The Fight Against US-Styled IP Is Not Only in Pharma, but Also on the Farm Front

As the countdown for President Trump’s India visit begins, India will need to tread with caution in the light of demands on the intellectual property front not only in pharma, but also in the area of agriculture.

As the countdown for President Donald Trump’s India visit begins, there has been much speculation about the nature and extent of the trade deal that could or could not be agreed upon between the two countries.

Irrespective of all other details, an issue that is certainly on the table is intellectual property (IP). India will need to tread with caution in the light of demands on that front not only in pharma, but also in the area of agriculture.

There are five good reasons why.

1. History of the issue

Lest it be forgotten, the US government raised a dispute at the World Trade Organisation’s dispute settlement body (DSB) soon after the WTO was set up. On July 2, 1996, the US requested consultations with India under the WTO concerning the alleged absence of patent protection for not only pharmaceutical but also agricultural chemical products in India, which it claimed were in violation of the provisions (Articles 27, 70.8 and 70.9) of WTO’s TRIPS Agreement. India lost that case and the amendments to the country’s Patent Act of 1970 subsequently followed.

But what is critical to retain and respect in the domestic patent law vis-a-vis agriculture is Section 3(j) that excludes from patentability “plants and animals in whole or in any part thereof other than microorganisms  but including seeds, varieties, and species, and essentially biological processes for production or propagation of plants and animals”. US seed multinational corporations (MNCs) want nothing less than patents on seeds.

Also read: Ahead of Trump’s Visit, Farmer Bodies Oppose Prospective Trade Deal with US

2. Special 301 report

The Office of the United States Trade Representative (USTR) annually prepares a report from a review of the state of IP protection and enforcement in US trading partners around the world. This report has been made every year since 1989 under its Trade Act of 1974.

In the report, it puts countries into different categories depending on the level of IP standards and how those are enforced. This exercise by USTR is to identify trade barriers to US companies from what it sees as inadequacies to IP protection in other countries. Ever since 1989, India has repeatedly been placed in either the ‘Priority Foreign Country’ category or listed on the ‘Priority Watch List’ for not having the IP levels that US wants. Therefore, an IP agreement can be anticipated. Any such agreement can only be about how to discipline India on IP.

3. Bilateral pressure

Even outside of any bilateral FTAs or BITs, the US always insists on IP in its trade and economic diplomacy in its bilateral dealings. Even before the arrival of the US entourage in India, a memorandum of understanding (MoU) on IP between the two sides has already been approved. The MoU covers the entire range of IP. It is not publicly known what it actually lays down with respect to agriculture. But the MoU was preceded by the Department of Promotion of Industry and Internal Trade (DPIIT) of the Ministry of Commerce and Industry (MoCI) discussing a review of India’s IP laws. It is the same department (then called DIPP) that in 2016 came out with the National IPR Policy, 2016 to appease the US side.

The policy seeks to bring more farmers into the IP system as well. It expressly states that it would reach out to the less visible and silent IP generators and holders, especially in the rural and remote areas, through campaigns tailored to their needs and concerns. These would include small businesses, farmers/plant variety users, holders of traditional knowledge, traditional cultural expressions and folklore, designers and artisans.

Thus far, IP systems (such as in the US) with an instrumental approach to grant monetary incentives to creators/inventors have proved incapable of granting remunerative rewards in equal measure to those socially and economically less privileged. India will have to seriously introspect if its IP law in agriculture – Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Act, 2001, has resulted in either more economic returns to farmers or led to social welfare in the seed sector.

The farmers’ varieties granted plant breeder rights under this law are yet to be mainstreamed. Also, cases of benefit sharing arrangements with those using farmers’ varieties as source material for developing commercial varieties are yet to work out. So any move to tighten the IP system will only widen the gap. The implementation of the law is in favour of corporate plant breeders who hold registrations for new plant varieties. This can put restrictions of use on both farmers and researchers.

Also read: PepsiCo Controversy: Globally, India Has Always Refused to Give in on IPR on Plant Varieties

4. China-US trade deal

China and the US signed a ‘Phase One’ trade agreement on January 15, 2020. The very first chapter of the economic and trade agreement is on intellectual property.

