UCB, Inc. v. Watson Labs. Inc.

Case Name: UCB, Inc. v. Watson Labs. Inc., Nos. 2018-1397, 2018-1453, 2019 U.S. App. LEXIS 18700 (Fed. Cir. June 24, 2019) (Circuit Judges Taranto, Schall, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Stark, J.) 

Drug Product and Patent(s)-in-Suit: Neupro® (rotigotine transdermal system); U.S. Patents Nos. 6,884,434 (“the ’434 patent”) and 8,232,414 (“the ’414 patent”)

Nature of Case and Issue(s) Presented: Neupro is a skin patch treatment for Parkinson’s disease. The ’434 patent is directed to the transdermal therapeutic system comprising rotigotine. The ’414 patent is directed to a specific polymorph of rotigotine (“Form II”). UCB sued Actavis for infringement of the ’434 and ’414 patents based on Actavis’s ANDA filing. The district court found the asserted ’434 patent claims valid and infringed under the doctrine of equivalents by Actavis’s ANDA products and that the asserted claims of the ’414 patent were invalid based on anticipation.

Actavis appealed both findings regarding the ’434 patent. On appeal, Actavis argued that UCB could not assert infringement under the doctrine of equivalents. Actavis also argued that the ’434 patent were also invalid on grounds of obviousness. UCB cross-appealed the invalidation of the ’414 patent, arguing that the evidence presented at trial did not support the court’s determination that the invention was in use before the correct invention date. The Federal Circuit affirmed the district court’s decision.

Why UCB Prevailed on the ’434 patent: The primary issue was whether Actavis’s use of a polyisobutylene-based adhesive was equivalent to the ’434 patent’s use of acrylate or silicone-based adhesives. The ’434 patent claim covered administration of rotigotine through a transdermal patch made of three layers. The adhesive layer included an effective amount of the free base form of rotigotine dissolved in an acrylate or silicone-based polymer adhesive. Actavis’s product met every other element of the asserted claims. UCB argued that, under the doctrine of equivalents, polyisobutylene-based adhesive was interchangeable with acrylate or silicone-based adhesives. In response, Actavis argued that UCB could not assert infringement under the doctrine of equivalents because UCB made a “narrowing amendment” after the examiner issued a restriction requirement. The examiner required UCB to elect claims to prosecute from either “Group I” or “Group II.” Group I claims all included an acrylate or silicone-based polymer adhesive. Group II claims were generically directed to “an adhesive.” Actavis argued that because UCB withdrew Group II claims, it gave up the scope of adhesives that were not silicates or acrylates. The Federal Circuit disagreed, explaining that a restriction requirement does not necessarily invoke prosecution history estoppel. The examiner’s restriction in this case did not relate to polyisobutylene or communicate anything about patentability of polyisobutylene-based adhesives, and related to an entirely different limitation.

Next, Actavis argued that UCB had chosen to draft narrow claims and could not expand the scope of the claims through the doctrine of equivalents. Specifically, Actavis argued that polyisobutylene was generally known in the art as a possible adhesive for transdermal patches, and that the patentee chose not to prosecute claims broad enough to cover it. But the Federal Circuit found that UCB’s claims corresponded directly to the specification and did not narrow to a subset of polymers. The claims recited all acrylate-based or silicone-based polymer adhesive systems. The Federal Circuit also found that the record did not sufficiently establish the inventor’s knowledge to support a conclusion that UCB surrendered polyisobutylene as an equivalent.

Actavis also argued that UCB’s infringement theory vitiated the acrylate or silicone-base polymer adhesive limitation. The Federal Circuit rejected this argument, stating that finding polyisobutylene to be an equivalent did not give the acrylate or silicone-based polymer adhesive system such a broad scope that the element disappeared entirely. Actavis then argued that a hypothetical claim including polyisobutylene-based polymers would ensnare prior art. The Federal Circuit affirmed the district court’s rejection of this argument. The prior art Actavis pointed to covered silicone and acrylate, which would invalidate both the actual and hypothetically broad claims. Additionally, Actavis did not offer examples of prior art that would be ensnared by adding polyisobutylene to the claim.

As to the actual equivalents analysis, the district court applied the (in)substantial differences test. The district court found that silicates, acrylates, and polyisobutylenes were the most commonly used pressure-sensitive adhesives at the time the ‘434 patent was filed. The court identified five properties that the adhesives shared: (i) they are pressure-sensitive, (ii) adhesive, (iii) biologically inert, (iv) non-irritating, and (v) non-toxic. The district court also held that a POSA would recognize that polyisobutylene is not substantially different from the adhesives within the scope of the claims because of their shared properties. The Federal Circuit concluded that the polyisobutylene-based adhesive system was an insubstantial modification of the claimed invention because the differences do not matter for how the claimed invention works.

Next, the Federal Circuit affirmed the validity of the ’434 patent. Actavis argued that the Cygnus prior art reference anticipated the ’434 patent. The district court found that Cygnus did not include rotigotine in free base form. Actavis also argued that the ’434 patent was obvious based on Cygnus’s combination with Lipp or Pfister. The district court concluded that neither Lipp nor Pfister filled the gap regarding rotigotine in a free base form because neither disclosed any anti-Parkinson’s drugs or rotigotine free base in the absence of water. The Federal Circuit affirmed the district court’s findings.

The Federal Circuit also affirmed the district court’s rejection of Actavis’s obviousness argument. First, Actavis did not show that a POSA would be motivated to combine relevant prior art. The transdermal patch field was sparse, and of the drugs available as patches rotigotine was the only active ingredient introduced as a patch before being available in another formulation. Actavis did not show why a POSA would think of using a transdermal patch based on the prior art’s disclosure of applying a liquid dose of rotigotine on the hairless skin on a rat’s neck. Second, Actavis did not show a reasonable expectation of success.

Why Actavis Prevailed on the ’414 patent: The ’414 patent claimed Form II, a polymorphic form of rotigotine, discovered during the dissolution step of manufacturing Neupro. UCB appealed the district court’s invalidation of the ’414 patent under § 102(a). UCB argued that the record did not support the district court’s inference that Form II was in actual use before the correct invention date. The district court found that Form II rotigotine was used before the patent’s filing date because it found that a patient had used patches from a certain lot of Neupro at least one week prior to the ’414 patent’s priority date. The district court found that those patches contained Form II rotigotine crystals.

On appeal, the Federal Circuit rejected UCB’s argument that there was insufficient evidence that there were Form II crystals in the patient’s patches. The Federal Circuit noted that the record showed that all lots where crystals were observed contained Form II. The Federal Circuit also rejected UCB’s argument that the patient’s worsened condition was not necessarily evidence of Form II use. The Federal Circuit held that the possibility of another cause of the patient’s worsened condition or that there were not enough crystals to cause the patient’s worsened condition was speculative and outweighed by other evidence in the record.