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 15, 2024 - Intellectual Property, Litigation, Pharma
Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories
By: Jeffrey W. Schmidt Ph.D., Meghan McLean Poon Ph.D. and Karen G Potter Ph.D.
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 obviousness-type double patenting (ODP) in the
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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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June 07, 2024 - Pharma, FDA
Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. Disclosure of a protocol summary of the
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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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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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July 20, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action
By: Mark D. McBriar Ph.D., Bu Yin Ph.D. and Ashley E. Sperbeck
Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. [1] The Supreme Court emphasized “the need for caution in granting a patent based on the
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July 10, 2023 - Cell + Gene Therapy, Biotech, Intellectual Property, Litigation, Pharma
Mitigating Patent Risk in Gene Therapy Development
By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt
This article was first published by IAM on June 2, 2023 in its Special Report 2023 Q2: New Frontiers of Pharma and Biotech IP Strategy. Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability
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June 20, 2023 - Biotech, Pharma, Intellectual Property, Litigation, Cell + Gene Therapy
Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.
Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable. As discussed below, the outlook for successful
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June 16, 2023 - Intellectual Property, Litigation, United States, Biotech, Pharma
Five Questions after Amgen v. Sanofi
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch: 1. What is the impact on
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Topic Archives: 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

Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories

By: Jeffrey W. Schmidt Ph.D., Meghan McLean Poon Ph.D. and Karen G Potter 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.

Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure

By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.

Medicare Drug Price Negotiation Program Final Guidance

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

By: Joseph R. Palmore

Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action

By: Mark D. McBriar Ph.D., Bu Yin Ph.D. and Ashley E. Sperbeck

Mitigating Patent Risk in Gene Therapy Development

By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt

Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

Five Questions after Amgen v. Sanofi

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.