JANSSEN PRODUCTS, L.P. et al., Plaintiffs,
LUPIN LIMITED et al., Defendants.
WILLIAM H. WALLS, District Judge.
Before the Court are Plaintiffs Janssen Products, L.P., Janssen R&D Ireland (collectively, "Janssen Plaintiffs" or "J. Pls."), the United States of America, and the Board of Trustees of the University of Illinois' (collectively, "Government Plaintiffs" or "Gov. Pls.") and Defendants Lupin Limited, Lupin Pharmaceuticals, Inc., Mylan Pharmaceuticals, Inc., Mylan Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd.'s (collectively, "Defendants") requests for claim construction under Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). These motions have been briefed and were argued before the Court on October 1, 2013. This Opinion sets out the construction of the disputed claims argued at the Markman hearing.
FACTUAL AND PROCEDURAL BACKGROUND
This consolidated action arises out of Defendants having filed Abbreviated New Drug Applications ("ANDAs") with the Food and Drug Administration (the "FDA") seeking approval to sell generic versions of the highly successful HIV drug PREZISTA® (also known by its compound name, darunavir) 75 mg, 150 mg, 300 mg, 400 mg, and 600 mg products owned by the Janssen Plaintiffs and the Government Plaintiffs. J. Pls.' Opening Markman Br. at 1 (ECF No. 185).
The Janssen Plaintiffs dispute two claim terms of U.S. Patent No. 7, 700, 645 (the "645 Patent") and one claim term of U.S. Patent No. 7, 772, 411 (the "'411 Patent"). The 645 Patent claims the ethanolate form of the drug that Janssen developed and sells as PREZISTA®. Id. The '411 Patent is directed to a process for manufacturing the compound (3R, 3aS, 6aR)hexahydrofuro[2, 3-b]furan-3-yl(1S, 2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino-1-benzyl-2-hydroxypropyl-carbamate, which is also known as darunavir, the drug in both PREZISTA® and Mylan's generic version of PREZISTA®. J. Pls.' '411 Opening Markman Br. at 4 (ECF No. 307).
The U.S. Government and University of Illinois are co-owners of U.S. Patent No. 7, 470, 506 (the "506 Patent"). These Government Plaintiffs dispute four terms in Claim 1 of the 506 patent with Defendants. The 506 Patent covers methods of using the active ingredients in the drug PREZISTA® to treat HIV-infected mammals. Gov. Pls.' Opening Markman Br. at 2 (ECF No. 187).
On September 15, 2011, this Court consolidated the patent infringement actions brought by the Janssen Plaintiffs for the purposes of pretrial proceedings and trial. ECF No. 71. On September 28, 2011, this Court also consolidated the Janssen actions with the patent infringement actions brought by the Government Plaintiffs for the purposes of pretrial proceedings, including the Markman hearing. ECF No. 79.
With respect to the 506 and 645 Patents, the parties exchanged Preliminary Claim Constructions on April 24, 2012. On April 27, 2012, the Janssen Plaintiffs served Amended Preliminary Claim Constructions. On May 22, 2012, the parties filed a Joint Claim Construction and Prehearing Statement. ECF No. 175. The parties filed their opening Markman briefs on July 11, 2012, ECF Nos. 185, 186, 187, and their responsive Markman briefs on September 24, 2012, ECF Nos. 212, 213, 214. With respect to the '411 Patent, the parties filed a Joint Claim Construction and Prehearing Statement on March 22, 2013, ECF No. 299, filed their opening Markman briefs on April 4, 2013, ECF Nos. 307, 308, and filed their responsive Markman briefs on May 10, 2013, ECF Nos. 335, 336.
It should be noted that when this action was initially filed, it included claims by Plaintiffs (including G.D. Searle, LLC) against Defendants regarding U.S. Patent Nos. 5, 843, 946; 6, 248, 775 B1; RE42, 889 E; and RE43, 596 (collectively, the "Searle Patents"). Between April 15, 2013 and July 15, 2013, Defendants converted their Paragraph IV certifications with respect to the Searle Patents to Paragraph III certifications, informing the FDA that they would not seek approval of their proposed generic products until after the expiration of the Searle Patents and their associated exclusivities. The submission of the Paragraph III certifications to the FDA resolved the parties' dispute over the Searle Patents, and this Court "so ordered" three dismissal stipulations as to the Searle Patents, as well as a stipulation removing G.D. Searle, LLC as a named party in the case. See ECF Nos. 378, 392, 415, 429.
STANDARD OF REVIEW
Claim construction is a legal issue for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976-78 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). To construe claim terms, a court should first look to intrinsic evidence-the claims themselves, the specification and the prosecution history. Philips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). The starting point of any analysis is the words of the claim. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). "When construing patent claims, there is a heavy presumption that the language in the claim carries its ordinary and customary meaning amongst artisans of ordinary skill in the relevant art at the time of the invention." Housey Pharm., Inc. v. AstraZeneca UK Ltd., 366 F.3d 1348, 1352 (Fed. Cir. 2004). The term's usage in the claim provides insight into its meaning, and claim terms must be interpreted in the context of the claims describing the patented invention. Kyocera Wireless Corp. v. Int'l Trade Comm'n, 545 F.3d 1340, 1347 (Fed. Cir. 2008).
The specification is particularly important in claim construction. "[C]laims must be read in view of the specification, of which they are a part." Phillips, 415 F.3d at 1315 (quoting Markman, 52 F.3d at 979); see also Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004) ("In most cases, the best source for discerning the proper context of claim terms is the patent specification wherein the patent application describes the invention."). When a patentee sets forth a definition of the disputed claim term in the specification, that definition "controls the meaning of [the claim term], regardless of any potential conflict with the term's ordinary meaning[.]" 3M Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir. 2003). Courts may also consider a patent's prosecution history-the complete record of all proceedings before the U.S. Patent and Trademark Office ("PTO") that led to the award of the patent. Vitronics, 90 F.3d at 1582.
