06 May 2010
New Delhi, India
Roche, a Swiss drugmaker, lost the patent in India on its anti–viral drug Valcyte, widely used by AIDS patients, after the patent office concluded it did not contain necessary innovation to qualify for marketing exclusivity, said lawyers involved in the case. The ruling would help local generic makers, like Ranbaxy Laboratories and Cipla, launch cheaper copycat version of the drug in the local market. These companies, along with Matrix Laboratories and Bakul Pharma, challenged the patent granted to Roche.
“This shows patents are being granted without proper examination,” said Anand Grover, who fought the case on behalf of two HIV patient groups. The patent was revoked for lack of ‘inventive step’ and under section 3(d) of the Indian patent laws, that rejects patent for incremental innovations unless it provides significant thereupatic efficacy over existing compounds. Roche India did not respond to ET’s query on whether it will appeal the decision.
Valcyte, whose chemical name is valgancyclovir, can also be used to prevent infection in patients who have received an organ transplant like kidney, heart, or kidney–pancreas.
The Patent Office has been active clearing more than 40,000 patent grants in the past three years. This has led to many disputes and put it in conflict with the interests of patients for whom affordability is vital, rather than rewarding a company for innovations, which at times, are dragged on with token improvements. It is ill–equipped to deal with the volume of patent applications. Its total staff remained at 170 for nearly six years despite surging cases.
The office has also ruled that patient groups are part of “person interested” under Indian patent laws and therefore can oppose drug patents. The ruling follows a Supreme Court directive to the Patent Office to re–consider the patent. “This will certainly engender more oppositions from civil society and patient groups and is a welcome development,” said patent expert Shamnad Basheer. “The reasoning for the revocation is very sound.” For Cipla, which launched Valcyte’s generic version in India in September 2008, the ruling is a relief since it escapes penalty payment to Roche for alleged violation of the patent. It has been a long legal battle for the non–government organisations, which opposed the patent.
These not–for–profit organisations appealed to the Madras High Court after Roche was granted patent in June 2007 without hearing opposition from patient groups.
In December 2008, the court directed the patent office to review its decision, but Roche moved the Supreme Court agaisnt the order. Subsequently, the top court directed the Assistant Patent Controller, Chennai, to hear the opposition. “The price of the drug remains unaffordable and its patent hampered the availability of generic versions of valgancyclovir,” said Leena Menghaney, an executive at Medicines Sans Frontieres.
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