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United States Court of Appeals for the Federal Circuit
June 24, 2019, Decided
[*1275] 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 [**2] 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.
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 Two-Phase Matrix for the Delivery of N-0923, a Dopamine Agonist" by Chiang et al. (Chiang). [**3] 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 [*1276] thereof." The only asserted independent claim reads:
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
927 F.3d 1272 *; 2019 U.S. App. LEXIS 18700 **; 2019 U.S.P.Q.2D (BNA) 231466
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
Prior History: [**1] 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.
UCB, Inc. v. Watson Labs., Inc., 2016 U.S. Dist. LEXIS 2459 (D. Del., Jan. 8, 2016)
patches, rotigotine, adhesive, district court, polymer, transdermal, patient, polyisobutylene, infringement, doctrine of equivalents, silicone-based, patent, invention, matrix, silicone, acrylate-based, back-sliding, solubility, prior art, argues, ensnarement, silicates, acrylate, skilled, polyisobutylene-based, invalidation, Products, artisan, inventors, polymorph
Patent Law, Infringement Actions, Doctrine of Equivalents, Prosecution History Estoppel, Defenses, Patent Invalidity, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, Doctrine of Equivalents, Fact & Law Issues, De Novo Review, Anticipation & Novelty, Anticipation & Novelty, Nonobviousness, Prior Knowledge & Use of Invention, Evidence, Burdens of Proof, Allocation, Civil Procedure, Appeals, Abuse of Discretion, Standards of Review