By Donald Zuhn —
In an article published in The Huffington Post on Sunday, Wake Forest University Law Professor Simone Rose accuses the Federal Circuit of failing in its duty as "keeper of the Constitution" with respect to the Court's July 29 decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office. Noting her background as a former registered patent attorney, Professor Rose writes that one question came to mind as she read the majority and concurring opinions, namely "[h]ow can the court allow chemical differences to supersede biological equivalence when the specific utility of the invention, namely detecting mutations linked to breast and ovarian cancer, depends on biological identity?" She argues that "[c]hemically modifying an isolated gene [i.e., "breaking . . . chemical bonds during the isolation process"] does not alter its biological heart (nucleotide sequence)," and that "[a]ccurately detecting BRCA mutations would be impossible without this biological identity."
As for the focus by the majority and concurring opinions on long-standing USPTO practice in issuing gene patents and on the impact an affirmance would have had on the biotech industry, Professor Rose (at left) contends that while "promoting innovation is a laudable goal, the Federal Circuit's broadening of what constitutes patent-eligible subject matter missed the bigger Constitutional target." According to the Professor, the Constitution's Patent Clause requires that the granting of exclusive rights under the patent system be balanced against providing access to basic knowledge. She therefore concludes that "[p]atenting products of nature such as isolated genes and gene sequences prevents access to these basic research tools during the term of the patent," and "[t]his impedes rather than promotes progress and is therefore in direct violation of the IP clause."
Professor Rose argues that federal courts have an obligation, as "keepers of the Constitution," to ensure that their analysis of 35 U.S.C. § 101 and controlling case law is "in harmony with the Constitutional mandate to promote progress of the useful arts." She contends that in AMP v. USPTO, "[t]he Federal Circuit should have taken this role seriously and upheld the lower court's invalidation of the BRCA isolated genes and gene sequence patents as patent-ineligible subject matter."
Interestingly, for Professor Rose, the end result of the invalidation of Myriad's patents would be Congress weighing in on the issue of gene patenting. Unlike the majority and concurring opinions, which state that if the law is to be changed, it is up to Congress and not the courts to change it, Professor Rose believes that a finding by the Federal Circuit of invalidity would have permitted (or encouraged) Congress to step in and "legislate a new 'Constitutional' framework of exclusive rights for this subject matter." Looking forward, the Professor says that she remains "hopeful" that the Federal Circuit sitting en banc or the Supreme Court "will be mindful of its role as the keeper of the Constitution and interpret the Patent Act's subject matter limitation to exclude the BRCA genes as patent-ineligible products of nature." She argues that an "appropriate legislative dialogue" on a solution that balances access and innovation can only begin after the courts determine that gene patents should be excluded as patent-eligible subject matter.
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