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Bayer Pharma AG v. Watson Laboratories, Inc.

United States District Court, D. Delaware

September 30, 2014



CHRISTOPHER J. BURKE, Magistrate Judge.

In this Hatch-Waxman action filed by Plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH and Bayer Healthcare Pharmaceuticals Inc. (collectively, "Bayer" or "Plaintiffs") against Defendant Watson Laboratories, Inc. ("Watson" or "Defendant"), Bayer alleges infringement of U.S. Patent No. 8, 071, 577 (the "577 Patent").[1] Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.


A. The Parties

Bayer manufactures and sells the drug product known as Natazia®, an FDA-approved oral contraceptive. (D.I. 1 at ¶¶ 15-17) Bayer is also the owner of the '577 Patent. ( Id. at ¶ 22)

Watson is engaged in the business of developing, manufacturing, and distributing generic versions of branded drug products throughout the United States.[2] (D.I. 8 at ¶ 6)

B. The '577 Patent

The '577 Patent is entitled "Multi-Phase Contraceptive Preparation Based on a Natural Estrogen[.]" (D.I. 1, ex. A)[3] The patent is based on U.S. Appl. No. 11/578, 771 and was issued on December 6, 2011. ( Id. )

The invention of the '577 Patent relates to a multiphase product for contraception based on a combination of natural estrogen[4] and a synthetic progestogen (e.g., dienogest). ( Id. at Abstract; cols. 1:8-10; 2:26-27) The patent's specification explains that the claimed composition, in comparison to other contraceptive products, "achieves a greater contraceptive reliability over the entire duration of the cycle, improves the cyclic bleeding behaviour, and controls side effects such as breast tenderness, headaches, depressive moods and libido changes and the like." ( Id., col. 2:3-10) While the product is "particularly suitable for oral administration, " other forms of administration are also possible. ( Id., col. 2:36-40)

The '577 Patent contains just three claims, all of which are independent claims. ( Id., col. 4:15-53) Claims 1 and 2 are purportedly composition claims directed to the Natazia product itself. ( Id., col. 4:16-41) Claim 3 is directed to the method of use of Natazia® ( Id., col. 4:42-53)

C. Procedural History

This case arises out of Watson's submission of Abbreviated New Drug Application ("ANDA") No. 202349 to the United States Food and Drug Administration ("FDA"), which seeks approval to market a generic version of Bayer's Natazia® product. (D.I. 1 at ¶ 1) Bayer is the holder of approved New Drug Application No. 022252, which covers Natazia®. ( Id. at ¶ 15) Natazia® tablets contain, as active ingredients, estradiol valerate and dienogest. ( Id. )

Bayer filed suit against Watson on December 18, 2012, (D.I. 1), alleging that Watson's submission of ANDA No. 202349 infringes at least one claim of the '577 Patent under 35 U.S.C. § 271(e)(2), ( id. at ¶¶ 28, 32). Further, Bayer alleges that upon FDA approval of Watson's ANDA, Watson will infringe the patent by making, using, offering to sell, and selling its generic oral contraception product. ( Id. at ¶ 32)

On February 15, 2013, the Court was referred this case by Chief Judge Leonard P. Stark to hear and resolve all pretrial matters, up to and including the resolution of case-dispositive motions. (D.I. 15) The parties completed briefing on claim construction on December 13, 2013. (D.I. 65, 66) The parties thereafter jointly suggested that a Markman hearing was not necessary, (D.I. 69), and the Court accordingly cancelled the Markman hearing that had previously been scheduled for January 14, 2014.


A. Claim Construction

It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). The proper construction of claim terms is a question of law for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir.1995), aff'd, 517 U.S. 370 (1996). The Court should generally give claim terms their "ordinary and customary meaning[, ]'" which is "the meaning that the term[s] 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." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir.2005) (citations omitted). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent, but rather should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321.

To that end, the Court should look first and foremost to the language of the claims, because "[i]t 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." Id. at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable" in discerning the meaning of particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[d]ifferences among claims can also be a useful guide, " as when "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.

