An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.
Pharmaceutical companies are eyeing the growing market in India; however, a thriving domestic generics industry is backed by a government wishing to keep the cost of drugs down. Strict Indian patent laws require that an invention be novel, and the government does not recognize patents for drugs they view as being changed slightly in order to extend patent protection. According to Wan, the Indian Patent Office also lacks a searchable patent database, which creates a long patent approval process.
In a potential game changer, Novartis is asking India’s Supreme Court for patent protection of its cancer drug Glivec. India rejected Novartis’ original patent application six years ago, stating the drug was unpatentable under India’s patent laws because it was a modification of an existing drug. Novartis is challenging India’s ruling.
It is being speculated that the result of the court case could have significant ramifications for both Western pharmaceutical companies and generic drug makers operating in India. If Novartis wins the battle, it could potentially open the door for other companies that have been denied a patent on the grounds their drug was not novel. According to The Economist, generic drugs make up approximately 90% of the drug market in India. An increase in patents granted to branded drugs could threaten the Indian generic industry and potentially increase the price of drugs in India.
What do you think? Are India’s patent laws too strict? If Novartis wins their case in India, will it open the door for other companies to gain patents?