Natco vs Pfizer: Joe Mathew Reports on Compulsory Licensing Decision


Two days back, we posted on a patent office decision, upholding the patentees’ right to be heard in the Natco vs Pfizer/Roche Compulsory licensing dispute.

Joe C Mathew of the Business Standard carries this succinct write up on the decision. I’ve been quoted in this report as stating that: “”I think Natco’s application itself is a weak one as they did not submit proof to suggest that there is a public health emergency in Nepal due to lack of availability of the drug.”

“Public health emergency” in the above quote was mistakenly substituted for “public health problem”. Neither Doha nor the Indian patents act require a “public health emergency”. Rather, they only require that there be a “public health problem” in Nepal. Even on this test, however, Natco’s case appears a weak one. As we stated in our previous post:

“I for one, am more interested in finding out if Natco will be successful in persuading the Nepal government to issue a TRIPS notification attesting to the fact that there is a pressing public health problem in Nepal. And I can hazard a guess that there must be considerable lobbying at the moment in Nepal by both parties to this dispute.

Till date, there is no such TRIPS notification and to this extent, Natco’s application is doomed to fail. As of now, from the little information we have (see the LC update below), the only permission by Natco is a drug regulatory clearance to import fixed quantities of drugs. Clearly, this cannot amount to conclusive evidence that Nepal has a public health issue. We need to find out if Pfizer is selling in Nepal and if so, what price is it selling at? Unless there is a genuine public health problem, Natco should not be permitted to use this mechanism to make some quick profits–that is not the purpose of the Doha Declaration. Rather the interests of Nepal and its cancer patents ought to come first.”

This sentiment seems to have been echoed by the patent office in its decision, where it notes that:

“i) The letter issued by the government of Nepal, said to be permission for importation of patented pharmaceutical product is not in the language as recognised by Indian patent rules. Therefore, this letter cannot be considered as permission for import by Nepal government.

ii) The requirement for the importation of the patented drug from India has not been notified to the TRIPS Council by the Govt of Nepal.”

I reproduce the report by Joe in the Business Standard:

Patent office to hear drug firms` views before granting licence
Joe C Mathew / New Delhi July 07, 2008, 0:13 IST

The Indian patent office will provide drug innovators a chance to explain their views before a decision to grant compulsory licences against their patented medicines is taken. The patent office’s decision has, for the first time, set rules for examining compulsory licence applications from local companies against multinational drug majors like Pfizer and Roche.

The patent office on July 4 dismissed a petition filed by Natco Pharma opposing the patent office’s move to seek the opinion of Pfizer before granting a compulsory licence to Natco. The application seeks granting a compulsory licence to manufacture and export generic version of Pfizer’s patented cancer medicine, Sunitinib, to Nepal.

The application was made under Section 92 (A) of the Patent Act and the Patent Rules, 2006, which allows the government to permit or issue compulsory licence to local manufacturers to export patent medicines to the countries, which do not have the capability to manufacture such medicines.

Since such licences are meant to be issued at the time of public health crisis, the Patent Rules do not spell out in detail the modalities of issuing them. Natco had argued that inviting patentee (Pfizer) to appear at the hearing to contest the grant of compulsory licence was not required under the patent law.

The patent office, however, felt that the arguments of the patentee shall be helpful in deciding the terms and conditions for granting such a licence and may also be helpful in avoiding the abuse of the provisions of Section 92 (A).

“I think Natco’s application itself is a weak one as they did not submit proof to suggest that there is a public health emergency in Nepal due to lack of availability of the drug. The patent controller, therefore, states in his order that one of the reasons for the ‘hearing’ is to ensure that the provisions of 92 (A) are not ‘abused’. This is a sound order and helps the patent office take a better decision on a complicated area of law,” Shamnad Basheer, a patent expert, said.

Natco is the first and the only Indian generic drug maker to seek the compulsory licence route to supply medicines to a least developing country.

Including the current one, Natco has two pending requests for compulsory licences to supply cancer medicines to Nepal. The other request is for permission to export Roche’s cancer medicine, Erlotinib.

The patent office decision will enable Pfizer to express its views on the compulsory licence application. Natco will be given time to respond to Pfizer’s submission before the patent office takes up the case for final hearing.

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.

2 comments.

  1. AvatarAnonymous

    If sufficient supply to market in nepal is not fulfilled by patenteee then Natco can apply for compulsory license.
    otherwise Natco should approach patentee for license.

    Health problem issue should require substantial declaration from Nepal Government.

    Reply
  2. AvatarOverworked, Underpaid

    I seem to be a ‘little’ late to the party.. but could this excellent website direct me to a copy of any orders passed in this license?

    Reply

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