New Delhi: Now that a committee tasked with overhauling India’s patent policy has withdrawn its report, Swiss drugmaker Novartis AG finds its case to patent cancer drug Glivec weakened.
The technical committee, headed by scientist R.A. Mashelkar, withdrew its report this week amid allegations of plagiarism by consumer activists. The report, which said even incremental changes in a drug should be patented, had been Novartis’ main line of defence in its fight, being waged against those same consumer groups in Madras High Court, to patent the lucrative cancer drug. “Novartis’ major argument supporting the case was this report which has proved to be flawed in itself,” said Y.K. Sapru, president of the Cancer Patient Aid Association, one of the parties opposing Novartis in court.
The drug maker is, however, treading with caution. “It would be inappropriate for us to comment on this action or on any potential impact it may or may not have on the legal case challenging the denial of our patent application for Glivec or section 3(d) of the Indian patent law,” Novartis India chairman Ranjit Shahani said in an e-mail interview with Mint. Section 3(d) is the specific provision in the Patents Act that stops drug modifications from getting patented—unlike laws in the US and Europe that favor sequential patents.
Shahani added that the company’s litigation merely sought clarity about India’s patent laws. Novartis first introduced the drug in 2002 in India;globally, the drug generated more than $2.5 billion in sales last year.
Officials at Novartis’ Basel, Switzerland, headquarters are using a sterner tone. While a growing middle class has made India a “very interesting market,” a lack of intellectual property protection would thwart major investment in the country, head of corporate research, Paul Herrling, said in a televised interview on Thursday, Bloomberg reported.
For the last few weeks, Lawyers Collective, an advocacy group opposed to patents, have been attacking the committee report saying it parroted a previous 2006 report on the pharmaceutical industry funded partly by Novartis.
That previous study was commissioned by the UK-based Intellectual Property Institute and funded by Interpat, a Swiss agency of drug multinational firms headed by Novartis.
Consumer groups, alongside left-wing politicians, have demanded that the Indian government disband the technical committee, saying it “had lost every shred of credibility”. They also recommended the creation of a new body, acommittee of parliamentarians and experts, to re-examine the issue. “The committee should be scrapped and nothing less than a joint parliamentary committee will do,” said Vandana Shiva, an environment activist.
Others, such as Leena Meghaney, country head of nobel prize-winning group Médecins Sans Frontières, questioned the integrity of such committee reports and whether lobbying and funding influences findings.
Novartis officials denied having any influence on the report or committee.
The Mashelkar report had stressed the need to patent modifications to drugs, known as drug derivatives. The global pharmaceutical industry has favored such patents because it prohibits others from taking existing drugs and improving upon them. But Indian pharmaceuticals, which have profited from manufacturing generic drugs, have largely opposed extending patents on the derivatives.
Last year, Novartis’ effort to patent Glivec was rejected by a patent controller, subsequent to which the firm filed a lawsuit challenging the order.
In the wake of recent accusations, Mashelkar sent a letter to Ajay Dua, secretary, department of industrial policy and promotion on Monday, stating his intention to withdraw the report as “certain technical inaccuracies had inadvertently crept in”. He has offered to resubmit the report in three months.
“These statements came in while the subgroups were preparing the drafts… there were 24 of them. I did what a scientist normally does… I have withdrew it and will re-examine it,” Mashelkar, who chaired the committee, told Mint. He added that he was “broken hearted” but sees the experience “as a lesson to be learnt”.
He declined to comment if he will merely rephrase the maligned sections in the report or make substantial changes to the basic tenor of the recommendations. An official in the industrial policy department said they are yet to receive any such letter.