Public Hearing : 2016 Special 301 Report

PhRMA wants USTR to ensure free reign to their greed while patients do not have any hope to have access.”

Truth will out. The above statement from UACT’s  testimony to the 2016 Special 301 public hearing held on March 1, 2016 reaffirms that though delayed, truth ultimately prevails.

Patent Kills Patient
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The public hearing for the 2016 Special 301 was held on March 1, 2016 at  the USTR. As much as I had wanted to, being a weekday I was unable to attend it. As of today, the recording and the transcript of the hearing  has not yet been released by the USTR (Perhaps today being the last day for submission of the supplemental information including written responses. For a timeline of the 2016 Special 301 Process, visit here).

From whatever is available in public domain , I’ve built up a picture of the public hearing. I’ve highlighted some pertinent points which have an influence in determining India’s designation under the Report. (For more on Special 301, see my posts here , here and here)


Traditionally, the public hearing commences with foreign governments designated as Watch List (WL) countries pleading to the USTR to get off the list.

Governments of Bulgaria, Czech Republic and Ukraine had ten minutes each to testify.  Not being designated as WL, Government of India  did not testify.

For the second session, sixteen non- governmental organizations testified. Just to reiterate from my previous post, out of these sixteen organizations, testimonies of the following are particularly noteworthy – (These organizations in their written submissions had recommended India to be designated as a Priority Watch List country.)

(i) Alliance for Free Trade With India (AFTI)

(ii) The Software Alliance (BSA)

(iii) International Intellectual Property Alliance (IIPA)

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

(v) U.S. Chambers of Commerce’s Global Intellectual Property Center (GIPC)

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

Testimonies of the Internet Association, the Intellectual Property Owner’s Association, the Program on Information Justice and Intellectual Property  and the Trademark Working Group is of relevance considering that they cited objections to India’s IPR framework in their written submissions.

Knowledge Ecology International, Public Citizen and Union for Affordable Cancer Treatment had filed for notice to intent to testify. They’ve traditionally been supporters of India’s pharmaceutical patent regime.


Only information pertaining to testimonies of AFTI, KEI, Internet Association, UACT and USIBC is available. I’ve tried summarizing their arguments (the portion focusing on India) –

(i) AFTI – Not to my surprise, it testified that India should be placed on PWL with a rigorous Out- Of- Cycle Review.  Considering it’s members (or rather cosy coterie), it played the usual rhetoric of –  (a) Weakness in India’s copyright system (b) Use of compulsory licenses and (c) Additional patentability criteria.

(ii) KEI –  Jamie Love testified on PhRMA’s, BIO’s and GIPC’s written submissions to the USTR which lashed out at India’s pharmaceutical patent regime. His defensive statement goes well with the proponents of access to affordable healthcare –

A number of the submissions supported by the pharmaceutical industry have targeted India. India is important both because it is a large country with more than a billion persons, and because it is frequently looked to as a supplier of affordable generic products in other countries.

KEI is working on compulsory licensing cases in several countries, and like others will look toward India to play a role in providing a supply of products.

He also made a cursory remark on sourcing prostrate cancer drug Xtamdi’s generic from India.

(iii) Internet Association – Ellen Schrantz testified for the inclusion of following three points in the 2016 Special 301 Report

(a) Support Balance in Copyright :  Limitations and Exceptions

( Support for fair use and other exceptions)

(b) Ancillary Copyright Laws : Issuance of warning to States that had enacted or were about to enact ancillary copyright laws.

(c) Domain Name Registrars : Distant  intermediaries not to  be reassigned IP enforcement responsibilities.

Though Schrantz’s did not testify, Internet Association in it’s written submission has made an objection to India’s copyright regime. It relates to the absence of a clear safe harbor framework for online intermediaries.

(iv) U.S. – India Business Council (USIBC) –  As per Buruc Kilic‘s tweet, USIBC in it’s testimony proposed for the introduction of patent linkage in India.

(v) Union for Affordable Cancer Treatment (UACT) – Last to testify, it came out strongly against PhRMA’s misrepresentation of the WTO rules on the issuance of compulsory licenses during national emergencies ( As evidenced by the opening quotation of this blog post.)

It also lauded Indian Supreme Court’s rejection of of the Bayer appeal of the Nexavar compulsory license.


To the best of my knowledge, this is all that is available in the public domain for now. If any one of you attended the public hearing or happen to be in possession of it’s transcript, please feel free to share.

Once the recording is released by the USTR, I’ll run through the entire testimony on ISGLP’s IPR blog.









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