Myriad Genetics: It’s Now Up to the Supremes
Article Date: Thursday, March 08, 2012
Written By: Frank W. Leak & Benjamin Schroeder, Ph.D.
On July 29, 2011, biotechnology companies from all over the world breathed a collective sigh of relief when the Federal Circuit issued its opinion in Molecular Pathology et al. v. U.S. Patent and Trademark Office, et al. (“Myriad Genetics”) and found that claims covering isolated DNA molecules are patentable subject matter under 35 U.S.C. § 101. 653 F.3d 1329 (Fed. Cir. 2011). Approximately one year prior to the CAFC appeal, Judge Robert Sweet from the United States District Court for the Southern District of New York issued an opinion in Myriad Genetics that shocked the patent community by holding that isolated human genes and methods of using those genes were unpatentable – a departure from over 30 years of PTO practice. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
Judge Sweet’s decision seemed to contradict what had appeared to be settled since the 1980 landmark Supreme Court decision, Diamond v. Chakrabarty, which held that claims to genetically modified organisms containing isolated DNA sequences were patentable. There had been a number of decisions since Diamond addressing issues relating to genes and isolated DNA sequences but none of them had considered whether isolated DNA and methods of using the sequences were unpatentable subject matter. University of Rochester v. G.D. Searle, 375 F.3d 1303, (Fed. Cir. 2004); University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164, 1169 (Fed. Cir. 1993); Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.Cir.1991); University of Rochester v. G.D. Searle, 249 F. Supp. 2d 216 (W.D.N.Y. 2003).
Rather, most of the cases since Diamond involved issues relating to whether the compositions and methods satisfied the written description and/or enablement requirements of 35 U.S.C. § 112. Judge Sweet, however, invalidated the claims at issue based upon what many patent practitioners consider to be the absolute minimal threshold to patentability.
It all began when on May 12, 2009, a collection of four medical associations, eight physicians, two advocacy groups (the American Civil Liberties Union and the Public Patent Foundation or “PUBPAT”), and six individual patients filed a declaratory judgment action in the Southern District of New York against The United States Patent and Trademark Office, Myriad Genetics, Inc., and the Utah Research Foundation over seven patents owned by Myriad Genetics. The 15 claims at issue related to isolated DNA molecules possessing certain nucleotide sequences from the BRCA1 and BRCA2 genes as well as methods for detecting mutations in BRCA1 and BRCA 2 by analyzing the sequence of DNA, RNA, or cDNA in a human sample and methods for screening potential therapeutics by monitoring cell growth. Patients having mutations in BRCA1 and BRCA2 demonstrate an increased susceptibility to breast and/or ovarian cancer. The Declaratory Judgment plaintiffs sought a declaration of invalidity because the claims were directed to unpatentable subject matter under 35 U.S.C. § 101 and because they violated the First Amendment to the Constitution as a restriction on the communication of information.
In finding that the composition claims at issue contained unpatentable subject matter, Judge Sweet reasoned that isolated DNA was no different than chemical compounds isolated in nature citing in support a series of cases in which such chemicals were found to be unpatentable. Association for Molecular Pathology, 702 F. Supp. 2d at 229 (citing American Fruit Growers, Inc. v. Brodgex Co., 283 U.S. 1 (1931); General Electric v. De Forest Radio Co., 28 F.2d 641 (3rd Cir. 1928); In re Merz, 97 F.2d 599 (CCPA 1935); The American Wood-Paper Co. v. The Fiber Disintegrating Co., 90 U.S. 566 (1874); Cocharne v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884); In re Marden, 47 F.2d 958 (CCPA 1931); Ex Parte Latimer, 1889 Dec. Comm’r Pat. 123 (1889)).
The method claims including those covering methods of analyzing or comparing a patient’s BRCA sequence with naturally occurring sequence to ascertain the presence of cancer-predisposing mutations were also found unpatentable because they did not satisfy the machine or transformation test as set forth in the 2008 Federal Circuit Bilski v. Kappos decision. Finally, Judge Sweet rejected the defendants’ position that the plaintiffs lacked standing to file the declaratory judgment action. Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, 669 F. Supp. 2d 365, 383 (S.D.N.Y. 2010).
