Federal Circuit No. 2014-1416

In this decision, the Federal Circuit (1) affirmed the judgment by the United States District Court for the District of Nevada that the subject matter of asserted claims of U.S. Patents 7,947,739 (the '739 patent), 8,022,106 (the '106 patent), and 8,273,795 (the '795 patent), owned by Ferring and covering Lysteda®, would not have been obvious under 35 U.S.C. § 103, (2) reversed the District Court's judgment that ANDA challenger, Watson's generic tranexamic acid product infringed those claims under § 271(e)(2) and § 271(a), and (3) vacated the District Court's order that the U.S. FDA reset the approval date of Watson's ANDA and permanent injunction for the manufacture, use, sale, or offer for sale of Watson's generic product.

The three Ferring patents are listed in the "Orange Book" (FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication), cover modified release formulations of trans-4-(aminomethyl)cyclohexanecarboxylic acid or tranexamic acid (Lysteda®). Lysteda® was given the fast track by the FDA for the treatment of menorrhagia. Watson filed an Abbreviated New Drug Application (ANDA) almost a year before the first of Ferring's patents issued, seeking market approval of generic tranexamic acid tablets. Watson submitted to Ferring a notice of certification regarding its proposed generic tranexamic acid tablet. Ferring sued asserting that Watson's ANDA constituted an act of infringement of Claims 1, 4-5, 8-10, 12 and 13 of the '739 patent, Claims 1, 5-8, 15-16, 18-19, and 30-37 of the '106 patent, and Claims 1, 5-6 and 8-10 of the '795 patent. Ferring alleged that Watson's uncoated cores and finished coated, commercial tablets infringed the patents. Watson received FDA approval of its ANDA on December 27, 2012, and launched its product at risk. Ferring did not move to enjoin.

Representative Claim 1 of the '739 patent recites "[a] tranexamic acid tablet formulation, comprising: tranexamic acid or a pharmaceutically acceptable salt thereof; and a modified release material, wherein the modified release material comprises a polymer selected from the group consisting of hydroxyalkylcelluloses, alkylcelluloses, cellulose ethers, partial esters thereof, and mixtures thereof; wherein the modified release material is present in the formulation in an amount from about 10% to about 35% by weight of the formulation; wherein the formulation provides an in-vitro dissolution release rate of the tranexamic acid or pharmaceutically acceptable salt thereof, when measured by the USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37±0.5ºC., of less than about 70% by weight tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes, and about 100% by weight tranexamic acid or pharmaceutically acceptable salt thereof released by about 120 minutes; and wherein each tablet of the formulation provides a dose of about 650 mg of tranexamic acid."

With respect to whether the asserted claims of Ferring's three patents were obvious under 35 U.S.C. § 103, the claims of the three patents were not found to be obvious because the prior art did not teach a dose of “about 650 mg” nor the modified release polymers claimed. In particular, the Federal Circuit determined that the art did not teach the "critical dissolution limitations" recited in the asserted claims. Instead, it was found that the prior art suggested use of lower dosages because of dose-dependent gastrointestinal side effects and generically taught that the active ingredient could be formulated with modified release materials. The Federal Circuit held that the cited prior art "neither set forth the limitations required by the asserted claims, nor provided any reason or motivation to combine those teachings to derive the claimed formulations with specific dissolution profiles."

With respect to the issue of infringement under § 271(e)(2), the Federal Circuit found that Watson's filing of an ANDA only constituted a technical act of infringement for jurisdictional purposes. However, once jurisdiction was established, the ultimate infringement inquiry focused on a comparison of the asserted patent claims and Watson's generic product described in its approved ANDA, which Watson was "bound by strict statutory provisions to sell only those products that comport with the ANDA’s description of the drug.” Here, Watson's ANDA was found to contain no specification addressing the manner in which its product dissolves in water. Further, evidence of dissolution from uncoated cores relied on by Ferring was insufficient since Watson was given FDA approval to market "final, coated commercial tranexamic acid tablets," which was the accused infringing article whose dissolution properties had to fall within the scope of Ferring's claims. Hence, the Federal Circuit found the evidence failed to establish that asserted claims of Ferring's three patents were infringed by the commercial embodiment Watson was authorized by the U.S. FDA to market.

With respect to the issue of infringement under § 271(a), although it was "undisputed" that Watson’s generic version of Lysteda® was encompassed by Ferring’s three patents, the Federal Circuit held there was insufficient evidence to support that the release of the active ingredient in Watson’s accused product was modified to satisfy the claim limitation of "modified release material." In reaching this conclusion, the Federal Circuit did not reject the District Court's construction of "modified release material," as "a material that modifies the release of the active pharmaceutical ingredient," and stated that, in view of the insufficient evidence, "just because a certain material can modify release of the active pharmaceutical ingredient tranexamic acid, does not necessarily mean that it actually does."