Patent Dispute Resolution Provisions of the BPCIA in Light of Amgen v. Sandoz Case Explored!
The Biologics Price Competition and Innovation Act (BPCIA) provides a regulatory pathway for approval of biological drugs as biosimilar to an existing product. Since its passage, litigation related to patent procedures under the BPCIA have arisen. In Amgen Inc. v. Sandoz Inc., the court construed several of the patent dispute resolution and market entry provisions of the BPCIA. The court held that a biosimilar applicant need not share its biosimilar application with the reference product sponsor, or necessarily abide by the BPCIA’s patent resolution procedures. The court also held that the biosimilar applicant must provide 180 days’ pre-marketing notice to the reference product sponsor after FDA approves the biosimilar product.
However, Sandoz has recently filed a petition for writ of certiorari, requesting the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. Consequently, Amgen filed an opposition, arguing that the questions presented in Sandoz’s petition are “not ripe for review.” Amgen also filed a conditional cross-petition and it’s still uncertain whether the Supreme Court will grant review.
Judge Newman dissented-in-part with respect to the majority’s ruling on the application sharing provisions. In her view, “the BPCIA reflects an explicit balance of obligations and benefits. When a beneficiary of the statute withholds compliance with provisions enacted to benefit others, the withholder violates that balance. The consequences of the majority’s ruling are significant, for the structure of the BPCIA requires that the subsection (k) applicant comply with the information exchange provisions, as a threshold to resolution of the Sponsor’s patent rights.”
In a two-hour LIVE Webcast, a notable panel of key practitioners and thought leaders brought together by The Knowledge Group will provide the audience with an understanding of all the important issues concerning Patent Dispute Resolution Provisions of the BPCIA in light of the Amgen v. Sandoz case. Speakers will also offer a discussion of the fundamentals as well as recent developments with regards to this significant topic.
Key topics include:
- Intro to BPCIA
- Compare Hatch-Waxman Act to BPCIA
- BPCIA “Patent Dance” Provisions—§ 351(l)
- Second Wave Litigation: Pre-commercialization Notice/PIs
- Litigation regarding Patent Dance and Commercialization Notice: Fact Patterns and Rulings
- Where are we going?
- Litigation: Key Take Home Points
- BPCIA Issues for RPS
- BPCIA Issues for aBLA Applicant
- Other Issues in Biosimilar Space
Akin Gump Strauss Hauer & Feld LLP
- Introduction to the BPCIA
- Passage of the BPCIA and Background Considerations
- Comparison of the Hatch-Waxman Act to the BPCIA
- BPCIA “Patent Dance” Provisions—42 U.S.C. § 262(l)
- Statutory Consequences of Not Dancing
- Non-compliance by aBLA Applicant (§ 262(l)(9))
- Non-compliance by RPS (§ 271(e)(6))
- Statutory Consequences of Not Dancing
- Pre-commercialization Notice and Preliminary Injunctions
- Pending Litigation
- Amgen Inc. v. Sandoz Inc. (Neupogen®)
- Janssen Biotech v. Celltrion Healthcare (Remicade®)
- Amgen Inc. v. Apotex Inc. (Neulasta® and Neupogen®)
- Amgen Inc. v. Hospira (Epogen®)
- Immunex/Amgen v. Sandoz Inc. (Enbrel®)
- Amgen v. Sandoz Inc. (Neulasta®)
Kilpatrick Townsend & Stockton LLP
- BPCIA Issues for Innovators
- Factors for Portfolio Development
- Portfolio Audit and Tiering
- BPCIA Confidentiality Provisions
- BPCIA Issues for Biosimilar Applicant
- Landscape Searches
- Develop Strategies for Challenge
- Deciding whether to Dance
- Challenges Options
- AIA Post-Grant Proceedings
- Use in Biosimilar Space
- Strategy Issues
- Other Issues in Biosimilar Space
- BPCIA – Guidelines for Application Approval
- Uncertain Interchangeability Standard
- Biosimilar Naming Issues
- Biosimilar Labeling Issues
Who Should Attend:
- Biotech and Pharma Lawyers
- Senior Management from Biotech and Pharma Industries
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Counsel
- Patent Litigators
- Patent and Health Services Professionals
- Other related/interested Professionals and Organization
Jason Weil’s practice focuses on patent litigation and client counseling in in a wide range of technologies, including monoclonal antibody and small molecule drugs, DNA sequencing technology, and medical devices. Dr. Weil currently represents a pharmaceutical company whose monoclonal antibody drug is the reference product in one of the first BPCIA litigations ever brought. Dr. Weil also represents a pharmaceutical company in a series of patent infringement suits related to a monoclonal antibody treatment for cancer.
Dr. Weil earned his J.D. with Highest Honors from The George Washington University Law School and served as a law clerk to the Honorable Richard Linn of the U.S. Court of Appeals for the Federal Circuit. Prior to law school, Dr. Weil earned his Ph.D. in Biology from the Johns Hopkins University, where he studied various aspects of viral RNA processing.
Jason Weil’s practice focuses on patent litigation and client counseling in in a wide range of technologies, including monoclonal antibody …
Tim Heverin's practice focuses on intellectual property litigation, licensing, and counseling. He has represented clients in patent infringement lawsuits in district courts throughout the United States and before the ITC.
Tim concentrates on life sciences and biotechnology. He spearheads the Firm’s biosimilars practice and has extensive experience litigating Hatch-Waxman and other pharmaceutical patent cases, in which he has represented brand name companies and protected intellectual property rights covering products such as Prezista®, Hytrin®, Tricor®, Istodax® and Kuvan®.
Tim Heverin's practice focuses on intellectual property litigation, licensing, and counseling. He has represented clients in patent infringement lawsuits in …
Jennifer Giordano-Coltart, Ph.D., focuses her practice on patent prosecution, portfolio management, transactional matters, and intellectual property strategy in the life sciences, biotechnology, and medical device fields. She prosecutes patents for clients in the U.S. and abroad and provides patentability, patent validity, infringement, and freedom-to-operate counseling to facilitate her clients’ business goals. In addition, Dr. Giordano-Coltart assists her clients with licensing and acquisitions, including patent analyses and negotiations. She also provides technical assistance on litigation matters and actions before the U.S. Patent and Trademark Office. Dr. Giordano-Coltart’s experience with a wide range of clients—investment groups, start-ups, mid-size and growing companies, and large, established industry leaders—informs her ability to tailor intellectual property strategies to the needs of her clients.
Jennifer Giordano-Coltart, Ph.D., focuses her practice on patent prosecution, portfolio management, transactional matters, and intellectual property strategy in the life …
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