India granting drug patents for mere modifications

India granting drug patents for mere modifications

Mumbai: India may have denied a patent to Swiss drug maker Novartis AG for its cancer drug Glivec because it considered this to be a mere modification of an existing molecule, but it has granted at least 10 patents in the past 12 months to foreign and local drug makers for what would appear to be mere modifications or new forms of known drugs.

The patents highlight inconsistency and lack of transparency in the functioning of India’s patent offices.

In October, Mint reported the findings of a month-long investigation that showed that some patents were awarded because of a nexus between so-called patent agents, or lawyers employed by drug firms to manage their patent application process, and patent officials. Under India’s patent law (specifically, section 3(d) of the Patent Act), patents cannot be granted to minor modifications or derivatives of known inventions.

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Companies that have allegedly benefited from the patent offices’ oversight of this law include the world’s largest drug maker Pfizer Inc., GlaxoSmithKline Plc., Wyeth Pharmaceutical Inc., Sun Pharmaceuticals Ltd, and India’s top generics or off-patent drugs maker Cipla Ltd. In 2006, India rejected a patent application for Glivec by Novartis citing this law. The decision has since been challenged by the company.

All these patents are for new forms of existing or previously known drugs, according to abstracts published by the Controller General of Patents, Designs and Trade Marks (CGPDTM). To be sure, the real claims made in the patent applications will be known only when each of these is examined. Such details, however, are not available in the public domain.

Queries sent by email to the office of the CGPDTM on Friday remained unanswered till late Tuesday. On Monday, an official at the office said on the phone that the CGPDTM would respond to the questions. “There is clearly a lenient approach on section 3(d) provisions now," said the head of research and development at a domestic drug firm, which recently received a patent for a new form of an existing drug compound. The executive did not want either himself or his company to be identified. Mint could not immediately ascertain the details of the said patent because data related to it is still not in the public domain. “What’s exactly happening in the patent grant process, is only a subject between the senior officials at the patent office and the applicant or an agent. Not even a patent examiner is privy to it," said an executive at the Chennai patent office who did not want to be identified.

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An executive at the Mumbai patent office who, too, did not want to be identified, said there were “oral instructions from higher officials at the department of industrial policies and promotion, which oversees the policies and key decisions related to intellectual property offices, to grant as many patents as possible, unless there are serious objections. The executive added that because of this, “provisions such as section 3(d), and post- and pre-grant oppositions are often redundant".

Post- and pre-grant opposition refer to individuals, companies, or organizations opposed to the grant of a patent for an invention or drug opposing the move before the grant (pre-) or within 12 months of the grant of the patent (post-) through a filing at the patent office. There was no pre- or post-grant opposition to the award of any of these 10 patents.

An expert admitted that while only a closer look at the patent application would show whether patent laws had been violated, the issue highlights the lack of transparency in the entire patent grant process.

“Unfortunately, members of the public, who end up paying the monopoly prices resulting from such patents and have every reason to be vigilant about the scrutiny involved in examining such applications, do not have ready access to such patent information," said Shamnad Basheer, the ministry of human resources development chaired professor in Intellectual Property Law at the National University of Juridical Sciences, Kolkata. Basheer added that the government had promised to make this information available through an online database by March. “One hopes that this deadline is adhered to, as this matter is of grave public importance and has immense implications for transparency and governance."

The companies that have benefited from the grant of such patents say their patents are valid. “We strongly believe that these patents, duly issued by the Indian Patent Office after full examination on the merits, are valid and enforceable," said a Pfizer spokesperson. “All of our Indian patents are subject to examination by the Indian Patent Office to ensure that they meet the requirements of the Indian Patents Act, which includes an examination of novelty of the invention over the prior art," a Glaxo spokesperson said in an email. Sun Pharma’s spokesperson Uday Baldota said the patent granted to his company is for new invention and it’s valid and enforceable in India.

An executive at Wyeth Ltd, the Indian arm of Wyeth, said that the patent application was filed by the parent, and that the Indian subsidiary doesn’t deal with such matters.