Government Continues Anti-DNA Patenting View in Myriad Supreme Court Amicus Brief

Access practice tools, as well as industry leading news, customizable alerts, dockets, and primary content, including a comprehensive collection of case law, dockets, and regulations. Leverage...

By Tony Dutra  

The U.S. government, apparently still without buy-in from the Patent and Trademark Office, filed another brief with the Supreme Court recommending against patent eligibility of claims to isolated DNA sequences (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, amicus briefs filed 1/31/13).

Twenty-two additional briefs by friends of the court--most supporting the American Civil Liberties Union's challenge in the case--were filed along with the petitioners' opening brief.

Patent owner Myriad Genetics Inc.'s response is due March 7 and is expected to be accompanied by similar support from amici within the following week.

The high court scheduled oral argument in the case for April 15.

Challenge Began in 2009

The case arose from a 2009 declaratory judgment challenge filed by the ACLU and the Public Patent Foundation.

They argued on behalf of the associations and individual plaintiffs that 15 claims in patents (U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) on isolated DNA, complementary DNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer were ineligible for patenting under 35 U.S.C. §101.

In its first decision on July 29, 2011, the Federal Circuit overturned a district court's finding of patent ineligibility of all 15 claims. The three members of the appeals court panel agreed that only one of the method claims and all the claims to cDNA are patent eligible, but the court was divided as to claims to isolated DNA (151 PTD, 8/5/11).

Then on March 26, 2012, a week after unanimously rejecting method claim patent eligibility in Mayo Collaborative Services v. Prometheus Laboratories Inc. 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (U.S. 2012)(55 PTD, 3/22/12), the Supreme Court granted the ACLU's petition for writ of certiorari in the instant case, vacated the Federal Circuit's opinion, and remanded the case for reconsideration (58 PTD, 3/27/12).

On remand Aug. 16, however, the appeals court panel came to the same conclusions, with all three judges writing essentially the same opinions that they had penned the first time. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012) (159 PTD, 8/17/12).

The ACLU petitioned again for certiorari on Sept. 25 (186 PTD, 9/26/12). The petitioners sought review of three questions: one related to isolated DNA, one on the method claims, and the third on standing.

On Nov. 30, the Supreme Court certified only the first question presented: “Are human genes patentable?” (231 PTD, 12/3/12).

ACLU, PubPat Say DNA a 'Product of Nature'

Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy, and Technology Project, filed the petitioners' brief on the merits Jan. 23 (18 PTD, 1/28/13).

The petitioners' primary argument is that the Supreme Court has repeatedly distinguished “a product or law of nature” as unpatentable under 35 U.S.C. §101, and that Myriad's isolated DNA claims--in a form representative of claims the PTO has granted in thousands of patents--are ineligible for patenting under every test the court has identified.

For the most part, the brief made the same arguments presented since the case was first filed. However, the petitioners also sought to take advantage of the Supreme Court's decision in Mayo v. Prometheus. Repeating a term the high court introduced in Mayo, the petitioners cited a patent eligibility test of “whether the patent is based on an inventive concept.” They said, “Isolation was a routine, conventional activity at the time these patents were obtained. The only addition to the progress of science disclosed by these claims is the law of nature itself: that this DNA encodes for the BRCA1 or BRCA2 gene or protein.”

Distinction Between cDNA and Isolated DNA

The United States, in a brief filed by U.S. Solicitor General Donald B. Verrilli Jr., generally echoed arguments it had presented when the case was before the Federal Circuit.

The government continued to compare patent eligible cDNA claims and ineligible isolated DNA claims--a distinction the ACLU rejects. The brief labels the former “synthetic molecules built by scientists” and the latter “isolated but otherwise unmodified human genomic DNA.”

The physical changes that occur in isolating DNA, the brief stated, “do not significantly alter the structure or function of the relevant DNA segments,” but rather “are simply inherent consequences of removing the original substance from its natural environment.”

Building on that premise, the government made a preemption argument. Any serious study of the DNA necessarily requires removing it from the human body, requiring the changes that Myriad's patents claim, and thus necessarily infringing the patents under Myriad's view, the government said. Researchers and those with other commercial uses of the BRCA genes are thus preempted from all future uses of a natural product.

“Because the removal process is a prerequisite to any exploitation of native DNA, respondents' isolated DNA claims are the practical equivalent of patents on the underlying naturally occurring BRCA genes themselves,” the brief contended in summary.

Mayo's Useful Guidance

The government further cited Mayo for support of its view, though unlike the petitioners, it never mentioned the “inventive concept” requirement.

Instead, despite the fact that Mayo involved method rather than composition claims, the brief argued that Mayo “provides useful guidance for determining whether particular modifications to a naturally occurring substance are sufficient to render the modified substance patent-eligible.”

Mayo also involved a “law of nature” exception to patent eligibility rather than the “product of nature” exception at issue in Myriad. Agreeing with the ACLU on this issue, the government saw a parallel between those two judicially created exceptions to patentability--“abstract idea” is the third--as well.

“The law-of-nature and product-of-nature exceptions to Section 101 do, however, reflect the same basic principle: a person should not receive a patent for simply discovering the existence and useful properties of something that already exists in nature,” according to the brief.

Tying the two together, the brief said in summary, “A composition claim that effectively prevents the public from studying and using a product of nature is just as objectionable as a method claim that prevents the public from studying and exploiting a law of nature.”

Government Recommends Without PTO Authors

The brief was once again notable for having no names of PTO counsel listed.

The PTO was a defendant early in the case, as the ACLU had made constitutionality claims as well. In its argument at the district court, the PTO defended the 2001 Utility Examination Guidelines (66 Fed. Reg. 1,092 (Jan. 5, 2001)) that declared isolated DNA patent eligible.

