Patent Evergreening in India: Response from the Other Side

Patently BIOtech

Thank you Adriana for commenting on my article Patent “Ever-Greening”: Novartis Confronts Patent Myth in India.  Before I respond, here is your full comment:

Adriana says:

Plant

Photo by Sterlic

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.

I appreciate your civil tone and participation but I am concerned that your comment and your sources are misleading.

First, your sources are inaccurate, misleading, and do not answer my question:

a.  The Wikipedia link has a large banner at the top stating “This article may require cleanup to meet Wikipedia’s quality standards. No cleanup reason has been specified. Please help improve this article if you can. (September 2009)” While the “clean up reason” is not specified, a rational observer can quickly determine on their own the reasons why this source should not be trusted (hint – one reason could include that it was probably written only by people on one side of the debate).

b.  The Medicins Sans Frontieres (MSF) link takes you to a video which actually was one of the causes of me writing the article in the first place.  I’ll ignore the ad hominem attacks and highlight the factual inaccuracies.  First, the video states that “the drug companies make a tiny little change to their drugs and ask for another 20 year patent.”  The video implies and MSF and India have stated elsewhere that this is an artificial extension (evergreen = the leaves (patent) never die) of the original patent.

Yet the innovators (often small companies spinning out of U.S. universities) cannot artificially extend their patents.  As stated in the article above and which you concede, they can file for new patents based on new inventions and generic companies can produce the older version once the older patent expires. As a result, no one is artificially extending any patent.  If a company gets a new patent on a reformulated existing drug it will be because it is a new invention (as recognized by countries such as the United States, Europe, China, Brazil, etc).  I’ll also ignore MSF’s ignorance that the 20 year patent clock runs from date of filing and not date of issuance and drug companies usually only get 12 years of actual patent life in the U.S. although in India it is usually much less.  In case you were wondering, per the Paris Convention U.S. inventors only have 12 months to file a patent application in India after they file in the U.S.

Now to your comment:

Your comment I think is reflective of MSF’s position.  It doesn’t appear that MSF objects to patent evergreening because none of the arguments I have heard are factually accurate or responsive.  MSF’s concern appears to be that access to medicines for the poor in developing countries is being harmed due to the price of the medicines, which MSF attributes to patents.  Simple enough for a political ad but it does not reflect reality.

The fact is that “patent linkage, data exclusivity, and generic infringement challenges” have nothing to do with patent evergreening as they do not extend the original patent nor do they result in additional patent life.  Each of these concepts deal with keeping generics from entering the market before the original patent expires (20 years from filing or about 12 years in real life).  I’m not sure exactly how forcing the Indian Patent Office to have a rational interpretation of the Section 3d “increased efficacy” law “opens the door” for generic delay through patent linkage or data protection as India does not legally have either patent linkage or data protection.  Regarding generic infringement, yes, if the Indian patent office is forced to clarify Section 3d increased efficacy requirements and that results in the Indian patent office giving Novartis a patent, then Novartis could take generic infringers to court and delay generic entry before the patent expires (that is exactly how a patent, not patent evergreening, works).

Here is our position on what is actually affecting access to medicines for the poor in developing countries.  And yes, we believe it actually reflects the complexities and solutions for bringing medicines to the poor in the developing world.  http://www.bio.org/advocacy/letters/options-increasing-access-medicines-developing-world

Patently BIOtech  |  Email This Post  |  Printer Friendly
Tags: , , ,

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>