MUMBAI: India’s strong stance on minor drug innovations could reverberate in national parliaments and courthouses of the developed world as Australia, the EU and Canada get ready to discuss and ban patent protection for frivolous improvements. A top Australian government body on Wednesday asked for changes in its patent laws relating to drugs saying that the indiscriminate grant of patents to incremental innovations should be checked and that an independent review should be set up to vet these proposals.
A draft report on the possible changes was released by IP Australia, the government body. Canadian lawyers and health industry officials are discussing tighter standards and taking comfort from the Indian law and the Supreme Court ruling on Monday denying patent protection to Glivec of Novartis. India was one of the first few countries to introduce a specific clause such as Section 3(d) way back in 1995 when it passed the product patent legislation. This section forces the patent applicant to prove the medical or therapeutic efficacy of any incremental innovation for which it is seeking a patent. The law came into effect from 2005 and Novartis filed the case against the Indian government in 2006.
Though the final decision on Novartis came only on Monday, the provisions of the Indian law was well known in international IP and pharma circles and countries and courts have been modifying their stance since then.
Last year, the Canadian Supreme Court refused to grant patent to Pfizer’s Viagra saying that the company has not proved the efficacy of the compound that it was seeking to patent. Last month, the European Union sounded an alarm last month over loose patent standards saying that there is widespread concern that patent quality is deteriorating and that the low patent quality threatens the functioning of the entire system.
India’s strong stance on minor drug innovations could reverberate in national parliaments and courthouses of the developed world.
“The Indian ruling is not an isolated one; we are seeing in Canada, courts are under pressure to strengthen their patent standards. What we are seeing is that the developed world is taking a cue from developing countries in drafting patent norms” said Ikechi Mgbeoji, lawyer, and associate professor with Osgoode Hall Law School based out of Toronto, Canada.
Last year, Argentina amended its patent act to incorporate a law that said “the discovery of a different or improved characteristic or property for a particular element or a group of elements already known in the prior art does not mean that the product or process is novel”. Other countries like Indonesia are also following suit taking a cue from Indian law. “What the Novartis decision does is give other countries an imprimatur from a highly respected court that restricting ever greening is an important public policy,” says Brooke Baker, professor of Law, Northeastern School of Law, who advised the Uganda government in drafting its patent law.
“I think that the decision could well embolden other countries to adopt India-style protections against ever greening,” he added. India’s Supreme Court on Monday declined to grant patent protection to Novartis’ blood-cancer busting drug Glivec. The denial created a world-wide stir and was widely welcomed by pharma NGOs, activists and aid organisations and by Indian government and domestic pharma companies. Novartis and other multinationals criticised the ruling saying that it is a setback to innovation and research. But the release of the Australian government report shows that Australia and health experts are also concerned about what they see as a widespread misuse of “evergreening” or trivial innovations in an effort to get patent protection.
“The decision by India’s SC is an important addition in our case as an example to the fact, that national courts and national laws can have more control over patents and limit patents,” said Dr Patricia Ranald, convenor of Australian Fair Trade and Investment Network, a lobby group that advises government on trade and investment decisions. The organisation was one of the many which submitted recommendations to the report.
She added that IP Australia’s draft report is recommending that Australia not extend patents any further and that existing patent law be reviewed to make it more difficult to obtain patents on drugs that really do not add to the medical efficiency or effectiveness of the medicines.