Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights
We write with the concern that under the statutory patent dispute resolution scheme, biosimilars sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification. As universities are commonly licensors of biological products, numerous university patents may be affected by biosimilar applications. We do not believe it is appropriate that our member institutions’ rights could be forfeited due to an inadvertent or intentional failure by a biosimilar applicant to notify the reference product sponsor, who in turn can notify the university licensor.</p>
Dear Commissioner Hamburg:
- The American Council on Education (ACE), representing the presidents of 1,800 U.S. accredited, degree-granting institutions, which include two- and four-year colleges, private and public universities, and higher education associations.
- The Association of American Medical Colleges (AAMC), a not-for-profit association representing all 141 accredited U.S. medical schools and 17 accredited Canadian Medical Schools; nearly 400 major teaching hospitals and health systems, and 90 academic and scientific societies.
- The Association of American Universities (AAU), an association of 59 U.S. and two Canadian preeminent research universities organized to develop and implement effective national and institutional policies supporting research and scholarship, graduate and undergraduate education, and public service in research universities.
- The Association of Public and Land-grant Universities (APLU), a research and advocacy organization of public research universities, land-grant institutions, and state university systems with member campuses in all 50 states, U.S. territories and the District of Columbia.
- The Association of University Technology Managers (AUTM), a global network of members from more than 350 universities, research institutions, teaching hospitals and government agencies as well as hundreds of companies involved with managing and licensing innovations derived from academic and nonprofit research.
- The Council on Governmental Relations (COGR), an association of 190 U.S. research universities and their affiliated academic medical centers and research institutes that concerns itself with the impact of federal regulations, policies and practices on the performance of research and other sponsored activities conducted at its member institutions.