Maximizing Pharmaceutical Patent Life Cycles

Wednesday, October 24, 2007

The rules of the pharmaceutical patent endgames are changing rapidly.

Pharmaceutical patent expirations equaling $140 Billion in losses will occur within the next ten years.
Congress, the PTO and the Courts are now reshaping the current pharmaceutical patent schematic.
A new pharmaceutical patent paradigm is about to emerge.

Over the course of the next ten years, patent expirations will cause a significant shifting in the pharmaceutical marketplace. Drug companies will suffer patent losses of a $140 billon. 2007 is a pivotal year for pharmaceutical companies – both brand name and generic – to rethink strategies not only in terms of this impending economic reality, but also in terms of the dramatic political, legislative, judicial and regulatory metamorphoses currently under foot. The air is replete with change on every front --- in Congress, at the PTO, and in the courts.

On the Hill, S.1082, the Kennedy-Enzi Bill a/k/a the FDA Revitalization Act recently passed the muster of the Senate. All eyes are now on the House as the industry ponders whether such items as PDUFA renewal, pediatric exclusivity and follow-on biologics --- all of which will have a strong bearing on pharmaceutical patents --- will be included in the Act’s final version. Congressional hearings continue over legislation that may potentially render authorized generics and brand name/generic settlements illegal. Meanwhile, the PTO rules on continuation and designated claims practice now lie in the hands of OMB for final approval. There is also strong indication that the Patent Reform bill will pass.

As for the courts, the Supreme Court and Federal Circuit are creating what is perhaps the most significant body of patent case law in years. Earlier this year, in MedImmune, the Supreme Court changed the standard for declaratory judgment actions. In Teva v. Novartis, the Federal Circuit applied the new MedImmune standard in a Paragraph IV case. As such, the MMA's provision on declaratory relief --- previously viewed as innocuous --- suddenly gained new teeth and the question of the day became whether all Orange Book listings are now subject to DJ jurisdiction. More recently, the test for obviousness also came into focus as the Federal Circuit’s ruling in the Norvasc case foreshadowed what the Supreme Court would ultimately decide in KSR. As a result, long held tactics for obtaining secondary patents now fall into serious doubt.

In this tumultuous sea of change, it is imperative that you as counsel to either a brand name or generic pharmaceutical company, have a complete understanding of the latest legal developments and their implications for your company's life cycle strategies. It's time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies' current strategies and tactics against competitors in both camps. The eighth American Conference Institute publication 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 event. An outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both the brand names and generics, as well as government representatives will provide insights on all the latest developments affecting life cycle management.