Merial Ltd. v. Velcera Inc.

877 F. Supp. 2d 1348, 2012 WL 2529421, 2012 U.S. Dist. LEXIS 90507
CourtDistrict Court, M.D. Georgia
DecidedJune 29, 2012
DocketCase No. 3:12-CV-75 (CDL)
StatusPublished

This text of 877 F. Supp. 2d 1348 (Merial Ltd. v. Velcera Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Merial Ltd. v. Velcera Inc., 877 F. Supp. 2d 1348, 2012 WL 2529421, 2012 U.S. Dist. LEXIS 90507 (M.D. Ga. 2012).

Opinion

[1352]*1352 ORDER

CLAY D. LAND, District Judge.

This Order constitutes the latest chapter in the intellectual property saga that may ultimately conclude with a determination of who has the legal right to an apparently magical formulation for ridding our dogs and cats of fleas and ticks. Plaintiffs Merial Limited and Merial SAS (collectively “Merial”) manufacture and sell a product known as Frontline Plus pursuant to U.S. Patent No. 6,096,329 (“the '329 Patent”). Frontline Plus, which is touted as the bestselling veterinary product in the world, is a parasiticide for dogs and cats containing the active ingredients flpronil and methoprene. Defendants Velcera Inc. and FidoPharm Inc. (collectively “Velcera”) have been working feverishly to develop and sell a generic version of Frontline Plus known as PetArmor Plus. Velcera’s first version of PetArmor Plus (“2011 PetArmor Plus”) had the exact same combination of active ingredients and the same type of inactive ingredients that exist in Frontline Plus. In a previous contempt proceeding, the Court enjoined Velcera from selling that version of PetArmor Plus. After the Court issued that order, Velcera made a minor amendment to the inactive ingredients, and it now seeks to sell that slightly modified product (“2012 PetArmor Plus”) in the United States.1 Merial has filed this patent infringement action claiming that 2012 PetArmor Plus violates its '329 Patent. Velcera responds that the '329 Patent is invalid under 35 U.S.C. §§ 112 and 103(a), and that even if it is valid, the sale of 2012 PetArmor Plus will not infringe the patent.

Presently pending before the Court is Merial’s Motion for Preliminary Injunction (ECF No. 5). Although Merial maintains that 2012 PetArmor Plus violates several claims of the '329 Patent, the resolution of the pending motion depends primarily on one key component of the patent, a requirement that the active ingredients, flpronil and methoprene, be present in “synergistic effective amounts.” Based on the following findings of fact and conclusions of law, the Court grants Merial’s motion.

FACTUAL AND PROCEDURAL BACKGROUND

The '329 Patent is assigned to Merial SAS, which granted Merial Limited an exclusive license to the patent. The '329 Patent claims topically applied (“spot-on”) compositions for protecting domestic dogs and cats from fleas and ticks. Specifically, the '329 Patent claims spot-on compositions containing synergistic effective amounts of the pesticide flpronil and an insect growth regulator that prevents immature parasites from reaching reproductive maturity, as well as at least one customary spot-on formulation adjuvant. The '329 Patent discloses a number of insect growth regulators, including methoprene.2 Merial asserts that in the flpronil plus methoprene compositions disclosed in the '329 Patent, the two active ingredients are present in synergistic effective amounts. In other words, Merial asserts that fipronil and methoprene are present in amounts sufficient to yield synergistic effects, meaning that the combination achieves improved results relative to either agent administered alone. The spot-on composition disclosed in the '329 Patent is intended to be applied to the skin of the dog or cat, usually to the neck or [1353]*1353between the shoulder blades. The active ingredients move across the body of the animal and become concentrated in the animal’s sebaceous glands, which are small oil-producing glands in the skin.

Merial markets compositions that combine fipronil and methoprene under the brand name Frontline Plus. Frontline Plus is the leading veterinary flea and tick treatment in the United States. Frontline Plus for Cats contains 9.8% fipronil and 11.8% methoprene, and Frontline Plus for Dogs contains 9.8% fipronil and 8.8% methoprene.

Veleera intends to sell two new veterinary products in the United States: LC-2010-3 Fipronil and S-Methoprene for Cats (PetArmor Plus for Cats) and LC-2010-4 Fipronil and S-Methoprene for Dogs (PetArmor Plus for Dogs). Each 2012 PetArmor Plus product has the exact same active ingredient formulation as the corresponding Frontline Plus product. Like Frontline Plus for Cats, 2012 PetArmor Plus for Cats contains 9.8% fipronil and 11.8% methoprene. And like Front-line Plus for Dogs, 2012 PetArmor Plus for Dogs contains 9.8% fipronil and 8.8% methoprene.

Veleera previously launched a product called PetArmor Plus in 2011, which it had developed in concert with Cipla Limited (“Cipla”). Prior to the launch of that product, Merial had obtained a default judgment against Cipla in an action in which Merial alleged that a Cipla fipronil/methoprene product, Protektor Plus, infringed Merial’s '329 Patent. As a result of that default judgment, Cipla and anyone acting in concert with Cipla was enjoined from, among other things, manufacturing or selling any product that infringed the '329 Patent. After the issuance of that injunction, Cipla and Veleera jointly developed and began selling 2011 PetArmor Plus. Upon learning of that allegedly infringing activity, Merial filed a contempt motion against Cipla for violating the previous injunction. ' Veleera intervened in that action to protect its interests regarding 2011 PetArmor Plus. After a hearing, the Court concluded that Veleera acted in concert with Cipla to violate the injunction by selling 2011 PetArmor Plus, and the Court found that the 2011 PetArmor Plus products infringed at least one claim of the '329 Patent. The Court entered an injunction against Veleera prohibiting Veleera from selling a veterinary product containing fipronil and methoprene if Cipla participated in the development, manufacture and/or packaging of the product. Merial Ltd. v. Cipla Ltd., No. 3:07-CV-125 (CDL), 2011 WL 2489753, at *17 (M.D.Ga. June 21, 2011) [hereinafter 2011 Contempt Order]. The Court’s decision was affirmed on appeal to the Federal Circuit. Merial Ltd. v. Cipla Ltd., 681 F.3d 1283 (Fed.Cir.2012) [hereinafter Fed. Cir. Op.].

After this Court’s contempt finding, Veleera severed ties with Cipla and reformulated the PetArmor Plus product with a minor formula amendment. Specifically, Veleera eliminated two inert ingredients, the crystallization inhibitors, and replaced their lost volume by increasing the amount of an existing inert ingredient that acted as a solvent. Based on the similarities between the reformulated 2012 PetArmor Plus and the previously enjoined 2011 PetArmor Plus, Merial filed a contempt motion against Veleera, arguing Velcera’s proposed launch of the reformulated product violated the injunction entered against Veleera. After an evidentiary hearing, the Court denied Merial’s motion, finding Merial failed to meet its burden of proving by clear and convincing evidence that Cipla participated in the development of 2012 PetArmor Plus, which was a condition of the Court’s injunction against Velcera. See BASF Agro B.V. v. Cipla, Ltd., No. 3:07-CV-125 (CDL), 2012 WL 2023310, at *1, *5 (M.D.Ga. June 5, 2012) (finding that [1354]

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Bluebook (online)
877 F. Supp. 2d 1348, 2012 WL 2529421, 2012 U.S. Dist. LEXIS 90507, Counsel Stack Legal Research, https://law.counselstack.com/opinion/merial-ltd-v-velcera-inc-gamd-2012.