4th Quarter - Report — REGENXBIO for REGENXBIO (2020)

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.

Copyright/Patent/Trademark CPT

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. Participated in meetings of the Section 101 Workgroup and Senate staff in preparation for discussion of legislative response to certain patent issues related to Section 101.

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

Health Issues HCR

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. Activities included responding to Interim Final Rule known as the "Most Favored Nation" reimbursement system for certain Part B drugs. 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.

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

Immigration IMM

Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries. Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.

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

Trade (domestic/foreign) TRD

Data protection period for biologic medicines as affected by the proposed USMCA trade agreement. Planned trade related activities for new Administration and 117th Congress.

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

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.