United States Court of Appeals 

for the Federal Circuit ______________________

UCB, INC., UCB MANUFACTURING IRELAND 

LIMITED, UCB PHARMA GMBH, LTS LOHMANN 

THERAPIE-SYSTEME AG,

Plaintiffs-Cross-Appellants

v.

WATSON LABORATORIES INC., ACTAVIS 

LABORATORIES UT, INC.,

Defendants-Appellants

______________________

2018-1397, 2018-1453

______________________

Appeals from the United States District Court for the 

District of Delaware in No. 1:14-cv-01083-LPS-SRF, Chief 

Judge Leonard P. Stark.

______________________

Decided: June 24, 2019 

______________________

JACK B. BLUMENFELD, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE, argued for plaintiffs-cross-appellants. Also represented by DEREK J. FAHNESTOCK,

MARYELLEN NOREIKA; JAMES TRAINOR, ROBERT COUNIHAN,

ADAM GAHTAN, KEVIN MCGANN, SILVIA MEDINA, Fenwick & 

West LLP, New York, NY. 

 JOHN C. O'QUINN, Kirkland & Ellis LLP, Washington, 

DC, argued for defendants-appellants. Also represented by 
2 UCB, INC. v. WATSON LABORATORIES INC.

WILLIAM H. BURGESS, CALVIN ALEXANDER SHANK; LEORA 

BEN-AMI, THOMAS F. FLEMING, CHRISTOPHER T. JAGOE, 

New York, NY. 

 ______________________

Before TARANTO, SCHALL, and CHEN, Circuit Judges.

CHEN, Circuit Judge.

This appeal concerns UCB, Inc., UCB Manufacturing 

Ireland Limited, UCB Pharma GmbH, and LTS Lohman 

Therapie-Systeme AG (UCB)’s U.S. Patent Nos. 6,884,4341

and 8,232,414.2 The ’434 patent claims a transdermal therapeutic system comprising rotigotine, a drug used for the 

treatment of Parkinson’s disease. The ’414 patent claims a 

polymorph of rotigotine. The United States District Court 

for the District of Delaware found that Watson Laboratories Inc. and Actavis Laboratories UT, Inc. (Actavis)’s generic products infringed the ’434 patent under the doctrine 

of equivalents. The district court also upheld the validity 

of the ’434 patent over Actavis’s obviousness and anticipation challenges. Actavis appeals the district court’s infringement and validity judgments. UCB cross-appeals the 

district court’s invalidation of the ’414 patent under 35 

U.S.C. § 102(a) as known and used by others in the United 

States before the date of invention. For the reasons articulated below, we affirm.

 

1 UCB Manufacturing Ireland Limited and LTS 

Lohman Therapie-Systeme AG are assignees of the ’434 patent. UCB, Inc. is a party to this case because it holds the 

approved New Drug Application for brand name drug 

Neupro, under which the ’434 patent is listed in the FDA 

publication, “Approved Drug Products with Therapeutic 

Equivalence Evaluations” (the Orange Book). 2 UCB Pharma GmbH is an assignee of the ’414 patent. 
UCB, INC. v. WATSON LABORATORIES INC. 3

TECHNICAL BACKGROUND

The technology at issue relates to a transdermal (via 

the skin) form of delivering a drug that treats Parkinson’s 

disease. Parkinson’s is a degenerative neurological condition linked to reduced dopamine levels in the brain, caused 

by degeneration and death of “dopaminergic” neurons. The 

’434 and ’414 patents relate to the compound rotigotine, a 

dopamine receptor stimulator, that has been used to treat 

Parkinson’s since the 1990s. Rotigotine comes in two 

forms: free base form and hydrochloride salt form.

Cygnus Therapeutic Systems conducted early attempts 

at transdermal rotigotine formulation circa 1994. J.A. 

118–19. Its system is described in patent application WO

94/07468 (Cygnus) and a 1995 article entitled “A TwoPhase Matrix for the Delivery of N-0923, a Dopamine Agonist” by Chiang et al. (Chiang). Rotigotine in the Cygnus 

system is present in the hydrochloride salt form, which is 

dissolved in water to create an aqueous phase in the patch’s 

matrix. Preliminary clinical trials using patches manufactured by Cygnus demonstrated proof of concept that a sufficient amount of rotigotine can be transdermally delivered 

for treatment of Parkinson’s. No commercial product resulted from Cygnus’s work. 

UCB developed a rotigotine transdermal patch without 

using water and filed the ’434 patent to cover such a patch. 

The patent is entitled “Transdermal therapeutic system 

which contains a d2 agonist and which is provided for treating Parkinsonism, and a method for the production 

thereof.” The only asserted independent claim reads: 

1. A transdermal therapeutic system comprising a 

self-adhesive matrix layer containing the free base 
4 UCB, INC. v. WATSON LABORATORIES INC.

[rotigotine3] in an amount effective for the treatment of the symptoms of Parkinson’s syndrome, 

wherein the matrix is based on [] an acrylate-based 

or silicone-based polymer adhesive system having 

a solubility of ≧5% (w/w) for the free base [rotigotine], all of said free base being present in the matrix in the absence of water; a backing layer inert to 

the components of the matrix layer; and a protective foil or sheet covering the matrix layer to be removed prior to use.

’434 patent, col. 7 ll. 55–67 (emphasis added). The claim 

covers administration of rotigotine through a transdermal 

patch made of three layers, the most relevant for this appeal being an adhesive layer in which an effective amount 

of the free base form of rotigotine is dissolved in an acrylate- or silicone-based polymer adhesive so that there is no 

water and at least 5% rotigotine by weight in the layer. Dependent claims cover use of polyvinylpyrrolidone (PVP), a 

solubility enhancer, as part of the adhesive system to 

achieve the claimed solubility. 

The FDA approved UCB’s rotigotine transdermal 

patches in May 2007, and UCB has been selling the product 

under the brand name Neupro since July 2007. Neupro’s

polymer adhesive system is silicone-based and contains 

PVP. 

Relevant to the other UCB patent in this appeal—the 

’414 patent—in June and July 2007, batches of rotigotine 

patches were manufactured for distribution in the United 

 

3 The claim covers the “S” enantiomer of rotigotine, 

with the chemical name “(–)-5,6,7,8-tetrahydro-6-[propyl-

[2-(2-thienyl)ethyl]amino]-1-naphthalenol.” ’434 patent, 

col 7 ll. 62–63. Enantiomers are two non-superimposable, 

mirror-image, three-dimensional structural configurations 

of the same molecule. 
UCB, INC. v. WATSON LABORATORIES INC. 5

States. Of particular relevance to the alleged public use of 

the ’414 patented product before its date of invention, laminate lot 47808 was produced during this period. 

Until August 2007, UCB manufactured Neupro 

patches by dissolving rotigotine in ethanol, among other 

steps, to create a rotigotine solution. It then prepared a 

coating mass from this solution and other components (including a silicone-based polymer), which, after drying, produced a matrix. The matrix did not contain crystalline 

rotigotine, and the rotigotine in the resulting patches, predistribution, was non-crystalline.

On August 7, 2007, an unknown solid precipitated during the dissolution step, causing UCB to halt manufacture 

of Neupro patches. Over the next few months, UCB investigated and determined that the solid was a polymorph of 

rotigotine, characterized by unique single-crystal X-ray diffraction parameters. Polymorphs are different three-dimensional, solid-state, crystalline structures of the same 

chemical compound. 

