Hartig Drug Co Inc v. Senju Pharmaceutical Co Ltd

836 F.3d 261, 2016 U.S. App. LEXIS 16404, 2016 WL 4651381
CourtCourt of Appeals for the Third Circuit
DecidedSeptember 7, 2016
Docket15-3289
StatusPublished
Cited by313 cases

This text of 836 F.3d 261 (Hartig Drug Co Inc v. Senju Pharmaceutical Co Ltd) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hartig Drug Co Inc v. Senju Pharmaceutical Co Ltd, 836 F.3d 261, 2016 U.S. App. LEXIS 16404, 2016 WL 4651381 (3d Cir. 2016).

Opinion

OPINION OF THE COURT

JORDAN, Circuit Judge

This appeal arises from a putative class action in which Hartig Drug Company Inc. (“Hartig”) filed a complaint against Senju Pharmaceutical Co., Ltd. (“Senju”), Kyorin Pharmaceutical Co., Ltd. (“Kyorin”), and Allergan Inc. (“Allergan”) (collectively, the “Defendants”), alleging antitrust violations involving medicated eyedrops manufactured by the Defendants. Hartig argues that the Defendants’ wrongful suppression of generic competition resulted in supra-competitive pricing of those eyedrops. Although not a direct purchaser of the medications, Hartig claims it has standing to sue because of an assignment of rights from AmerisourceBergen Drug Corporation (“AmeriSource”) which is a direct purchaser.

The District Court dismissed Hartig’s complaint under Federal Rule of Civil Procedure 12(b)(1) for lack of subject matter jurisdiction. In its opinion, the Court ruled that an anti-assignment clause in a distribution agreement between Allergan and AmeriSource barred any assignment of antitrust claims from AmeriSource to Hartig, leaving Hartig without standing to sue and divesting the Court of subject matter jurisdiction. We conclude that the District Court erred in treating antitrust standing as an issue of subject-matter jurisdiction. Accordingly, we will vacate and remand for further proceedings.

I. Background

A. Factual Background 1

Kyorin researchers developed an antibiotic called gatifloxacin and, in 1990, were awarded a patent on the drug. In 1997, Kyorin licensed Senju to develop, manufacture, and commercialize ophthalmic solutions containing gatifloxacin. Later, in 2001, Senju researchers obtained U.S. Patent No. 6,333,045 (the “’045 Patent”) claiming aqueous liquid pharmaceutical compositions containing gatifloxacin and methods of utilizing them. The named inventors on that patent assigned their rights to Kyorin and Senju jointly.

Kyorin and Senju also “licensed to Aller-gan the right — including a license under the ’045 [P]atent — to market aqueous liq *265 uid gatifloxacin ophthalmic products in the United States.” (A33.) Allergan filed New Drug Applications (“NDAs”) with the Food and Drug Administration for a 0.3% gatifloxacin solution (branded “Zymar”), and for a 0.5% gatifloxacin solution (branded “Zymaxid”); those NDAs were approved in 2003 and 2010 respectively. Am-eriSource subsequently began purchasing Zymar and Zymaxid eyedrops directly from the Defendants and selling them to Hartig, an Iowa-based drug store chain.

Hartig alleged that the Defendants engaged in a number of illegal practices to prevent or delay the introduction into the market of generic alternatives to Zymar and Zymaxid. 2 First, the Defendants filed a baseless lawsuit against another pharmaceutical company, Apotex, claiming patent infringement and delaying FDA approval of that company’s generic version of Zy-mar. Next, the Defendants engaged in so-called “product hopping” (A35) — discouraging doctors from prescribing generic alternatives to the original 0.3% Zymar eye-drops by phasing out that product in favor of “new” 0.5% Zymaxid eyedrops. To buy time for that shift in marketing strategy, the Defendants prolonged the Apotex litigation by filing a frivolous motion for a new trial. They also asked the United States Patent and Trademark Office to reexamine claims of the ’045 Patent, but failed to disclose material information both from the trial record in the Apotex case and from their own expert that undermined their reexamination claims. After the FDA approved Apotex’s 0.3% gatiflox-acin eyedrops, the Defendants sued Apo-tex a second time. Although the courts .ultimately held that the Defendants’ suit was barred by claim preclusion, Apotex was deterred from launching a generic competitor to Zymar. Since then, the Defendants have filed numerous lawsuits against competing drug manufacturers to bar the market entry of generic equivalents to both Zymar and Zymaxid.

B. Procedural Background

Hartig filed its complaint in the United States District Court for the District of Delaware on June 6, 2014. Styled as a class action, the complaint alleged that, were it not for the Defendants’ violations of the Sherman Antitrust Act, generic versions of the gatifloxacin eyedrops would have been sold after Kyorin’s patent on gatifloxacin expired in 2010. 3 Hartig alleged that the “Defendants’ unlawful scheme effectively denied direct purchasers of Zymar and Zymaxid the benefits of competition and of less expensive, generic versions. As a result, [Hartig] and members of the Class ... -have paid supracom-petitive prices for Zymar and Zymaxid and [Zymaxid’s] generic equivalent ].” 4 (A24.)

The complaint acknowledged that Hartig was only an indirect purchaser of the two gatifloxacin products and that Hartig obtained the products through Am- *266 erisource, a direct purchaser. That point was — and is — significant because, under the so-called “direct purchaser rule” recognized in Illinois Brick Co. v. Illinois, 431 U.S. 720, 97 S.Ct. 2061, 52 L.Ed.2d 707 (1977), a direct purchaser of a product has standing to sue under federal antitrust statutes whereas an indirect purchaser does not. Nevertheless, the complaint alleged that AmeriSource had entered an assignment agreement with Hartig that

conveyed, assigned, and transferred to Hartig all of its rights, title and interest in and to all causes of action it may have against Defendants under the antitrust laws of the United States or of any state arising out of or relating to Ameri-source’s purchase of Zymar and Zymax-id to the extent such product was subsequently resold to Hartig... . 5

(A24-25 ¶ 9.)

Allergan responded to Hartig’s suit by filing a motion to dismiss under Federal Rule of Civil Procedure 12(b)(1) for lack of subject matter jurisdiction. Kyorin and Senju jointly filed a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. 6 Aller-gan’s 12(b)(1) motion argued that Hartig lacked “[sjtanding to sue under the antitrust laws” because an anti-assignment clause in the Distribution Services Agreement (“DSA”) that Allergan had with Am-eriSource expressly prohibited either party from assigning the agreement or related rights and obligations without prior written consent from the other party. Hartig v. Senju, et al., D. Del., CA No. 14-719-SLR Docket Item (“D.I.”) 15, at 4; see id., at 5-9. The DSA is not mentioned in Hartig’s complaint, but it was appended to Aller-gan’s motion to dismiss as an exhibit to a declaration from one of Allergan’s corporate officers, a Mr. Kafer.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

FLOYD v. UNITED STATES
D. New Jersey, 2024
HARTWELL v. EZRICARE, LLC
D. New Jersey, 2024
KERKHOFF v. EZRICARE, LLC
D. New Jersey, 2024
in Re: Zohar III, Corp. v.
Third Circuit, 2024
BRADLEY v. LORD
D. New Jersey, 2024

Cite This Page — Counsel Stack

Bluebook (online)
836 F.3d 261, 2016 U.S. App. LEXIS 16404, 2016 WL 4651381, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hartig-drug-co-inc-v-senju-pharmaceutical-co-ltd-ca3-2016.