Disgruntled Novartis questions the worth of Indian patents
This article was originally published in Scrip
Stung by the rising tide of voices supporting the recent Indian Supreme Court verdict rejecting a patent for Glivec ((imatinib mesylate), Novartis sought to dispel certain ‘myths’ around the issue , while emphasizing that improving access to healthcare requires much more than products and affordability.
The Swiss multinational also appears set to face another round of fire-fighting amid reports that it was granted 219 patents in India so far and has applications for another 1,100 pending. Novartis, though, has questioned the ‘on ground’ effectiveness of patent grants in India.
Novartis India’s vice-chairman and managing director, Ranjit Shahani, appeared to take umbrage to suggestions by activists of Novartis trying to ‘evergreen’ patents. “The so called evergreening [clause] is to prevent undue financial gain through minor tweaking. There was no prior drug ever, so no question of undue financial gain,” Mr Shahani said at a roundtable in Mumbai.
Mr Shahani said that imatinib free base was never a drug and that beta crystalline form is the only form of Glivec that has ever been on the market. ‘It [the beta crystalline form]is the only form of Glivec that has ever gone through human trials. There’s no question of evergreening,’ Mr Shahani said.
Activists have in the past argued that Novartis has been seeking a patent in India on the salt form (mesylate) of an existing medicine (imatinib), a practice commonly used to extend the patent life of products and thereby the monopoly and high prices of medicines.
The Supreme Court recently held that the beta crystalline form of imatinib mesylate failed in both the tests of invention and patentability as provided under specific clauses and Section 3(d) of India’s Patent Act (scripintelligence.com 2 April 2013). Section 3 (d) broadly deals with incremental inventions that are not patentable unless they show improved efficacy or unless a known process results in a new product or employs at least one new reactant. The court, though, acknowledged that Novartis’ patent described physicochemical properties of the beta crystalline form that might be better - more beneficial flow, better thermodynamic stability, and lower hygroscopicity. These, the Court ruled, were "otherwise beneficial", but cannot be taken into account for the purpose of the test of section 3(d).
NGOs had earlier lashed out against what they claimed were Novartis' attempts to dilute the Section 3(d) safeguard, which they say could have a crippling effect on the Indian generic industry. They claimed that Novartis was attempting to get the legal framework for examining patent applications in India relaxed.
…CML patients
Novartis also claimed that generally bandied figures on India having 300,000 chronic myeloid leukemia (CML) patients were exaggerated.
It claimed that of the estimated 42,000 CML patients in India, the actual numbers that have access to healthcare was around 32,044. “The total size of [the Indian] market for all cancers is Rs22 billion. If there indeed were 300,000 patients, [the ] size of market for CML alone, a rare leukemia, even at one-tenth the cost quoted for Glivec would be Rs36 billion ,’’ Mr Shahani said.
Novartis estimates that 28,407 CML patients are treated with Glivec and generic versions, with 16,413 on the Glivec International Patient Assistance Programme (GIPAP) and around 400 on its co-pay programme, Novartis Oncology Access, in India. Novartis’ comparable 10 day co-pay price (the bulk of the co-pay patients fall into the 10 day payment bracket) works out much cheaper than Indian generic versions, the company claimed. An immediate response from Indian firms could not be got on Novartis’ claims. ‘Show me one patient who’s ever had to pay the reported price of Rs120,000 per month for Glivec in India,’ Mr Shahani said. Generic versions of Glivec, including those from Indian firms Natco and Cipla, are available on the domestic market at around Rs5,000 ($92.08) or so per month (including trade discounts) to patients.
..219 patents
Novartis also reacted sharply to reports suggesting that it had 219 patents in India and was making a hue and cry of one rejected patent –for Glivec.
Mr Shahani told Scrip that the number of patents granted was moot if patents, after grant, were "nullified". Listing the high-profile patents overturned in India, he said that the numbers so far might be small but that the ‘story they tell is large’:
Pfizer’s patent for Sutent (sunitinib malate) – revoked;
Roche’s Pegasys(pegylated interferon alfa-2a) – revoked;
Bayer's Nexavar (sorafenib tosylate) – compulsory licensed;
Merck’s Januvia (sitagliptin) - patent in place but a local state regulatory in Sikkim granted a license to Glenmark.
“So it is pointless talking about the large number of patents granted.” Said Mr Shahani. “On the ground, effectively are they there? […] The story is that India is still not ready to provide the ecosytem necessary which will encourage innovative products to be launched,