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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC., et al.

, Plaintiffs,
V.

MYLAN PHARMACEUTICALS, INC., Defendant.

) ) ) ) ) ) ) ) )

C.A. No. 10-528 (GMS)

ORDER CONSTRUING THE TERMS OF U.S. PATENT NOs. 6,573,293 and 7,211,600 After having considered the submissions of the parties on the matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of U.S. Patent Nos. 6,573,293 and 7,211,600: A. 1. The '293 Patent The term "catalytic activity" as used in claim 22 is construed to mean "the rate of phosphorylation oftyrosine under the influence, direct or indirect, ofRTKs and/or CTKs or the phosphorylation of serine and threonine under the influence, direct or indirect, of STKs." 1

Pfizer claims that it acted as its own lexicographer in drafting its claims. The court agrees. "[T]he inventor's lexicography" of claim terms in the specification "governs." Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005); PHT Corp. v. Invivodata, Inc., WL 1189552, at *1 (D. Del. May 19, 2005). Thus, when "a patent applicant has elected to be a lexicographer by providing an explicit definition in the specification for a claim term ... the definition selected by the patent applicant controls." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998); see also 3M Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir. 2003) ("[T]he definition in the specification controls[.]"). Here, Pfizer explicitly defined this term in the patent's specification. ('293 Patent, col. 14:66-15:2.) Furthermore, Mylan's proposed limitation of this term to solely in vitro methods of measurement is unfounded. Nothing in the claim language itself requires that the claim be limited to in vitro methods of measurement. To the contrary, when inventors in this field intended to limit the scope of the patent to in vitro measurement techniques, they did so explicitly, as exhibited in the '600 patent. See Phillips, 415 F.3d at 1314 (describing instances in which the "use ofthe term within the claim provides a firm basis" for construing or limiting the term). The inventors' express definition is also supported by the remainder of the specification, which states that catalytic activity may occur either in vitro or in vivo. The invention is explicitly

2.

The term "contacting" as used in claim 22 is construed to mean "bringing a compound of this invention and a target PK together in such a manner that the compound can affect the catalytic activity of the PK, either directly, i.e., by interacting with the kinase itself, or indirectly, i.e., by interacting with another molecule on which the catalytic activity of the kinase is dependent. " 2

B.
1.

The '600 Patent


The term "catalytic activity" as used in claim 1 is construed to mean "the rate at which a protein kinase phosphorylates a substrate, determined through in vitro methods."3

2.

The term "abnormal condition" as used in claim 1 is construed to mean "one or more gastrointestinal stromal tumors. " 4

directed to a "method of modulating the catalytic activity" of [protein kinases] ... using a compound of this invention which may be carried out in vitro or in vivo." ('293 Patent col. 5:45-50) (emphasis added). Moreover, the specification reports data generated from specific in vivo tests relating to catalytic activity, i.e., "phosphorylation and subsequent signaling in vivo." (!d. at col. 244:60-63) (emphasis added). 2 The court finds that Pfizer acted as its own lexicographer by explicitly providing a definition for this term in its patent. ('293 patent, col. 15:3-22); see lntervet Inc. v. Merial Ltd., 617 F.3d 1282, 1296 (Fed. Cir. 2010) ("Because the patentee acted as his own lexicographer ... the definition in the specification controls") (citations and quotations omitted). Additionally, here too, the court fmds Mylan's proposed in vitro limitation to be unwarranted. The definition in the specification does not require that the contacting have an in vitro as opposed to an in vivo effect. ('293 Patent col. 15:3-5.) It merely requires the compound to be able to affect the catalytic activity of the protein kinase, regardless of the context for that effect. (ld.) Furthermore, the language immediately following the definition unambiguously states that having an in vitro effect is only one of the ways that "contacting" can occur. (!d. at col. 15:8-10.) It states that "[s]uch 'contacting' can be accomplished 'in vitro,' i.e., in a test tube, a petri dish or the like." (Id.) 3 Mylan contends that Pfizer's proposed construction cherry-picks elements of the definition found in the patent. Specifically, Mylan's claim that "[p]laintiffs proposed construction ... selects one sentence from a five-sentence definition." (D.I. 66 at 5.) The court disagrees. Only one sentence of the specification defines this term: '"[C]atalytic activity' used above, in the context of the invention, defines the rate at which a protein kinase phosphorylates a substrate." ('600 patent, col. 4:51-53.) The next sentence, which Mylan argues is part ofthe defmition, merely proffers an example. It provides, "Catalytic activity can be measured, for example, by determining the amount of a substrate converted to a product as a function of time." (!d. at col. 4:53-55.) Mylan also contends that this term is limited to in vitro methods. Here, the court agrees. Unlike claim 22 of the '293 patent-which does not have any in vitro limitation-daim 1 of the '600 patent expressly claims "[a] method for treating an abnormal condition ... [with a] formula that inhibits, in vitro, the catalytic activity of c-kit kinase .... " ('600 patent, col. 32:11-16.) Therefore, claim 1 ofthe '600 patent is limited to in vitro methods. 4 The parties agreed to this construction prior to the hearing. (D.I. 33 at 1.)

Dated: February

_lj_, 201 2

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