Public Hearing (Update) : 2016 Special 301 Report

Many of you may be wondering about my deafening silence on the 2016 Special 301 Report, which I’ve otherwise been aggressively pursuing. (For more on the Special 301, see my posts here, here, here and here). Unfortunately, even after a fortnight,  the transcript and the video of the public hearing has not yet been released. This is somewhat strange considering that the video for  the 2015 Special 301’s public hearing was uploaded within 9 days of the hearing.  Hopefully, by this week, we should see it’s release.

Post hearing comments were submitted by the American University Washington College of Law , the Footwear Distributors and Retailers of America, the Trademark Working Group, the Computer and Communications Industry Association, the Union for Affordable Cancer Treatment, the Internet Association, the Global Intellectual Property Center. Organizations which submitted India related comments were – 

(I) The Trademark Working Group : It brought to the Committee’s notice, the increased costs incurred by a U.S. company to the tune of $ 3,515 as Attorney’s Fees in India due to an absence of multi – Class applications for trademark registrations.

(II) The Union for Affordable Cancer Treatment (UACT) : It countered PhRMA’s demand of  India being placed on the Priority Watch List due to it’s unpredictability of issuing compulsory licenses on essential life­- saving cancer drugs.

(III) The Global Intellectual Property Center (GIPC) : It highlighted the issuance of final Guidelines for Examination of Computer Related Inventions ( “CRI”) by the Government of India. According to GIPC, this denial of patents to all computer related inventions was contrary to prevailing international norms.

Needless to say, I’ll bring forth my views on the public hearing after it’s release.

 

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
Image Courtesy: timesofindia.com

INTRODUCTION :

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)

THE HEARING :

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.

TESTIMONY :

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.

CONCLUSION : 

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.

 

 

 

 

 

 

 

 

Written Submissions : 2016 Special 301 Report

USTR logo
This trademark is the exclusive property of the Office of the United States Trade Representative, including all titles, interests and proprietary rights that may arise under it. USTR DOES NOT endorse the views of this blog post.

With the public hearing for the 2016 Special 301 Report going on at the USTR, I want to bring forth some pertinent statistics pertaining to the written submissions. These statistics have been deduced by me based on the written comments made as of February 19, 2016. To view the entire docket of the written comments made, visit here.

For a timeline of the 2016 Special Report, visit here. ( For more on the Special 301 Report, visit my post here and here. I also have a working Op-Ed in progress which I will share with the readers once it is published.)

STATISTICS:

Total Written comments received : 75 (Including notices of intent to testify and duplicate submissions)

Written comments serving as source of information for designating countries : 66

Notices of intent to testify and repetitions:

Watch List

Number of organizations recommending India to be designated as a Priority Watch List Country (PWL) : 11

 (It is pertinent to note that none of the trade groups have recommended India to be either designated as a Priority Foreign Country or as a Watch List Country. I’ve compiled a list of organizations that demand India to be designated as PWL alongwith their substantive areas of concern. Whether they recommended for heightened scrutiny by way of an Out- of-Cycle Review has also been included. The file is available here.)

Number of organizations that made no recommendation for countries to be designated but made adverse comments on India’s IPR framework : 5

These include-

(i) The Internet Association

(ii) The Intellectual Property Owner’s Association

(iii) Croplife America

(iv) The Trademark Working Group

(v)  Program on Information Justice and Intellectual Property

Number of organizations that did not designate any country : 5  

These are inclusive of organizations that expressed their dismay over the Special 301 Process being partisan and serving U.S. trade interests. These include –

(i) The Generic Pharmaceutical Association of America 

(ii) International Generic and Biosimilar Medicines Association (IGBA) 

(iii) Alibaba Group 

(iv) Knowledge Ecology International – Submitted notice of intent to testify on the usage of compulsory licenses including cancer drug patents in India.

(v) Public Citizen – Defended India’s patent regime as complying with WTO standards.

