Topic Archives: Litigation

January 10, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 3)

By: Hilary R. Hoffman and Bethany J. Hills

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 Enforcement Trends In 2019, …›

January 9, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 2)

By: Hilary R. Hoffman and Bethany J. Hills

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 press releases about …›

January 8, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 1)

By: Hilary R. Hoffman and Bethany J. Hills

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 …›

December 9, 2019 - Intellectual Property, Litigation, Pharma, United States

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis and Anthony Michael Parenti

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 …›

November 22, 2019 - Biotech, FDA, Healthcare, Intellectual Property, Litigation, Pharma, Regulatory, United States

FDA Approves 25th Biosimilar

By: Steve Keane

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 …›

September 10, 2019 - Announcements, Intellectual Property, Litigation, United States

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 …›

September 4, 2019 - Biotech, Intellectual Property, Litigation, Pharma, United States

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 the …›

July 9, 2019 - Intellectual Property, Litigation, Pharma, United States

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. The …›

June 5, 2019 - Litigation, Pharma, Product Liability + Class Action, United States

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

By: Erin M. Bosman, Julie Y. Park, and Benjamin S. Kagel

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 …›

January 11, 2019 - European Union, Intellectual Property, Litigation, Pharma, Regulatory

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 …›