Under the agreement, China has agreed to crack down on business practices that the Trump administration has criticised, which include those related to IP. It has also committed to ensure additional purchases of US agriculture products by $32 billion over two years. Such trade deals is what Trump needs back home in election year. Any trade deal in the future with India will surely have a full-fledged IP chapter.

5. Legal cases by US MNCs

It is essential that India develops its negotiating position on IP in agriculture based on its own experience with US MNCs. Three legal cases in Indian courts are important to keep in mind.  The US Monsanto Inc. has sued domestic seed companies in India on the issue of payment of technology user fees over IP-protected biotechnology in cottonseeds. Monsanto even sued the Competition Commission of India (CCI) at the Delhi high court against its investigation orders. CCI had held that there is prima facie case of contravention of Sections 3(4) & 4 (abuse of dominant position) of the Competition Act by the company.

Another wholly-owned subsidiary of a US MNC – PepsiCo India Holdings Pvt Ltd, actually filed cases through 2018-2019 against several farmers in Gujarat for alleged violation of its IP rights over a potato variety. This is despite a clear legal provision [Section 39(1)(iv)]on farmers’ rights in India’s PPV&FR Act that guarantees farmers’ inherent seed freedoms, even if a plant variety has been granted an IPR.

The fight against US-styled IP is not only in pharma, but also on the farm front.

Shalini Bhutani is a legal researcher and policy analyst based in Delhi; she tracks how trade rules interface with agriculture and biodiversity in the Asian region.

Startup India: Only 4% of Applicants Got Tax Breaks in First 30 Months

The ‘rigorous’ screening process, blamed for the delay, was recently relaxed by the department of industrial policy and promotion.

New Delhi: In the first 30 months since its launch, only 88 startups of the 11,422 recognised by the government were certified for tax exemption under the flagship Startup India scheme.

Data accessed by the Indian Express shows that until July 24, 2018, the department of industrial policy and promotion (DIPP) was able to grant tax exemption only to 4% of applicants under the scheme. While there were 2,197 applicants till that date, 11,422 were recognised by the department. The startups need to be recognised before availing tax breaks. If these startups are also considered, the gap between those recognised under the scheme and those that actually received exemptions is far wider.

This could partly be the reason the DIPP has relaxed the “rigorous screening procedure” under the scheme, the Indian Express reports.

The flagship scheme, announced by Prime Minister Narendra Modi during his 2015 Independence day address, provides tax exemption for two aspects: income and investment raised. Startups can avail income tax exemptions for three years in a block of seven years if they have been incorporated between April 1, 2016 and March 31, 2019. According to the Indian Express, startups and their angel investors are allowed exemption under the Income Tax Act as per which “closely-held companies, when issuing shares, are charged 30 per cent tax on the difference between funds raised as per the actual valuation and the fair-market value of the company”. This is also referred to as angel tax.

Also Read: Startup India: Right Intention, Misplaced Efforts

To avail these exemptions, startups recognised by the DIPP are required to undergo the Inter Ministerial Board’s (IMB) screening mechanism. The mechanism was said to be “rigorous” and was blamed for the delay in providing tax breaks.

The DIPP relaxed the screening process last Wednesday, under which the IMB’s role has been removed to avail the breaks under the Income Tax Act. For these type of breaks, startups will now directly be evaluated by the Central Board of Direct Taxes (CBDT). Under the fresh guidelines, firms can apply through the DIPP’s website. The applications would be forwarded to the CBDT, which is required to evaluate and respond within 45 days of receiving the application.

A government official involved in the exercise told Indian Express, “Tax exemption is typically granted to unique and innovative startups. So the IMB scrutiny was justified. But given the rate of progress, this route is being eased now.” The IMB will still process the three-year tax exemption on the incomes of startups.

Tax exemption was provided to the companies on the basis of innovativeness and potential for job creation. However, the “rigorous screening” has allowed only a fraction of the total recognised startups to avail the exemptions.

