Sun Pharma Glob. FZE v. Lupin Ltd.

• Decision Date: 30 September 2021
• Docket Number: Civil Action 18-2213 (FLW)
• Parties: SUN PHARMA GLOBAL FZE and SUN PHARMACEUTICAL INDUSTRIES, INC., Plaintiffs/Counterclaim-Defendants, v. LUPID LTD. and LUPIN PHARMACEUTICALS, INC., Defendants/Counterclaim-Plaintiffs.
• Court: U.S. District Court — District of New Jersey

SUN PHARMA GLOBAL FZE and SUN PHARMACEUTICAL INDUSTRIES, INC., Plaintiffs/Counterclaim-Defendants,
v.
LUPID LTD. and LUPIN PHARMACEUTICALS, INC., Defendants/Counterclaim-Plaintiffs.

Civil Action No. 18-2213 (FLW)

United States District Court, D. New Jersey

September 30, 2021

NOT FOR PUBLICATION

OPINION

Hon. Freda L. Wolfson U.S. Chief District Judge

Plaintiffs Sun Pharma Global Fze and Sun Pharmaceutical Industries, Inc., manufacture BromSite, ^[1] the commercial embodiment of U.S. Patent No. 8, 778, 999 (“the '999 Patent”), which is used to treat and prevent pain associated with cataract surgery.^[2] In 2018, Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc., filed an Abbreviated New Drug Application^[3] (“ANDA”) with the Federal Drug Administration (“FDA”) to market a generic, bioequivalent version of BromSite. Plaintiffs sued for infringement and Defendants counterclaimed, seeking a declaratory judgment that the BromSite patent is invalid because it is obvious, indefinite, and/or unenforceable for inequitable conduct, which Dr. Lyle Bowman allegedly committed during prosecution before the Patent & Trademark Office (“PTO”). I held a five-day remote bench trial in March 2021. Pursuant

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to Fed.R.Civ.P. 52(a), I herein set forth my findings of facts and conclusions of law. After considering the evidence, and based on the trial record, I find that Defendants' ANDA does not literally infringe the ‘999 Patent; regardless, the ‘999 Patent is obvious in light of U.S. Patent No. 6, 159, 458 (“Bowman I”)^[4] as well as indefinite because it does not specify a critical measurement parameter on spin time; and Dr. Bowman did not commit inequitable conduct before the PTO by not disclosing Bowman I.

I.OVERVIEW

A. The '999 Patent

Plaintiffs own the '999 Patent, pursuant to a March 2016 agreement with Insite Vision Inc., the original assignee, whom they acquired in 2015. PTX Nos. 004-005, 012, 046; Tr. at 50:13-53:15. Named inventors are Drs. Kamran Hosseini, Lyle Bowman, Erwin C. Si, and Stephen Pham. Claim 1 of the '999 Patent has five parts: (i) the active ingredient bromfenac; (ii) a “flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer” vehicle, colloquially called “polycarbophil”; (iii) a certain pH range; (iv) a certain viscosity range; and a “topical ophthalmic composition.” In full, it discloses:

[a] topical ophthalmic composition formulated for application to the eye, said composition comprising a therapeutically effective amount of bromfenac and a flowable crosslinked carboxy-containing polycarbophil and mucoadhesive polymer wherein the composition has a viscosity in the range of about 1, 000 to about 3, 400 cps and a pH of about 7.4 to about 8.5

Id.

Bromfenac is a non-steroidal anti-inflammatory (“NSAID”) first patented in 1990 and approved by the FDA in 2005. DTX Nos. 175, 355, 364; Tr. at 156:13-16, 158:23-159:2 (Bowman); id. at 622:9-15, 626:3-635:25 (Hanes). It is indicated for “treatment of postoperative

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inflammation and prevention of ocular pain in patients undergoing cataract surgery.” PTX No. 016. Topical eye drops are the preferred drug delivery method for the eye. Tr. at 373:14-374:4 (Olejnik); id. at 554:25-555:21 (Hanes). However, the eye rapidly blinks them away, which limits absorption time and efficacy. Id. at 374:5-376:5 (Olejnik); id. at 556:22-558:18 (Hanes). A mucoadhesive polymer adheres the drop to preocular tissue for a sustained period, thereby resisting the eye's natural drainage mechanisms and enhancing bioavailability. Id. at 128:4-20 (Bowman); id. at 376:10-377:3 (Olejnik); id. at 558:20-562:10, 598:8-599:21 (Hanes). InSite used proprietary “DuraSite” technology for this purpose, and with it, developed various ophthalmic solutions starting in the 1980s. See, e.g., id. at 125:23-126:7 (Bowman); DTX Nos. 25, 251, 942. One of those solutions was AquaSite and another was AzaSite. DTX Nos. 251, 142. By 2008, InSite focused exclusively on “low-risk” projects, or “[e]xisting commercial ophthalmic products enhanced by [the] DuraSite vehicle to outperform the current commercial profile.” DTX Nos. 4768, 1291, 423; Tr. at 170:17-171:13 (Bowman). Chief among them: BromSite, the commercial embodiment of the ‘999 Patent.

