Pharmaceutical life cycle management under the UK competition spotlight
19 July 2010European Pharmaceutical Contractor
Lifecycle management involving product development and regulatory and/ or patent protection for successor drugs is an important aspect of the business plan of most research-based pharmaceutical manufacturers. An ongoing investigation by the UK Office of Fair Trading (“OFT”) has highlighted whether certain practices associated with lifecycle management can be challenged under UK competition law, particularly in circumstances where the branded manufacturer has introduced a successor drug and withdrawn and de-listed the prior version from the National Health Service prescription channel.
The case involves a novel theory of antitrust harm in the UK and in Europe, although the issue of successor drugs as a lifecycle management strategy has been considered in some U.S. antitrust decisions. The case provides an important opportunity for the OFT to clarify when certain lifecycle management practices can be challenged under competition law.
For a more detailed analysis of the issues, please see the attached article by Robert F. Leibenluft and Suzanne Rab in the June 2010 edition of the European Pharmaceutical Contractor.