Biologics Price Competition and Innovation Act: Purple Book, Dispute Resolution, Exclusivities, and Court Treatment
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Thursday, January 5, 2023
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide patent counsel on the Biologics Price Competition and Innovation Act (BPCIA). The panel will discuss the Purple Book and issues related to exclusivities and the retroactivity of the BPCIA. The panel will also address the ongoing debate over whether the BPCIA's patent dispute resolution procedures are allowed or required and the litigation that has followed. The panel will look back at the 12 years of the BPCIA and discuss where things are going.
Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.
Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.
Dr. Yang focuses on complex patent litigation before U.S. district courts and inter partes review (IPR) proceedings in the chemical, pharmaceutical, and biotechnological fields. She has experience representing pharmaceutical patent holders in Hatch-Waxman litigations and has drafted numerous appellant and appellee briefs for pharmaceutical clients at the U.S. Court of Appeals for the Federal Circuit. She has handled various aspects of trial preparation, including fact and expert discovery, depositions of key witnesses and experts, and motion practice, along with other pre-litigation due diligence and position analysis. She also has worked on multiple IPR cases on behalf of petitioners or patent owners and has been involved in all aspects of those cases. In addition, she has conducted a variety of due diligence analysis in the biotechnological field for licensing, acquisition, freedom-to-operate, and startup fundraising.
Mr. Raich, Ph.D., leader of Finnegan’s biotechnology and pharmaceutical practice group, represents innovative companies developing biologics, pharmaceuticals, medical devices, and diagnostics. As a patent lawyer with a doctorate in cellular and molecular biology, he focuses his practice on patent litigation, pre-litigation counseling, and contentious proceedings at the U.S. Patent and Trademark Office (USPTO), applying his technical expertise and courtroom insight to develop simple, persuasive positions for clients.
The BPCIA, signed into law in 2010, is over 12 years old and has seen almost 100 drugs approved as biosimilar to or interchangeable with an FDA-licensed reference biological product. However, growing pains still exist. There is an ongoing disagreement about patent dispute resolution procedures (the "patent dance") under the BPCIA. Further, a Federal Circuit decision raises questions about limiting the venue in Hatch-Waxman, which may impact venue in BPCIA cases.
Further, language from the Purple Book Continuity Act of 2019 (tucked into the Further Extension of Continuing Appropriations Act, 2021), signed into law in December 2020, impacts the biologics regulation landscape. The statute requires reference product sponsors to provide the FDA with copies of any patent lists within 30 days of when they were first provided to biosimilar applicants as part of the "patent dance."
The listings of biologic products in the Purple Book must include, e.g., the nonproprietary name, the patent information, licensure and marketing status, and exclusivity periods. The FDA must update the list every 30 days. Previously, the exchange of information under the BPCIA patent dance was undertaken confidentially between the reference product BLA holder and the biosimilar applicant and providing patent lists to the FDA was voluntary. While the enacting legislation indicates that the patent holder "shall" provide this information to FDA, no consequences are specified for failing to comply.
Counsel should stay abreast of the latest biosimilar court decisions and regulatory actions to make informed decisions regarding participation in the patent dance, dispute resolution, and more. For example, considerations for applicants include possible outcomes of deciding whether to initiate a patent dance and when to provide commercial marketing notice. Considerations for reference product sponsors include possible outcomes when deciding which patents to identify during the patent dance and how to respond to commercial marketing notices.
In addition, reference product sponsors must consider preparing for infringement suits and declaratory judgment actions if the applicant does not comply with the patent dance. While the new law advances transparency, it also may lead to more validity/unpatentability challenges of specific patents, affect the scope of potential license negotiations, or provide information for possible design-around options.
Listen as our authoritative panel of patent attorneys examines the BPCIA and its impact. The panel will discuss the Purple Book requirements, issues related to exclusivities, and the disputed retroactivity of the BPCIA. The panel will review the case law from 12 years of the BPCIA and discuss where things are going.
- BPCIA framework
- Purple Book
- Exclusivities
- Disputed retroactivity of the BPCIA
- BPCIA litigation
- Court decisions
- PTAB decisions
- Future of BPCIA
- Best practices
The panel will review these and other key issues:
- What the Purple Book and the new transparency requirements mean for biologics companies
- How the courts are treating BPCIA issues
- Implications of the potential unavailability of IPR and PGR for biosimilars
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