UCB filed a patent application to cover the newly discovered Form II polymorph of rotigotine. This resulted in 

the ’414 patent, entitled “Polymorphic form of rotigotine 

and process for production,” with a priority date of November 28, 2007. The claims read:

1. A polymorphic form of rotigotine characterized 

by at least one parameter selected from the group 

consisting of:

(a) a powder X-ray diffraction spectrum 

comprising at least one peak at the following °2θ angles (± 0.2): 12.04, 13.68, 17.72, 

and 19.01;

(b) a Raman spectrum comprising at least 

one peak at the following (±3 cm-1): 226.2, 

297.0, 363.9, 737.3, 847.3, 1018.7, and 

1354.3 cm-1
6 UCB, INC. v. WATSON LABORATORIES INC.

(c) a DSC peak with a Tonset at 97°C. ± 2°C. 

measured with a heating rate of 10°/min; 

and 

(d) a melting point of 97°C. ± 2°C.

2. The polymorphic form of rotigotine of claim 1, 

wherein the polymorphic form of rotigotine is characterized by at least the following powder X-ray diffraction peaks at °2θ angles (± 0.2): 12.04, 13.68, 

17.72 and/or 19.01. 

3. A polymorphic form of rotigotine having a powder X-ray diffraction spectrum substantially as 

shown in FIG. 1.

’414 patent, col. 8 ll. 48–64.

On November 12, 2007, UCB submitted a Field Alert 

Report to the FDA, alerting the FDA that “small crystalline 

structure (snowflakes)” had been observed on the active 

surface of Neupro patches that had already been manufactured and distributed. J.A. 4833–34. UCB informed the 

FDA that “testing confirmed on November 7, 2007 that the 

snowflakes contain crystalline structures of a polymorph 

variant (Form 2) of the active ingredient Rotigotine.” J.A. 

4833. According to its report, many of the examined 

patches contained snowflakes; of 29 batches of product, 

only one did not have any patches containing visible snowflakes. J.A. 4838. For batches manufactured for distribution in the United States, over 90% of the examined 

patches contained crystals by November 12, 2007. J.A. 

6144.

On November 30, 2007, two days after the priority date

of the ’414 patent, a female patient experienced an adverse 

event while being treated with Neupro. J.A. 5965. An

Alert Report submitted by UCB states that the patient received samples of Neupro in September 2007 and “responded well” to treatment. Id. In November 2007, she 

purchased Neupro patches that were from lot 47808. Id. 
UCB, INC. v. WATSON LABORATORIES INC. 7

While using these patches, the patient began “clearly backsliding, experiencing previous symptoms of losing mobility, 

shaking and freezing.” J.A. 5966. The Report indicated 

that the patient used the lot 47808 patches for “one week,” 

implying that she was using the patches before the ’414 patent’s priority date of November 28, 2007. After experiencing this back-sliding, the patient “was reverted to the 

samples of the newer lot number” and “an improvement in 

the patient was noted.” Id. 

PROCEDURAL HISTORY

Actavis filed an Abbreviated New Drug Application 

(ANDA) for generic versions of transdermal rotigotine 

patches, and UCB filed suit for infringement of the ’434 and 

’414 patents under 35 U.S.C. § 271(e)(2). The case proceeded to a four-day bench trial on the validity and infringement of claims 1, 5, 7, and 14–15 of the ’434 patent, 

and the validity of claims 1–3 of the ’414 patent.4

The district court found infringement of all the asserted ’434 patent claims by Actavis’s ANDA products (the 

Accused Products) under the doctrine of equivalents. Actavis’s products use a polyisobutylene adhesive, rather 

than the claimed acrylate-based or silicone-based polymer 

adhesives, but the district court found the adhesives in this 

context to be substantially similar and that nothing in this 

case barred application of the doctrine of equivalents. J.A. 

138–54.

The district court then upheld the validity of claims 1, 

5, 7, 14, and 15 of the ’434 patent, rejecting, in relevant 

part, Actavis’s arguments of anticipation under 35 U.S.C. 

§ 102 by the Cygnus prior art reference and obviousness 

 

4 Actavis stipulated to infringement of the ’414 patent claims.
8 UCB, INC. v. WATSON LABORATORIES INC.

under 35 U.S.C. § 103 over Cygnus with Lipp5 or Pfister,6

and over Timmerman7 with Miranda.8 J.A. 154–62.

The district court also found the ’414 patent claims invalid under § 102(a) because the Form II polymorph of rotigotine was used by others in the United States before the 

invention date—Neupro patches with Form II crystals

were administered to at least one patient before November 

28, 2007. J.A. 180–84.

Actavis appeals the district court’s infringement and

above-listed validity findings on the ’434 patent. UCB 

cross-appeals the district court’s invalidation of the ’414 

patent. We have jurisdiction pursuant to 28 U.S.C. 

§ 1295(a)(1). 

DISCUSSION

A. Infringement of the ’434 Patent

The only infringement issue relevant to this appeal is 

whether the Accused Products have a “matrix . . . based on 

[]an acrylate-based or silicone-based polymer adhesive system.” ’434 patent, col. 7 ll. 59–61. Actavis does not dispute 

 

5 Canadian Patent No. 2,120,599, entitled “Transdermal Therapeutic Systems Containing Crystallization 

Inhibitors,” listing Ralph Lipp et al. as inventors.

6 European Patent Application EP 0524776, entitled 

“Silicone pressure sensitive adhesive compositions for 

transdermal drug delivery devices and related medical devices,” listing Willliam Richard Pfister et al. as inventors.

7 A journal article published by Timmerman et al., 

entitled “Microdialysis and striatal dopamine release: stereoselective actions of the enantiomers of N-0437.”

8 International Patent Application WO 95/18603, entitled “Transdermal Device Containing Polyvinylpyrrolidone as Solubility Enhancer,” listing Jesus Miranda as an 

inventor.
UCB, INC. v. WATSON LABORATORIES INC. 9

that its Accused Products literally meet every other element of the asserted claims. The Accused Products use a 

polyisobutylene adhesive, which is different from the 

claimed acrylate-based or silicone-based polymer adhesives. But UCB argued that, under the doctrine of equivalents, polyisobutylene-based adhesives are 

interchangeable with the claimed adhesives.

1. Limits to the Application of the 

Doctrine of Equivalents

First, we agree with the district court that UCB was 

not “barred” from asserting the doctrine of equivalents here

because of prosecution history estoppel, intentional narrow 

claiming, vitiation, or ensnarement.

a. Prosecution History Estoppel

Prosecution history estoppel can limit application of

the doctrine of equivalents because “[i]f a patentee surrenders certain subject matter during prosecution, the patentee is then barred from using the doctrine of equivalents 

to recover for infringement based on that same subject 

matter.” Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 904 F.3d 965, 975 (Fed. Cir. 2018), cert. denied, 139 S. Ct. 1265 (2019). 

The original patent application for the ’434 patent had 

17 claims, which were cancelled in a preliminary amendment prior to any Patent Office action. J.A. 5010. New 

claims 18–33 all included an “acrylate-based or siliconebased polymer adhesive system having a solubility of ≥ 5%

(w/w) for [rotigotine free base].” J.A. 5010–15. That claim 

language was never amended during prosecution. New

claims 34–41 were generally directed to processes for preparing a transdermal therapeutic system that included “an 

adhesive,” without specifying any particular adhesive. J.A. 

5013–15.

The examiner then issued a restriction requirement, 

asking the applicant to elect to prosecute claims from 
10 UCB, INC. v. WATSON LABORATORIES INC.

Group I (claims 18–33) or Group II (claims 34–41). J.A. 

