Academic journal article Harvard Law Review

Patent Act of 1952 - Patentable Subject Matter

Academic journal article Harvard Law Review

Patent Act of 1952 - Patentable Subject Matter

Article excerpt

The traditional account of patent law assumes that profits generated from patent exclusivity incentivize innovation. (1) However, many leading biotechnology innovators work for universities, government agencies, and nonprofit organizations; (2) these researchers may be driven by incentives including grant funding, academic recognition, and altruism. (3) Tensions among researchers in different sectors recently came to a head over the question of gene patentability: while for-profit companies insisted that they need patent exclusivity to attract capital investment, not-for-profit entities maintained that innovation requires a free flow of information. (4) Last Term, in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., (5) the Supreme Court took a middle ground, holding that molecules isolated from native DNA are not patent eligible, but certain molecules synthesized in a laboratory can be patented. (6) Focusing on rules derived from statutes and precedent, the Court did not discuss underlying incentives. Avoiding this policy debate was reasonable because reconciling disparate incentives for biotechnology research requires a legislative solution.

In 1990, researchers at the University of California, Berkeley, published a paper revealing the general location of a gene linked to breast cancer. (7) Soon after, a competing group of scientists founded Myriad Genetics and obtained more than $50 million in venture capital funding to pursue related research. (8) In 1994 and 1995, Myriad announced that it had located and sequenced two breast cancer susceptibility genes, now termed BRCA1 and BRCA2. (9) Myriad then developed clinical tests to detect BRCA gene mutations that correlate with a substantially higher risk of developing breast and ovarian cancer. (10)

Myriad obtained a variety of patents related to its discoveries. (11) While some of the patents covered testing methods (the "method claims"), others involved isolated DNA molecules and synthetic cDNA molecules (the "composition claims"). (12) Myriad's patents gave it the exclusive right to isolate the BRCA genes and to create BRCA cDNA. (13) And when other institutions infringed the patents, Myriad took aggressive enforcement action. (14) Since genetic testing requires gene isolation, the patents made Myriad the sole provider of BRCA1 and BRCA2 testing, (15) generating hundreds of millions in revenue. (16)

In 2009, a group of organizations and individuals filed suit under the Declaratory Judgment Act, (17) seeking to invalidate fifteen of Myriad's composition and method claims. (18) The plaintiffs included six nonprofit organizations that engage in research and advocacy, eight university-affiliated scientists whose work was impeded by Myriad's patents, and six individuals who were unable to obtain desired BRCA screenings because of Myriad's monopoly on testing. (19)

Aided by briefing from more than two dozen amici, (20) Judge Sweet of the Southern District of New York granted summary judgment for the plaintiffs. (21) In a prior proceeding, the court had found that all of the plaintiffs had standing. (22) Turning to the merits, the court noted that U.S. law allows patenting of "any new and useful process, machine, manufacture, or composition of matter." (23) To be patentable, an invention or discovery must satisfy three requirements: novelty, utility, and statutory subject matter. (24) This suit involved only the third requirement, generally termed "patent eligibility." (25) As the Supreme Court has determined, no one may patent "laws of nature, physical phenomena, and abstract ideas." (26) To be patent eligible, an invention must have "a distinctive name, character, or use." (27) Without this limitation, the law would provide "too much patent protection" and would "impede rather than 'promote'" scientific progress. (28)

Applying this standard, Judge Sweet found for the plaintiffs on all claims. (29) Starting with the composition claims, he argued that a "clear line" of Supreme Court precedent has established that "purification of a product of nature, without more, cannot transform it into patentable subject matter. …

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