Thursday, September 04, 2008

Novartis "Glivec" Case: Supreme Court In Favour of a "Technical" IPAB

Joe C Mathew, a leading pharma/patent analyst with the Business Standard has this very interesting account of the Supreme Court proceedings in the Novartis case. He notes in pertinent part that:

"The Supreme Court on Tuesday suggested that the Centre should consider having an expert member on the Intellectual Property Appellate Board (IPAB) that reviews decisions of the Indian patent office.

Hearing the case, Justice SH Kapadia and Justice B Sudershan Reddy suggested that the central government should consider the appointment of a fresh technical member to hear the first case pending before the recently constituted IPAB. The government is expected to submit its response on Friday.

The case went to the apex court after the Madras High Court had asked the government to hear an appeal from Swiss pharmaceutical major Novartis against the rejection of a patent for its cancer medicine Glivec, without the panel having an expert member.

In response, Natco Pharma, the key opponent in the Glivec patent case, moved the Supreme Court last December. In January, Natco secured an interim stay order on the HC verdict. The company’s position is that a ‘technical member’ is a must on the panel.

The litigation is an offshoot of the country’s first and most discussed patent fight initiated by Novartis against the rejection of patent protection for Glivec in the country.

In November 2007, the Madras High Court approved a government suggestion to allow IPAB to go ahead with the patent rejection hearing case on Glivec without a technical member."

Joe has merely recounted what transpired in the Supreme Court--we still await the Supreme Court's final ruling on this point. But from his account, it would appear that the court is clearly in favour of having a "technical IPAB" decide the contentious Novartis-Glivec case.

The key questions remaining are: what kind of a technical member would be optimal; how quickly can the government do this, given that this matter has already suffered inordinate delays? In this context, I want to throw up one suggestion and would like to hear from our readers as to what they think:

Can we have a system of ad hoc technical experts? And might such an ad-hoc panel include leading patent counsels/practitioners from India? But before I elaborate on this suggestion, a little more background on the case:

SpicyIP had in earlier posts decried the attempt of the government to have the IPAB decide this highly technical patent issue without a technical member. To get a sense of the technical issues involved (i.e. whether or not the beta crystalline form claimed by Novartis is patentable), see our latest post here see here). In a previous post, we noted that as per the current legal regime, a patent matter at the IPAB cannot be heard without a technical member:

"Section 84 (2) of the Trademarks Act states that every IPAB bench must consist of at least one technical member and one legal member. And section 116 (2) of the Patents Act lays down the qualifications for a "technical member". In short, a technical member ought to have been a Controller of Patents for at least 5 years or should have been a patent agent for at least 10 years. This being so, I fail to understand how the government can now ignore these provisions and have an IPAB bench without a "technical member". If accepted, the Government proposal above would mean that an IPAB bench consisting of just the Chairman (Justice Ansari) and the Vice Chairman (ZS Negi) will decide a sophisticated patent matter.

Neither of them qualify as "technical members". Given that India has had only about 80 odd patent cases till date, I'd be surprised if Justice Ansari who retired as a High Court judge prior to his joining the IPAB has heard more than one patent case in his entire career as a judge.

If the scheme proposed by the government is accepted by the parties and put into operation, aren't we making a mockery of the legislation creating a specialized IP tribunal (IPAB)? I'm assuming that the philosophy underlying its creation was that IP disputes called for some level of specialised expertise not normally possessed by ordinary judges.

On another note, I just wish I knew that if all parties to a dispute agreed, we could subvert a statutory provision—during my days as an IP attorney in India, there were plenty of times when I sat with opposite counsels and moaned about statutory provisions that neither of us liked!!

So what next? Parties to a dispute decide that they don't like a provision in the Civil Procedure Code mandating that a court cannot grant more than 3 adjournments, barring exceptional circumstances? Or that none of the parties want the judge to apply sections X and Y of the Patents Act that is not entirely to their liking? Or perhaps, they draft their own codes that they wish the judge to apply!!

A classic case of "I told you so". Spicy IP had warned right at the start that shifting the forum from the Madras High Court to the IPAB midway through the litigation was a bad idea. Come to think of it, isn't this what we are getting now--a non specialised team sitting in judgment over this complicated patent dispute.

What are the possible ways forward?

