Saturday, January 01, 2005

Editorial critique of new Indian ordinance in Financial Express

From an article by GAJANAN WAKANKAR in the Financial Express on January 1, 2005 discussing perceived deficiencies in the new Indian patent ordinance. Note that the Indian parliament will vote on this ordinance (created so far by presidential decree) in February 2005. The change which goes into effect on Jan. 1, 2005 is not final until the parliament votes, so that writing editorial criticism of the ordinance could impact the final version of the law.

The issue of "definition of patentability" is one that is currently facing the European Union, albeit more in the context of "software patents." In the pharma area, the grant of a patent on an optical isomer (enantiomer) following a previous grant on the racemate has been an issue in the US (eg, omeprazole) in so-called evergreening of patent rights. Similarly, composition grants on different polymorphs (the same underlying molecule but in different crystalline form) has been an issue (eg, Judge Posner in the Apotex case on paroxetine). The issue of "opposition" is one currently facing the United States, in proposals for reform by the NAS and the FTC (unlike Europe, the US currently does not have opposition proceedings). Mr. Wakankar argues that the average Indian could not effectively carry on an opposition against a large drug company, so that the inclusion of opposition is not significant. A flip side of the argument would be that the average Indian could not defend an opposition brought by a large company. Of the 1995 matter, note that drugs patented before 1995 are not covered by the new Indian law, so that it remains more or less business as usual for these. Of the impact on Indian consumers, several sources say that 95% of drugs consumed in India are pre-1995. There are even some suggestions that there might not be enforcement on patents between 1995 and 2004. Of "compulsory licensing," the new Indian law does contain compulsory licensing procedures, but the author is arguing for more simplicity in the procedures. Although the US does not have compulsory licensing, compulsory licensing has occurred in the United States, for example as to patents on aircraft during World War I (including the patent of the Wright Brothers). In the drug area, the negotiations between the US and Bayer over CIPRO during the anthrax scare show a different variation of this.

#1. DEFINITION OF PATENTABILITY. The first and foremost omission is in defining patentability properly, to avoid continued renewal of the patent called ‘ever-greening.’ It is necessary to stop applications for the patenting of minor changes such as salts, esters, polymorphs, hydrates, isomers, metabolites, or changes in purity level, particle size, blood levels, etc.

#2. OPPOSITION. [The JPC party] added two more grounds, non-disclosure of the source of biological material used in invention and anticipation by traditional knowledge. The present ordinance does away with this right and replaces it by a weak ‘Representation by way of Opposition,’ and that after considerable political pressure.
Once a patent is granted, big drug companies, particularly MNCs, will see that opposition proceedings linger as long as possible. Then, even if the patent is cancelled ultimately, they would’ve enjoyed the benefits all these years. The average NGO or Indian would be ill-prepared to carry on a costly legal battle against a patent-holding multinational company. Trips is silent on this matter, meaning countries have full powers to decide. Therefore, full-fledged and appealable pre-grant opposition provisions must be retained. Incidentally, most EU countries have these.

#3. BREAKPOINT AT 1995. Another omission which will affect patients is sudden stoppage of economically-priced medicines already in production, post-1995, on the basis of government-issued manufacturing licences. The ordinance only states that this type of domestic production can continue upto the date of grant of patent.

#4. COMPULSORY LICENSING. The existing CL procedure is extremely lengthy and complicated. Even where product/process patents are genuinely granted, there is a distinct possibility of exorbitant abusive prices and inadequate supplies from patent-holders.
The ordinance has not been able to utilise all flexibilities provided in the Trips agreement and the Doha Declaration.


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