‘Reliance Defence Had Neither Land nor an Industrial License at Time of Rafale Deal’

A complaint letter to the CBI has provided documents to show that RDL applied for 289 acres of land near Nagpur only on June 16, 2015, even though PM Narendra Modi announced the new agreement on April 10.

New Delhi: A crucial aspect of the Rafale deal, which had gone relatively unnoticed, was brought to light by former BJP Union ministers Yashwant Sinha and Arun Shourie and advocate Prashant Bhushan in their complaint against prime minister Narendra Modi and former defence minister Manohar Parrikar’s alleged “abuse of authority” to the Central Bureau of Investigation for allegedly abusing their authority on Thursday.

In the complaint letter to the CBI, the three told the CBI that Anil Ambani-owned Reliance Defence Limited neither had any land to set up its defence manufacturing unit nor did it have an industrial license when it made a joint venture (JV) offset agreement with Dassault Aviation for the purchase of 36 Rafale fighter aircrafts in 2016.

Alleging that the prime minister ignored these crucial aspects while recommending the RDL as an offset partner to Dassault, the three said that the prime minister’s decision to enter into a sudden inter-governmental agreement with France by retracting the previous purchase agreement that the United Progressive Alliance (UPA) government had struck with Dassault was a motivated one.

Also read: Yashwant Sinha, Arun Shourie, Prashant Bhushan Move CBI for Rafale Deal Probe

The complaint mentions that by overlooking the public sector undertaking, the Hindustan Aeronautics Limited (HAL), which was supposed to get both the offset deal and Dassault’s technology, in the UPA deal, Modi intended to benefit the RDL and its owner Anil Ambani. The three questioned the PM’s logic behind sidelining a company like HAL, which has more than 50 years of experience in aerospace, and recommending RDL, which was formed merely 12 days before Modi announced the purchase of 36 aircraft in April 2015 and had no whatsoever experience in the field.

Although the government has said that it had nothing to do with Dassault’s decision to choose its offset partner and that the deal that Modi concluded with France was purely a government-to-government agreement, the arguments Sinha, Shourie and Bhushan make was further boosted by former French president Francois Hollande’s recent statement indicating that the Indian government suggested RDL as the service provider for the Rafale deal.

Modi announced the new agreement on April 10, 2015, and as per Dassault’s own admission, the French company at the same time agreed to partner with the RDL through a JV to form Dassault Reliance Aerospace Limited, in which RDL would have 51% stake. The complainants provided documents to show that RDL applied for 289 acres of land in Mihan, near Nagpur in Maharashtra, only on June 16, 2015. They said that Reliance issued a press release claiming the same on land inauguration ceremony on August 29, 2015. “We started on June, 16, 2015, with first presentation and in less than 10 weeks we got the land. This is a record,” the complaint quoted from the RDL’s press release.

“Mr. Modi abused his influence to ensure that Mr. Ambani got the land at a throwaway price of 64 crores for 289 acres, in a record time. The very same land is supposed to be used for the Joint Ventures between Reliance and Thales, which is another sub-vendor in the Rafale deal and other Joint Ventures of Reliance with other vendors globally,” the complaint said.  

More importantly, the three alleged that the Modi “misused his influence to ensure that the Defence Acquisition Council”, whose approval is needed in all defence deals, complied with his objectives. They claimed once Ambani got the offset deal, it moved swiftly to get all the licences required, and not the other way around.

“Mr. Ambani applied and got various industrial licenses for a number of his defence companies on 22nd of June, 2016,” said the complaint.

Credit: Special arrangement

The complaint reads:

“From the industrial licenses obtained, it is clear that Mr. Ambani, was emboldened by his great heist, and notwithstanding his zero experience in the defence sector, wanted a slice of each and every defence deal, confident in his accomplice, Mr. Modi’s, ability to swing any deal in his favour as the offset partner. Therefore, the incorporation and seeking of various licenses to acquire offsets in helicopters, missiles, land and naval platforms, propulsion systems, unmanned aerial vehicles, naval vessels, “all kinds of night vision devices, sensors, navigation systems & surveillance equipments” and so on and so forth. It would seem that there is nothing that this gentleman with an exceptional track record of failure and insolvency in each and every other industry he has ever undertaken can not do when it comes to a highly skilled and capital intensive sector such as defence. At the time of grant of these licenses, Ms. Nirmala Sitharaman, was the Commerce Minister. She was later elevated to Defence.”

