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 …›
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 …›
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 …›
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 …›
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 …›
On May 9, the United States Patent and Trademark Office (“PTO”) published a notice in the Federal Register that it is modifying its patent term adjustment (“PTA”) procedures in view of the Federal Circuit’s decision in Supernus Pharmaceuticals v. Iancu.[1] Under the PTO Duty …›
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 …›
With Artificial Intelligence (AI) and Machine Learning (ML) rapidly becoming significant players in multiple areas of science and technology, it came as no surprise to witness a full house for Athena’s program “Taking Artificial Intelligence (AI) and Machine Learning (ML) from Concept to Application,” …›
On May 22, 2019, members of Congress made available for public comment a one-page draft of a bill that aims to rewrite the patent eligibility provisions of the Patent Act to address the muddled jurisprudence spawned by the Supreme Court cases of Mayo Collaborative …›
On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009, effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC …›