MoFo Life Sciences

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 13, 2020 - United States, Litigation, Intellectual Property
Should Cos. Use USPTO's New Fast-Track Appeals Program?
By: 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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January 08, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 1)
The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in
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December 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Striking the Balance in Trade Secret and Corporate Espionage Disputes
By: Matthew A. Chivvis
In 2017, the Commission on the Theft of American Intellectual Property issued a report to Congress estimating that the theft of trade secrets could cost the United States economy as much as $600 billion annually. In the years following, news reports indicate that alleged
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November 22, 2019 - United States, FDA, Litigation, Biotech, Healthcare, Pharma, Regulatory, Intellectual Property
FDA Approves 25th Biosimilar
On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the pharmaceutical
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Topic Archives: Litigation

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

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

By: 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)

2019 FDA Enforcement and Related Litigation Trends (Part 1)

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis

FDA Approves 25th Biosimilar