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Merck Sharp & Dohme Corp. v. Actavis Laboratories FL, Inc.

United States District Court, D. New Jersey

June 27, 2017



          PETER G. SHERIDAN, U.S.D.J.

         This matter comes before the Court on a Second Amended Joint Claim Construction and Prehearing Statement (hereinafter “Joint Claim Construction”) regarding U.S. Patent No. 5, 661, 151 (“the '151 patent”), submitted by Merck Sharp & Dohme Corp. (“Merck” or “Plaintiffs”) and Actavis Laboratories FL, Inc., Andrx Corporation, Actavis Pharma, Inc. and Actavis, Inc. (collectively, “Actavis”) pursuant to L. Pat. R. 4.3. (See D.I. 128).

         The '151 patent is directed to the synthesis and clinical use of antifungal compound posaconazole, which is used for treating or preventing fungal infections. Noxafil®, a brand name pharmaceutical drug for treating or preventing fungal infections, especially in people with weak immune systems, includes the active ingredient poscanazole.

         In order to market and sell Noxafil®, Merck listed the '151 patent in the Food and Drug Association's (“FDA”) Approved Drug Products with Therapeutic Equivalence Applications, commonly known as the Orange Book. See 21 U.S.C. § 355(B)(1). Thereafter, Actavis filed an Abbreviated New Drug Application (“ANDA”) with the FDA in order to seek approval to market a generic version of Noxafil®. See 21 U.S.C. § 355(j)(1). Accordingly, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Merck initiated this suit against Actavis because Actavis' request to market the generic version of Noxafil® is done prior to the expiration of the '151 patent.

         As noted in the Joint Claim Construction, the parties dispute the meaning of the following claim terms recited in claim 12 of the '151 patent -“pharmaceutical[] composition, ” and “pharmaceutically acceptable carrier” (collectively “disputed claim terms”).

         On May 2, 2017, pursuant to L. Pat. R. 4.6, the Court held a Markman hearing to define the aforementioned two claim terms. These terms are construed below.


         The '151 patent is generally directed to the synthesis and clinical use of antifungal compound posaconazole, which is used for treating and/or preventing fungal infections. (See Abstract of the '151 patent). The '151 patent filed on June 2, 1995, as Application No. 460, 752, is a continuation-in-part of an application filed under the Patent Cooperation Treaty (“PCT”). The PCT application is a continuation-in-part of another application filed on December 21, 1993. As such, the potential effective filing date of the '151 patent is December 21, 1993. The '151 patent discloses antifungal compounds of formula I and pharmaceutical compositions, which are expected to exhibit anti-allergic, anti-inflammatory and immunomodulating activities. The pharmaceutical composition contains a fungicidally effective amount of other antifungal compounds such as cell wall active compound. (Id. at col. 56, ll. 40-67).

         The '151 patent further discloses that pharmaceutical compositions are formulated by combining the compound of formula I or an equivalent amount of a pharmaceutically acceptable salt of compound I with a suitable, inert, pharmaceutically acceptable carrier or diluent. Examples of suitable pharmaceutical compositions include solid or liquid compositions for oral administration such as tablets, capsules, pills, powders, granules, solutions, suppositories, troches, lozenges, suspensions or emulsions. (Id. at col. 57, ll. 40-50).

         Further, the '151 patent discloses that a solid carrier can be one or more substances which may act as diluents, flavoring agents, solubilizers, lubricants, suspending agents, binders or tablet disintegrating agents, or as an encapsulating material. The carrier can also be a finely divided solid which is in admixture with the finely divided active compound. In a tablet form, for example, the active compound is mixed with the carrier that has the necessary binding properties. The carrier is added in suitable proportions such that the tablet is compacted in the desired shape and size. (Id. at col. 57, ll. 45-55).

