- - Wednesday, May 1, 2013

Acourt ruling in India could stifle medical innovation worldwide.

On April 1, the Indian Supreme Court rejected a patent request for a version of the cancer treatment Gleevec, citing a 2005 law intended to thwart companies from obtaining fresh patents for minor changes to a medicine.The law itself, and the court’s decision, is a boon to India’s prosperous $26 billion generic-drug industry. The blatant failure to protect the intellectual property of biopharmaceutical innovators, though, will have terrible consequences for drug development and patient health.

Bringing a medicine to market is a long and complicated process. According to the Tufts Center for the Study of Drug Development, it takes 10 to 15 years for an experimental drug to reach the market. Including the costs of failures, each medicine costs an average $1.2 billion to develop.

Generic-drug manufacturers don’t have these massive upfront development costs. They don’t need to worry about investing in research and development for revenue. They piggyback on the research and investments of the pharmaceutical companies that create the brand names. India’s generic-drug manufacturers are among the largest in the world.

Gleevec, a cancer treatment from Swiss-based pharmaceutical company Novartis, was a major pharmaceutical breakthrough for cancer patients around the world. A patient advocacy group in Mumbai lauds it as “the only lifesaving drug” for chronic myeloid leukemia.

Gleevec is patented in nearly 40 countries, including China and Russia. Because the drug was introduced in India before the country enacted its first patent law in 2005, the treatment has gone unpatented.

When Novartis applied for a patent on a beta crystal reformulation of Gleevec, an important improvement that makes the medicine more stable, Indian regulators denied it, saying the difference between the two versions was too small. Novartis filed a petition with the Indian Supreme Court in 2009 to challenge the denial.

Novartis went to court not only to defend its patent interests for Gleevec, but also to defend the larger principle that intellectual-property protections are essential to innovation and the advances of medical science. The Indian Supreme Court’s decision essentially tells innovators not to bother improving on their products because they will reap no reward for doing so.

Some are trumpeting the case as a victory for patient access. The generic version of Gleevec costs about $175 per month per patient, compared with $2,600 for the brand-name drug.

The raw price comparison misses the point. Ninety-five percent of the 16,000 Indian patients prescribed Gleevec receive the medication at no charge through a program Novartis has established to ensure that poor, uninsured patients get the medications they need regardless of ability to pay. The other 5 percent are reimbursed or insured or are enrolled in a generous co-pay program.

Novartis has provided $1.7 billion worth of Gleevec to Indian cancer patients since 2002 and donated $2 billion worth of medicines to more than 100 million patients worldwide in 2012 alone.

Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.

Patent protection does foster continued progress. Sometimes progress comes in the form of a big breakthrough, but sometimes it’s just a matter of an incremental advance. Either way, the work behind new medicines should be protected.

The Indian Supreme Court’s ruling is a blow to global public health. India’s generic-drug industry will profit, but patients will suffer the consequences.

Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.

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