Gasper LaRosa

The article discusses a recent PTAB decision considering a patent owner's motion for additional discovery to compel depositions related to questions regarding the real parties in interest.

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the Federal Circuit sided with Sandoz in ruling the BPCIA preempts state law remedies for noncompliance with 42 U.S.C. § 262(Ɩ)(2)(A) ("patent dance")

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit.

The Result: The court found that the commercial marketing of Apotex's proposed biosimilar versions of Amgen's Neulasta® and Neupogen® would not infringe on a patent held by Amgen.

Looking Ahead: Amgen v. Apotex underscores the importance of fact witness testimony and other factual evidence to support arguments… Show more

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit.

The Result: The court found that the commercial marketing of Apotex's proposed biosimilar versions of Amgen's Neulasta® and Neupogen® would not infringe on a patent held by Amgen.

Looking Ahead: Amgen v. Apotex underscores the importance of fact witness testimony and other factual evidence to support arguments regarding infringement. Show less

The Court sided with Sandoz on matters relating to enforceability of a provision requiring applicants to provide license applications and manufacturing information to the sponsor of the referenced product, and on the timing of marketing notices relative to FDA approval.

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics Price Competition and Innovation Act ("BPCIA").

Effective January 18, 2017, a new Final Rule by the Department of Health and Human Services clarifies certain clinical trial disclosure requirements and expands others. Notably, the submission of results information for unapproved drugs, biologics, and device products is now required. The changes mean that more and different types of information on clinical trials, published by the National Institutes of Health at ClinicalTrials.gov, will be accessible to the public. This potentially risks… Show more

Effective January 18, 2017, a new Final Rule by the Department of Health and Human Services clarifies certain clinical trial disclosure requirements and expands others. Notably, the submission of results information for unapproved drugs, biologics, and device products is now required. The changes mean that more and different types of information on clinical trials, published by the National Institutes of Health at ClinicalTrials.gov, will be accessible to the public. This potentially risks placing otherwise patentable subject matter in the public domain. Parties have 90 days after the effective date to comply with the Final Rule. Show less

In May 2016, the U.S. International Trade Commission (“ITC”) released its report (“ITC report” or “report”) on the Trans-Pacific Partnership (“TPP”) Agreement,[1] concluding that the TPP Agreement would likely benefit U.S. industries that rely on intellectual property rights by requiring:
Five to eight years of market exclusivity for new biologic products;
Transparency from parties regarding regulatory bodies and procedures; and
Commitments related to patents and data protection to… Show more

In May 2016, the U.S. International Trade Commission (“ITC”) released its report (“ITC report” or “report”) on the Trans-Pacific Partnership (“TPP”) Agreement,[1] concluding that the TPP Agreement would likely benefit U.S. industries that rely on intellectual property rights by requiring:
Five to eight years of market exclusivity for new biologic products;
Transparency from parties regarding regulatory bodies and procedures; and
Commitments related to patents and data protection to decrease infringement losses. Show less