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Caught between a Rock and a Hard Place: Patenting in the Life Sciences and the Written Description Requirement

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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


1 Houldsworth, A., Pharma Patent Owners in the US are under Pressure Like They Have Never Been Before, IAM (Nov. 26,
2018), https://www.iam-media.com/law-policy/us-pharma-patent-owners-under-pressure-never.
2 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).
3 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).
4 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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