New Delhi: A Council of Scientific and Industrial Research (CSIR) undertaking has objected to patent claims by Avesthagen Ltd, a Bangalore-based biotech firm, the first time an Indian company has been challenged for seeking rights over traditional cures.
Avesthagen had filed a patent application at the European Patent Office (EPO) for using Arjuna, a medicinal herb, as a tonic for treating obesity and diabetes in 2003.
The row could reignite the controversy over biotech companies trying to claim patent rights over herbal formulations known to traditional systems of Indian medicine such as Ayurveda, Siddha and Unani.
Avesthagen denied that it had been dissuaded from pursuing the patent.
The application “lapsed due to oversight and not due to any other reason” and the company is in the process of reinstating it, an Avesthagen spokesperson said in an email.
The application was challenged in 2009 by officials at the Traditional Knowledge Digital Library (TKDL), an initiative spearheaded by CSIR and the health ministry, which has compiled an online database of 148 books on Indian systems of medicine.
V.K. Gupta, director of TKDL, and head of CSIR’s IT (information technology) division, said he had informed EPO last July that Avesthagen’s claims were not novel and that Arjuna was well known to ancient systems of Indian medicine to be a cure for several ailments, including heart and obesity disorders.
CSIR said in a 26 April press statement that Avesthagen, among other firms, had “themselves decided to withdraw their application on being confronted with TKDL evidence”.
According to EPO rules, patent applicants must pay an annual renewal fee to keep their filings from lapsing.
The most recent communication on the issue that’s available on the EPO website is a 6 April notice by the patent examiner’s office that terms the firm’s application as “deemed to be withdrawn due to non-payment of renewal fee”.
Records also show that the company had paid application renewal fees every year since 2003, but hadn’t done so for 2009, the deadline for which was 31 August.
“It’s obvious they are letting the patent application lapse,” said Gupta in a phone conversation with Mint. “They’ve known of our objections since last July, but have not communicated anything to the patent office. They’ve diligently paid renewal fees every year except last year, till they learnt of our objections.”
To be sure, Avesthagen has a two-month window to reinstate its claims. EPO patent rules don’t oblige the company to respond to CSIR. Experts say the company has to justify the patentability of its application only if EPO so requires.
“Keeping a patent application alive for six years is expensive. So a company that has paid the lawyer fees, six years of renewal fees, has made substantial investments,” said Srividhya Ragavan, an intellectual property (IP) specialist and professor of law at the University of Oklahoma College of Law. “It could well be that they are waiting for legal advice after CSIR posted their observations to the EPO. On the other hand, the long delay does raise speculation that they may be withdrawing their patent application. Also, a communication from a government agency is usually taken quite seriously.”
Companies that are unsure of the validity of their patent claims choose to withdraw their applications by terminating fee payments, said T.C. James, director of National Intellectual Property Organization.
“Usually, patent applicants stop paying fees if they are not confident of their patent application,” he said. “Rarely does a patent applicant explicitly say that they are withdrawing because they feel their patent is indefensible. However, the verdict is still unclear.”
TKDL, which contains around 30 million pages of text on traditional Indian formulations translated into English, Japanese, French, German and Spanish, has signed agreements with leading international patent offices such as EPO and the United States Patent and Trademark Office. This allows patent examiners in these countries to scan the texts and check if patent claims are indeed novel or a mere appropriation of formulations known to traditional India medicine.
In the past, India has got the US and Europe to revoke patents granted to American companies on the use of turmeric, neem and basmati rice.
TKDL has estimated that over 2,000 wrong patents concerning Indian systems of medicine were being annually granted, simply because India’s traditional knowledge has existed in languages such as Sanskrit, Arabic, Urdu and Tamil and was, therefore, inaccessible to international patent offices, CSIR said.
“We are confident that their claims cannot hold in the patent office. We wouldn’t challenge it in the first place if we had the slightest doubt,” said TKDL’s Gupta, referring to Avesthagen.
Avesthagen has around 450 patent applications in its IP portfolio. Among these proprietary technologies is ADept, an Indian medicinal plant resource that details more than 3,000 formulations mentioned in traditional Indian medicinal systems.