5160–62. The applicant elected Group I, but did so “with 

traverse,” meaning that it disputed that any election was 

necessary. J.A. 5163–65. In response, the examiner explained the reason for restriction: Group II claims required 

use of PVP as a solubility enhancer, but PVP would only be 

required for a silicone-based polymer, not acrylate-based 

polymer, because rotigotine is soluble enough in the latter 

to not need an enhancer. J.A. 5160, 5206. So, “the process 

of group II [was] only applicable on silicone-based polymer 

and not on acrylate-based polymer,” while “group I read[] 

on a matrix based on acrylate polymer or silicone polymer.” 

J.A. 5206. Further, the examiner pointed out that “the 

product of group I requires the product to be substantially 

free from inorganic silicate, while the process of group II

requires the inorganic silicate.” Id. The examiner thus 

concluded that “the two groups do not have the same technical features,” finalized the restriction requirement, and

withdrew the Group II claims from further consideration. 

J.A. 5206–07.

Actavis argued that UCB’s election of the Group I 

claims after the examiner issued a restriction requirement 

should prevent UCB from now asserting infringement under the doctrine of equivalents. The Group II claims were

not limited to silicone- and acrylate-based polymer adhesive systems. In Actavis’s view, because UCB withdrew 

those claims, it gave up claim scope of adhesives that are 

not silicates or acrylates and should not be allowed to recapture that subject matter through the doctrine of equivalents. 

The district court disagreed with Actavis’s reading of 

the prosecution history, and we do as well. J.A. 142–44. A

restriction requirement does not necessarily invoke prosecution history estoppel. See Bayer Aktiengesellschaft v. Duphar Int’l Research B.V., 738 F.2d 1237, 1243 (Fed. Cir. 

1984). Whether a patentee’s actions in the face of a restriction requirement give rise to estoppel must be judged 
UCB, INC. v. WATSON LABORATORIES INC. 11

“from the viewpoint of a [skilled artisan], and when the issue includes consideration of formalities of patent practice, 

experience in patent law and procedures is presumed.” 

Merck & Co. v. Mylan Pharm., Inc., 190 F.3d 1335, 1340 

(Fed. Cir. 1999). In Merck, this court determined that the 

patentee’s decision to limit the claims to a certain subset—

in response to the examiner’s restriction requirement and 

obviousness rejection—“were primarily in consideration of

the patentability rejection under § 103.” Id. at 1340–41. 

Thus, this court concluded that Merck’s actions gave rise 

to prosecution history estoppel.

Here, the examiner’s restriction requirement did not 

relate to polyisobutylene, and the examiner was not communicating anything about the patentability of polyisobutylene-based adhesive systems. UCB never added a 

polyisobutylene-excluding limitation by amendment, and 

its election cannot be read as such. Moreover, even if UCB 

had claimed “an adhesive” in the elected claims, as Actavis 

argues it should have done in order to keep polyisobutylene 

within the claim scope, the technical differences that triggered the restriction requirement would still have remained and still would have required the same restriction: 

the Group II claims required inorganic silicate and applied 

only to a subset of adhesives that needed PVP, while Group 

I did not have those limitations. Thus, the restriction requirement here, and UCB’s election in response, do not indicate a surrender of polyisobutylene as an equivalent. 9

 

9 Actavis also cites to Pacific Coast Marine Windshields Ltd. v. Malibu Boats, LLC, where this court found 

that in the prosecution of a design patent on a marine 

windshield, “[b]y cancelling figures showing corner posts 

with two holes and no holes, the applicant surrendered 

such designs and conceded that the claim was limited to 

what the remaining figure showed—a windshield with four 
12 UCB, INC. v. WATSON LABORATORIES INC.

Because we conclude that UCB did not make a narrowing amendment in respect to the restriction requirement, 

we reject Actavis’s argument that UCB had the burden to 

show that a “narrowing amendment” was unrelated to patentability.

Accordingly, we find no good basis in the prosecution 

history here to bar the application of the doctrine of equivalents to polyisobutylene-based polymer adhesive systems.

b. Narrow Claiming

Relatedly, Actavis argued to the district court that 

UCB had chosen to draft narrow claims and should not be 

permitted to expand the scope of those claims through the 

doctrine of equivalents. Specifically, Actavis argued that 

Dr. Mueller, an inventor of the ’434 patent, knew that polyisobutylene was a polymer that could be used in transdermal patches but chose not to prosecute a claim broad 

enough to cover polyisobutylene. J.A. 4219. On appeal, 

Actavis makes the broader argument that polyisobutylenes 

were generally known in the art, citing Dr. Mueller’s 

knowledge as an example. The Cygnus prior art reference

 

holes in the corner post—and colorable imitations thereof.” 

739 F.3d 694, 703 (Fed. Cir. 2014); Oral Arg. at 6:35–8:35. 

But due to the nature of design patents, the differences between the figures in that case made the claim scope of each 

figure, as to the relevant hole limitation, mutually exclusive. In contrast, as we explain, the inclusion of polyisobutylene under the adhesive claim limitations in the two 

groups of claims here is not so clearly mutually exclusive. 

In any event, we have never held that a restriction and 

election during prosecution of a utility patent application, 

without more, can constitute prosecution history estoppel 

for claim scope covered by the restricted and then cancelled 

claims, and we decline to do so here, given that there were 

other reasons for the restriction.
UCB, INC. v. WATSON LABORATORIES INC. 13

also mentions polyisobutylene as a possible adhesive for 

transdermal patches. J.A. 5705, 5708–09.

The district court disagreed with Actavis, citing this 

court’s holding in Ring & Pinion Service Inc. v. ARB Corp.

that “[t]here is not, nor has there ever been, a foreseeability 

limitation on the application of the doctrine of equivalents” 

as to claim limitations that have never been amended or 

relied on during prosecution, because “[e]xcluding equivalents that were foreseeable at the time of patenting would 

directly conflict with [prior Supreme Court and Federal 

Circuit case] holdings that ‘known interchangeability’ supports infringement under the doctrine of equivalents.” J.A. 

145; 743 F.3d 831, 834 (Fed. Cir. 2014) (citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 36

(1997); Graver Tank & Mfg. Co. v. Linde Air Products Co., 

339 U.S. 605, 609 (1950); Abraxis Bioscience, Inc. v. Mayne 

Pharma (USA) Inc., 467 F.3d 1370, 1382 (Fed. Cir. 2006); 

Interactive Picture Corp. v. Infinite Pictures, Inc., 274 F.3d 

1371, 1383 (Fed. Cir. 2001); and Corning Glass Works v. 

Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1261 (Fed. Cir. 

1989)).

We understand Ring & Pinion to hold that foreseeability at the time of claim drafting is not a per se bar to the

application of the doctrine of equivalents. But, at the same 

time, Ring & Pinion does not foreclose consideration of 

foreseeability of an asserted equivalent as one factor that 

may, in some cases, help show that the facts cannot support 

infringement under the doctrine of equivalents.

Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC is an 

example of such a case. 683 F.3d 1356, 1366 (Fed. Cir. 

2012). There, Cadbury asserted infringement of U.S. Patent No. 5,009,893, which claimed a chewing gum that combined menthol with a coolant claimed as an “N-substitutedp-menthane-carboxamide of [a specific formula].” Id. at 

1358. One such carboxamide was called “WS-3.” Id. The 

accused infringing product used a coolant called “WS-23,” 
14 UCB, INC. v. WATSON LABORATORIES INC.

which the parties, on appeal, agreed did not fall within the 

literal scope of the carboxamides claimed in the ’893 patent. Id. at 1359, 1365. But the district court ruled on 

summary judgment that WS-23 was “not an equivalent of 

WS-3 for purposes of the ’893 patent.” Id. at 1365. This 

court affirmed, citing several reasons. First, the “disclosure of the ’893 patent focuse[d] narrowly on N-substituted-p-menthane carboxamides, and not on carboxamides 

generally,” because it focused on advantageous characteristics unique to N-substituted-p-menthane carboxamides

such as its “unexpected[ly] heightened cooling sensation in 

edible products” and its structural similarity to menthol itself—characteristics not shared by WS-23. Id. at 1365–66. 

