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October 6, 2010

Jumping Line

The 1984 Hatch-Waxman Act created a path for generic drug companies to line up for manufacture of drugs coming off patent. Teva tried to jump the line for donepezil, an Alzheimer treatment drug, from Eisai, who was first in line for permission to make a generic version. Teva did this by filing a DJ of noninfringement. The district court dismissed, citing lack of jurisdiction, figuring no actual controversy between Eisai and Teva. The CAFC reversed and remanded. Teva v. Eisai (CAFC 2009-1593) is essential reading, in its entirety, for those interested in the intricacies of the drug patent game, as this precedential ruling changes the game, albeit in a nuanced way.

Posted by Patent Hawk at October 6, 2010 9:01 PM | Declaratory Judgment


Declaratory Judgement jurisprudence presents two contradictory legal precedents that have been set aside by the courts. One is Caraco Vs Forest lab and the other one is Janesson vs Apotex. The Caraco case presents judicially created article III controversy despite Forest labs issues a covenant not sue declaration. The Caraco case precludes the entry of generic companies to make available the low cost generic version to the public and hence presents a potential cognizable injury to the generic company. The Janesson vs Apotex does not present article III controversy as Apotex stipulated to the validity of the product patent. The Eisai vs Teva presents yet another article III controversy as the situation in this somewhat resembles the Caraco case. Despite statutory disclaimers have been issued against two patents and Eisai declared covenant not to sue on the remaining two patents, the listing of patents in the Orange Book proved impending blocking mechanism for the generic entry unless court verdict prevails upon the Orange Book listing patents as non-infringing or invalid. Hence, the situation is bit different from the aforesaid cases.

Posted by: K.M.Senthil Kumar at October 13, 2010 9:28 PM