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In re Copazone '775 Patent Litigation

United States District Court, D. Delaware

December 1, 2017

IN RE COPAZONE '775 PATENT LITIGATION

          ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 9, 155, 775 ("THE '775 PATENT") AND 9, 763, 993 ("THE '993 PATENT"). [1]

         After considering the submissions of the parties and hearing oral argument on the matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of U.S. Patent Nos. 9, 155, 775 ("the '775 Patent") and 9, 763, 993 ("the '993 Patent"):

1. The term "controlled room temperature" in the '775 patent is construed to mean "includes at least the range of greater than or equal to 17.8° C to less than or equal to 24.6° C."[2]
2. The term "filtering the aqueous pharmaceutical solution at a temperature of above 0° C to 17.5° C to produce a filtrate" in the '775 patent and the terms "(iii) filtering the first filtrate at a temperature of above 0° C. to 17.5° C. through a second filter to produce a second filtrate" and "(ii) filtering the aqueous pharmaceutical solution at a temperature of above 0° C. to 17.5° C. to produce a filtrate" in the '933 patent are construed to mean "filtering the aqueous pharmaceutical solution, wherein the temperature of the aqueous pharmaceutical solution is between 0° C and 17.5° C, inclusive of 17.5° C."[3]
3. The term "wherein the filterability of the aqueous pharmaceutical solution is improved as compared to the filterability of the solution at controlled room temperature" in the '775 patent is construed to mean "wherein the filterability of the aqueous pharmaceutical solution is improved as compared to the filterability of the solution if the solution were at controlled room temperature, as measured by, e.g., a lower increase in pressure on the filter."[4]

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Notes:

[1] All docket citations refer to Civil Action NO. 16- 1267-GMS. The abbreviation "Tr." refers to the transcript from the Markman Hearing on November 2, 2017, D.I. 157.

[2]The parties' dispute centers on whether the person having ordinary skill in the art ("POSA") would know to consult the United States Pharmacopeia ("USP"), which is extrinsic to the patent, to determine the appropriate temperature during filtration. Markman Hr'g Tr. 36:3-4. The court adopts Defendants' construction of the term because its construction comports with the description of the term in the asserted patent and the intrinsic evidence. Phillips v. AWH Corp., 415 F.3d 1303, 1317, 1320-21 (Fed. Cir. 2005) (explaining that extrinsic evidence is "less significant than the intrinsic record in determining the legally operative meaning of claim language.'") (citing C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).

Plaintiffs' proposed construction relies solely on evidence extrinsic to the patent, namely the USP. First, Plaintiffs argue that "controlled room temperature" should have its plain and ordinary meaning as found in the USP. (D.I. 118 at 4.) To support this position, Plaintiffs argue that the USP-NF guidelines state that "controlled room temperature" means "[t]he temperature maintained at the usual and customary working environment of 20° to 25° (68° to 77° F)." (D.I. 118 at Ex. A.) Plaintiffs, argue that the Federal Food, Drug, and Cosmetic Act'("FDCA") tells the skilled artisan that the USP is where to look for the definition of "controlled room temperature" and that Abbott Labs. v. Lupin Ltd., shows the USP decides the issue. (D.I. 118 at Ex. A); Markman Hr'g Tr. 37:21-25, 38:1-8, 11:20-25, 27:14-25; Abbott Labs. v. Lupin Ltd., 753 F.Supp.2d 382, 418 (D. Del. 2010). Second, Plaintiffs argue that "controlled room temperature" has a specific definition because when the patent recites a temperature other than a controlled room temperature, it provides a numerical range. Markman Hr'g Tr. 16:11-14. Plaintiffs argue that it is a misreading of the range from Table 2 to include 17.8° to 24.6° C because the proper reading is the plain and ordinary meaning, in accordance with the USP, at 20°to 25° C. Markman Hr'g Tr. 17:8-24. Defendants cite to various pharmacopeias, including Europe and Japan, to show that the definition of "controlled room temperature" is not uniform. (D.I. 125-1, Ex. 5 at 2); Markman Hr'g Tr. 30:20-23.

