1st Quarter - Report

REGENXBIO for REGENXBIO

Firm
Client
Income
—
Expenses
$163,000
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

Issues related to biotechnology firms engaged in developing gene therapies, including: Successor legislation to the 117th Congress Guthrie-Schrader MVP Act (H.R. 7389) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Amendments to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies.

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

Bills named: H.R. 7389 (118th)

Trade (domestic/foreign) TRD

Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics. Strong patent and regulatory data protection for biopharmaceuticals in 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: Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES

Copyright/Patent/Trademark CPT

Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations. Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products The ongoing PTO-FDA collaboration on drug pricing

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; Patent & Trademark Office (PTO); Food & Drug Administration (FDA); SENATE; Justice, Dept of (DOJ)

Immigration IMM

Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.

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

Proposals to allow the direct expensing on R&D expenditures, including the Hassan-Young bill, S.866, he American Innovation and Jobs Act.

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: S. 866 (118th)

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.