The BPCIA Patent Dance – What Biosimilar Companies Need To Know

December 28, 2016
The Center for Biosimilars Staff

Live webcast on what biosimilar companies need to know.

The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, announced today that it has scheduled a live webcast entitled: The BPCIA Patent Dance — What Biosimilar Companies Need To Know.

On or 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:

This 2-hour webcast will discuss the following key provisions:

-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

Speakers/Faculty Panel

Pepper Hamilton LLP

Pierre E. Queiroz de Oliveira

Attorney

Nevrivy Patent Law Group P.L.L.C

Daniel J. Nevrivy, PH.D.

Attorney

Leydig, Voit & Mayer

Jamaica P. Szeliga

Partner

For an updated list of the faculty panel, please visit:

https://theknowledgegroup.org/event-homepage/?event_id=2114