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Domestic pharmaceutical companies, after challenging the drug patent regulations in Europe and US, are now adopting measures to challenge patents offered to the companies having their base outside India.
Many companies have submitted their applications to gain marketing rights of medicines that are regulated by patents in India. Global drug makers including Pfizer, Roche, Merck, and Bayer have the patent rights. India gave permission for the product patent protection for medicines from the month of January 1, 2005.
Hetero drugs and Sun Pharma sought marketing approval from the Drugs Controller General of India (DCGI) for generic editions of Selzentry, which is an anti-HIV medicine of Pfizer and is protected by patent rights in India. DCGI is working on both applications.
Patent challenge means that a company has gained the marketing approval to introduce its products in the market. And the company, which owns patent for the drugs, can sue another company for violation of the patent rights.
Joint managing director of Cipla, Amar Lulla said companies based in India submit their applications for marketing approval for the product patent protection for many reasons. He added, “It could be because we feel the patents are invalid or it could be for exports to countries where there is no patent infringement”.
The companies also approach the drug regulator for marketing approval so that they can export these drugs to lesser developed nations, which are not bound by any product patent protection. Pharmaceutical giants like Cipla, Ranbaxy and APC Pharma have acquired such no-objection-certificates from the drug controller authorities to export generic editions of Baraclude (entecavir). Baraclude is administered to the patients who are suffering from viral infections of hepatitis-B. Bristol Myers Squibb has also obtained a product patent protection for the medicine in India.
The Indian drug companies have an access to marketing approval for product patent protection, as according to the drug laws in India medicine’s patent status and its marketing approval are the different issues. A senior official from the regulatory body told, “Whenever a company applies for a new drug, we ask them about the patent status of the product. If the company is willing to take the risk of launching a product irrespective of the patent status of the medicine, it’s their decision. Our role is to see if the medicine is safe and efficacious”.
According to domestic pharmaceutical companies marketing approval does not mean violation of the patent right of anyone. However, if a company is planning to introduce that product, then it can be said to be violation of one’s patent rights. Secretary General of Indian Pharmaceutical Alliance (IPA), which is a reputed club of large drug companies in India, D G Shah said “Approval from the drugs controller does not mean the companies are going to market the product. For small firms, it could be preparedness to hit the market at the first opportunity, if a big domestic player opposes and reverses the patent”.
Cipla introduced the generic edition of the bird flu medicine, oseltamivir, while the Gilead’s application for patent rights for Tamiflu was still pending. The Gilead application was later refused by the patent official.
Multinational companies are worried over the provision that enables companies to apply for marketing approval for a drug with a legal patent. Bayer, the German pharmaceutical company, had sued Cipla to stop it from obtaining marketing approval for its drug, which had patent protection. The German conglomerate sought the court to prevent the drug controller from granting marketing approval for generic editions of Nexavar (sorafinib tosylate), which is a cancer drug protected by patent rights, to competitors like Cipla in this field. The judicial proceeding is going on and the decision of the drug regulator in this regard is dependent on the final verdict in the legal proceedings.
Business Standard
January 8, 2010
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