MoFo Life Sciences

August 16, 2024 - Intellectual Property, Healthcare, Pharma
Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers
By: Paige N. Chandler Ph.D., Meghan McLean Poon Ph.D. and Matthew A. Chivvis
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would
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August 14, 2024 - Intellectual Property, Healthcare
The PTAB Axes Skin Treatment Patent Under Amgen
By: Mark D. McBriar Ph.D.
The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. ( See Forte Biosciences Inc v. University of Massachusetts , PGR2023-00014.) The PTAB found UMass’s claims
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June 28, 2024 - Healthcare, United States, Pharma, Medical Devices + Diagnostics
USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative
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December 22, 2023 - European Union, Asia, Healthcare
Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions
By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Paige Zhang Ph.D.
Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated guidelines to add a framework for analysis of antibody patentability. Although not all countries
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December 04, 2023 - Healthcare
Digitalization of German Healthcare System to Receive Legislative Boost in 2024
By: Robert Grohmann
It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the end of August, the current German Government agreed
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October 24, 2023 - FDA, Healthcare
New FDA Guidance on COVID-19 Vaccines
By: Brigid DeCoursey Bondoc
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023 , when it announced that
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August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
Elena Klonoski, a summer associate in our Boston office, and Lauren Limbach, a summer associate in our Washington, D.C. office, contributed to the drafting of this post. 1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated
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August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits
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July 24, 2023 - FDA, Healthcare, Litigation, Pharma, United States
Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures
By: Joseph R. Palmore
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the
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June 21, 2023 - Litigation, Healthcare, United States
Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits
By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore
On June 16, 2023, the Supreme Court issued a decision in United States ex rel. Polansky v. Executive Health Resources, Inc. , giving the United States government broad power to dismiss qui tam FCA lawsuits even when it has initially declined to intervene. We have
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Topic Archives: Healthcare

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

By: Paige N. Chandler Ph.D., Meghan McLean Poon Ph.D. and Matthew A. Chivvis

The PTAB Axes Skin Treatment Patent Under Amgen

By: Mark D. McBriar Ph.D.

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Paige Zhang Ph.D.

Digitalization of German Healthcare System to Receive Legislative Boost in 2024

By: Robert Grohmann

New FDA Guidance on COVID-19 Vaccines

By: Brigid DeCoursey Bondoc

Medicare Drug Price Negotiation Program Final Guidance

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

By: Joseph R. Palmore

Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits

By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore