DC findings of infringement and validity of one UCB rotigotine patent and invalidity of another as anticipated by use in a single patient in a clinical trial affirmed


UCB, Inc. et al. v. Watson Laboratories, Inc. et al.

Docket No. 2018-1397, -1453
TARANTO, SCHALL, CHEN
June 24, 2019

Brief summary: DC decisions finding that UCB’s ‘434 patent was infringed under DOE and not invalid and UCB’s ‘414 patent invalid for anticipation affirmed:

– DC decision that UCB’s OB-listed ‘434 patent is infringed and valid affirmed (NDA N021829 for Neupro®; DC “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”; prior art provided “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”); and,

– DC decision that UCB’s non-OB-listed ‘414 patent invalid for anticipation under § 102(a) affirmed (DC “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”).

Summary: This appeal relates to UCB’s US 6,884,434 and 8,232,414 relating to a transdermal delivery system for the Parkinson’s drug rotigotine and rotigotine polymorph, respectively. The ‘434 patent (directed to a delivery system including rotigotine free base (S enantiomer) “present in the matrix in the absence of water”) is one of eight Orange Book-listed patents for rotigotine (NDA N021829 for Neupro®). The ‘414 patent, directed to the rotigotine “Form 2” polymorph, is not listed on the OB for Neupro®. Actavis appealed DC finding that the ‘434 was infringed and not invalid. UCB appealed the DC’s invalidation of the ‘414 patent under § 102(a) as known and used by others in the US before the date of invention (“Neupro patches with Form II crystals were administered to at least one patient before November 28, 2007.”)

The FC panel opinion explains regarding the ‘434 patent that “[t]he 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.’” Actavis argued that “[t]he Accused Products use a polyisobutylene adhesive, which is different from the claimed acrylate-based or silicone-based polymer adhesives”, while UCB argued that under the doctrine of equivlaents (DOE) those are “interchangeable with the claimed adhesives.” The FC panel explained its agreement with the DC “that UCB was not ‘barred’ from asserting the doctrine of equivalents here because of prosecution history estoppel [PHE], intentional narrow claiming, vitiation, or ensnarement” (Power Int., FC 2018; e.g., “[a] restriction requirement does not necessarily invoke prosecution history estoppel” (Bayer, FC 1984; Merck, FC 1999 (PHE where limiting claims to a subset was “primarily in consideration of the patentability rejection under § 103”), distinguishing this case from the design patent Pacific Coast case (FC 2014)), “UCB never added a polyisobutylene-excluding limitation by amendment, and its election cannot be read as such.”; no “narrowing to a subset”, “evidence of the inventor’s knowledge here at the time of filing is not as clear as in Wrigley” (FC 2012), “UCB’s claiming of acrylates and silicates does not bar treating polyisobutylenes as an equivalent for infringement purposes”; no vitiation (Akzo, FC 2016 (DOE “infringement theory . . . fails if it renders a claim limitation inconsequential or ineffective”), DC “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”; no ensarement (Intendis, FC 2016 (“A patentee may not assert ‘a scope of equivalency that would encompass, or ensnare, the prior art’”, 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”)). The FC panel also agreed with the DC on the merits of the DOE argument (Voda, FC 2008; Mylan, FC 2017 (“the substantial differences test may be more suitable . . . for determining equivalence in the chemical arts”); e.g., “a skilled artisan “would recognize that polyisobutylene is not substantially different from the classes of adhesives literally within the scope of the claims”, the “differences do not matter for how the claimed invention works”, findings regarding “interchangeability”, DC “explicitly stated…infringement requires a comparison of the accused product (the ANDA product) and the claims”).

Actavis also appealed the DC’s conclusion that invalidity of the ‘434 patent was not shown since “Actavis did not provide an adequate rationale for combining the references’ teachings” (the Miranda and Timmerman references), “noting that Actavis did ‘not explain why a [skilled artisan] would have been motivated to start from the patches taught by Miranda’”, and no reasonable expectation of success since “the transdermal patch field was a relatively sparse one at the pertinent date” and “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” (“a skilled artisan “would have confronted a significant challenge to create a patch that was successful at treating Parkinson’s disease”). The FC panel affirmed the DC’s decision since there was “an evidentiary gap as to why a skilled artisan would think of using a transdermal patch, as taught in Miranda, based on Timmerman” and no reasonable expectation of success (e.g., “Miranda discloses thousands of combinations for making transdermal patches” and is “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.”)

UCB argued the DC should not have held the ‘414 patent invalid under pre-AIA § 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.” The FC panel agreed, however, concluding that the DC “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” (i.e., a patient “had received samples of Neupro in September 2007 and ‘responded well’ to treatment”, “report shows that all [patches] had crystals within a month of storage”, “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”). FN14 explained that UCB waived any arguments regarding an earlier date of invention since UCB “failed to raise any issue with the invention date until post-trial briefing”, even though it knew Actavis was reliant upon the Nov. 28, 2007 filing date in its arguments (Bausch, FC 1986; Chimie, FC 2005). The FC panel therefore found no clear error with the DC’s anticipation finding (Ecolochem, FC 2000).

This entry was posted in Anticipation (35 USC 102), Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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