Novartis patent matter: where were we looking?

There is a really nice article in Economic Times dated August 13, 2007. It is something which is so true and most of us have lost sight of in the Novartis Glivec matter. It is about healthcare and infrastructure that is in woeful condition in India. While the activists have been rallying about the fact that patents are bad for the healthcare and patients in India, nobody has ever made a hue and cry about the miserable condition of hospitals and healthcare in India.

The really good part about the article is the facts and statistics which speak volumes about the state of affairs in India. The article clearly brings out the fact that for the Indian poor, intellectual property is not the issue. The real issue is the healthcare infrastructure. Some startling facts, I have culled out and listed below:

(a) About 60% of Indian do not have access to basic, off patent (generic) medicines;

(b) Despite pumping cheap generic AIDS drugs for years, only 5.5% of India’s AIDS sufferer were receiving any drugs by end of 2006

(c) According to a 2005 report by Transparency International, the health system is the most corrupt service sector in India. The transport network is so bad that rural people struggle to get to a clinic, even if one exists within 200 kms of their home

(d) An estimated 400, 000 Indian children under five die each year from preventable diarrhea.

(e) Children are going without routine vaccinations

(f) Simple anti-infectives are out of reach of the majority of rural poor

The authors of the column are A Van Gelder and P Steven, analysts at International Policy Network, a think-tank based in London. I do not know where they may have got the statistics and I do not vouch for the accuracy either. What I can definitely vouch for is that being an Indian myself, I know without my own facts and figures that they are not way off the mark.

Instead of looking at intellectual property as an enemy, people should start viewing it in the light of as an essential economic tool. A good IP regime is beneficial for everyone. It is beneficial for the economic growth of the country since intellectual property protection is amongst the first things that foreign companies look at before investing. On the other hand for the public it is good since intellectual properties such as patents act as guarantees for good quality and effective drugs. It is not an unknown fact that there is a huge market in India for copy drugs that do not international standards and untested drugs.

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….

Novartis Loses or did the court play monkey??

The High Court has passed an order dismissing the petition. A closer look at the order seems to suggest that the Court has said that the court cannot decide whether the Act is in accordance with TRIPs.

What has the court decided or has the court decided anything?? I cannot say by reading from the few articles that have been released as well as by NDTV article reproduced below, if the court decided upon the constitutionality or did it just pass the buck?

At the moment it appears to be just monkey business and I will keenly look forward to an update and possibly a copy of the order.


Press Trust of India

Monday, August 6, 2007 (Chennai):

The Madras High Court has dismissed a petition filed by Swiss pharmaceutical major Novartis AG relating to the patent right for one of its products.

The plea challenged the constitutional validity of Section 3 (d) of the Patents (amendment) Act 2005 for patenting the beta crystalline form of imatinib mesylate.

Quashing the petition, a division bench comprising Justice R Balasubramanian and Justice Prabha Sridevan held that the court cannot decide whether the Act was in accordance with trade related aspects of intellectual property rights (TRIPS) agreement or not.

The Intellectual Property Appellate Board (IPAB) on July 21 had rejected the plea by Noivartis to exclude a technical member from a bench constituted to hear its appeal against rejection of patent right to beta crystalline form of imatinib mesylate.

Counter affidavit

The firm objected the appointment of S Chandrasekaran on the IPAB bench on the ground that he had 'disabled himself' to hear its appeal against rejection of its patent right, as he had deposed in the counter affidavit filed in the Madras High Court.

Rejecting the objection, the IPAB bench comprising board Chairman M H S Ansari and S Chandrasekaran had noted: "The submissions made by Chandrasekaran have no relevance as they were based on his official capacity as a statutory authority before assuming the post of adjudicator and hence must be eschewed from consideration on the facts of the instant matter."

Originally, the company had filed an appeal and a petition in the Madras High Court.

The appeal challenged rejection of its patent application for beta crystalline form of imatinib mesylate, sold under the brandname Gleevee / Glivec.

