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Galderma Laboratories Inc. v. Amneal Pharmaceuticals, LLC

United States District Court, Third Circuit

July 30, 2013


Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE. Of Counsel: Gerald J. Flattmann, Jr., Esquire and Christine Willgoos, Esquire of PAUL HASTINGS, New York, NY. Attorneys for Plaintiffs.

Mary B. Matterer, Esquire, Kenneth L. Dorsney, Esquire, and Richard K. Herrmann, Esquire of MORRIS JAMES LLP, Wilmington, DE. Of Counsel: H. Keeto Sabharwal, Esquire, Paul A. Ainsworth, Esquire, Jonathan Tuminaro, Esquire, and Dennies Varughese, Esquire of STERNE, KESSLER, GOLDSTEIN & FOX, PLLC, Washington, DC. Attorneys for Defendants.


STARK, U.S. District Judge


Plaintiffs Galderma Laboratories, Inc., Galderma Laboratories, L.P., and Supernus Pharmaceuticals, Inc. (collectively, "Plaintiffs" or "Galderma") filed suit against defendants Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals Co. (I) PVT. LTD. (collectively, "Defendants" or "Amneal"), alleging infringement of United States Patent Nos. 7, 749, 532 ("the '532 patent") and 8, 206, 740 ("the '740 patent") (collectively, the "patents-in-suit" or "Chang patents").[1] (See Docket Item ("D.I.") 1, 128) The patents-in-suit are each entitled "Once Daily Formulations of Tetracyclines" and relate to the Oracea® drug product, a delayed-release doxycycline capsule approved for the treatment of rosacea.

The Court held a Markman hearing on November 30, 2012. (See Transcript of November 30, 2012 Markman hearing (D.I. 158) (hereinafter "Tr."))[2]


"It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWHCorp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). Construing the claims of a patent presents a question of law. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed. Cir.1995), aff'd, 517 U.S. 370, 388-90 (1996). "[T]here is no magic formula or catechism for conducting claim construction." Phillips, 415 F.3d at 1324. Instead, the Court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.

"[T]he words of a claim are generally given their ordinary and customary meaning .. . [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent specification "is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

While "the claims themselves provide substantial guidance as to the meaning of particular claim terms, " the context of the surrounding words of the claim also must be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment.. . [b]ecause claim terms are normally used consistently throughout the patent...." Id. (internal citation omitted).

"Differences among claims can also be a useful guide.. . . For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).

It is also possible that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481 F.3d 1371 (Fed. Cir. 2007).

In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. The prosecution history, which is "intrinsic evidence, " "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

A court may also rely on "extrinsic evidence, " which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the Court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. Overall, while extrinsic evidence "may be useful" to the Court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a ...

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