Number of organizations that designated other countries except India : 8  

These include –

(i) U.S. Dairy Export Council & National Milk Producers Federation

(ii) REACT

(iii) Bridgestone Americas, Inc 

(iv) Footwear Distributors and Retailers of America (FDRA) 

(v) American Apparel and Footwear Association (AAFA) 

(vi) Computer & Communications Industry Association (CCIA)

(vii) Advanced Access Content System Licensing Administration

(viii) The Sports Coalition 

Number of Indian organizations that submitted their written comments: 3

They defended India’s IP regime and include –

(iii) The Federation of Indian Chambers of Commerce and Industry (FICCI) 

(iv) Indian Pharmaceutical Alliance (IPA) 

(v) Confederation of Indian Industries (CII)  

Medicines Should Not be a Luxury
This image is the exclusive property of Medecins Sans Frontiers (MSF) as part of it’s “The Access Campaign.”  MSF DOES NOT endorse the views of this blog post.

Number of Corporations that made India specific comments but did not designate : 3

(i) Boeing – Was overall in favor of India’s existent IP regime. Unlike many corporations, Boeing does not view India IP’s regime as a trade barrier for itself.

(iii) Honeywell International Inc. – Lauded India’s IP regime and did not view it as an impediment for itself to conduct business in India.

(ii) General Electric Company – Expressed some concerns over India’s IP regime. These include –

(a) Backlog in patent and trademark offices.

(b) Absence of protection for trade secrets.

Number  of comments made by Governments and organizations of various nations except India : 22

These include –

(i)  Government of Bulgaria

(ii) Arabian Anti-Piracy Alliance

(iii) Government of Ecuador

(iv) Embassy of Ukraine to the USA, Intent to Testify

(v) HBO Latin America Group 

(vi) Ministry of Industry and Trade of the Czech Republic

 (vii) Embassy of Indonesia

(viii) Taipei Economic and Cultural Representative Office in the U. S.

(ix) Registro de la Propiedad Intelectual ( Ministry of Guatemala)

(x) Swiss Federal Institute of Intellectual Property IPI / State Secretariat for Economic Affairs SECO

(xi) Ministerio De Economia Y Competitividad

(xii) Panama Ministry of Trade and Industries

(xiii) Ministry of Economic Development and Trade of Ukraine

 (xiv )Bedreddine Radi

(xv) Comments of the Government of the Philippines

(xvi) Department of Special Investigation under Ministry of Justice

(xvii) Office of Commercial Affairs, Royal Thai Embassy

(xviii) Misin Salud, Fundacin Karisma y Fundacin Ifarma

(xix)  Government of the Republic of Costa Rica

(xx) Apex – Brasil 

(xxi) Canadian Patent Utility Coalition

(xxii) Federation of Industries of the State of So Paulo, National Confederation of Industry and Brazil Industries Coalition 

Number of Notice of Intent to Testify : 3 (excluding Knowledge Ecology International)

These include –

(i) Union for Affordable Cancer Treatment (UACT) 

(ii) The Computing Technology Industry Association (CompTIA)

(iii) Embassy of Czech Republic in D.C.

A noteworthy aspect is the absence of Government of India to submit a notice of intent to testify at the public hearing. I’ll be covering the public hearing at ISGLP’s blog as soon as the details are in public domain. (the hearing is expected to continue until March 4th, 2016). Watch out for this space!

 

 

 

 

My Blog Post On India And The Special 301 Process

Last year when soliciting feedback on my blog,  my dear friend Pratik Sanwaria had asked me to cover the Special 301 Process. That time, I procrastinated his cogent suggestion even though the India – U.S IPR standoff is of immense interest to me.

With the release of the 2016 Global IP Index and the 2016 Special 301 Report due for release, I thought the time was ripe to dig my nose into these issues. Hence, when I was asked to start the ISGLP’s IPR blog, I readily chose to write on the Special 301 Process in the context of India. (For people interested in the Global IP Index, read my post here).

The blog post titled, ” India’s Tryst With the Special 301 Process : The Story Until Now and Future” can be read here. Due to technical constraints, currently there is neither a comments section nor social media icons to share the post via ISGLP’s blog. Thus, for wider dissemination and constructive feedback, kindly use this platform.

ISGLP logo
ISGLP’s IPR Blog

I’m also in the process of writing a paper critically analyzing India’s designation under the Report since it’s inception until 2016. Once published, I’ll share it.

Leaks, Leakages & Intellectual Property : Draft Indian IPR Policy Text Out

The world saw her as a feistyfem
Impervious to, that she too had a heart
Unleashing the damsel in distress in her

(This amateurish autobiographical poetic device, resonates my apparent state of helplessness and frustration – though only figuratively. Having spent two consecutive sleepless nights in analyzing the draft National IPR Policy, I lost the final draft to a technical glitch. What you will read now, is a shoddy piece of analysis done in an hour. Kindly bear with it, for I am not in the frame of mind to peruse that highly “pedantic” policy document for the nth time.)

