Negotiating two noble goals – ‘access to essential medicines’ vs. ‘pharma innovation’
Novartis has asked for clarification on a set of patents related to Gleevac, a leukemia drug. Today’s New York Times describes the battle between Novartis and Indian generic drug manufacturers in an article entitled, Battle Pits Patent Rights Against Low-Cost Generic Drugs.
Most of you are probably very familiar with the ongoing debate pitting further pharmaceutical innovation against access to essential medicines. This article does not resolve this issue, but it does provide further evidence that international agreements on IP rights have emboldened ‘big pharma’. At issue here is breakthrough vs. incremental innovations of pharmaceuticals. According to the article,
It would also effectively tighten patent legislation passed by India in 2005 to limit the manufacture of generic drugs. The law was intended to bring India in line with the World Trade Organization’s agreement on intellectual property rights.
The 2005 law allows patents to be granted on new versions of older, off-patent medicines if the new version can be shown to represent a significant improvement on the original, but not in the case of “incremental innovations.”
According to Novartis the new version allows for better absorbtion into the body over previous and off patent versions of the leukemia drug. John Gilardi states “If there is no patent protection, we will not see billions of dollars being invested in the research of medicines,”. But, monetary investment aside, at what point does expanding the protections on intellectual property decrease incentives to innovate. Without in depth familiarity of the case, it seems the Indian court ruled that the new version did not represent a significant incremental innovation. The issue of patent violation was never seriously on the table.
Novartis already gave free supplies of Gleevac to 6,800 patients in India suffering from the rare form of leukemia that it was developed to combat. He [John Gilardi] said that number represented more than 90 percent of all the cases in the country.
Donations as a model does not represent a sustainable solution to the “access to essential medicine” problem. Yet, it has been and continues be trumped as a possible model for mitigating the problem. See Making Sight Affordable (Part I): Aurolab Pioneers Production of Low-Cost Technology for Cataract Surgery for a discussion of this issue for intraocular lenses.