Mumbai: Three top multinational drug makers—Pfizer Inc., Novartis AG and Eli Lilly and Co.—won almost one-third of the 81 contentious drug patents granted in alleged breach of two important rules contained in India’s modified patents regime.
The three firms were together granted local patents for 25 products that were otherwise considered non-patentable in the country. Fifty-one were given to other foreign drug makers, including F Hoffmann La Roche AG, Schering Corp., Merck Patent GmbH; the remaining five went to local drug makers.
The patents were granted in the first four years of the patents regime that took effect in 2005. They were allegedly issued overlooking section 3(d) and (e) of the amended intellectual property law, which restrict protection being granted to already known and long-ago patented drugs and their combinations.
A domestic industry lobby, the Indian Pharmaceutical Alliance (IPA), last year demanded a review of these patent grants. Neither the names of the drugs granted the patents nor the identity of their makers had been made public.
Now, a report endorsed by the country’s patent enforcement authority, the department of industrial policy and promotion (DIPP), has made public the data compiled by the industry lobby.
Graphic: Paras Jain/Mint
The report prepared by former DIPP director T.C. James also said during the first four years of India’s new patents regime, the country’s four patent offices granted several patents for incremental innovations or modified forms of long-existing drugs.
The restrictions were incorporated in the law when it was amended in 2004, before the country introduced a new product patent regime for pharmaceuticals and agricultural products as a signatory to the Trade Related Intellectual Property Rights Agreement of the World Trade Organization.
These rules were introduced as a precaution against possible grant of frivolous patents for products claiming incremental innovations.
James said in a phone interview on Tuesday that the report was prepared in response to a demand by the US-India Business Council (USBIC) that section 3(d) of the Indian patent law be abolished.
Data showed that the patents had been granted to the drugs for “mere incremental innovation”, said James, who is currently director of the National Intellectual Property Organisation, the only non-governmental organization in the field of intellectual property recognized by the United Nations-affiliated World Intellectual Property Organization.
A patent right gives its holder a market monopoly that’s actually meant to compensate the inventor of such products for a certain period—typically 15-20 years.
By patenting essential drugs that do not actually qualify for such protection, companies could potentially misuse the monopoly provision, said an industry consultant who didn’t want to be named citing a potential conflict of interest and client confidentiality.
Mint has in the past reported about patents being granted to both foreign and local drug makers for already known drugs with incremental innovation. Indian patent law allows protection of incremental innovations only in some cases where the efficacy of a newly claimed innovation is proved to be superior to the older drug forms.
“Pfizer believes that these patents, duly issued by the Indian Patent Office, after full examination of the merits, constitute appropriate and patentable subject matter under the Indian patent law,” said a Pfizer spokesperson from New York in an email response.
An email query sent to Eli Lilly did not elicit any response as its corporate communications adviser Lauren R. Cislak was travelling. A Novartis spokesperson said he needs more time to reply as many of his team members were on Easter holidays.
“India’s patent system currently provides adequate opportunity to challenge patents that have been allegedly granted wrongly,” said Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, an industry lobby that represents foreign drug makers in India.
One practical difficulty that opponents face is the vague description of patent details published by the patent office before and after the grant of product protection.
“There were no evidences ever produced by these patent applicants that the modified forms of old drugs are superior in efficacy to qualify for a patent here,” said Dilip G. Shah, secretary general of IPA, who compiled the list of patents granted to modified forms of existing drugs.
IPA had appealed to the controller general of patents and James, when he was director of DIPP, for a review of the patent approvals.
“An investigation was on at the department to find out the routes of the frivolous patent grants, and the situation has improved a lot now due to a strict vigil while scrutinizing patent applications,” he said.
India’s controller general of patents, designs and trademarks P.H. Kurian said: “At the present law, there is no provision to review already granted patents by the patent office once the post-grant opposition period (one year after the grant) is over. But it can be revoked by moving the Intellectual Property Appellate Board or courts of law against the wrongly granted patents.”
Lison Joseph contributed to this story.