Topic Archives: Pharma

September 19, 2019 - AI + Robotics, 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 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 and Jana Brun

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 …›

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 …›