Mylan has been granted review of patents for Allergan’s blockbuster eye-care drug, Restasis (cyclosporine ophthalmic emulsion), by the US Patent & Trademark Office’s Patent Trial and Appeal Board (PTAB).

The PTAB is instituting Inter Partes Reviews (IPR) of Allergan’s patents related to the methods of providing therapeutic effects using cyclosporin components, which include US patent numbers 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; and 9,248,191. Each of these patents are listed in the US Food and Drug Administration’s (FDA) Orange Book in connection with Restasis 0.05% and will expire on August 27, 2024. The PTAB’s decision on the IPRs is expected in the fourth quarter of 2017.

Restatis is one of Allergan’s top-selling drugs with approximately $1.08 billion in global sales for the nine months ended September 30, 2016.

Allergan said in a company statement issued on December 8, 2016 that it is “disappointed 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 FDA’s Orange Book covering Restasis. The company’s Hatch-Waxman litigation involving these patents against Mylan and other generic defendants remain pending in the United States District Court for the Eastern District of Texas.

Source: Allergan