(Image taken from here)
Most of the regular readers of Spicy IP would by now be familiar with the growing controversy and debates surrounding Section 3(d) of the Indian Patents Act, 1970 (For a detailed list of Spicy IP posts relating to this provision, see here). A while ago, a post had also been made on how other countries like Thailand had been coming up with legislative provisions similar to S. 3(d) within their own IP regimes (see here). For those who are not familiar with the provision, it seeks to prevent “ever-greening” of patents, by stating that only pharmaceutical derivatives demonstrating significantly enhanced efficacy are patentable. 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.
Recently, a piece of news has been brought to the attention of the Spicy IP team. Apparently, the 3(d) wave is spreading to other developing countries also, the current case in point being Argentina. On May 2, 2012, the Argentine Patent Office (also known as the National Institute of Industrial Property, or INPI), along with the Ministries of Industry and of Health, have issued a few resolutions (Joint Resolution Nos. 118/2012, 546/2012 and 107/2012), which include a set of new guidelines for examining the patent applications relating to chemical/pharmaceutical inventions. The resolutions have become effective from May 9, 2012 and will be applied by the Argentine authorities to all pending applications too.
A closer look at these guidelines will reveal that they intend to restrict the patentability of certain categories of pharmaceutical inventions, such as claims directed to polymorphs, hydrates, solvates, salts, esters and other derivatives of known compounds (processes to obtain the same will be considered mere routine experimentation), single enantiomers where the racemic mixture is already known (although novel and inventive processes for obtaining enantiomers may be patentable if they are clearly disclosed and the resulting compound is fully characterized by spectroscopic data), compounds represented by Markush structures (if the specification does not include examples representing all the compounds claimed), selection patents, active metabolites, etc.
The resolutions also prescribe that prodrugs must be supported by the specification, which must include the best method for obtaining them and their characterization. The specification must also demonstrate that the prodrug is inactive or less active than the active compound. New formulations as well as the preparatory processes should generally be deemed obvious over the prior art. However, exceptions are in place insofar as claims directed to formulations are concerned. Such a claim can be deemed acceptable if the invention caters to a long-felt need in a non-obvious manner. Claims relating to combinations of known active compounds, second medical uses or dosage regimes have been termed equivalent to methods of treatment and hence excluded from patent protection.
Apart from the above, the resolutions do contain certain additional flexibility that may be useful to the applicants. They allow any additional example/information filed during prosecution of an application to be considered so long it does not broaden the original disclosure.
Insofar as manufacturing methods are concerned, they must produce an industrial result to be deemed acceptable. Hence manufacturing procedure of active compounds disclosed in a specification must be reproducible and applicable on an industrial scale, which can also be considered a progressive move by the Argentine authorities.
While it remains to be too soon to comment on the resulting effectiveness of these new guidelines in the Argentine context, what remains true is that with the passage of time, more and more IP regimes are leaning towards a stance favourable to the approach adopted by Section 3(d). No doubt such a trend is likely to induce anxiety in the minds of the inventors engaged in pharmaceutical research.