It’s been a little over five years since the U.S. Supreme Court issued its landmark decision in FTC v. Actavis, finding that payments made by brandname drug companies to generic manufacturers in patent settlements can raise antitrust concerns. The prolific and ongoing litigation stemming from that decision is limited to the small-molecule drugs governed by the Hatch-Waxman regulatory scheme. Now some commentators believe that the FDA has set down a pro-competition gauntlet regarding large molecule biologic drugs governed by the BPCIA — and that the FTC is not far behind.
Up until now the economic arguments associated with pharmaceutical IP and antitrust litigation were based on the pattern of small molecule drugs, where generics usually achieve a substantial share of the market quickly with large price discounts. But the complexity and costs of developing biosimilar drugs, along with substantially different regulatory and market conditions, has already shaped a different pattern for biosimilar competition, raising new issues of which practitioners need to be aware.
Our panel – a veteran pharma litigator, an antitrust lawyer who formerly worked at the FTC and who was involved in FTC v. Actavis, and a healthcare economist and expert witness – will address these issues and look ahead and discuss:
-The likely shape of settlements in patent litigation between innovator biologic companies and biosimilar aspirants
-In light of FTC challenges to a series of contemporaneous business deals including patent settlements, the future of non-cash forms of compensation
-As multiple patents in biosimilar infringement litigation can be asserted in staggered waves over time, whether “at-risk” entry is more or less likely than for traditional generic drugs
- Nicholas Mitrokostas, Goodwin Procter, LLP
- Richard Mortimer, Analysis Group
- Michael Perry, Baker Botts LLP