HC allows Cipla to sell Roche drug

Delhi High Court on Wednesday allowed Cipla Ltd to continue selling its lung cancer drug which is a copy of Tarceva (Known as erlonitib), the branded, patented version owned by Swiss drug giant Roche AG.

Roche had sought an interim injunction against the sale of the drug erlotinib, a generic form. On January 2008 Cipla launches generic version of Tarceva

Patent war journey :

Roche had filed a patent application in India for erlonitib in Mar 13, 1996.

On July 13, 2005 DCGI gives approval to Roche for marketing Tarceva in India

On July 13, 2007 Patent granted for Tarceva in India

On January 19, 2008 Roche files infringement lawsuit at Delhi High Court

On  March 19, 2008 HC allows Cipla to sell version of Roche drug

Tarceva’s cost is Rs 4,800 per tablet, while Cipla sells the generic version, called Erlocip, at Rs 1,600 per tablet.

Sources said the price differential was a key factor behind Wednesday’s ruling.

But my concern is that whether such ruling discourages MNCs to file their patent application in India. It would be absurd if erlotinib patent gets invalid on the basis of pre 1995 invention of same class of drug called gefitinib.

 

Ranbaxy signs deal with CD Pharma for Inersan

Ranbaxy Laboratories has entered into an exclusive marketing agreement for India and Nepal with CD Pharma for Inersan, a patented probiotic preparation.

Inersan is used for the treatment of dental problems like periodontitis, gingivitis and halitosis. According to a release issued by Ranbaxy today, there is no drug available for the treatment of these dental problems in the country today.

 

 

Pfizer's anti-smoking drug: India Versus US

Anti-smoking drug varenicline commercially available as Champix in India, has been launched by Pfizer Ltd., an Indian unit of US pharmaceutical giant. This particular drug branded Chantix in US has been warned by US FDA regulators as the drug causes “changes in behavior, agitation, depressed mood, suicidal thoughts, attempted and completed suicide”. The FDA continues its review of the adverse event reports, and concludes that there may be an association between Chantix and serious mood and behavior symptoms.”

I personally feel that Indian regulators must ask Pfizer to display safety information prominently on its label.

New Patent Filed by Venus Remedies

Venus Remedies announced in a press release that its Intellectual Property Rights (IPR) Department has filed its 7th Patent Application with the Indian Patent Office for a novel, safe, low dose, non-irritating, highly efficacious and physiologically compatible antibiotic for the treatment of bacterial / multi-bacterial infections in children.

The Patent titled “A Low Dose Combination Anti-biotic Formulation” is a novel treatment developed at Venus Medicine Research Centre. This formulation, a Fixed Dose Combination of a latest generation Carbapenem and a latest generation Amino-glycoside, will be the best available solution for treatment of multi-bacterial infections in Neo-Natals and children being 4-8 times more effective at the lowest possible dosage levels- Approx.83% reduction in dosage from conventional therapies-, minimal ototoxicity and nephrotoxicity among all available known similar treatments world wide till date.

Teva sues FDA on generic form of J&J's Risperdal

Teva Pharmaceutical Industries Ltd said on  March 04,Tuesday it filed a lawsuit against the U.S. Food and Drug Administration seeking 180-day exclusivity for the Israeli company's generic form of Johnson and Johnson's Risperdal schizophrenia drug.

Risperdal, which has global annual sales of about $3.5 billion, is expected to lose its U.S. patent protection in late June and face immediate competition from one or more generic drug makers.

Teva, which in 2001 sought U.S. approval for its copycat tablet forms of Risperdal, claims it should have the generic market to itself for the first six months because it was the first generic drug maker to approach the FDA.

In seeking approval for its product at the time, Teva notified the FDA that it planned to officially challenge J&J's main Risperdal patent.

But because the FDA later in 2001 informed Teva it had removed Risperdal from its Orange Book of registered patents, analysts have said the agency will likely allow all approved generics to launch their products in June.

Teva said on Tuesday its lawsuit asks for a relisting of the patent, contending the FDA failed to provide legal notice it was removing the Risperdal patent prior to Teva's challenge.