Biosimilars Litigation Under the BPCIA: Latest Developments and Strategies in 2017
Since its enactment as a component of the Patient Protection and Affordable Care Act on March 23, 2010, the Biologics Price Competition and Innovation Act (collectively known as BPCIA) has continually created an abbreviated approval pathway for producers of biological products. Primarily, the act caters for products which are “biosimilar” to or “interchangeable” with FDA-licensed biological products.
One of the most significant cases on BPCIA was the recently culminated Amgen-Sandoz Fight, which created a buzz on the industry and questioned how mandatory the “Patent Dance” is.
In a two-hour LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will discuss the significant and latest issues surrounding the BPCIA. Aside from the updates and recent developments, they will further discuss 2017 strategies which will be helpful for both innovators and biosimilar applicants.
Key issues that will be covered in this course are:
- Supreme Court to hear the Amgen-Sandoz Fight
- Case Background
- The Neupogen® // Zarxio™ Biosimilar Dispute
- Questions the Supreme Court will address:
- Is Patent Dance mandatory?
- Is 180-day notice of commercial marketing mandatory? When must it be given?
- Implications of possible Supreme Court decision outcomes
- What open questions does the Supreme Court case not address?
- 2017 BPCIA Strategies Outlook
Brian V. Slater (Chair/Moderator), Partner
Kramer Levin Naftalis & Frankel LLP
Introduction and Background
- Introduction and brief background on BPCIA
- Overview of BPCIA “Patent Dance”
- Where are we now? Discussion of biosimilar litigation and IPRs to date.
Christine Willgoos, Special Counsel
Kramer Levin Naftalis & Frankel LLP
Is the Patent Dance Mandatory?
- Overview of the Amgen v. Sandoz decision, including the rulings below, the split decision of the Federal Circuit, and the grant of certiorari by the Supreme Court
- First issue taken up by Supreme Court in Amgen v. Sandoz – does the BPCIA mandate that the applicant provide the reference product sponsor (RPS) with a copy of application and manufacturing info or is the Patent Dance optional?
- Discussion of RPS/applicants perspectives, the pros and cons of various possible outcomes, policy issues, and what issues will not be addressed by the Supreme Court
Azy Kokabi, Partner
Sughrue Mion, PPLC
Is the 180-day notice of commercial marketing mandatory?
- Is the notice of commercial marketing a stand-alone provision that is mandatory? If so, in what circumstances?
- Can notice be provided only after the FDA approves the biosimilar application? Includes discussion of rulings below and arguments by the parties
- Discussion of RPS/applicants perspectives, pros/cons, and possible outcome by the Supreme Court
Who Should Attend:
- Biotech and Pharma Lawyers
- Senior Management from Biotech and Pharma Industries
- In-House Counsel
- Patent Attorneys
- Patent Licensing Attorneys
- Patent Counsel
- Patent Litigators
- IP Counsel
- Bio and Pharma Manufacturing Companies
- Other related/interested Professionals and Organizations
Brian V. Slater, is Chair of the Life Sciences practice at Kramer Levin Naftalis & Frankel LLP. Mr. Slater has over 25 years of patent litigation experience, including serving as first chair for clients including Forward Pharma, Gilead, Merck and Sanofi. He has litigated biotechnology cases relating to fusion proteins, diagnostic kits and labeled nucleotides, and he counsels biologic/biosimilar clients on navigating the BPCIA litigation pathway. He also has litigated numerous cases under the Hatch-Waxman Act, most recently helping Merck to win a judgment of patent infringement against Xellia Pharmaceuticals relating to a patent covering the life-saving, antifungal drug, Cancidas®.
Clients describe Mr. Slater as “a great decision maker” (IAM Patent 1000 2012) who is “admired for his strategic nous and calm demeanor in pressurized litigation scenarios” (IAM Patent 1000 2013) and is “brilliant on biosimilars.” (IAM Patent 1000 2014).
Brian V. Slater, is Chair of the Life Sciences practice at Kramer Levin Naftalis & Frankel LLP. Mr. Slater has …
Christine Willgoos litigates patent actions on behalf of pharmaceutical and biotechnology companies, leading trial and appellate teams in Hatch-Waxman and biologic drug litigation, often involving blockbuster drugs. Ms. Willgoos is an accomplished courtroom advocate with significant experience, including trials and appeals, preliminary injunctions, oral arguments and Markman hearings. She currently represents clients in cases concerning immunoassay technology, cancer drugs and multiple sclerosis drugs.
In addition to litigation, Ms. Willgoos counsels clients in business and legal matters relating to patent portfolios, including antitrust, patent prosecution, life cycle management and regulatory issues.
Christine Willgoos litigates patent actions on behalf of pharmaceutical and biotechnology companies, leading trial and appellate teams in Hatch-Waxman and …
Azy Kokabi is a partner at Sughrue Mion, PPLC, an intellectual property law firm in Washington DC. Ms. Kokabi focuses her practice on patent infringement litigation in Federal Courts, with particular experience in Hatch-Waxman litigations. Her experience has encompassed technical areas that include pharmaceuticals, protein synthesis, recombinant DNA technology, and medical devices. Ms. Kokabi also counsels clients on intellectual property issues, including validity and infringement of intellectual property rights, licensing and contract matters. Ms. Kokabi, a registered patent attorney, has served as counsel in multiple interferences and inter partes review proceedings involving chemical and biotechnology patents.
She has lectured on numerous topics including strategies for pharmaceutical litigation strategies, including biosimilar litigation, AIA procedures, and Patent Law Reform. Ms. Kokabi was also recognized as one of the Rising Stars in Intellectual Property Litigation for the DC area (Super Lawyers Magazine).
Azy Kokabi is a partner at Sughrue Mion, PPLC, an intellectual property law firm in Washington DC. Ms. Kokabi focuses …
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About Kramer Levin Naftalis & Frankel LLP
Kramer Levin Naftalis & Frankel LLP is a premier, full-service law firm with offices in New York, Silicon Valley and Paris. Firm lawyers are leading practitioners in their respective fields. The firm represents public and private companies – ranging from Global 1000 to middle-market and emerging growth companies – across a broad range of industries, as well as funds, institutions and individuals.
About Sughrue Mion, PPLC
Sughrue Mion is a leading global intellectual property firm, helping thousands of companies from around the world navigate the complexities of patent and trademark law since 1957. Sughrue’s practice is focused solely on intellectual property law, and the firm has helped its clients secure more patents than any other U.S. patent firm. Sughrue brings unmatched experience in litigation, patent interference proceedings and Post Grant Review, including ex parte and inter partes reexamination proceedings. This expertise provides the firm’s clients with a clear advantage navigating the new America Invents Act (AIA). In addition to their legal expertise, Sughrue’s attorneys have technical and scientific backgrounds ranging from biosimilars to nanotechnology, allowing for a true understanding of their clients’ businesses and business challenges.