Given the myriad strategic considerations that companies need to take into account prior to engaging in Paragraph IV litigation, the addition of patent reform has further complicated already complex brand/generic wars. Both branded and generic companies are analyzing the AIA to ascertain the effect on Hatch-Waxman litigation and debating how post-grant review could potentially impact the playing field for life sciences companies. Add the potential for biosimilars litigation into the mix, and this chess match enters three dimensions, representing nothing less than a geometric increase in complexity. In this session, our expert faculty will use hypothetical situations to explore the implications of patent reform for Paragraph IV and biosimilars litigation and provide guidance on what you should be doing now to prepare for the costly and convoluted litigation that is likely to come.
Topics of discussion will include:
• Exploring the effects of Fresenius v. Baxter
– Can a jury verdict ever be considered final now?
– Is it best practice to simply file an IPR at the outset?
– Can this holding extend beyond verdicts to settlements? Is it possible for a generic brand not subject to a “reverse pay settlement” to initiate an IPR?
• Understanding when pre-issuance submission of prior art to the PTO as outlined by this procedure would be used in a Hatch-Waxman scenario
• Examining scenarios in which the application of the pending pharmaceutical patent might actually be strengthened as opposed to diminished by the invocation of third party pre-issuance statements
• Determining when it makes sense for a patent holder in Paragraph IV situations to pursue supplemental reexamination
• Framing the concept of prior art in the pharmaceutical/biologics context
• Weighing considerations for when a challenge should be brought under PGR in a Hatch-Waxman challenge
• Analyzing the patenting process for drugs and biologics
• Seeking patent protection during the pre-approval process
• IP and regulatory redress for time lost during the pre-approval process
• Distinguishing the patenting process for drugs from that of biologics—which biologics are treated as drugs and why?