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 about …›
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, …›
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 …›
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 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 …›
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 …›
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 …›
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 …›
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 …›
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 …›