By Donald Zuhn --
In one of nine amicus briefs filed in late October in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case, amici Rosetta Genomics Ltd., Rosetta Genetics, Inc., and George Mason University focus solely on the patentability of Myriad's isolated DNA claims, and conclude that "isolated DNA composition claims, such as the ones at issue in this case, correspond to patentable subject matter under 35 U.S.C. § 101" (see brief). Amici begin by noting that the Myriad case has "generated significant public comment regarding so called 'gene patents.'" and that "[t]he ACLU and Plaintiffs-Appellees have welcomed, and in fact encouraged, the public attention and resulting controversy." The brief argues that Plaintiffs-Appellees' "simplistic viewpoint" of seeking judicial abolition of gene patents as a way of resolving public policy questions "mischaracterizes and misunderstands what motivates scientific innovation, and ignores the high cost and risks of failure associated with placing any medical product into the hands of doctors and patients." The brief addresses two issues: how the judicial abolition of gene patents will deter and not stimulate innovation, and why isolated DNA claims constitute patentable subject matter under § 101.
With regard to the first issue, amici argue that "[c]ontrary to Plaintiffs-Appellees short-sighted view, abolishing patents on genetic inventions will have more of a dampening effect on research and development ('R&D') in relevant medical fields than any patent right could ever have." According to the brief, absent the funding incentive provided by patents for "'translating' a specific innovation into a viable benefit for patients, . . . the entire U.S. system for developing biomedical therapies for patient use will become unworkable, as it necessarily will lead to a significant financial loss for any initial innovator." Amici argue that "[t]his significant loss will occur, not in small part, due to the fact that other non-innovating for-profit entities will have every incentive to piggyback and freeload off the significant effort and investment of original innovators." Without gene patents, the brief predicts a world in which "[b]iotech/pharma companies, who are otherwise solely responsible for getting products to doctors and patients, will have neither the finances nor the potential of future returns needed to attract necessary investment to support continued efforts to innovate."
While amici note that the District Court acknowledged the "deep disagreement" regarding the impact of gene patents on innovation, the brief also notes that the Court "[n]evertheless . . . apparently summarily assumes that gene patents negatively impact scientific knowledge and innovation in biotech and biomedical fields." To support this assumption, the Court refers to two studies offered by Plaintiffs-Appellees: the Murray study and the Cho study. Amici contend, however, that "[t]he district court does not consider nor critique whether the methodology used in the Murray study actually provides relevant information," and "the Cho study reports the perceptions of certain basic researchers regarding the impact of patents on their research, but does not explore the validity of those perceptions" (emphasis in original). Amici argue that "[o]ne should not dictate patent policy based on perceptions that are not grounded in legal reality," adding that both studies "fail[] to illuminate whether gene patents actually increase or decrease public knowledge and innovation." With respect to the impact on innovation of the patents at issue in the case, amici convincingly point out that:
Over 18,000 scientists have conducted research on the BRCA1 and BRCA2 genes, and have published more than 7,000 papers on those genes since Myriad's patents issued. Such scientists include eight Plaintiffs-Appellees and their declarants in this case, who have themselves published over 48 scientific papers on the BRCA1 and BRCA2 genes.
Moving to the brief's second issue -- why isolated DNA claims constitute patentable subject matter under § 101 -- amici note that the District Court's decision "heavily relies on the notion that DNA are 'physical carriers of information.'" Notwithstanding the District Court's creation "for the first time [of] a new and devastatingly sweeping interpretation of the law, [that is] in direct contradiction to Supreme Court precedent," amici suggest that "[m]any other naturally-occurring molecules manifest 'a physical embodiment of information." As but one example, amici propose an amino acid sequence of a protein, which determines the protein's three-dimensional structure and biological properties.
Turning to Judge Dyk's concurring-in-part and dissenting-in-part opinion in Intervet Inc. v. Merial Ltd., which questions whether isolated DNA claims are patentable under § 101, amici believe the opinion is noteworthy because it provides one Judge's thoughts on the issue and indicates which cases Judge Dyk believes are most relevant (i.e., Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)). Amici contend that "[t]he science at hand makes it abundantly clear that an isolated DNA composition 'is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty.'" In particular, the brief states that "[l]ike the man-made bacteria in Chakrabarty, 'isolated DNA' differs chemically in size and composition from anything that naturally exists in nature," and "[c]ontrary to Plaintiffs-Appellees' scientifically erroneous assertions to the district court, the human body does not have a mechanism for isolating DNA, and consequently, isolated DNA is not found in the body." In addition, amici argue that "[i]solated DNA do not merely 'serve the ends nature originally provided,'" but rather have "a vast number of other uses and properties, [which] are unique to isolated DNA and cannot be duplicated with naturally-occurring DNA." The brief lists the use of isolated DNA to make purified proteins by recombinant means, as primers to synthesize DNA in PCR, to create transgenic animals, and in the diagnosis of disease as a few of these other uses.
In support of their argument that isolated DNA claims constitute patentable subject matter under § 101, amici note that the "[o]ver nearly twenty years, the USPTO has issued tens of thousands of patents directed to isolated nucleic acids." The brief indicates that in the past 17 years, 23,710 patents have been issued that have claims reciting "(isolated or purified) and (nucleotide or DNA or RNA or 'nucleic acid' or 'SEQ ID NO')," and 35,504 patents have been issued that have claims reciting "SEQ ID NO." Despite this large number of patents, the brief states that an ALLFEDS search for decisions including the terms "(patent) and (isolated or purified) and (nucleotide or DNA or RNA or "nucleic acid" or "SEQ ID NO")" identified only 204 cases. Thus, amici argue that their data appear to confirm a Nature editiorial that "[r]eports of researchers being blocked from access to patented DNA sequences or being sued for infringement are extremely rare." Amici also point to Congress' failure to pass H.R. 977 as supportive of their position (see "Science Progress Article Examines Impact of Gene Patents on Research" and "The Continuing Threat to Human Gene Patenting"). Lastly, the brief discusses Judge Learned Hand's determination in Parke-Davis & Co. v. HK. Mulford & Co., 189 F. 95 (S.D.N.Y. 1911), that claims directed to purified adrenaline were patentable, stating that:
"[The inventor] was the first to make it available for any use by removing it from the other gland-tissue. . . . It became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.
Amici suggest that similarly, "it was not until identification and purification of the BRCA1 and BRCA2 genes that the isolated nucleotide sequences could be used in a variety of highly important and beneficial methods including disease diagnosis."
For additional information regarding this and other related topics, please see:
• "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
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