Judge Farnan: Claim Construction

In UCB, Inc. et al. v. KV Pharmaceutical Company, C.A. 08-223-JJF (D. Del. Aug. 18, 2009) Judge Farnan provided claim constructions for disputed terms of a patent pertaining to “multiparticulate pharmaceutical dosage forms that include both immediate release (“IR”) beads and extended release (“ER”) beads.” The parties disputed the meaning of the claim terms “approximately” and “about,” and Defendant contended that a specific claim term was indefinite. Id. at 5. The Court construed the disputed terms as follows:

“The Total Amount of Methylphenidate Hydrochloride Present Is About 10 to 40 mg”
Plaintiffs argued that, according to its plain and ordinary meaning, the word “about” should be defined as “approximately.” Id. at 6-7. Defendant, pointing to the use of the word in the specification, argued that the definition should be more precise so that the term would require “precision within ‘rounding’ or ‘measurement error.’” Id. Ultimately, the Court chose to adopt the Plaintiffs construction. Noting Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1327-28 (Fed. Cir. 2007), the Court held that a narrow construction was inappropriate here because the evidence relied upon by Defendant did not support the proposed construction. Id. at 9-13. Defendant argued that because the word “approximately” is also a claim term, construing “about” to mean “approximately” would give “two different claim terms . . . the same meaning.” Id. at 13. The Court responded that “notwithstanding this consideration, without a more concrete basis for either Defendant’s construction or some alternative construction of “about,” the most appropriate construction of “about” is simply “its ordinary and accepted meaning of ‘approximately.’” Id. (quoting Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005).

“The Immediate Release Beads Are Present in an Amount of About 20 to 40 Percent and the Extended Release Beads Are Present in an Amount of About 60 to 80 Percent”
The Court applied the same legal principles here to construe “about,” and reached the same conclusion giving “the term ‘about’ its ordinary and customary meaning of ‘approximately’” Id. at 16.

Plaintiffs contended that this term required no construction, whereas Defendant asked the Court to construe this term to mean “almost exactly,” which was its plain and ordinary meaning according to the American Heritage College Dictionary. Id. at 17. The Court agreed with Plaintiff’s position, because although “Defendant’s extrinsic dictionary definition clearly supports such a construction, without some meaningful corresponding basis for it in the intrinsic record, the Court will not paraphrase the ordinary word ‘approximately’ as ‘almost exactly.’” Id.

“Water”The Defendant contended that the term should be construed to mean “purified water (per the USP)” whereas Plaintiffs thought no construction was necessary. Id. at 18. The Court agreed with Defendant. Id. “[B]ecause the claim specifically itself calls for the testing to be done in a USP apparatus, it is appropriate to construe the claim term ‘water’ in terms of the definition set forth in the USP.” Id. at 19. This construction is not “an improper importation of a limitation from the extrinsic record, . . . because the claim itself calls for testing to be done in a USP apparatus . . . .” Id.

“An Amount Up to 20 Percent” and “An Amount Up to About 4 Percent”
The Defendant argued that these terms were indefinite, whereas Plaintiffs contended that “the specification confirm[ed] that the percentages [were] weight percentages on the total weight of the coated particle.” Id. at 20-21. “A claim will be found indefinite only if it ‘is insolubly ambiguous, and no narrowing construction can properly be adopted . . . .’” Id. at 21 (quoting Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008). Looking at the limitation of the claim, the Court decided to construe the claim as Plaintiffs’ contended because it was the “only reasonable interpretation . . . .” Id. at 22-23.

The Court also addressed Defendant’s arguments regarding the validity of a certain claim. Defendant argued that “Claim 1 of the ‘215 patent [was] inoperative as calling for the impossible.” Id. at 25. The Court ultimately decided to reserve its decision on that issue due to the early stage of the litigation. Id.

UCB, Inc. et al. v. KV Pharmaceutical Company, C.A. 08-223-JJF (D. Del. Aug. 18, 2009)

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