Once the RDL obtained the required licenses, the three said, it was only on September 23, 2016, more than a year after Modi first announced the inter-governmental deal, “the main procurement contract was officially signed along with the offset contract as mandated by the defence procurement procedure (DPP).

They also allege that the Modi tried to cover up the procedural violations – resulting out of sudden incorporation of Reliance in the deal; no discussion about the company had happened at the national level – DPP was amended on August 5, 2015, two months after the new agreement was concluded in France, to accommodate the new deal of which the RDL was a part.

“The amendments only dealt with offset conditions. Evidently, even in August of 2015, when the main procurement contract was yet to be signed, somebody in the government was overly concerned with Offsets. The said amendment was thereafter incorporated in DPP, 2016, verbatim, which came into effect on 1st of April, 2016,” the three alleged in the complaint.

Also read: ‘Reliance Violated Its Industry Licence Conditions in Executing Offsets for Rafale Deal’

In an accusation that could also open a can of worms, the trio said that the prime minister had no authority to nullify the UPA’s request for proposal (RFP) in which 126 Rafale aircraft had to be bought and which was already “at an advanced stage”. They said the DPP was accordingly amended to incorporate the cancel a previous agreement too to fulfil the objectives of the prime minister.

“The original deal was officially killed on 24th of June, 2015, by retracting the Request for Proposal (RFP) that was issued in 2007. No such provision for retraction of RFP existed in the Defence Procurement Procedure at the time. Again, this is so that no politician —once the entire process has been gone through as per the requirements of the Services, and the equipment has been extensively tested (over three years in this case by the IAF), and the bids have been properly scrutinised —can at the very last moment hold the L1 supplier hostage using the threat of retraction of RFP for the purposes of rent seeking/ corruption/undue advantage. To cover up the conspiracy, an amendment regularising retraction of RFPs was incorporated only on 23rd of July, 2018.”

Submitting their complaint, they said that the prime minister and his defence ministry have abused the authority in what was a case of cronyism. They added that this, however, has compromised national security. The Indian Air Force required 42 squadrons while Modi has purchased only 36, which in itself is significantly lower than the previous order of 126 jets.

The government claimed that it struck the deal with France as it was a case of emergency requirement. However, the complainants said that none of the 36 jets have landed in India even after three years since the deal was concluded. The business deal may simply have got a private company, which was on the verge of insolvency, out of troubled waters, they allege.

‘Reliance Violated Its Industry Licence Conditions in Executing Offsets for Rafale Deal’

A complaint sent to the CBI by Prashant Bhushan, Yashwant Sinha and Arun Shourie has alleged that Reliance Aerostructure Ltd violated the conditions of its DIPP licence in its manufacture of Falcon jet parts in Nagpur.

New Delhi: Did Anil Ambani-owned Reliance Aerostructure Ltd (RAL) run afoul of the terms of its industry licence by embarking on the joint venture with Dassault Aviation for the 36-Rafale deal?

This allegation, and more, is made out in a complaint sent to the Central Bureau of Investigation by advocate-activist Prashant Bhushan and former BJP Union ministers Yashwant Sinha and Arun Shourie.

According to the complaint, by changing the location of its industrial unit (from Gujarat to Maharashtra) and the “article that is permissible to be manufactured” (from military aircraft to civilian business jets), RAL may have violated the conditions of the licence issued to it by the Department of Industrial Policy and Promotion (DIPP).

Also read: Yashwant Sinha, Arun Shourie, Prashant Bhushan Move CBI for Rafale Deal Probe

Generally-speaking, when a company looks to set up a manufacturing unit it is required to obtain a licence from the DIPP, which authorises the location of the plant and the type of product or article that can be manufactured.

As of July 2018 – in a section titled “Industrial Licences Issued for Manufacture of Items under Defence Industries –  the DIPP’s website states that the licence given to Reliance Aerostructure Limited is for “Amreli in the state of Gujarat” and for “manufacture and upgrade of airplanes and helicopters specially designed for military application”.

