Mumbai: After US commerce secretary Gary Locke wrote to his Indian counterpart seeking fair treatment for an American drugmaker at the country’s patent tribunal, the US government has written to India’s patent controller suggesting the removal of certain key clauses in its working manual.
While the legality of a foreign government addressing such suggestions directly to a department head is debatable, experts in Indian patent law say the changes sought are against India’s intellectual property (IP) rights law.
The US embassy in New Delhi sent the suggestions as a part of comments invited by the Indian patent office from stakeholders including patent agents, consultants and trade bodies on its recently revised working manual.
An email query to the office of Kalpana Reddy, first secretary for intellectual property at the US embassy in New Delhi, who signed the letter to the patent office, remained unanswered.
The manual is an official guide for examiners and officers on the country’s IP law while processing a patent application and granting a patent, and, therefore, an internal working policy document.
The US government, in its letter addressed to P.H. Kurian, India’s controller general of patents, designs and trademarks, has suggested changes in four key sections in the manual.
These include a suggestion to remove the term “therapeutic efficacy”, mentioned in the manual to define the eligibility criteria for drug patents under Section 3(d) of the patent law.
It also suggests broadening the scope of computer programmes’ patentability by removing the words “integrated with novel software or machine specific”, including terms to allow the import of goods for deciding on compulsory licensing as well as to qualify for working patents. The fourth relates to patentability of bio-resources.
Mint has reviewed a copy of the US embassy’s letter.
“The suggestions are welcome but, in any case, they are not binding on the department if they are found inappropriate or not fit to be incorporated,” said Kurian.
The revised manual was put up on the patent office’s website inviting comments by 31 December.
A.P. Venkateswaran, a former foreign secretary and an expert on external affairs, said the US government’s direct correspondence to the patent department does not reflect an ideal inter-government communication.
“If all foreign governments want to directly interact with various Indian departments on policy matters, it will only lead to security chaos,” he said.
Any correspondence between two governments on policy matters should be in consultation with the external ministry, he said.
“A direct correspondence from a foreign government with a local department is allowed on routine business, if any. But a policy correspondence should be strictly with the knowledge of the external ministries of the concerned governments” and ideally with the ministry concerned, he said.
“One of the suggestions in the US government’s letter was to disregard a Madras high court judgement on the controversial Novartis’ Glivec patent case,” said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, a lobby of Indian drugmakers.
The US government’s letter states, “The manual defines the term efficacy under Section 3(d) of Patents Act as therapeutic efficacy... referencing the Madras high court decision in the Novartis case. The interpretation of the efficacy is an open issue that is currently pending before the Supreme Court of India. We suggest that the manual not define efficacy as therapeutic efficacy pending the Supreme Court decision on this matter.”
Feroze Ali, a patent lawyer who represented Indian companies in the Novartis versus Indian patent office case in the Madras high court, disagrees with this reference in the US government’s letter.
“The Madras high court order in the Novartis case defining drug patentability on the basis of therapeutic efficacy (for modified discoveries) is final and not challenged. So it is the law at present,” he said.
“Novartis has appealed against the IPAB (Intellectual Property Appellate Board) order in the imatinib mesylate (Glivec) case. The judgment being referred to in the US letter is the challenge to Section 3(d), which was negatived by the Madras high court. Novartis has not appealed against the Madras high court order,” said Shah.
A Novartis India spokesperson agreed. “The Supreme Court appeal was filed by Novartis AG (the parent company) against the order of IPAB. The appeal relies upon all such grounds of merit of the patent application that are permissible by law,” she said.
“The Madras high court clarified that the term efficacy in Section 3(d) meant therapeutic efficacy. And any drug derivative that did not demonstrate enhanced therapeutic efficacy would not be patenable. Given that the patent office is bound by a high court ruling, it was perfectly justified in including this the definition in the manual,” said Shamnad Basheer, a professor in IP law at the National University of Juridical Sciences, Kolkota.