The BPCIA Patent Dance – What Biosimilar Companies Need To Know
For about seven years now, the Biologics Price Competition and Innovation Act (“BPCIA”) of 2009 has continually facilitated entry of biosimilar products into the market. By allowing submission of an abbreviated Biologics License Application (“aBLA”) to an already approved and licensed FDA product, BPCIA aids in making the pioneer and the applicant meet halfway. However, meeting halfway is not as easy as it sounds. There are matters to deal with: agreements and disclosures to be settled down before the commercial marketing of a biosimilar product begins. Patent disputes are among the most debated, and often controversial issues that biosimilar companies are faced with.
In its second part, BPCIA addresses certain patent resolution issues. Commonly called as the "patent dance", 42 U.S.C. § 262(l) provides the steps and schedule when a reference sponsor product and a biosimilar applicant exchange "confidential information" about the aBLA. Typically, the confidential information disclosed by the applicant is its application and manufacturing trade secrets.
Indeed, the music hasn't stopped for biosimilar companies, and "patent dance" is still obviously becoming a dance craze for them. Questions remain as to whether or not companies facing the "dance" will minimize the potential for litigation under the BPCIA, and to what extent will this craze bring the industry.
The Knowledge Group has assembled a panel of key thought leaders to provide the audience with an in-depth analysis of the BPCIA "Patent Dance" and its recent developments. In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders will help biosimilar companies understand the important aspects of this significant topic. Speakers will also offer best practices in helping the audience better understand the steps and legal issues brought by the latest litigations.
This 2-hour webcast will discuss the following key provisions:
- An Overview of 42 U.S.C. § 262(l)
- Nature of the abbreviated Biologics License Application (“aBLA”)
- The 180-day Notice of Commercial Marketing
- A Closer Look at the "Patent Dance"
- Deeper Study of the Significant Cases:
- Amgen v. Apotex
- Amgen v. Sandoz
Pierre E. Queiroz de Oliveira, Attorney
Pepper Hamilton LLP
- Overview of biologics regulation
- Overview of the BCPIA
- The BCPIA “patent dance” procedure and timeline
Daniel J. Nevrivy, PH.D., Attorney
Nevrivy Patent Law Group P.L.L.C
- Before filing aBLA
- Identification of all relevant patents and pending applications relevant to the reference product
- Analysis of patent strengths/weaknesses/expirations
- Design around strategies/formulation/process development
- Development of positions (noninfringement, invalidity, etc.)
- After filing aBLA
- Understanding 42 USC § 262(l) (particularly (2)(A) and (8)(A)) in light of Amgen v. Sandoz and Amgen v. Apotex and strategic considerations (whether to opt in, what patents to list, etc.)
Jamaica P. Szeliga, Partner
Leydig, Voit & Mayer
- Preparing for litigation under the BPCIA--considerations of scope, forum, and timing
- Current litigation landscape--who, what, and where
- Litigation predictions: what will be the key issues faced next?
Who Should Attend:
- Pharma Industry Lawyers
- Pharmaceutical Companies
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Counsel
- Patent Litigators
- IP Counsel
- Other related/interested Professionals and Organizations
Pierre Queiroz de Oliveira is an attorney in the Intellectual Property Practice Group of Pepper Hamilton LLP. Dr. Queiroz de Oliveira concentrates his practice on intellectual property transactions and counseling, with a substantial portion of his work directed to patent preparation and prosecution, due diligence and licensing matters. Dr. Queiroz de Oliveira has extensive basic science experience and holds a Ph.D. in molecular pharmacology from the University of Pittsburgh School of Medicine. During his tenure at the University of Pittsburgh, Dr. Queiroz de Oliveira was selected as a Fellow in molecular pharmacology. His scientific and technological experience include pharmacology, pharmaceuticals and drug development, molecular biology, biochemistry and organic chemistry. Dr. Queiroz de Oliveira has been published in a number of peer-reviewed journals and his research has been presented at numerous national meetings. He can be reached at firstname.lastname@example.org.
