News & Analysis as of

Healthcare Life Sciences Biotechnology

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

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A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more

Skadden, Arps, Slate, Meagher & Flom LLP

Report on Hong Kong-Listed Biotech Companies - June 2024

点击此处阅读调查报告全文 Our fourth annual report on Hong Kong-listed biotech companies examines how the sector performed during the continuing challenging market conditions of the last full calendar year. Although the number of...more

Fenwick & West LLP

Reflections on the J.P. Morgan Healthcare Conference: Key Themes for 2024

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The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

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The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 4, Issue 7, August 2023

You may be Entitled to Financial Compensation…for Your Data - “Without all of our writings and photos that AI companies are using to train their models, they would have nothing to sell.” Why this is important: This...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

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China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Linda Liu & Partners

CNIPA’s Requirements on Supplementary Experimental Data and Inventiveness Evaluation of CN Patent Application in Biology and...

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On December 14, 2020, the China National Intellectual Property Administration released “Announcement about Amendments to the Guidelines for Patent Examination (Announcement No. 391)” on its website, showing that the amended...more

Knobbe Martens

Recessions and Patent Applications: Navigating the Ups and Downs of the Innovation Economy

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As predictions of an economic recession in the United States loom, 2023 has started with extensive layoffs throughout the tech industry. Though not to an equal degree, the biotechnology, pharmaceutical, and life science...more

Schwabe, Williamson & Wyatt PC

SUPREME COURT RULING: Amgen Inc. et al. v. Sanofi et al, May 18, 2023

Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more

Bradley Arant Boult Cummings LLP

Supreme Court Delivers the Final Blow to Amgen

The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more

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

Supreme Court Affirms Federal Circuit’s Decision in Amgen v. Sanofi

This morning, the US Supreme Court issued its opinion in Amgen v. Sanofi, a closely watched case concerning patent law’s enablement requirement. Under that requirement, codified at 35 U.S.C. § 112(a), a patent specification...more

McDermott Will & Emery

FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

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Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more

Skadden, Arps, Slate, Meagher & Flom LLP

Report on Hong Kong-Listed Biotech Companies - April 2023

点击此处阅读调查报告全文 Our third annual report on Hong Kong-listed biotech companies examines how the sector performed during the challenging conditions for capital markets globally over the past 12 months. Although aggregate listing...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

Nelson Mullins Riley & Scarborough LLP

The Promise of Brain-Delivered Gene Therapy

Gene therapy aims to treat the underlying genetic cause of a disease rather than only the symptoms. It involves the delivery of properly functioning DNA into a patient’s genetic material to correct an underlying genetic...more

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

White & Case LLP

PMB performs as pharma groups repurpose their portfolios

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After a year of historic profits in 2021 following the mass roll-out of COVID-19 vaccines and related treatments, big pharma companies armed with cash for deals have been shifting their attention - Overall, pharma, medical...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Issue 23, 2022

Complex, Customized CRISPR Combo Could Help Patients Cure Their Own Cancer - “In a small phase 1 clinical trial run by PACT Pharma, researchers edited the genes of 16 patients’ immune cells to work against their cancer,...more

Knobbe Martens

Researchers Develop Blood Clot Test Based on Single Drop of Blood

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The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone....more

Arnall Golden Gregory LLP

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more

Fenwick & West Life Sciences Group

Biotech Industry at Inflection Point with ESG Initiatives

Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance...more

White & Case LLP

Healthcare M&A on track to set new record in 2021

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Heightened interest in medical suppliers, contract research organizations and biotech firms resulted in an impressive year for healthcare dealmaking- Dealmaking within the pharma, medical and biotech sector continued from...more

McDermott Will & Emery

What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?

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In the second installment of McDermott’s webinar series, HPE Europe 2020: What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?, moderator and McDermott partner Emmanuelle Trombe and industry...more

Bass, Berry & Sims PLC

Key Takeaways from the Nashville Kayo Women in Healthcare and Finance Pop Up Discussion

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Investors’ interest in healthcare continues to grow and healthcare-related deal flow in private equity appears to be at an all-time high. On November 5, Bass, Berry, & Sims member Tatjana Paterno moderated a Kayo Women in...more

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