MoFo Life Sciences

August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
By: Stacy Cline Amin and Wendy C. Chow
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: 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
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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, 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
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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
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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 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
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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
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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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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
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March 24, 2023 - Pharma, Healthcare, United States
CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023
By: Stacy Cline Amin and Wendy C. Chow
The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological
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March 23, 2023 - Biotech, Pharma, Licensing + Commercial, Asia, Regulatory
China Eyes New Export Controls for Life Sciences Technologies
By: Tyler Xiu, Bu Yin, Gordon A. Milner, Chuan Sun and Janet Xiao
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“ MOFCOM ”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the
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