Second, the claim was drafted to cover only a subset of Nsubstituted-p-menthane-carboxamides, indicating a narrowing even beyond the specification. Id. at 1366. Third, 

there was clear evidence in the record that the inventors of 

the ’893 patent were introduced to WS–3 and WS–23 by a 

salesman for the distributor of the compounds during the 

same sales call, where they were told that the two compounds were appropriate for the same uses, and yet, the 

inventors still drafted their claims narrowly to recite certain N-substituted-p-menthane carboxamides, as opposed 

to a broader category of carboxamides that would include 

WS–23. Id. 

The facts are different here. Wrigley does not support 

treating the present facts as precluding a finding of equivalence.

Actavis does not argue that the ’434 patent’s specification relies on any unique characteristics of acrylate or silicone-based polymer adhesive systems that would not be 

present in a polyisobutylene-based system. The language 

in the Summary of the Invention stating that the claimed 

system “is essentially characterized by a matrix on the basis of an acrylate-based or silicone-based non-aqueous polymer adhesive system having a solubility for [rotigotine 

free base] of >5% (w/w), which matrix is substantially free 
UCB, INC. v. WATSON LABORATORIES INC. 15

of inorganic silicate particulates,” is just a recitation of the 

qualities of the matrix; the passage does not identify

unique characteristics of acrylate or silicone-based polymer 

adhesive systems to the exclusion of other systems. ’434 

patent, col. 2 ll. 35–40. And the fact that the specification

repeatedly recites acrylate- and silicone-based polymers is 

irrelevant to the issue of whether it describes those polymers in a manner that would suggest to a skilled artisan 

that polyisobutylene is not an equivalent. For this inquiry, 

the specification states that the “adhesive’s dissolving capacity for the active substance is an important parameter 

for the development of matrix systems, just as the mobility 

of the active substance in the matrix, and its transfer via 

the contact surface to the skin.” Id. at col. 3 ll. 15–18. As 

explained in detail below, the district court found record 

evidence that there was no substantial difference between 

the claimed adhesive systems and polyisobutylene-based 

polymer adhesive systems for these parameters.

Furthermore, the claims also correspond directly to the 

specification by reciting all acrylate-based or silicone-based 

polymer adhesive systems, without narrowing to a subset 

as in Wrigley.

Finally, the evidence of the inventor’s knowledge here 

at the time of filing is not as clear as in Wrigley. Actavis 

points to a feasibility study done by the inventors in January 1996. J.A. 5913–43. The document describes that “[f]or 

the formulation of matrix systems with a self-adhesive matrix formulation the following adhesives are most commonly used: silicone based adhesive[,] polyacryl resin 

based adhesives[,] polyisobutylene based adhesives[, and] 

adhesives on the basis of styrene/ isoprene A-8-A blockpolymers.” J.A. 5916 (emphasis added). The inventors explained that “the suitability of silicone based matrix 

formulation was already demonstrated by Cygnus,” so they 

chose to concentrate on “polyacrylic resins and styrene/isoprene/styrene blockpolymers.” Id. No reason was given for 

not testing polyisobutylene-based adhesives. Further, one
16 UCB, INC. v. WATSON LABORATORIES INC.

inventor testified that he had “limited experience” with polyisobutylene as a liquid but was “not so familiar” with its 

polymer form. J.A. 4219.

Thus, in contrast to Wrigley, there is not enough indication from the patent specification, claims, or the record 

evidence of the inventor’s knowledge here to conclude that

UCB surrendered polyisobutylene as a possible equivalent. 

In the absence of such facts, we agree with the district court 

that UCB’s claiming of acrylates and silicates does not bar 

treating polyisobutylenes as an equivalent for infringement purposes. J.A. 146–48.10

 

10 Actavis cites two additional cases for this issue: 

Carnegie Mellon University v. Hoffmann-La Roche Inc., 

541 F.3d 1115 (Fed. Cir. 2008), and Tanabe Seiyaku Co. v. 

International Trade Commission, 109 F.3d 726 (Fed. Cir. 

1997). Appellants’ Op. Br. at 48–49. Carnegie Mellon was 

decided under the vitiation doctrine, which we address separately herein. In Tanabe, the applicant “chose to define 

its invention in terms of specific base-solvent combinations, 

rather than in terms of categories of bases and solvents,” 

but also proceeded to define the success of its invention “in 

terms of the exact base-solvent combinations” during prosecution such that “a review of the prosecution history by a 

competitor would reinforce the suggestion in the claim language and specification that using other ketone solvents 

. . . is not an insubstantial change [and would suggest] that 

other ketone solvents may result in lower yields than the 

claimed solvents.” 109 F.3d at 732. In affirming the International Trade Commission’s finding of no infringement 

under the doctrine of equivalents, the Tanabe court largely 

relied on the interchangeability/substantial differences

doctrine and evidence that butanone was not as successful 

as the claimed acetone. 109 F.3d at 732–34. Prosecution 
UCB, INC. v. WATSON LABORATORIES INC. 17

Further, we note as a policy matter that the patent system should not incentivize inventors to claim equivalents 

that they had not invented or tested, just because they 

know of the possibility of an equivalent, and also should 

not force inventors to delay filing for a patent on what they 

have invented while testing all known possible equivalents 

for fear of being unable to assert infringement under the 

doctrine of equivalents in the future.

c. Vitiation

“Under the doctrine of equivalents, an infringement 

theory . . . fails if it renders a claim limitation inconsequential or ineffective.” Akzo Nobel Coatings, Inc. v. Dow Chem. 

Co., 811 F.3d 1334, 1342 (Fed. Cir. 2016). This vitiation 

doctrine ensures that “the application of the doctrine [of 

equivalents] . . . is not allowed such broad play as to effectively eliminate that element in its entirety.” Warner-Jenkinson, 520 U.S. at 29. Vitiation “is not an exception or 

threshold determination that forecloses resort to the doctrine of equivalents, but is instead a legal conclusion of a 

lack of equivalence based on the evidence presented and

the theory of equivalence asserted.” Cadence Pharm. Inc. 

v. Exela PharmSci Inc., 780 F.3d 1364, 1371 (Fed. Cir. 

2015). For example, in Carnegie Mellon University v. Hoffmann-La Roche Inc., this court concluded that finding Taq

bacteria equivalent to E. coli bacteria would essentially 

render the “bacterial source [is] E. coli” claim limitation 

meaningless and would thus vitiate that limitation of the 

 

history was a factor in the court’s analysis, but not one that 

by itself barred consideration of infringement under the 

doctrine of equivalents. Thus, Tanabe does not bar consideration of the doctrine here, even if the prosecution history 

was as suggestive in the instant case (which as explained 

above, it is not).
18 UCB, INC. v. WATSON LABORATORIES INC.

claims. 541 F.3d 1115, 1129 (Fed. Cir. 2008) (affirming

summary judgment of noninfringement).

