News & Analysis as of

Life Sciences Proposed Legislation

Ballard Spahr LLP

Life Sciences Perspective On Emerging U.S. Patent Reform Efforts

Ballard Spahr LLP on

Though largely absent from mainstream news, proposed reforms to patent law are poised to affect everything from biotech startups to major pharmaceutical R&D programs. Specifically, there are four ongoing bipartisan efforts to...more

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

Jones Day on

Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

Knobbe Martens on

The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Biotech Act

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more

Perkins Coie

SAFE Sunscreen Standards Act: Bipartisan Push to Modernize U.S. Sunscreen Regulation

Perkins Coie on

On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Bergeson & Campbell, P.C.

BIOTech Caucus Will Advance Domestic Bioeconomy and Competitive Posture

On June 26, 2025, Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus. According to Houlahan’s June 26, 2025, press release, the Caucus’ mission “is to advance...more

Bergeson & Campbell, P.C.

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the...more

Fenwick & West LLP

House Reconciliation Bill Would Restore Expensing for Domestic R&D Prospectively

Fenwick & West LLP on

On May 22, 2025, the U.S. House of Representatives passed a reconciliation bill (commonly referred to as the “One Big Beautiful Bill”), which would restore expensing for domestic research and development expenses incurred in...more

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

Knobbe Martens on

For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, May 29, 2025

Cozen O'Connor on

Gov. Shapiro Counters Federal Cuts with $50M Innovation Push - As the Trump administration slashes federal research funding, Governor Josh Shapiro (D) is proposing a $50 million state investment to boost Pennsylvania’s life...more

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

Hogan Lovells

AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

Epstein Becker & Green

Will Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 2025

Epstein Becker & Green on

On May 17, 2024, Colorado Governor Jared Polis signed Colorado’s historic artificial intelligence (AI) consumer protection bill, SB 24-205, colloquially known as “Colorado’s AI Act” (“CAIA”), into law....more

Epstein Becker & Green

As State Legislatures Debate Strengthening the Corporate Practice of Medicine Limitations, a Drug Manufacturer’s Lawsuits Shine a...

Epstein Becker & Green on

Drug manufacturer Eli Lilly has filed suit against four companies involved in making, prescribing, and/or selling compounded versions of its weight loss and diabetes drugs ZEPBOUND® and MOUNJARO®....more

Morrison & Foerster LLP

April 2025 Update on Regulation of New Genomic Techniques in the EU

On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

Latham & Watkins LLP on

On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more

Quarles & Brady LLP

The 340B Program in 2024: A Tumultuous Year in Review

Quarles & Brady LLP on

The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more

Foley Hoag LLP

BIOSECURE Act: Industry Closely Following in the Lame Duck

Foley Hoag LLP on

Congress is back in session with a loaded agenda for the lame duck period. One of the top issues the life sciences industry is tracking is the potential passage of the BIOSECURE Act. Speaker Johnson has signaled the House...more

McDermott Will & Schulte

Trending in Telehealth: October 21 – 28, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

Trending in Telehealth: September 30 – October 7, 2024

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

Trending in Telehealth: September 17 – 30, 2024

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

Trending in Telehealth: July 16 – 22, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

Jones Day on

The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Fenwick & West LLP

Update on the BioSecure Act

Fenwick & West LLP on

The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more

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