December 4, 2020
The meaning and scope of the term “about,” which was used to modify numerical ranges in patent claims was a central issue in Par Pharmaceutical, Inv v. Hospira (Fed. Cir. November 23, 2020). The two patents at issue (U.S. Patent Nos. 9,119,876 and 9,295,657) pertain to Par’s Adrenalin® products and methods using epinephrine and the case arose from Hospira’s ANDA to make and market the generic of Par’s product, which as one might expect caused Par to file suit against Hospira for patent infringement under 35 USC 271(e).
Claim 1 of the ’876 patent (emphasis from opinion):
A composition comprising:
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of about 2.8 to 3.8 mg/mL of a pH raising agent,
in the range of about 0.1 to 1.1 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and
in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent,
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.
From the title of this post it should be apparent that one of the key issues was the scope and meaning of “about” defining the tonicity regulating agent.
During discovery, the parties submitted agreed-upon claim constructions, including one for the term “about,” which appears in all the numerical-range claim limitations at issue. J.A. 76. They agreed that “about” should be construed as having its “plain and ordinary meaning, i.e., approximately.
As one might expect there were expert opinions from both parties that disputed what the plain and ordinary meaning of “about” defines as it pertained to Hospira’s ANDA product. After summarizing the respective positions, Judge Taranto (with Judges Dyk and Stoll):
“When ‘about’ is used as part of a numeric range, ‘the use of the word “about” avoids a strict numerical boundary to the specified parameter.’” Cohesive, 543 F.3d at 1368 (citing Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995)). The authorized extension beyond the stated numbers in the range is cabined to what “a per-son having ordinary skill in the art . . . would reasonably consider ‘about . . .’ to encompass.” Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Fed. Cir. 2018). Where, as here, there is no narrowing claim construction proposed based on particular intrinsic-evi-dence statements or actions, the general considerations set forth in Cohesive govern. The extension effected by “about” must be tied to “the purpose of the limitation in the claimed invention—not the purpose of the invention itself.” Id. It also requires examination of whether the extension is by a “modest amount,” Conopco, Inc. v. May Dep’t Stores Co., 46 F.3d 1556, 1562 (Fed. Cir. 1994), considering the “critical-ity of the [numerical limitation] to the invention,” Cohesive, 543 F.3d at 1368 (quoting Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1327 (Fed. Cir. 2007)) (alteration in original), as well as the “technologic and stylistic context” of the invention, Pall, 66 F.3d at 1217. Thus, in Conopco, we concluded that the ordinary and customary meaning of “about” could not extend the up-per bound of “‘about 40:1 to 1:1’” “as far as the prior art would allow” and could not reach as far as “162.9:1,” given the criticality of the ratio and that such an interpretation would result in an impermissible “expansion” of the term “about,” as opposed to a mere “stretch” by “a modest amount.” 46 F.3d at 1560–62.
Although defining the outer reaches of “about” in a claimed range can be a matter of claim construction, “[w]hen the claims are applied to an accused device, it is a question of technologic fact whether the accused device meets a reasonable meaning of ‘about’ in the particular circumstances.” Modine Manufacturing Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996), abrogated on other grounds by Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000), rev’d, 535 U.S. 722 (2002).
Judge Taranto agreed with the district court’s findings that “about 6 to 8 mg/mL of a tonicity regulating agent” covers 9 mg/ml of sodium chloride in Hospira’s composition (“the evidence supported a finding that “about 8” encompasses 9, considering the purpose of the upper limit.”):
Dr. Elder explained the purpose of both ends of the claim range—to avoid hypertonicity of the solution (which would lead to cell shrinkage) and to avoid hypotonicity of the solution (which would lead to cell swelling) and thereby achieve isotonicity, which is the stated goal of Hospira’s inclusion of sodium chloride. J.A. 156–58. And he explained why it was clear that a “physiologically acceptable” concentration would include concentrations as high as 9 mg/mL, there being nothing critical to the exact numbers in the claimed range given the purposes of the upper and lower limits.
Other points of the affirmance looked at the issues of (A) what is the relevant comparison pertaining to the metal complexing agent: “Hospira’s argument is that the analysis should have focused entirely on the characteristics of the composition that Hospira was likely to sell, not on what compositions the ANDA, if approved, would allow Hospira to market.” And (B) what is and what is not the pH lowering agent: “Hospira argues that the trial court improperly accepted Par’s counting not just hy-drochloric acid but also citric acid as a pH lowering agent. Hospira contends that citric acid—specifically, the citric acid that remains after subtracting the amount that serves as a transition metal complexing agent—cannot be a pH lowering agent because it is already included in the buffer system that counts toward meeting the claim limitation re-quiring a certain amount of pH raising agent.”