Here, Actavis argues that UCB’s doctrine of equivalents infringement theory should fail because it vitiates the 

“acrylate-based or silicone-base polymer adhesive system” 

limitation of claim 1. We do not agree that finding polyisobutylene to be an equivalent gives the element “an acrylate-based or silicone-based polymer adhesive system” such 

broad play that the element would disappear entirely. See 

Warner-Jenkinson, 520 U.S. at 29. The district court did 

not broaden the right to exclude so widely as to cover all 

adhesive systems and vitiate the “acrylate-based or silicone-based” claim language. As explained below, the district court here conducted a specific analysis as to whether 

polyisobutylene would be covered, and it had adequate reasons for why a skilled would understand that polyisobutylene, specifically, would work just as well as acrylate or 

silicone for the claimed transdermal patch. Accordingly, 

we agree with the district court that vitiation does not bar 

application of the doctrine of equivalents here. J.A. 146–

47.

d. Ensnarement

Actavis also contends that UCB’s infringement theory 

is improper because it “ensnares” the prior art. See Intendis GMBH v. Glenmark Pharm. Inc., USA, 822 F.3d 1355, 

1363 (Fed. Cir. 2016) (“A patentee may not assert ‘a scope 

of equivalency that would encompass, or ensnare, the prior 

art.’”) (quoting DePuy Spine, Inc. v. Medtronic Sofamor 

Danek, Inc., 567 F.3d 1314, 1322 (Fed. Cir. 2009)). “A helpful first step in an ensnarement analysis is to construct a 

hypothetical claim that literally covers the accused device.” 

DePuy Spine, 567 F.3d at 1324. “Next, the district court 

must assess the prior art introduced by the accused infringer and determine whether the patentee has carried its 

burden of persuading the court that the hypothetical claim 

is patentable over the prior art.” Id. at 1325. “In short, 
UCB, INC. v. WATSON LABORATORIES INC. 19

[the court] ask[s] if a hypothetical claim can be crafted, 

which contains both the literal claim scope and the accused 

device, without ensnaring the prior art.” Intendis, 822 F.3d 

at 1363.

Actavis argues that a hypothetical claim including polyisobutylene-based polymers would ensnare the prior art. 

But the prior art that Actavis points to covers silicone and 

acrylate polymers as well; its theory, if correct, would thus 

invalidate both the actual and hypothetically broader 

claims. Actavis offers no examples of prior art that would 

be ensnared by the addition of polyisobutylene to the claim, 

in contrast to the claim as is. 

The district court “disagree[d]” with Actavis’s contention that there is an ensnarement issue here and found 

that “UCB’s equivalence theory does not ensnare the prior 

art.” J.A. 147–48 (emphasis added). We concur and do not 

find that the district court erroneously placed the burden 

on Actavis to prove ensnarement. Actavis’s ensnarement 

argument is substantively a patent invalidity challenge, 

which we address later in this opinion. See Jang v. Boston 

Sci. Corp., 872 F.3d 1275, 1288–89 (Fed. Cir. 2017) (explaining that ensnarement and validity are “two different 

concepts”).

2. Merits

Second, we find no clear error with the district court’s

substantive application of the doctrine of equivalents.

Infringement under the doctrine of equivalents is a factual question, VirnetX, Inc. v. Cisco Sys., Inc., 767 F.3d 

1308, 1322–23 (Fed. Cir. 2014), which we review for clear 

error on appeal from a bench trial. Pfizer, Inc. v. Apotex, 

Inc., 480 F.3d 1348, 1359 (Fed. Cir. 2007).

The Supreme Court has set out two frameworks for 

evaluating equivalency. Warner-Jenkinson, 520 U.S. at

39–40. The relevant framework here, which the district 

court applied, is the (in)substantial differences test, under 
20 UCB, INC. v. WATSON LABORATORIES INC.

which“[a]n element in the accused device is equivalent to a 

claim limitation if the only differences between the two are 

insubstantial.” Voda v. Cordis Corp., 536 F.3d 1311, 1326 

(Fed. Cir. 2008). This court has explained that “the substantial differences test may be more suitable . . . for determining equivalence in the chemical arts,” and identified

“structural equivalen[cy]” as particularly relevant when 

comparing chemical equivalents. Mylan Institutional LLC 

v. Aurobindo Pharma Ltd., 857 F.3d 858, 869 (Fed. Cir. 

2017).

The purpose of the adhesive polymer in the disputed 

claim element is to act as a scaffold for the drug and to provide adhesion to a patient’s skin for the transdermal patch. 

The district court found that, at the time the ’434 patent 

was filed, silicates, acrylates, and polyisobutylenes were 

the most commonly used pressure-sensitive adhesives in 

transdermal patches. J.A. 127. The district court then 

identified a set of properties that silicates, acrylates, and

polyisobutylenes share: they are pressure-sensitive, adhesive, biologically inert, non-irritating, and non-toxic. J.A. 

121–28. Thus, the district court found that a skilled artisan “would recognize that polyisobutylene is not substantially different from the classes of adhesives literally 

within the scope of the claims.” Id. at 128. 

The district court also made fact findings as to the differences between polyisobutylene and silicates/acrylates. 

“Polyisobutylene is an organic polymer, consisting exclusively of carbon and hydrogen atoms, forming a non-polar 

backbone, without any functional groups,” and accordingly 

is non-polar and hydrophobic. Id. Silicates and polyacrylates, unlike polyisobutylene, may contain functional 

groups that may be polar and/or reactive. So, due to differences in polarity, polyisobutylene has different adhesiveness compared to acrylate- and silicone-based adhesives. 

Id. Further, polyisobutylene, unlike silicone- or acrylatebased polymers, does not allow for crosslinking agents to 

be used to increase adhesion or reduce cold-flow. Finally, 
UCB, INC. v. WATSON LABORATORIES INC. 21

rotigotine contains atoms that can interact with certain 

functional groups that can be present in silicone- and acrylate-based polymers, but rotigotine does not interact significantly with polyisobutylene. Id.

The district court explained that these differences do 

not matter for how the claimed invention works, as evidenced by the comparative results between UCB’s Neupro 

product and the Accused Products, called PIB Neupro 

(Neupro with polyisobutylene substituted for silicone). The 

district court noted that permeation results for Neupro and 

PIB Neupro were comparable in terms of transdermal delivery of rotigotine at the intended wear time of 24 hours, 

and that Actavis chose polyisobutylene because it worked

just as well as silicone. J.A. 129. The district concluded

that “[t]hese results show that the polyisobutylene-based

polymer adhesive system did not alter the way rotigotine is 

transdermally delivered compared to a silicone-based polymer adhesive system,” nor did it “alter rotigotine transdermal delivery rates,” showing that “polyisobutylene is 

interchangeable with silicone in the claimed polymer adhesive system.” Id. Accordingly, the district court concluded 

that “[t]he polyisobutylene-based adhesive system is an insubstantial modification of the claimed invention.” Id. 

As for the dependent claims, which recite the use of 

PVP as a solubility enhancer, the district court found that 

the Accused Products use PVP as a solubility enhancer for 

rotigotine—in the same way as the claimed silicone-based

polymer adhesive system. J.A. 130. The district court cited 

Actavis’s stability testing (1) confirming that PVP was necessary in the polyisobutylene-based polymer adhesive system to fully dissolve the necessary amount of free base and 

prevent crystallization and (2) disclosing that this amount 

was within the range of PVP claimed in the ’434 patent. Id. 

Further, both a polyisobutylene-based polymer adhesive 

system and the claimed silicone-based polymer adhesive 

system use a hydrophobic adhesive with inherently low solubility for rotigotine free base in which rotigotine-PVP 
22 UCB, INC. v. WATSON LABORATORIES INC.

complexes are dispersed. Id. So, the district court reasoned that just because “polyisobutylene has some different properties (e.g., lack of heteroatoms and functional 

groups, different polarity, etc.),” this “does not change how 

the polymer adhesive system works”: “the polymer functions as a scaffold for the drug,” and “[r]otigotine-PVP complexes form in both silicone polymers and polyisobutylene

to increase drug solubility and allow for drug mobility.” 

