Friday, October 31, 2008

Zydus drags Teva to court

B D Narayankar

ZYDUS CADILA, an Ahmedabad-based pharmaceutical company, has dragged Teva pharmaceuticals, the world’s largest generic drug maker, to court in the US, seeking damages for Teva’s anti-trust violations and unfair trade practices relating to risperidone drug. The Rs 25,000 crore drug is widely used for treating schizophrenia.

In a recent filing with the Virginia district court, Zydus, through its US subsidiary Zydus pharmaceuticals, presented a lawsuit against Teva on the grounds that Teva’s patent was in violation of unfair trade practices and that Zydus was under no legal obligation to provide its classified documents to Teva for approval before manufacturing the risperidone API (active pharmaceutical ingredient) and the finished dosage forms.

The US Sherman Act of 1890 forbids any contract or combination that restraints trade or any monopoly or attempts to monopolise.

Zydus has denied any infringement of Teva’s patent claims and alleged that Teva obtained the US patents 6750341 and 7256195 wrongfully with the intent to deceive the US patent and trademark office. The company has thus filed for declaratory judgement against Teva’s patent claims. Zydus also claims that it has not infringed on any valid claim of Teva’s patents.

In its filing, Zydus also said that Teva’s representatives have been allegedly advising Zydus’ 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.”

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’ 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.

Source: Meri News

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