Industry Trend Analysis - Allergan Patent Manoeuvre Creates New Defence Strategy - NOV 2017

BMI View: Allergan ' s US patent manoeuvre is innovative and controversial, exploiting a legal loophole. O pponents of this move will watch to see if other companies follow suit. Should this happen, pressure to change the law will increase, but the reality of the situation, particularly in regard to Native American sensitivities and economics, makes such a change unlikely. Consequently, this could be a viable option for other pharmaceutical companies.

Allergan and the Saint Regis Mohawk Tribe have entered into an agreement under which the Tribe now owns all FDA Orange Book-listed patents for Restasis (cyclosporine ophthalmic emulsion) 0.05%, with Allergan having been granted exclusive licences to the patents related to the product. Additionally, the Tribe, a recognised sovereign tribal government, is filing a motion to dismiss the ongoing inter partes review (IPR) at the US Patent and Trademark Office (PTO) of the Restasis patents based on their sovereign immunity from IPR challenges. However, Allergan and the Tribe stressed that the agreement has no impact on the pending ANDA patent litigations regarding proposed generic versions of Restasis which recently completed a five-day trial in the Federal District Court in Marshall, Texas.

Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed because of ocular inflammation. The drug is protected by six patents listed in the Orange Book, all of which expire on August 27 2024. These are US Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; and 9,248,191. Between August and September 2015, Allergan brought patent infringement actions related to five of the patents against Akorn, Apotex, Mylan Pharmaceuticals, Teva Pharmaceuticals USA ( Teva Pharmaceutical Industries), InnoPharma and Pfizer; these actions were filed in the US District Court for the Eastern District of Texas. Additionally, in September 2015, Allergan brought further cases against InnoPharma and Pfizer in the US District Court for the District of Delaware. In February 2016, Allergan filed an amended complaint covering the sixth patent. A month later, a further generic company, FamyCare (a subsidiary of Mylan) notified Allergan that it had filed an ANDA with a Paragraph IV notice for a proposed generic version of Restasis. A further action against TWi Pharmaceuticals USA was initiated in July 2016, but was settled in January 2017. A further case was filed against Deva Holding in December 2016; this case is scheduled to be heard in October 2018.

US Restasis Sales Are Essential
Allergan's Quarterly Restasis Sales (USDmn)
Source: Allergan, BMI

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