J.A. 131.

The district court thus concluded that “[p]olyisobutylene is interchangeable with silicone in the claimed polymer 

adhesive system, resulting in an insubstantially different 

system that also uses dispersed rotigotine-PVP to effect 

≥5% solubility.” J.A. 132.

On appeal, Actavis argues that the district court erroneously relied on evidence comparing UCB’s branded 

Neupro product with (a) Actavis’s ANDA product and 

(b) PIB Neupro. Appellants’ Op. Br. at 57. The crux of Actavis’s argument is that Neupro is not equivalent to the asserted claims because it undisputedly contains 5 molecules 

of water for every 7 molecules of rotigotine. Id. at 74 (citing 

J.A. 4620:23–28:12 (testimony by UCB’s expert); J.A. 5946, 

5951–52 (Neupro validation document disclosing ratio and 

stating that Neupro patches have final “water content” of 

0.3%)). Actavis argues that because it has water, Neupro 

does not have free base rotigotine in the patch’s matrix “in 

the absence of water” as required by ’434 patent claim 1. 

Since it is not equivalent to the claims, Actavis argues that 

any comparison between it and the Accused Products is a 

legally erroneous basis for infringement. 

But the district court explicitly stated whether Neupro

is or is not an embodiment of the claims is not dispositive 

of the infringement question because “infringement requires a comparison of the accused product (the ANDA 

product) and the claims.” J.A. 149 n.6. 
UCB, INC. v. WATSON LABORATORIES INC. 23

And the district court only relied on Neupro and PIB 

Neupro for points unrelated to water content. The district 

court observed that “[b]oth Neupro itself and the ’434 patent in exemplary embodiments use silicone adhesives . . . 

that have a solubility for rotigotine of less than 0.1%” to 

make the point that the low solubility of polyisobutylene 

was not a concern that would differentiate it from silicates. 

J.A. 151. The district court also pointed out that Actavis 

started with Neupro and substituted polyisobutylene for 

silicone to make PIB Neupro because it viewed the two as 

interchangeable. J.A. 129. And the district court cited the 

comparative permeation studies because they showed no 

statistical difference in the amount of rotigotine delivered 

between the two adhesives. J.A. 152. It is not clear how 

any of these conclusions are affected by the water content 

of Neupro. Regardless, as summarized above, the district 

court had many non-Neupro-related reasons for finding 

substantial similarity here.

We do not find clear error in any of the district court’s 

fact findings as to polyisobutylene’s characteristics as compared to silicates and acrylates. We also do not find clear 

error in the district court’s fact findings as to what a skilled 

artisan would have known about the interchangeability of 

polyisobutylene-based adhesives and silicone-based adhesives (i.e., why the similarities matter more than the differences for the claimed system). Giving credit to those fact 

findings, we affirm the district court’s conclusion that the 

Accused Products infringe the claims under the doctrine of 

equivalents.

B. Validity of the ’434 Patent

This court reviews legal conclusions from a bench trial 

de novo and factual findings for clear error. Pfizer, 480 at

1359. Anticipation is a factual question that we review for 

clear error; we review the legal conclusion of obviousness

de novo and the underlying fact findings for clear error. Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 
24 UCB, INC. v. WATSON LABORATORIES INC.

655 F.3d 1291, 1302 (Fed. Cir. 2011) (citations omitted). 

Actavis appeals the district court’s rejection of three of its

proposed invalidity grounds: (1) anticipation by Cygnus, 

(2) obviousness over Cygnus in combination with Lipp or 

Pfister, and (3) obviousness over the combination of Timmerman and Miranda.

1. Cygnus-Based Anticipation and Obviousness

The Cygnus prior art patent application generally discloses controlled-release drug formulations that can be 

used with transdermal patches. J.A. 5704. The application 

describes “a novel matrix composed of a continuous hydrophobic domain and a dispersed particulate hydrated silicate domain,” “which may be used to administer 

hydrophilic drugs in a sustained manner.” J.A. 5706. Rotigotine is listed as an exemplary hydrophilic drug in Example 15. J.A. 5717–18. In that example, skin flux (rate 

of absorption) studies are presented of patches containing, 

in relevant part: rotigotine, a phosphate buffer (which is a 

water-based solution), and a silicone-based adhesive. Id. 

Example 15’s patches are further described in Chiang. J.A. 

155, 4827–28.

The district court found that Cygnus did not disclose a 

crucial element of claim 1: a patch containing rotigotine in 

free base form. J.A. 157–58. Cygnus states the chemical 

name of rotigotine free base: S(-)-2-(N-propyl-N-2-

thienylethylamine)-5-hydroxytetralin. J.A. 5717. Rotigotine, however, can exist in free base form or in salt form. 

J.A. 157. Actavis presented Example 15 of Cygnus as evidence that Cygnus teaches a free base form existing in a

patch. J.A. 158. In that example, rotigotine is present as 

a salt in a phosphate buffer water solution, where most of 

the rotigotine would be in charged salt form and only 1.28% 

could be present in neutral free base form. Id. 

On appeal, Actavis points to Cygnus’s Example 15 as 

teaching a patch with some rotigotine in free base form. 

But Actavis’s argument has a fatal flaw: there is nothing 
UCB, INC. v. WATSON LABORATORIES INC. 25

in Cygnus that teaches a water-free patch with rotigotine 

in free base form. All the patches in Cygnus’s examples—

including those with rotigotine—contain significant 

amounts of water (10–15% w/w) such that even the 1.28% 

of rotigotine present in free base form in Example 15 would 

necessarily be in the presence of water because of the phosphate buffer.11 Accordingly, it was not clearly erroneous 

for the district court to find that “merely providing the 

chemical name [in the specification] for the rotigotine free 

base” was not enough to disclose that the base was present 

in the absence of water. J.A. 158. 

Thus, we agree with the district court’s conclusion that 

Actavis did not present “sufficient evidence that rotigotine 

free base is present in a patch that is water-free” in Cygnus. Id.

Neither Lipp nor Pfister fills this gap. Both disclose 

transdermal patches containing PVP, but neither discloses

any anti-Parkinson’s drugs, much less rotigotine free base 

in the absence of water.12 

 

11 Actavis contended at Oral Argument that Cygnus 

discloses substituting other solvents for water: “Other hydrophilic polar solvents such as ethanol, propylene glycol, 

low molecular weight (200 to 400 mw) polyethylene glycol, 

isopropyl alcohol, N-butanediol, m-pyrol and benzyl alcohol 

may be substituted for water or included in the hydrophilic 

domain of the matrix.” Oral Arg. at 3:07 (citing J.A.5209). 

But the district court found that “Actavis [] presented no 

evidence” that use of such solvents would actually result in 

rotigotine free base in a water-free patch. J.A. 158. Actavis 

does not show on appeal that the district court erred in that 

finding.

12 Actavis also argues that all of the asserted ’434 patent claims are “obvious as claiming well-known 
26 UCB, INC. v. WATSON LABORATORIES INC.

