Caught between a Rock and a Hard Place:

Patenting in the Life Sciences and the Written Description Requirement

July 1, 2019

Regardless of whether a life science company is a biotech start-up or a pharmaceutical giant, its patents are the keys to the kingdom.1 In the post-AIA, “first-to-file” world, quickly filing a patent application is more critical than ever.2 Rushing to file, though, comes with real risk. Applicants seeking patents on emerging life science technologies, like gene-editing, immunotherapy, and RNA interference, often face written description rejections at the Patent Office.3 Further, even when an inventor successfully obtains claims based on an early filing, those patents may not survive a written description challenge brought by a competitor.4

Originally Published on the AIPLA website in connection with the 2019 Spring Meeting

Houldsworth, A., Pharma Patent Owners in the US are under Pressure Like They Have Never Been Before, IAM (Nov. 26,
See Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229, slip op. at 1 (U.S. Jan. 22, 2019) (explaining that the meaning of “on-sale” was not altered by the America Invents Act (“AIA”), and that even a “secret sale” may invalidate a patent); 35 U.S.C. 102(a)(1), (2) (setting forth the requirements for novelty under the AIA by reference to effective filing dates).
See Application No. 15/316,792, Improved T Cell Compositions, Final Rejection dated Nov. 14, 2018 at 12-13 (rejecting claims for the transduction of T cells in the presence of a PI3K inhibitor because the specification only supports exposing T cells to the inhibitor during the activation or stimulation phases); Application No. 13/842,859, Methods and Compositions for RNA-Directed Target DNA Modification and for RNA-Directed Modulation of Transcription, Non-Final Rejection dated Sept. 15, 2015 at 4 (rejecting claims to a modified Cas9 protein that cleaves only one strand of DNA because the claims read on a broad genus of modifications and the specification did not sufficiently describe a representative number of modifications); Application No. 
10/832,432, RNA Interference Mediating Small RNA Molecules, Applicant Remarks dated Oct. 25, 2005 at 7 (arguing that the disclosure of an RNA strand that is 19-25 nucleotides in length, with one, 3’ nucleotide overhang clearly encompasses a claimed, double stranded RNA that is 16-22 nucleotides in length).
See, e.g., FWP IP Aps v. Biogen MA, Inc., No. 2017-2019, 2018 U.S. App. LEXIS 29943 (Fed. Cir. Oct. 24, 2018); Otonomy, Inc. v. Auris Med., AG, 2017-1850, 2017-1880, 2018 U.S. App. LEXIS 21569 (Fed. Cir. Aug. 1, 2018).


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Sharon Roberg-Parez

Former Partner

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