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BY OUR CORRESPONDENT
28 October,2006: New product patent regime in India has unleashed a spate of oppositions from domestic drug makers even before granting of intellectual property rights to innovator
MNCs.
India went complying TRIPS (Trade-Related Intellectual Property Rights) since the beginning of 2005, following obligations as a signatory to
WTO.
Product patent era, that ensued, came with a radically changed patent law which gave way to protection of IP rights by originator firms. The move was in sharp contrast to those laws which allowed only patenting of processes and permitted copying of inventions made by other companies which was prevailing for many decades.
However, the new patent policy came up with certain strings attached. It included clauses like pre-grant opposition and post-grant opposition of patents. That means concerned parties can oppose the IP claims made by innovator companies before and after the granting of patents.
As the country is yet to grant a sizeable number of patents on the thousands of patents applications filed with the authorities, the cases for post-grant opposition is comparatively less. But, in case of pre-grant oppositions the instances are very many.
"Because, India’s new patent regime allows anyone to oppose a patent application by bringing to the patent examiner’s notice, information which would show that the patent is deficient,’’ says an industry expert.
Till date, Indian pharma companies have filed 148 pre-grant oppositions to patent applications in India, according to industry and legal sources.
India’s leading drug firms Ranbaxy Labs and Cipla are believed to have filed around 55 and 15 oppositions, respectively. While the mid-sized Torrent Pharma is accounted for more than 50 of these pre-grant oppositions.
Among these, Torrent has opposed the grant of a patent on Astra Zeneca’s cholesterol drug rosuvastatin, while Ranbaxy has filed for pre-grant opposition against Pfizer’s anti-fungal drug voriconazole. Ajanta Pharma has opposed Eli Lilly’s patent application on erectile dysfunction drug tadalafil, and Cipla and Hetero have opposed Wockhardt’s patent application on anti-bacterial drug nadifloxacin.
Even as the desi industry continues to defend pre grant opposition arguing that such a provision gives domestic pharma companies a chance to provide the patent examiner with information he may otherwise be unaware of, the transnational drug makers find this as a real bane.
"Pre-grant oppositions are only making the process of the grant of the patent more procedural,’’ says Ranjit Shahani, vice-chairman and managing director, Novartis and president of the Organisation of Pharmaceutical Producers of India
(OPPI).
However, the home-grown companies in India feels that patents justifiably provide innovative companies protection from generic competition. It takes 12 years, on an average, for a new drug to travel from the lab to the patient, and costs an estimated $802m. However, many experts feel patents should not be granted unduly.
Therefore, Indian patent law states that a patent may be opposed, if the invention obtained from the opponent was previously published or “publicly known”. Lack of any significant innovative step or failure to provide information on foreign applications can also be grounds to oppose a patent.
“Patients should not have to pay a premium on drugs, which are not truly innovative, and patents being applied for in India are deficient, bogus or not patentable,” says Amar Lulla, MD, Cipla.
As patented drugs enjoy a situation of monopoly in the market, they are not priced as competitively as generic products. “Pre-grant oppositions are a mechanism to protect Indian consumers,” he adds.
The multinational pharmaceutical companies that have filed patent applications for their blockbuster drugs in India find oppositions not only from desi firms but from public health NGOs also.
Interestingly, patient groups and public health NGOs have already filed pre-grant opposition on select drugs (mainly HIV / AIDS drugs) in patent offices across the country. The NGO intervention is a totally new phenomenon as opposition to patent applications was entirely an industry initiative during the pre-product patent days
The NGOs' determination to ensure cheap generic drug options available would see them fight tooth and nail against all apparently 'frivolous' patent applications. On the contrary, the domestic companies could be persuaded to drop their oppositions by striking mid-way deals and business compromises.
BY OUR PHARMA CORRESPONDENT |
