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Biotechnology Healthcare

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

Napoli Shkolnik on

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

Foley Hoag LLP

Healthcare Issues to Watch Following the FY2024 Spending Deal

Foley Hoag LLP on

Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

Knobbe Martens

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

Knobbe Martens on

On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

Fenwick & West LLP

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

Fenwick & West LLP on

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

Jones Day on

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

Ankura

Is Your DNA Safe? DNA Sequencing Machines Found to Contain Critical Vulnerabilities

Ankura on

Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Knobbe Martens

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

Knobbe Martens on

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

McDermott Will & Emery on

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

Foley & Lardner LLP

The Role of AI in Health Care M&A: Driving Value in a Difficult Market

Foley & Lardner LLP on

Health care merger and acquisition (M&A) activity reached a significant level in 2022, even if not matching 2021’s record-breaking standard. This reflects the overall economy’s holding pattern in which resources are still...more

Pierce Atwood LLP

New England and First Circuit Class Action Tracker

Pierce Atwood LLP on

Pierce Atwood's Class Action Defense group is pleased to present this New England and First Circuit Class Action Tracker, which focuses on the filings and decisions in state and federal courts within the boundaries of the...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

White & Case LLP

Global healthcare M&A delivers strong performance

White & Case LLP on

Dealmaking in the pharma, medical and biotech (PMB) subsectors was driven by both old and new market trends in 2022 - Following a ground-breaking year for dealmaking in 2021, global healthcare M&A remained robust in 2022,...more

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