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Novartis patent decision signals serious problems ahead for medical drugs development
The Indian Supreme Court’s recent decision not to allow Novartis a patent for cancer treatment Imatinab, marketed as Glivec, highlights a series of interlinked patent and public policy issues.
The original Imatinab compound was discovered in the 1990s. A patent application was filed, but not in India. Later, the beta crystal form of Imatinab was discovered to be the best form for use as a drug. A patent application for this moiety was filed in many countries, including India. This has been granted elsewhere, but in 2005 the Indian Patent Office rejected it. Novartis appealed through the Indian courts.
In recent years the world’s patent offices have sought to harmonise IP standards and have been consistently raising the bar for inventiveness. While a new compound useful in treating a disease will almost always be considered sufficiently inventive, it is much more challenging to show that a new form or polymorph of a known drug is.
While the Glivec polymorph patent has been granted in other countries the notion of inventiveness is subjective. In this context, the Novartis decision can be seen as harsh but legally justifiable.
It is unfortunate that the decision follows a stream of judgments that have favoured the generics industry over pharmaceutical companies engaged in R&D. Last year the Indian courts granted a compulsory licence to manufacturer Natco Pharma, allowing it to make a generic version of Bayer’s cancer drug Nexavar, and generics companies succeeded in revoking Pfizer’s patent for Sutent.
The past few years have not been easy for innovators, with many drugs losing patent exclusivity and R&D challenges in replenishing the pipeline. Growing sales in China and India could bolster revenues and underpin future R&D, but despite their regional superpower status, many of their people cannot afford patented medicines.
In the short term, the decision is good news for India’s generic market and for patients who will gain access to the drug: worldwide, a Glivec tablet sells for $20 to $30; the generic version will retail in India for $6 (£4).
Longer term, the US must decide whether it wishes its public to pay for R&D advances that benefit the rest of the world. In Europe state healthcare providers can introduce drug price controls, thereby lowering costs. US patients pay full price for their medications. For innovators, the situation in Europe provides some reimbursement, whereas when their technology is appropriated by the generics industry in India there are no returns.
The debate is polarised: affordable access to healthcare vs funding future R&D. Generic drug companies can sell medicines more cheaply, but this does not allow innovators to recoup their investment and stymies the development of new medicines. It is a vicious cycle: lower innovator profits lead to less R&D and higher prices for other new drugs. There must be a compromise on pricing.