Novartis Trouble Over Diclofenac Patent

Earlier this month, on May 03 US-based Biogan Biopharmaceutical and Swiss-based Jagotec filed a patent infringement lawsuit against Novartis Consumer Health Inc. (NCH) in the US District Court for District of New Jersey alleging infringement of the US Patent Nos. 5,852,002 (the ‘002 patent), 5,929,048 (the ‘048 patent) and 5,985,850 (the ‘850 patent) covering topical gel formulation of Diclofenac sodium, marketed as Solaraze®. The subject patents are assigned to Jagotec and exclusively licensed to Bioglan, and are directed to claims for dosage form and method of treatment. The complaint is filed in response to NCH submission of New Drug Application (NDA) No. 22-122 to the US FDA under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act along with Para IV certification (21 USC § 355(b)(2)(A)(iv)) seeking approval to sell diclofenac sodium topical gel before the expiration of Solaraze Orange Book listed ‘002, ‘048 and ‘850 patents. In its complaint, Bioglan alleged that NCH had actual and constructive notice of the ‘002, ‘048 and ‘850 patents prior to the filing of the NCH NDA and filed the NDA with a Para IV certification without adequate justification for claiming the patents will not be infringed.

PDL Biopharma Sued Sun Pharmaceutical Over Cardene® I.V. Patent

On April 16 and 17, 2007 US-based biopharmaceutical company PDL Biopharma has filed patent infringement complaints in the US District Court for the Eastern District of Michigan Southern Division and District Court for the District of New Jersey against India-based generic drug manufacture - Sun Pharmaceutical Industries alleging infringement of the US Patent No. 5,164,405 (the ‘405 patent) covering marketed Cardene® I.V. formulation. Cardene® I.V. is a parenteral composition of nicardipine hydrochloride in 2.5 mg/ml dosage strength. The complaint filed in response to Sun’s submission of the abbreviated new drug application (ANDA) No. 78-405 to the US FDA seeking approval to sell generic approval of injectable nicardipine hydrochloride product before the expiration of the Orange Book listed ‘405 patent. In its complaint, PDL Biopharma alleged that Sun’s ANDA product would infringe, either literally and/or under the doctrine of equivalents, at least one claim of the ‘405 patent pursuant to USC 35 § 271(e)(2).

Apotex Moves Para IV for Allergan’s Alphagan

Canadian generic drug maker – Apotex has made a Para IV certification with its Abbreviated New Drug Application (ANDA) Nos. 78-479 and 78-480 to manufacture and market generic version of Allergan’s Alphagan P, generically known as brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Alphagan five Orange Book listed patents – US 5,424,078; US 6,562,873; US 6,627,210; US 6,673,337; and US 6,641,834 (collectively “Allergan Patents”). Subsequently Apotex notified Allergan, and in response of which Allergan filed a complaint for patent infringement in the US District Court for the District of Delaware alleging that submission of Apotex’s ANDAs for approval to sell brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Allergan patents will constitutes an act of infringement under USC 35 § 271(e)(2). Allergan patents cover various aspects of the Alphagan P 0.15% and 0.10%.

Smithkline Blocks Generic Avandaryl

On May 11, 2007 Smithkline Beecham filed a patent infringement lawsuit against Teva Pharmaceutical Industries alleging that the Teva’s submission of ANDA for approval of sell generic version of Smithkline’s Avandaryl would constitute an act of infringement pursuant to 35 USC § 271(e)(2). In its complaint, Smithkline alleged that the Teva proposed generic formulation would infringe Avandaryl Orange Book listed patents – US 5,002,953 (the ‘953 patent) and US 5,741,803 (the ‘803 patent). Earlier Teva submitted ANDA with Para IV certification to the FDA for marketing approval of generic version of Avandaryl (combination of rosiglitazone maleate and glimepiride) before the expiration of the ‘953 and ‘803 patents. The ‘953 patent is directed to substituted thiazolidinedione derivatives exemplified by markush structural formula which covers rosiglitazone as 5-(4-[2-(N-methyl-N-(2-pyridyl) amino) ethoxy] benzyl) 2, 4-thiazolidinedione. The ‘803 patent is species patent covering maleic acid salt of rosiglitazone.

Abbott Moved Patent Infringement Complaint Against Wockhardt

Abbott Laboratories - the RLD status holder of Depakote ER has filed a patent infringement complaint in the US District Court for the District of New Jersey against India-based generic drug manufacture - Wockhardt Ltd. alleging that Wockhardt’s ANDA # 78-705 submitted to the US FDA for generic approval of divalproex sodium extended release tablets infringes Abbott’s US Patent No. 6,713,086 (the ‘086 patent) expiring on December 18, 2018. The complaint is intended to prevent the FDA from approving Wockhardt’s generic version of Depakote ER before expiry of the ‘086 patent. In its complaint, Abbott alleged submission of ANDA # 78-705 for approval to sell divalproex sodium extended-release tablets in 500mg dosage strength before the expiration of the ‘086 patent will constitutes an act of infringement pursuant to 35 USC § 271(e)(2). The ‘086 patent is directed to controlled release formulation of divalproex sodium.

Dr. Reddy’s Burns Down to Aciphex Patent Dispute

ut Eisai Inc has successfully defended its U.S. Patent 5,045,552 (the ‘552 patent) for the heart burn drug Aciphex, knocking down India-based Dr. Reddy’s Laboratories and Israel-based Teva Pharmaceuticals Industries Ltd. move to launch their respective generic versions of Aciphex before the ‘552 patent expiry in May 2013. Aciphex, generically known as Rabezpraxole Sodium, is co-marketed by PriCara (Unit of Ortho-McNeil) and Eisai in the United States raking up US sales of US $1 billion in 2006. In its ruling, the US District Court Southern District of New York ruled that the ‘552 patent is enforceable, which in earlier ruling, confirmed the validity of the ‘552 patent. During trial Dr. Reddy’s and Teva alleged, among other things, that the ‘552 patent is unenforceable because of Eisai’s inequitable conduct before the United States Patent & Trademark Office during prosecution of the patent, which judge Gerard Lynch ruled against Dr. Reddy’s and Teva after defendants (Dr. Reddy’s and Teva) failed to establish the defense of inequitable conduct by clear and convincing evidence.