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Intellectual Property Protection Regulatory Requirements Life Sciences

Jones Day

Revolutionizing EU Design Protection: Key Changes Under the New Designs and Models Regulation

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May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...more

Morgan Lewis

Exploring the Legal Frontier of Space and Satellite Innovation

Morgan Lewis on

For companies in the aerospace and defense industry, the future of space innovation involves far more than rockets and satellites. Intellectual property, technology transfers, data privacy, and life sciences are among the...more

MoFo Life Sciences

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

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The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

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

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

Troutman Pepper Locke on

A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

Morgan Lewis

M&A Considerations Across the Evolving Life Sciences Sector: Key Takeaways

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In the latest installment of the Morgan Lewis M&A Academy, partners Laurie Burlingame and Luciana Griebel provided an overview of current market trends in mergers and acquisitions (M&A) and strategic partnerships within the...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

MoFo Life Sciences on

Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

MoFo Life Sciences

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

MoFo Life Sciences on

On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more

Husch Blackwell LLP

Navigating Life Sciences Transactions: Lessons from the Field

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This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Goodwin

US Emerging as Top Global Medtech Destination

Goodwin on

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

Polsinelli

Federal Circuit Refuses to Rehear Case Involving Orange Book Listing of Device Patents

Polsinelli on

Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more

Husch Blackwell LLP

Navigating Life Sciences Transactions: A Five-Part Series

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The life sciences industry is built on breakthroughs and partnerships. From early-stage biotech startups to established medtech and pharma companies, success often depends on navigating complex business transactions, securing...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: New Frontiers and Challenges

Foley & Lardner LLP on

Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Goodwin

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

Goodwin on

On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s...more

MoFo Life Sciences

Patents and Trade Secrets in AI and Life Sciences

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

Haug Partners LLP on

This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Smart & Biggar

Federal Court rules on patent listing again, confirms generic not required to address patent submitted before ANDS filing but...

Smart & Biggar on

On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...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

Hogan Lovells

Overview on the functioning of the trademark system in Europe - Pharma Marks Insights series: Part II

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As we have seen in the first article of our series, trademarks play an important role in the protection of your pharmaceutical and life science products and can add significant value. But to understand the benefits but also...more

Mintz - Venture Capital & Emerging Companies...

MintzTech Connect Industry News: Spotlight on Surgimatix, Inc

Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more

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