Biosimilar Litigation and Your BPCIA Compliance: Key Strategies In Light of AbbVie v. Boehringer
The previous year saw an increase in biosimilar filings in the U.S., including the recent suit filed by AbbVie in the U.S. District Court for the District of Delaware against Boehringer Ingelheim regarding Boehringer Ingelheim’s adalimumab product, Cyltezo®, a proposed biosimilar to AbbVie’s Humira®. The complaint alleges infringement of 8 patents in the initial phase of litigation, as Boehringer Ingelheim was able to cap the scope of litigation by complying with the procedures of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This case reflects the benefits of complying with the BPCIA's patent dispute resolution procedure, also known as patent dance.
In this LIVE webcast, a panel of distinguished professionals and thought leaders will discuss the latest legal and regulatory updates that are continuously changing the biosimilar landscape. They will review the on-goings of the AbbVie v. Boehringer Ingelheim litigation and give insights on the benefits and risks of engaging in the BPCIA's patent dance. Speakers will also provide considerations in adopting appropriate litigation strategies.
Key issues that will be covered in this course are:
- Biosimilar Litigation Landscape Post Sandoz v. Amgen
- Complying with BPCIA: AbbVie v. Boehringer Ingelheim
- The Benefits and Risks of Patent Dance
- Recent Legal and Regulatory Updates
- Strategic Considerations for Biosimilar Litigation
- Significant Trends and Legal Updates
Dean L. Fanelli, Ph.D., Partner
Seyfarth Shaw LLP
- Biologics – Top-Earning Drugs
- Biosimilar Predictions (Global)
- U.S. Generics v. Biosimilars
- FDA Activity
- U.S. Litigation
Jamaica Potts Szeliga, Partner
Seyfarth Shaw LLP
- Appellate Decisions
- Sandoz v. Amgen: Case No. 15-1039 (S. Ct.); Case No. 15-1499 (Fed. Cir.)
- TC Heartland: Case No. 16-341 (S. Ct.)
- Apotex v. Amgen: Case No. 17-1010 (Fed. Cir.)
- Critical Issues
- Participation in the Patent Dance
- Estoppels in aBLA, dance disclosures
Timothy J. Shea, Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.
- The “Patent Dance” – Phase I (No Agreement on Patents to Litigate)
- U.S. Biosimilar Litigation – Dist. Ct. Developments
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. Fanelli’s expertise lies in patent portfolio creation and management, counseling, technology transactions, due diligence, opinion work, including drafting novelty, freedom-to-operate, and invalidity opinions, and inter partes review and post grant review proceedings. Dr. Fanelli also has significant experience with the interplay between patent and FDA laws under the Hatch-Waxman Act, and he regularly handles IP issues attendant to mergers, acquisitions, and financing for life sciences companies as well as ANDA analyses associated with Hatch-Waxman paragraph IV litigation.
Dr. Fanelli received his J.D. from The George Washington University Law School and received his Ph.D. in organic chemistry from Temple University, where he studied the syntheses of biologically active amino acids and amino acid derivatives under the supervision of Dr. Franklin A. Davis.
Dean L. Fanelli, Ph.D. is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington, D.C. office. Dr. …
Jamaica Szeliga is a partner in the Litigation Department of Seyfarth Shaw LLP’s Washington, D.C. office.
Ms. Szeliga’s practice focuses primarily on intellectual property litigation relating to pharmaceutical, biotechnology, and chemical matters. She also litigates patent disputes involving other technologies, including medical devices, mechanical inventions, communications, and high tech products, and further has significant experience in design patent litigation.
With respect to litigation, Ms. Szeliga has participated in several bench and jury trials and managed litigations at all stages. As part of her experiences, Ms. Szeliga has drafted and argued dispositive motions, coordinated complex fact discovery, managed expert discovery, taken and defended fact and expert depositions, examined witnesses at trial, engaged in mediation and dispute resolution processes, and briefed multiple appeals. She also has been a member of several joint defense groups, and has litigated against such groups, particularly in the context of Hatch-Waxman ANDA matters.
Jamaica Szeliga is a partner in the Litigation Department of Seyfarth Shaw LLP’s Washington, D.C. office. Ms. Szeliga’s practice focuses …
Tim Shea is Director in the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced for more than 20 years. Mr. Shea specialises in advising biopharmaceutical companies and research institutions on complex legal issues relating to the protection, enforcement, and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genetic and medical diagnostics, biotherapeutics, and drug delivery. Mr. Shea has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments. He has published and spoken extensively on IP issues related to therapeutic antibodies and biosimilars. In addition, a significant portion of his practice involves counseling emerging companies on strategies for creating, protecting, and leveraging their IP assets to grow their businesses.
Mr. Shea’s full professional biography is available online at the following link: https://www.skgf.com/timothyshea
Tim Shea is Director in the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced …
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Method Of Presentation:
Experience in patent law
NY Category of CLE Credit:
Areas of Professional Practice
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About Seyfarth Shaw LLP
Seyfarth Shaw LLP has more than 850 attorneys and provides a broad range of legal services in the areas of intellectual property, labor and employment, employee benefits, litigation, corporate and real estate. With offices in Atlanta, Boston, Chicago, Houston, London, Los Angeles, Melbourne, New York, Sacramento, San Francisco, Shanghai, Sydney and Washington, D.C., Seyfarth’s clients include over 300 of the Fortune 500 companies and reflect virtually every industry and segment of the economy. A recognized leader in delivering value and innovation for legal services, Seyfarth’s acclaimed SeyfarthLean client service model has earned numerous accolades from a variety of highly respected third parties, including industry associations, consulting firms and media. For more information, please visit www.seyfarth.com.
About Sterne, Kessler, Goldstein & Fox P.L.L.C.
Sterne, Kessler, Goldstein & Fox is an intellectual property law firm of 170+ professionals devoted solely to providing outstanding patent, trademark, Patent Office litigation, district court, and International Trade Commission legal services.
For more than 36 years, Sterne, Kessler, Goldstein & Fox helped companies build and enforce worldwide IP portfolios. Sterne Kessler has a proven track record at U.S. district courts, federal appeals courts, and the International Trade Commission, with worldwide oppositions, 175+ inter partes reviews, 50+ interferences, 400+ reexaminations, and covered business method patent reviews. They are the leader in both inter partes reviews and covered business method reviews in the biotech and pharmaceutical industry.
Sterne Kessler provides a full range of IP services, including: Patent preparation and prosecution, including management of worldwide prosecution, patent Office litigation, including oppositions, reexaminations, interferences, inter partes reviews (IPR), and covered business method (CBM) proceedings, patent litigation in U.S. district courts, state courts, the United States Court of Appeals for the Federal Circuit, and the United States International Trade Commission, strategic patent portfolio development and portfolio management, patent searching conducted at Sterne Kessler, as well as searching by vendors managed by Sterne Kessler, opinions on patentability, freedom to operate, patent infringement, and patent validity, advice on licensing, technology transfer, commercialization, monetization and due diligence; a number of their attorneys are Certified Licensing Professionals: Copyrights, Trademarks and Design Patents.