Indian pharma giant Zydus Cadila, has taken Teva pharma, the big daddy of generic business, to court in the USA, seeking damages for Teva's antitrust violations and unfair trade practices relating to antipsychotic Risperidone.
Teva had gained exclusivity over Risperdal (Risperidone), branded by Johnson &Johnson, in June 2008, which was later withdrawn by USFDA after court's decision on Sep 14, 2008 (as reported earlier by this blog), Teva almost enjoyed 90 days exclusivity on this product before the court's decision. Zydus Cadila received the USFDA' s final approval to market multiple strengths of generic Risperidone on October 19, 2008. According to the patent petition filed on October 14 by Zydus Cadila, Teva, through a letter dated September 15, 2008, demanded that Zydus should refrain from marketing any Risperidone products until Teva could complete an analysis of Zydus's abbreviated new drug application (ANDA) and review the processes by which such products would be made. The Confidential Disclosure Agreement (CDA) attached to the demand letter requires that Zydus stipulate and agree that Teva's counsel not be disqualified from representing Teva with respect to the prosecution of the pending patent. Zydus has denied any infringement of Teva's patent claims and alleged that Teva obtained the following US Patents wrongfully with the intent to deceive the USPTO.
US6750341 (Teva) : Covers novel forms of risperidone, designated Form A, Form B and Form E. Methods for their preparation are also disclosed. The present invention also relates to processes for making risperidone. Pharmaceutical compositions containing the new forms of risperidone and methods of using them are also disclosed.
US7256195 (Teva): which covers a solid or solid-containing pharmaceutical formulation comprising a crystalline form of risperidone with a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable excipient, wherein the crystalline form of risperidone is characterized by x-ray powder diffraction peaks at 14.0.+-.0.2 and 21.7.+-.0.2 degrees two-theta.
In its filing, Zydus also said that Teva's representatives have been allegedly advising Zydus's customers that a legal action by Teva against Zydus would result in unsellable stock, should they purchase API or any formulation using API from Zydus. Teva is also allegedly threatening both Zydus and its customers with legal action to curtail any distribution of Zydus Risperidone API and API formulation (Source: Link to Economic times news)
IPPharmadoc believes that the above startegy adopted by Teva to threaten generic players by citing its polymorph patents, is to stop further generic challenge after USFDA declined Teva's 180 days exclusivity on Risperidone. The estimated sale targets set by Teva will not be achieved and the Teva will face further generic challenge with approval of other generic players ANDA.
Generic players
Till now, Teva, Mylan, Dr. Reddy, Pliva, Apotex, Zydus, Aurobindo, Wockhardt and Torrent had got final approval to market this product. Around 10-15 generic players are ready to enter into the US market on this product.
Eralier news of IPPharmadoc on Risperidone Here
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