The UK's Competition Appeal Tribunal (the "CAT") has overturned a finding of abuse of dominance against Pfizer Inc. and Flynn Pharma Ltd. The ruling followed appeals by those companies against a 2016 Competition & Markets...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
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
6/30/2017
/ Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Legislative Agendas ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OMB ,
Pharmacies ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
6/20/2017
/ Anti-Competitive ,
Antitrust Investigations ,
Antitrust Violations ,
Competition Authorities ,
Enforcement Actions ,
EU ,
European Commission ,
Generic Drugs ,
Italy ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Price Gouging ,
Spain ,
Treaty on the Functioning of the European Union (TFEU) ,
UK Competition and Markets Authority (CMA)
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more
On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part...more