If Novartis’s “improved” version of Glivec is not more therapeutically efficacious, why is the Novartis decision such a big deal?

By Adriana Benedict

Last week, Ryan Abbot blogged here about the Novartis case decided last Monday by the Supreme Court of India.  Since then, there have been a broad range of reactions to the case, but many of them appear to have left a lurking elephant in the room.

I’d like to attempt to provide some clarity to a question that seems to have created a lot of confusion surrounding the impact of the Novartis decision: If the older alpha crystalline form of imatinib mesylate (generic Glivec) is already available in India, and the newer beta crystalline form is not more therapeutically efficacious, then why does it matter whether or not Novartis can get a patent on the newer version of Glivec?  The simple answer is that for the most part, it doesn’t really, in terms of the availability of generic Glivec.  At most, it may make a difference for some Indian patients who will do better with the beta crystalline form.  And it will make some difference for Novartis, which will now forego a potential market of these Indian patients who would prefer to take (and can afford to pay for) the beta crystalline version.  But the alpha crystalline form of imatinib mesylate was already available in generic form in India, and it would have continued to be available in generic form in India regardless of the outcome of this case.  So why all the commotion?

First, the Novartis decision means that Indian generic manufacturers can now produce the beta crystalline form of imatinib mesylate with impunity.  This means that Novartis is likely to face competition in its production of the beta crystalline form, over which it would otherwise have held a global monopoly.  Indian generic manufacturers may now produce and export the beta crystalline form to other countries, which means that many more cancer patients in developing countries will have access to it.  Novartis’s markets in these countries may be disrupted through parallel importation of cheaper generics.

Second, the Supreme Court’s ruling ensures that Novartis can’t resort to a number of tactics commonly associated with the term “evergreening” to regain some of the market share for imatinib mesylate.  These strategies might include, for instance, marketing the beta crystalline form to prescribing physicians as if it were actually more effective than the alpha crystalline form.  A study published by BMC Medicine found that this kind of evergreening—which is common particularly in switching from a racemic form to a single enantiomer form, with little to no proven increased efficacy—can reduce reliance on generics, at huge costs to society without commensurate therapeutic benefit.

Third, even though the Supreme Court of India was clear that its decision did not rule out the possibility of patenting “incremental innovation” in India, the decision serves as precedent for decisions made by the Indian Patent Office concerning other instances of minor improvements on existing medical compounds which do not rise to the level of increased therapeutic efficacy.  The Indian Patent Office is now bound by the Supreme Court’s interpretation of increased efficacy as increased therapeutic efficacy.  This is particularly important as applied to anti-retrovirals, TB drugs and other medicines for infectious diseases that require second- and third-line combinations and adherence-increasing treatment options to deal with drug resistance, adverse side effects, and other patient-specific dosing requirements and courses of treatment.  For instance, a new oral form of a drug that is not more therapeutically efficacious than an older injectable form would still be a better option for patients who require daily doses.  After Novartis, the Indian Patent Office is not obliged to grant patents on minor changes to existing chemical compounds unless the inventor can demonstrate increased therapeutic efficacy, which is not always the case with the aforementioned therapies.  In this way, the Novartis decision is not only a victory for cancer patients, but for countless other patients in developing countries who may benefit from newer drugs whether or not those drugs are more therapeutically efficacious in the broader population.

In sum, the gains for patients in developing countries have been both over- and under-stated.  While cancer patients in India were never at risk of losing access to generic Glivec, many patients around the world who rely on Indian generics are now assured that their access to these drugs will not be affected by applications for patents on slightly altered drugs that can’t show increased therapeutic efficacy.

abenedict

abenedict

Adriana Lee Benedict was a Student Fellow during the 2012-2013 academic year. At the time, she was a second-year student at Harvard Law School interested in promoting access to medicines and biomedical research. She graduated from Harvard College with a concentration in History and Science, a secondary concentration in government, and a certificate in Mind/Brain/Behavior, and subsequently completed a Master of Science in the Department of Global Health and Population at the Harvard School of Public Health. Adriana pursued health and human rights work in Kenya, Tanzania, India, Peru and Colombia, and is was the co-chair of the Harvard chapter of the Universities Allied for Essential Medicines. Adriana’s research interests lie at the intersection of intellectual property and health law, public interest protections in international trade regimes, pharmaceutical research and licensing, and the international right to health. As a Student Fellow, Adriana analyzed regulatory implementation of the NIH Public Access Policy alongside an evaluation of alternative approaches to pharmaceutical R&D, with a special consideration of the impact of international trade and investment agreements on domestic R&D policies.

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