The industrial licence granted to RAL. Credit: DIPP

Description of the industrial licence granted to RAL. Credit: DIPP

However, as Reliance Defence has made clear over the past few months, the joint venture between RAL and Dassault will in fact work out of a production facility located in Nagpur, Maharashtra and will be make parts for the company’s Falcon business jets, which are normally used for civilian purposes.

“This is in clear violation of the condition of the licence that R.A.L obtained from the D.I.P.P. R.A.L. cannot take a licence for “Manufacture and Upgrade of Airplanes and Helicopters Specially Designed for Military Application”, and then enter into a JV to manufacture parts for a civilian aircraft under that same licence,” the CBI complaint notes.

“To be clear, civilian aircrafts [sic] are in fact included in the list of eligible products/ services towards the discharge of offsets. But what products/services actually get allowed by the government to be used to discharge the offset obligations is controlled through the issue of the industrial license that specifies what can be manufactured,” it adds.

By violating the licence condition, the trio argue, RAL should be rendered “ineligible as an offset partner for Dassault as per the offset guidelines”.

Also read: The Moral Headwinds from Rafale and the Rajan List are Bound to Batter Modi

“R.A.L. has evidently failed to comply with the licensing requirements stipulated by the DIPP by [a] changing location of manufacturing without due amendment in license & [b] by starting process of manufacturing a ‘new article’ i.e. civilian Falcon aircrafts as opposed to “Manufacture and Upgrade of Airplanes and Helicopters Specially Designed for Military Application”,” the statement notes.

“It has violated Clause 4.2 of the Offset Guidelines. The Finance Minister’s statement, shows that government is aware of this fact. However, Mr. Modi’s influence has ensured that no action has been taken against R.A.L. thus far.”

It is unclear at the moment whether the Reliance-Dassault joint venture received a separate industrial licence that approved the Nagpur location and manufacture of Falcon business jets. The Wire has sent Reliance Infrastructure a questionnaire and will update this story if and when a response is received.

Third Time Lucky? After Red Flags, Railways Reboots Rs 2,700 Crore Trainset Tender Yet Again

The DIPP had earlier raised concerns over a pre-bidding condition in the tender process that disqualified many domestic manufacturers.

New Delhi: The Indian Railways has decided to discharge its Rs 2,700 crore tender process for manufacturing aluminium-bodied trainsets after the Department of Industrial Policy and Promotion (DIPP) raised red flags over deviations in the bidding criteria. 

A trainset is a group of coaches that are coupled mechanically and electrically and come with driving cabins at both ends. Generally speaking, the process of acceleration and deceleration is faster in a trainset when compared to trains that are hauled by locomotives.

As reported first in The Wire, the railway ministry took note of the DIPP observations on how certain tender conditions may have been in violation of the Narendra Modi government’s public procurement process. The railways, according to sources, decided on March 15, 2018 to opt for a fresh tender.

Now it will be re-tendered with revised bidding conditions and an enhanced work order that will hopefully enable wider participation from interested players, sources close to the development said.

The railways’ integrated coach factory (ICF) near Chennai had floated a global tender in late 2017 for the Rs 2,700-crore project, which involves the manufacturing 291 aluminium-bodied coaches. While pre-bid meetings had attracted seven global players, the last day for submission of bids saw only one interested consortium due to certain pre-bidding conditions. 

Among others, one of the pre-conditions was that the manufacturer should have five years experience of supplying to G8 countries, a requirement that was red-flagged by the DIPP.

Even though the last date of the bid submission was extended from January 29 to February 6, the Stradler-Medha consortium emerged only bidder after the the final submission of bids.

After the last date of submission, a leading Indian rolling stock manufacturer complained to DIPP drawing attention to the alleged violation of the public procurement order which resulted in elimination of other players.

Taking note of the complaint, DIPP secretary Ramesh Abhishek in a letter to Railway Board Chairman Ashwani Lohani observed that the eligibility conditions set in the trainset tender “prima facie seem to be non-compliant to the Public Procurement (preference to make in India) order”.

