Late last month, the Federal Circuit affirmed a District Court grant of a preliminary injunction based on claim construction involving the effect of two "wherein" clauses in Allergan Sales, LLC v. Sandoz, Inc.
The litigation involved Allegan's U.S. Patent Nos. 9,770,453, 9,907,801, and 9,907,802, which are directed to the ophthalmic drug Combigan®. As explained in the opinion, the claimed invention is "topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension . . . preferably formulated as 0.01 to 0.5 percent by weight brimonidine and 0.1 to 1.0 percent by weight timolol solution in water at a pH of 4.5 to 8.0, e.g. about 6.9," where the formulation described in the claims is Combigan® and generic versions of it. Claim 1 of the '453 patent is representative:
A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate, wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day and wherein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.
At issue were the two "wherein" clauses italicized in the claim. According to the Federal Circuit, these clauses found support in Example II of the common specification between these related patents.
The District Court construed each of the wherein clauses as being limiting, i.e., that they were "material to patentability and express the inventive aspect of the claimed invention." This aspect was the ability of Combigan® to reduce frequency of administration from three times (TID) to twice (BID) per day without a reduction in efficacy and with a decrease in adverse side effects. Sandoz argued that these clauses were merely a statement of intended results and were not so limiting, inter alia, because the only affirmative steps recited in the claim were to administer the drug formulation. Under the District Court's construction, the Court held that Allergan had shown a reasonable likelihood of success in showing infringement by Sandoz' generic product, and granted the injunction. This appeal followed.
The Federal Circuit affirmed in an opinion by Judge Wallach, joined by Chief Judge Prost and Judge Newman; the Chief Judge also wrote a concurring opinion. Regarding claim construction, the panel reviewed the plain meaning of the claim language, the specification, and the prosecution history; because the District Court did not consider extrinsic evidence their review was de novo. While the opinion notes "some overlap" between the language of the wherein clauses and the results set forth in the specification of administering the formulation, the panel opined that proper claim construction requires the claim language to be considered in view of the specification as a whole, citing Sinorgchem Co., Shandong v. Int'l Trade Comm'n, 511 F.3d 1132, 1145 (Fed. Cir. 2007), and Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016). The specification describes experimental comparative results of the formulation administered according to the asserted claims on the patents-in-suit and the prior art, demonstrating the disclosed formulation to be "superior." In the Court's view, "the specification demonstrates that Allergan believed the increased efficacy and safety of the claimed methods to be material to patentability." The panel found evidence of similar reliance on these superior properties in the prosecution history, the opinion citing specific passages where patentee argued that the claims were patentably distinct from the prior art based on the properties recited in the wherein clauses. Finally, the opinion states that the Examiner relied on the distinctions found in the wherein clauses to find the claims "novel and non-obvious over the prior art." Accordingly, the Federal Circuit affirmed the District Court's claim construction and the grant of summary judgment, explaining in a footnote that the parties agreed the correctness of that decision would "stand or fall" on the claim construction issue.
The Chief Judge wrote separately in concurrence because while agreeing with the panel decision her reasoning regarding the limiting nature of the "wherein" clauses took a different logical path. She characterized the posture of the case as being "unusual," due to the reliance by all on the claim construction issue. The Chief Judge found no fault with the panel's application of the claim construction rubrics established by case law that she says constitute "a well-established set of legal standards governing claim construction," and also stating that "the majority has already ably articulated those standards in detail." To this able articulation, the Chief Judge added "one narrow but crucial point" that bears consideration in her view. And that is that the plain meaning of the language of the claims, which is mentioned almost summarily in the main opinion, "on its face confirms that these clauses give meaning and purpose to the other manipulative steps of claim 1." The Chief Judge then makes her case that the claim, written in "open" claim language ("comprising") has no basis for limiting the combination of components, expressly recited or encompassed by "comprising," with any language other than the "wherein" clauses:
Without the "wherein" clauses, the only other limitation guiding the physician is that the drug is administered "twice" per day. . . . Sandoz provides no basis for us to conclude with any certainty that the safety and efficacy requirements of the "wherein" clauses would always result from two doses of (1) any formulation of the combination at (2) any interval in a 24-hour period.
The Chief Judge used these circumstances to conclude that in these claims the "wherein" clauses bear the burden of limiting the formulations and administration of those formulations to those that satisfy the limitations recited in the "wherein" clauses (which is an operable definition of what a claim limitation does). She also found that these clauses each recite with specificity and particularity what is required to satisfy them, in contrast with wherein clauses in other contexts that operate (as Sandoz unsuccessfully argued here) merely to recite an intended result. And as in the main opinion, the Chief Judge found these conclusions are supported by both the specification and the prosecution history.
The Chief Judge ends her concurring opinion with a discussion of the role of claim language in the claim construction exercise:
As it is, claim construction can be difficult. For instance, litigants often encounter uncertainty over whether a claim's preamble is limiting or not. I see no reason to inject further uncertainty into the notice provided by the body of a claim. Given the specificity, clarity, and material limits the "wherein" clauses add to the scope of claim 1 on their face, Sandoz's position deserves rigorous scrutiny from the start. We should not begin with the presumption that text in the body of the claim may be meaningless and can only be saved by clear statements in the specification or prosecution history.
For Chief Judge Prost, the name of the game is the language of the claim, and resort to the specification and prosecution history is only taken to ensure that the claim language has been properly interpreted.
Allergan Sales, LLC v. Sandoz, Inc. (Fed. Cir. 2019)
Panel: Chief Judge Prost and Circuit Judges Newman and Wallach
Opinion by Circuit Judge Wallach; concurring opinion by Chief Judge Prost
