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Smithkline Beecham Corp. v. Apotex Corp.

March 5, 2010


The opinion of the court was delivered by: Baylson, J.


I. Introduction

Plaintiffs SmithKline Beecham Corp., Smithkline Beecham, p.l.c., and Beecham Group, p.l.c. (collectively, "GSK"), allege, inter alia, that Apotex Corp., Apotex, Inc., and Torpharm, Inc. (collectively, "Apotex"), infringed upon GSK's United States Patent Number 6,080,759 (filed Sept. 2, 1997) ("'759 Patent"), which "relates to novel compounds, to processes for preparing them and to their use in treating medical disorders." '759 Patent, col. 1, ll. 9-11. In particular, the '759 Patent "provides paroxetine hydrochloride anhydrate substantially free of bound organic solvent." Id., col. 1, ll. 53-55. Presently before the Court are the parties' briefs on claim construction pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir.1995) (en banc), aff'd 517 U.S. 370. (Docket Nos. 497, 499.) On February 24, 2010, the Court heard oral argument on claim construction.

II. Legal Standard

Generally, a claim term is given its "ordinary and customary meaning," that being the definition given by "a person of ordinary skill in the art in question at the time of the invention." Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir . 2005) (en banc). The Federal Circuit has explained that the claim construction inquiry begins by looking at the intrinsic evidence: the language of the claims, the specification, and the prosecution history.

"[T]he claims themselves"-that is "the use of a term within the claim," "[o]ther claims of the patent in question, both asserted and asserted," and "[d]ifferences among claims"-"provide substantial guidance as to the meaning of particular claim terms." Id. at 1314. "[I]t is [also] appropriate for a court . . . to rely heavily" on the specification, the patentee's written description, for guidance as to the meaning of the claims." Id. at 1314. In fact, "the 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.'" Id. at 1315 (quoting Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Additionally, the court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. Though "less useful" and "often lack[ing] the clarity of the specification," "the 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's scope narrower than it would otherwise be." Phillips, 415 F.3d at 1317.

Apart from intrinsic evidence, the court is also authorized to rely on extrinsic evidence, that being "'evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.'" Id. (quoting Markman, 52 F.3d at 980). Such evidence, through "shed[ding] useful light on the relevant art," is "less significant than the intrinsic record in determining the legally operative meaning of claim language," and "is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1317, 1319 (internal quotation marks omitted).

III. Discussion

The parties dispute the construction of several terms relating to the following: (A) "paroxetine hydrochloride anhydrate Form A" ("Form A"); (B) "crystallizing a paroxetine hydrochloride in an organic solvent or a mixture of organic solvents"; (C) "organic solvent not removable by drying"; (D) "displacing the solvent with a displacing agent"; and (E) "a melting point of about 123-125§ C."*fn1

A. "Paroxetine Hydrochloride Anhydrate Form A"

Claim Term GSK's Construction Apotex's Construction "paroxetine hydrochloride [no proposed construction] paroxetine hydrochloride in anhydrate Form A" anhydrate form and having the physical-chemical properties recited in claim 10 "a process to prepare a process to prepare a form of [no proposed construction] paroxetine hydrochloride paroxetine hydrochloride anhydrate Form A" anhydrate comprising the following characteristics: a melting point of approximately 123-125°C; IR bands at approximately 513, 538, 571, 592, 613, 665, 722, 761, 783, 806, 818, 839, 888, 906, 924, 947, 966, 982, 1006, 1034, 1068, 1091, 1134, 1194, 1221, 1248, 1286, 1340, 1387, 1493, 1513, 1562, 1604, 3402, and Claim Term GSK's Construction Apotex's Construction 3631 cm-1; a DSC maximum endotherm, measured at 10° C per minute, of approximately 126° C in an open pan and approximately 121° C in a closed pan; characteristic X-ray diffractogram peaks at approximately 6.6, 8.0, 11.2, and 13.1 degrees 2 theta; characteristic solid state 13C-NMR spectrum peaks at approximately 154.3, 149.3, 141.6, and 138.5 ppm, and having solvent of crystallization content less than the amount not removable by conventional drying conditions Claim 10 of the '759 Patent, which Claims 11, 14, and 15 incorporate by reference, describes "a process to prepare paroxetine hydrochloride anhydrate Form A." '759 Patent, col. 18, ll. 7-8. Apotex urges the Court to construe only "paroxetine hydrochloride anhydrate Form A" ("Form A") (Apotex Opening 13-14), and GSK contends that the Court should instead construe "a process to prepare" Form A (GSK Opening 9-11).

