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Myriad: 'Human Invention' Separates Product of Nature, Patentable Isolated DNA

Friday, March 22, 2013
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By Tony Dutra – Mar 22, 2013

Judicially created exceptions to patent eligibility, such as a “product of nature,” exclude only things that lack human intervention, according to a March 11 respondents’ brief filed by isolated DNA patent holder Myriad Genetics Inc. (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, respondent brief filed 3/7/13).

The company, challenged by the American Civil Liberties Union and the Public Patent Foundation, acknowledged other arguments in favor of allowing isolated DNA claims to pass the filter of 35 U.S.C. §101. However, the brief relied more on the human ingenuity involved in its “identification, definition, and isolation” of the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer.

The high court has 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 PubPat on behalf of several associations and individual plaintiffs (78 PTCJ 64, 5/15/09).

They argued that 15 claims in seven 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 were ineligible for patenting under Section 101.

In its first decision in 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 (82 PTCJ 449, 8/5/11).

Then, in 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) (83 PTCJ 727, 3/23/12), 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 (83 PTCJ 761, 3/30/12).

On remand, 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) (84 PTCJ 696, 8/24/12).

The ACLU petitioned again for certiorari (84 PTCJ 901, 9/28/12). 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?” (85 PTCJ 165, 12/7/12).

ACLU, PUBPAT SAY DNA A ‘PRODUCT OF NATURE.’
Christopher A. Hansen, staff attorney with the ACLU’s Speech, Privacy, and Technology Project, filed the petitioners’ brief on the merits Jan. 23 (85 PTCJ 447, 2/1/13).

The petitioners’ primary argument was that the Supreme Court has repeatedly distinguished “a product or law of nature” as unpatentable under Section 101, and that Myriad’s isolated DNA claims—in a form representative of claims the PTO has granted in thousands of patents—were ineligible for patenting under every test the court has identified.

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 U.S. government, apparently still without buy-in from the Patent and Trademark Office, filed a brief recommending against patent eligibility (85 PTCJ 600, 3/8/13).

The government, which had argued separately before the Federal Circuit as well, continued to compare patent eligible cDNA claims and ineligible isolated DNA claims—a distinction both the ACLU and Myriad have rejected, albeit with opposite arguments. The U.S. brief labeled the former “synthetic molecules built by scientists” and the latter “isolated but otherwise unmodified human genomic DNA.”

The government also 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 pre-empted from all future uses of a natural product.

Twenty-two additional briefs by friends of the court—most supporting the ACLU’s challenge in the case—were filed along with the plaintiff’s opening brief (85 PTCJ 600, 3/8/13).

THREE-PART ACLU TEST CUMBERSOME AND AMBIGUOUS
Myriad’s brief, filed by Gregory A. Castanias of Jones Day, Washington, D.C., claimed that the ACLU’s reasoning required application of a “cumbersome three-part test”—the “inventive concept” requirement of Mayo; a “markedly different characteristics” test from Diamond v. Chakrabarty, 447 U.S. 303, 206 U.S.P.Q. 193 (1980); and the “pre-emption” test that the government had highlighted.

“These formulations possess neither the crispness nor the legal accuracy required to determine whether a composition is the product of human ingenuity,” Myriad said.

Instead, it argued, the Supreme Court has ruled only that Section 101 contains an “implicit exception[:] ‘[L]aws of nature, natural phenomena, and abstract ideas’ are not patentable,” as repeated in Mayo, 132 S. Ct. at 1293.

“The touchstone of this implicit exception is the absence of human ‘invention,’ ” Myriad asserted.

The brief argued that the invention requirement under Section 101 parallels the “minimal level of creativity” threshold of copyright law, enhanced by “more nuanced” analysis for obviousness under Section 103 and other barriers to patentability.

MYRIAD’S HUMAN INGENUITY ON THREE LEVELS
The invention of Myriad here, according to brief, was that it had “successfully identified, defined, and isolated the BRCA molecules …. This momentous scientific advancement displayed Myriad’s inventor’s significant scientific skill, insight, and invention.”

The company claimed the following as its inventions:


  • That its researchers were able to “define and locate the precise genetic regions associated with mutations predisposing a patient to breast and ovarian cancers”;

  • That “Building on this foundation, Myriad then studied the BRCA genes to identify their particular structures, attributes, and characteristics”;

  • And, that with this understanding, the final step was to “improve existing techniques for diagnosing an individual’s hereditary cancer risk by designing isolated DNA molecules and producing them in the laboratory.”


“The creation of new molecules never before available to the public is invention,” Myriad stated, in summary.
DON’T UPSET SETTLED EXPECTATIONS
The second most prominent argument in the Myriad brief was related to “the investing and inventing communities’ settled expectations” since Chakrabarty and more particularly since the PTO’s 2011 Final Examiner Guidelines on Utility Requirement, 66 Fed. Reg. 1,092 (Jan. 5, 2001) (61 PTCJ 252, 1/12/01; 61 PTCJ 262, 1/12/01).

