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Gene Patent Verdict Shakes-Up Health Care Industry

April 6, 2010

Below is a 60-minutes feature on the recent breakthrough court ruling on patenting genes.  Below that is a NW law firm, Stoel Rives, that describes its potential impact on the health care industry

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The End of Patentability for Genes?

By Kaye D. Fleming and Seth D. Levy
Stoel Rives, Oregon law firm

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 Asspc/ fpr 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).

Disclaimer: This advisory is a publication of Davis Wright Tremaine LLP. Our purpose in publishing this advisory is to inform our clients and friends of recent legal developments. It is not intended, nor should it be used, as a substitute for specific legal advice as legal counsel may only be given in response to inquiries regarding particular situations.

  
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Dr. James Rohack, AMA President April 8, 2010

The American Medical Association emphatically agrees with the Federal court’s decision to invalidate Myriad’s patents on genes linked to breast cancer. The ruling is a clear legal victory that prevents overly broad medical patents from harming patients’ access to care.

By staking claims on the BRCA1 and BRCA2 genes, Myriad exclusively controlled the use of these breast cancer genes when isolated from the human body. These patents gave Myriad a broad monopoly that hampered scientific discovery and medical care.

The AMA joined with other health care organizations in an amicus brief in this groundbreaking case supporting the position that genes are unpatentable products of nature, not discoveries of man.

The court’s decision supports the AMA’s deep belief that physicians should not be stifled in what care they can provide because a part of human biology has been patented. Medical discoveries that provide insight into natural human biology must remain available to all and exclusive to none.

maasoumah June 15, 2010

this helped me a lot
people should read this 🙂
thank you

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