AAM Files Amicus Brief in Allergan IPR Proceeding

The Association for Accessible Medicines (AAM), a trade association that represents biosimilar and generic drug makers, has filed an amicus brief in support of Mylan, Teva, and Akorn in their inter partes review (IPR) proceeding against Allergan, owner of embattled patents covering cyclosporine ophthalmic emulsion (Restasis).

In September 2017, the Ireland-based Allergan announced that it had transferred its patents for the blockbuster dry-eye drug to the Saint Regis Mohawk Tribe, which agreed to invoke sovereign immunity from IPR proceedings in exchange for regular royalties on Restasis’ sales. While an October 2017 district court ruling deemed the patents in question invalid on the basis of obviousness, the IPR challenge is still pending, and the US Patent and Trade Mark Office allowed interested parties to file amicus curiae briefs until December 1, 2017 as the legal system grapples with the implications of Allergan’s patent protection strategy.

In its brief, AAM sides with generic drug developers challenging Allergan’s patents, and argues in favor of the patents being subject to IPR. First, says AAM’s brief, IPRs “do not offend the dignity of sovereign tribal entities” because they do not allow private parties to subject sovereign entities to a coercive process, but instead allow a federal agency to review a patent that it has issued. Second, AAM holds that the courts have in other cases refused to dismiss actions when private parties attempt to “frustrate judicial adjudication of property rights” by conveying property to tribal entities. Finally, argues AAM, the Patent Trial and Appeal Board (PTAB) has the right to complete its review irrespective of the company’s transfer of patent to the Tribe, as “nothing in the governing statutes or regulations precludes the [PTAB] from completing its resolution of an instituted IPR in this situation.”

According to the brief, “…allowing a drug company patent owner to force an IPR to halt on the eve of an IPR hearing, by paying tens of millions of dollars to rent tribal immunity, would reward bad-faith behavior. It would also provide other holders of weak but extremely profitable patents with a roadmap for shielding their patents from review while wasting the valuable resources of their competitors and the [PTAB].”

AAM’s senior vice president and general counsel Jeff Francer told The Center for Biosimilars^® in an e-mail that “Abuse of the patent system by some brand name pharmaceutical companies is harming patients by denying access to affordable medicines. AAM believes it is important for the US Patent and Trademark Office to see through such schemes and ensure that granted patents are truly innovative. This is what Congress designed the (IPR) process to accomplish.”