MoFo Life Sciences

September 15, 2023 - Litigation, Intellectual Property, United States
Patent Term Adjustment Takes a Hit in Cellect Decision
By: Meghan McLean Poon and Zachary A. Nora
Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and have different expiration dates due only to patent term adjustment (PTA).
... ›
July 24, 2023 - FDA, Healthcare, Litigation, Pharma, United States
Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures
By: Stacy Cline Amin, Joseph R. Palmore, Wendy C. Chow and Will Baker
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
... ›
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, Bu Yin, Ashley E. Sperbeck and Shawn O. Meade
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
... ›
July 10, 2023 - Cell + Gene Therapy, Biotech, Intellectual Property, Litigation, Pharma
Mitigating Patent Risk in Gene Therapy Development
By: Daralyn J. Durie, Janet Xiao 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
... ›
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
... ›
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 and Bu Yin
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
... ›
June 16, 2023 - Intellectual Property, Litigation, United States, Biotech, Pharma
Five Questions after Amgen v. Sanofi
By: Meghan McLean Poon and Kelsey J. Roberts Kingman
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
... ›
June 12, 2023 - Intellectual Property, Litigation, Digital Health, Healthcare, United States
United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim
By: Joseph R. Palmore, J. Alex Ward and Adam L. Braverman
On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc. , clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits
... ›
May 03, 2023 - Announcements, Healthcare, Litigation, Regulatory, United States, FDA
FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims
By: Brigid DeCoursey Bondoc and Claudia M. Vetesi
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties
... ›
April 21, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Is DOE Now in Vogue?
By: Matthew A. Chivvis and Qiwen Zhong
On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi , a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was
... ›