Constitutional validity

The petition challenged the constitutional validity of the provisions of the Patents (Amendment) Act 2005, on the basis of which the firm's plea for patent was rejected.

Since there was no IPAB bench, which is the competent authority to hear the appeals against rejection of patent, the company moved to the high court.

During the course of hearing, the Centre notified the constitution of IPAB bench. Following this, a Division Bench of Justice R Balasubramanian and Justice Prabha Sridevan, which was hearing the matter, referred the appeal to the board.

However, the high court had reserved orders on the petition challenging the validity of the provisions of the Patents (Amendment) Act, 2005

NOVARTIS MOVES HIGH COURT TO REMOVE CHANDRASEKHARAN)

There is now a row about Chadrasekharan being part of the IPAB, when it was he who has passed the order against Novartis in the opposition proceeding and is now listening to his own appeal. The IPAB has rejected the claims of Novartis and have allowed Chadrasekhran to be a part of the PAB for Novartis appeal. Novartis has filed a writ with IPAB challenging this situation. This how the situation stands today.

This post is more as a reply to Shamnads post on Spicy IP (NOVARTIS MOVES HIGH COURT TO REMOVE CHANDRASEKHARAN) and I have thought I should post it at IPUN as well.

The way I see things is that the purpose of the two forums, IPAB and High Court, are different. High Court is the correct forum at the moment to handle the question of constitutional validity of Section 3(d). IPAB’s job is to decide upon the technical grounds and nothing to do with constitutionality.

To the extent that Chandrasehekaran should not be a part of the IPAB bench deciding Novartis case is justified. But to say that the matter regarding technicality should be transferred to Madras High Court is not correct. The case may be very important and is required to deal with issues which are sensitive, but to say that High Court is more sensitised to the matter is again not entirely correct. If the case should run its course, then it should run its course in the respective forums i.e. one deciding constitutionality and the other deciding upon the appeals on technical grounds. Let this be trial by fire for the IPAB. If the matter is taken is away from IPAB, the whole purpose of constituting the IPAB is defeated. If High Court is to be end all of all litigation then IPAB should be scrapped. This case may be important in several aspects but I repeat that it should run its course in the respective race courses.

The point which seems to be missed here is that all IPAB (accepted sans Chandrasekharan!) has to do is not allow the appeal simply on technical grounds of Novartis missing the required deadline to file the application in India by claiming priority from a country which was not a convention country without even getting into Section 3(d), obviousness or any other debate. By simply doing this, the IPAB would have rendered the correct decision and the onus would be on High Court to decide upon the constitutionality. The way things are poised, it seems (I may be totally wrong) that Novvartis is less bothered about their application not being allowed and more bothered about Section 3(d) on which the fate of its several applications rests as well its future patent strategies in India.

I am reproducing a portion of the Controller’s order regarding priority and as a third person I see no flaw in it especially since everybody knows that patents are highly time sensitive and the applicants are required to be aware of the this.

“The Opponent said this application was filed in India on 17th July, 1998 as a convention application claiming Swiss priority date of 18th July, 1997 whereas Switzerland was not a convention country on that date. Further, Section 133 did not have and does not have any retrospective effect. The Opponent cited a decision of the High Court of Calcutta in the case of Danieli AC Officine Meccaniche SPA, Italy in support of his argument. In the present case also, Switzerland became convention country only in September, 1998. Hence no priority may be claimed from Swiss application.

The Applicant said that priority date is only a facility provided to the Applicant to avoid anticipation by publication of the invention between priority date and the filing date in India. It is the discretion of the Applicant to claim priority. I agree with the contention of the Opponent that this application wrongly claims priority.”

To sum it up, I believe that IPAB has been provided with an escape route and it should be allowed to use this and smartly pass the matter to High Court in correct fashion which would show that IPAB has done what is to be done without creating a fuss. This I believe also forms a part of running the course. Yes there may be writs and all, but no fingers would be pointed towards IPAB for passing a wrong judgment. I am not defending IPAB, but I am trying to see the logical and correct manner of approaching this unique situation.