INDIA BUSINESS WORLD - March 16^th - March 31^st - 2008

PFIZER FILES TWO SEPARATE PATENT INFRINGEMENT CASES AGAINST RANBAXY LABORATORIES

In a bid to extend the exclusivity of its $13-billion anti-cholesterol drug Lipitor, Pfizer—the world’s largest drugmaker—has filed two separate patent infringement cases against Ranbaxy Laboratories. Pfizer wants to prevent the Indian company from launching generic versions of Lipitor (Atorvastatin) and Caduet (a combination drug of Lipitor) in the US until 2016.

At present, Ranbaxy can launch Atorvastatin only in March 2010. The lawsuits seek to extend that ban by six more years. According to estimates, it is expected to generate $1 billion in the first six months after launch. A delayed launch will therefore be a big setback for the Indian drugmaker.

The US drugmaker filed the suits in the Delaware district court, alleging that Ranbaxy would infringe upon the process patents of both its drugs if it were to sell low-cost versions in the US market. A Ranbaxy spokesperson declined to comment. Ranbaxy, riding on many litigations, has been able to advance the launch date of its Lipitor version by 15 months to March 2010. The patent for Lipitor in the US expires in July 2011.

Incidentally, Pfizer’s latest offensive against Ranbaxy is on expected lines as Lipitor accounts for about a quarter of its total global sales. Caduet, which is a combine of Lipitor and hypertension drug Norvasc, had $568 million in sales in 2007.

As drug discoveries dry up, innovator companies are desperately trying to fend off generic competition to protect existing patented drugs.

For Ranbaxy too, big bucks are riding on the drug’s launch. It is the first generic company to challenge the patent and if successful, will get six months exclusive marketing rights along with the innovator company.

Industry experts are divided on the development’s impact. While some believe Pfizer’s move is boosted by its recent success in the Canadian court and it might be able to delay Ranbaxy’s generic launch, others think that the impact can’t be gauged before the court decision.

The Federal Court of Appeal of Canada had overruled a lower court order that will prevent Ranbaxy from getting regulatory nod to launch a Lipitor copy till July 2010. Ranbaxy is fighting patent battles with Pfizer to launch low-cost versions of Lipitor in over 15 countries. It was successful in invalidating Pfizer’s patent in Norway and the UK, but received an adverse ruling in Spain.