B. Procedural History

Plaintiffs sued Defendants for infringement on February 15, 2018, claiming that Defendants' generic contains a chemically identical bromfenac ophthalmic solution in all the same proportions.^[5] Compl., at 2, 7-8. Defendants respond that their generic does not infringe because it has a different viscosity. Defendants also challenge the validity of the ‘999 Patent on the grounds that it is obvious, indefinite, and that Dr. Bowman, who prosecuted it before the PTO, failed to submit prior art he invented, namely Bowman I. Answer, at 10-11; ECF No. 165, at 2-3.

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I conducted a five-day bench trial, via Zoom, on March 22-26, 2021. Various fact and expert witnesses testified. For Plaintiffs: Drs. Bowman, Hosseini, Si, and Pham, the latter three by deposition; corporate witness Dr. Bharati Nadkarni, by deposition; and Dr. Orest Olejnik, who I accepted as an expert in “the design and development of ophthalmic pharmaceutical formulations.”^[6] For Defendants: Dr. Daniel Bloch, who I accepted as an expert in statistical analysis, and Dr. Justin Hanes, who I accepted as an expert in “the fields of pharmaceutical science, drug delivery, and drug design and development, ophthalmic formulation, with specialized expertise in pharmacokinetics and mathematical modeling of the same.”

II. INFRINGEMENT

Under 35 U.S.C. § 271(e)(2)(A), an ANDA that describes “a drug claimed in a patent” constitutes an infringing act. In re Brimonidine Pat. Litig., 643 F.3d 1366, 1377 (Fed. Cir. 2011). “[A]n infringement inquiry provoked by an ANDA filing . . . is focused on a comparison of the asserted patent against ‘the product that is likely to be sold following ANDA approval.'” Alcon Rsch. Ltd. v. Barr Lab'ys, Inc., 745 F.3d 1180, 1186 (Fed. Cir. 2014) (citation omitted). “In a bench trial, ” whether the ANDA infringes is a question of fact. Vanda Pharms. Inc. v. W.-Ward Pharms. Int'l Ltd., 887 F.3d 1117, 1125 (Fed. Cir. 2018); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006). The patentee must prove by a preponderance of the evidence that every claim limitation found in the patent is also found in the ANDA product, either literally or under the doctrine of equivalents.^[7] Roche Palo Alto LLC v. Apotex, Inc., 531 F.3d 1372, 1377

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(Fed. Cir. 2008); Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1366 (Fed. Cir. 2003). “If any claim limitation is absent . . ., there is no literal infringement as a matter of law.” Bayer AG v. Elan Pharm. Rsch. Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000) (“Literal infringement require the patentee to prove that the accused device contains each limitation of the asserted claim(s).”).

In the ANDA context, infringement inevitably hinges on minor details of specific claims because the accused generic must be pharmaceutically and therapeutically equivalent to the patented product as a matter of law, 21 U.S.C. § 355(j)(1), yet it cannot be deemed infringing based on the fact of the ANDA alone. See, e.g., Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997) (“[A] district court's inquiry in a suit brought under § 271(e)(2) is the same as it is in any other infringement suit . . . . The occurrence of the [statutorily] defined ‘act of infringement' does not determine the ultimate question whether what will be sold will infringe any relevant patent.”); see also Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990) (observing that § 271(e)(2) “define[s] a new (and somewhat artificial) act of infringement for a very limited and technical purpose that relates only to certain drug applications”). Ultimately, the claims in the patent define the invention, Autogiro Co. v. United States, 384 F.2d 391, 395-96 (Ct. Cl. 1967), and they must measure up against each element of the ANDA. SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985).

A. The ANDA

Claim 1 of the '999 Patent discloses five limitations: bromfenac, polycarbophil, a pH range, a viscosity range, and a method of treatment. Supra. Except for viscosity, which I will discuss at length infra, Defendants' ANDA by its terms meets every limitation in Claim 1. Defendants propose an ophthalmic solution intended for use in the eye, like BromSite. PTX No. 149; Tr. at 386:21-25 (Olejnik) (describing prescribing information for generic, which instructs patients to

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“instill one drop, in dosage and administration, . . . of bromfenac ophthalmic solution to the affected eye, ” in part by tilting the head back and squeezing the bottle, mirroring BromSite's directions). Defendants also propose a bromfenac concentration of 0.075%, the same as BromSite's. PTX No. 020-F. In fact, Defendants' ANDA cross-references clinical data from InSite indicating that 0.075% is a therapeutically effective amount. Id.; Tr. at 393:8-9 (Olejnik). Next, BromSite requires a flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer, or polycarbophil, equal to between 0.5 to 1.5% of the composition's weight. Tr. at 394:6-12 (Olejnik). BromSite specifically contains 0.875% polycarbophil. PTX No. 17-A; Tr. at 394:19-22 (Olejnik). Defendants' generic specifies the same polycarbophil weight. PTX No. 020-F. Finally, Plaintiffs indicate a pH range between 7.4 and 8.5. PTX No. 119. BromSite's pH in particular is 8.3. Tr. at 396:5-6 (Olejnik). Defendants propose an identical pH value for their product. PTX No. 020-F; Tr. at 396:11 (Olejnik) (clarifying that Defendants' product returned the following pH numbers during testing: 8.22, 8.25, 8.17).

That is, Defendants seek to market a topical eye treatment with the same safety profile and efficacy, expected adverse events...