A slightly dated piece reported on IP Komodo (a wonderful blog dealing with IP issues from East Asia) caught Spicy IP’s attention. It states that The Thailand Health Systems Research Institute is planning to introduce an Indian Section 3(d) equivalent provision in its Patent Act. This is aimed at curbing the practice of ever greening in Thailand, since out of 2,000 patents granted over the last 10 years over 1,900 consist only of mere changed formulations, alternate medical uses or chemical selections.
For example, the Bristol Myers AIDS drug Atazanavir originally patented in 1997 was further patented in 2005 in respect of further medical uses and again in 2008 on the formulation itself. It is believed that if the evergreening patent is granted, it could extend the validity of the Atazanavir patent to 2028 from 2017, and in the process block attempts by others to manufacture generic versions.
Fallacies
This argument however fails to make a distinction between incremental innovation and ever greening. It assumes that alternate medical uses and pharmaceutical derivatives amount to ever greening of patents. As explained over here , it is important to distinguish between incremental innovation and ever greening. Ever greening refers to an improper extension of patent monopoly in relation to a specific pharmaceutical product, while incremental innovation refers to sequential developments of existing products and technologies that can help bring in improved products to the market. It would therefore be incorrect to classify all incremental innovations as tantamount to ever greening.
Incremental Innovation v. Ever Greening- Indian Section 3(d)
Some commentators have stated that such a provision would prevent the incentive for incremental innovation known to be a highly successful method of producing drugs. However, as pointed out here and here, the Indian Section 3(d) does not seek to prohibit incremental innovation.
In fact it draws a distinction between ever greening and incremental innovation.
Section 3(d) reads as below: – The following are not inventions within the meaning of this Act:-
the mere discovery of a new form of a known substance which does not result in increased efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
Section 3(d) aims to prevent “ever-greening”. It states that only those pharmaceutical derivatives that demonstrate significantly enhanced efficacy are patentable. This may occur either when a manufacturer supposedly ‘stockpiles’ patent protection by obtaining separate 20-year patents on multiple attributes to a single product or when drug manufacturers try to patent wide range of inventions connected with modifications of their products, including minor features such as inert ingredients and the form, colour and scoring of tablets.
By making derivatives with added efficacy patentable, Section 3(d) encourages sequential developments of existing products or technologies that help bring in improved products to the market, capable of addressing unmet public health needs.
Therefore, it does not seek to prohibit incremental innovations from being patented at all. It is based on the premise that incentives are just as necessary for sequential pharmaceutical developments as they are for new chemical entities.
If the aim is to prevent ever greening in Thailand, introducing an Indian Section 3(d) type provision would adequately prevent it and at the same time would not prove to be detrimental to innovation.
Next Steps
As reported here, the next phase of research in Thailand would look into the impact of ever greening patents on people of various economic means by studying the top 100 kinds of pharmaceuticals, such as cholesterol blockers, glucosamine, diabetes, heart disease and Aids drugs. The study is expected to be completed by January 2012 at the end of which the results will be submitted to the Department of Intellectual Property to seek ways of protecting Thailand from ever greening of patents.
