Mumbai: Challenging the near-monopoly of global generic giant Teva Pharmaceutical Industries Ltd in the about $2 billion (nearly Rs10,000 crore) US market for the cardiac drug carvedilol, India’s Glenmark Pharmaceuticals Ltd has filed its counterclaims in the US district court of New Jersey, claiming Teva’s two patents for making the drug is invalid and unenforceable.
The Indian firm’s actions were first reported in Thursday’s The Economic Times.
Glenmark, which is fighting a patent infringement case on carvedilol filed by Teva in August, has accused the Israeli drug firm of engaging in fake litigations and violating anti-trust law.
“Teva is studying Glenmark’s counterclaim and will respond appropriately to the court. Teva believes that its patents are valid and Glenmark infringes those patents,” said Teva’s spokeswoman Shir Altay, in an email response to Mint query.
A Glenmark spokesperson declined to comment, “as the matter is in the court now”.
Carvedilol was originally patented by GlaxoSmithKline Plc. Widely used for treating congestive heart failure, it is sold under the brand name Coreg.
Since Glaxo’s patent on this drug expired in 2007, at least nine generic companies (or those that make off-patent drugs), including three Indian firms—Dr Reddy’s Laboratories Ltd, USV Ltd and Glenmark—have got approvals for copies of Coreg from the US Food and Drug Administration (FDA).
Teva had patented two different processes of making the active pharma ingredient (API) of this drug, and blocked most of the other generic manufacturers from entering the market on the strength of this.
Teva sued all the generic companies who have received the FDA approval for the drug and most of them settled the case with Teva and some of them even agreed to supply the API to Teva exclusively.
Though the product patent has expired in US, the market price has not come down significantly in the absence of competition. While Glaxo sells the product at $246 for 100 tablets, Teva’s price is $213.
“Teva has...monopolized the market for carvedilol API by enforcing a patent it knows is invalid and prosecuting generic manufacturers that do not purchase carvedilol API from Teva in order to secure contracts with those companies,” Glenmark said in its counterclaim which has been reviewed by Mint.
According to an executive of an Indian drug marker involved in a similar case in the US, if there is a ruling in favour of Glenmark, “it will certainly trigger an anti trust investigation against Teva’s share in this generic cardiovascular drug market.” Mint couldn’t immediately ascertain whether the ruling would indeed trigger action by the Federal Trade Commission that looks into anti trust issues.