Pierre Queiroz de Oliveira is an attorney in the Intellectual Property Practice Group of Pepper Hamilton LLP. Dr. Queiroz de …
Dr. Nevrivy is a patent attorney specializing in biotechnology and pharmaceutical patent law. His practice includes drafting and prosecuting domestic and international patent applications, counseling clients regarding intellectual property strategies and portfolio management, freedom to operate, due diligence, patentability, invalidity and noninfringement. In particular, he has significant experience helping companies navigate the complex patent issues associated with the development and launch of proprietary products.
Dr. Nevrivy is a patent attorney specializing in biotechnology and pharmaceutical patent law. His practice includes drafting and prosecuting domestic …
Jamaica Potts Szeliga is a partner at Leydig, Voit & Mayer in its Washington, D.C. office. Ms. Szeliga is a former clerk for the United States Court of Appeals for the Federal Circuit and is registered to practice before the United States Patent and Trademark Office. Her practice focuses primarily on intellectual property litigation, where she has participated in ANDA litigation on behalf of both brand and generic companies. She has also litigated cases involving biotechnology and biologics, medical devices, telecommunications, electronics, consumer goods, and mechanical products.
Ms. Szeliga graduated magna cum laude from Harvard Law School in 2002, and received her Bachelor of Science degree in Chemistry, with a minor in Biology, with distinction, from Stanford University in 1999. She is admitted to the District of Columbia and the New York State bars.
Jamaica Potts Szeliga is a partner at Leydig, Voit & Mayer in its Washington, D.C. office. Ms. Szeliga is a …
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About Pepper Hamilton LLP
Pepper Hamilton LLP is a multi-practice law firm with more than 500 lawyers nationally. The firm provides corporate, litigation and regulatory legal services to leading businesses, governmental entities, nonprofit organizations and individuals throughout the nation and the world.
Pepper Hamilton LLP’s Intellectual Property Department helps its clients protect and commercialize their intellectual property assets while minimizing the risk of liability. They assist companies with the full gamut of intellectual property matters, including patents, copyrights, trademarks, trade secret protection, unfair competition, privacy, and technology-related transactions. They recognize that IP is a vital part of any company’s asset portfolio, and, when conflicts arise, they work to efficiently resolve disputes through litigation or alternative methods. As a truly global practice, their IP experience extends beyond the United States. They structure, draft and negotiate agreements between both domestic companies and domestic companies and their foreign counterparts.
About Nevrivy Patent Law Group P.L.L.C
Nevrivy Patent Law Group P.L.L.C. is an intellectual property (IP) law firm located in Washington, D.C. The firm is committed to providing clients with the highest quality legal representation that is responsive, cost-effective, and aligned with their business goals.
The firm’s attorneys have extensive experience in IP law and a very high level of technical competence and scientific knowledge. The firm’s client base and experience enable it to appreciate the unique issues that each client faces and to tailor the representation to suit their business and technical needs. The firm’s clients are located throughout the U.S. and internationally and include inventors, start-ups, emerging growth and mid-size companies, Fortune 500 firms and leading research universities.
Technology areas of focus include biologics, pharmaceutical formulations, chemicals, chemical syntheses and processes, fuel cells, drug discovery, beverages and food science, polymers, agrochemicals, pigments, paper products, oil/gas refinery technologies, energy, pharmaceuticals and drug delivery technologies, stem cells and regenerative medicine, diagnostics and personalized medicine, molecular biology, biochemistry, vaccines, microbiology, antibodies, therapeutic methods, consumer products, mechanical devices, veterinary medicine, genomics, inflammation, cancer, small molecules, organic chemicals, optics, semiconductors, advanced materials, nanotechnology and nanobiotechnology.
About Leydig, Voit & Mayer
At the forefront of intellectual property law for more than a century, Leydig, Voit & Mayer provides valued advice and trusted counsel on intellectual property issues to industry leaders around the world. Leydig's IP litigation, licensing, and prosecution services encompass patent, trademark, copyright, trade secrets, Internet and other IP issues, including post-grant proceedings. The firm represents clients in various industries including pharmaceuticals, chemical and chemical engineering, software, electronics, manufacturing and machine design, biotechnology, medical devices, financial services, and consumer products. The wealth of litigation and technical experience of the firm’s attorneys and staff enables the firm to tailor its services to the unique needs of each client.