Patent “Ever-Greening”: Novartis Confronts Patent Myth in India

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India’s ‘increased efficacy’ patentability requirement for medicines prevents an improved form of a known drug from receiving a patent unless the new form is significantly more effective than the previously-known form. This provision aims to accomplish one task: stop patent “ever-greening.”  This issue has risen to prominence lately as the New York Times reports on the Novartis suit challenging patent ever-greening requirements in India’s Supreme Court.

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So what is patent ever-greening?  Opponents claim that corporations pursue patenting strategies that involve ‘tweaking’ their medicines to apply for new patents which artificially extend their patent life.  This ‘tweaking’ subverts access to medicines for poor people.  India argues that Indian generic companies stand uniquely positioned to provide medicine to the poor and patent ever-greening directly threatens their ability to do so.  A compelling argument, if it was true or remotely based on fact.

Let me be clear.  Poor patients in the developing world face real access problems for medicines – patented or unpatented. BIO has been directly engaged in studying the problem and suggesting real answers.  However, patent ever-greening, if it is a real problem at all, in no way contributes to the access problem.

Restrictions on so called ‘patent ever-greening’ ignore the fundamental nature of invention and commercialization.  Patents exist to incentivize both invention and commercialization of that invention.  However, measuring the value of each invention is almost impossible to accomplish.  There are many inventions which represent a marginal increase but are in fact a huge innovation.  Imagine an improved jet engine that is “only” 5% more fuel- efficient. Would you be surprised if such an engine would quickly take a major market share? Now imagine an improved heat tolerant vaccine which is about as effective as the original vaccine, but no longer requires refrigeration.  An outright ban on incremental innovation through the use of patent ever-greening restrictions rejects all valuable incremental innovation, automatically deeming it not “patent-worthy.”

Other inventions seem clearly inventive to our society but have little commercial impact in the real world.  For example, wind power generation has only recently emerged when the economics (i.e. price and environmental costs) of oil production has created a market for alternative fuels.   India has become an innovative world leader in advanced wind turbine technology and its champion (Suzlon) captured 7.7% of the world market in 2006.  I find it odd that India’s efficacy requirement does not apply to their innovative wind turbine sector (here is an interesting story of patent intrigue in the wind turbine industry in India).

Finally, Incremental innovation patents do not extend the patent life of the underlying drug.  Any generic company can produce and market the earlier version of the branded drug when the original patent expires.  If the brand company ‘tweaks’ the drug and files for a new patent, the generic company only infringes the new patent if they produce the ‘tweaked’ drug.  However, after the original patent expires, the generic can still produce the earlier version.

Consider your own experience.  You go to the drug store to buy medication.  You can choose to pay more for a branded version which has an extended release mechanism or buy the generic version of the same drug which does not. If you think the patented extended-release formulation is a meaningless “tweak,” you will probably opt for the cheaper, generic version of the original drug. You have access to the drug regardless of the so called ‘patent ever-greening.’

So what does ‘patent ever-greening’ limit access to?  I don’t know.  Indian generics (and generic companies elsewhere) can still manufacture the original, off-patent drugs. And poor patients in developing countries can access the first generation of the drug.  Where is the ‘patent ever-greening’ problem?

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2 Responses to Patent “Ever-Greening”: Novartis Confronts Patent Myth in India

  1. Adriana Benedict says:

    While patients in India may still be able to access a generic form of off-patent imatinib mesylate (Glivec) if Novartis wins their legal challenge (because this “original form” was never patented in India due to India’s patent law not allowing product patents on medicines prior to 2005), a legal interpretation of Section 3(d) (the Indian IP clause in question, which aims to prevent “evergreening” by excluding from patentability the “new form of a known substance”) extending patentability to the beta-crystalline form of imatinib mesylate would open the door for future generics to be delayed by “evergreening” strategies (such as patent linkage, data exclusivity, and generic infringement challenges). These strategies, among others, effectively prevent generic companies from being able to produce the original drug as long as the chemical entity in question is still covered by patent.

    You may also find this Wikipedia entry (http://en.wikipedia.org/wiki/Evergreening) and this MSF presentation (http://www.msfaccess.org/content/evergreening-drugs-attack-access-medicines) useful in answering your question.

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