Mumbai: The prime minister’s office (PMO) has been dragged into a dispute between foreign and local drug makers over changes to the intellectual property rights (IPR) regime.
The domestic industry, represented by the Indian Pharmaceutical Alliance (IPA), is critical of an intervention by the PMO that it says seeks amendments to the patent law and other legislation on the basis of a submission by the foreign drug makers’ lobby, the Organization of Pharmaceutical Producers of India (OPPI).
The local drug makers say the PMO’s actions will have an adverse impact on the direction of IPR law enforcement, since some of these issues are currently in court and being considered by government committees.
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There was no response to an emailed query sent to OPPI for comment. The PMO didn’t respond to requests for comments. The director who issued the note at the PMO was not available for comments despite calls made to his office.
The dispute relates to India’s IPR regime, which prevents patenting of known drugs, and linking the marketing approval of drugs with their patent status, among other issues.
“The proposal moved by the PMO, if implemented, would destabilize the IPR regime by reversing its key provisions as it aims at TRIPS (trade related aspects of intellectual property rights) plus IPR regime,” said Dilip G. Shah, secretary general, IPA. “It has grave implications, not just for the domestic pharmaceutical industry but for the country as a whole. It would seriously compromise availability and access to affordable medicines.”
“The impact will be felt across the developing and the least developed countries as they are all dependent on India for their requirements of quality medicines at affordable prices,” Shah said.
In July, the PMO asked the department of pharmaceuticals under the ministry of chemicals and fertilizers to coordinate with the ministry of health and department of industrial policy and promotion (DIPP) under the ministry of commerce to examine certain issues raised by OPPI over amendments to the Patents Act, the implementation of regulatory data protection and beefing up judicial capacity to handle matters relating to IPR. IPA is likely to make a counter submission to the PMO shortly.
The PMO note, reviewed by Mint, states that the principal secretary to prime minister discussed issues relating to the research-based pharmaceutical industry in India with OPPI in May. The note was addressed to the secretaries in charge of health, DIPP, law and pharmaceuticals. OPPI submissions attached to the PMO note highlighted that a legislative review in India’s Patents Act was needed on the scope of Section 3(d), particularly in terms of its ambiguous application, which will have an impact on the entire innovation ecosystem of the country.
Shah says the current IPR regime has prompted local companies to invest in research, which has risen 17 times to Rs.2,380 crore in 2006 from Rs.140 crore in 1995, when the TRIPs agreement was signed. “Give the national industry a chance to prove their capability in research and development before succumbing to the pressures of the multinational companies,” he said.
India’s patents law, which was amended in 2004, states that no modified forms of already known drugs are patentable. Section 3(d) specifies that the salts, derivatives and different forms of previously known molecules cannot be granted patent protection unless they significantly enhance therapeutic function.
This provision was challenged unsuccessfully in a suit filed by Swiss drug makerNovartis AG in the Madras high court after the company’s patent application for a beta crystalline form of a known cancer drug, imatinib mesylate, was rejected by the Chennai patent office in 2005. The Supreme Court’s decision on Novartis’ appeal is awaited.
Another OPPI proposal forwarded by the PMO is the need to link the patent office and the drug regulatory authorities. OPPI has sought the alignment of the applicable statutes, so that rights granted under one statute are not taken away under the other.
A case filed by German drug maker Bayer AG and its local associates is questioning the Drug Controller General of India’s right to approve a generic version of liver cancer drug Nexavir by Cipla Ltd. This case is also pending with the Supreme Court after the Delhi high court rejected Bayer’s petition.
“The judiciary is perfectly capable of handling patent cases, and courts taking decisions that lead to even the revocation of patents are an accepted practice the world over,” said Pratibha Singh, a noted patent lawyer. Singh represented Cipla in the above litigation.