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The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular standard of § 112(a) into two separate requirements, namely “enablement” and “written description”, and by going a step further to treat enablement as a question of law when no such distinction was ever envisaged by Congress or held by the Supreme Court. This judicially created approach in recent years has set aside over a century of patent practice to now make it exceedingly difficult to obtain meaningful patent protection for biopharmaceutical innovations and as a result has impeded investment and progress for developing lifesaving treatments. This article examines this legal scheme and highlights why changes to current patent disclosure laws and a return to a single 35 U.S.C. § 112(a) standard is necessary to avoid disrupting and inhibiting future innovation in the essential fields of pharmaceuticals and biotechnology.


21 UIC REV. INTELL. PROP. L. 121 (2022)