BPCIA Litigation: Updates & Developments in 2016
In July 2015, the U.S. Court of Appeals for the Federal Circuit has issued the Amgen Inc., v. Sandoz Inc. ruling which holds that the “patent dance” provisions of Biologics Price Competition and Innovation Act (BPCIA) are optional. It further interprets that a 180-day notice of marketing should be provided by biosimilar applicants after the U.S. Food and Drug Administration (FDA) licensed their products. How district courts will rule in the light of the Amgen decision will be an interesting development as more BPCIA “patent dances” are starting to emerge.
The Amgen case is one of the (BPCIA) litigations worthy of critical attention from the healthcare industry. Other remarkable lawsuits include Daimler AG v. Bauman, Astrazeneca AB v. Mylan Pharms., Inc., and Allergan Inc. v. Actavis Inc.
Litigators should critically monitor these cases as developments significant to the healthcare industry are expected to arise.
In a two-hour LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will offer an in-depth discussion of the significant and latest issues surrounding BPCIA Litigations. Speakers will examine the cases’ implications to the healthcare industry in 2016 and beyond.
Key topics include:
- BPCIA Legislative Backdrop
- Daimler AG v. Bauman Decision’s Implications to Future BPCIA Cases
- Personal Jurisdiction Theories and Post-Daimler ANDA cases:
- Astrazeneca AB v. Mylan Pharms., Inc.
- Allergan Inc. v. Actavis Inc.
- Janssen Products, L.P. et al. v. Mylan Pharms. Inc. et al.
- The Amgen Inc. et al. v. Sandoz Inc. “Biosimilar Patent Dance” Ruling
- Compliance Issues and Requirements
- Regulatory Forecasts
Stacie Ropka, PhD , Counsel
Axinn, Veltrop & Harkrider LLP
- Will the Supreme Court grant cert (if decision is reached at time of webinar will change to what it means if they accept or deny)
- Implications if Supreme Court grants cert and ultimately decides aBLA applicant must have final FDA approval before can provide effective notice of commercial marketing (will also discuss implications if Supreme grants cert on commercial marketing by denies Amgen cross-petition re early steps of BPCIA dance are optional and vice versa)
- Implications if Supreme Court grants cert and ultimately decides do not need final FDA approval before aBLA applicant can provide effective notice of commercial marketing
- If Supreme Court denies hearing will discuss what it means to have a Fed Cir opinion that aBLA applicant must have final FDA approval before can provide effective notice of commercial marketing
Sailesh K. Patel, Partner
Schiff Hardin LLP
- Ongoing litigations with BPCIA
John J. Molenda, Ph.D., Partner, Co-Chair of Healthcare & Life Sciences Group
Steptoe & Johnson LLP
The Strategic Use of IPRs in Biologics and Biosimilars Litigation
- Strategic considerations
- Forum-related advantages and disadvantages (PTAB v. District Court)
- Argument selection
- Strategic nuances
- Brand v. brand litigation
- BPCIA litigation
- Current trends
Vishal C. Gupta, Partner
Steptoe & Johnson LLP
- Biosimilar naming and labeling
Who Should Attend:
- Patent Attorneys
- Patent Licensing Attorneys
- Bio/Pharma and Related Attorneys
- FDA Attorneys
- Compliance and Risk Attorneys
- Patent Consultants
- Professionals coming from Biotech and Pharmaceutical Firms
- Other Related/interested Professionals
Stacie Ropka holds a PhD in Microbiology and Immunology. Her practice is focused on IP litigation, due diligence and client counseling with an emphasis on the life sciences, biologics and biologic-based pharmaceuticals. Stacie keeps abreast of the technology and related law by regularly attending both scientific and legal conferences.
Prior to attending law school, Stacie held a faculty position at SUNY Upstate Medical University. She also spent many years as a research scientist in the fields of neurology, virology and immunology, both at Northwestern University and SUNY Upstate Medical University, and has presented her original research at numerous scientific conferences.
Stacie is a member of the American Bar Association, The American Society for Microbiology and The Antibody Society.
Stacie Ropka holds a PhD in Microbiology and Immunology. Her practice is focused on IP litigation, due diligence and client …
Mr. Patel co-chairs the Pharmaceutical and Biotech Practice at Schiff Hardin. He focuses on intellectual property litigation and has extensive experience representing pharmaceutical companies in highly complex Hatch-Waxman patent litigation involving prescription pharmaceutical drugs and other matters in federal courts throughout the country. He also assists companies in Paragraph IV and Biosimilars design strategies.
