MoFo Life Sciences

January 05, 2021 - United States, Litigation, Intellectual Property
Considerations for ANDA and BPCIA Litigation
By: Matthew A. Chivvis and Michael Ward Ph.D.
Matthew Chivvis , life sciences IP litigation partner in Morrison & Foerster’s San Francisco office led session 5 of our course on Legal Topics for Scientists, Entrepreneurs, and Start Ups. Matthew discussed the Hatch-Waxman and Biologics Price Competition and Innovation Act for generics and
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November 09, 2020 - Licensing + Commercial, United States, Corporate + Venture Capital, FDA, United Kingdom, Litigation, Startup, Regulatory, Intellectual Property, Announcements
Legal Topics for Scientists, Entrepreneurs, and Start Ups
By: Michael Ward Ph.D., Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn
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October 07, 2020 - United States, FDA, Litigation, Intellectual Property
Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process
By: Michael Ward Ph.D.
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot
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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
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
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 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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February 27, 2020 - United States, FDA, Agtech, Litigation, Privacy + Data Security
January FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our January recap is below. 1. FDA, USDA and EPA announce joint platform to streamline information
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January 10, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
Our earlier posts ( part 1 and part 2 ) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice
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January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
Yesterday , we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published
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Topic Archives: Litigation

Considerations for ANDA and BPCIA Litigation

By: Matthew A. Chivvis and Michael Ward Ph.D.

Legal Topics for Scientists, Entrepreneurs, and Start Ups

By: Michael Ward Ph.D., Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis

Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process

By: Michael Ward Ph.D.

Personalized Medicine Claims Get a Boost under New MPEP Revision

By: Meghan McLean Poon

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

By: Karen G Potter

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

By: Eric Akira Tate

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

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

January FDA Updates

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)