News & Analysis as of

Pharmaceutical Industry Innovation

Haug Partners LLP

Swiss Court Signals More Lenient Approach to AI Inventions

Haug Partners LLP on

On June 26, 2025, the Swiss Federal Administrative Court (“Court”) issued its decision in case B-2532/2024, resolving a high-profile dispute over whether an artificial intelligence (“AI”) system can be named as an inventor...more

Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

Foley & Lardner LLP on

The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

A&O Shearman on

On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Bergeson & Campbell, P.C.

House Subcommittees Will Hold Hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology” on June 5

On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

McDermott Will & Schulte

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Patent Considerations for Antibody Drug Conjugates (ADCs)

In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more

Goodwin

Goodwin’s 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical Diagnosis and Treatment Gaps

Goodwin on

Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more

Morgan Lewis - As Prescribed

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Hogan Lovells

JPM Women’s Breakfast promotes gender diversity in trials, offers financing tips

Hogan Lovells on

Meeting Tuesday morning at the J.P. Morgan Healthcare Conference this year, women leaders in life sciences, women’s health, and entrepreneurship met for a dynamic conversation that celebrated and empowered trailblazing women...more

Morgan Lewis - As Prescribed

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Fenwick & West LLP

What Startups and Big Pharma Need to Know About AI Drug Discovery

Fenwick & West LLP on

Integrating AI tools into drug discovery introduces a mix of opportunities and challenges for startups and large pharmaceutical companies. These challenges often center on intellectual property (IP) risks, licensing...more

ArentFox Schiff

What You Need to Know: 2025 Updates to EU Design Protection

ArentFox Schiff on

The European Union (EU) has approved updates to its design protection legislation to modernize the framework and support innovation across member states....more

Hutchison PLLC

UNC’s Eshelman Innovation: Fueling North Carolina’s Next Big Breakthroughs

Hutchison PLLC on

North Carolina’s vibrant entrepreneurial ecosystem is a powerhouse for innovation, but there’s always room to improve, especially when it comes to turning cutting-edge research into real-world solutions. John Bamforth,...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Ed Hernandez, who oversees drug product manufacturing at Eli Lilly, an international pharmaceutical company. Ed discusses how Eli Lilly...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in...

Maynard Nexsen on

This episode, Matthew and Heather chat with Paul Testa, an Executive Vice President of Kyowa Kirin, a pharma group that develops innovative specialty drugs to raise the health and well being of people across the globe. Paul...more

McDermott Will & Schulte

Pharma and MedTech Services Investment Summit 2024

The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Womble Bond Dickinson

[Webinar] Innovation Interchange Summit: The Power Of Cross-Industry Insight - May 16th, 11:00 am - 4:00 pm ET

Womble Bond Dickinson on

Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more

McDermott Will & Schulte

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

Smart & Biggar on

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

Polsinelli on

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

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