Sanofi-Aventis U.S. LLC v. Fresenius Kabi United States, LLC
| Decision Date | 22 September 2016 |
| Docket Number | Civil Action No. 14-7869 (MAS) (LHG),Civil Action No. 15-2520 (MAS) (LHG),Civil Action No. 15-2631 (MAS) (LHG),Civil Action No. 14-8079 (MAS) (LHG),Civil Action No. 14-8082 (MAS) (LHG) |
| Parties | SANOFI-AVENTIS U.S. LLC et al., Plaintiffs, v. FRESENIUS KABI USA, LLC, et al., Defendants. |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
This is a consolidated action involving three patents covering Plaintiffs Sanofi-Aventis U.S. LLC ("Sanofi U.S."), Aventis Pharma S.A. ("Aventis"), and Sanofi's (collectively, "Plaintiffs") Cabazitaxel Injection, which is prescribed and sold in the United States under the trademark JEVTANA® KIT ("Jevtana"), and a method for treating prostate cancer. Defendants have filed Abbreviated New Drug Applications ("ANDAs") with the United States Food and Drug Administration ("FDA"), seeking to market generic versions of Jevtana and challenging the validity of Plaintiffs' patents. This matter comes before the Court for the construction of claims in two of Plaintiffs' patents: U.S. Patent No. 7,241,907 (filed Dec. 18, 2014) (the "'907 Patent") and U.S. Patent No. 8,927,592 (filed Mar. 3, 2015) (the "'592 Patent"). (ECF Nos. 58, 59.) The Court has considered the parties' submissions, heard oral argument on February 23, 2016, and thereby conducted its Markman hearing. See Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). Based on the parties' arguments and the intrinsic evidence, discussed below, the Court adopts Defendants' construction of the disputed terms in the '592 Patent and the '907 Patent.
In 2004, the FDA approved the use of the drug combination docetaxel and prednisone for hormone refractory metastatic prostate cancer. (Pls.' Opening Br. 2, ECF No. 59.) Thereafter, however, some patients' cancer became resistant to docetaxel, which led to cancer progression during or after docetaxel treatment. (Id.) The '592 Patent discloses and claims methods of treating patients with prostate cancer, which has progressed after docetaxel treatment, by administering cabazitaxel, and the '907 Patent discloses and claims acetone solvate solid state forms of cabazitaxel. (Decl. of Roger J. Kiley ("Kiley Decl."), Ex. 2 ("'907 Patent"), ECF No. 57-7; Kiley Decl., Ex. 3 ("'592 Patent), ECF No. 57-8.) The parties dispute the meanings of the terms of the '907 Patent and '592 Patent for Jevtana. (Joint Claim Construction and Prehearing Statement, Exs. A, C ("Proposed Constructions"), ECF No. 51-1.) The parties dispute the meaning of the term "acetone solvate" in the '907 Patent and the meanings of the following terms in the '592 Patent: "a method for treating a patient"; "administering . . . to the patient"; "wherein the cabazitaxel is in the form of an acetone solvate"; and "wherein the cabazitaxel is in the base form." (Proposed Constructions A-1 to A-5, A-10 to A-16, C-1 to C-5.)
Claim construction is a threshold issue that must be addressed before analyzing claims of infringement and/or invalidity. Claim construction is a question of law to be decided by a judge, not a jury. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 391 (1996). "[W]ords of a claim 'are generally given their ordinary and customary meaning.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (3d Cir. 2005) (quoting Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). "[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question [the "POSA"] at thetime of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3d at 1313. "Claim construction begins with the intrinsic evidence of the patent—the claims, the specification, and the prosecution history—and may require consultation of extrinsic evidence to understand the state of the art during the relevant time period." Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., No. 14-7992, 2016 WL 4408990, at *2 (D.N.J. Aug. 17, 2016) (citing Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831. 841 (2015)). "Extrinsic evidence—testimony, dictionaries, learned treatises, or other material not part of the public record associates with the patent—may be helpful but is 'less significant than the intrinsic record in determining the legally operative meaning of claim language.'" MBO Labs., Inc. v. Beckton, Dickinson & Co., 474 F.3d 1323, 1329 (Fed. Cir. 2007) (quoting Vitrionics Corp., 90 F.3d at 1317). "[I]f the meaning of the claim limitation is apparent from the intrinsic evidence alone, it is improper to rely on extrinsic evidence other than that used to ascertain the ordinary meaning of the claim limitation." Bell Atl. Network Servs., Inc. v. Covad Commc'ns Grp. Inc., 262 F.3d 1258, 1268-69 (Fed. Cir. 2001).
