MoFo Life Sciences

September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act
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September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At
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August 18, 2020 - United States, Litigation, Intellectual Property
Personalized Medicine Claims Get a Boost under New MPEP Revision
By: Meghan McLean Poon Ph.D.
The United States Patent and Trademark Office (USPTO) published the latest revision to its Manual of Patent Examining Procedure (MPEP) on June 30, 2020. According to the Executive Summary, in this revision, nearly all of the 27 chapters have been updated to incorporate new
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August 12, 2020 - United States, Litigation, Pharma, Intellectual Property
Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible
By: Karen G Potter Ph.D.
The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as
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August 07, 2020 - Licensing + Commercial, United States, Litigation
California Supreme Court Clarifies Standards for B2B Non-Competition Agreements and Disputes in California
By: Eric Akira Tate
This week, on August 3, 2020, the California Supreme Court issued its opinion in Ixchel Pharma, LLC v. Biogen, Inc. , which resolved two questions regarding the standards to be applied for non-competition agreements and disputes between businesses in California. The first was whether
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July 25, 2020 - United States, COVID-19, Intellectual Property
Bill Proposes 10 Additional Years for COVID-19 Inventions
A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily curtail patent owner enforcement rights. Passage is not certain,
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July 13, 2020 - United States, Litigation, Intellectual Property
Should Cos. Use USPTO's New Fast-Track Appeals Program?
By: Joe Adamczyk, Anita Choi and Michael Ward Ph.D.
Joe Adamczyk, Anita Choi, and Michael Ward authored an article for Law360 covering the U.S. Patent and Trademark Office’s (USPTO) decision to begin accepting petitions for the fast-track appeals pilot program, a new program aimed at shaving off time during ex parte appeal. “Appeals
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July 08, 2020 - United States, FDA, COVID-19
FDA Establishes Clear Requirements for COVID-19 Vaccine
By: Matthew Karlyn
On June 30, 2020, the U.S. Food and Drug Administration released its much anticipated guidance on the licensure of COVID-19 (SARS-CoV-2) vaccines. According to the New York Times , there are currently over 145 COVID-19 vaccines in development across the globe with 20 in
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June 29, 2020 - United States, COVID-19, Intellectual Property
Expedited Trademark Applications for COVID-19-Related Goods and Services
By: Joyce Liou and Eoin Connolly
Recognizing the need for companies to quickly get products to market that might help combat the COVID-19 pandemic, the United States Patent & Trademark Office is now paving the way for shorter examination timelines for qualifying trademark applications. This could prove especially useful in
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June 02, 2020 - United States, Healthcare, Privacy + Data Security
FTC Seeks Comments on Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”), which requires vendors of personal health records (PHR) and related entities that aren’t covered by HIPAA to provide notice
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Topic Archives: United States

First Decisions Limit PREP Act Immunity in Coronavirus Context

By: Erin M. Bosman and Julie Y. Park

Pediatric Exclusivity for Biologics

Personalized Medicine Claims Get a Boost under New MPEP Revision

By: Meghan McLean Poon Ph.D.

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

By: Karen G Potter Ph.D.

California Supreme Court Clarifies Standards for B2B Non-Competition Agreements and Disputes in California

By: Eric Akira Tate

Bill Proposes 10 Additional Years for COVID-19 Inventions

Should Cos. Use USPTO's New Fast-Track Appeals Program?

By: Joe Adamczyk, Anita Choi and Michael Ward Ph.D.

FDA Establishes Clear Requirements for COVID-19 Vaccine

By: Matthew Karlyn

Expedited Trademark Applications for COVID-19-Related Goods and Services

By: Joyce Liou and Eoin Connolly

FTC Seeks Comments on Health Breach Notification Rule

By: Melissa M. Crespo