Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory and antitrust laws have introduced greater complexity and higher risk into these strategies.
On October 23, 2015, a distinguished panel of BakerHostetler partners led an exclusive seminar in person and online at which they discussed these and related issues and provided suggestions for developing successful life cycle management strategies. Partners Carl Hittinger, Lee Rosebush, Lance Shea and Maurice Valla are all deeply knowledgeable attorneys with decades of experience in helping clients meet their pharmaceutical business objectives.
We are delighted to share with you a brief on the seminar highlights, and hope you enjoy these insider perspectives on issues and approaches for developing successful life cycle management strategies.
Individual pieces are also available for each attorney here:
- Patent-Based Exclusivity by S. Maurice Valla
- Five Types of Exclusivities by Lee H. Rosebush
- Antitrust Considerations in Pharmaceutical Life Cycle Management by Carl W. Hittinger
- ANDA Approval Litigation: Arguing for Practical Exclusivity by Lance L. Shea
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.