PTAB institutes Mylan IPR challenges on Allergan patents for RESTASIS

USPTOLast week the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) instituted six separate inter partes reviews (IPRs) against patents owned by Allergan plc (NYSE:  AGN), which cover RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%. RESTASIS® is an eye drop that helps increase the eyes’ natural ability to produce tears.

Each of the patents is listed in FDA’s Orange Book and are set to expire on August 27, 2024. The patents are being challenged by Mylan Pharmaceutical Inc. Allergan says they anticipate PTAB decisions on the IPRs sometime during the fourth quarter of 2017. The patents being challenged are U.S. Patent Nos. 8,629,111 (the “‘111 patent”), 8,633,162 (the “‘162 patent”), 8,642,556 (the “‘556 patent”), 8,648,048 (the “‘048 patent”), 8,685,930 (the “‘930 patent”), and 9,248,191 (the “‘191 patent”).

Each of these patents, with the exception of the ‘191 patent, were previously challenged by Apotex Corporation in IPRs filed on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any decision on institution. See e.g. Judgment Termination of Proceeding, IPR2015-01283.

In a press release issued by Allergan the company explained they were understandably disappointed in the PTAB decision and were weighing their options. The substance of the brief press release read:

Allergan is dissapointed (sic) in the PTAB’s decision to institute IPR proceedings regarding the patents that protect RESTASIS®.  Allergan is currently reviewing the grounds for the decision to institute, and will continue to vigorously defend the patents in the IPR proceeding and pursue all legal options available to protect its products and intellectual property rights for this product.

Allergan’s portfolio of intellectual property includes six patents listed in the Orange Book covering RESTASIS®. Allergan’s Hatch-Waxman litigations involving these patents against Mylan and other generic defendants remain pending in the United States District Court for the Eastern District of Texas.

Each of the challenged patents share a common specification, originally being filed as a nonprovisional patent application Ser. No. 10/927,857, filed on August 27, 2004, which claimed priority to a provisional patent application Serial No. 60/503,137, which was filed on September 15, 2003. The panel that instituted these IPRs will, therefore, be able to essentially review a single patent while they are able to receive six times the credit in terms of work production. For this reason it has been said by those familiar with PTAB incentives that it is far more likely IPR challenges will be instituted when multiple challenges are being brought against the same patent, or at least against patents that share a common specification. The panel that decided to institute these IPRs will ultimately decide the outcome of these IPRs as well.

A perverse incentive to initiate related IPRS exists thanks to the fact that the same panel will hear the challenge on the merits and that they will essentially receive six times the work credit for deciding these related challenges.

The institution decisions in each of the IPR challenges are below:

  1. IPR2016-01127 re: the ‘930 patent
  2. IPR2016-01128 re: the ‘111 patent
  3. PR2016-01129 re: the ‘556 patent
  4. IPR2016-01130 re: the ‘162 patent
  5. IPR2016-01131 re: the ‘048 patent
  6. IPR2016-01132 re: the ‘191 patent



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One comment so far.

  • [Avatar for John White]
    John White
    December 13, 2016 09:27 am

    Ah, the unexpected consequences of statutory revision. The AIA and PTAB and IPR et al was brought to us by the same cabal now hovering in DC that says they can now “fix” the patent system with more “reform”. That is the very definition of insanity, allowing the “fix” by those that created calamity!