“The USPTO has granted over 40,000 patents drawn to genetic material, almost 3,000 of which are specifically directed to isolated DNA molecules,” according to the brief.

The patent owner said that the Supreme Court should not “depar[t] from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another,” quoting from Mayo‘s holding regarding the reverse situation of patent ineligibility.

In fact, Myriad said that the instant case was “the mirror image of Mayo,” featuring “the established rule for over 100 years … that isolates or extracts from natural materials that reflect human invention are eligible for patents, and the USPTO and courts have concluded for over 30 years that particular claimed isolated DNA molecules reflect patent-eligible human ingenuity.”

Myriad also used the argument on settled expectations to counter the government’s proposed distinction between DNA and cDNA. Pointing to the fact that the PTO had not signed on to the brief—unprecedented in patent cases at least since the Federal Circuit’s 1982 creation, according to Myriad—there was “no basis for the United States’ appellate lawyers to substitute their judgment for that of the USPTO, the agency with relevant expertise.”

MYRIAD PROVIDES CLAIM CONSTRUCTION
A continuing issue in the case is related to the scope of the claims. The district court essentially reduced the claims to the information content of the isolated DNA (79 PTCJ 661, 4/2/10). None of the three Federal Circuit opinions accepted that characterization, but neither did they provide detail on what the claims covered. Myriad offered its own claim construction on pages 10-12 of the brief.

By Tony Dutra – March 22, 2013The Myriad brief also devoted five pages to contesting standing in the case, even though the Supreme Court had not certified the related question. The Federal Circuit held that only one plaintiff had standing, a genetic researcher named Harry Ostrer. Myriad referred to “Ostrer” throughout the brief as the petitioner in the case.

“In short, this is a lawyer-driven case with no concrete interest to support a declaratory-judgment action,” it concluded.

PRO-MYRIAD AMICUS SUPPORT
Prior to Myriad’s filing, nine of the amicus briefs supported neither party, though some clearly tilted to Myriad’s side. The American Intellectual Property Law Association, for example, said, “the Federal Circuit correctly held that the claimed isolated DNA molecules passed muster under section 101.”

Twenty-three amicus briefs were filed in the March 11-14 period explicitly expressing support for Myriad’s position:


  • the American Bar Association, in a brief filed by current ABA President Laurel G. Bellows;

  • the Animal Health Institute and Merial Ltd., filed by Judy de Leon Jarecki-Black of Merial, Duluth, Ga;

  • the Association of American Physicians and Surgeons, by David P. Felsher of New York;

  • the Boston Patent Law Association, by Erik Paul Belt of McCarter English, Boston;

  • Ananda Mohan Chakrabarty, the inventor in the 1980 case that enabled biotechnology patents, in a brief filed by Jonathan E. Singer of Fish & Richardson, Minneapolis;

  • the Coalition for 21st Century Medicine, by Jeffrey A. Lamken of MoloLamken, Washington, D.C.;

  • CropLife International, by Evan A. Young of Baker Botts, Austin, Texas;

  • the Federal Circuit Bar Association, by Claire Laporte of Foley Hoag, Boston;

  • the Franklin Pierce Center for Intellectual Property, by Ann M. McCrackin of Schwegman, Lundberg & Woessner, Minneapolis;

  • physicians Larry Geier, William Harb, Adam Ofer, and Donald Aptekar, filed by Matthew S. Hellman of Jenner & Block, New York;

  • Genetech Inc., by Seth P. Waxman of Wilmer Cutler Pickering Hale & Dorr, Washington, D.C.;

  • Immatics Biotechnologies G.m.b.H., by Kristine L. Roberts of Baker Donelson, Memphis;

  • the Intellectual Property Owners Association, by Paul H. Berghoff of McDonnell Boehnen Hulbert & Berghoff, Chicago;

  • Jeffrey A. Lefstin, a law professor at the University of California, Hastings College of the Law, San Francisco, filed by Kevin B. Laurence of Stoel Rives, Salt Lake City;

  • Lynch Syndrome International, whose brief was not available;

  • MPEG LA L.L.C., by Daryl L. Joseffer of King & Spalding, Washington, D.C.;

  • the NanoBusiness Commercialization Association, by Andrew S. Baluch of Foley & Lardner, Washington, D.C.;

  • the National Venture Capital Association, by Lynn H. Pasahow of Fenwick & West, Mountain View, Calif.;

  • the New York Intellectual Property Law Association, by Matthew B. McFarlane of Robins, Kaplan, Miller & Ciresi, New York;

  • the Pharmaceutical Research and Manufacturers of America, by Kurt G. Calia of Covington & Burling, Redwood Shore, Calif.;

  • the Philadelphia Intellectual Property Law Association, by Paul F. Prestia of Ratner Prestia, Brewyn, Pa.;

  • Target Discovery Inc., by David S. Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, D.C.; and

  • the University of Baltimore/Johns Hopkins University Center for Medicine and Law, by Bruce D. Abramson of the Rimon law firm, San Francisco.


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