US Patent Board Allows Mylan’s Challenge to Restasis Patents to Move Forward

March 2, 2018: By Joan McKenna

Mylan announced Feb. 26 that its inter partes review challenge of six patents protecting Allergan’s Restasis will go forward after the US Patent Trial and Appeal Board (PTAB) denied a motion to terminate the challenge.

The St. Regis Mohawk Tribe, which now holds the patents, filed the motion in 2017 on the grounds that it has sovereign immunity from patent challenges.

Allergan transferred Restasis’ patents to the tribe in September 2017 and licensed them back.

Mylan said the PTAB denied the tribe’s motion Feb. 23, holding that the tribe did not establish that tribal sovereign immunity applied to inter partes review proceedings.

Mylan said the patent board tentatively scheduled an oral hearing April 3 and said it would render a final decision on the patentability of the challenged patents by June 6.

In October 2017, the Eastern District of Texas held Allergan’s Restasis patents invalid in the US courts system. The case is currently on appeal.

Dublin-based Allergan has been preparing for the launch of a generic version of Restasis in 2018 by paring costs.

Competitors are also lining up to challenge Allergan’s Botox brand. On March 1, Mylan, of Canonsburg, Pennsylvania, announced plans to bring a lower-priced biosimilar version of Botox to market through a collaboration with Newark, California-based Revance Therapeutics.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

Aerie Submits NDA for Roclatan to US FDA

Surface Raises $20 Million in Series A Financing from Flying L Partners

iSTAR Announces ‘Promising’ Early-Stage Results for MINIject MIGS Device

Carl Zeiss Meditec Revenues Total $723.8 Million in the First Half of FY2018, a 4.5 Percent Increase

Moorfields Team Develops Drink-Based Dye for Diagnosing Retinal Disease in Children

Supreme Court Upholds Inter Partes Review Process for Challenging Patents

Study Indicates Ophthalmology Residents Face High Burden of Burnout, Depression

Takeda Makes Firm $62.2 Billion Bid for Shire

Valeant to Rebrand as Bausch Health Companies in July

Hoya Receives CE Mark for Vivinex IOL with 4-in-1 MultiSert Preloaded Delivery System

Tilganga Institute of Ophthalmology Gets $930 Thousand Grant to Double IOL Production

Abpro Postpones $60 Million IPO; Company Has Anti-VEGF/ANG-2 Product Candidate

Valeant Reports Q1-2018 Revenues of $1.9 Billion, a Decline of 5 Percent

Glaukos’ Net Sales Grow 12 Percent in Q1-2018

Second Sight Reports 16 Argus II Implants in Q1-2018

Omeros’ Omidria Revenues Drop 86 Percent in Q1-2018; Company Attributes Decline to Temporary Loss of Pass-through Status

Bausch + Lomb Starts Clinical Trial for New Ophthalmic Viscosurgical Device

NEI Awards LayerBio $1.2 Million to Develop Sustained-Release Glaucoma Drug

Bausch + Lomb Launches Lumify, OTC Eye Drop with Low-Dose Brimonidine for Ocular Redness

Aerie Launches Rhopressa in US as Treatment for Lowering IOP

Coming soon

2018 Cataract Surgical Equipment Report: A Global Market Analysis for 2017 to 2023