Topic Archives: Biotech

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 …›

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 …›

October 1, 2019 - Asia, Biotech, Intellectual Property, Licensing + Commercial, Regulatory

China Patent Eligibility Update: Human Embryonic Stem Cells

By: Can Cui

On September 23, 2019, China National Intellectual Property Administration (“CNIPA”) announced its proposed amendments to China’s Guideline on Patent Examination (the “Guideline”), which is the counterpart of the Manual of Patent Examining Procedure in the U.S. The proposed amendments will become effective November …›

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 …›

June 27, 2019 - Announcements, Biotech, Blockchain, Corporate + Venture Capital, Medical Devices + Diagnostics, Pharma, Privacy + Data Security, United States

Morrison & Foerster Hosts 2nd Annual Blockchain Healthcare Summit

By: Kristen J. Mathews, Spencer D. Klein, F. Dario de Martino, Jonathan Bockman, and Tracy A. Bacigalupo

Five Morrison & Foerster attorneys recently participated in the 2nd Annual Blockchain Healthcare Summit in our New York City office, and provided an overview of the current state of the industry, including a discussion of blockchain-enabled applications for compliance, privacy, practitioner credentialing, patient medical …›