The Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) recently 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 make tears. Mylan Pharmaceutical Inc. says they expect PTAB decisions on the IPRs sometime during the fourth quarter of 2017.
All the challenged patents are set to expire on August 27, 2024 and are listed in FDA’s Orange Guide. 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”). 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 patents, with the exception of the ‘191 patent, were formerly challenged by Apotex Company in IPRs submitted on June 4, 2015. The Apotex IPRs were settled on December 16, 2015, prior to any institution determination.
In a press release, the firm explained they were weighing their options and were understandably dissatisfied in the PTAB decision to move forward with these IPR challenges. Allergan said:
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.
All of the patents that are challenged share a standard specification, initially being submitted as a patent application on July 27, 2004, which claimed priority to a previously filed provisional patent application submitted on September 15, 2003. The PTAB panel that implemented these IPRs will, thus, be able to essentially review a single patent specification while they are able to receive six times the credit in terms of work production toward the satisfaction of their quota. This strange incentive, which encourages the institution of IPR challenges when multiple challenges relate to the same patent, has been criticized within the industry.
Ultimately, the panel that decided to institute these IPRs will decide the outcome of these IPRs as well.
The institution decisions in each of the IPR challenges are below:
- IPR2016-01127 re: the ‘930 patent
- IPR2016-01128 re: the ‘111 patent
- PR2016-01129 re: the ‘556 patent
- IPR2016-01130 re: the ‘162 patent
- IPR2016-01131 re: the ‘048 patent
- IPR2016-01132 re: the ‘191 patent
Tags: Inter Partes Review, IPR, patent, patents, PTAB, USPTO
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