Donepezil (Aricept) 5 mg and 10 mg Tablets: The district court declined Teva’s request for DJ

The US district court for the district of New Jersey declined M/S Gate pharma’s declaratory judgment request of non-infringement against 4 patents listed by innovator for Donepezil (Aricept) 5 mg and 10 mg Tablets

Following patents are listed In the Orange book for 5 and 10 mg tablets of Donepezil hydropchloride:

US4895841 (Expiry: NOV 25, 2010)- Product patent

US5985864 (Expiry: DEC 30,2016)- Polymorph (Form-II, III, IV and V)

US6140321 (Expiry: DEC 30,2016)-polymorph

US6245911 (Expiry: DEC 01,2018)-Polymorph A, B and C

US6372760 (Expiry: MAR 31,2019)- Formulation

Ranbaxy filed (first para IV filer) ANDA with Para IV certification against ‘864, ‘321, ‘911, ‘760 and Para III against product patent ‘841.

Generic player Teva filed ANDA on Oct, 2004, with Para IV certification against ‘864, ‘321, ‘911, ‘760 and Para III against product patent ‘841. Later, in Oct, 2005, Teva amended it’s ANDA with Para IV against product patent ‘841. Due to Para IV filing against product patent, Teva also got First Filer status.

Also, in late 2005, a subsidiary of Teva, M/S Gate Pharma filed ANDA with different API of Donepezil, with Para III certification against all O.B Patents. However, after nearly two years, Gate amended it’s ANDA on Nov, 2007 with Para IV against all patents.

Subsequently, innovator sued Gate and Teva for the infringement of ‘841 and the district court found the patent valid, enforceable and issued preliminary injunction against generic launch, as reported by this blog Here.

After the said decision, with an aim to trigger Ranbaxy’s exclusivity (and Teva’s, too), the Gate filed DJ action of non-infringement, citing ANDA approval delay by USFDA. Further, innovator has already disclaimed ‘864 and ‘721 patents and for '911 and '760 patents innovator issued ‘convenant not to sue’ to Teva. In its opposing motion, innovator Esai contends that the court lacks subject matter jurisdiction because Teva’s claim for DJ present no justiciable controversy.
The US district court for the district of New Jersey declined Gate pharma’s declaratory judgment of non-infringement against ‘864, ‘321, ‘911 and ‘760.

The district court opined that M/S Teva did not risk a lawsuit from innovator Eisai or face the threat that the USFDA might block its ANDA approval process.

Earlier, Apotex has also filed DJ action of non-infringement against above 4 patents with an aim to trigger Ranbaxy’s 180 days exclusivity.