BPCIA Disclosure Requirements: What You Need to Know in 2016 and Beyond
On October 16, 2015, the Federal Circuit declined the petitions for rehearing by the panel and rehearing en banc in Amgen Inc. v. Sandoz, Inc. The petitions arose following the Federal Circuit’s decision in July 2015 that interprets key provisions of the Biologics Price Competition and Innovation Act (BPCIA).
The BPCIA provides creation of an abbreviated license pathway for biosimilars. A biosimilar application must demonstrate that the product is "highly similar" to or "interchangeable" with a biological product previously approved by the U.S. Food and Drug Administration.
Two important aspects of the BPCIA are: the disclosure of a biosimilar's application and manufacturing information between the biosimilar applicant and the reference product sponsor, and the 180-day notice of commercial marketing that the application must provide to the product sponsor. These disclosures, commonly referred to as the "patent dance", are found by the Federal Circuit to be optional during the Amgen case.
The Federal Circuit's decision leaves several issues open. Among these issues is the question on how much information must be disclosed during the patent dance. Such important issue will definitely impact compliance with BPCIA disclosure requirements. Therefore, biosimilar applicants and reference product sponsors must be well-informed of the changing demands on the "patent dance" compliance.
In this two-hour LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will offer the audience with an overview of the latest trends, critical issues and best practices with respect to BPCIA disclosure requirements.
Key issues that will be covered are:
- Overview of the BPCIA’s “patent dance”
- Understanding the Federal Circuit’s Decision in Amgen v. Sandoz
- Latest Trends and Critical Issues on Biosimilar Litigation
- Best Compliance Practices on BPCIA Disclosure Requirements
Crystal Lohmann Parker, Senior Attorney
Ropes & Gray LLP
Richard de Bodo, Partner
Morgan Lewis & Bockius LLP
- Quick intro to the BPCIA and the patent dance (Crystal)
- Amgen v. Sandoz-- Uncertainty in the law created by Sandoz’s petition for writ of certiorari and Amgen’s conditional cross-petition, including the questions presented by the parties and the fight over how far the Supreme Court should go if it decides to hear the case (Richard)
- The pending BPCIA litigations in district courts and the Federal Circuit: The statutory interpretation questions these pending cases are raising to fill in the holes left by the Federal Circuit’s decision in Amgen v. Sandoz and when we might get answers (Crystal)
- Avoiding the BPCIA: The potential use of IPRs or avoiding the abbreviated pathway all together to avoid the uncertainty of the BPCIA (Richard)
Who Should Attend:
- Counsel for BioPhama Products Manufacturing Companies
- Counsel for Biosimilars Manufacturing Companies
- Bio/Pharma and Related Attorneys
- Senior Members from Biological Products Manufacturing
- Senior Members from Biosimilars Manufacturing Companies
- Other Related/Interested Professionals or Organizations
Richard de Bodo is lead trial counsel in high-stakes, cutting-edge patent and trade secret cases for many of the world’s leading pharmaceutical, life sciences, and technology companies. Rich has an outstanding track record litigating and trying Hatch-Waxman cases and cases relating to biologic drugs, biosimilars, biotechnology, and medical devices. He has won significant victories in federal and state courts, arbitrations, the International Trade Commission (ITC), the U.S. Patent Office, and other forums for companies seeking to protect U.S. and international markets for their products or seeking to launch new products and overcome barriers to entry. Rich has extensive experience counseling companies seeking to launch biosimilars in the U.S. under the Biologics Price Competition and Innovation Act (BPCIA) and representing them in litigation, negotiations, and U.S. Patent Office proceedings. Rich serves as the practice leader of Morgan Lewis’s life sciences intellectual property practice.
Rich has consistently been rated as one of the best intellectual property and life sciences lawyers in the U.S. According to Chambers USA, “Clients are impressed by [Rich’s] brilliant mind and unmatched strategic skills.” Chambers quotes one of Rich’s clients that, “When the stakes are high, [Rich] is the only person I’d go to. [He] gets the job done in a measured and calm manner.” Another client stated: “[Rich] is the person you need when you’re faced with highly complicated IP legal matters that involve many variables.”
Rich is a thought leader in the intellectual property and life sciences fields, and regularly lectures and provides commentary on developments in the law. Rich has taught trial advocacy and litigation strategy at the National Institute of Trial Advocacy, the Hastings College of Advocacy, and numerous continuing education programs. Before practicing law, Rich served as a judicial clerk in the US Court of Appeals and the US District Court.
Richard de Bodo is lead trial counsel in high-stakes, cutting-edge patent and trade secret cases for many of the world’s …
Crystal Lohmann Parker is an associate at Ropes & Gray, based in New York. Crystal’s practice focuses primarily on patent litigation, in particular Hatch-Waxman litigation and cases involving medical devices and medical screening techniques. Crystal has represented clients in all stages of litigation up to and including bench trials, jury trials, arbitrations and appeals.
Crystal Lohmann Parker is an associate at Ropes & Gray, based in New York. Crystal’s practice focuses primarily on patent …
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About Morgan Lewis & Bockius LLP
With over 2,000 lawyers, patent agents, benefits advisers, regulatory scientists, and other specialists in 28 offices across North America, Europe, Asia, and the Middle East, Morgan Lewis has purposefully developed its capabilities to serve the complete life sciences product life cycle and all aspects of the healthcare and life sciences industry. We provide comprehensive litigation, corporate, transactional, regulatory, intellectual property, and labor and employment legal services to clients of all sizes—from globally established industry leaders to just-conceived start-ups. We understand and work creatively to solve the business, transactional, regulatory, intellectual property (IP), litigation, and related issues that our clients face along the product life cycle, from innovation protection and emerging business issues, through regulatory development and approval, to reimbursement, marketing, and distribution.
The diversity of our life sciences industry clients gives us a unique and comprehensive insight into the business and legal challenges facing all aspects of the sector, including large, midsize, and emerging biopharma companies, medical devices, food and agriculture, consumer healthcare products companies, and healthcare providers.
We represent companies that operate in the life sciences sector as well as entities that invest in it, such as venture capital and private equity funds focused on the industry. As a full-service firm with offices in the financial and regulatory centers of critical importance to the industry globally, we are uniquely situated to provide assistance over the complete range of industry activities.
About Ropes & Gray LLP
Ropes & Gray is one of the world’s premier law firms, with more than 1,100 lawyers and legal professionals serving clients in major centers of business, finance, technology and government. The firm has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Tokyo and Seoul, and has consistently been recognized for its leading practices in many areas, including intellectual property, litigation, life sciences, health care, private equity, M&A, finance, investment management, hedge funds, tax, securities litigation, government enforcement, and privacy & data security.