4th Quarter - Report — REGENXBIO for REGENXBIO (2021)

Firm

REGENXBIO

Client

REGENXBIO

Income

—

Expenses

$60,000

Expense method

A: Lobbying Disclosure Act definitions

What was lobbied

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

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.

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

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.

Lobbyist	Covered 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); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Justice, Dept of (DOJ); Health & Human Services, Dept of (HHS); Homeland Security, Dept of (DHS); State, Dept of (DOS); Food & Drug Administration (FDA)

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

Health Issues HCR

Development of Value Based Agreement (VBA) legislation. 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. Advocated in favor of a VBA amendment offered during the House E&C markup of the BBB bill. Participated in strategy sessions related to confirmation hearing for the Commissioner of Food and Drugs nominee.

Lobbyist	Covered 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; State, Dept of (DOS); Justice, Dept of (DOJ); Centers For Medicare and Medicaid Services (CMS); Homeland Security, Dept of (DHS); Patent & Trademark Office (PTO); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS)

Bills named: H.R. 3 (117th), S. 2543 (117th), H.R. 19 (117th)

Immigration IMM

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

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