In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term... that differs from the meaning [that term] would otherwise possess." Id. at 1316. In that case, "the inventor's lexicography governs." Id. Even if the specification does not contain a special definition of the term-at-issue, it "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 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). In addition to the specification, a court should also consider the patent's prosecution history, if it is in evidence, because it "can often inform the meaning of the claim language by demonstrating how the inventor understood the invention[.]" Phillips, 415 F.3d at 1317 (citations omitted).

Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises[, ]" can also "shed useful light on the relevant art." Id. (internal quotation marks and citations omitted). Dictionaries (especially technical dictionaries) may be useful in this process because they typically provide "the accepted meanings of terms used in various fields of science and technology[.]" Id. at 1318. However, the United States Court of Appeals for the Federal Circuit has cautioned that "heavy reliance on [a] dictionary divorced from the intrinsic evidence risks transforming the meaning of the claim term to the artisan into the meaning of the term in the abstract, out of its particular context, which is the specification." Id. at 1321. Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. at 1317 (internal quotation marks and citations omitted); accord Markman, 52 F.3d at 981.

In utilizing these resources during claim construction, courts should keep in mind that "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.'" Shire Dev., LLC v. Watson Pharms., Inc., 746 F.3d 1326, 1330 (Fed. Cir.2014) (quoting Phillips, 415 F.3d at 1316).

B. Indefiniteness

A patent claim must "particularly point[] out and distinctly claim[] the subject matter which the inventor... regards as the invention." 35 U.S.C. § 112. If it does not, the claim is indefinite and therefore invalid. Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2125 (2014). Recently, in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120 (2014), the Supreme Court of the United States set out the test to be applied in the indefiniteness inquiry: "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Nautilus, 134 S.Ct. at 2124.[6]

The primary purpose of the definiteness requirement is to ensure that patent claims are written in such a way that they give notice to the public of what is claimed, thus enabling interested members of the public (e.g., competitors of the patent owner) to determine whether they infringe. All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 779-80 (Fed. Cir. 2002). Put another way, "[a] patent holder should know what he owns, and the public should know what he does not." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 731 (2002). Indefiniteness is to be evaluated from the perspective of someone skilled in the relevant art at the time the patent was filed. Nautilus, 134 S.Ct. at 2128 (citing cases).

Like claim construction, indefiniteness is a question of law for the court. H-W Tech., L.C. v., Inc., 758 F.3d 1329, 1332 (Fed. Cir. 2014); Pi-Net Int'l Inc. v. JPMorgan Chase & Co., ___ F.Supp.2d ___, Civ. No. 12-282-SLR, 2014 WL 1997150, at *3 (D. Del. May 14, 2014). The Federal Circuit has stated that "[a]ny fact critical to a holding on indefiniteness... must be proven by the challenger by clear and convincing evidence." Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366 (Fed. Cir. 2003); see also Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed. Cir. 2008).[7]


The parties dispute the meaning of two sets of terms found in claims 1 and 2 of the '577 Patent, which the Court will refer to in shorthand as the "phase" terms or limitations and the "daily" terms or limitations. (D.I. 54 at 11, 16; D.I. 55 at 1) Although claims 1 and 2 are purportedly composition claims that cover the Natazia® product, Watson contends that "[t]he whole invention' disclosed in the patent is a method of using a particular combination of old, well-known and well-understood drugs in a particular order on a daily basis." (D.I. 65 at 2-3 (emphasis in original)) Resolution of the parties' disputes all boils down to whether, as Watson argues, claims 1 and 2 are hybrid claims that recite both a product and a method of using that product at the same time. (D.I. 54 at 1; D.I. 65 at 1-2) If so, Watson argues, the claims are indefinite and invalid as a matter of law. (D.I. 54 at 1; D.I. 65 at 2)

While the disputed terms are found in claims 1 and 2 only, claim 3 is also relevant to the parties' arguments. Accordingly, all three of the '577 Patent's claims are ...

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