On the allegation of bias by NATCO


Image from here.

Independent of the defamation issue, there is another issue that we need to discuss and that is the allegation by Natco that Shamnad’s opinions on its lawsuit against Bristol Myers Squibb (BMS) are biased towards BMS and that he has colluded with them. At some level, I guess this a professional hazard of running a blog.


This is a very serious allegation and I am guessing that Shamnad is already taking steps to sue Natco for this potentially defamatory statement that lacks any factual basis.  A close reading of Shamnad’s post (that Natco took issue with) will reveal that Shamnad also criticizes BMS for their attempts at drug patent linkage. In pertinent part he states:


“More worrying than Natco’s fatal legal blunder is BMS’ alleged attempt to sneak in drug patent linkage, despite our courts holding such linkage to have no valid legal basis in India. Natco alleges that BMS was behind a show cause issued by the Uttarakhand drug regulator to divest Natco of its regulatory approval.” 


“Given that drug patent linkage has been held to have no legal basis in India by both a single judge and an appellate division bench of the Delhi High Court (and effectively confirmed by the Supreme Court as well, which refused to admit the appeal from the Division Bench), BMS will have to answer to a serious charge of bad faith, if Natco’s allegations are indeed true.”

Secondly, some time ago, when BMS had sued Hetero for this very same patented drug, Shamnad took serious issue with the attempted drug patent linkage. I repeat from his post here:


“From a policy perspective too, any such linkage is hugely problematic. Apart from issues of institutional competence, such linkage contravenes the very essence of the Bolar provision, a patent defence that permits generic companies to safely generate regulatory data while the patent is in force and pursue their drug regulatory application process, so that no time is lost between the expiry of a patent and the entry of a generic product in the market. Such linkage also virtually results in the introduction of a “data exclusivity” like norm, a norm that a government committee (Satwant Reddy Committee) suggested, ought not to be introduced into India at this stage.”


How then can NATCO claim that Shamnad is biased towards BMS and against Natco? As an independent academic, he has expressed his views on a patent litigation of wide public interest. In fact, this litigation was already in the public eye through mainstream media reports before SpicyIP covered it, attesting to the fact that it was a matter of public interest. In fact as I discussed in my earlier post today, mainstream media reports had pointed to the potentially murky regulatory issues that may arise as a result of the approval granted in this case. An ET news report had this to say: “Hyderabad-based generic drugmaker Natco Pharmahas started selling copies of global pharma major Bristol MyersSquibb’s cancer drugDasatinib, sold under the brand name of Sprycel, in the Indian market, after it got a marketing licence from the Uttarakhand government to sell a generic version of the drug. The move is sure to kick off a fresh controversy in the regulatory framework over patent issues.”


In the past, drug companies have approached the Drug Controller General of India (DCGI) to obtain manufacturing licences for selling drugs in the country. However, this is one of the rarest of rare case, where a drugmaker has applied for a licence of a patented product through a state government.When this report is viewed in light of the recent Parliamentary Standing Committee document on regulatory approvals, it is quite clear why there was high public interest in this case.


Funnily enough, Shamnad was the one who defended Natco’s right to obtain such approvals legitimately from a State authority and he is quoted in this news report as stating:


“A patent expert said that Natco is well within its right to obtain a licence from a state government to sell the drug in the Indian markets. The regulator’s only job is to look at safety and efficacy of drugs, and it is not obliged to look at validity of patents,” said Shamnad Basheer, professor in Intellectual Property Law, National University of Judicial Sciences.”


And now, soon as he criticizes NATCO about one of its cases, he is being accused of bais against Natco!


Natco also appears to have conveniently forgotten that Shamnad lavished liberal praise on it for its bold CL strategy just a few months ago.  For instance, in his interviewto a mainstream media publication, he stated:


….if the medicine is for the public, what good is it if the public cannot access it, says intellectual property expert Mr Shamnad Basheer. The judgment, a baby step for Natco, is, in fact, a giant leap for rest of the generic pharmaceutical companies, he says.”


In fact, even in the very same post that Natco has issues with, Shamnad had clearly stated:


For the longest time, Cipla ranked as our leading poster child for the debate on patents and access to affordable medicines….

The tables began turning early this year, when another Indian generic company, Natco filed India’s first post TRIPS compulsory licensing application seeking to slash the patented prices of Bayers’ patented anti-cancer drug, Nexavar. In the wake of the compulsory licensing decision, Natco catapulted to prominence as our national hero; a bold pharmaceutical company that refused to cave in to international pressure or to bed foreign partners, but insisted on pioneering the delivery of cheaper and more affordable drugs through a new “compulsory licensing” route.”

As we have stated several times on this blog, as a blog, we are committed to an objective analysis of IP law. If we feel the need to criticize some company for what we think is poor strategy we will do so candidly. Being objective does not mean that we cannot express our independent opinion.


As of now Natco may be in serious trouble for casting aspersions on a reputed academic; particularly since those aspersions are obviously contradicted by Shamnad’s own earlier writings and views in favour of Natco. 
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Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

3 comments.

  1. Manish Garg

    First of all, any new drug to be introduced in the Indian market needs to approach DCGI for approval and then go for local FDA…what appearing fishy here is how come that local FDA approves a new drug yet to be approved by DCGI..state FDA appears to have violated the basic forms of approval process….

    Reply
  2. Anonymous

    Does bias in opinion invite liability ? I don’t think so. He is free to be biased in his opinions if he wants to. Natco can walk away from this blog anytime. If at all Natco wants more limelight, they could sue Google instead. That is exactly what highly media conscious institutes or schools IIPM and GIIS Schools have done, invoking IT Act alongside alleged defamation. They can thank the architects of the IT Act if they find any words “annoying”, “insulting” etc. Wonder why “biased” was left out, though.

    Reply
  3. Anonymous

    Does bias in opinion invite liability ? I don’t think so. He is free to be biased in his opinions if he wants to. Natco can walk away from this blog anytime. If at all Natco wants more limelight, they could sue Google instead. That is exactly what highly media conscious institutes or schools IIPM and GIIS Schools have done, invoking IT Act alongside alleged defamation. They can thank the architects of the IT Act if they find any words “annoying”, “insulting” etc. Wonder why “biased” was left out, though.

    Reply

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