A decade ago, at ACI’s first Maximizing Pharmaceutical Patent Life Cycles conference, we discussed the possible introduction of an abbreviated pathway for follow-on biological products and contemplated its impact on life cycle strategies. We continued to explore this topic at every iteration of this conference that followed.
FOBs are here: that which we once contemplated is now a reality.
The pharmaceutical industry must assess how this new application process for biosimilars under Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) will interact with existing patent life cycle planning under Hatch-Waxman and other mechanisms.
We have entered a new era with the introduction of biosimilars, however, other and more familiar anxieties under Hatch-Waxman still abound.
Potential patent losses for small molecules are projected to exceed $40 billion by 2012 alone1 as patent protections on more brand name drugs, including some notable block busters, are set to expire. New decisions affecting forfeitures, Orange Book listings, methods claims and claims drafting are shaping the evolution of Hatch-Waxman. There is also concern over how proposed patent reform legislation may be yet another game changer. Moreover, the aggressive stance of various agencies including the PTO, FDA and FTC on various components of Hatch-Waxman adds to this uncertainty.
Now is the time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies’ current Hatch-Waxman – and BPCIA – strategies and tactics against competitors in both camps.
This 11th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry leading conference:
- Focused panels on differences between Biosimilar Applications and ANDAs which will allow you to assess how elements of these applications processes will impact decisions in life cycle management
- Access to key fi gures from the USPTO (Invited), FTC, USP and FDA (Invited), who will provide you with direct insights into the logic of these agencies on some of the most pressing matters affecting pharmaceutical life cycle patent strategies, including:
- PTA and PTE determinations
- Pay-for-Delay settlements and product switching
- Biological products and substitutions
- Proposed forfeiture regulations
- Analyses of key cases that have affected patent life cycle planning and tips for using these rulings to your advantage
Also, by popular demand, we have brought back our specialized classes on:
- Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals
- The Master Class on Patent Term Adjustment and Patent Term Extensions for Pharmaceutical and Biological Patents and have updated them to address not only Hatch-Waxman matters, but some of the most pressing issues concerning biosimilars as well.
Additionally, in response to your request for more in-depth information on extending patent life in foreign jurisdictions and IP maneuvering in emerging BRIC markets, we are pleased to offer a workshop on:
- Pharmaceutical Patent Life Cycle Strategies for the EU and Emerging Markets
Nearly 2,500 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for over the last ten years. This updated event will bring you the latest legal strategies and tactics for successful maneuvering in the evolving pharmaceutical patent endgame.
With all that’s at stake, you cannot afford to miss this conference.
Don’t delay – register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line at www.americanconference/LifeCycles.
Conference Details
