In pursuance to its investigation into India’s trade, investment and industrial policies, the U.S. International Trade Commission (USITC) is holding a public hearing on February 13, 2014. Professor Srividhya Ragavan (University of Oklahoma College of Law), Brook Baker (Northeastern University School of Law), and Sean Flynn (American University Washington College of Law) submitted a statement to the USITC on issues pertaining to India’s patent regime.
This is a welcome intervention and provides a nuanced understanding of Indian patent laws and implementation. It is also instrumental in clarifying and rectifying certain misunderstandings regarding the Indian patent regime as evidenced by the GIPC IP Index.
The main theme of the submission is that whatever may be the effect of India’s patent policies on the profits of multinationals, the regime and its implementation are in consonance with the TRIPS. On the key issues of the Novartis case and Compulsory Licensing, the submission emphatically drives home the point that both instances are not TRIPS violative.
As stated, the Novartis judgment is well reasoned, reasonable and TRIPs permissible: “In essence, the Supreme Court of India, in a well-reasoned decision, found that beta-crystalline form of imatinib mesylate, was revealed and claimed in a pre-TRIPS patent and thus was time barred from patentability in India unless it showed significantly enhanced efficacy. Unfortunately for Novartis, the Supreme Court of India found that Novartis offered no evidence of increased efficacy of the relevant compound whatsoever, and thus that the patent was unmeritorious under section 3(d).” Also, the frequent reasoning of 40 other countries granting a patent to Gleevec has also been rebutted strongly “The argument that several other countries agreed that Gleevec was patentable despite being a mere variation of an existing, previously patented chemical entity is inconsequential to India’s own patent determination.”
On compulsory licensing the submission stated that India has the most sophisticated compulsory licensing system, only one compulsory license has been granted so far and “as a mark of its careful scrutiny, the Indian patent office rejected an application to compulsorily license Dasatinib.”
To contextualize these and other issues, the submission briefly explains and traces the history of the Indian Patent Act and the 2005 amendment, noting that the Preamble, Article 7 and Article 8 of the TRIPS allow countries to adjust their intellectual property laws to meet local needs. In dealing with introduction of a product patent regime, the submission notes that India’s ‘worldwide’ prior art and novelty standard is much broader than that which prevailed in the US till 2011. On the inventive step aspect, it was highlighted the US’s weak nonobviousness standard has become a cause for concern and a cause for the deteriorating standards of granted patents. Related to the weak nonobviousness standard, secondary patents have become commonplace in the US, teaching a lesson to other countries to strengthen regimes that prevent evergreening : “The low standards of inventiveness in the US has been alleged Such strategic patenting became commonplace in the United States thanks to the steady lowering of standards, especially for determining nonobviousness, has in turn contributed to such strategic patenting, which is now subject of much scrutiny in the United States.
The struggles of the United States with a barrage of secondary patents on medicines have served as a lesson to other countries, including India.
In the United States such patents are easily issued although they can be invalidated by litigation. Rather than accepting the resource investment, cost, judicial time and the loss of access to the public inherent in the U.S. model for combating evergreening, India’s Section 3(d), enacted in the 2005 amendment.”
Other provisions of the Patent Act such as exhaustion of rights, the bolar provision, opposition mechanism, creation of the IPAB etc. have been explained and highlighted in the submission.
The USITC launched this investigation on a request jointly filed by Senate Committee on Finance and the House Committee on Ways and Means. The USITC is an independent, nonpartisan, factfinding federal agency and is due to deliver its report by November 30, 2014.
Meanwhile, the U.S. Chamber of Commerce, in a submission to the Office of U.S. Trade Representative (USTR), has requested that India be classified as a Priority Foreign Country (a designation given to the worst offenders when it comes to protecting intellectual property and which could result in trade sanctions)