The court agrees with Defendants for three main reasons. First, the provision of the USP that Plaintiffs cite defines controlled room temperature in terms of storage and shipping conditions, not the temperature at which the solution is filtered. (D.I. 118, Ex. A at 317.) Indeed, the FDCA tells the POSA to refer to the USP-NF only where no storage requirements for a prescription drug are established. 21 C.F.R. § 205.50(c)(1). Second, the specification shows the controlled room temperature to include 17.8° to 24.6° C. '775 Patent at 11:35-65. The specification, therefore, explains that an improved filtration process was necessary to avoid the pressure buildup on the second filter. '775 Patent at 10:5-15; (D.I. 128 at ¶ 23, 11:45-58.) Also, Table 2 for Experiment Number 1 identifies 17.8° to 24.6° C as the temperature of the solution held in the receiving vessel for the controlled room temperature at 13 hours. '775 Patent at 11:35-65. The range in Table 2 is the only place in the specification that indicates the temperatures encompassed by the control room temperature. Markman Hr'g Tr. 23:22-25. The court remains unconvinced that a POSA would look to the USP storage conditions for the filtration temperature. Finally, as noted above, the definition of "controlled room temperature" seems to vary among pharmacopeias which begs the question, what is the plain meaning of the term? Phillips, 415 F.3d at 1318. "[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." PM///M, 415F.3dat 1319.

The intrinsic record fully supports Defendants' proposed construction. Markman Hr'g Tr. 26:16-17. The specification explicitly states that controlled room temperature includes the range 17.8° to 24.6° C and that filtration in that range is undesirable because of the pressure buildup in the second filter. Markman Hr'g Tr. 22:18-21.

[3] The parties' dispute centers on: (1) whether the reduced temperature filtration, 0° to 17.5° C is maintained for the entirety of the filtration process; and (2) whether there was a clear disclaimer of all processes without "improved filterability" in the '775 parent that carries over to the '993 continuation. Markman Hr'g Tr. 61:1-7, 17-24.

First, Defendants argue that Plaintiffs' proposed construction broadens the claim by allowing filtration at virtually any temperature. Markman Hr'g Tr. 64:16-19. In contrast, Defendants claim their construction accounts for the POSA's understanding that the temperature is maintained throughout filtration. Markman Hr'g Tr. 62:18-25. Plaintiffs argue that when the patentee chose to use the words "is maintained" they did so. Markman Hr'g Tr. 49:11-14. Specifically, these words appear in Claim 14, not Claim 1 of the '775 Patent and do not appear in Claims 1 or 19 of the '993 Patent. Markman Hr'g Tr. 49:18-22. The court will, therefore, not read the limitation into the '993 Patent.

Second, Defendants argue that the '993 child must include the "improved filterability" steps in the '775 Parent. Markman Hr'g Tr. 72:1-2, 6-12; (D.I. 156 at ¶ 6174-82.) Specifically, Defendants argue when the parent and child share related subject matter, the child applicant cannot recapture claim scope previously disclaimed without notifying the examiner they are rescinding the disclaimer. Markman Hr'g Tr. 73:1-9, 18-25. The close relation of subject matter, however, does not conclusively answer the question of whether the disclaimer travels between generations of patents. Ormco Corp. v. Align Tech., Inc.,498 F.3d 1307, 1314 (Fed. Cir. 2007). At least one court has determined that the disclaimer in the parent does not apply to the child when the parent's claim scope changed as a result of an amendment. Sanofl v. Glenmark Pharm. Inc., USA, 204 F.Supp.3d 665, 703 (D. Del. 2016). In that case, the disclaimer made during prosecution of the parent did not carry over to the child because the amendment occurred through explicit ...


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