Rotigotine - USA

On Nov. 14, 2017, Chief Judge Leonard P. Stark of district of Delaware issued a decision in Rotigotine (Neupro®) case & found one patent valid & infringed while another patent invalid in a Hatch-Waxman proceeding challenged by Actavis.

This patent infringement action was brought by Plaintiffs UCB, Inc., UCB Manufacturing Ireland Limited, UCB Pharma GMBH, and LTS Lohmann Therapie-Systeme AG (collectively, "UCB" or "Plaintiffs") under the Hatch-Waxman Act. Plaintiffs filed suit against Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc. (collectively, "Actavis" or "Defendants"), which submitted an Abbreviated New Drug Application ("ANDA") to market a generic version of Neupro®, a patch for transdermal delivery of rotigotine for treatment of Parkinson's disease. Plaintiffs assert U.S. Patent Nos. 6,884,434 and 8,232,414. The '434 patent is listed in the Orange Book and generally describes and claims transdermal systems containing rotigotine as a free base for treatment of Parkinson's disease. The '414 patent claims a certain polymorphic form of rotigotine. In June 2017, the Court held a four-day bench trial.

With respect to US’434 patent, the only difference between the disputed element and Actavis' matrix is the use of a polyisobutylene-based polymer adhesive system instead of an acrylate- or silicone-based polymer adhesive system as literally claimed. Court having considered the purpose for which the polymer is used in the patent, the qualities it has when combined with the other ingredients and the scaffold function that it is intended to perform, (Graver Tank. 339 U.S. at 609) the Court found that polyisobutylene and the recited silicone and acrylate polymers are not substantially different in the context of these claims. Accordingly, the Court concluded that UCB has proven by a preponderance of the evidence that Actavis infringes claim 1 of the US’434 patent. Having found Actavis' ANDA products to infringe claim 1 of the '434 patent, the Court further finds that the ANDA products also infringe the asserted dependent claims. Court also concluded that Actavis has failed to meet its burden to prove by clear and convincing evidence that the asserted claims are invalid for anticipation or obviousness.

The US'414 patent claims a new polymorphic form of rotigotine, Form II. Actavis contends that the claims of the '414 patent are invalid because: (1) the invention was derived from LTS scientists not named as inventors, (2) prior art inherently discloses Form II, and (3) Form II was used in the United States before the date of the invention. Court concluded that Actavis has failed to meet its burden to prove invalidity by clear and convincing evidence under its derivation and inherent anticipation theories, but has met its burden to prove by clear and convincing evidence that the claims of the '414 patent are invalid because the invention was in use in this country before the patent's priority date. Because on November 30, 2007, just two days after the priority date, a female patient experienced an adverse event while being treated with Neupro from lot no. 47808. The Report indicated that the patient was on the lot 47808 patches for "one week," before she experienced adverse event. Further, it is reasonable to infer that the 47808 patches used by the patient contained Form II rotigotine. By November 12, 2007, the vast majority of patches tested from this lot contained visible snowflake crystals corresponding to Form II. Thus, the Court found that Form II rotigotine, the invention of the '414 patent, was used in this country before the priority date by at least one patient

CONCLUSION: Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the Court concludes that: (1) Actavis infringes claims 1 5, 7, 14, and 15 of the '434 patent; (2) claim 1 of the '434 patent is not invalid due to anticipation; (3) claims 1, 5, 7, 14, and 15 of the '434 patent are not invalid due to obviousness; (4) claims 1-3 of the '414 patent are not invalid due to derivation or inherent anticipation; and (5) claims 1-3 of the '414 patent are invalid under§ 102(a) because the claimed invention was in use in the United States before its priority date.