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From Antitrust Law Daily, August 29, 2016

Monopolization, patent misuse counterclaims survive in Abilify® suit

By Greg Hammond, J.D.

A generic pharmaceutical company adequately stated unlawful monopolization and patent misuse counterclaims against the marketer of the brand name drug Abilify®, in a patent infringement action brought by the marketer. Although the federal district court in Newark, New Jersey, concluded that the generic pharmaceutical company sufficiently alleged antitrust injury and that the marketer engaged in an impermissible attempt to prolong the life of its long-standing monopoly in the aripiprazole market, the court bifurcated and stayed the counterclaims for judicial economy reasons, pending resolution of the patent infringement issues (Otsuka Pharmaceutical Co., Ltd. v. Apotex Corp., August 26, 2016, Simandle, J.).

Otsuka Pharmaceutical Co., Ltd. holds New Drug Application No. 21-436 for aripiprazole tablets, which the pharmaceutical company markets under the trade name Abilify®. Generic pharmaceutical company Apotex Corp. subsequently filed an Abbreviated New Drug Application (ANDA), seeking approval to market generic aripiprazole tablets in the United States, prior to expiration of the Patents-in-Suit. After Apotex provided Otsuka with confidential access to its ANDA and supporting materials, Otsuka filed suit, alleging patent infringement. Apotex brought counterclaims for unlawful monopolization and patent misuse. The two counterclaims survived an earlier motion to dismiss, but were later amended. Otsuka consequently renewed its motion to dismiss the counterclaims, or—in the alternative—to bifurcate and stay discovery on the counterclaims pending resolution of the primary patent infringement issues.

Antitrust injury. The court denied the motion to dismiss the monopolization counterclaim, finding that Apotex plausibly alleged the elements of an antitrust injury. Apotex claimed that Otsuka initiated meritless infringement actions and subsequently pursued preliminary injunctions against ANDA filers, in order to prevent any and all competitors from competing in the marketplace and to maintain its exclusive monopoly over the aripiprazole market. The pursuit of litigation that forestalls entry into the generic market and effectively extends a long-standing monopoly, as alleged in this case, constitutes precisely the type of "anticompetitive behavior" that the antitrust laws seek to redress, the court stated. Further, Apotex alleged numerous instances of Otsuka injuring the entire aripiprazole market, demonstrating an overall market impact instead of mere impact on itself alone.

Apotex also pleaded sufficient facts that would support a nexus between Otsuka’s filing of its lawsuit and Apotex’s delay in approval of its ANDA from April to July 2015, including: (1) Otsuka’s present action against Apotex for infringement; (2) Otsuka’s March 2015 motion for a temporary restraining order and preliminary injunction; (3) Otsuka’s April 2015 suit against the FDA; and (4) Apotex’s eventual reception of approval for the ANDA.

Patent misuse. Lastly, the court concluded that Apotex sufficiently alleged a patent misuse counterclaim because Apotex plainly asserted that this action amounted to an impermissible attempt to prolong the life of Otsuka’s long-standing monopoly in the aripiprazole market. Apotex specifically claimed that Otsuka wielded the Patents-in-Suit beyond their permissible "physical or temporal scope" in order to obtain a market advantage.

Nevertheless, the court granted Otsuka’s request to bifurcate and stay the antitrust and patent misuse counterclaims because resolution of the underlying patent infringement issue could moot the counterclaims, thereby preserving judicial economy.

The case is No. 14-8074 (JBS/KMW).

Attorneys: Brian Ronald Zurich (Pepper Hamilton LLP) for Otsuka Pharmaceutical Co., Ltd. Michael S. Weinstein (Cole Schotz PC) for Apotex Corp., Apotex Inc. and Hetero Labs Ltd.

Companies: Otsuka Pharmaceutical Co., Ltd.; Apotex Corp.; Apotex Inc.; Hetero Labs Ltd.

MainStory: TopStory Antitrust NewJerseyNews

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