Mumbai: Adding significant ammunition to an ongoing government investigation involving drug giant Roche and a key patent granting office in India, there is now new evidence that an India patent was approved for the drug some three years after a similar application was turned down in the US by the US Patent and Trademark Office.
The office of India’s controller general of patents, based in New Delhi, is conducting an inquiry whether the decision of the Chennai Patent Office to grant Roche a patent for its anti-infection drug, valganciclovir, violated Indian rules.
Roche executives insist the US and Indian decisions cannot be linked because of different laws.
“The patent for this product was granted fully in compliance with the Indian law,” says Roche India managing director Girish Telang.
Arrayed against F Hoffmann-La Roche Ltd’s India unit is Mumbai-based non-profit, Lawyers Collective, which had opposed the patent in 2006, 11 months before Roche’s Indian unit eventually got the patent in June 2007, without a pre-grant opposition being heard.
It is quite unclear how Roche has been able to obtain the patent. Most multinational drug companies in India have had the opposite problem—they claim drugs for which the rest of the world gives patent protection are not being protected in India.
A review of a US PTO document by Mint shows that a key patent application for the same drug was rejected by that office back in 1994 because the drug had been in the so-called public domain for three years.
The document also shows that while the original Roche claim for a comprehensive patent was indeed rejected, a patent was granted to the crystalline form of the drug based on findings that a modification eases the manufacturing process for the drug. But, in India, the Roche patent covers both the basic compound as well as a crystalline form, giving the drug maker a much more formidable patent.
“Both these findings show that the Chennai patent office has not considered the fact that the invention of this product was prior to 1995 and the already granted patent in the US was for a modification, which does not claim any treatment efficacy aspects,” says Chan Park, a senior technical and policy adviser at Lawyers Collective.
An email query sent to V. Rengaswamy, chief patent controller at the Chennai office, received a cryptic reply late on Monday.
“Since your query relates to a published patent, you can purchase a copy of the specification and get clarified,” he wrote, while ignoring the questions about whether the drug, which Roche sells as Valcyte brand, was a pre-1995 drug or not.
This is an important distinction in India as the country’s laws allow drugs to be patented on the condition that they don’t pre-date a crucial 2005 amendment by more than 10 years. The Indian law also restricts patent grants to any modifications of known substances unless the same is shown improving the treatment substantially.
Some patent experts see the Roche application, which claims that its first-ever patent application for the drug was dated 28 July 1994, as making valganciclovir the first pre-1995 drug compound to be patented in India, giving it renewed ammunition to try and claw back the patent.
S.M. Laud, company secretary and director of Roche Scientific Co. (India) Pvt. Ltd, agreed the Valcyte patent application in India made identical claims as in its 1994 US application, but insisted no rules had been violated.
“The company’s patent filing was strictly in line with the patent law in India, which allows an application to be filed within 12 months from the priority date (the date of the first patent application for the product anywhere in the world). Roche’s first application in the US was in July 1994, and the filing in India was within the 12 months from that date. It is irrelevant to compare the same with the US patent as each country has its own law.”
Roche had applied for 28 claims in its US patent application in 1994 and repeated them in India. However, the US patent office had rejected all but six of them as they were not “new” and “obvious”. But the Chennai patent document shows that it had admitted at least 12 of Roche claims that had previously been rejected by US patent office.
“This is extremely puzzling,” insists Park. “The Chennai Patent Office must have been aware of the fact that the Indian law requires the patent applicant to keep the patent office informed about the status of equivalent foreign applications under Section 8 of the Indian Patents Act.”
The Lawyers Collectives’ petition was made on behalf of two patient groups, the Indian Network for People Living with HIV/AIDS and Tamil Nadu Networking People with HIV/AIDS, in July 2006. The collective is a non-governmental organization that works for AIDS patients’ access to medicine in India as also civil and women’s rights.
The Roche drug is prescribed for infections related to HIV/AIDS and also organ transplantation.