BPCIA Litigation: Latest Developments for 2015 and Beyond
Five years after the Biologics Price Competition and Innovation Act (BPCIA) has been passed into law, litigation related to the patent resolution procedure for biosimilars has begun to rise.
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. Speakers will examine the new BPCIA legal framework created to resolve patent disputes between biosimilar applicants and patent holders as well the updates to recent biosimilar-related cases.
Key issues that will be covered in this course are:
- Biologics Price Competition and Innovation Act (BPCIA) – An Overview
- Latest Framework for Biosimilar Patent-Related Dispute Resolution
- Recent Developments in BPCIA Litigation such as:
- Implications of Amgen v. Sandoz of patent exchange and notice of commercial marketing
- Alternatives for patent resolution
Kevin M. Nelson, Partner
Duane Morris LLP
Patrick C. Gallagher, PH.D., Attorney
Duane Morris LLP
- The Federal Circuit Sandoz decision and what it means for the future of biosimilar litigation
- Will the Supreme Court be asked to chime in on the filgrastim decision
- Comparison of the biosimilar litigation scheme with the H-W litigation scheme
- Litigation alternatives (e.g. IPR proceedings) and their use in the biosimilar space
Sheila Swaroop, Partner
Knobbe Martens Olson & Bear LLP
- Overview of the major phases of the BPCIA patent exchange
- Summary of the Federal Circuit’s current analysis of the BPCIA
- Recent efforts to avoid the patent exchange procedures of the BPCIA
- Avenues other than the BPCIA for challenging biologic patents
Stacie L. Ropka, Ph.D., J.D., Counsel
Axinn, Veltrop & Harkrider LLP
- Effect of providing notice of commercial marketing
- Timing of 1. providing notice of commercial marketing by aBLA and 2. filing preliminary injunction by RPS
- Facts/issue re commercial marketing before the Fed Cir in Amgen v. Sandoz
- The 7/21/2015 holding by the Fed Cir in Amgen v. Sandoz
- Remaining questions re effective notice of commercial marketing after the Fed Cir opinion in Amgen v. Sandoz
Lucian C. Chen, Shareholder
Farney Daniels PC
- What is a drug vs what is a biologic?
- What is a biosimilar?
- European market vs. U.S. market
- Hatch Waxman Act vs BPCIA
- NDA process vs. BLA process
- Patent litigation under Hatch-Waxman vs BPCIA
- Sandoz v. Amgen
- Sandoz files biosimilar application
- Amgen sues Sandoz in N.D. Cal.
- FDA approves Zarxio
- Amgen files for injunction at Fed. Cir.
- Fed. Cir. decision
- Tee up issues
- The patent dance is optional
- Notice of commercial marketing follows approval
- 180 days of extra exclusivity?
- En banc review or Supreme Court?
- Injunction expires today, September 2
Timothy J. Shea, Director
Sterne, Kessler, Goldstein & Fox PLLC
- Questions unanswered by the Fed. Cir. decision in Amgen v. Sandoz
- The role of process patents in biosimilars litigation: how and when they will be asserted going forward
- Discussion of Amgen v. Apotex litigation
Who Should Attend:
- Bio/Pharma and Related Attorneys
- Patent Attorneys
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Consultants
- Professionals coming from Biotech and Pharmaceutical Firms
- Patent Litigators
- Health Services Professionals
- Life Sciences and Health Care Practice Consultants/Advisors
- Compliance and Risk Officers
- Other Related/Interested Professionals
DePaul University College of Law, J.D., 2001; Indiana University, B.A., 1998.
Mr. Nelson represents generic drug companies in patent litigation brought under the Hatch-Waxman Amendments, with a focus on large-scale patent infringement actions. Mr. Nelson also represents clients before the U.S. Food and Drug Administration in regulatory matters. Mr. Nelson has advised clients on biosimilars applications and litigations, as well as on copyright and trademark litigation and oppositions. Admitted in Illinois.
DePaul University College of Law, J.D., 2001; Indiana University, B.A., 1998. Mr. Nelson represents generic drug companies in patent litigation …
DePaul University College of Law, J.D., cum laude, 2007; University of Kentucky, Ph.D., Molecular Genetics, 2001; University of Wisconsin, B.S., Genetics, 1997.
Mr. Gallagher focuses his practice in the area of intellectual property law with a focus on representing generic drug companies in Hatch-Waxman pharmaceutical patent litigation. Mr. Gallagher has been involved in all aspects of Hatch-Waxman practice, including advising on Abbreviated New Drug Application (ANDA) filings, development of noninfringement and invalidity arguments for FDA-required notice letters, and in every phase of litigation through trial and appeal to the Federal Circuit Court of Appeals. Admitted in Illinois and registered before the USPTO.
