Intellectual Property Owners Association

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Intellectual Property Owners Association’s weekly
one-hour webinar series on current topics in IP

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Registration Fee: $135 per user
Save with an Unlimited Annual Pass
Government/Academic Rates are
available upon written request to
meetings@ipo.org

Hosted and produced by
journalist Pamela Sherrid
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2018 Scheduled Webinars

 

Biosimilars in the Antitrust Spotlight: Patent Litigation and Settlement

Thursday, 4 October 2018 at 2:00 PM- 3:00 PM ET  

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 date 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

Speakers:

  • Nicholas Mitrokostas, Goodwin Procter LLP
  • Richard Mortimer, Anaylsis Group
  • Michael Perry, Baker Botts LLP 

Patent Prosecution History Estoppel: Litigation, Prosecution, and Due Diligence Perspectives

Tuesday, 9 October 2018 at 2:00 PM- 3:00 PM ET 

Speakers:

  • Bryan DinerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP 
  • Bryan NolanMayer Brown LLP 
  • James TrainorFenwick & West LLP