2. Obviousness over Timmerman and Miranda

The district court also rejected Actavis’s argument that 

the asserted claims of the ’434 patent would have been obvious in light of Miranda combined with Timmerman. Miranda describes (1) transdermal patches based on silicone 

or polyacrylate-based polymer adhesives, (2) PVP as a solubility enhancing agent, (3) an active ingredient present in 

concentrations between 3% and 10%, and (4) solvents that

are not water. J.A. 5780, 5787, 5788, 5808–09. Miranda 

does not specifically name rotigotine as a suitable drug for 

its patches, but it does include a list of other drugs that are 

used to treat Parkinson’s disease. J.A. 5797. Timmerman 

is a 1988 study in which rats were treated transdermally 

on the skin of their necks with a solution containing rotigotine free base. J.A. 4811–18. Timmerman deduced that 

transdermal application of rotigotine was superior to oral 

administration because it induced a much longer duration 

of action of the drug (13 hours) in comparison with the oral 

mode (5 hours). J.A. 4811, 4816. Timmerman concluded

that “transdermal administration . . . may provide a most 

useful way of administering the drug for therapeutic use.” 

J.A. 4817.

The district court found that Actavis did not provide an 

adequate rationale for combining the references’ teachings, 

noting that Actavis did “not explain why a [skilled artisan] 

would have been motivated to start from the patches 

taught by Miranda.” J.A. 161–62. The district court then 

found that it was not persuaded that a skilled artisan

 

components.” Appellants’ Op. Br. at 72. But Actavis does 

not explain in any detail how a skilled artisan would understand or combine such evidence to arrive at the claimed 

invention. Actavis did not meaningfully develop this argument below or on appeal, and we do not find it sufficient to 

render any of the asserted ’434 patent claims obvious.
UCB, INC. v. WATSON LABORATORIES INC. 27

would have reasonably expected the combination to be successful because: (1) the transdermal patch field was a relatively sparse one at the pertinent date (only 8 

transdermal patches were available at the time of the invention of the ’434 patent in 1998, and even now, only 20 

drugs are available in patch form), and (2) of the drugs 

available as patches, rotigotine is the only active ingredient 

that was introduced as a patch without first being available in a different type of formulation. J.A. 162. So, even 

accepting Actavis’s contention that Miranda provides a 

“recipe” or “check list” for making transdermal patches, the 

district court reasoned that a skilled artisan “would have 

confronted a significant challenge to create a patch that 

was successful at treating Parkinson’s disease,” especially 

in light of Chiang’s teaching that path formulation can 

have a dramatic effect on observed rate of absorption 

through the skin (skin flux). Id. Ultimately, the district 

court was not persuaded that the claimed invention would 

have been, at the time of the invention, “as trivial and 

straightforward as simply combining rotigotine free base of 

Timmerman with the patch recipe of Miranda.” Id. 

On appeal, Actavis argues that the district court failed 

to find obviousness over this combination only because it 

applied an “unduly rigid” analysis in concluding that Actavis had not shown a motivation to combine or reasonable 

expectation of success. Appellants’ Op. Br. at 62 (citing 

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)). Actavis argues that the district court’s concern over why a 

skilled artisan would have been motivated to start with Miranda is misplaced because starting with Miranda was not 

part of its obviousness theory. As a threshold matter, we 

agree with Actavis that, under the flexible framework of 

KSR, it should not matter whether a proposed obviousness 

combination starts with Timmerman or Miranda. But 

even accepting Actavis’s argument that a skilled artisan 

would start with Timmerman, there is still an evidentiary 

gap as to why a skilled artisan would think of using a 
28 UCB, INC. v. WATSON LABORATORIES INC.

transdermal patch, as taught in Miranda, based on Timmerman’s “transdermal administration” disclosure of applying a liquid dose of the drug on the hairless skin on the 

neck of a rat. 

As to lack of reasonable expectation of success, we affirm the district court’s finding. Miranda discloses thousands of combinations for making transdermal patches. 

First, it discloses huge ranges for the percent by weight of 

the rubber, polyacrylate, PVP, co-solvents, and drugs in the 

patches. J.A. 5806. Second, it discloses hundreds of drugs, 

of which anti-Parkinson drugs are just a small category 

and where that category does not even list rotigotine. J.A. 

5789–802, 5797. Third, Miranda lists ethanol as just one 

of many possible solvents. J.A. 5808. Finally, it teaches 

that “[t]he amount of drug to be incorporated in the composition varies depending on the particular drug, the desired 

therapeutic effect, and the time span for which the device 

is to provide therapy.” J.A. 5803. 

Based on the above, it was reasonable to conclude that 

Miranda is less of a “recipe” for the claimed rotigotine 

transdermal patch and more of a list of thousands of possibilities out of which a skilled artisan would have to select 

the claimed combination as one to try. Miranda does not 

provide a reasonable expectation of success for making a 

transdermal patch of rotigotine without undue experimentation, and Timmerman cannot fill in this gap, as it does 

not contemplate using a patch to administer rotigotine 

transdermally. Chiang’s disclosure that “[o]ne of the major 

obstacles for developing a transdermal delivery system is 

to deliver sufficient amounts of the drug through the skin,” 

J.A. 4827–28, and its conclusion, as summarized by the district court, that “path formulation can have a dramatic effect on observed skin flux,” J.A. 162, further suggest that 

transdermal drug administration is not a straightforward 

task such that narrowing down Miranda’s teachings to the 

claimed invention could be achieved via routine experimentation. J.A. 4827–28. And the district court found that the 
UCB, INC. v. WATSON LABORATORIES INC. 29

transdermal patch field was not a common, widespread one 

during the relevant time, and that of the drugs available 

as patches, rotigotine was the only active ingredient that 

was introduced as a patch without first being available in 

a different type of formulation. J.A. 162. All of these facts 

support the district court’s conclusion that a skilled artisan 

would not have had a reasonable expectation of success in 

combining Miranda and Timmerman, even if there was a 

motivation to do so.

Since we find no reversible error in the findings by the 

district court about the prior art we have already discussed, we do not reach Actavis’s arguments challenging 

additional findings regarding secondary considerations. 

Those considerations are unnecessary here, as they can 

only further support the rejection of the obviousness challenge.

Accordingly, we affirm the district court’s findings upholding the validity of the asserted ’434 patent claims.

C. Invalidity of the ’414 Patent

On cross-appeal, UCB asks this court to reverse the 

district court’s invalidation of the asserted ’414 patent

claims due to prior public use under § 102(a) because the 

record evidence allegedly did not support the district

court’s inferences as to how UCB’s Form II invention was 

in actual use before the correct invention date. Cross-Appellants’ Op. Br. at 62–63.

A patent may be found invalid if “the invention was 

known or used by others in this country” before invention 

by the applicant. 35 U.S.C. § 102(a) (pre-AIA).13 This is

 

13 The Leahy-Smith America Invents Act (AIA) 

changed 35 U.S.C. § 102. Pub. L. No. 112-29, § 3(b), 125 

Stat. 284, 285–86 (2011). However, because the 
30 UCB, INC. v. WATSON LABORATORIES INC.

because “[i]f the invention was known to or used by others 

in this country before the date of the patentee’s invention, 

the later inventor has not contributed to the store of 

knowledge, and has no entitlement to a patent.” Woodland 

Tr. v. Flowertree Nursery, Inc., 148 F.3d 1368, 1370 (Fed. 

Cir. 1998). “For prior art to anticipate because it has been 

‘used,’ the use must be accessible to the public.” Minnesota 

Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 

(Fed. Cir. 2002). “[P]rior knowledge and use by a single 

person is sufficient.” Coffin v. Ogden, 85 U.S. 120, 124 

(1873).

