By Sherri Oslick --
On Tuesday morning, attendees at the BIO International Convention had the opportunity to attend a session entitled "The Myriad Case and the Patentability of Isolated DNA Molecules," presented by the team from Wilmer Hale that submitted a joint amicus curiae brief to the Federal Circuit on behalf of BIO and the Association of University Technology Managers (AUTM) (see "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO"). The presentation was well organized and well presented, and struck a balance so as to appeal to both those familiar with the case as well as those who may not have been. The slides from the presentation can be found here.
The session was introduced by Seth Waxman, former Solicitor General of the United States. Mr. Waxman noted that there is relatively little law with regard to the patentability of isolated and purified DNA molecules, and that while the USPTO struggled with the standards for examining applications claiming such molecules, ultimately the USPTO issued generally permissive guidelines. The Myriad case was described by Mr. Waxman as a "frontal challenge" to the patentability of isolated and purified DNA molecules.
Mark Fleming provided the historical context of the case, which involves fifteen claims in seven patents covering isolated DNA molecules linked to breast cancer (BRCA1/BRCA2), including methods for detecting mutations in these genes. The claims at issue were challenged on three grounds, two constitutional grounds and the primary ground of patentability under 35 U.S.C. § 101. As Mr. Fleming pointed out, the parties named as plaintiffs in the case were well thought out by the ACLU, the entity behind the suit. There were four medical associations (led by AMP), eight physicians, two advocacy groups, and six patients who claimed they were unable to access the test for BRCA1/BRCA2 mutations due to Myriad's patents. Defendants included the patent owner (University of Utah Research Foundation) and Myriad Genetics as the exclusive licensee, and the USPTO, whose involvement was limited to the constitutional issues.
The case was decided on summary judgment by Judge Sweet of the Southern District of New York with a 153 page opinion finding the claims unpatentable. Judge Sweet's opinion centered around two basic principles: 1) that purification of a naturally occurring substance is not patentable; 2) however, if the naturally occurring substance is transformed and has "markedly different characteristics" from a product of nature, it is patentable subject matter. DNA, according to Judge Sweet's opinion, "carries genetic information" and is "the physical embodiment of laws of nature." In other words, isolated DNA is not different from naturally occurring DNA, and it is the fact that isolated DNA (like natural DNA) is a carrier of information that makes it useful, not the fact that it is isolated. As to the remaining issues, the method claims were found invalid under Bilski, the constitutional claims were dismissed without prejudice, and the challenge to plaintiffs' standing was rejected.
On appeal to the Federal Circuit, Mr. Fleming noted that the U.S. government took a Solomonic approach in its position, splitting the baby as it were, such that some DNA (engineered, including cDNA) was patentable and some (isolated and unmodified) was not. This, as Mr. Fleming advised, marked a radical change in the government's position, and in fact the government, who co-owned four of the seven patents at issue, was arguing that its own patents were invalid.
Allen Nunnally followed Mr. Fleming and presented the position of BIO in its amicus brief on the issue on appeal of the patentability of composition claims to isolated DNA molecules. BIO argued that both isolated DNA as well as cDNA was patentable, noting that § 101 of the Patent Act is broad and is only meant to be a threshold test to exclude laws of nature, physical phenomena, and abstract ideas. Isolated DNA molecules, in BIO's view, represent new compositions of matter that do not exist in nature, are clearly transformed (separated from carrier proteins, covalent bonds broken, etc.), and which differ from their natural counterparts; cDNA represents an even greater difference from naturally occurring DNA. As to the District Court's interpretation of DNA as "information," BIO noted that such a characterization was mere metaphor, and that, simply put, isolated DNA molecules were chemical compositions of matter. Further discussion centered on BIO's position that isolated DNA patents would not discourage innovation, that invalidating isolated DNA patents would have far-reaching negative consequences, and that isolated DNA patents do not impede research or harm patients.
Following Mr. Nunnally, Tom Saunders offered a lively presentation on the oral arguments in the appeal, held on April 4, 2011 with Judges Lourie, Bryson, and Moore on the panel. On the issue of the plaintiffs' standing to sue, the panel focused its inquiries on the adequacy of the affidavits used to establish standing. Mr. Saunders indicated that there was little relationship between the focus in oral arguments at the Federal Circuit and the focus at the District Court level, including a minimal focus at the Federal Circuit on the idea of DNA as information. Oral argument was dominated by hypotheticals, including those trying to analogize the isolated aspect of the claimed DNA molecules. Questions from the panel revealed that the judges were struggling on where to draw the line, where their opinion might have very far reaching implications without knowing what those implications might be. Overall, it was Mr. Saunders' assessment that the panel was leaning toward keeping the USPTO's precedent in finding isolated DNA molecules to be patentable.
Looking forward, with almost certainty there will be a request for rehearing en banc, followed by a petition for certiorari to the Supreme Court (all panel members agreed that the plaintiffs structured the case with the ultimate goal of Supreme Court review), and the possibility of Congress taking up the issue.
Overall, this BIO International Convention breakout session provided a well organized and balanced summary of the Myriad case from start to today, as we await a decision from the Federal Circuit.
Finally, Patent Docs would like to thank Mr. Saunders for providing access to the presentation slides, for allowing them to be shared with our readers, and for mentioning Patent Docs during the presentation.
For additional information regarding the AMP v. USPTO ("Myriad") case, please see:
• "AMP v. USPTO: Oral Argument at the Federal Circuit," April 4, 2011
• "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO -- Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO -- Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO -- Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO -- Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO -- Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying - Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th -- Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010