Speaking Engagement

ACI Summit on Biosimilars

Monday, June 25, 2018 - Thursday, June 28, 2018

12:00 AM GMT - 12:00 AM GMT

New York, NY

300 W. 44th St.

New York , USA

Paul Hastings is a proud sponsor of the ACI Summit on Biosimilars to be held at the InterContinental New York Times Square from June 25-27. Issac Ashkenazi and Eric Dittmann, Paul Hastings partners, Litigation Department, will speak during the Summit.

Monday, June 25, 2018 - 10:45 amUpdate on Hot-Button Litigation Issues and the Impact on the Biologics Market and Strategies 

Program Description

  • Amgen v. Hospira – whether manufacturing without selling falls within the safe harbor

  • Amgen v. Sanofi and Regeneron

    • Whether the “newly-characterized antigen” test can be used to satisfy the written description requirement

    • Whether consideration of post-priority-date embodiments should be included in an invalidity analysis

  • Amgen-Abbvie settlement and launch date for Amgen’s Humira biosimilar


Isaac AshkenaziPartnerPaul Hastings LLP (New York, NY)

John Joseph Molenda, Ph.D.Partner, Co-Chair, Healthcare & Life Sciences PracticeSteptoe & Johnson LLP (New York, NY)

Gregory A. Morris, Ph.D.Partner and Leader, Life Sciences LitigationHonigman Miller Schwartz and Cohn LLP (Chicago, IL)

Irena Royzman Ph.D.PartnerPatterson Belknap Webb & Tyler LLP (New York, NY)

Milan VinnolaOf CounselPolsinelli PC (Denver, CO)

Monday, June 25, 2018 - 1:45 pm**NOW… You can Dance if You Want to

**Program DescriptionNow that one year has passed since Sandoz v. Amgen, the biologics industry still finds itself in a state of uncertainty with respect to the dance, and choosing the most successful “dance moves.” This interactive panel will include an in-depth analysis of several mock fact patterns where the parties will address the most pressing challenges still keeping the market up at night, including:

  • Benefits and risks of taking part in the patent dance

  • What is the minimum requirement necessary to constitute compliance

  • Strategic use of notice of commercial marketing

  • Pros and Cons for biosimilar makers to provide manufacturing information

  • Settlements and potential antitrust concerns

SpeakersEric W. Dittmann PartnerPaul Hastings LLP (New York, NY)  

Chuck Klein 

Co-chair, Intellectual Property PracticeWinston & Strawn LLP (Washington, DC) 

Christopher LohPartnerFitzpatrick, Cella, Harper & Scinto (New York, NY) 

Nicholas MitrokostasPartner, IP LitigationGoodwin Procter LLP (Boston, MA) 

Rachel MoodieVice President Intellectual Property, BiosimilarsFresenius Kabi SwissBioSim GmbH (Aubonne, CH)

ModeratorLaurie HillVice President of Intellectual PropertyGenentech (South San Francisco, CA)

For more information, visit the Summit website.

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