Speaking Engagement

12th Annual Paragraph IV Disputes

Tuesday, April 24, 2018 - Wednesday, April 25, 2018

12:00 AM BST - 12:00 AM BST

New York, NY

102 North End Ave.

New York , USA

Meet and network with the key influencers shaping the law, policy and proceedings of Paragraph IV litigation.

Each spring, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and legislative developments affecting Hatch-Waxman litigation. 

Paul Hastings is a proud sponsor of this conference. Partners Joseph O'Malley, Global Chair of the Intellectual Property practice, and Bruce Wexler, Chair of the Life Sciences Industry Practice Group, will speak at their respective sessions:

Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary ConsiderationsApril 24, 2018 - 11:00am

Program DescriptionDeciphering recent Federal Circuit opinions addressing inherency and anticipation in an ANDA setting

  • Millennium Pharm. v. Sandoz, Inc., Appeal no. 2015-2066 (Fed. Cir., July 17, 2017)

    Dissecting the concept of inherent obviousness and establishing the correct standard

  • Honeywell International, Inc. v. Mexichem Amanco

  • Requirements for rejections based on inherency and burden of proof determinations

  • Understanding how ‘that which may be inherent is not necessarily known’ and that which is unknown cannot be obvious

Examining inherency rejections

Survey of recent cases at the District Courts highlighting the importance of secondary considerations in an obviousness determination

Examining trends at the District Court and PTAB indicating a receptiveness to the use of secondary considerations

Applying these findings to ANDA litigation

  • Analyzing factors of commercial success, unmet need, licensing

  • Exploring the ongoing debate on copying and its relevance or irrelevance to Hatch-Waxman litigation

Speakers:Bruce M. WexlerPartnerPaul Hastings LLP (New York, NY)

Tony V. PezzanoPartnerHogan Lovells LLP (New York, NY)

John SnowShareholderPolsinelli PC (Chicago, IL) 

Stephen R. SmerekPartnerWinston & Strawn LLP (Los Angeles, CA)

Moderator:Donna M. MeuthAssociate General Counsel, Intellectual PropertyEisai (Andover, MA)

The Devil in the Label Details: A New Test for Induced InfringementApril 24, 2018 - 1:45 pm

Program DescriptionThe Federal Circuit recently issued new guidance for evaluating divided and contributory infringement of pharmaceutical method-of-use patents. In Sanofi v. Watson, the Federal Circuit held that drug product labeling “as a whole” may be used to support a claim of induced infringement, thus providing guidance for enforcing method-of-use patents, as new uses for drugs are revealed. This panel will explore this finding. Points of discussion will include:

Reviewing the state of the law on induced infringement and its repercussions for Hatch-Waxman

Understanding how extensive labeling information on a generic drug may encourage an act of inducement

  • Intent to induce vs. actual inducement

Looking beyond indications and usage and dosage and administration to establish inducement

Comprehending the importance of how the doctor’s reading of the label as a whole may lead to an act of induced infringement

Speakers:Joseph O’MalleyPartnerPaul Hastings LLP (New York, NY)

Michael P. DoughertyPartnerHogan Lovells (New York, NY)

Robert C. Millonig, Jr., Ph.D.DirectorSterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Wendy Petka, Ph.D., J.D.Senior Director and Senior Patent CounselTheravance Biopharma US, Inc. (South San Francisco, CA)

Conrad New York102 North End Ave.New York, NY 10282

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