DePaul University College of Law, J.D., cum laude, 2007; University of Kentucky, Ph.D., Molecular Genetics, 2001; University of Wisconsin, B.S., …
Sheila Swaroop is a partner at Knobbe Martens Olson & Bear LLP. She is a registered patent attorney and holds an undergraduate degree in molecular biology from Harvard University and a J.D. from UC Berkeley. Ms. Swaroop is experienced with advising clients on intellectual property strategies for biosimilars, litigating intellectual property disputes in district court and the International Trade Commission, and conducting Patent Office proceedings.
Sheila Swaroop is a partner at Knobbe Martens Olson & Bear LLP. She is a registered patent attorney and holds …
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 …
Lucian Chen is a registered patent attorney and partner in Farney Daniels’ New York office. He practices a broad range of intellectual property and commercial law spanning multiple technology areas, with an emphasis on complex pharmaceutical and biotechnology patent litigation, particularly cases involving the Hatch-Waxman Act. Mr. Chen has broad experience representing clients in high-stakes patent litigation cases involving products as varied as computer software, antifungals, antibiotics, personal electronics, osteoporosis therapies, oral contraceptives, and cholinesterase inhibitors. His extensive involvement in all aspects of patent litigation spans counseling clients and initiating litigation, through to both bench and jury trials. Mr. Chen is the Editor-in-Chief of Biotechnology Law Report, the leading journal on law and government regulation of biotech. He holds a B.A. in biology from the Johns Hopkins University, an M.P.H. in health management from Columbia University and a J.D. from St. Johns University.
Lucian Chen is a registered patent attorney and partner in Farney Daniels’ New York office. He practices a broad range …
Tim Shea is Director in the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced for 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 …
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About Duane Morris LLP
Duane Morris LLP, a law firm with more than 700 attorneys in offices across the United States and internationally, is asked by a broad array of clients to provide innovative solutions to today’s legal and business challenges.
Evolving from a partnership of prominent lawyers in Philadelphia a century ago, Duane Morris’ modern organization stretches from the U.S. to Europe and the Middle East, and now across Asia. Throughout this global expansion, Duane Morris has remained committed to preserving its collegial, collaborative culture that has attracted many talented attorneys. The firm’s leadership, and outside observers like the Harvard Business School, believe this culture is truly unique among large law firms, and helps account for the firm continuing to prosper throughout changing economic and industry conditions.
Duane Morris lawyers hold leadership positions in bar associations, as well as in educational, cultural and charitable organizations and with community groups. Many of the firm’s attorneys come to Duane Morris after having held senior positions in government agencies and large corporations. This range of experience is further enriched by the diverse backgrounds of the firm's attorneys. Duane Morris has long been committed to recruiting, retaining and promoting talented female and minority lawyers, many of whom hold leadership roles at the firm.
About Knobbe Martens Olson & Bear LLP
Knobbe Martens has one of the largest and most experienced biotechnology groups in IP law, with more than 75 attorneys and scientists representing clients in all stages of their business and technology development. It maintains a talented litigation group adept in all aspects of biotechnology IP law. The extensive Hatch-Waxman litigation practice combined with its deep technical expertise in biotechnology uniquely position Knobbe Martens to develop and implement effective IP strategies for biosimilars.
About Axinn, Veltrop & Harkrider LLP
Axinn’s Biotech and Life Sciences practice 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 Farney Daniels PC
An impressive array of prominent corporations, innovative start-ups, and pioneering individual innovators trusts the lawyers at Farney Daniels to handle a wide range of complex, high-stakes intellectual property cases. This diverse collection of clients appreciates that our attorneys combine decades of large firm experience with the nimbleness and creativity of a small, entrepreneurial law firm. In large part because we offer cutting-edge work set in the congenial collegiality of a litigation boutique, we attract the top notch legal talent required to deliver consistently the skill, insight, attention to detail, and value our clients expect from their counsel.
Our attorneys have successfully handled myriad matters involving huge potential damages and possibly-crippling injunctions in federal district and appellate courts across the nation, and before the International Trade Commission, as well as the Federal Trade Commission. Nonetheless, we recognize that every matter is important to our clients; thus we bring the same level of care and effort to each endeavor entrusted to the firm, regardless of size.
About Sterne, Kessler, Goldstein & Fox PLLC
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.