The End of Patentability for Genes?
By Kaye D. Fleming and Seth D. Levy 04.01.10
In a ruling that is sure to send shockwaves throughout the scientific and medical communities, Federal District Court Judge Robert W. Sweet, sitting in the Southern District of New York, held that all of the claims at issue in seven of Myriad Genetics’ breast cancer gene patents are invalid, including those directed toward methods of using isolated genes as markers for breast cancer.
In a ruling that is sure to send shockwaves throughout the scientific and medical communities, Federal District Court Judge Robert W. Sweet, sitting in the Southern District of New York, held that all of the claims at issue in seven of Myriad Genetics’ breast cancer gene patents are invalid, including those directed toward methods of using isolated genes as markers for breast cancer.
This case received a great deal of attention in the press, after it was filed by the American Civil Liberties Union on behalf of various professional medical organizations, scientists, cancer survivors and others against the U.S. Patent and Trademark Office and Myriad Genetics, among others, to seek judicial review as to whether human genes could indeed be patented.
In the 1990s, Myriad Genetics obtained several patents claiming the isolated genes BRCA1 and BRCA2, and methods of using these genes to identify the presence of certain mutations in a subject’s genetic material. Of these patents, seven were at issue in this case.
In his lengthy opinion, Judge Sweet held the claims at issue from the seven patents invalid for failing to recite patentable subject matter under 35 U.S.C.§101. In finding the claims directed toward isolated genes invalid, Judge Sweet opined that both U.S. Supreme Court and lower court precedent have established that purifying a product of nature, but doing nothing more, does not itself create subject matter that is patentable under §101. Instead, “the purified product must possess ‘markedly different characteristics’” than that of naturally existing products.1 Judge Sweet held the isolated BRCA1 and BRCA2 genes as claimed are not “markedly different” from their native DNA, and therefore are not patentable subject matter.
Judge Sweet also rejected Myriad’s argument that the isolated genes should be patentable based on the subject matter patentability of other chemical compounds as determined by other courts.2 In rejecting this argument, Judge Sweet described the genes as having “informational quality,” a quality not found in other chemical compounds, thus making genes unique. Judge Sweet used this uniqueness of DNA compared to other chemical compounds found in cells to distinguish case law supporting patentability of these other chemical compounds.
Regarding the method claims, Judge Sweet narrowly distinguished the Myriad patent claims from the medical diagnostic claims that were upheld in Prometheus Laboratories Inc. v. Mayo Collaborative Services,3 finding that the claims in the Myriad patents are directed to abstract mental processes of “analyzing” or “comparing,” and are not “transformational” in the same manner as the patent claims in Prometheus.
Judge Sweet also drew heavily from the opinion of the Court of Appeals for the Federal Circuit in In re Bilski4 to find that the method claims at issue in the contested patents were invalid. Bilski is currently under review by the U.S. Supreme Court, and it, too, is receiving a great deal of attention. A decision from the Court is expected in Bilski in the coming weeks, and, regardless of the outcome, it will have a significant impact on the determination of what qualifies as patentable subject matter in the United States. But this also means that the legal authority relied upon so heavily by Judge Sweet may soon change.
It is expected that this case will be appealed to the Federal Circuit, and likely from there to the U.S. Supreme Court, as the issue of patentable subject matter, and the more specific focus on genetic testing, continue to be tested in the courts.
FOOTNOTES
1 Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-4515, slip op. at 121 (S.D.N.Y. March 29, 2010).
2 See, e.g., Merck & Co. v. Olin Mathieson Chem. Corp., 253 F. 2d 156 (4th Cir. 1958) and Parke-Davis & Co. v. H.K. Mulford Co., 189 R.2d 95 (S.D.N.Y. 1911).
3 581 F.3d 1336 (Fed. Cir. 2009).
4 88 USPQ2d 1385 (Fed. Cir. 2008).
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