Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370

Allergan sued Sandoz under three patents covering a twice-daily ophthalmic combination of brimonidine (0.2% w/v) and timolol (0.68% w/v) (Combigan®), alleging Sandoz's ANDA product would infringe method claims that include "wherein" clauses reciting specific efficacy and safety outcomes versus prior art brimonidine TID.
The patents' specification includes an Example I formulation (Combigan®) and Example II clinical data showing the formulation was as effective when dosed BID as brimonidine TID and reduced certain adverse events.
The District Court construed the claim "wherein" clauses as claim limitations because they were material to patentability and expressed the invention's inventive aspect, and granted a preliminary injunction to Allergan.
Sandoz appealed, arguing the "wherein" clauses are non-limiting statements of intended or inherent results and thus should not limit claim scope; if construed non-limiting, Sandoz contends the claims are obvious.
The Federal Circuit reviewed claim construction de novo (intrinsic record dispositive) and affirmed, holding the "wherein" clauses limiting because the specification and prosecution history treated those results as material to patentability.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether the claim "wherein" clauses are claim limitations	Allergan: clauses are limiting—specification and prosecution relied on the efficacy/safety results to define novelty and nonobviousness	Sandoz: clauses are mere statements of intended/inherent results of administering the recited dosages and thus non-limiting	Clauses are limiting; intrinsic evidence (specification + prosecution) shows they were material to patentability
Whether prosecution history supports limiting construction	Allergan: during prosecution relied on the claimed efficacy/safety to distinguish prior art; Examiner allowed claims on that basis	Sandoz: prosecution statements do not necessarily create claim limitations (cites cases where unsolicited assertions or irrelevant remarks were non-limiting)	Prosecution history explicitly relied on the "wherein" clauses and the Examiner credited those distinctions; therefore they act as claim limits
Relevance of prior case law cited by Sandoz (e.g., Bristol-Myers, Copaxone, Minton)	Allergan: those cases are distinguishable because here the clauses were material and relied on	Sandoz: those precedents show similar clauses were non-limiting	Court distinguished those cases on the facts and reliance during prosecution; precedent favoring non-limiting treatment did not apply

Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293 (Fed. Cir. 2006) (claim construction begins with claim language and PHOSITA meaning)
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (specification and prosecution history guide claim meaning)
Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005) (a whereby/wherein clause that is material to patentability cannot be ignored)
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001) (where a clause merely states intended result duplicative of dosage limits, it is non-limiting)
Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003) (a clause expressing intended result is not given weight when it adds nothing to mechanical steps)
In re Copaxone Consol. Cases, 906 F.3d 1013 (Fed. Cir. 2018) (disputed claim language not limiting where it was unnecessary to examiner's allowance)
Griffin v. Bertina, 285 F.3d 1029 (Fed. Cir. 2002) (whereby clauses can give meaning to manipulative steps and be limiting)
ACCO Brands, Inc. v. Micro Sec. Devices, Inc., 346 F.3d 1075 (Fed. Cir. 2003) (construing claims consistent with examiner's reasons for allowance)
Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (U.S. 2015) (when extrinsic evidence is unnecessary, claim construction reviewed de novo)