The Hindu Business Line : Sun Pharma in patent infringement case

DESPITE the patent-challenge strategy for the US generic drugs market being fraught with litigation, Indian drug companies do not seem to have entirely given up this option.

The most recent example is Mumbai-based Sun Pharma — whose recent filing in the US market for a generic version of cancer-related drug Ethyol (amifostine) has been challenged by the US-based Medimmune Oncology.

Ethyol is used as an adjunct to cancer therapy, which protects against the side effects of chemotherapy and radiation treatment. Ethyol injection is reported to reduce toxicities associated with cancer therapies.

According to industry sources, Sun Pharma has been sued, earlier this month, by Medimmune Oncology for a patent infringement by Sun's filing in the US market for generic Ethyol.

Sun Pharma had filed a Drug Master File for generic Ethyol (the chemically-equivalent version of the original drug) in the US market, earlier this year. "Ethyol injection protects against harmful effects of Cisplatin and radiation treatment used in anti-cancer treatment," an industry representative said.

The drug is reported to have clocked revenues of $94 million in 2003 in the US and its patents expire in July 2012/December 2017, an analyst tracking the company said.

Commenting on the adoption of the Para IV strategy or the patent-challenge route adopted by the domestic drug company, the analyst said that the strategy cannot be ignored because of the "jackpot" that they hit, if they win the case.

The strategy, however, did take a beating earlier this year following the high-profile setback that Dr Reddy's Laboratories suffered in its legal battle with Pfizer over the latter's hypertension drug Norvasc.

"All is well as long as companies win the patent-challenge cases. But shareholder pressure begins to build if companies do not win their cases, as the entire exercise can burn a deep hole in the companies' pocket," an industry representative observed.

"Indian drug companies are learning from these experiences and are being more careful. Some of them are mixing the aggressive patent-challenge strategy, with a more safe collaborative strategy of alliances. In this case, Sun has picked a niche product where an alteration in the drug is possible and that makes their case strong," an analyst observed.

But the end is far from sight, in the given case, with Sun Pharma now having to defend its filing in the Courts. So no revenue can be expected from this filing in the current or forthcoming fiscal, said an analyst tracking the company.

More Stories on : IPR | Courts/Legal Issues | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
Top priority to taming inflation, says PM

Settlement of 400 tax arrears cases to be expedited

Mixed response to strike — AIMTC rebuts Govt claims

Govt may allow bidding for coal mining blocks

Sun Pharma in patent infringement case

The sum & substance of personal loans