1. Appoint another technical member. This has the added advantage that if similar situations arise in future (where a technical member such as Chandrasekharan is recused on account of bias), we have a clear way out. In fact, the government should use this as a perfect opportunity to appoint such a person. It may take a little while but it's well worth the effort.

2. Continue with the solution recommended by the government of having a panel without a technical member---and make a mockery of the system. Of course, this might lead to tricky questions of why tax payer money was wasted in creating this specialised IP tribunal.

3. Shift the litigation back to the High Court. A solution that is not very likely at this stage."

Conclusion: Ad Hoc Technical Experts--Lessons from the UK?

Back to the ongoing proceedings at the Supreme Court. Natco, represented by Harish Salve is vehemently protesting any move to hear the matter without a technical member. And rightly so--as we've kept repeatedly contending, this pretty much makes a mockery of the IPAB.

Novartis, represented by Shanti Bhushan wants the matter to go ahead without a technical member, since it is worried about any ensuing delays in the matter.

As for the government stand in this matter: till lately, the government was in favour of the matter being decided without a technical member. However, during the hearings on Tuesday, the government apparently changed its stand and is now willing to consider appointing a technical member to the IPAB. It is however worried that the process may take a while and unduly delay the matter before the IPAB. The judges who appear to favour the position taken by Natco, have asked the government to come back with proposals on how it wishes to go forward i.e. in terms of devising criteria for selecting techincal member, the likely timelines etc.

On the point of delay (a point which both the government and Novartis are worried about), I'm not entirely sure how a further 6 month delay (assuming it takes 6 months to appoint a technical expert) is likely to harm the litigants to such a significant extent that it far outweights our interests in adhering to the wishes of our Parliament that has clearly indicated its preference in having a "specialised" and "technical" IP body decide this dispute. We ought also to consider the fact that there are likely to be other patent matters where Chandrasekharan might need to be recused: Are we going to make a mockery of the IPAB and decide all these patent matters without a technical member only in the name of speed?

If the goverment is worried about the delays in appointing a regular "technical" member, it ought to consider appointing ad hoc technical experts. After all, we've had a tradition of ad-hoc judges (though many are skeptical of its success) and there is no reason why we cannot replicate the same for the IPAB.

It may also help to study a rather unique solution prevalent in the UK judicial system, whereby noted IP experts (particularly leading IP counsels) are part of a panel and appointed as ad-hoc judges from time to time to decide IP matters. Of course, the lawyer that is chosen as the ad-hoc judge in this regard is only picked if he/she has no interest/stake in the matter otherwise.

And we've had some great decisions from these ad hoc judges. Peter Prescott, a leading IP counsel in the UK (readers may be familiar with his leading copyright treatise along with ex-Judge Hugh Laddie and Mary Vittoria), has rendered some very thoughtful decisons, that have often measured up to and sometimes even bettered the ones rendered by regular judges. Illustratively, see this decision in CFPH LLC for his rather "philosophical" take on the menaing of the term "technology":

"Many have tried to frame an acceptable definition, but to the best of my knowledge none have succeeded. It is like the equally vexing question, "What is Art?". The hard truth is this: concepts of that sort have no existence, and words of that sort have no meaning, except by human convention; but human beings are hopelessly in disagreement at the margin. And it is, precisely, at the margin of uncertainty that cases come up for decision."

Interestingly, this system of ad hoc IP experts in the UK was touched upon by Arun Jaitley during his arguments in the Roche vs Cipa matter. As we've noted in previous posts, the appellate bench deciding this matter has expressed their concern re: their lack of specialised/technical skill sets and will no doubt dwell very seriously on the extent of deference that they ought to accord to a decision from a technical body such as the patent office . I'll come back with a separate update on this matter soon.

Back to the Novartis/IPAB issue: Personally, my own view is that we need to think through new solutions (such as ad hoc technical experts), rather than take the easy way out and make a mockery of a system that was evolved with the specific aim of having a "specialised" body with "technical" expertise decide IP disputes. What do our readers think?


1 comment:

  1. Uday Gokhale8:47 PM

    I agree with you Shamnad. I had suggested in a comment in one of your early posts on this case to appoint an expert ..ad hoc technical expert.. like Dr. Prabuddth Ganguli who is an excellent organic chemist besides an expert in IPR. I would like to see you appointed there.

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