This week should be designated as the “week of leaks in the IP world” . On Saturday, the highly contentious – TPP’s, final negotiated draft IP chapter was leaked. ( Jeremy Malcolm‘s substantive analysis is a worthwhile read). And today,  just when I had called it a night (well past midnight),  my phone beeped signalling that the final draft of India’s National IPR Policy  had been leaked (perhaps the only disadvantage of literally living in two time zones!). Hence, burning the midnight oil seemed inevitable.

Images - National IPR Policy
Image Courtesy : www. slideplayer.com

Whilst I am still in the process of reading and analyzing the draft policy, I started-off with the section on Traditional Knowledge (G.W. IP folks know how sensitive this issue is to my heart) and have made a steadfast progress towards the section on public health- for reasons best known to all of us.

Before going in for publication, there was no extensive commentary from SpicyIPSwaraj Paul Barooh’s post is a quick snapshot on the timeline of the National IPR policy andPrashant Reddy does a quick overview of the draft text (I reckon that it will take few days for an extensive analysis to come-by).

Traditional Knowledge Section of Draft IPR Policy (Page 33-35)

Without sounding overtly dramatic, I salute to the IPR think tank for coming out with such a comprehensive policy on TK , though it’s merit and implementation is an altogether different matter.  Never ever did I imagine that TK would garner such extensive attention from our policy makers.

Having extensively researched on biopiracy, TK and other associated issues as part of my LL.M. research, I will highlight and analyse some substantive issues of the policy that raises my eye-brows  (Please note that I do not claim to be an expert and this is merely a feeble attempt on my part to analyse the TK policy of the draft National IPR Policy)

(I) Development of a sui generis legislation to provide a holistic and comprehensive legal framework to preserve, safeguard, protect and develop TK and TCE’s – 

This proposal for developing a sui generis framework is a welcome initiative. However, not spelling out the definite contours of the proposed sui generis legislation leaves much to the whims and fancies of our “subject-matter” expert legislators (note the sarcasm!).

While, I understand that a policy cannot be akin to law, it would have benefited had the IPR think tank given some concrete suggestions on what should be incorporated in the proposed legislation. (Honestly, after riffling through the entire draft text of the policy, at the outset the policy seems banal, bereft of any concrete proposals).

(II) Guidelines for establishing prior informed consent and benefit sharing will be reviewed and strengthened so that benefit sharing is improved and assured – 

Now this proposed policy again suffers from vagueness. It would have helped had specific guidelines been spelled out, their structural weakness identified and solutions to combat them proposed.

My primary concern with this part of the Draft IPR Policy is it’s complete absence to address the issue of ownership, making it superfluous. Seeking the prior informed consent of the TK holder before co-opting it, is morally, ethically and legally a sound policy. However, absence of addressing the issue of ownership makes this proposal redundant.

Following questions come to my mind – how can prior informed consent of a TK holder be sought when ownership cannot be ascertained?In whom does the ownership vest – is it the entire community or a specialized group of people in that community who spearhead the profession as TK holders?

For better illustration of the readers, take the case of Yoga – whose ownership has been a highly contentious issue. For protecting yoga and  other forms of TK from usurpation, a legislative or policy initiative spelling out the issue of ownership would go a long way.

Another example that crosses my mind is that of famous “Madhubani” paintings of Bihar and Nepal – who will qualify as custodians of this art form? Will it be each artisan sufficiently skilled in the art or will there be community ownership or will ownership rights vest with a union of artisans? (There can be endless permutations and combinations on this issue and my intent is not to get embroiled into critically examining the best strategy for addressing the issue of ownership, which is worthy of a doctoral dissertation).

One of the primary objectives of constituting the IPR think tank was to – “identify areas in IPR where study needs to be undertaken and give recommendations to the Ministry of Industry & Commerce“.  My not-so perfect eye sight (with glasses on) could not spot even a single recommendation.

(Dear emmetropic readers, should you spot “anything remotely in the nature of concrete recommendations”, then kindly intimate thy ignorant, blind author!)

