On December 9, 2014, the Patent Trial and Appeal Board issued Final Written Decisions in three inter partes review (“IPR”) proceedings upholding the patentability of U.S. Patent Nos. 8,206,740, 8,394,405, and 8,394,406 (“the Chang patents”) covering the formulation for Oracea® (doxycycline capsules, 30 mg immediate release, 10 mg delayed release).  See IPR2013-00368, Paper No. 94; IPR2013-00371, Paper No. 96; IPR2013-00372, Paper No. 92.  These are the first Final Written Decisions to be issued in an IPR proceeding concerning pharmaceutical patents in the context of a Hatch-Waxman dispute between brand and generic companies – and they are the first IPR win for the brand in that context. 

Paul Hastings represented Galderma Laboratories and Supernus Pharmaceuticals in the Oracea® IPRs (argued by Gerald J. Flattmann, Jr. and Gregory A. Morris on August 12, 2014), as well as in prior wins regarding the related Chang ’532 patent following a July 2011 bench trial before Judge Stark in the District of Delaware and a Federal Circuit appeal decided in August 2013.  The Paul Hastings IPR and litigation teams also included attorneys Evan Diamond, Vanessa Yen, Jennifer Nguyen and James Evans, and Foley & Lardner LLP was also lead counsel of record in the IPRs.  Read the Board’s Final Written Decisions regarding the three Chang patents here, here, and here.

Oracea® is a specially formulated once-daily, 30 mg immediate-release, 10 mg delayed-release doxycycline composition indicated for the treatment of the inflammatory lesions (papules and pustules) of rosacea, and the Chang patents cover this novel once-daily, low dose formulation and its use to treat rosacea. Oracea® is marketed in the United States by Galderma Laboratories, L.P., and the Chang patents are assigned to Supernus Pharmaceuticals, Inc. and exclusively licensed to Galderma. 

The Oracea® IPRs were instituted based on petitions filed in June 2013 by Amneal Pharmaceuticals, which holds an ANDA seeking FDA approval for a generic version of Oracea®.  At the time Amneal filed its IPR petitions, Amneal was the defendant in a Hatch-Waxman litigation before the United States District Court for the District of Delaware (Stark, J.), which Galderma and Supernus commenced in September 2011, and to which the Chang ’740 patent was added in July 2012.[1]  Amneal continued to challenge the validity of the Chang ’532 and ’740 patents in the district court litigation – and then in the IPRs, challenged the patentability of the Chang ’740 patent and other related Chang patents – despite the same district court having upheld the validity of the Chang ’532 patent in prior litigations against Mylan, Lupin, and Impax,[2] in decisions affirmed per curiam by the Federal Circuit.[3]  (See our prior alert on the Federal Circuit decision here.) 

In the district court and in its IPR petitions, Amneal argued that the Chang patents were obvious over a published international patent application relating to formulations of tetracycline drugs (“Ashley”), either alone or in combination with an issued patent relating to formulations of the drug minocycline (“Sheth”).  In December 2013, the Board instituted IPRs for the Chang patents, on the grounds of alleged obviousness over a combination of Ashley and Sheth.  In its Final Written Decisions, however, the Board ruled Amneal failed to show that Ashley and Sheth rendered the Chang claims unpatentable – even under the Board’s “preponderance of the evidence” standard.[4]  In particular, the Board credited Galderma and Supernus’s argument, supported by expert testimony developed during discovery, that a combination of these two documents does not disclose or render obvious a once-daily doxycycline formulation with immediate release and delayed release components in the specific dosages and ratios claimed in the Chang patents.[5]

The three Final Written Decisions in the Oracea® IPRs represent not only the first final decisions to be issued in any Hatch-Waxman related IPR proceeding, but the first wins for the brand company on all challenged claims in such proceedings.  While IPR proceedings have become widely used in technology-related patent disputes, they also have increasingly become part of generic companies’ toolkit in Hatch-Waxman patent challenges.  In a number of cases, generics have used IPRs as a “second bite at the apple” when they are already embroiled in parallel patent litigation before a federal district court.[6]  As these Final Written Decisions demonstrate, however, the Board’s lower “preponderance of the evidence” standard for unpatentability[7] and wider “broadest reasonable interpretation” standard for claim construction[8] are no guarantee that the Board will reach any different conclusion than a federal district court applying a “clear and convincing evidence” threshold for invalidity[9] and the claim construction approach of Phillips.[10]  These decisions are early data points that may impact the settlement calculus in pending and future IPR proceedings between brand and generic companies.