Understanding the BPCIA Litigation Pathway Amidst the Increasing Biosimilar Disputes
The Biologics Price Competition and Innovation Act (BPCIA) encourages competition and innovation in the biologics market by providing an abridged pathway for the approval of a biosimilar license application along with a twelve-year market exclusivity. The BPCIA also determines patent infringement disputes by setting out a process and addresses potential litigation following a license application. To streamline biosimilar litigation, the BPCIA implements patent statutes that introduce a new artificial patent infringement act, requires information exchange cycles, envisions two waves of litigation, and restricts patent declaratory judgment actions under certain conditions.
Biosimilar litigation is expected to rise as the number of drug manufacturers considering the addition of biosimilars to their drug product portfolios, continues to grow. To dodge costly pitfalls and irreversible mistakes, a complete understanding of the BPCIA litigation pathway should be considered.
The Knowledge Group has assembled a panel of key thought leaders and professionals to help the audience better comprehend the BPCIA Litigation landscape amidst the increasing Biosimilar Disputes. This panel will also present an in-depth analysis and understanding on the current issues surrounding biosimilar litigation and will provide the audience with practical strategies in bringing out the best in these lawsuits in a rapidly evolving legal climate.
Key topics include:
- An Overview of the BPCIA
- The BPCIA Litigation Pathway
- Notable Cases
- Practical Litigation Strategies
- Trends, Developments and Updates
Timothy J. Shea, Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Recent Supreme Court case
- IPR’s and how they’re used in the biosimilar industry
- Accounting for parallel proceedings – litigation and IPR’s, notice provisions
Thomas A. Haag, Partner
Seyfarth Shaw LLP
- When to get your IP attorney involved
- Finding, evaluating, and working around covered patents
- Organizing and memorializing strategy
Jamaica P. Szeliga, Partner
Seyfarth Shaw LLP
- How BPCIA differs from Hatch-Waxman
- A comparison of the three paths to biosimilar litigation completion
- Key decision-making: forum, participation in the dance, the number of patents to proceed with in BPCIA litigation, at-risk launch
Dr. Dean L. Fanelli, Partner
Seyfarth Shaw LLP
- Biologics are big money (discussion of top 15 drugs and how many are biologics)
- Update on biosimilar status: number of biologics approved, number of biologics on market, current price discount in US v. Europe
- Updates on key biosimilar litigations
- Updates on legislative efforts
Who Should Attend:
- Biotech and Pharma Lawyers
- Senior Management from Biotech and Pharma Industries
- In-House Counsel
- Patent Attorneys
- Patent Agent
- Patent Licensing Attorneys
- Patent Counsel
- Patent Litigators
- Biotech and Pharma Companies
- Other related/interested Professionals and Organizations
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 …
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 …
Thomas Haag is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington D.C. office where he cochairs the firm’s chemical & life science patent team. His practice focuses on pharmaceutical and biotechnology patent counseling, due diligence and licensing/transactional matters; as well as Hatch-Waxman litigation and patent opinion work.
He has extensive experience strategically managing large patent portfolios, drafting and negotiating biomedical patent licenses, asset purchase agreements and jointdevelopment agreements. Dr. Haag’s technical expertise is in molecular biology related technologies including those in the fields of immuno-oncology, cancer/infectious disease vaccines, nucleic acid-based therapeutics, stem-cell therapeutics, gene editing and therapy, epigenetics, transgenic plants, next generation sequencing (NGS), biologics and biosimilars.
Previously, Dr. Haag was a Founding Partner and Chair of Fanelli Haag PLLC. Fanelli Haag was acquired by Seyfarth Shaw LLP in October 2016. Fanelli Haag was a leading intellectual property boutique law firm focused on issues facing the biotechnology, pharmaceutical, nanotechnology and chemical industries.
Thomas Haag is a partner in the Intellectual Property Department of Seyfarth Shaw LLP’s Washington D.C. office where he cochairs …
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Basic Knowledge in Patent Law
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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.
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.