Mr. Patel is registered to practice before the United States Patent and Trademark Office and has a background in chemical and biomedical engineering. He is an adjunct professor of pharmaceutical patent law at the Chicago-Kent School of Law and is a frequent writer and speaker on Hatch-Waxman and Biosimilars patent issues. Mr. Patel was selected by the National Law Journal as a “Top 40 under 40” lawyer. He has also been recognized as a “Leading Lawyer,” “Super Lawyer” and “IP Star” by Managing IP.
Mr. Patel co-chairs the Pharmaceutical and Biotech Practice at Schiff Hardin. He focuses on intellectual property litigation and has extensive …
John Molenda is co-chair of Steptoe's Healthcare & Life Sciences Industry Group and is a member of the firm's Executive Committee. His practice focuses on appellate and district court patent litigation, opinions of counsel, due diligence, and post-grant proceedings. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, medical devices, and computer software.
Dr. Molenda's practice has a particular focus on biologics and biosimilars. He currently represents two pharmaceutical companies in a case involving blockbuster biologics to lower cholesterol, and he provides pre-litigation strategic counseling concerning application of the Biologics Act to biosimilars programs. He is coordinating the strategy for a global monoclonal antibody biosimilars program and co-led the legal aspects of an EPO biosimilars program. He has spoken on biologics for ACI, Knowledge Congress, BIOTECanada, and Canaccord Genuity, and moderated Federal Circuit Bar Association webcasts.
John Molenda is co-chair of Steptoe's Healthcare & Life Sciences Industry Group and is a member of the firm's Executive …
Vishal Gupta, a partner in Steptoe’s New York office, focuses his practice on complex patent litigation, counseling, and intellectual property transactions. He is experienced in a wide range of technologies including biologics, pharmaceutical compounds and formulations, manufacturing processes, medical devices, and electromechanical apparatuses.
Mr. Gupta litigates patent cases (including those arising under the Hatch-Waxman Act) in federal courts throughout the country. He has managed teams through all phases of litigation including numerous summary judgment motions, claim construction (Markman) proceedings, preliminary injunctions, trials and Federal Circuit appeals.
Mr. Gupta also has extensive experience in strategic counseling, due diligence, licensing, technology transactions, opinions, pre-suit investigations, and settlement agreements/negotiations.
Vishal Gupta, a partner in Steptoe’s New York office, focuses his practice on complex patent litigation, counseling, and intellectual property …
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About Axinn, Veltrop & Harkrider LLP
Axinn’s Biotech and Life Sciences practice has a focus on the inter partes review (“IPR”) process and provides counseling services and pre-litigation strategies to assist clients in the selection, development, approval and marketing of technologies and therapies targeted to cancer, autoimmune disease and reconstructive surgery.
Axinn’s life sciences team includes attorneys who have garnered experience as bench scientists; teachers of medicine and medical device invention and design; research and formulation scientists; biomedical, genetic and process development engineers; members of professional societies for engineers and scientists; scientific authors and sought-out media analysts; and litigators with extensive trial experience. In addition, Axinn’s biotechnology and life sciences team is well-versed in all aspects of the Biologics Price Competition and Innovation Act (BPCIA), and regularly guides clients through the complex patent and noticing provisions of the BPCIA.
About Schiff Hardin LLP
Schiff Hardin LLP is a national law firm with more than 400 lawyers located in Atlanta, Chicago, Dallas, New York, San Francisco, Ann Arbor and Washington D.C. With attorneys admitted to more than 100 jurisdictions, we serve domestic and international clients across business sectors and legal disciplines. More than 50 of our lawyers are identified with our Intellectual Property practice. A team of our attorneys concentrate their practices in pharmaceutical and biologics patent litigation and counseling. Schiff Hardin has substantial experience in assisting generic pharmaceutical manufacturers and developers of biosimilar products.
About Steptoe & Johnson LLP
For more than seven decades, Steptoe has established a reputation for vigorous advocacy in complex litigation and arbitration, successful representation of clients before governmental agencies, and creative and practical advice in guiding business transactions. The firm has more than 500 lawyers and other professionals in offices in Beijing, Brussels, Century City, Chicago, London, Los Angeles, New York, Palo Alto, Phoenix, and Washington.
Our intellectual property practice represents clients across a wide range of industries in patent litigation and prosecution as well as in trademark, copyright, and licensing matters. Our lawyers rely on strong technical backgrounds in electrical engineering, mechanical engineering, chemistry, biochemistry, and materials science.