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Insight Center: Webinars

The BPCIA Patent Dance - What Biosimilar Companies Need to Know

Speakers: Pierre E. Queiroz de Oliveira, Daniel J. Nevrivy and Jamaica P. Szeliga

1/10/2017
3:00 - 5:00 PM (EST)
The BPCIA Patent Dance - What Biosimilar Companies Need to Know

Presented by The Knowledge Group

For about seven years now, the Biologics Price Competition and Innovation Act (“BPCIA”) of 2009 has continually facilitated entry of biosimilar products into the market. By allowing submission of an abbreviated Biologics License Application (“aBLA”) to an already approved and licensed FDA product, BPCIA aids in making the pioneer and the applicant meet halfway. However, meeting halfway is not as easy as it sounds. There are matters to deal with: agreements and disclosures to be settled down before the commercial marketing of a biosimilar product begins. Patent disputes are among the most debated, and often controversial issues that biosimilar companies are faced with.

In its second part, BPCIA addresses certain patent resolution issues. Commonly called as the "patent dance", 42 U.S.C. § 262(l) provides the steps and schedule when a reference sponsor product and a biosimilar applicant exchange "confidential information" about the aBLA. Typically, the confidential information disclosed by the applicant is its application and manufacturing trade secrets.

Indeed, the music hasn't stopped for biosimilar companies, and "patent dance" is still obviously becoming a dance craze for them. Questions remain as to whether or not companies facing the "dance" will minimize the potential for litigation under the BPCIA, and to what extent will this craze bring the industry.

The Knowledge Group has assembled a panel of key thought leaders to provide the audience with an in-depth analysis of the BPCIA "Patent Dance" and its recent developments. In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders will help biosimilar companies understand the important aspects of this significant topic. Speakers will also offer best practices in helping the audience better understand the steps and legal issues brought by the latest litigations.

Key topics include:

  • An overview of 42 U.S.C. § 262(l)
  • Nature of the abbreviated Biologics License Application (“aBLA”)
  • The 180-day notice of commercial marketing
  • A closer look at the "patent dance"
  • Deeper study of the significant cases:
    • Amgen v. Apotex
    • Amgen v. Sandoz

CLE credit available.

Registration

Early Bird Discounted Rate (On or before 12/31/2016): $199 - $249
Regular Rate (Registration after 12/31/2016): $299 - $349
Government / Nonprofit Rate: $149

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