On the 27th of July, both the Times of India and the ET carried a news report titled “U.S. doublespeak on patent waiver”. The report alleges hypocrisy on the part of the U.S. in objecting to India’s decision to grant a CL for Bayer’s patent over Nexavar since the U.S. itself has recently authorized the import of cancer drugs from India in a bid to meet a critical shortage of cancer drugs in the USA. The opening line of the report states “The United States, which is crying foul over a patent waiver for a cancer drug in India, has itself resorted to similar steps to "reduce disruptions" in supply of two medicines - and that too through an executive order. In addition, the order's mandate may not be limited to these drugs alone but could extend to several others.”
The timing of the report is a bit surprising, along with the fact that it does not mention the dates of any of the events. A cursory mentioning of these dates is absolutely necessary to lend some context and perspective to the overall story.
For instance the Executive Order from President Obama authorizing the US FDA to take steps to counter the drug shortage in America is dated 31st October, 2011. The US FDA order allowing for import of the drugs in question from Sun Pharma in India is dated 21st February, 2012. The decision by the former Controller-General P.H.Kurian to grant a CL licence for Nexavar is dated March 12th, 2012 and the deposition by the USPTO Deputy Director before the Senate Committee was on the 27th of June, 2012. I’m not quite sure as to why the ToI and the ET have carried this news report without mentioning any of these dates?
The incomplete reporting does not end over there. The report quotes D.G. Shah of the Indian Pharmaceutical Alliance as saying “This is a compulsory licence. But the difference is that our system is justiciable and there is a process. In case of the US, even the patent right-holder will wake up one morning and discover that the patent had been revoked”. I’m not sure if Shah was selectively quoted but this statement from Shah gives the impression that the U.S. has in fact waived the patent rights over Doxil and methotrexate. That would be inaccurate.
Methotrexate is an ancient drug, dating back to the 1950s and there is no exclusivity over the drug. There is thus no question of the US government waiving any IP rights over this drug. For the second drug, as per the Orange Book, the patent for Doxil expired in the year 2009. The drug however continues to enjoy a period of market exclusivity until May 17th, 2014 due to its orphan drug status.
I’m not sure of the circumstances in which the US allows for the waiver of market exclusivity or whether the government has to compensate the IP rights holder for granting such a waiver. I’m awaiting confirmation on that limited point. If the US government is indeed waiving IP rights without compensating the rights holder it should really not be giving India any grief about Nexavar.
Having said that, I think too much has been made out of the deposition of Teresa Ray, USPTO deputy director before the Senate Committee, especially since most media outlets seem to have ignored the USTR’s 301 Report rather placid comments on the Nexavar CL decision. I had covered that report over here.