Patent

NOVARTIS MOVES HIGH COURT TO REMOVE CHANDRASEKHARAN


As anticipated by an earlier SPICY IP post, the Economic Times now reports that Novartis filed a writ petition before the High Court challenging the decision of the IPAB to keep Chandrasekharan on the panel.

Not a particularly huge fan of “I told you so…”, but SPICY IP had cautioned against the very transfer of the case itself to the IPAB in one of the earliest posts, stating that this was a bad move. We had first noted in April 2007:

“…in this climate of uncertainty, it may make better sense to have the Chennai High Court continue with the Novartis case—as this is too important and too sensitive a matter to leave in the hands of the IPAB, particularly when its “patent” section has begun functioning only now.

Also, in the light of the fact that an IPAB order can be appealed to the High Court, we may just end up with more delayed litigation. It makes better sense to have the matter decided by the Chennai High Court at this stage (without it having to come back to the High Court after the IPAB takes a shot at it). “

And later, after the case was transferred from the High Court to the IPAB, SPICY IP had noted in June 2007:

“….what is damaging is his [Chandrasekharan’s] direct involvement at a time when Novartis appealed the patent office order before the Madras High Court. He filed an affidavit before the court defending the rejection of the patent application by the patent office. This being so, having him continue on the IPAB flouts cardinal principles of natural justice, particularly the one stating that no one can be a judge in his own cause (for those of you with a penchant for dead languages, “nemo debet essa judex in propria cause”).

There is a clear and legitimate apprehension of bias here and as many of us were taught in law school “Justice must not only be done, but must also be seen to be done”. The government should take immediate steps to recuse him—(or he should do it himself). Else, an otherwise strong case for the government (on merits) may suffer. But if he is so recused, what happens?

Should the IPAB go ahead and decide the matter without him? Doesn’t seem like a particularly sensible option for me. Justice Ansari (Chairman of the IPAB), who is on the IPAB panel along with Chandrasekharan may have excellent credentials –but is no patent expert. In fact, the IPAB never functioned till recently because it had no technical member. Chandrasekharan’s appointment was with a view to fill in this lacuna.

But more importantly, Chandrasekharan was hastily appointed in the wake of the Novartis litigation and the governments’ desire to have the matter shifted to the IPAB. One can only second-guess the reasons for the government wanting to do so— perhaps from fears that one of the Madras High Court judges was pro Novartis—as the learned judge had, in an earlier matter involving the exclusive marketing right (EMR) of Novartis over Gleevec, upheld the validity of the EMR and injuncted several generics (in sharp contrast with a Mumbai High Court order that questioned the validity of the EMR in question).

Whatever be the reasons, it is paradoxical that the government tries to get away from a supposedly biased judge by running into the warm embrace of another one. But “paradox” is a familiar bedfellow as far as IP law/policy in India goes. One hopes that better sense prevails and a new technical member is appointed to the IPAB to replace Chandrasekharan in this matter. Perhaps the IPAB may end up getting an excellent technical member and may begin churning out excellent patent jurisprudence in the coming years. Or perhaps the matter will continue as it is—and Chandrasekharan’s presence will make a dent in an otherwise strong case for the Indian government. We’ll have to wait to see how this saga unfolds….”

Time has proved that the saga we envisaged is now playing out–and we are caught up in a great litigation theatrical–perhaps, the time is now ripe for a Bollywood script on patents….. “Novartis, Chandrasekharan aur Woh”??

Below is a reproduction of the text of the ET article:

“Triggering a fresh legal wrangle, Swiss drug major Novartis on Wednesday filed a writ petition with the Madras High Court contesting the Intellectual Property Appellate Board (IPAB)’s decision to let former Patent Controller General S Chandrasekaran hear its appeal for Glivec.

“We expect the opportunity to explain our case clearly to an objective board. Because the current technical member of the appellate board was responsible for the original rejection of the Glivec patent, and was a party in the patent appeal in the high court, where he filed an affidavit on behalf of the offices of the Controller General of Patents, we believe he cannot act as an impartial member of the Appellate Board”, a Novartis’ spokesperson said on Wednesday.

Novartis had filed a petition with the IPAB last month insisting that the newly appointed technical member to the board had refused its patent for anti-cancer drug Glivec in the first place, and should therefore not hear its appeal. However, the IPAB dismissed Novartis objection.

“I honestly do not understand the stand of the IPAB, said Novartis’ vice chairman and MD Ranjit Shahani. Novartis is not against the IPAB. On the contrary we believe that its creation is a great step towards setting up a strong IP regime in the country,” he said.

In a separate case, the Delhi High Court recently held that Mr Chandrasekaran could not hear Magotteaux International’s appeal to the patent office decision to reject one of its patent application. Following the rejection of its patent application by the Delhi Patent office, Magotteaux International, a Belgian company, had filed an appeal with the Delhi High Court. The case was then transferred to the IPAB. However, like Novartis, Magotteaux filed a petition with the high court, insisting that Mr Chandrasekaran should not hear its appeal as it was under his tenure that its patent application was rejected in the first place.

It is for the same reasons that Novartis is today opposed to Mr Chandrasekaran hearing our appeal on Glivec, said Mr Shahani. Novartis hopes that the Madras High Court will, like the Delhi High Court did for Magotteaux, rule in its favour. The Madras Patent Office rejected Novartis’ patent application for Glivec in January 2006, arguing that the Basel-based drug maker’s innovation was obvious and did not meet the requirements of section 3(d), a legal clause specific to the Indian patent law, which stipulates that modifications of already-known medicines cannot be patented unless they make the drug significantly more effective.

