See LAW.com news (3)
-President and CEO of Myriad Genetics: ...we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation. More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents. …In this case, the ACLU Plaintiffs sought a declaratory ruling that 15 claims under seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16 patents covering BRACAnalysis(R) which also were not challenged. See Myriad’s website.(4)
Judge Sweet observes in the Opinion that 2 complicated areas of science and the law are involved in this case regarding the patentability of isolating human genes and the comparison of their sequences and that resolution of the issues presented concern to breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors and those seeking to advance public health.
(1) http://www.pubpat.org/brcasjgranted.htm(2) http://www.pubpat.org/assets/files/brca/brcasjgranted.pdfJudge Robert Sweet’s Opinion (156pp).
(3) http://www.law.com/jsp/article.jsp?id=1202447064274&Genes_Linked_to_Breast_Ovarian_Cancers_Are_Ruled_Unpatentable
(4) http://investor.myriad.com/releasedetail.cfm?ReleaseID=455348

A few highlights of the Opinion:
Judge Sweet’s Opinion describes the current understanding of the knowledge of molecular biology at issue, based on the Facts set forth in the parties’ statements and experts’ declarations, along with 2 referenced texts. The Opinion sections entitled: ‘Development of Genetics as a Field of Knowledge’ and ‘Molecular Biology and Gene Sequencing’(pp29-51) focus on DNA, what is extracted and purified DNA, and presents the general question of the case: whether DNA should be treated no differently from any other chemical compound so that its purification from the body using well-known techniques renders it patentable by transforming it into something distinctly different, or, that this characterization is a ‘Lawyer’s trick” that circumvents the prohibitions on the direct patenting of DNA in our bodies, DNA representing the physical embodiment of biological information.
Brief descriptions about the many parties involved are set forth and their concerns are identified beginning with a human geneticist and Associate Professor at Columbia University who states that because of the patents-in suit she cannot tell research subjects in her studies the results of their BRCA1/2 tests and cannot offer those clinical testing services. Other plaintiffs set forth complaints concerning insurance coverage issues, gaining second opinions regarding interpretations the tests because Myriad is the sole provider, costs of the tests in comparison to Ontario where the cost is 1/3 of Myriad’s $3000 cost per test (the Ontario regional public healthcare plan is ignoring the patent, and other important concerns including those of defendants). (pp 52-72)
Disputed issues regarding the impact of gene patents on the advancement of science and medical treatment as well as the impact of Myriads patent on BRCA1/2 testing are not resolved with respect to the motions decided in the case, and the referenced Cho declaration provides interesting information about studies and surveys on these subjects, as discussed in the Opinion.
The discussion of the patent claims includes analysis of the disputed terms DNA and isolated DNA (p83); in conclusions of law (p98) Judge Sweet observes the scope of broad relief of patentable subject matter as provided by 32 USC section 101, but that it is not without limitations. The analysis and discussion on methods claims under patent law reflects on what the scientists are doing when they analyze and compare DNA sequences. There is also a brief statement on the applicability of U.S. obligations agreed to in TRIPS, which permits governments to incorporate public health concerns into their IP laws among other conclusions on it.

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