Patent

ALLEGATIONS OF BIAS IN THE NOVARTIS PATENT LITIGATION


Whilst most of us await the Madras High Court judgment on the constitutionality of section 3(d) of the Indian Patents Act, here’s an update on what’s going on at the IPAB (Intellectual Property Appellate Board), the specialized IP tribunal in India. As mentioned in an earlier post, the Novartis litigation was split up—the patentability issue was referred to the IPAB and the constitutionality issue was to continue with the Chennai High Court.

Before the IPAB could even begin to wade into the turbulent waters of what it means to be a more “efficacious” salt form, Novartis has raised objections to the presence of Mr Chandrasekharan (ex Controller of the Patent Office) on the IPAB panel. Novartis alleges that the Gleevec application was rejected by the patent office at a time when Mr Chandrasekharan was Controller. Therefore, having Chandrasekharan sit in judgment over whether he got it right the first time around violates cardinal principles of natural justice. To complicate matters, Chandrasekharan filed an affidavit at the earlier stages of the Novartis litigation before the Madras High Court, supporting the rejection of Novartis’ patent application.

The Financial Express Reports:

“The Intellectual Property Appellate Board (IPAB), which has been formed to give a verdict on various patent cases across the country, may reject Novartis objection on the presence of S Chandrasekharan, the former patent controller, on IPAB. Novartis had objected to Chandrasekharan’s presence on the board saying he was responsible for Glivec being denied product patent in 2006, when he was the controller general of patents.

Experts close to the development say that IPAB will consider the fact that Chandrasekharan was actually not responsible for the decision on Glivec’s patent application. IPAB will consider Novartis’ objection on July 2.

An attorney from Madras High Court, who is close to the Glivec case, told FE, “The role of Chandrasekharan is entirely different now. While he was in the Chennai patent office, he had administrative responsibilities only. It was not he who took the decision.”

“Subramaniam, who is the examiner and Rengaswamy, the patent controller, took the final decision and as Chandrasekhar was the final authority, he gave the final consent. Anyway, he was not directly involved with the decision finally taken,” the attorney added.

Says Ranjit Shahani, vice-chairman and managing director, Novartis India Ltd, “The government has taken a step forward in creating a fully functioning patent system by setting up IPAB. However, we objected to the appointment of the former controller general of patents as the technical member since it was in his tenure that the patent was rejected and he was also acting as a party to the recent court case reviewing the decision of the Indian Patent Office to reject our patent. We believe it would not be in the interests of natural justice for him to hear our appeal.”

Another patent attorney opined that if IPAB rejects Novartis’ objection on these grounds, Novartis could go to the high court again with a writ petition alleging favouritism in IPAB’s action.

If the court finds Novartis’ arguments are true, IPAB will have to appoint another technical member removing Chandrasekharan, he added.

At present, Justice Ansari is the legal member while Chandrasekhran is the technical member.

Novartis has challenged section 3(d) of Indian Patent Law, according to which, any new use or a new variant of an old substance cannot be patented without having any significant efficacy. On this basis, the Chennai Patent Office had rejected Novartis¹ patent application for anti-leukemia drug, Glivec. Novartis approached the Madras High Court against the verdict arguing that Section 3 (d) of Indian Patent Act is not compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement that India had signed in 2005.”

No doubt, Chandaraskeharan was not directly involved with the rejection of the Novartis patent application by his Assistant Controller, Rengaswamy. One might argue that his involvement was in an administrative capacity, as head of the patent office. Whether this distinction between judicial versus administrative capacity is sufficient to enable him to adjudicate on the matter in an appellate capacity is a moot issue. However, what is damaging is his 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….

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.

7 comments.

  1. Avatarchandra

    shamnad
    Mr.chandrasekharan , according to this article “http://www.rediff.com/money/2005/feb/07guest.htm” is an Engineer.May be a chemistry /drugs related person may be appointed as Technical member.lest an Engineer becoming a Technical member to determine,how much efficay is patentable ,will be a joke on the nation

    Reply
  2. AvatarEssenese

    Shamnad,
    In a matter that recently came up before the Delhi High Court, it was the petitioners contention that chandrashekhar, in his capacity as CG, had acted on this issue and thus he should not be allowed to hear the appeal before the IPAB. This view was endorsed by the Delhi High Court that has directed that the appeal be heard by the IPAB, but chandrashekhar is not to be the technical member.
    Though there are currently three members appointed as technical members, if the remaining two are not competent to hear the case then the court may consider the appointment of a scientific advisor as provided by section 115 of the Act.

    Reply
  3. AvatarShamnad Basheer

    Thanks for your comments, Chandra,

    You’re right in a way. Although, to have technology specific “technical members” at the IPAB (which is an appellate body) may not be a very practical option for a nation that is just beginning to come to terms with sophisticated patent concepts.

    My own view is that so long as he/she has a good appreciation for the scientific concepts underlying the case (with or without the help of scientific advisors), and some decent legal acumen, we can look forward to nuanced patent decisions.

    The need for specialisation and super specialisation in some of these areas is an interesting debate. If you look at the US, where patent professionals are highly specialised in their area of expertise, we have someone like Judge Randall Rader who is an English major but renders some really incisive patent decisions. So it depends on the person as well.

    Reply
  4. Avatarchandra

    shamnad
    sir hugh laddie in his foreword to IPR COMMISION”s report said that
    whether IPR’S (INCLUDING PATENTS)are good or bad ,developed countries have
    the means to mitigate the problems created by them ,but the same cannot be said about developing countries”.
    my point is this just as any body can err,in high profile cases like this
    we should not give any room for error
    .efficacy clause was based on such rationale ,which the U.S doesnot have.it is in public interest that we have subject specilized technical member’s having sound legal knowledge.After all we are a country of 1.1 billion ,not counting NRI’S! i feel drawing
    parallel’s with the most liberal patent
    regime will be unfair.by the way pl
    let me know about the practice on the otherside of atlantic in such matters!

    Reply
  5. AvatarShamnad Basheer

    Dear Chandra,

    Much as I would like to concur with you, the sad fact remains that a bigger population does not always mean a bigger talent pool to pull folks out for all disciplines–particularly patents.

    We have a severe shortage when it comes to patent professionals in the country and we have a relative resource crunch (compared to the richer developed nations) when it comes to staffing our patent office/courts.

    The point of the comparison with the US was to suggest that even where resources are relatively more abundant and the propensity is to go in for more specialisation, a judge with a non science background still does a great job with rendering sophisticated patent decisions.

    You’ll therefore appreciate that in a country like India that is only beginning to toy with complicated patent concepts, having a pharma expert at the IPAB for pharma cases, a biotechnologist for biotech cases, an electrical expert for electronic cases and a mechanical engineer for mechanical patents is not really practical.

    Reply
  6. Avatarchandra

    when the whole country was crying foul over the nonexistant yoga patent’s,a non resident indian law professor was making right noises!being an optimist i feel may be
    we can also find technical members,after all both naiudamma and
    mashelkar were nri’s when they brouht
    in! as a stopgap arrangement the law
    professor from usa is my choice for the technical member,and iam not kidding…

    Reply
  7. AvatarShamnad Basheer

    Dear Chandra,

    You’re very kind with your comments. If only I had some more years of experience, and more importantly, if only I had some solid patent prosecution experience…

    Thanks,

    Shamnad

    Reply

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