MoFo Life Sciences

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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September 10, 2019 - United States, Litigation, Intellectual Property, Announcements
Morrison & Foerster Launches Complimentary Tracker For Northern District Of California IP Cases
We are pleased to announce the launch of the MoFo NDCal IP Resource Center. This complimentary resource is available to the public and provides insights on the judges, trends, and decisions for intellectual property cases for the last five years in the United States
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September 04, 2019 - United States, Litigation, Biotech, Pharma, Intellectual Property
Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel
By: Janet Xiao and Meghan McLean Poon
In a recent decision, Ajinomoto v. ITC , the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by
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July 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy
By: Karen G Potter
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services ,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature.
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June 05, 2019 - United States, Product Liability + Class Action, Litigation, Pharma
Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer
By: Erin M. Bosman and Julie Y. Park
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck Sharp &
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January 11, 2019 - Litigation, European Union, Pharma, Regulatory, Intellectual Property
The EU General Court’s Ruling on Pay for Delay
By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that
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March 01, 2018 - United States, Litigation, Pharma, Intellectual Property
PTAB Rejects Tribal Immunity Proceedings
By: Matthew I. Kreeger and Shouvik Biswas
On February 23rd, 2018, a panel of the Patent Trial and Appeal Board (PTAB or “Board”) decided that: (1) Indian tribal sovereignty did not apply to post-grant proceedings established under the America Invents Act (AIA) and (2) licensing agreements between a tribe and a
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Topic Archives: Litigation

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

Morrison & Foerster Launches Complimentary Tracker For Northern District Of California IP Cases

Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel

By: Janet Xiao and Meghan McLean Poon

Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

By: Karen G Potter

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman and Julie Y. Park

The EU General Court’s Ruling on Pay for Delay

By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann

PTAB Rejects Tribal Immunity Proceedings

By: Matthew I. Kreeger and Shouvik Biswas