The district court reasonably found that a patient in 

the United States used Neupro patches that contained 

Form II rotigotine before November 28, 2007—the ’414 patent’s filing date—and that therefore, the ’414 patent 

claims were invalid under § 102(a).14 J.A. 183. A female 

 

application from which the ’414 patent issued has never 

contained a claim having an effective filing date on or after 

March 16, 2013, or a reference under 35 U.S.C. §§ 120, 121, 

or 365(c) to any patent or application that ever contained 

such a claim, the pre-AIA § 102(a) applies. Id. § 3(n)(1), 125 

Stat. at 293.

14 UCB disputes whether November 28, 2007 is the 

appropriate date of invention for the ’414 patent. Generally, “the date of invention [is] presumed to be the filing 

date of the application until an earlier date is proved.” 

Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 

796 F.2d 443, 449 (Fed. Cir. 1986). It is the patentee’s burden to present evidence of an earlier invention date. See 

Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576–78 (Fed. 

Cir. 1996). UCB assumed November 28, 2007 as the date 

of invention for its arguments against derivation (not on 

appeal), was on notice of Actavis’s reliance on the date for 

§ 102(a) purposes at least as of the district court’s pre-trial 
UCB, INC. v. WATSON LABORATORIES INC. 31

patient had received samples of Neupro in September 2007 

and “responded well” to treatment. J.A. 5965. In November 2007, however, this patient purchased Neupro patches 

that were from lot 47808—one of the lots later discovered 

to have contained Form II rotigotine. Id.; J.A. 181–82.

While using these lot 47808 patches, the patient began

“clearly back-sliding, experiencing previous [Parkinson’s] 

symptoms of losing mobility, shaking and freezing.” J.A. 

5966. The patient experienced the adverse event two days 

after the priority date of the ’414 patent, but she had been 

using the patches for “one week,” necessarily implying that 

she was using the patches before the ’414 patent’s priority 

date of November 28, 2007. Id. After experiencing this 

back-sliding, the patient “was reverted to the samples of 

the newer lot number” and “an improvement in the patient 

was noted.” Id. 

The district court found that Form II rotigotine was 

used in the United States before the November 28, 2007 

priority date of the ’414 patent based on (1) record evidence 

that most, if not all, of lot 47808’s patches sent to the 

United States contained Form II rotigotine, and (2) the patient’s back-sliding with the lot 47808 patches and subsequent improvement on different patches. 

 

order, and failed to raise any issue with the invention date 

until post-trial briefing. Under these circumstances, we 

find that the district court did not abuse its discretion in 

finding that UCB waived any argument of a date of invention earlier than November 28, 2007. Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005) (Unless a 

procedural ruling raises issues unique to patent law, we 

apply the law of the appropriate regional circuit.); Springer 

v. Henry, 435 F.3d 268, 275 n.4 (3d Cir. 2006) (The Third 

Circuit reviews a district court’s decision that a party has 

waived an issue for trial for abuse of discretion.).
32 UCB, INC. v. WATSON LABORATORIES INC.

On appeal, UCB first argues that there is insufficient

evidence that there were Form II crystals in the patient’s 

Neupro patches before the ’414 patent’s filing date. But the 

district court explained that the patient’s patches were 

from lot 47808 and concluded that the whole batch had 

Form II crystal because so many of the retained and later 

tested samples from that lot contained Form II. J.A. 181–

82. The district court also pointed to the patient’s “backsliding” symptoms as indicative of the Form II crystals’ 

presence. J.A. 183. To argue that the patches used by the 

patient may not have contained Form II crystals, UCB 

points to a report showing that out of the twenty patches 

tested in that lot, nine of them did not have crystals initially. J.A. 4853. But that same report shows that all had 

crystals within a month of storage. Id. The patches used 

by the patient were stored for far longer than that; they 

were made in June/July 2007 and used in November 2007. 

J.A. 181; J.A. 5966. UCB further argues that the crystals 

observed on the patches may not have necessarily been 

Form II, as apparently it is impossible to distinguish Form 

I from Form II by sight. Cross Appellants’ Op. Br. at 69

(citing J.A. 4838; J.A. 4282–83). But in this record, all lots 

where crystals were observed were confirmed to contain 

Form II. J.A. 4852–53.

Second, UCB argues that the patient’s “back-sliding” 

symptoms are not necessarily evidence of Form II use. 

Cross-Appellants’ Op. Br. at 69–70. UCB argues that the 

patient’s other health issues might have contributed to 

those symptoms, citing record evidence that “[t]he impact 

of crystals on product efficacy in patients depends on the 

extent of drug release, variability at the level of the patient 

and product, and psychological patient factors.” J.A. 4850. 

We understand this statement to suggest that the “backsliding” is different from patient to patient. But it is not 

relevant, where, as here, the baseline for the “back-sliding” 

is the patient’s own responsiveness to patches she took before and after the patches likely containing Form II. UCB
UCB, INC. v. WATSON LABORATORIES INC. 33

also points out that the patient’s physician suspected different causes for the backsliding because the patient was 

“checked for co-morbidity, suspecting a cold or lung problems due to wildfires,” the patient suffered from conditions 

other than Parkinson’s, she was on several other medications, and her improvement after the switch to patches 

from a different lot number was temporary, with her conditioning declining again thereafter. J.A. 5966. Finally,

UCB argues that a document the district court relied on 

actually shows that there was not enough Form II on the 

patches to cause back-sliding. Cross-Appellants’ Op. Br. at 

70–71. That document explains that ~one-third of a 

patch’s surface area needs to be covered in Form II crystals 

to cause back-sliding, and many of the tested samples from 

the affected batches had an affected surface area of < 30%. 

J.A. 4850. But another report in the record shows affected

areas >40%. J.A. 4848. That there might have been other 

causes for the back-sliding or that there may not have been 

enough crystals on the patches to cause back-sliding are 

speculative facts that are reasonably outweighed by other 

evidence in the record.

Third, UCB argues that Form II cannot penetrate the 

skin, so it has no therapeutic function in a patch, and therefore, the patches administered to the patient in November 

2007 do not count as “use” of the ’414 patent’s invention 

under § 102. Cross-Appellants’ Op. Br. at 62–63. But the 

’414 patent claims simply cover Form II rotigotine, without 

any limitations as to its use. If it was present in the 

patches that were administered to the patient, § 102(a) 

does not require that the invention be used for a particular 

purpose. The case cited by UCB, 3M v. Chemque, 303 F.3d 

1294, 1306–07 (Fed. Cir. 2002), stands for the inapposite 

proposition that evidence of product samples being sent to 

third parties is not sufficient to show that those samples 

were actually used by the third parties. The case here is 

different; there is evidence that patient actually used the 

patches with Form II rotigotine crystals in it. The patient’s 
34 UCB, INC. v. WATSON LABORATORIES INC.

use of the patches fairly counts as public use under 

§ 102(a).

Anticipation under § 102(a) is an issue of fact reviewed 

for clear error. Ecolochem, Inc. v. S. Cal. Edison Co., 227 

F.3d 1361, 1367 (Fed. Cir. 2000). There is plenty of evidence that most, if not all, of the patches in lot 47808 contained crystals, and that those crystals contained Form II. 

There is also evidence that the patient, who reported backsliding only after one week of using lot 47808 patches and 

who reported improvement (even if short-lived) when a 

new set of patches was used thereafter, used patches with 

Form II and that her symptoms matched up with use of 

Form II. J.A. 5966. We do not find clear error in the district court’s finding that Actavis presented clear and convincing evidence of public use before the date of invention 

under § 102(a). Accordingly, we affirm the district court’s 

invalidation of the asserted ’414 patent claims.

CONCLUSION

We affirm the district court’s judgment of infringement 

and validity of the asserted ’434 patent claims, as well as 

invalidity of the asserted ’414 patent claims.

AFFIRMED

COSTS

No costs.