2nd Quarter - Report

REGENXBIO for REGENXBIO

Firm
Client
Income
—
Expenses
$82,000
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 to reauthorize the FDA Prescription Drug User Fee Act (PDUFA),S.4348 and H.R. 7667, including "rider"amendments such as those pertaining to the FDA accelerated approval pathway (H.R. 6696 and H.R. 6963. Development of Value Based Agreement (VBA) legislation, H.R.7389, introduced by Reps. Schrader, Guthrie and Mullin on 4/4/22. Development of this Congress' versions of House and Senate drug pricing legislation (e.g., building upon last Congress' bills, including H.R. 3, H.R. 19, and S. 2543.), including drug pricing proposals under discussion as part of the Build Back Better reconciliation bill and in any revised versions of drug pricing legislation Congress is considering in 2022.

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

Bills named: H.R. 3 (117th), S. 2543 (117th), H.R. 6963 (117th), H.R. 19 (117th), H.R. 6696 (117th), H.R. 7389 (117th), H.R. 7667 (117th), S. 4348 (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. 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; Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES

Copyright/Patent/Trademark CPT

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. 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: Justice, Dept of (DOJ); SENATE; HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO)

Bills named: S. 1425 (117th), H.R. 2883 (117th), H.R. 2873 (117th), H.R. 2891 (117th), S. 4430 (117th), S. 1428 (117th), H.R. 2884 (117th), S. 1435 (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: Homeland Security, Dept of (DHS); State, Dept of (DOS); HOUSE OF REPRESENTATIVES; SENATE

Taxation/Internal Revenue Code TAX

Legislative proposals to reinstate direct expensing of R&D investment such as included in the draft Senate version of the Build Back Better legislation and in some versions of the "U.S.- China" competitiveness legislation.

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

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.