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Roxane Labs., Inc. v. Camber Pharms. Inc.

Case Name: Roxane Labs., Inc. v. Camber Pharms. Inc., No. 2016-1028, 2016 U.S. App. LEXIS 20590 (Fed. Cir. Nov. 17, 2016) (Circuit Judges Lourie, Mayer, and O’Malley presiding; Opinion by Lourie, J.) (Appeal from D.N.J., Chesler, J.)

Drug Product and Patent(s)-in-Suit: Calcium acetate capsules; U.S. Patent No. 8,563,032 (“the ’032 patent”)

Nature of the Case and Issue(s) Presented: Roxane owns the ’032 patent, directed to a capsule formulation of calcium acetate granules, with each capsule containing a dose of 667 mg calcium acetate on an anhydrous basis. Pharmaceutical capsules for human use are available in a variety of sizes, including size 5 (the smallest), 4, 3, 2, 1, 0, 00, and 000 (the largest). The claims of the ’032 patent require that the calcium acetate granules be contained within “a pharmaceutically acceptable capsule…that is size 00 or less.” Camber manufactures and sells calcium acetate in elongated size 00 capsules. A size 00 elongated capsule has the same diameter as a standard size 00 capsule, but has a greater length and a larger fill volume.

Roxane sued Camper in district court alleging infringement. On Camper’s motion, the district court transferred the action to the District of New Jersey, having found that the convenience of the parties and witnesses as a whole and the balance of public and private interests favored the transfer of venue to New Jersey. The DNJ issued an order construing the claim limitation “size 00 or less” as “unambiguous,” that “nothing in the patent…suggests that the applicants understood ‘size 00’ to mean a family of capsule sizes” that included both standard and elongated size 00 capsules, and that the intrinsic record consistently indicated that “size 00” refers to a single capsule size with a specific weight and fill capacity. In other words, “size 00 or less” excludes capsules of size 00 elongated. As a result, Roxane stipulated to a judgment of non-infringement. Roxane now appeals the DNJ’s claim construction and the S.D. Ohio’ order transferring the case. The Federal Circuit affirmed.

Why Camber Prevailed: The Federal Circuit first addressed the transfer motion issue. Roxane argued that the district court abused its discretion in transferring the action, and that the court made two legal errors: (i) that the court afforded no weight to Roxane’s choice of forum; and (ii) that the court considered the convenience of employee witnesses as the most important factor. According to Roxane, a plaintiff’s choice of forum controls unless the factors of convenience strongly favor transfer. Camber responded that it was within the broad discretion of the district court to transfer the action. The Federal Circuit found that while the district court recognized that Roxane’s choice to litigate in Ohio is “[t]he most significant factor weighing against transfer,” it also found that other factors, including the location of the complained-of activity, greatly weighed in favor of transfer. Camber’s operations and employees are located in New Jersey or nearby New York; all documentary evidence relating to the marketing and sales of the accused products was located in either New Jersey or New York; and the accused products were designed and developed in New Jersey. On that record, the Federal Circuit found no abuse of discretion.

Next, the Federal Circuit turned to the issue of claim construction. In construing the claim term-at-issue here, the district court relied only on the intrinsic record. Therefore, the Federal Circuit’s standard of review is de novo. Roxane argued that the district court erred in construing the claims as excluding size 00 elongated capsules. According to Roxane, “size 00” refers to either non-elongated or elongated size 00. Put another way, Roxane argued that capsule “size” only designates capsule diameter, not length or volume. Roxane additionally asserted that the district court ignored the “pharmaceutically acceptable” claim language, which imposes a requirement for ease-of-swallowability that is primarily determined by capsule diameter. Camber responded that the district court correctly construed “size 00” as designating a capsule of one specific size, not a family of capsules. Camber further argued that all descriptions of “size 00” in the written description and prosecution history of the ’032 patent are limited to one specific capsule size, and that nothing in the intrinsic record suggests that the applicants intended a broader meaning of “size 00” to encompass size 00 elongated. Camber relied on a declaration filed by coinventor Dr. Uraizee as well as the two capsule size charts in the prosecution history to resolve any remaining doubt on the meaning of “size 00.”

The written description of the ’032 patent refers to “size 00” twice. First, it states that “[a]ccording to one embodiment of the invention, the capsule is a size 00 capsule containing 667 mg of calcium acetate.” It then describes in Example 1 that “[t]he final blend was then filled into size 00 capsules using an IMA capsule filling machine wherein the resulting filled capsules had a weight of 880 mg and contained 760 mg of the final blend, including a 667 mg dose of calcium acetate.” The disclosed example thus refers to size 00 capsules as having the same weight (880 mg) when filled with the same amount of the final blend (760 mg). As the district court noted, however, an empty size 00 capsule and an empty size 00 elongated capsule share the same diameter, but have different lengths and presumably different weights. Thus, a size 00 capsule would have a different weight than a size 00 elongated capsule when both are filled with the same amount of the final blend. Accordingly, the size-family definition now advocated by Roxane did not reconcile with the usage of “size 00” in the written description.

More importantly, the prosecution history indicated that “size 00” refers to standard, non-elongated size 00 capsules. When the Examiner rejected the claims as being obvious over prior art, which taught filling a size 0 capsule with 667 mg of compressed anhydrous calcium acetate, he cited another reference, a capsule size chart, to support the rejection. That capsule size chart did not list any elongated capsule sizes; it only listed standard, non-elongated capsules, including size 0 and size 00 with specific fill volumes of 0.68 mL and 0.95 mL, respectively. Thus, the Examiner considered “size 00” to be standard size 00, not elongated size 00.

The Federal Circuit also found that the Uraizee declaration treated “size 00” as capsules of one size having a particular fill capacity, rather than a family of capsules having a range of fill capacities. Roxane conceded to the district court that Dr. Uraizee only tested one capsule size—standard size 00, not size 00 elongated. Furthermore, in its Reply Brief filed at the PTAB during prosecution, Roxane emphasized that claim 1 did not cover capsules that are larger and have more fill capacity than “size 00.” Accordingly, Federal Circuit found that the Uraizee declaration and Roxane’s prosecution arguments clearly indicated that size 00 elongated capsules, which have a greater fill volume than the standard size 00 capsules tested by Dr. Uraizee, were outside the scope of the claims. Because the intrinsic record unambiguously and fully resolves the proper construction of “size 00 or less,” the Federal Circuit did not address the extrinsic evidence.

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