The Battle Over Generic Drugs in India (and elsewhere)

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A few days ago, in a courtroom in India, a landmark ruling was made that could impact future legal battles over the sale of generic versions of expensive medications in India. When the Delhi High Court rules that Cipla, the country’s largest drug maker, could sell its own version of the lung cancer drug, Tarceva (erlotinib), made by Roche. The generic version will reportedly cost about a third of the proprietary version.

The lawsuit had been brought by Roche against Cipla. Roche accused Cipla of patent infringement, but the judge, Justice Manmohan Singh, sided with Cipla, agreeing that the generic version has a different molecular structure from Roche’s original. The ruling upholds Roche’s patent on its molecular structure, but allows Cipla to produce its own version, which (presumably) has the same mechanism of action and yields the same outcomes as the Tarceva molecule. The case had been ongoing for four years and the ruling is considered to be a landmark judgment, though Roche could very well appeal.

The timings are interesting, as they seem to set the stage for the reopening of another years-long drama involving yet another cancer drug. The Switzerland-based pharmaceutical company Novartis sued the Indian government years ago over its decision to allow generic versions of the drug to be sold there. First filed six years ago, the case was reopened just yesterday. At the same time, Pharmalot reports that the Indian court has just told Novartis to lower the price at which Gleevec (Glivec outside of the U.S.) is sold in India.

The patent battle over Gleevec is, needless to say, bitter and complicated. Gleevec is a tyrosine kinase inhibitor that treats chronic myelogenous leukemia (CML), a rare cancer that is slow-growing but fatal. Gleevec targets a malfunctioning enzyme that is the product of a genetic abnormality present in more than 95% of patients with CML. For almost all patients with CML, Gleevec or its second- or third-generation counterparts enable people with CML to live a normal, healthy life (and lifespan) with minimal, if any, side effects. (Forgive this brief commercial interruption, but my forthcoming book, The Philadelphia Chromosome, tells the incredible story behind the creation of this groundbreaking drug. More on that another time!)

Gleevec is expensive, but somewhere in the neighborhood of 90% of CML patients in India get the drug for free. So either the company is still making a bunch of money from the remaining 10% of paying patients (some of whom receive a deep discount) or Novartis is fighting the ruling as a way to establish clear guidelines for future branded drugs that may be sold in India.

Although the drama between Novartis and the Indian government is a fascinating case study in its own right, the fight also raises larger questions about drug patents abroad. Cipla was established in the 1930s by Khwaja Abdul Hamied, a nationalist and follower of Mahatma Gandhi. The company became famous in 2001 when it decided to sell a triple-combination antiretroviral therapy for HIV/AIDS for a price that came to less than a dollar per day, a shock in light of the $10,000-per-year cost of antiretroviral therapy produced by other pharmaceutical companies.

Patents on pharmaceuticals are a contentious issue for many countries around the world, for the obvious reason that the average person in most countries can’t afford to pay for brand-name drugs. The high price of many patented drugs goes against the belief held by many governments that citizens should be guaranteed the best possible delivery of healthcare. In 1994, the World Trade Organization administered The Agreement on Trade Related Aspects of Intellectual Property, known more commonly as TRIPS. The agreement increased the scope of protection for intellectual property that has had the possibly unforeseen consequence of restricting access to medications among impoverished people.

Interestingly, when the discussions that eventually led to TRIPS first began in 1986, fifty countries did not provide patents for pharmaceutical products. Stretching back even further, India had implemented a policy in 1970 that permitted “reverse engineering,” a process used to create generic versions of medications in developing countries — essentially, the Indian government was disallowing patented drugs.

Currently, all WTO Members except for those categorized as “least developed countries” are required to issue 20 years of patent protection in all fields. The purpose was to spur innovation (isn’t that always the stated purpose behind patent regulations?) but the outcome has been restricted access because many people in WTO countries cannot afford to pay for the drug, and no one is allowed to sell a generic version.

Subsequent amendments have attempted to solve the problems resulting from TRIPS. There’s TRIPS flexibilities, the Doha Declaration of 2001, and measures taken by individual governments (for example, rulings in Brazil, Venezuela, and South Africa that ensured access to antiretroviral therapy).

Reverse engineering, the process that allowed Cipla to become one of the world’s most prominent generic drugmakers, has been ruled unlawful by India’s Patents Act, passed in 2005, and will no longer be permitted as of 2015. When that Act comes into play, it could mean the end of an era for generic drugs in India.

In the meantime, the patent battle over Gleevec in India continues, as do concerns about ever-diminishing access to medications worldwide. Once again, it’s the tussle between the fact that drug making is a for-profit business and the wish for unrestricted access to beneficial medications for people with serious illnesses everywhere. At the very least, people with lung cancer in India can look forward to generic Tarceva.

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