By Donald Zuhn --
In an amicus brief filed on October 28 in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case, Alnylam Pharmaceuticals, Inc. supports reversal of the District Court's decision and asks the Federal Circuit "to provide clear guidance on patent-eligibility to remove the unnecessary cloud cast by the decision below." Alnylam begins its brief by noting that the biopharmaceutical company's "sole concern as amicus is to support the traditional interpretation of 'composition of matter' under Section 101 as embracing all forms of compositions -- including compositions which are derived from natural products and which derive their beneficial effect from their interactions with natural phenomena."
A large portion of Alnylam's brief is spent discussing the relevance of In re Bergy, 596 F.2d 952 (C.C.P.A. 1979), and Diamond v. Chakrabarty, 447 U.S. 303 (1980), to the Myriad appeal, and the irrelevance of decisions such as Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). With respect to Bergy and Chakrabarty, the brief states that:
The modern field of biotechnology has been domestically keyed to the landmark opinion In re Bergy, 596 F.2d 952 (C.C.P.A. 1979) (Rich, J.), and the imprimatur given Bergy through Supreme Court affirmance in Diamond v. Chakrabarty, 447 U.S. 303 (1980). These rulings kept the door of patenteligibility wide open for any "composition of matter" under 35 U.S.C. § 101 -- without prejudice as to whether an individual patent-eligible composition of matter was patentable based upon considerations of novelty, nonobviousness, formal matters or enforceability issues under 35 U.S.C. §§ 102, 103(a), 112, and 282(1).
Amicus further notes that "Bergy held that a microorganism, per se, is patent-eligible subject matter under Section 101, whether in the form of a biologically pure culture (Bergy) or a man-modified version (Chakrabarty)." In Chakrabarty, the Supreme Court determined that an engineered microorganism is patent-eligible under § 101 -- "the antithesis of the view taken by the district court here." Alnylam argues that "Chakrabarty is still good law and its holding is binding on this issue, while other cited precedent represents dicta in cases having nothing to do with patent-eligibility."
One of the cases having nothing to do with patent-eligibility, according to the brief, is Funk Bros. Seed Co., which instead "concerned a claim to a new mixture of individually old bacteria, analyzed under pre-1952 standards for nonobviousness, and is not relevant to today’s standards for patent-eligibility under Section 101 in light of Chakrabarty and Bergy." Amicus explains that:
Funk involved a claim to a garden variety "composition of matter" -- a new mixture of individually old bacteria -- that had absolutely nothing to do with what is today patent-eligibility under Section 101, but everything to do with whether there was patentable "invention" in the sense of the pre-1952 Hotchkiss [v. Greenwood, 52 U.S. (11 How.) 248 (1851),] test under what is now Section 103(a) nonobviousness.
The brief adds that "[p]rior to the 1952 Patent Act, an invention which was 'obvious' was instead termed to lack patentable 'invention," and that in Funk Bros. Seed Co., the Supreme Court found that the patent at issue "lacked 'invention' -- in other words, that it was obvious." Thus, "Funk has absolutely nothing whatsoever to do with patent-eligibility under 35 U.S.C. § 101." Alnylam finds support for this interpretation in Prof. Donald Chisum's treatise on patents, which states that "[Funk] is perhaps best viewed as an interpretation of the nonobviousness or 'invention' requirement, and not of the statutory classes of subject matter."
Because "[t]he patentable 'invention' of the claimed mixture of bacteria in Funk v. Kalo was said to reside in a secret of nature, wherefore, the invention was obvious -- or lacked 'invention,'" and this case did not concern the issue of patent-eligibility, Alnylam concludes that "chemical compounds (compositions of matter) are patent-eligible, even if they are analogous to those found in nature; even if they are keyed to or designed to operate via natural phenomena or processes; and even if they were discovered during research of those natural phenomena."
Amicus spends the last few pages of its brief explaining why "judicial exclusion of certain 'compositions of matter' from patent-eligibility would take an unambiguous term and move the United States into an interpretation of law that is inconsistent with its international treaty obligations, contrary to the rule laid down by Chief Justice John Marshall more than 200 years ago in Murray v. Schooner Charming Betsy, 6 U.S. (2 Cranch) 64 (1804)." The brief argues that:
To the extent that this Court does anything other than send a strong message of support for broad Bergy-based standards of patent-eligibility, the message would be transmitted around the world that the United States itself is not living up to the promise of TRIPS Article 27 to provide "patent rights enjoyable without discrimination as to . . . the field of technology[.]" TRIPS Agreement, art. 27(1).
For additional information regarding this and other related topics, please see:
• "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," October 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