Defendants appealed to the Federal Circuit and, on July 29, 2011, the Court of Appeals for the Federal Circuit issued its much anticipated decision. First, on the issue of standing, the Federal Circuit held that all but one of the plaintiffs lacked standing which, according to the panel, was sufficient for the Federal Circuit to rule on the substantive issues. Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011).
The Federal Circuit reversed the lower court on all of the product claims holding that the isolated DNA molecules do not in fact occur in nature and thus are patentable subject matter under 35 U.S.C. § 101. Id. at 1350. Judge Lourie opined that the claimed isolated DNA had markedly different chemical characteristics relative to DNA in nature. According to Judge Lourie, the claimed isolated DNAs “exist in a distinctive chemical form – as distinctive chemical molecules – from DNAs in the human body, i.e., native DNA.” Id. at 1351. Such chemical differences include chemically-severed sequences, significantly fewer nucleotides, and the free-standing nature of isolated DNA molecules.
As to the method claims, the Federal Circuit reversed the lower court’s decision as to those that related to screening potential cancer therapeutics via changes in cell growth rates. Id. at 1358. However, the Federal Circuit affirmed the District Court’s ruling on the method claims that were directed to comparing or analyzing DNA sequences because they merely consisted of the abstract mental steps of “comparing two nucleotide sequences” and did not relate to anything transformative under the machine-or-transformation test. Id. at 1357.
The ACLU and PUBPAT filed a petition for writ of certiorari to the United States Supreme Court on Dec. 7, 2011 and the matter has been fully briefed. In their petition, the ACLU and PUBPAT offered the simple question, “[a]re human genes patentable?” and slightly broadened the 35 U.S.C. § 101 inquiry from their previous arguments. Petition for Writ of Certiorari, The Association for Molecular Pathology v. Myriad Genetics, No. ___, (U.S. Dec. 7, 2011), at i. In doing so, the plaintiffs argued that the “useful” prong of 35 U.S.C. § 101 requires that isolated DNA molecules differ functionally from natural DNA sequences and not merely in chemical composition. Id. at 16-19.
Plaintiffs’ petition also raised the First Amendment argument again relating to whether patent protection of DNA molecules “violate the First Amendment because they block scientific inquiry into the patented DNA.” Id. at 30. The basis for this argument is that DNA patents “grant control over a body of knowledge and pure information.” The respondents, however, countered referencing studies and papers that have involved BRCA since the patents first issued.
Nine amicus briefs were filed in support of the petitioner plaintiffs asserting mainly public policy arguments. Filers of the amicus briefs include the AARP, American Medical Association, Canavan Foundation, Cancer Council Australia, Certain Academics in Law, Medicine Health Policy and Clinical Genetics, Information Society Project at Yale Law School, Kaiser Permanente, Kali N. Murray and Erika R. George, Knowledge Ecology International, and the National Women’s Health Network.
The Supreme Court is expected to consider the ACLU/PUBPAT petition in late February and potentially determine whether to grant certiorari as early as late February or early March. Interestingly, it appears that the defendant respondents are not contesting the Federal Circuit’s ruling on the method claims covering comparing a patient’s BRCA sequence with naturally occurring sequence to ascertain the presence of cancer-predisposing mutations. Needless to say, one cannot downplay the importance of the Supreme Court’s decision. But given the Supreme Court’s willingness of late to tackle difficult patent law questions, particularly questions involving 35 U.S.C. § 101, chances are good that they will do so again. •
Disclaimer: The opinions expressed are those of the author and do not necessarily reflect the views of the firm or its clients. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
Frank Leak is one of the founding principals at Leak & Schroeder, PLLC with over 10 years experience as a patent attorney in North Carolina. Frank practices and resides in Winston-Salem, North Carolina.
T. Benjamin Schroeder is the other founding principal at Leak & Schroeder, PLLC, and focuses his practice on patent, trademark, copyright and general intellectual property matters. Ben also practices and resides in Winston-Salem, North Carolina.
Views and opinions expressed in articles published herein are the authors' only and are not to be attributed to this newsletter, the section, or the NCBA unless expressly stated. Authors are responsible for the accuracy of all citations and quotations.