By Donald Zuhn --
Last week, the American Civil Liberties Union (ACLU), ACLU of Utah Foundation, Inc., Public Patent Foundation (PUBPAT), Association for Molecular Pathology (AMP), Breast Cancer Action, and AARP submitted an amici curiae brief in two infringement actions brought by Myriad Genetics, Inc. (and the University of Utah Research Foundation, Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, and Endorecherche, Inc.) against Ambry Genetics Corp. and Gene by Gene, Ltd. The amici brief was submitted in support of Ambry Genetics and Gene by Gene, which have opposed Myriad's motion for a preliminary injunction. The brief notes that the ACLU and PUBPAT represented several individual and organizational plaintiffs, including fellow amici AMP and Breast Cancer Action, in Association for Molecular Pathology v. Myriad Genetics, Inc., where the Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Amici indicate that as a result of their participation in AMP v. Myriad, they are "well-positioned to inform this Court about the issues raised and decided in the AMP litigation and the public interest at stake in invalidating patents that create monopolies on genetic information."
As the brief notes, in AMP v. Myriad, several of the amici challenged fifteen claims in seven of Myriad's patents because Myriad had asserted those claims when sending cease-and-desist letters to other laboratories that were conducting genetic testing, and that "[t]he decision to focus on these claims was by no means a concession that any of Myriad's other claims is valid." The brief also notes that the fifteen challenged claims can be subdivided into three groups: nine claims directed to "isolated DNA," five claims directed to methods of screening BRCA1 or BRCA2 genes, and one claim directed to a method of screening potential therapeutics. Amici point out that only the isolated DNA claims were before the Supreme Court, and as a result, "[t]he Federal Circuit's affirmance of the district court judgment striking the five method claims therefore stands as the law of the case, as does its ruling on the other method claim."
The brief indicates that Myriad has asserted six method claims and four primer claims in its motion for a preliminary injunction enjoining Ambry Genetics and Gene by Gene. Noting that the asserted method claims all involve comparing a sequence from a patient sample to a reference sequence, the brief first points to representative claim 8 of U.S. Patent No. 5,753,441, which recites:
The method of claim 1 wherein a germline nucleic acid sequence is compared by amplifying all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids.
The brief then sets forth claim 1 of the '441 patent, from which claim 8 depends, which recites:
A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
The brief then reminds the District Court that claim 1 was invalidated by the Federal Circuit in AMP v. Myriad, and suggests that "the question presented to this Court is whether a preliminary injunction should issue based on method claims that add routine, additional steps -- such as 'amplifying' using an unspecified set of primers and 'sequencing' -- to what is undoubtedly unpatentable subject matter."
In laying out their argument, amici contend that "[d]espite the unanimous rulings [by the Supreme Court] in Mayo and AMP, Myriad continues to aggressively defend its monopoly on examining the BRCA genes, pointing to patent claims that were not the subject of the previous suit but are clearly invalid under those decisions and the Federal Circuit's earlier ruling." According to amici, the claims being asserted by Myriad are "clearly invalid" because they only add "routine, data-gathering steps such as 'amplifying' and 'sequencing'."
In discussing the impact of the impact of the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., amici explain that "Mayo described two key factors in determining whether a method is patent-eligible: whether it is based on an inventive concept, and whether the patent ties up the use of the underlying natural phenomena," and conclude that the asserted claims "fail both tests." With respect to the first test, amici argue that "the method here is even less inventive than the methods set out in Prometheus' claims [because] Myriad's method claim assesses pure biological facts that do not depend on the administration of a man-made drug for their existence." As for the second test, amici argue that:
The Court's decision on this motion will also affect the ability to engage in basic scientific activities regardless of whether the laboratory professional is doing so for the purpose of providing breast and ovarian cancer risk testing for patients. The patent claims that Myriad is asserting are not limited to that context. Any scientist who engages in the basic steps of amplifying part of the BRCA1 gene and sequencing the amplified segment as part of a research study would violate these claims. As a consequence, these patents prevent any scientist from examining or understanding the underlying law of nature -- whether a particular BRCA1 gene contains an alteration from the wild-type -- and using that law of nature in any way.
Amici also argue that the granting of a preliminary injunction would violate the First Amendment and Patent Clause of the U.S. Constitution by conferring upon Myriad exclusive control over a body of knowledge. In particular, the brief contends that Myriad has used its exclusive rights "to amass an enormous amount of information critical to the health of every American," and that Myriad "refuses to allow others to obtain the information themselves by performing the basic methods at issue in this litigation, or to share the information with the medical and scientific communities." Amici argue that "[t]he claims thus give entire control over a body of knowledge and over pure information to Myriad."
Amici further argue that a preliminary injunction would harm the public interest because "an injunction would allow Myriad to continue to impede our acquisition of greater knowledge about the BRCA1 and BRCA2 genes." The brief again criticizes Myriad for refusing to share its BRCA1 and BRCA2 data with the scientific community, contending that "Myriad's conduct flies in the face of the professional ethical standards set out by the American Medical Association, which calls on laboratories, researchers and providers to publicly share data on genetic variants." The brief concludes by suggesting that the District Court's decision on the preliminary injunction motions will "impact whether or not patients and their physicians and genetic counselors have the option of seeking testing from the numerous laboratories that are fully capable and willing to provide clinical testing of these genes and whether scientists can freely engage in research without fear of liability."
For additional information regarding this and other related topics, please see:
• " Why Does Myriad Think It Can Win BRCA Gene
Lawsuits?" July 30, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013
• "Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)," June 13, 2013
• "Supreme Court Issues Decision in AMP v. Myriad," June 13, 2013