Sovereign Immunity, Intellectual Property, and the Life Sciences: Investigation and Analysis of the Preserving Access to Cost Effective Drugs Act

biotechnology;patent;USPTO;sovereign immunity;public;academic;PTAB;IPR;biology;biotech;law;patent law;PACED;inventorship

Spero, Esq., Alanna M. M.

University:Havard University

Department:Biology

关键词: biotechnology;    patent;    USPTO;    sovereign immunity;    public;    academic;    PTAB;    IPR;    biology;    biotech;    law;    patent law;    PACED;    inventorship;   

Others  :  https://dash.harvard.edu/bitstream/handle/1/42004073/SPEROESQ-DOCUMENT-2019.pdf?sequence=1&isAllowed=y

美国|英语

来源: Digital Access to Scholarship at Harvard

【 摘 要 】

Between 2011 and 2013, significant changes and case law decisions were made regarding United States Patent Law.These changes have added fuel to the criticism and discourse specifically within life sciences patenting.Areas of ongoing disagreement between patent examiners and authorities, industry leaders, and other inventors, including entities of both private and public inventorship, have included focus on the provisions of sovereign immunity and their application (or lack thereof) to patent prosecution and challenges.However,no set standard of sovereign immunity in patent law has beenconsistently and ubiquitously applied .Recently, the United States senate introduced S.2514, a bill known as “PACED” that, if passed, would deliver a vital blow to the ability of U.S. State Universities and academics’ ability to obtain and license patents. (Text: S.2514 — 115th Congress [2017-2018]).Despite the severity of consequences of PACED, little forethought has been investigated prior to the bill moving forward, as the bill purports to prevent private corporations from using the “sovereign immunity shield” granted to public entities. The aim of this investigation is to provide an objective analysis into the affordances of sovereign immunity, including their relevance and application to life sciences patent law, based on both the nature of life sciences in patent practice and the origination, history of application, and intent of sovereign immunity.