“The district court's judgment in this case, however, prompted the United States to reevaluate whether such patents are consistent with the settled principle that patent protection does not extend to products of nature,” the government said in the current brief. “Based on that review, the United States concluded that, although the PTO has properly issued patents on cDNA and other synthesized genetic materials, isolated DNA is not patent-eligible subject matter.”

In the first oral argument before the appeals court, the government stated explicitly that “the PTO has been wrong” in issuing patents on isolated DNA (65 PTD, 4/5/11). The current brief is not so explicit, arguing instead that the PTO's Utility Examination Guidelines were in response to a question of the “utility” requirement of Section 101.

The PTO's history on the issue is relevant in that Judge Kimberly A. Moore's concurrence relied to some extent on the settled expectations of the patent community in light of the PTO's guidelines.

The government's brief argued that the current case is the first to test the PTO's guidelines, and that those settled expectations carry no more force than the expectation of a typical patent owner whose patent might eventually be found invalid. According to the brief, “this case is therefore unlike prior patent-law disputes where the Court has given weight to reliance interests engendered by established judicially-created doctrines.”

Active Pro-ACLU Amicus Briefing

In addition to the government's contribution, 22 amicus briefs were filed in the Jan. 28-31 period. Thirteen supported the ACLU's position:

• AARP, filed by Barbara A. Jones of AARP Foundation Litigation, Pasadena, Calif.;

• American Medical Association, by Lori B. Andrews of the Chicago-Kent College of Law at the Illinois Institute of Technology, Chicago;

• Canavan Foundation, by John Lawrence Hendricks of Hitchcock Evert, Dallas;

• Ethics & Religious Liberty Commission of the Southern Baptist Convention and D. Brian Scarnecchia, filed by Sarah M. Shalf of the Emory Law School, Atlanta, Ga.;

• fifteen law professors, by Joshua D. Sarnoff of the DePaul University College of Law, Chicago;

• GeneDx and law professors, by Aaron X. Fellmeth of Scottsdale, Ariz.;

• Genformatic L.L.C., by Earl Landers Vickery of Austin, Texas;

• International Center for Technology Assessment, by George A. Kimbrell of the Center for Food Safety, San Francisco;

• InVitae Corp., by William Paul Atkins of Pillsbury Winthrop Shaw, McLean, Va.;

• Eileen Marie Kane, professor at the Penn State Dickinson School of Law, University Park, Pa.;

• Knowledge Ecology International, Washington, D.C., by staff attorney Krista L. Cox;

• Kali Nicole Murray of the Marquette University Law School, Milwaukee, and Erika R. George of the University of Utah, Salt Lake City; and

• National Women's Health Network, by Debra L. Greenfield of the University of California, Los Angeles.

The AARP, the AMA, Kane, KEI, and the NWHN all filed briefs before the Federal Circuit as well (117 PTD, 6/19/12).

The medical services community has repeatedly submitted briefs supporting the patent challengers. Joining the AMA in its brief were the American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, and Medical Society of the State of New York.

AIPLA, Watson Generally Support Myriad

Nine of the amicus briefs supported neither party:

• academics in law, medicine, health policy, and clinical genetics, including E. Richard Gold, professor of law at McGill University, Montreal, Canada;

• American Intellectual Property Law Association, filed by Barbara R. Rudolph of Washington, D.C.;

• CLS Bank International, by Mark A. Perry of Gibson Dunn & Crutcher, Washington, D.C.;

• Fédération Internationale des Conseils en Propriété Intellectuelle, by Maxim H. Waldbaum of Eaton & Van Winkle, New York;

• Institute of Professional Representatives Before the European Patent Office, in a brief which simply referred the court to a 2009 declaration in the case by Joseph Straus, former chair of the Intellectual Property Rights Committee of the Human Genome Organization;

• Paul R. Juhasz of Houston, for himself;

• on behalf of Eric S. Lander, filed by Gideon A. Schor of Wilson Sonsini Goodrich & Rosati, New York;

• Sigram Schindler Beteiligungs G.m.b.H., by Chidambaram S. Iyer of Washington, D.C.; and

• on behalf of James D. Watson, by Matthew James Dowd of Wiley Rein, Washington, D.C.

Watson and colleague Francis Crick discovered the double helix structure of DNA and were awarded the Nobel Prize in Physiology of Medicine in 1962.

Lander identified himself as one of the principal leaders of the Human Genome Project and now has research and teaching positions at Harvard University and the Massachusetts Institute of Technology.

CLS Bank is the patent challenger in a Section 101 case--patents on computer-based inventions are at issue--under review by the Federal Circuit sitting en banc. CLS Bank International v. Alice Corp., No. 2011-1301 (Fed. Cir., argued Feb. 8, 2013).

Can Experimental Use Exception Apply?

The AIPLA and 15 law professors' briefs addressed one point that could become an issue in the case--the extent to which the “experimental use exemption” may resolve the preemption argument.

The AIPLA cited Madey v. Duke University, 307 F.3d 1351, 64 U.S.P.Q.2d 1737 (Fed. Cir. 2002)(28 PTD, 2/11/13), in saying that “[t]his experimental use exception applies to non-commercial research, such as that conducted in not-for-profit university laboratories.”

However, the professors contended that there has been a “recent radical restriction of the scope of the experimental use 'exception' to infringement,” citing three cases, including Madey. And the AMA, in a prior brief but not the one filed in January, argued that the Federal Circuit rendered the exemption “for all practical purposes a nullity” in Madey.

By Tony Dutra  

Text of the ACLU brief is available at

Text of the U.S. brief is available at

Texts of amicus briefs are available at

Request Intellectual Property on Bloomberg Law