Weekly Policy Blog: Federal Update- Four New Pieces of Legislation Introduced

CBSA advocates for policies that allow patients to receive access to critical life-saving novel technologies. We applaud members of Colorado’s Congressional delegation for supporting patient access to tests that offer early detection of cancer. CBSA thanks Senator Michael Bennet for re-introducing the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act, (S. 2085) legislation alongside Sens. Mike Crapo (R-ID), Tim Scott (R-SC) and Ben Cardin (D-MD). This bill is a companion piece to H.R. 2407, and seeks to create a pathway for Medicare to cover multi-cancer early detection (MCED) screening tests once they are approved by the FDA. CBSA also thanks Representatives Jason Crow, Yadira Caraveo, Diana DeGette, Joe Neguse, and Brittany Pettersen for co-sponsoring H.R. 2407.

CBSA has supported and engaged on this legislation since it was first introduced in 2020.

Additional New Pieces of Legislation to Watch

In June, three additional bills were introduced in Congress that impact our life sciences ecosystem, because of their emphasis on intellectual property, patent eligibility, and medical supply chains. This educational piece provides an overview of the current bills. CBSA’s Policy + Advocacy team is reviewing the proposed bills now and will evaluate whether to take a formal position at the appropriate time, in consultation with our Policy Committee and advocacy partners at the federal level.

The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act

Introduced by Sens. Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI). According to Sen. Coons’ announcement, “This bill supports inventors, encourages investments in intellectual property, secures U.S. global technology leadership, and protects economic and national security.”

The press release laid out proposed changes to the Patent Trial and Appeal Board (PTAB) that are detailed below:

  • “Require standing for PTAB challengers and limit repeated petitions challenging the same patent;
  • Harmonize PTAB claim construction and burden of proof with federal district court;
  • End duplicative patent challenges by requiring a party to choose between making its validity challenges before the PTAB or in district court; and
  • Increase transparency by prohibiting the USPTO director from influencing PTAB panel decisions.”

The Patent Eligibility Restoration Act of 2023, (S. 2140)

Introduced by Sens. Chris Coons (D-DE) and Thom Tillis (R-NC). According to Sen. Tillis’ announcement, this bill “will restore patent eligibility to important inventions across many fields, while also resolving legitimate concerns over the patenting of mere ideas, the mere discovery of what already exists in nature, and social and cultural content that everyone agrees is beyond the scope of the patent system.” 

The bill would clarify eligibility for novel innovations, including gene therapy.

The Medical Supply Chain Resiliency Act

Introduced by Sens. Tom Carper (D-DE) and Thom Tillis (R-NC). According to Sen. Carper’s announcement, this bill “would authorize the President to engage in trade negotiations in order to ensure that critical medical goods and services are delivered safely, swiftly, and efficiently to patients in the United States and around the world.”

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