India Liberates True Innovation

In a landmark ruling that is being celebrated by public health advocates around the world, the Indian Supreme Court rejected patent protection claims by Swiss pharmaceutical giant Novartis for its cancer drug Glivec, concluding that the compound “did not satisfy the test of novelty or inventiveness,” which is required under Indian patent law.

The core issue in the Glivec case is a dubious legal and business tactic called “evergreening,” which is frequently deployed by pharmaceutical companies to extend the life of their profitable expiring patents by making minor modifications to a compound by tweaking its dosage or formula, for example, to ward off generic competitors. The Court found that Glivec’s active ingredient, imatinib mesylate, was already known, rejecting Novartis’s contention that the drug was novel because it was more easily absorbed in the body. It concluded that Glivec failed “in both the tests of invention and patentability.”

Leena Menghaney, access campaign manager for Doctors Without Borders, hailed the ruling, “The Supreme Court’s decision prevents companies from abusing the patent system to get unwarranted patents on existing medicines.”

The Supreme Court’s decision is a shot in the arm for India’s burgeoning generic drugs industry that has become a vital lifeline to developing countries, supplying one-fifth of the world’s generic drugs.

Until recently, India did not allow patents on drug compounds. In 2005, the country was coerced into expanding patent protection under U.S. and international drug industry pressure and World Trade Organization rules. Intellectual property rules have long been built around the interests of Western corporations, who for decades now have been engaged in large-scale biopiracy, pillaging traditional herbs and medicines, which don’t enjoy patent protection. After the 2005 revisions to India’s patent law, profitable international drug companies have been seeking to slow and even shut down Indian generic drug manufacturers through concerted legal challenges to protect their oversized profits. In 2012, Novartis alone reported profits of almost $10 billion.

In recent years, Indian courts and its patent regime have begun pushing back against pharmaceutical multinationals. Last year, India’s Patent Office ruled against patent protection for Bayer’s cancer drug Nexavar and revoked Roche’s patent on the hepatitis-C drug Pegasys and Pfizer’s patent on the cancer drug Sutent.

Predictably, pharmaceutical industries and their mouthpieces have launched a relentless public relations campaign, warning of stifling of innovation and threatening to pull out of India because of its weak intellectual protection laws. In a statement Novartis warned that the Supreme Court’s judgment “discourages innovative drug discovery essential to advancing medical science for patients.” Ranjit Shahani, managing director of Novartis India, added, “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”

Novartis’s concerns for global health are touching, really?

For all of global pharma’s bluster, the fact is that the Indian Supreme Court is not rejecting the idea of patenting drugs. What it is repudiating is the attempt by pharmaceutical giants to use legal loopholes to extend the life of patents that have already expired. As Pratibha Singh, a lawyer representing Indian generic drug manufacturers, said after the decision, “Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug.”

Rather than stifle invention, the Indian Supreme Court’s ruling should actually accelerate it, forcing drug companies to focus on genuine innovations rather than merely tweaking existing compounds to advance their commercial interests and stifling generic competitors, the real engine for innovation.

These valuable policy implications of the Indian Supreme Court’s decision are already beginning to reverberate around the world, as the European Union, Australia, Canada and other countries begin to weigh laws to crack down on “evergreening” abuses by drug companies.