While Glivec is a new medicine, patented in over 40 countries around the world, Novartis is seeking patent protection in India for a crystalline form of the drug, as the original molecule was invented prior to 1995, and is therefore not eligible for a patent in India. Novartis has last year filed a petition with the Madras High Court challenging the constitutionality of Section 3(d).”

In another news item, DNA reports:

“Novartis has moved the Madras High Court on Wednesday against the Intellectual Property Appellate Board’s (IPAB) decision in the Glivec case, in which the company is fighting the case to obtain a patent on its anti-cancer drug. In the case involving Magotteaux International, Delhi High Court said that Chandrasekaran cannot be a technical member on IPAB as he has earlier dealt with the matter under appeal. “Though Novartis wants Chandrasekaran out of the case, it is difficult. In the earlier decision IPAB passed has mentioned that Chandrasekaran has to continue on the doctrine of necessity,” said Anand Grover, lawyer of opposition representing Cancer Patients Aid Association.

He further explained: “The high court has separate powers when compared with the appellate board. As IPAB has no choice except for Chandrasekaran, the case depends on whether the high court will appoint another person as the technical member of the board.”

I’m sure this must be a case of misreporting–as no one in their right mind would invoke the “doctrine of necessity here”!! Not enough that the government, for reasons best known to it, hastily shifted an ongoing case from the High Court to the IPAB……. is it now fair to argue that since we can’t do any better, we may as well have this “potentially biased” person sit in judgment over something on which he’d already made up his mind?? With the world closely watching the gradual unfolding of our new patent regime, why is the government hell bent on making a mockery of the system and creating a dent in an otherwise strong case?

The most practical solution now is to recuse Chandrasekharan from the panel and appoint another in his stead. Or if we can’t find another person, then to have the case transferred back to the High Court. After all, the Madras High Court has already heard arguments–and is relatively better placed to render judgment. Maybe a little bit of a merry go round–but this is nothing new to those who’ve tasted litigation in India–particularly in matters with significant political undertones…..

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

4 comments.

  1. AvatarVaibhav Vutts

    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.

    Reply
  2. AvatarVaibhav Vutts

    hellloo!! The Novartis matter has been dismissed and the petition has been quashed! But is this the right decision??

    From what i can gather from the NDTV post is that the petition was dismissed on the ground that Madras High Court cannot decide if the Patent Act is in compliance with TRIPS. This is too lame! May be i need to get the order to see what are the reasons. At the moment it just seems as if the buck has been passed!

    We were waiting for the case to run its own course. This road has hit a deadend! What do you think of this??

    I may reacting prematurely, but it seems nothing has been decided

    Reply
  3. AvatarShamnad Basheer

    Thanks for your thoughtful comments. You’ve not read my last paragraph carefully. I repeat:

    “The most practical solution now is to recuse Chandrasekharan from the panel and appoint another in his stead. Or if we can’t find another person, then to have the case transferred back to the High Court. After all, the Madras High Court has already heard arguments–and is relatively better placed to render judgment.”

    In other words, let the IPAB decide the matter if we can find another person to substitute for Chandrasekharan (and you seem to be in agreement with the fact that Chandrasekharan should be recused, owing to the potential for bias). If not, let it revert to the High Court, which had anyway heard the matter and would have rendered a decision, but for this abrupt appointment of Chandrasekharan to the IPAB and consequential enablement of IPAB to decide “patent” disputes.

    As for whether this damages the credibility of the IPAB…..well, it wasn’t like the IPAB was doing patent appeals prior to this!! Chandrasekharan’s appointment is what gave the IPAB its “patent” competence–and if he can’t sit in on this matter and we can’t find an alternative “patent” person to substitute, no one in their right minds is going to construe this as terribly damaging to the future of the IPAB. I’m sure we can do better than this in future!!

    On the merits of the matter, I’m not so sure that “priority” is really a clincher here. You have to remember that a “priority” date only helps with pushing back the date in relation to which we assess “novelty”. Novartis files the application in India on July 17, 1998 and attempts to claim a Swiss priority date of July 18, 1997. However, as you rightly point out, since Switzerland was not a convention country at that time, Novartis cannot claim this 1997 priority date. But the only consequence of this is that “novelty” will now be judged with respect to July 17, 1998 and not July 18, 1997. In other words, if nothing has been published between July 18, 1997 and July 17, 1998, this change of “priority” date does not impact Novartis.

    Lastly, I’m with you on the fact that the section 3(d) has been blown out of proportion. This may just stem from the fact that companies like Novartis and Ranbaxy (which is one of the parties opposing Novartis’ application in this regard) are really using this case to set the standards for interpreting section 3(d). Else, this case could have been easily disposed off under regular “non obviousness” or “inventive step” principles that are enshrined in our patents act. I guess a lot of us tend to forget that even if Novartis crosses the section 3(d) threshold, it still has to further cross the hurdle of proving that the alleged “invention” involves an “inventive” step or that it is not obvious to a person skilled in the art.

    I hope this clarifies some of the issues you raise.

    Reply
  4. AvatarVaibhav Vutts

    Yes it does clear up a lot of things. Thanks! I also read in ET today about the Novartis judgement. ET was much more clear then NDTV post and my reaction was indeed premature.

    To quote from ET “A division bench comprising Justice R Balasubramanium and Justice Prabha Sridevan ruled that Section 3(d) of the Patents Act is valid and could not be termed vague, ambitious or unconstitutional.”

    As i see, the court has taken the correct approach and as you have rightly pointed out WTO is teh deciding body to ascertain if the provision is TRIPS compliant.

    Reply

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