REGENXBIO

Copyright/Patent/Trademark

Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability. Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences

TargetedSENATE · HOUSE OF REPRESENTATIVES · Health & Human Services, Dept of (HHS) · Justice, Dept of (DOJ) · State, Dept of (DOS) · Patent & Trademark Office (PTO) · Food & Drug Administration (FDA) · Centers For Medicare and Medicaid Services (CMS) · Homeland Security, Dept of (DHS)

Health Issues

Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation. Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.