Topic Archives: Pharma

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 19, 2019 - AI + Robotics, Data Analytics, FDA, Pharma, Product Liability + Class Action, Regulatory, United States

Artificial Intelligence and Pharma

By: Bethany J. Hills

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›

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 29, 2019 - Biotech, European Union, Intellectual Property, Pharma

CJEU on Genuine-Use of Trademarks in Clinical Trials

By: Wolfgang Schönig and Robert Grohmann

The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process of executing clinical trials as a prerequisite for obtaining market authorization. In this context, the fact that trademark laws in most jurisdictions …›

July 23, 2019 - Asia, Biotech, Intellectual Property, Pharma, Regulatory

China’s new administrative regulations on human genetic resources as applied to foreign persons

By: Can Cui

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human …›

July 19, 2019 - Biotech, European Union, Intellectual Property, Pharma, Regulatory

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

By: Wolfgang Schönig

In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled in …›