After intrinsic evidence, a court may look to extrinsic evidence, including dictionary definitions, technical treatises or expert testimony. Expert testimony may provide useful background information, but "opinion testimony on claim construction should be treated with the utmost caution." Vitronics, 90 F.3d at 1585. Such testimony "may only be relied upon if the patent documents, taken as a whole, are insufficient to enable the court to construe disputed claim terms. Such instances will rarely, if ever, occur." Id.
I. The '645 Patent
The Janssen Plaintiffs have asserted Claims 1-8 of the 645 patent against Defendants. J. Pls.' Opening Markman Br. at 18-24 (ECF No. 185). The terms in dispute are "solvate" and "ethanolate solvate of the compound (3R, 3aS, 6aR)-hexahydrofuro[2, 3-b]furan-3-yl(1S, 2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate" (the "Solvate Phrase").
The Janssen Plaintiffs argue that "solvate" should be defined according to the definition in the patent specification as "a crystal form that contains stoichiometric or non-stoichiometric amounts of solvent." Id. at 7; id., Ex. 2 at col. 4:45-47. Defendants claim that "solvate" should be defined as "a crystalline form that contains solvent incorporated at a regular position in its lattice structure." Defs.' Opening Markman Br. at 1, 14 (ECF No. 186). This Court adopts the Janssen Plaintiffs' proposed construction of "solvate, " and this same construction will apply to the use of "solvate" in the Solvate Phrase, as discussed later in this Opinion.
Defendants contend that the Janssen Plaintiffs' construction is based on a single statement from the 645 Patent specification, whereas the remainder of the intrinsic evidence shows that the claims were further narrowed during prosecution. Id. at 2. Defendants support their construction by relying on the specification's discussion of other terms, the prosecution history, and the opinion of their expert, Dr. Laird. Id. at 2, 14-15.
With regard to the specification's discussion of other terms, Defendants point to the definition of pseudopolymorphs as "polymorphic crystalline forms that have solvent molecules incorporated in their lattice structures." Id. at 8; J. Pls.' Opening Markman Br., Ex. 2 at col. 4:48-50 (ECF No. 185). Defendants also highlight the definition of crystalline as referring to "a form in which the position of the molecules relative to one another is organized according to a threedimensional lattice structure." Id. at col. 4:37-39; Defs.' Opening Markman Br. at 9 (ECF No. 186). Defendants argue that these definitions, among others, show that the invention intended to be covered by the 645 Patent "excludes polymorphs in which the solvent molecules are not incorporated within the lattice structure." Id.
With regard to the prosecution history, Defendants primarily argue that the claims of the 645 Patent, as originally filed, were broadly directed to several different solvates of darunavir. Id. at 10. The Examiner subsequently issued an Office Action requiring the applicants to select a single invention. Id. The applicants then allegedly selected the ethanolate solvate of darunavir (i.e. a crystalline form of darunavir wherein the solvent is incorporated into the lattice structure) to further narrow down the claims. Id. at 10-11.
Defendants' argument surrounding their proposed construction of the term "solvate" must fail. The Federal Circuit has clearly and repeatedly directed courts to the patent specification for guidance. See, e.g., Vitronics, 90 F.3d at 1582 ("The specification acts as a dictionary when it expressly defines terms used in the claims...."); Sinorgchem Co., Shandong v. Int'l Trade Comm'n, 511 F.3d 1132, 1136 (Fed. Cir. 2007) ("[Federal Circuit] opinions have repeatedly encouraged claim drafters who choose to act as their own lexicographers to clearly define terms used in the claims in the specification."); Honeywell Int'l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007) ("[T]he patentee's definition governs, even if it is contrary to the conventional meaning of the term.") (citation omitted).
Extrinsic evidence, including the opinion of Defendants' expert, Dr. Laird, cannot be used to contradict the express definition in the specification. Honeywell, 493 F.3d at 1361; Vitronics, 90 F.3d at 1584 (noting that expert testimony "may not be used to vary or contradict the claim language... [or] the import of other parts of the specification.") The Federal Circuit has also frequently reiterated that the patent specification, and not expert testimony, is the single best guide to determining the meaning of a disputed claim term. See Phillips, 415 F.3d at 1315; General Protecht Group, Inc. v. Int'l Trade Com'n, 619 F.3d 1303, 1310 (Fed. Cir. 2010).
That being said, the rest of the specification and prosecution history are relevant to this inquiry. See Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005) ("The purpose of consulting the prosecution history in construing a claim is to exclude any interpretation that was disclaimed during prosecution.'") (citation omitted); Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003) (if inventor "unequivocally disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary meaning of the claim congruent with the scope of the surrender"); Howmedica Osteonics Corp. v. Zimmer, Inc., No. 05-897 (WHW), 2007 WL 1231773, at *3 (D.N.J. Apr. 23, 2007) (summarizing authority).
Defendants' arguments regarding the patent specification's discussion of other terms do nothing to alter that fact that the specification does explicitly define "solvate." J. Pls.' Opening Markman Br., Ex. 2 at col. 4:45-47 (ECF No. 185). Defendants even acknowledge that definition. Defs.' Opening Markman Br. at 9 (ECF No. 186) ("[T]he patent describes solvate' as a crystal form that contains either stoichiometric or nonstoichiometric amounts of solvent.'").
The rest of the specification does not support Defendants' contention that the patent was narrowed. As an example, Defendants point to the definitions of the terms "pseudopolymorphs" and "crystalline, " yet neither of these alters the definition of the term "solvate" or mentions that the solvent is required to be incorporated in a lattice at "regular ...