1. The Parties' Contentions*fn2

According to GSK, the parties do not dispute that the construction of Form A terms should recite each of the "characteristics" listed in Claim 10, '759 Patent, col. 18, l. 5, because Form A "was not otherwise known in the pharmaceutical sciences," meaning that "the person of ordinary skill would not understand [it] to have a meaning independent of the definition set out in the '759 Patent." (GSK Opening 10.) GSK avers that Apotex's Opening Construction Brief amended an earlier construction that "actually listed several of the analytical characteristics of Form A," by proposing a new construction that only referenced the "properties recited in claim 10," which "does not serve to clarify the meaning of the claim term in a way that will be understandable to the jury, because it does not define what 'properties' it refers to." (GSK Resp. 7.) GSK, initially contended that the intrinsic record indicates that Form A has the "characteristics" listed in Claim 10, and urged the Court to construe the process of preparing Form A by specifying "certain analytical data . . . , including melting point, IR, DSC, X-ray, and C-NMR data." (GSK Opening 10.)

GSK also argues that Claim 10 defines Form A "as having solvent of crystallization content less than the amount not removable by conventional drying conditions,"and that, "by definition, Form A contains less crystallization solvent than the amount not removable by drying." (GSK Opening 11.) GSK contends that the intrinsic record supports an inclusion of comparative crystallization content language in construing Form A. (GSK Opening 12.) According to GSK, the specification and prosecution history indicate that the "applicants . . . understood Form A to be the product of a process that required use of a displacing agent to remove solvent not removable by conventional drying conditions." (GSK Opening 12.) GSK then argues that Apotex's construction "impermissibly omits" that requirement, is "inconsistent with the patent specification[,] and should be rejected." (GSK Opening 12.) As noted below, GSK agreed at oral argument to a simpler cross-reference to Claim 10.

Apotex responds that "[o]ne needn't look further than to claim 10" to understand, and that the parties do not dispute, that Form A has the "specific physical-chemical properties" listed in that claim, and that the intrinsic history indicated that GSK repeatedly explained that these properties differentiated Form A from "prior-art paroxetine hydrochloride anhydrate." (Apotex Opening 14; see also Apotex Resp. 1.) Apotex further avers that "[t]here is also no dispute that claim 10 is a process claim that requires Form A." (Apotex Resp. 1.) Apotex, however, contends that its construction does not fail to "account for a lower level of crystallization solvent for Form A," but that "Apotex addresses this issue where proper-in its construction of the claim terms 'organic solvent not removable by drying' and 'displacing.'" (Apotex Resp. 1-2.) Apotex therefore urges the Court to adopt its proposed construction.

2. Analysis

The intrinsic evidence plainly provides that Form A has the "characteristics" listed in Claim 10: The specification expressly includes the same embodiments in its description of Form A, see '759 Patent, col. 3, ll. 12-17, and in prosecuting the patent, GSK maintained that the patent itself provided the only definition for Form A, which was not a commonly understood term in the pharmaceutical sciences (see GSK Opening Ex. 12, at GSK 007573332), and distinguished prior art based on Form A's listed "characteristics" (see Apotex Opening Ex. 9, at 4; Ex. 11, at 3-4; & Ex. 15, at 2-3.)

The parties do not dispute that the "characteristics" should be incorporated into the Court's claim construction. In their briefing, the parties contested whether a cross-reference to Claim 10 suffices to explain Form A to the jury; however, at oral argument, GSK's counsel stated that GSK does not believe that the terms relating to Form A need to be construed and does not have a problem with cross-referencing Claim 10. GSK's counsel also represented that it is not necessary to include in the definition language respecting "crystallization content," so long as the construction explained that "Form A is what you get when you follow the steps in Claim 10."

Apotex's counsel then responded that Apotex "agree[s] in principle" to GSK's stance, but still disagrees with the crystallization content language.

The Court has determined that construing Form A by way of a cross-reference to Claim 10 of the Patent is by no means confusing, and that there is no need to restate these characteristics or Claim 10's language respecting crystallization content. At the end of oral argument, the Court suggested that Form A be construed as "paroxetine hydrochloride in anhydrate form, having the 'characteristics' and following the steps recited in Claim 10." The parties did not object to this construction at oral argument, and confirmed in post-argument supplemental letter briefs that they find the Court's tentative construction to be acceptable. (GSK Supp. Br. 1; Apotex Supp. Br. 1.) The Court therefore adopts this construction of Form A. The Court will not construe "a process to prepare" Form A, because the parties do not dispute that Claim 10 describes the Form A preparation process, and GSK proposed only a redundant definition that uses the claim term's own words of "a process to prepare."

B. "Crystallizing a Paroxetine Hydrochloride in an Organic Solvent or a Mixture of Organic Solvents"

Claim Terms GSK's Construction Apotex's Construction "crystallizing a paroxetine crystallizing paroxetine [no proposed construction] hydrochloride in an organic hydrochloride in a mixture solvent or a mixture of organic comprising one or more solvents" carbon-based solvents substantially free of water Claim 10 also provides that the Form A preparation process comprises "crystallizing a paroxetine hydrochloride in an organic solvent or a mixture of organic solvents." '759 Patent, col. 18, ll. 8-11. GSK urges the Court to construe the term (GSK Opening Br. 12-15), and Apotex offers no ...

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