4th Quarter - Report

REGENXBIO for REGENXBIO

Firm
Client
Income
—
Expenses
$70,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

5 issue areas, each in the filer's own words, with who lobbied on it and where.

Health Issues HCR

Legislative proposals contained in year end Omnibus Appropriations Bill (H.R. 2617) including certain unenacted PDUFA "riders" such as clinical trial diversity and the FDA accelerated approval program.(H.R. 6696 and H.R. 6963.) In addition, provisions in the omnibus bill related to the funding of newborn screening programs as well as the enactment of a National Academy of Medicine study of NBS. Continued work on Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22.

LobbyistCovered position, as disclosed
BRUCE ARTIM Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Bills named: H.R. 6696 (117th), H.R. 6963 (117th), H.R. 7389 (117th), H.R. 2617 (117th)

Trade (domestic/foreign) TRD

Proposed Covid-19 IP waivers under consideration by the U.S. Congress, Biden Administration, World Health Organization and World Trade Organization, including proposals to expand the waiver beyond vaccines to therapeutics and diagnostic products. Retention of 12 years of regulatory data protection for biologics in international trade agreements.

LobbyistCovered position, as disclosed
BRUCE ARTIM Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: SENATE; HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO)

Copyright/Patent/Trademark CPT

Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

LobbyistCovered position, as disclosed
BRUCE ARTIM Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: Patent & Trademark Office (PTO); Justice, Dept of (DOJ); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 2884 (117th), S. 1435 (117th), H.R. 2883 (117th), S. 1428 (117th), S. 1425 (117th), H.R. 2873 (117th), S. 4430 (117th), H.R. 2891 (117th), S. 4734 (117th)

Immigration IMM

Monitoring for proposed changes in immigration laws affecting non-U.S. citizen scientists and their families.

LobbyistCovered position, as disclosed
BRUCE ARTIM Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: SENATE; Homeland Security, Dept of (DHS); HOUSE OF REPRESENTATIVES; State, Dept of (DOS)

Taxation/Internal Revenue Code TAX

Legislative proposals to reinstate direct expensing of R&D investment such as considered but not included in the year end Omnibus Appropriations bill, H.R.2167.

LobbyistCovered position, as disclosed
BRUCE ARTIM Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 2167 (117th)

Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.