On June 1-2, the American Conference Institute (ACI) held its 6th Annual Summit on Biosimilars to its largest crowd ever, over 150 participants. New this year was considerable discussion about the first approved biosimilar, Sandoz’s Zarxio® (figrastim-sndz), which is a highly similar (not interchangeable) biosimilar, as well as several biosimilar lawsuits hung up on procedural issues regarding the so-called “patent dance.” The patent dance is the statutory mechanism under the Biosimilars Price Competition and Innovation Act (BPCIA) by which biosimilar and the reference biological product manufacturers may share information leading to an exchange of patents that may be litigated prior to and after product launch. Co-chair Seth Field, Ph.D., Lead IP Counsel, Merrimack Pharmaceuticals, Inc. summed it well when he said that the biosimilar lawsuits were “the intersection where all the accidents happen.” Another co-chair, Don Ware, Partner and Chair, Intellectual Property Department, Foley Hoag LLP, noted that we have not even got to the issues that were debated in the beginning, i.e., “Would the patents protect the innovator’s biological products from biological competition?”

After a discussion on the finalized biosimilar guidances and FDA’s standards for biosimilarity and the potential for interchangeability, the topic turned to state biosimilar substitution laws and naming. McGuireWoods’ Brian Malkin moderated a panel that included relatively new consensus language developed since last year for biosimilar substitution of interchangeable biosimilars that has been agreed upon by the following trade organizations: Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Generic Pharmaceutical Association (GPhA). While naming still remains a contentious issue, the issues from last year regarding substitution appear to be resolved by limiting substitution to interchangeable biosimilars, permitting “dispense as written” to permit physicians to require innovator biological products rather than interchangeable biosimilar versions, and requiring certain notifications after dispensing interchangeable biological products to physicians via electronic health record or other means for physicians to be aware that substitution occurred.

Day one then wrapped up with a discussion of biosimilars around the world and a judges’ spotlight on lessons from the Hatch-Waxman experience for biosimilars litigation. From the world view, there has been varying update of biosimilars, where Ali Ahmed, Chief Intellectual Property Counsel, Fresenius Kabi US, LLC, noted that from his review of the global biosimilars environment, bridging studies will be increasingly critical, despite different regulatory regimes for market approval. Regarding inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB), U.S. Patent and Trademark Office, the Honorable Roy S. Payne, Magistrate Judge, U.S. District Court for the Eastern District of Texas noted that the affiliated district litigation will not necessarily be stayed because an IPR is filed. The Honorable Lora M. Green, Administrative Patent Judge, PTAB suggested that attorneys call the PTAB if there is a question particularly regarding a deposition rather than to conduct the deposition and have a problem later that cannot be fixed. Both judges suggested, among other things, that advocates focus their arguments on several key issues well rather than tackling too many issues at once.

The second day focused on patent litigation strategies. Ware noted that the patent exchange process does not appear to be working because at this point, many product 12-year biological product exclusivities have run and FDA’s approval time is perceived as shorter than the patent exchange process leading up to litigation. Once biosimilar applicants are filing at year 4 following approval of an innovator and there is 8 years of exclusivity left, Ware speculated, the patent exchange process may make more sense, but it is still unclear how much, if any, of the patent dance is mandatory or will be followed. Others, like Nicholas Boivin, Head of Intellectual Property, Merrimack Pharmaceuticals, speculated that if the Federal Circuit decides that the patent dance is voluntary, the BPCIA may be opened up for a fix by amendment, perhaps modifying the exclusivity periods as well, which continue to be debated.

A pricing discussion started off by Joseph Fuhr Jr., Ph.D., Professor Economics, Widener University, where he noted that the predictions are that there will be about 5-6 entrants per large biological product market, with U.S. market uptake expected to be higher than in Europe. Each biosimilar will likely have its own payment code, but it is also possible that some biosimilars may have the same code. Once biosimilars enter a market, the innovator may also lower its price to compete. After all, the BPCIA was passed to help reduce the cost of biological products, leading in theory to greater access and lower government cost for reimbursement.

Aside from IPR reviews, some panels discussed other potential tactics such as filing certain patent challenges in the International Trade Commission, where the process is swift, but the remedy may only be an injunction to prevent entry of infringing products. The conference concluded with presentations on obtaining adequate patent protection looking at key cases, circling back to Ware’s initial comment.