Novartis dealt a body blow by Swiss government

The much awaited judgment in the Novartis’s case of challenging the constitutional validity of Section 3(d) of the Indian Patents Act, 1970 was quite an anti-climax. There were hopes that the Chennai High Court would render a landmark and ground breaking judgment. This was more of a hype and several persons had already predicted that Chennai High Court will not be adjudicating on the constitutionality of Section 3(d) [for reference see Shanmnad’s comments on SPICY IP titled Monday, August 06, 2007 Novartis Loses At The High Court: Focus Now Shifts To Ipab http://spicyipindia.blogspot.com/]

If the facts and circumstance are taken into account, one would realise that the Court has rendered the correct judgement. There appeared to be no way out for the Court and leave alone passing the buck, the correct forum is WTO Dispute Resolution, not Courts in India.

For Novartis the recourse was therefore WTO to challenge the patent regime especially Section 3(d). This recourse has been dealt a body blow because of the comments of Doris Leuthard, Swiss Federal Councillor to the Department of Economic Affairs. She has said that, 'The Swiss government never gets involved in any judicial pronouncement of other countries. We accept any case which is settled in India. It is normal litigation in which one party happens to be a company while other is a country'. She has also stated that “We must have a reliable TRIPS system, and the one in India is good enough”. For the full story go to http://www.forbes.com/markets/feeds/afx/2007/08/08/afx3998070.html.

So what does this mean for Novartis? It seems that Novartis has only the recourse of going to the Supreme Court of India challenging the order of Chennai High Court. This shall only mean protraction of the matter with a high probability with Supreme Court up holding the decision of Chennai High Court.

It seems that Novartis should quietly accept this fate accompli and work through Swiss government to change some policies and provisions in the Indian patent law. The reason for this suggestion is that the Swiss minister is in India to set up a joint committee to develop a dialogue on issues of intellectual property. There will also be exchange of information and ideas. May be if Novartis plays its hand right, it could work things in its favour and still extract something from this losing scenario. This might seem far-fetched and a long term suggestion, but I would like to hang on to the axiom “something is better then nothing”

The IPAB matter is still to decided. Mr. Chandrasekhran’s removal from the Board hearing this matter should be confirmed by the court. This is merely a technical issue and the odds are heavily against Novartis for the IPAB to rule in its favour. The fact is heavily against Novartis has been discussed on Duncan Bucknell’s blog (http://duncanbucknell.com/blog/110/). Some excerpts are reproduced below which will help thro light on the Novartis’s weak situation:

“Unfortunately, for Novartis, Ranbaxy and Natco were able to prove that the increased efficacy is not present since Novartis themselves have stated that free base form and the salt form compared with β-crystal form of imatinib mesylate and the difference in bioavailability is only 30 per cent and also the difference in bioavailability may be due to the difference in their solubility in water.

Unfortunately again for Novartis they were not able to show any improvement in the efficacy of the β-crystal form over the known substances rather was proved that the base can be used equally in the treatment of diseases or in the preparation of pharmacological agents wherever the β-crystal is used.

The second and more significant problem that Novartis has run into is that of the imantib mesylate (IM) itself. The opponents (Ranbaxy and Natco) have successfully been able to prove that imatinib mesylate salt inherently existed in the β-crystelline form which is the most stable form of the salt. Even the affidavit of Novartis in the opposition proceedings states that the β-form is thermodynamically more stable. Ranbaxy and Natco were able to show through prior publications and studies done by two reputed government institutions Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Technology, Delhi that the salt exists in the β-crystalline form. These experiments were performed not once but at least ten times and at all times the crystals were found to exist in the β-form. Hence the invention has been compromised/ anticipated before even the application by Novartis was filed.

….the opponents were able to show that " 1993 patent discloses methanesulphonic acid as one of the salt forming groups and also the 1993 patent specification states that the required acid additions salts are obtained in a customary manner. Further, claims 6 to 23 of the 1993 patent claim a pharmaceutically acceptable salt of the base compound. The patent term extension certificate for the 1993 patent issued by the US Patent Office specifically mentions imatinib mesylate (Gleevec R) as the product. All these points clearly prove that imatinib mesylate is already known from the prior art publications and the Opponent has satisfactorily proved that the salt normally exists in the β-form which is the most thermodynamically stable product. Hence I conclude that the Opponent has succeeded in proving that this invention is anticipated by prior publication."

…..the hitch is that Novartis faces an uphill task to prove the following "and" conditions:

1. That the invention is not barred by Section 3(d); and

2. That the compound is novel; and

3. That it is non-obvious; and

4. That Novartis did not disclose that the application was based upon a non-convention country nor did it make any efforts to change this position. This has been viewed as a misleading tactics. Though probably this is the weakest of the four, but still will be required to be proved”

Therefore, it indeed appears to be the end of the road for Novartis in this matter. What are your thoughts on this matter….