2016 Special 301 : Thoughts on the Public Hearing

Today, I finally got the chance to review the testimonies made to the USTR for the 2016 Special 301. ( See here, here, here  here, here,and here on 2016 Special 301. On a side note, I’m still grappling with USTR’s unusual delay in uploading its transcript and video. As per  Mr. Mehta, they should’ve been uploaded to USTR’s website within a fortnight).


Image - US - India IPR Relations


In my previous post, I had analysed submissions made by various trade groups and not – for- profit organizations, on India’s IPR regime. Out of those, following testified at the public hearing – (please note that only submissions pertaining to India have been highlighted)

(A) Alliance for Free Trade With India (ATFI) :

Brian Pomper, Executive Director expressed concerns over India’s leaked Draft National IPR Policy, primarily on two grounds – (a) Onerous local manufacturing requirements and (b) Failure to ensure regulatory data protection.

He opined that India had not made substantive and measurable improvements in its IPR regime. And hence, at a minimum, an Out – of – Cycle review was warranted.

Question raised by Christine Peterson of the USTR : How would he characterize the initiatives taken in the past 12 months by the Modi Government? 

According to him, there were some positive developments. However, due to the broad sweep of its member companies, more was expected. Data exclusivity was a major area of concern.

Question raised by Jean Bonilla of the U.S. Department of State : What were his views on the Make in India initiative? 

It was a general policy matter, which every country was free to decide. However, provision in the Draft National IPR Policy to give expedited review to patent applications filed by entities that committed to manufacturing in India was partial treatment. 

(B)  Business Software Alliance (BSA)

Leticia Lewis, Director for Policy opined that revised guidelines on the patentability of computer-related inventions issued by the Indian Patent Office was extremely troubling. It was violative of TRIPS as it prevented many software-enabled innovations from receiving patent protection in India.  

(C) Intellectual Property Owners Association (IPO)

Mark  Lauroesch, Executive Director expressed concern over  India’s requirement on the existence of a  contractual relationship between the patent owner and the would-be misappropriator for bringing a misappropriation action. 

Question raised by Michael Smith of the USPTO :How did the introduction of utility model protection (such as that proposed by India’s Draft National IPR Policy) increase litigation? (This was based on IPO’s written submission made to the USTR. The relevant excerpt from their submission is, “There is also a recommendation to add utility model protection to support the informal segment of India’s economy. Although there might be some benefits, this might also lead to increased litigation and uncertainty for innovators operating in India, as has been the case with a similar system in China. ” – Pg. 14).

He answered that with utility models, no examination was required. Because of this more questionable IP rights were formulated. and perhaps asserted. This lead to an increase in litigation.

(D) Knowledge Ecology International (KEI)

James Love, Director of KEI testified that based on his review of the submissions, many were focused on India. Couple of the submissions stated that India had agreed not to issue compulsory licenses by signing an agreement. If the U.S. Government was in  possession of the agreement, it should be made public. They would definitely like to see it. 

Question raised by Stevan Mitchell of the U.S. Department of Commerce : Based on ATFI’s submission there was inadequate protection for trade secrets in India. As the Subcommittee would analyse the adequacy and effectiveness of India’s trade secret laws, were there any principles or considerations  that he suggested should be kept in mind?

He hoped that the USTR would not have an overly broad view of what constituted trade secret and that it would’nt discourage governments from mandating transparency.


(E) Pharmaceutical Research and Manufacturers of America (PhRMA)

Chris Moore, Deputy Vice President for International Policy at PhRMA expressed that restrictive patentability criteria (u/s 3 (d) of the Indian Patent Act, 1970) prevented introduction of new dosage forms and combinations that could promote adherence and lower overall health care costs by innovators and generics. Weak patent enforcement posed a serious problem. After additional duties and assessments, effective tariffs on medicines in India was as high as 20 %.  All of this mandated India to be placed on Priority Watch List with an Out – Of- Cycle review.

