Generic Drug Companies Use IPR as Both an Alternative and Supplement to Paragraph IV Certification

The traditional mechanism by which generic drug companies challenge innovator patents is through the Paragraph IV certification process, as provided under the Hatch-Waxman Act. Recently, however, generic companies have begun to employ inter partes review (IPR), a new pathway for challenging patents created by the America Invents Act (AIA) of 2011, an alternative or supplement to Paragraph IV. The IPR route can be particularly attractive for a generic company that is not a first-filer, and thus ineligible for the 180 days of generic exclusivity provided under Hatch-Waxman for the first generic to succeed in a Paragraph IV challenge.

A recent example of this involves RESTASIS, an ophthalmic product for the treatment of dry eye manufactured and distributed by Allergan. FDA approved Allergan’s New Drug Application in December of 2002. On November 14, 2011 Actavis submitted an ANDA, with Paragraph IV certification, to FDA in order to obtain approval for a generic form of RESTASIS. On August 30, 2013, FDA informed Actavis that FDA had refused receipt of its ANDA based on certain deficiencies in the filing. On December 23, 2014, a judge in the Eastern District of Texas found Actavis’ ANDA filing insufficient to trigger infringement under § 271(e)(2), but declined to decide certain questions relating to Actavis’ status as a first filer.

On June 4, 2015, Apotex (another generic drug company) filed petitions for IPR of the five patents listed in the Orange Book with respect to RESTASIS, i.e., US patent numbers 8,633,162; 8,629,111; 8,685,930; 8,648,048; and 8,642,556. Apotex states in its petitions that there are no related matters, i.e., it is not involved in any other litigation with Allergan relating to these patents.

A generic company can also employ IPR concurrently with a paragraph IV challenge. For example, Mylan filed ANDAs, with paragraph IV certifications, seeking approval to market generic versions of AstraZeneca products ONGLYZA and KOMBIGLYZE.  In response, AstraZeneca sued Mylan (as well as other generic challengers) for allegedly infringing US patent numbers RE’44,186 and 8,628,799 under 35 USC (e)(2)(A).  On June 4, 2015 Mylan filed an IPR challenging RE’44,186.