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Ferring Pharmaceuticals Inc. v. Par Pharmaceutical, Inc.

United States District Court, D. Delaware

July 25, 2017

FERRING PHARMACEUTICALS INC. and FERRING INTERNATIONAL CENTER S.A., Plaintiffs;
v.
PAR PHARMACEUTICAL, INC., Defendant.

          Mary W. Bourke, Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE; Dana K. Severance, Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE; Daniel M. Attaway, Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE; John W. Cox, Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Atlanta, GA. Attorneys for Plaintiffs

          Steven J. Fineman, Esq., RICHARDS, LAYTON & FINGER, PA, Wilmington, DE; Katharine C. Lester, Esq., RICHARDS, LAYTON & FINGER, PA, Wilmington, DE; Richard J. Berman, Esq., ARENT FOX LLP, Washington, DC; Janine A. Carlan, Esq., ARENT FOX LLP, Washington, DC; Taniel Anderson, Esq., ARENT FOX LLP, Washington, DC; Ahmed Abdel-Rahman, Esq., ARENT FOX LLP, Washington, DC. Attorneys for Defendant

          AMENDED TRIAL OPINION

          ANDREWS, U.S. DISTRICT JUDGE

         Plaintiffs brought this patent infringement action against Par Pharmaceutical, Inc. on February 20, 2015. (D.I. 1). Defendant filed an Abbreviated New Drug Application ("ANDA"), seeking to engage in the commercial manufacture, use, and sale of a generic version of Ferring's Prepopik product. (D.I. 170-1 at 3, ¶¶9-10). Plaintiffs allege that Defendant's submission of this ANDA infringes U.S. Patent Nos. 8, 450, 338 ("the '338 patent") and 8, 481, 083 ("the '083 patent"). (D.I. 170 at 3, ¶l)

         The product at issue in this case is a treatment used as preparation for colonoscopy. (D.I. 170-1 at 2, ¶8). Plaintiffs' Prepopik product is comprised of sodium picosulfate, magnesium oxide, and citric acid. (Id. at 2, ¶5). The Court held a bench trial on November 8-9, 2016. (D.I. 178, 179) ("Tr."). Prior to trial, Defendants dismissed all invalidity defenses with prejudice. (D.I. 165). Therefore, the only issue addressed at trial was whether Defendant's proposed ANDA product and process infringe the '338 and '083 patents.

         I. LEGAL STANDARDS

          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). The patent owner has the burden of proving infringement by a preponderance of the evidence. See Smith Kline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).

         II. INFRINGEMENT OF THE '083 AND '338 PATENTS

         Plaintiffs assert claims 1, 4-12, and 17-18 of the '338 patent and claims 1 and 7-11 of the '083 patent. The parties agree that if Defendant's ANDA product meets all limitations of claim 1 of the '338 patent and if the process by which it makes its ANDA product meets all limitations of claim 8 of the '338 patent, then all limitations of the asserted dependent claims of the '338 patent are met. (D.I. 170-1 at 6-7, ¶¶34-35). Independent claim 1 is a composition claim and reads as follows:

         1. A composition comprising sodium picosulphate coated granules having a spray-coated layer of sodium picosulphate coating a potassium bicarbonate core.

         ('338 patent, claim 1). Claim 8 is a process claim and reads as follows:

8. A process for the preparation of a composition according to claim 1 wherein said process comprises steps of:
(a) spray coating a solution of sodium picosulfate on to potassium bicarbonate; and
(b) drying the sodium picosulfate and potassium bicarbonate thereby obtaining sodium picosulphate coated granules, Wherein the sodium picosulfate coated granules have a layer of sodium picosulfate coating a potassium bicarbonate core.

('338 patent, claim 8). Independent claim 7 is identical to claim 8, with the exception of the preamble, which in claim 7 reads, "A composition prepared by a process comprising the steps of."

         There is no dispute that Defendant's ANDA product is a composition comprising sodium picosulfate and potassium bicarbonate. (D.I. 170-1 at 6, ¶¶29, 31). There is also no dispute that Defendant's ANDA product contains granules. (Id. at 6, ¶32).

         The parties also agree that if Defendant's ANDA product meets all limitations of claim 1 of the '083 patent, then all limitations of the asserted claims of the '083 patent are met. (Id. at 7, ...


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