While the genus antibody claim was effectively killed by the U.S. Supreme Court in Amgen v. Sanofi, it lives on in Europe despite a few recent setbacks at the European Patent Office ("EPO") and the Unified Patent Court...more
The UK Supreme Court's ruling in Warner Lambert v Actavis resulted from deliberations over the proper approach to matters relating to infringement of second medical use patent claims. The standard proposed by the UK Supreme...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
6/18/2018
/ Biosimilars ,
EU ,
European Commission ,
Exports ,
Generic Drugs ,
Intellectual Property Protection ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Supplementary Protection Certificate ,
Transparency
The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more
6/18/2018
/ EU ,
Incentives ,
Intellectual Property Protection ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
The Decision: The French Cour de cassation, in a case concerning a dosage regime patent, recently clarified the "plausibility" requirement, an element of sufficiency of disclosure or inventive step.
The Result: The wording...more