(III) India will continue to engage actively and constructively in the deliberations in various international forums to develop legally binding international instrument(s) to protect TK, GR and TCE –  

Engage actively and constructively in the deliberations in various international forums….(BIG YAWN)” –  Suffers from acute banality and vagueness. Primary point that strikes me is the absence of defining the scope of these “various international forums” – does it include WIPO, WTO, CBD or any other fourth forum whose existence I am not yet aware of (maybe the United Nations Security Council ! – readers please appreciate the humor of the situation. However, these are precisely the sort of anomalies you can expect in the absence of precision).

Have’nt negotiations been going on since the past fourteen years at WIPO? I was expecting a nail hitting policy clearly spelling out India’s strategy to press for an internationally binding legislation on TK.

Further, why is there no mention of India’s stance on pressing for addition of Article 29 bis to TRIPS. To refresh the memory of readers, six developing countries led by India had proposed to the TRIPS Council for adding Article 29 bis warranting for disclosure of origin of genetic resources as one of the requirements for seeking patent protection.

(IV) Databases will be developed for documenting oral traditional knowledge taking care that the integrity of the said knowledge is preserved and traditional ways of life of communities are not compromised – 

While I am appreciative that development of databases for codifying oral traditional knowledge finds habitat in the National IPR policy, I would have applauded had the policy been based upon a permissive approach (consent of the TK owner is sought). Any endeavour aimed towards preservation of TK without involving all stakeholders (especially the owners and holders of TK) would be an anathema to the ethical, moral and human rights paradigm of intellectual property.

(V) The scope and coverage of Traditional Knowledge Digital Library (TKDL) will be enlarged to include additional medical formulations –  

Given that considerable opinion has been voiced from all quarters against the structural and legal defects of TKDL and it’s inadequacy in addressing patent related biopiracy (read Gopika’s post here, Sumathi’s post here, Balaji’s post here  and here, Madhulika’s posthere and my  research paper here), it is unfathomable that there is a proposal for enlarging TKDL’s scope at the cost of taxpayers money (I am by no means suggesting that nothing should be done to curb patent related biopiracy).

Rather than enlarging the scope of TKDL, I was hoping to see a  concrete redressal  mechanism for addressing the inadequacies. (By the way, TKDL has received scathing remarks even internationally).  As I  have opined in my paper, protecting TK entails international negotiations – rather than creation of a TKDL natured database. Hence, enlarging it’s scope is likely to be a futile endeavour.

(VI) TKDL will be appropriately utilized for defensive protection against wrong grant of patents through selective access to patent offices abroad under confidentiality agreements- 

Given that the average cost of revoking a patent internationally lies anywhere in the range of $0.2-0.6 million, as a citizen of a developing country, I would rather expect scarce resources to be directed towards welfare endeavors rather than patent revocation proceedings (Just to clarify again, I am by no means suggesting that patent related biopiracy should be tolerated).

Answer to protecting TK does not lie in defensive protection but rather in a robust positive protection strategy wherein rights of communities over their resources are clearly recognized.

(VII) Initiatives for international co-operation in exploration of traditional health and wellness systems will be encouraged by introducing strategic research collaborations with reputed research centres – 

After all the cynical comments, I wholeheartedly welcome this proposal by the IPR think tank. Infact, my eyes were searching for exactly the same worded policy.

The Merck- Costa Rican deal serves as a model agreement which India can explore and possibly replicate (obviously after weighing the pros and cons).

(The Merck- Costa Rican deal strikes the most amongst pharma-patent lawyers in the U.S. – I was personally told about it’s existence by none other than the Honorable Gerald Mossinghoff , who also mentored my LL.M. research. There is an interesting remark that he made, which goes at the root of India- U.S. IPR standoff. I may have discussed this with many of you. Being a public forum, I will restrain making his comments public. Patriotic Indian lawyers keen to know about his remarks should talk to me in person – you shall hear nothing but the truth!).

With this, I conclude my scathing analysis of the draft IPR policy- just the portion dealing with TK. The only words that come to my mind after reading this text of the Draft IPR Policy are “banality”  and “indefinite“. Not to mention, a half-hearted attempt to write IP policy – which is likely to resonate for years to come.

Prashant Reddy aptly puts it- “ I for one pray that the wrong text has been leaked“. Let’s all pray during this pious period of Navaratri for a miracle to happen. (I am fasting for straight nine days for the Goddess to manifest and overturn this seemingly scholarly draft National IPR Policy!)