MoFo Life Sciences

September 15, 2023 - Litigation, Intellectual Property, United States
Patent Term Adjustment Takes a Hit in Cellect Decision
By: Meghan McLean Poon Ph.D.
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).
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August 29, 2023 - Intellectual Property, Medical Devices + Diagnostics, United States
A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States
By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.
Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. By way of the Patent Act of 1952, the United
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August 14, 2023 - Intellectual Property, United States
Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research
By: Tina D. Reynolds
A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic manufacturing and jobs, the policy could have the unintended effect of discouraging U.S. company
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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 31, 2023 - Intellectual Property, United States
It Takes Two to Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration
By: Muzamil Huq, Joyce Liou and Morgan O'Neill Mitruka
On July 18, 2023, the phrase “Taco Tuesday” was returned to the public after Taco John’s submitted a notice of abandonment for its TACO TUESDAY trademark registration before the United States Patent & Trademark Office’s Trademark Trial and Appeal Board. Taco John’s, a popular
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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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June 30, 2023 - Agtech, United States, European Union, Regulatory
The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of
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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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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: United States

Patent Term Adjustment Takes a Hit in Cellect Decision

By: Meghan McLean Poon Ph.D.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.

Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research

By: Tina D. Reynolds

Medicare Drug Price Negotiation Program Final Guidance

It Takes Two to Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration

By: Muzamil Huq, Joyce Liou and Morgan O'Neill Mitruka

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

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

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

Five Questions after Amgen v. Sanofi

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