News & Analysis as of

Life Sciences IP License Pharmaceutical Industry

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

Goodwin on

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

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While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Goodwin

Regulatory and Commercial Updates on Bio-Thera’s BAT2506 (golimumab)

Goodwin on

​​​​​​​On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...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

Fenwick & West LLP

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

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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

Goodwin

Recent Biologics Deals - December 2024

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Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on...more

Goodwin

Teva and mAbxience Add Additional Oncology Biosimilar Candidate, Expanding Strategic Partnership

Goodwin on

​​​​​​​On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further...more

Goodwin

Life Sciences Licensing and M&A Update: Catching Up on Recent Decisions Affecting Commercially Reasonable Efforts Definitions and...

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Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

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Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

American Conference Institute (ACI)

[Event] 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities - May 20th - 21st, Boston, MA

Hosted by American Conference Institute, the 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities returns for another exciting year with curated programming that will highlight leveraging...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

McDermott Will & Schulte

[Event] Life Sciences Dealmaking Symposium - November 9th, Boston, MA

McDermott Will & Schulte on

Please join McDermott for our highly anticipated Life Sciences Dealmaking Symposium! Now in its 12th year, the Symposium offers a unique platform for education, insight sharing, purposeful networking and strategic...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Hogan Lovells

JPM2023 Trendspotting: driving growth through collaboration

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

American Conference Institute (ACI)

[Complimentary Conference] Pharma & Biotech Patent Litigation - February 23rd - 24th, 9:00 am - 5:00 pm CET

15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more

Proskauer - The Patent Playbook

When Nondisclosure Agreements and Pharmaceutical Trade Secrets Intersect

In the United States, the scale of trade secret theft is estimated to be between $180 billion and $450 billion annually. Among the targets of this theft are pharmaceutical companies, which are some of the most...more

Proskauer - The Patent Playbook

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Morgan Lewis

Taking Advantage of the New Purple Book Patent Requirements for Biologics

Morgan Lewis on

New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

Adler Pollock & Sheehan P.C.

Driving Revenue And Deal Flow Through An Intelligent IP Strategy: Strategies For Smaller And Early-Stage Life Science Companies....

Part I described various strategies to help smaller and early-stage life science companies establish an intelligent IP strategy and Part II described various strategies used when preparing for a transaction. In this Part III,...more

Haug Partners LLP

Takeda Defeats Motion to Dismiss Patent and Contract Claims

Haug Partners LLP on

On September 9, 2020, Judge Richard G. Andrews of the United States District Court for the District of Delaware ruled in favor of Takeda Pharmaceuticals U.S.A., Inc. in the case Takeda Pharmaceuticals U.S.A., Inc. v. Mylan...more

Herbert Smith Freehills Kramer

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more

McDermott Will & Schulte

[Event] Life Sciences Bootcamp for In-House Counsel - July 18th, San Francisco, CA

McDermott’s cross-functional team of life sciences professionals present the inaugural Bay-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. ...more

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