News & Analysis as of

Clinical Trials Pharmaceutical Industry Intellectual Property Protection

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

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

Foley & Lardner LLP on

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

MoFo Life Sciences on

Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

Fenwick & West LLP on

As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

A&O Shearman on

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

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

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...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

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Troutman Pepper Locke

IP Considerations for Naming Clinical Trials

Troutman Pepper Locke on

With hundreds of thousands of clinical trials being conducted worldwide on an annual basis, creating a unique name for a new trial can prove almost impossible. When even a brief internet search can return multiple trials...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

Jackson Walker on

Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

HaystackID

[Webcast Transcript] Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

HaystackID on

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Anticipation

BakerHostetler on

Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more

BakerHostetler

Promoting the Progress of Science: How Clinical Stage Patent Strategies Can Bring New Pharmaceuticals to Market

BakerHostetler on

Pharmaceutical companies only need patents for compositions of matter and general methods of use, right? Wrong. Discoveries can happen well into Phase III and IV and pharmaceutical companies should seek patent protection for...more

International Lawyers Network

Compulsory Licensing in Russia in the view of COVID-19

Nowadays the sphere of healthcare is becoming one of the mostly discussed because of a mass spread of the coronavirus pandemic (also COVID-19). Confirmed cases of COVID-19 around the world have passed more than a 2.4 million....more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

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