Mumbai: An expert group has suggested significant changes to India’s patent regime that will address contentious provisions that barred the issue of patents to anything that isn’t a new chemical or medical entity and to drugs built around microorganisms.
If accepted, the recommendations made by the group headed by former director general of Council of Scientific and Industrial Research (CSIR) R.A. Mashelkar in its revised report submitted to the government earlier this month could see the processing of at least a 1000 patent applications under these two categories that are pending with the Indian patents office. These patents have been filed by companies and individual scientists from India as well as other countries and many have to do with biotech drugs.
The expert group was appointed by the Union government in April 2005 after some political parties demanded that India not allow patents to new forms of existing drugs and natural substances. It submitted a report in December 2006 but withdrew it in early 2007 after it was discovered that a key paragraph on patent law had been copied word-for-word from other sources without any attribution.
An embarassed Mashelkar had then attributed the error to a “slip” and said a new report would be submitted in three months. According to the report, restricting drug patents only to new chemical entities and keeping microorganisms out of it would amount to a violation of the Trade Related Intellectual Property Rights (TRIPS) agreement.
The group has concluded that “linking the grant of patents for pharmaceutical substances only to a new chemical entity or to a new medical entity” may prima facie amount to “excluding a field of technology” even when this satisfies the basic requirements of patentability.
Similarly, completely excluding drugs and other products involving microorganisms from being patented would also violate the international trade agreement, the report said.
Indian patent law, last amended in 2005 before the country re-introduced product patent regime in the pharmaceuticals and agriculture space, says patents cannot be issued to “a mere discovery of a scientific principle for the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature.”
Since microorganisms are essentially living things from nature, a patent grant to products involving this has not been clearly defined so far.
However, the latest report has cautioned that every attempt should be made not to grant patents to any applications that will result in “evergreening” of existing or known products or discoveries with a fresh exclusivity.
Evergreening is a term used to describe an attempt to merely extend the life of an existing patent by filing the same discovery or innovation with incremental changes or modifications.
A patent is a commercial rights protection that is offered to an inventor who spends money and time to bring out a new product which has a use and value for the industry.
The report retains the existing safeguards in the Indian patent law that prevents unsubstantiated or incremental innovations from patenting. Under Section 3 (d) of the law, new forms of known drugs or substances do not qualify for a patent in the country unless the claimed new form improves the efficacy of the product significantly.
The Indian patent office has the full authority to determine what is patentable and what would constitute only a trivial change with no significant additional improvements, the report said. According to intellectual property law experts and a few representatives of the local pharma industry, the revised report has re-established the safeguards in India’s patent law. “There has been an attempt to strengthen the conclusions. The revised report rightly concludes that any outright exclusion of an entire class of inventions would violate TRIPS pact,” said Shamnad Basheer, a professor in IP (intellectual property) law at the National University of Juridical Sciences at Kolkata.
Dilip G. Shah, secretary general of Indian Pharmaceutical Alliance, said patentability of microorganisms has to be dealt with caution. India’s stand has been to prevent commercial exploitation of the country’s vast biodiversity and traditional knowledge by developed countries. “The country has stood for mandatory declaration of source of origin and benefit sharing in such patents,” he said.