Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space

9:00 AM – 12:00 PM ET | June 15, 2016 | New York

MBHB Partner Kevin Noonan, Ph.D. is a featured presenter at this three-hour ACI-sponsored program.

Program Overview:

  • Avoiding conflicts of interest as the lines between branded companies and generic companies blur in the biosimilars space

    • Overview of the Rule 11 mandates

    • What is the duty of care required?

      • Law firms representing both reference products and biosimilars: will the arguments you made in one case come back to haunt you in another?

    • Applying traditional conflicts analysis and principles when agreeing to work for a client: are ABA comments to the model rules instructional?

  • Navigating the tricky confidentiality issues inherent in the dossier exchange process under the BPCIA

    • How do you use the information that you get access to during the patent dance?

    • Maintaining required confidentiality while advocating for your company or client

  • What are the limitations of disclosure of biosimilar applications?

  • Obtaining the help of an outside expert or technical specialist

  • USPTO spotlight: What are OED’s expectations of attorneys in this space?

    • Understanding when to raise the inequitable conduct defense under the continually evolving Therasense standard

  • Rule 36 affirmations of inequitable conduct cases

  • Update on recent relevant inequitable conduct cases

    • Complying with the USPTO duty of disclosure: what to submit and how much?

  • Analysis of the PTO’s 2013 Rules of Professional Conduct

  • Overview of key provisions including conflicts, sanctions and experts

  • How do these work with the ABA model rules and state bar rules?

This program is being conducted as part of the American Conference Institute’s (“ACI”) 7th Annual Summit on “Biosimilars: Legal, Regulatory, Commercial and Patent Strategies for the Emerging U.S. Biosimilars Landscape.”

Sponsored by: American Conference Institute

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