Formulated by the finance ministry, the policy aims to ensure that the tender conditions are strictly in sync with the public procurement order taking into account the interests of Indian manufacturers. The DIPP had pointed out that “the stipulated requirement that the bidder should have an prior experience in supplying to G8 countries in the last five years would most certainly go against the domestic manufacturers and in favour of a restricted number of global players – there is no justification for taking supply to G8 countries as a condition.”

After examining the issue, the railway ministry has decided to opt for re-tendering and communicated the same to the ICF. “It has been carefully examined in the board. It has been noted that the government of India policy ‘Public Procurement – preference to make-in-India Order 2017’ has not been fully implemented in the tender for procurement of trainsets,” Railway Board communicated to the ICF.

“Keeping in mind that Railway Ministry is obliged to implement the provisions of Government of India rules in letter and spirit and that it is an opportunity of enhancing the tendered quantity which is likely to bring better competition and rates, it has been decided to undertake procurement de novo. ICF may therefore short-close the proceedings in the existing tender confirmation to this office,” the directive to the ICF said.

Equipped with improved passenger comforts, automatic door system and 160 km per hour maximum speed, the trainsets with both seating and sleeper berths are expected to run on Rajdhani routes.

Second cancellation

Incidentally, this is the second time that the trainset tender is being discharged. The railway ministry’s attempts at procuring modern trainsets had to also be scrapped as none of the shortlisted bidders submitted the quotes citing inadequate work order.

Proposed to be manufactured at ICF, the ambitious project (known as Train-20) envisages the rolling out 15 light weight aluminium-bodied trainsets, a first in Indian Railways.

Now the work order in the revised tender is expected to increase up to 30 trainsets instead of just 15.   

Arun Kumar Das is a senior journalist and can be contacted at akdas2005@gmail.com

New Government Report Affirms India’s Patient-First Commitment on Pharma Patents

A government review says it is well within its rights to put Indian patients and the Indian generic pharmaceuticals industry first.

A government review says it is well within its rights to put Indian patients and the Indian generic pharmaceuticals industry first.

India supplies cheap generic medicines to large parts of the world. Credit: PTI

As various countries await the US’s ‘Special 301 report’, where the US government discusses intellectual property negotiations with other countries, , the Indian government has published a report of its on the same topic, affirming its sovereign commitments  to India’s generic drugs industry and healthcare.

The report was prepared by the Department of Industrial Policy and Promotion (DIPP) in the Ministry of Commerce. It reviews India’s positions on the subject and reiterates the government’s stance – domestically and multilaterally – apropos patents, trademarks and copyrights.

Significantly, the report makes multiple comments about the protection of public rights on pharmaceutical patents via the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation (WTO). India signed up to TRIPS in 1995, and following a 10-year transition period, assumed its terms as binding.

The DIPP report itself reads that the TRIPS agreement “should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

It also comments on patent issues like data exclusivity, patent linkage and compulsory licensing, all of which impact how a country can approach patents – either with a view to protecting the private rights of industry or balancing the rights of the public as well.

Supporting the use of TRIPS-flexibilities

The document reaffirms India’s commitment to the TRIPS and makes it clear that it is within India’s rights to use the TRIPS provisions to protect public health. Excerpt:

“A review of the Doha Declaration on the TRIPS Agreement and Public Health adopted on November 14, 2001, clarifies any further doubts in this regard. Paragraph 4 of Doha Declaration has expressly noted that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, the Agreement should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”

The Doha Declaration was the outcome of the Doha round of talks on the TRIPS in 2001 and summed up the agreements made by the WTO on issues like intellectual property.

It also responds to pressure by developed countries applied on those like India to adopt ‘TRIPS-plus’ provisions like data exclusivity, which are designed to benefit international pharmaceutical companies.

The Wire had earlier reported on how developed countries were forcing India to give in on patents, such as at the Regional Cooperation on Economic Partnership (RCEP) discussions. India had hosted one round of RCEP talks in July 2017. There, negotiators from countries such as Japan and South Korean had asked others to consider ‘TRIPS-plus’ provisions. Before a later round of talks, many India officials told The Wire that India would not in fact cross any “red lines” on generics.