Question raised by Maureen Pettis of the U.S. Department of Labour : What was the economic impact of restrictive patentability criteria on U.S.  pharmaceutical industry? 

He answered that the economic impact was difficult to quantify.

(F) Public Citizen  

Burcu Kilic, Public Citizen’s Global  Access to Medicines Program came out in support of India’s patentability criteria. She opined that S. 3(d) of Indian Patent Act, 1970 was structured as a subject matter eligibility threshold and not as a  patentability test. Thus, was TRIPS compliant and should not be cited in the the Special 301 (on India’s TRIP’s -compliant interpretation of patentability criteria).

Further, she also came out in support of India’s stance on issuance of compulsory license for a cancer medicine.  She said that issuance of CL complied with India’s patent law ,  which was narrower than TRIPS permissible limits. 

Question raised by Mary Critharis of the USPTO : Public Citizen in its written submission had remarked with respect to India that countries should be given the flexibility to determine patentability standards. On this, she asked whether there were any situations in which a new form, a new formulation or a new structure could be given patent protection? Or did it believe that there should be a policy barring all such innovations.

Burcu Kilic answered that Indian patent law afforded due protection to new inventions. S.3 (d) of the Patent Act, 1970 was formulated as a test to determine whether the subject matter was a new invention. And if the subject matter was new use, it was subjected to the patentability by the Indian Patent Office. However, there was a major problem with these so – called inventions. They were mostly second-rate patents ( implying thereby that they were not new inventions).


Patrick Kilbride, Executive Director for International IP remarked that he expected Indian Government  to instill legal certainty in the marketplace. Threat of issuance of compulsory license and patentability of computer-related inventions were major areas of concern. 

(H) U.S. – India Business Council (USIBC)

Mukesh Aghi, President of USIBC remarked that important developments related to India’s IP regime had taken place in the last  12 months. Some  of them were (a) Frequent interaction between U.S. and Indian Government (b) Improved transparency and frequent dialogue with the industry. (c) Denial of compulsory licenses (d) Capacity building.

Following are some pertinent recommendations made by him – (a) Consultation with industry  on the guidelines for the examination of patent application for computer-related inventions.(b) Consolidation of  enforcement of the Copyright Act and related international convention (c) Issuing guidelines for interpretation of s. 3(d) of Patents Act, 1970.

Question raised by Won Chang of the U.S. Department of the Treasury : How was Make in India related to IP? Would it lead to  intellectual property reforms?

Mukesh Aghi answered that for Make in India to be successful, a world class IP policy was imperative.

Question raised by Stevan Mitchell of the U.S. Department of Commerce : Did USIBC have a chance to review ATFI’s submissions (considering that both were Indian centric trade organizations)? And how were USIBC’s views different from ATFI’s?

He had not reviewed ATFI’s submissions but based on statistics its member companies were assured by the IP policy commitment made by the Indian Government.


To my delectation (though it may be short lived), the testimonies by pro – industry trade groups were not as acerbic vis- a-vis India’s IPR regime. And as usual, Jamie’s outright testimony by tabling statistics tickled my funny bone.

As I neared the last testimony, the buoyancy of my mood turned into dejection. For, it came to my knowledge only today that Manon Ress of the Union for Affordable Cancer Treatment, an organization whose work I support in heart and spirit was a cancer patient since 2010 (May force be her to fight out the disease). In her testimony, she welcomed Indian Supreme Court’s rejection of the Bayer appeal on Nexavar’s compulsory license. 

What needs to be seen is whether the release of the National IPR Policy coincides with the 2016 Special 301 Report. The National IPR Policy is up for Cabinet’s consideration while the 2016 Special 301 Report would be released somewhere around April 30, 2016.

Even if the National IPR Policy is unveiled before the release of 2016 Special 301, it would not have any effect on India’s status. However, if the Policy appeals to U.S. trade organizations, its status could potentially be upgraded in the 2017 Special 301.














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