The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Biosimilars
Wednesday, June 04 to Friday, June 06, 2014
InterContinental New York Barclay, New York, NY
Thursday, June 6th | 8:30am
Analyzing the Arguments in the First BPCIA Case, Sandoz Inc. v. Amgen Inc.: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public
Seth Fidel, PhD
Lead IP Counsel
Merrimack Pharmaceuticals, Inc. (Cambridge, MA) Foley Hoag LLP (Boston, MA)
Donald R. Ware
Foley Hoag LLP (Boston, MA)
· Review of the case and Judge Chesney’s decision regarding the ability to bring a declaratory judgment action to invalidate patents pre-suit
o Examining Judge Chesney’s ruling that ruling that the Act requires biosimilars maker to seek approval before filing suit
o What does this mean for biosimilars manufacturers looking to make early challenges to innovator patents?
o Anticipating a Circuit split: will proactive companies attempt to make this argument in other jurisdictions?
o Should innovators be wary of more “jump the gun” lawsuits like Sandoz v. Amgen to avoid the litigation dance?
· The patent dance macabre: Following the rules of the BPCIA and dealing with the strict litigation timelines and the patent exchange as outlined in the BPCIA
· Understanding what this means to the timing of patent filings: What must companies be doing now in light of Judge Chesney’s interpretation of the litigation timeline?
o Putting contingency plans in place now to comply with the strict timeframes
o Managing the logistics of the IP exchange process, given the extreme deadlines
o When should biosimilars give notice of application post-Sandoz?
o Is it even possible to comply with the rules and resolve litigation pre-launch under the rubric of this argument?
o Is filing a notice of commercial marketing early in the process still a viable strategy?
· Developing patent certainty: What does this mean for companies’ BLA versus biosimilar application analysis and for companies’ choice to bring quasi-litigation at the PTO?
Thursday, June 6th | 9:30am
The Most Powerful Tool in Your Arsenal: Using Inter-Partes Review at the PTO to Revamp Branded and Biosimilar Litigation Strategies
Dorothy P. Whelan
Fish & Richardson P.C. (Minneapolis, MN)
Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)
Teresa “Terry” Stanek Rea
Crowell & Moring LLP (Washington, DC)
• Anticipating how the complex patent resolution provisions in the BPCIA will interplay with the administrative patent validity proceedings at the PTO including:
o Inter-partes review (IPR)
o Post-grant review (PGR)
o Supplemental examinations
o Derivation proceedings
• Adjudicating patent validity at the PTO level
o Deciding whether to forego the clear and convincing litigation standard in favor of the preponderance of the evidence standard
o Factoring in collateral estoppel considerations
o Parallel litigation in two forums: Creating a record in the patent office and managing multiple concurrent proceedings
o Exploring judicial recourse from PTO decisions: how much deference must a Court accord to the patent office?
• Making the timing work: Complying with the tricky timelines in the AIA while factoring in both the complex timeframes under the BPCIA and its statutory mandate that litigation be resolved prior to approval
• Lessons learned from the first life sciences IPRs which have been filed: what are the benefits in the biosimilars context?
• Using IPRs to clear freedom to operate in anticipation of a launch
o Updating your freedom to operate analysis to account for new AIA standards
• The second wave of patent reform: understanding how the new proposals modifying the AIA may affect the biosimilars strategies you already have in place