The '907 Patent provides a method of making an acetone solvate of cabazitaxel. Claim 1 of the '907 Patent provides that it is "[a]n acetone solvate of [cabazitaxel]." ('907 Patent col. 3 l. 61-64 (emphasis added).) Claim 2 of the '907 Patent provides that it is "an acetone solvate of [cabazitaxel] comprising from about 5 to about 7 percent by weight of acetone." (Id. at col. 4 l. 1-5 (emphasis added).) The '592 Patent is directed to a method for treating a patient with prostate cancer by administering cabazitaxel. Claim 3 of the '592 Patent provides "[t]he method according to claim 1, where the cabazitaxel is in the form of an acetone solvate," and claim 4 of the '592Patent provides "[t]he method according to claim 3, in which the acetone solvate contains between 5% and 8% by weight acetone." ('592 Patent col. 18 l. 61-64.) The parties agree that the term "acetone solvate" should be construed to have the same meaning in both the '907 Patent and '592 Patent. The parties, however, dispute the construction of this term. In the joint claim construction brief, the parties propose the following constructions:
Plaintiffs' Proposed Construction Defendants' Proposed Construction A crystalline solid containing between about 0.02% and 7.2% by weight acetone and exhibiting a powder x-ray diffraction pattern consistent with that of Figure 1 of the '907
[P]atent.
| A solid crystalline material that incorporates |
| between 5% and 8% by weight of acetone |
| molecules within the crystal lattice. |
(Proposed Constructions A-1.) Importantly, the parties dispute the amount of acetone required to be present in the acetone solvate and whether the phrase "and exhibiting a powder x-ray diffraction pattern consistent with that of Figure 1 of the '907 [P]atent" should be read into the construction of "acetone solvate." (Id.) The crux of the parties' dispute is whether a POSA reading the specifications and claims in the '907 Patent and '592 Patent would understand "acetone solvate" to mean a channel solvate, such that the amount of acetone could vary from as little as 0.02% to as high as 7.2%, or whether a POSA would understand the term to mean a non-channel solvate, such that the amount of acetone could only vary from 5% to 8% by weight, which represents approximately the acetone stoichiometry.
In support of their position that "acetone solvate" should be construed in the '907 and '592 patents to mean a channel solvate, Plaintiffs rely on, among other things, a "Drying Study"described in the '907 patent. (Pls.' Opening Br. 3.) This "Drying Study" provides that when the "product" was placed at 100°C for twenty-one hours the "residual acetone content" was 0.02%. Citing this "Drying Study," Plaintiffs assert that "the '907 Patent expressly describes an acetone solvate containing as low as 0.02% acetone and teaches a POSA how to make such a solvate." (Id. at 4.) Defendants, however, argue that the "Drying Study" "is nothing more than a demonstration that excessive heating over 70°C destroys the claimed acetone solvate." (Defs.' Opening Br. 8 (emphasis in original).)
As an initial matter, the "Drying Study," which is included in the specifications in the '907 Patent, is an important part of the intrinsic evidence and must be considered in construing the claim. McNeil-PPC, Inc. v. Perrigo Co., 443 F. Supp. 2d 492, 502 (S.D.N.Y. 2006) (); see also Phillips, 415 F.3d at 1315 (). The Drying Study begins by referencing Example 1 of the acetone solvate, which contains 7.2% of acetone, and states that:
[t]he product is again placed in an oven and successively dried for 18 hours at 60°C under a reduced pressure of 0.7 kPa, for 3 hours at 60°C under a relative humidity of approximately 80% (reduced pressure of 160 mmHg). At this stage, the content of water is 0.2% and the content of acetone is 4.7% (194g). At this same stage, 1 aliquot of 1g of the bath is dried under a reduced pressure of 5 mmHg successively for 18 hours at 80°C (residual acetone content of 0.5%) and then for 21 hours at 100°C (residual acetone content of 0.02%). The remainder is dried at about 90°C under a reduced pressure of 5 mm Hg for 31 hours (acetone 1.7% water 0.3%, assay with regard to such of 96.5%, purity greater than 99%).
('907 Patent col. 3 l. 4-19 (emphasis added).) The '907 Patent does not, however, indicate whether the products of the Drying Study are intended to be embodiments of acetone solvate. The reference to the Drying Study in the Description of the Invention suggests the contrary....
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