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U.C. Davis Business Law Journal




The biotechnology industry is one of the fastest growing fields in research and development. This may be attributed to the decision in Diamond v. Chakrabarty, where the Supreme Court held that a biotechnology invention was patent-eligible subject matter under 35 U.S.C. § 101. However, recent Supreme Court rulings have left the boundaries of § 101 uncertain, unworkable, and difficult for biotechnology industries to gain patent protections for their inventions. Before Congress enacted the AIA in 2011, the courts were the biggest influence on shaping the doctrine of patent eligible subject matter under § 101. But now with the new AIA post-grant proceedings, the PTAB plays an influential role in determining subject-matter eligibility.

Through the new AIA post-grant proceedings, the PTAB has the ability to hear petitions that challenge the validity of a patent under §§ 101, 102, 103, or 112. But after the recent decision in Praxair Distribution., Inc. v. Mallinckrodt Hospital Products IP Ltd., the PTAB may now begin exerting too much influence over the doctrine of § 101. This decision, a case heard in inter partes review, threatens to stretch the PTAB’s power dangerously thin. Under the AIA, cases reviewed in inter partes review may not present challenges on patentable subject matter under § 101. However, in Praxair, the PTAB used parts of a § 101 analysis to determine that the claims were ineligible subject matter. The Federal Circuit affirmed the PTAB’s reasoning, suggesting that PTAB may be able to expand the reach of § 101 and allow petitioners to bring eligibility claims in inter partes review—where it is statutorily not allowed. Overall, the PTAB’s power over eligible subject matter makes it easier for applications and patents to be invalidated under §101. This could particularly harm biotechnology and bioscience industries where patent protection is at a disadvantage.

This Note will discuss how the Supreme Court and PTAB have affected the subject-matter eligibility under § 101 and how this impacts patent rights for biotechnology innovation. Specifically, this Note will discuss how the PTAB’s decision in Praxair has expanded the scope of inter partes review and further added to the uncertainty of patentable subject matter.

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University of California - Davis

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