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 brand¬name drug companies to generic manufacturers in patent settlements can raise antitrust concerns. The prolific and ongoing litigation stemming from that decision is limited to date to the small-molecule drugs governed by the Hatch-Waxman regulatory scheme. Now some commentators believe 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 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.
Panelist will 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 business deals contemporaneous with 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.
Goodwin's Nick Mitrokostas will be a panelist at this webinar.
For more information, visit the event website.