Biotechnology & the Patent Quid Pro Quo: When Is “This” Enough For “That”?

Abstract

Patents play a key role in incentivizing investment in life-saving therapeutic innovations. But, over the past fifteen years, courts have increasingly found patents to life science inventions invalid for insufficiently disclosing the invention. Patent law’s disclosure requirements are the inventor’s end of a quid pro quo bargain: in exchange for their disclosure, inventors receive a limited monopoly over their invention. The limited monopoly incentivizes the inventor to invest in their innovation, while the disclosure requirement encourages investment in innovation by enabling competitors to assess the proprietary landscape to determine where they can freely operate and where they should seek collaborations through licensing. Disclosure requirements balance these innovation incentives by requiring inventors to disclose enough based on the state of the art in the field. The recent string of life sciences patents invalidated for insufficient disclosure creates unpredictability and demands reliable methods to disclose enough. Drawing from recent Federal Circuit decisions, this Note identifies and evaluates methods to disclose enough under one prong of the patent disclosure requirement (the written description requirement) for a common type of claim to life science inventions subject to written description challenges (combination genus claims). Based on mismatches between current written description jurisprudence and the science it governs, this Note advocates for adoption of the policy- and science-aligned approaches to satisfy the written description requirement.

Details

Publisher:
Stanford University Stanford, California
Citation(s):
  • Christine R. O’Brien Laramy, Biotechnology & the Patent Quid Pro Quo: When Is “This” Enough For “That”?, 27 Stan. Tech. L. Rev. 264 (2024).
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