Ucb, Inc. v. Watson Laboratories Inc., 927 F.3d 1272

Background

UCB owns two patents: the ’434 patent covering a water‑free transdermal patch with rotigotine free base dissolved in an acrylate‑ or silicone‑based polymer adhesive (≥5% w/w), and the ’414 patent claiming a Form II polymorph of rotigotine.
UCB marketed Neupro (silicone adhesive with PVP) beginning 2007; in mid‑2007 some batches (notably lot 47808) developed crystalline precipitates later identified as Form II polymorph.
Actavis filed an ANDA to market generic rotigotine patches using a polyisobutylene (PIB) adhesive; UCB sued for infringement of the ’434 and ’414 patents under 35 U.S.C. § 271(e)(2).
At bench trial the district court found Actavis’s products infringed the asserted claims of the ’434 patent under the doctrine of equivalents (DOE) and upheld those claims against Actavis’s anticipation and obviousness challenges.
The district court found the asserted claims of the ’414 patent invalid under pre‑AIA 35 U.S.C. § 102(a) as Form II rotigotine had been used in the United States before UCB’s priority date (patient exposure to lot 47808).
The Federal Circuit affirmed: DOE infringement and validity of the asserted ’434 claims were upheld; the asserted ’414 claims were held invalid for prior public use.

Issues

Issue	UCB (Plaintiff) Argument	Actavis (Defendant) Argument	Held
Whether Actavis’s PIB adhesive infringes the ’434 patent under the doctrine of equivalents	PIB adhesive is an insubstantial substitute for claimed acrylate/silicone adhesives; PVP use parallels claimed systems; DOE available	Claim language limits adhesives to acrylate or silicone; prosecution history/reasonable foreseeability or vitiation/ensnarement should bar DOE	Held: DOE applies; PIB is an insubstantial difference and interchangeable for claimed function; infringement affirmed
Whether prosecution history estoppel or narrowing claim drafting bars DOE	Election during PTO restriction did not surrender PIB equivalents; no narrowing amendment excluding PIB	Electing Group I after restriction surrendered broader adhesive scope, precluding DOE	Held: No estoppel—restriction/election did not amount to a narrowing amendment surrendering PIB
Validity of asserted ’434 claims: anticipation/obviousness (Cygnus, Lipp/Pfister, Timmerman/Miranda)	Claims are nonobvious and not anticipated; Cygnus uses water/salt form and does not disclose water‑free free‑base patches; Miranda/Timmerman not reasonably combinable with expectation of success	Cygnus anticipates or renders claims obvious; Miranda + Timmerman supply patch recipe and rotigotine teaching	Held: Cygnus does not disclose rotigotine free base in absence of water; combinations (with Lipp/Pfister or Timmerman/Miranda) do not render claims obvious—validity upheld
Validity of asserted ’414 claims: prior public use under § 102(a) (Form II polymorph)	Patches used by patient may not have contained Form II before priority date; Form II lacks therapeutic use so not a § 102 use	Lot 47808 patches delivered in US contained Form II; a US patient used those patches before priority date—public use invalidates patent	Held: Substantial evidence that lot 47808 patches contained Form II and were used by a US patient before priority date; § 102(a) public use invalidates the ’414 claims

Key Cases Cited

Warner‑Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (Sup. Ct. 1997) (doctrine of equivalents frameworks)
Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605 (Sup. Ct. 1950) (DOE principles)
Ring & Pinion Serv. Inc. v. ARB Corp., 743 F.3d 831 (Fed. Cir. 2014) (foreseeability not per se bar to DOE)
Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012) (limiting DOE when specification and prosecution indicate deliberate narrowing)
Merck & Co. v. Mylan Pharm., Inc., 190 F.3d 1335 (Fed. Cir. 1999) (prosecution history estoppel may arise from amendments/reasons tied to patentability)
Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 904 F.3d 965 (Fed. Cir. 2018) (prosecution history estoppel overview)
Intendis GmbH v. Glenmark Pharm. Inc., USA, 822 F.3d 1355 (Fed. Cir. 2016) (ensnarement doctrine and hypothetical claim test)
DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009) (ensnarement and hypothetical claim construction)
Carnegie Mellon Univ. v. Hoffmann‑La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008) (vitiation doctrine applied to biological source limitation)
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (standard of review for bench trial findings)
Minnesota Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294 (Fed. Cir. 2002) (public use must be accessible to the public under § 102)