Article 39.3 of the TRIPS says governments can seek data from the industry but that such data will have to be protected from “unfair commercial use”. At the same time, TRIPS allows countries to make an exception “where necessary to protect the public.”

Countries have different periods of time during which the industry is allowed to keep its their data secret or “exclusive”. The US, Japan, South Korea and others have been pushing India to extend this period of exclusivity. In other words: to go beyond TRIPS into ‘TRIPS-plus’.

The impact of this is that it would delay the entry of generic drugs into the market.

On this, the the DIPP report says, “A large proportion of the Indian pharmaceutical industry is producing generic drugs. Extending data exclusivity at this stage would have a considerable impact on the Indian industry, especially in the short run. More importantly, data exclusivity provisions will impact access to medicines, which is a major social/human cost for a country which still has a large population living below the poverty line.”

It also says that other TRIPS-plus measures like patent linkage are “undesirable for the impact it will have by delaying introduction of generics.” Patent linkage is a measure by which the approval of any generic drug would be linked to the patent status of its branded equivalent, potentially inhibiting the approval of the generic variant. “There is no express provision under the TRIPS Agreement providing an obligation on the member countries to provide for protection akin to Patent Linkage,” the report says.

It also reiterates that the Drug Controller General of India (DCGI), whose office receives applications for approving drugs, is not required, empowered or qualified to examine the existence of patents before approving drugs. The report says that any attempt by the DCGI to follow the idea of patent linkage would be beyond their delegated powers.

The report also deals with the issue of compulsory licenses – when a government can allow a third party to produce a patented product, often for pressing public needs. India has issued only one compulsory license thus far, for the drug Nexavar (sorafenib), used to treat advanced renal cell carcinoma.

“The provisions relating to Compulsory Licenses under the Patents Act are fully compliant with Articles 30 and 31 of the TRIPS agreement and Article 15 of the Paris Convention.”

The report also references the work of the UN, Nobel laureate and economist Joseph Stiglitz and Bernie Sanders under a section titled, “Statements/Comments/Views favouring India’s stance on access to Health Care.” Specifically, that Stiglitz had said in 2015, “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well.”

The document also quotes Sanders as having said, “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

Railways’ Trainset Project Hits Red Flag Over Tender Criteria

Mandating that bidders have “prior experience in supply to G8 countries” would almost certainly favour “a restricted number of global players”, the department has said.

Mandating that bidders have “prior experience in supply to G8 countries” would almost certainly favour “a restricted number of global players”, the DIPP has said.

This is the second time the procurement process for train sets has gone awry. Credit: PTI

This is the second time the procurement process for train sets has gone awry. Credit: PTI

New Delhi: The department of industrial policy and promotion (DIPP) has raised red flags over the tender process of the Indian Railways’ Rs 2,700 crore trainset project –  which has resulted in a single bidder outcome –  and has sought clarification from the state-run transport on alleged deviations from the Modi government’s public procurement policy.

A trainset is a set of coaches coupled mechanically and electrically with driving cabins at both ends and distributed traction power across the train.The acceleration and deceleration is faster in a trainset as compared to other trains hauled by locomotives.

In a letter to Railway Board chairman Ashwani Lohani, DIPP Secretary Ramesh Abhishek has observed that the eligibility conditions set in the trainset tender “prima facie seem to be non-compliant to the public procurement (preference to make in India) order.”

Formulated by the finance ministry, the policy aims to ensure that the tender conditions are strictly in sync with the public procurement order and take into account taking into account the interest of Indian manufacturers.

Equipped with improved passenger comforts, automatic door system and 160 km per hour maximum speed, the trainsets with both seating and sleeper berths are expected to run on Rajdhani routes.

The global bidding for the Rs 2,700 crore project, which involves manufacturing 291 aluminium-bodied coaches at the integrated coach factory (ICF) near Chennai, drew only one consortium on the last day of the tender submission on February 6, 2018 due to certain pre-bidding conditions.

