Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests
- 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... ›
Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy
By: Karen G Potter Ph.D.
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.... ›Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office
By: Karen G Potter Ph.D.
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... ›Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer
By: Erin M. Bosman and Julie Y. Park
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 Sharp &... ›Artificial Intelligence and Machine Learning: Real-world applications
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,”... ›Congress releases bipartisan draft bill to repair the law on patent eligibility
By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.
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... ›Manufacturing Waiver Weakens SPC Protection in Europe
By: Wolfgang Schönig
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 Regulation will enter... ›The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR
By: Miriam H. Wugmeister
There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds... ›Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment
The Federal Circuit ruled on January 23, 2019, that the United States Patent and Trademark Office (“PTO”) erred in reducing the term of a patent owned by Supernus Pharmaceuticals by 546 days, during which time the company could not have furthered prosecution of the... ›A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe
By: Wolfgang Schönig
In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years. Once a patent has been filed,... ›