Section 3(d) Scrutiny: Indian Patent Database will be Ready by March 2009

CH Unnikrishnan, a well known pharma/patent reporter with the Mint ran a very interesting story a couple of days back on the likely section 3(d) scrutiny at the patent office. He states:

“India may have denied a patent to Swiss drug maker Novartis AG for its cancer drug Glivec because it considered this to be a mere modification of an existing molecule, but it has granted at least 10 patents in the past 12 months to foreign and local drug makers for what would appear to be mere modifications or new forms of known drugs.”

As readers are aware, under section 3(d), derivatives of existing molecules (mere modifications) are not patentable unless they demonstrate “increased efficacy”.

In his private communication to me, Unni points to several applications that implicate section 3(d), including:

2 patents to Cipla : Nos 219034 for inclusion complex of esomeprazole with cyclodextrins, and 219022 for for alendronate monosodium salt

4 patents to pfizer: nos 204325 for eletriptan hydrobromide monohydrate, 204343 for a polymorph of propylamino ..methyl, 201140 for crystalline form a macrolide antibiotic, 204344 for piperydinylaminomethylchroman derivative

1 patent to schering: no. 202128 for a crystalline polymorph of tetrahydro ……..

1 patent to Wyeth: No 201649 for a salt of O desmethyl-venlafaxine

1 patent to Sun Pharma: no 204126 for piprazinyl derivative

1 patent to Glaxo: No 204151 for derivatives of oxazoles and thiazoles

1 patent to AstraZeneca: No 204158 for imidazo pyridine derivative

I cautioned that one could not arrive at a conclusion either way (that the patent office had scrutinised the applications thoroughly and checked them for compliance with section 3(d) OR that they had not), without having a look at the complete specification, claims as granted, file history etc.

Unfortunately, since we do not have a complete online patent database as yet, members of the public cannot easily access such information and determine the level of scrutiny. Fortunately, at the Kolkata stakeholders meet, this issue was raised and the government committed to making patent information available by the end of March 2009. Knowing Mr NN Prasad and his commitment towards increasing transparency and the efficiency of the patent system, I for one, am hopeful that this deadline will be adhered to.

The Mint report quotes me in this light, stating that:

“An expert admitted that while only a closer look at the patent application would show whether patent laws had been violated, the issue highlights the lack of transparency in the entire patent grant process.

“Unfortunately, members of the public, who end up paying the monopoly prices resulting from such patents and have every reason to be vigilant about the scrutiny involved in examining such applications, do not have ready access to such patent information,” said Shamnad Basheer, the ministry of human resources development chaired professor in Intellectual Property Law at the National University of Juridical Sciences, Kolkata. Basheer added that the government had promised to make this information available through an online database by March. “One hopes that this deadline is adhered to, as this matter is of grave public importance and has immense implications for transparency and governance.”

At the Kolkata patent stakeholders meet, we also stressed that the prosecution history/file history of every patent application ought to be made public, so as to provide for greater transparency in the patent grant process. This kind of information is public in the more experienced IP jurisdictions (I shudder from the use of the word “more sophisticated” or “more mature” IP regimes) such as the US (PAIR system) and the EU. And there is no reason why an IT savvy country that is the world’s largest democracy should not commit to making its processes more transparent by publishing this information.

Lastly, at the Kolkata meet, we also pointed out that the patent office has had a history of issuing internal circulars, directives etc, on the basis of which patentability decisions are made. However, these circulars are “secret” and applicants are never informed of them. Here again, Mr Prasad committed to making this information also available and SpicyIP lauds him and his team for making such substantial commitments towards increasing transparency. For those interested in such secret circulars, see this paper of mine (freely downloadable at SSRN) which deals with one such biotechnology circular, which denied patent protection to anything that contained “living material”. (See chapter titled “Secret Internal Circulars: Hiding From the Law”: page 321 onwards).

This circular and its underlying reasoning (talk about “circular reasoning) was struck down by the Kolkata High Court in the Dimminaco case. The court found that absent a statutory exclusion of “living matter”, the patent office could not come up with its own rules through directives etc.

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