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Biotechnology Corporate Counsel

MoFo Life Sciences

Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting In Allergan USA V. MSN Laboratories

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On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

Womble Bond Dickinson

Supreme Court Focuses Scope of Patent Enablement - What Patent Owners Need to Know

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A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

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Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

Goodwin

2022 Year in Review: Securities Litigation Against Life Sciences Companies

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We are proud to present our seventh annual Securities Litigation Year in Review publication, in which we analyze data for securities class actions filed nationally against publicly traded pharmaceutical, biotechnology,...more

Fenwick & West LLP

The Evolution of ESG Disclosure for Biotech Companies

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Despite some recent criticisms of environmental, social and governance (ESG) initiatives and their proponents, demands for ESG information, including by large institutional investors and regulators, are expected to continue....more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Arnall Golden Gregory LLP

Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Jones Day

Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

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China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.  This new system will also create a new form of pharmaceutical patent litigation in...more

Hogan Lovells

Failure to remove unlawful advertising attracts $12 million penalty

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On 29 July 2021, the Federal Court of Australia (the “Court”) handed down its largest ever pecuniary penalty for serious, sustained and knowing contravention of the Therapeutic Goods Act 1989 (Cth) (“TG Act”). The decision...more

A&O Shearman

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

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Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

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On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Foley & Lardner LLP

Another Diagnostic Patent Falls Under 101

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In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

Foley & Lardner LLP

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

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Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more

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