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Biotechnology

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

Paul Hastings LLP

Navigating Current Challenges in Biotech M&A

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The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle...

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Recorded at SCbio’s 2025 annual conference, Matthew and Lauren welcome Kendalle O’Connell, President & CEO of MassBio, a powerhouse life sciences organization and the driving force behind Massachusetts’ thriving life sciences...more

Goodwin

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

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On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

Proskauer Rose LLP

Question of the Week: How are expiring patents fueling M&A in the life sciences industry?

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Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more

DLA Piper

CDR Scanning Offers Hope for Genus Claims for Antibodies

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In the landmark Amgen v. Sanofi case (previously covered here), the Supreme Court affirmed that patent claims drawn to a genus of monoclonal antibodies, which were claimed in terms of their function and the epitope to which...more

Beveridge & Diamond PC

Mexico Bans the Cultivation of Genetically Modified Corn, Opening Door for Other Restrictions in the Future

According to a March 21, 2025 report issued by the U.S. Department of Agriculture (USDA)’s Foreign Agricultural Service, the scope of Mexico’s recent ban on the cultivation of genetically engineered (GE) corn is “ambiguous”...more

Woodruff Sawyer

Special Report: Biotechnology Companies & Securities Class Action Litigation (2024)

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In 2024, biotechnology companies were the second most targeted industry for securities class action litigation, according to the D&O Databox™, Woodruff Sawyer’s proprietary database of securities class action suits. The...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

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The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Bergeson & Campbell, P.C.

APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a...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

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Upcoming EU Bioeconomy Strategy

The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Carbon Accounting Tool: American Biogas Council Announces Launch

The American Biogas Council (“ABC”) announced on March 3rd its launch of its Biogas Carbon Accounting Tool (“Tool”). The stated goal of the Tool is to: …provide this science-based tool to any entity generating...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

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On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Six

On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more

Bergeson & Campbell, P.C.

President Trump Revokes 2022 EO on Advancing Biotechnology and Biomanufacturing

On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a...more

Knobbe Martens

Jepson Claim Preamble Requires Written Description Support for Conventional Aspects of the Invention

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IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation).  Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim,...more

Paul Hastings LLP

FDA Funding Changes Could Impact Biotech M&A

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With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry...

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Recorded at SCbio’s 2025 annual conference, Heather and Matthew welcome Arda Ural, who serves as the Americas Life Sciences Sector Leader for EY. Arda provides a rundown of his keynote, highlighting the key issues and trends...more

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

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Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

Goodwin

Where were biologics-related patents involved in BPCIA litigation invented?

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Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more

Faegre Drinker Biddle & Reath LLP

Trump Administration’s America First Investment Policy to Bring Changes to CFIUS and Outbound Investment Reviews

Below is a summary of some of the measures identified in the Policy, and some suggestions for what foreign and domestic investors should be considering as this goes into effect....more

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