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Takeda Pharmaceutical Company Ltd., et al v. Mylan

October 11, 2012


The opinion of the court was delivered by: Denise Cote, District Judge


Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals North America, Inc., Takeda Global Research and Development Center, Inc., Watson Pharmaceuticals, Inc., and Andrx Labs, LLC (collectively "Takeda") have brought suit under the Hatch-Waxman Amendments, 35 U.S.C. § 271(a),(b),(c), and/or (e)(2)(A), to enjoin Mylan Inc. and Mylan Pharmaceuticals, Inc. (collectively "Mylan") from obtaining FDA approval of their Abbreviated New Drug Application for a generic extended release tablet comprising a combination of pioglitazone hydrochloride and metformin hydrochloride. This tablet is intended to treat Type 2 diabetes. The plaintiffs allege that Mylan has infringed on ten of their patents.*fn1

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), Mylan has proposed constructions of claims in six of the ten patents.*fn2 Mylan does not contend that any term in the claims requires clarification. It argues instead that other portions in the patents' specifications require a limitation to be placed on claim terms. Takeda responds that no construction of the claims is necessary, but in any event that the specifications do not reflect an intent to limit the scope of the claims in the way proposed by Mylan.

Mylan's arguments rest on language found in several portions of the specifications: the abstracts for two of the patents, and in other sections of the specifications for all six patents. The only portion of Mylan's motion that has any conceivable merit is the portion that relies on the abstracts for two of the patents. That argument is considered at the end of this Opinion, following a description of the relevant legal principles and the specifications for the six patents, and the analysis and rejection of Mylan's argument addressed to all six patents. For the following reasons, Mylan's proposed constructions are rejected.

The patents at issue pertain to the product ACTOPLUS MET® XR. ACTOPLUS MET® XR is a once-daily, controlled release oral diabetes medicine used for treatment of Type 2 diabetes. It combines metformin hydrochloride and pioglitazone hydrochloride into a single product. The controlled release of a drug may help to regulate the exposure of a patient to the drug over time, assist a drug to reach a targeted site in the patient's body, and improve patient compliance with a drug regimen by reducing the required number of administrations.

Some controlled release drug delivery systems make use of an expanding polymer. An expanding polymer swells in the presence of water or biological fluids. When used in a controlled release pharmaceutical tablet, an expanding polymer pushes the active ingredient, contained in the core of the tablet, out through a passageway in the drug capsule's membrane and into the patient's body. Mylan contends here that Takeda's patent claims require the non-employment of an expanding polymer.

Although Takeda contends that Mylan's arguments do not require any claim construction, this Opinion will address Mylan's contentions nonetheless. It is true that district courts are not required to construe every term appearing in a patent claim. 02 Micro Intern Ltd. V. Beyond Innovation Tech. Co. Ltd., 521 F.3d 1351, 1362 (Fed. Cir. 2008). Many words have an ordinary meaning that is evident to a lay person who is not skilled in the art at issue. Claim construction "is not an obligatory exercise in redundancy," and thus, if the parties have no actual dispute over the ordinary meaning of such a term, the court is not obligated to construe it. U.S. Surgical Corp. v. Ethicon Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997).

But, where the parties dispute "the scope of a claim term," the court has a duty to resolve the dispute. 02 Micro, 521 F.3d at 1362. Since the parties dispute whether the inventor has evidenced the intent in the specifications of these patents to use the contested claim terms in a specialized manner, it is appropriate to address Mylan's proposed constructions.

"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. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). In construing a patent claim, which is a matter of law, terms are given their ordinary meaning, which is the meaning the terms would have to one of ordinary skill in the art in question. Id. at 1312-13. The heavy presumption of ordinary and customary meaning is overcome, however, if the patent evidences a sufficiently clear intent to define the term differently. CCS Fitness v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002), see also Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc., 467 F.3d 1370, 1376 (Fed. Cir. 2006); SciMed Life Systems, Inc. v. Advanced Cardiovascular Sys. Inc., 242 F.3d 1337, 1344 (Fed. Cir. 2001).

The primary source of meaning of a claim term is the intrinsic evidence, which includes the patent itself and its prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Ordinarily, a patent's specification is the most probative evidence of the patent's meaning, and is dispositive of the meaning of a disputed term in a claim. Phillips, 415 F.3d at 1315. Courts must tread carefully, however, for while they may use the specification to construe disputed terms they must avoid the "danger of reading limitations from the specification into the claim" itself. Id. at 1323.

The specification usually contains an abstract, a description of the field of the invention, background on the invention, a summary of the invention, a detailed description of the invention, drawings, and lastly, the claims. The claims are the part of the patent that sets the metes and bounds on the patent holder's right to exclude. A claim can be further subdivided into a preamble, transition term, and the limitations.

Limiting language found in parts of the specification other than the claims, such as the stated objectives of the invention or any descriptions of preferred embodiments, should usually not be imported into the claims. See Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 326 F.3d 1215, 1223 (Fed. Cir. 2003); Electro Med. Sys., S.A. v. Cooper Life Scis., Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994). There are circumstances, however, in which the specification demonstrates with sufficient clarity that the invention is actually narrower than the ordinary meaning of the claim language would suggest. SciMed Life Sys., 242 F.3d at 1345. One situation in which the "specification may limit the scope of the claims," is where the inventor has acted as "his own lexicographer" and has used the specification expressly to define terms that appear in the claims. Teleflex Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). When this occurs, those definitions are controlling even if they vary from the ordinary and customary meaning of the claim terms. Vitronics Corp., 90 F.3d at 1582.

Additionally, "[t]he patentee may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope." Teleflex Inc., 299 F.3d at 1325. In determining the significance of limiting language in the specification the court should examine "whether the specification refers to a limitation only as part of less than all possible embodiments or whether the specification read as a whole suggests that the very character of the invention requires the limitation be a part of every embodiment." Alloc Inv. v. Int'l Trade Comm'n, 342 F.3d 1361, 1370 (Fed. Cir. 2003). Thus, it is important "not to confuse exemplars or preferred embodiments in the specification that serve to teach and enable the invention with limitations that define the outer boundaries of claim scope." Intervet Inc. v. Merial Ltd., 617 F.3d 1282, 1287 (Fed. Cir. 2010).

Mylan does not contend through this motion that any term in the claims of the six patents does not have its common and ordinary meaning. Instead, it argues that material in other parts of the specifications in the six patents reflects an intent to add a limitation to each claim. First, Mylan relies on two passages that appear in nearly identical language in each of the six patents' specifications. For two of the patents, Mylan also relies on the abstracts of those two patents. Therefore, this Opinion will address the issues common to all six patents before proceeding to a discussion of the impact of the abstracts on the construction of the claims in two patents: the '859 and '162 Patents.

A. The Specifications of the Six Patents

Mylan's argument with respect to each of the six patents

rests on nearly identical language in the specifications and claims of these patents. In each instance, Mylan contends that language in the specification implies a limitation on the claims, specifically, a limitation on the use of an expanding polymer. A ...

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