         During prosecution of the patent application of the '151 patent, the examiner rejected the claimed subject matter. Applicant amended the then pending claims to include claim term “in vivo” to differentiate over the cited art. (See Image File Wrapper of the '151 patent, Applicant's Arguments/Remarks Made in an Amendment, filed May 24, 1996). This amendment was made in response to patent examiner's rejection mailed on November 22, 1995. Additionally, arguments against the obviousness rejection under 35 U.S.C. § 103 were also made. (Id.)

         After mailing a final rejection on August 21, 1996, the examiner conducted a personal interview with the Applicant's representative. During the personal interview, the enablement rejection under pre-AIA (“America Invents Act”) 35 U.S.C. § 112, first paragraph, was discussed, and the Applicants agreed to provide an affidavit demonstrating that enablement exists for use of “in vivo” esters. (See Examiner Interview Summary Record mailed on December 19, 1996).

         Accordingly, the Applicant filed a response to the outstanding Office action with a declaration from Dr. Ashit K. Ganguly, a co-inventor of the '151 patent. In its response, the Applicant essentially argued that based on the specification one skilled in the art would be able to readily determine which of the ester compounds would be soluble or suspendible in a pharmaceutically acceptable aqueous media. (See Applicant's Arguments/Remarks filed on January 29, 1997; citing Declaration of Dr. Ganguly at ¶ 17).

         Further, Applicants noted that they are “amending claim 17 of this application to cover a preferred embodiment, and to recite that such esters of the compounds of the claimed invention have a solubility in a pharmaceutically acceptable media of at least about 1 to about 50 mg/ml.” (Id. at 6). Thereafter, on February 7, 1997, a notice of allowance was mailed by the patent examiner, which was later followed by a corrected notice of allowance on February 27, 1997. No reasons for allowance in-particular were provided by the patent examiner when issuing the notice of allowance.


         “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) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). Claim construction determines the correct claim scope, and is a determination exclusively for the court as a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The focus in construing disputed terms in claim language “is on the objective test of what one of ordinary skill in the art at the time of the invention would have understood the term[s] to mean.” Id. at 986.

         To determine the meaning of the claims, courts start by considering the intrinsic evidence. Phillips, 415 F.3d at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Comms. Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861.

         The claims themselves provide substantial guidance in determining the meaning of particular claim terms. Phillips, 415 F.3d at 1314. First, the context in which a term is used in the asserted claim can be very instructive. Id. Other asserted or non-asserted claims can aid in determining the claim's meaning because claim terms are normally used consistently throughout a patent. Id. Differences among claims can also assist in understanding a term's meaning. Id. For example, when a dependent claim adds a limitation, there is a presumption that the independent claim does not include that limitation. Id. at 1314-15.

         “[C]laims ‘must be read in view of the specification of which they are a part.'” Id. at 1315 (quoting Markman, 52 F.3d at 979). “[T]he 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. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). This is true because a patentee may define his own terms, give a claim term a different meaning than the term would otherwise possess, or disclaim or disavow the claim scope. Id. at 1316. In these circumstances, the inventor's lexicography governs. Id. The specification may also resolve the meaning of ambiguous claim terms “where the ordinary and accustomed meaning of the words used in the claims lack sufficient clarity to permit the scope of the claim to be ascertained from the words alone.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). But, “[a]lthough the specification may aid the court in interpreting the meaning of disputed claim language, particular embodiments and examples appearing in the specification will not generally be read into the claims.” Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); also see Phillips, 415 F.3d at 1323 (“although the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”).

         The prosecution history is another tool to supply the proper context for claim construction. It “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 that it would otherwise be.” Phillips, 415 F.3d at 1317.

         “Extrinsic evidence 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. Although extrinsic evidence can be useful, it is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.'” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc., 388 F.3d at 862).

         Dictionaries and treatises may aid a court in understanding the underlying technology and the manner in which one skilled in the art might use claim terms, but dictionaries and treatises may provide definitions that are too broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly, expert testimony may aid a court in understanding the underlying technology and determining the particular meaning of a term in the pertinent ...

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