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Reckitt Benckiser Pharmaceuticals Inc. v. Dr. Reddy's Laboratories S.A.

United States District Court, D. Delaware

August 31, 2017


          Mary W. Bourke, Dana K. Severance, Daniel M. Attaway, WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE. Attorneys for Plaintiffs.

          Daniel A. Ladow, James M. Bollinger, Timothy P. Heaton, J. Magnus Essunger, TROUTMAN SANDERS LLP, New York, NY; Charanjit Brahma, TROUTMAN SANDERS LLP, San Francisco, CA; Robert E. Browne, Jr., TROUTMAN SANDERS LLP, Chicago, IL; Puja Patel Lea, TROUTMAN SANDERS LLP, Atlanta, GA; Jeffrey B. Elikan, Jeffrey Lerner, Erica N. Andersen, Ashley M. Kwon, COVINGTON & BURLING LLP, Washington, DC. Attorneys for Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. and RB Pharmaceuticals Limited

          James F. Hibey, STEPTOE & JOHNSON LLP, Washington, DC; Cassandra A. Adams, STEPTOE & JOHNSON LLP, New York, NY. Attorneys for Plaintiff MonoSol Rx, LLC

          Richard D. Kirk, Stephen B. Brauerman, Sara E. Bussiere, BAYARD, P.A., Wilmington, DE; Elaine H. Blais, Robert Frederickson, III, Molly R. Grammel, Alexandra Lu, Kathryn Kosinski, GOODWIN PROCTER LLP, Boston, MA; Ira J. Levy, Robert V. Cerwinsky, GOODWIN PROCTER LLP, New York, NY; John Coy Stull, GOODWIN PROCTER LLP, Washington, DC. Attorneys for Defendants Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc.



         Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., [1] RB Pharmaceuticals Limited, [2] and MonoSol Rx, LLC (collectively, "Plaintiffs") bring this suit against Defendants Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc. (collectively, "DRL"[3]). This opinion addresses claims of infringement and invalidity with respect to U.S. Patent No. 8, 017, 150 (the '"150 patent").

         The Court held a one-day bench trial with respect to this patent on November 7, 2016. (D.I. 298 ("Tr.")). The parties filed joint proposed findings of fact (D.I. 273), post-trial briefing with respect to infringement (D.I. 277; D.I. 286; D.I. 294), and post-trial briefing with respect to invalidity (D.I. 276; D.I. 287; D.I. 292). Having considered the documentary evidence and testimony, I make the following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).

         I. BACKGROUND

         Plaintiff Indivior is the holder of approved New Drug Application No. 22-410 for Suboxone® sublingual film, which is indicated for maintenance treatment of opioid dependence. (D.I. 228-2, Admitted Fact Nos. 13-14, 20). The active ingredients of Suboxone® sublingual film are buprenorphine hydrochloride and naloxone hydrochloride. (D.I. 228-2, Admitted Fact Nos. 15-18). Suboxone® sublingual film is available in four dosage strengths (buprenorphine hydrochloride/naloxone hydrochloride): 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg. (D.I. 228-2, Admitted Fact Nos. 16-18). Since the approval of NDA No. 22-410, Suboxone® Sublingual Film has been exclusively manufactured in the United States by Plaintiff MonoSol and exclusively sold in the United States by Plaintiff Indivior. (D.I. 228-2, Admitted Fact No. 19).

         The '150 patent, entitled "Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom, " issued on September 13, 2011. (D.I. 228-2, Admitted Fact No. 24). The '150 patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalences Evaluations (the "Orange Book") as covering Suboxone® Sublingual Film. (D.I. 228-2, Admitted Fact No. 26). MonoSol owns the '150 patent and Indivior is an exclusive licensee of the ' 150 patent. (D.I. 228-2, Admitted Fact No. 25).

         Plaintiffs are asserting independent claim 1 and dependent claims 4, 5, 8, and 9 of the '150 patent against DRL. (D.I. 273 at p. 110). Claim 1 of the '150 patent reads:

         1. A mucosally-adhesive water-soluble film product comprising:

an analgesic opiate pharmaceutical active; and
at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer;
the water-soluble polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;
the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100, 000 to 300, 000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600, 000 to 900, 000; and the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component.

(JTX-1 ('"150 patent"), claim 1).


         A. Infringement

         A patent is infringed when a person "without authority makes, uses, offers to sell, or sells any patented invention, within the United States ... during the term of the patent.. .." 35 U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope. See Id. The trier of fact must then compare the properly construed claims with the accused infringing product. See Id. This second step is a question of fact. Bai v. L&L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).

         "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an accused product does not infringe an independent claim, it also does not infringe any claim depending thereon. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989). However, "[o]ne may infringe an independent claim and not infringe a claim dependent on that claim." Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1359 (Fed. Cir. 2007) (internal quotation marks omitted). A product that does not literally infringe a patent claim may still infringe under the doctrine of equivalents if the differences between an individual limitation of the claimed invention and an element of the accused product are insubstantial. See Warner- Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39-40 (1997). The patent owner has the burden of proving infringement by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).

         B. Obviousness

         The presumption that all patents are valid is the starting point for any obviousness determination. 35 U.S.C. § 282. A patent claim is invalid as obvious under 35 U.S.C. § 103 "if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." Id. § 103(a); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07 (2007). Obviousness is a question of law that depends on the following factual inquiries: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the relevant art; and (4) any objective indicia of nonobviousness. See KSR, 550 U.S. at 406; see also Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1347 (Fed. Cir. 2012). A court is required to consider secondary considerations, or objective indicia of nonobviousness, before reaching an obviousness determination, as a "check against hindsight bias." See In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012). Relevant secondary considerations include commercial success, long felt but unsolved needs, failure of others, praise, unexpected results, and copying, among others. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17- 18 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S. Int'l Trade Comm 'n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).

         "Generally, a party seeking to invalidate a patent as obvious must demonstrate ... that a skilled artisan would have had reason to combine the teaching of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so." In re Cyclobenzaprine Hydrochloride, 676 F.3d at 1068-69. "The Supreme Court has warned, however, that, while an analysis of any teaching, suggestion, or motivation to combine known elements is useful to an obviousness analysis, the overall obviousness inquiry must be expansive and flexible." Id. at 1069. The improvement over prior art must be "more than the predictable use of prior art elements according to their established functions." KSR, 550 U.S. at 417. Evidence of obviousness, however, especially when that evidence is proffered in support of an "obvious-to-try" theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite, " "small, " or "easily traversed, " and "that skilled artisans would have had a reason to select the route that produced the claimed invention." In re Cyclobenzaprine Hydrochloride, 676 F.3d at 1072. Obviousness must be proven by clear and convincing evidence. Id. at 1078.


         A. Infringement

         I. Findings of Fact

         1. A person of ordinary skill in the art ("POS A") would understand that only polyethylene oxide ("PEO") and hydrophobic cellulosic polymers ("HCPs") are actually claimed by the patent.

         2. The specification of the '150 patent identifies polyvinyl pyrrolidone ("PVP") as an alternative to HCP in a list of useful "Film-Forming Polymers." 3. Example EA in the ' 150 patent specification-which is described as an "example of the present ...

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