Among others, one of the pre-conditions was that potential manufacturers should have an existing make-in-India facility for bidding and five years experience of supplying to G-8 countries.

Though the pre-bid meetings had attracted around seven global players and the last date of the bid submission was extended from January 29 to February 6, the Stradler-Medha consortium emerged the only bidder after the final submission.

After the last date of submission, a leading Indian rolling stock manufacturer complained to the DIPP, drawing attention to the alleged violation of the public procurement order which resulted in the elimination of other players.

Taking note of the complaint, the DIPP pointed out “The stipulated requirement that the bidder should have an prior experience in supplying to G8 countries in the last five years would most certainly go against the domestic manufacturers and in favour of a restricted number of global players – there is no justification for taking supply to G8 countries as a condition.”

According to the tender’s conditions, the first train set of 20 coaches shall be manufactured complete in all respects at the successful bidder’s premises and shall be dispatched to the ICF.

From the second trainset onwards, the successful bidder “shall supply the components, electrics, furnishing material etc. sourced from themselves or their vendors to ICF and assembly of the trainset car body, bogie, painting and furnishing shall be carried out at ICF”.

There is an option to manufacture up to 10 trainsets at the successful bidder’s premises and ship these to the ICF. However, the last four trainsets and spare coaches should be assembled at the ICF.

Seeking a closer examination of the issue, the DIPP secretary has sought an action-taken report from the Railways.

“I would therefore request you to examine the grievance and take appropriate action for compliance of PPP-MII order. This department may please be informed of the comments/action taken in this regard,” the secretary’s letter to the CRB concluded.

Sources said the concerned officials are currently examining the issue and will respond to the DIPP’s query.

The Railways will now have to take a call on whether to go ahead with the only consortium or opt for retendering with revised conditions, said a senior railway official with knowledge of the matter. 

To be manufactured at the ICF, the project known as Train-20, envisages rolling out 15 light weight aluminium-bodied trainsets, a first for Indian Railways.   

Flawed bidding processes

The railway ministry’s attempts at procuring modern trainsets has had a unfruitful past. In June 2015, the-then railway minister Suresh Prabhu announced a global tender for “procurement-cum-maintenance and manufacture of 15 train sets with 315 coaches”.

However, by May 2016, none of the five short-listed bidders decided to submit quotes. According to media reports from the time, all the companies asked for an increase in “the quantum of work under the tender”.

This tender was in 2017 split into two different procurement processes (called the Train-18 and Train-20 projects).

Arun Kumar Das is a senior journalist and can be contacted at akdas2005@gmail.com.

Modi’s New Intellectual Property Rights Policy Will Only Benefit Players with Deep Pockets

The new policy fails to enact a balanced regime and instead is tilted in favour of rights-holders.

The new policy fails to enact a balanced regime and instead is tilted in favour of rights-holders.

Credit: OpenSource Obscure, Flickr CC BY 2.0

Credit: OpenSource Obscure, Flickr CC By 2.0

In November 2014, five national governments wrote to the Department of Industrial Policy and Promotion (DIPP) to inform the policy-making process of India’s first national intellectual property rights policy (IPR policy). The DIPP received 300 submissions from various other stakeholders, including NGOs and civil society, multinational companies, businesses and trade associations, cutting across various sectors. The policy-making process itself was marred by bizarre, unfair and unexplained steps such as the sudden disbanding of the first think tank put in charge for producing a draft policy, an opaque and long-drawn process of releasing a first draft, the leak of a near-complete final draft and no publication of responses (yet) of the 300 odd submissions that were made by stakeholders. Finally, the DIPP released the policy last week.

Despite the long and extensive drafting process, the policy is tilted in favour of right-holders, and places undue reliance on IPRs to stimulate innovation and growth. It obviously claims otherwise, but there are some fundamental flaws in the policy’s premise which render the DIPP’s claims meaningless. Delving briefly into the subject of IPRs, it is a matter of principle that a balanced intellectual property (IP) regime, i.e. a model that balances rights with adequate limitations/exceptions, contributes optimally to the holistic development and growth of the nation. Limitations or exceptions are flexibilities in the law, which cut down absolute monopoly conferred by IPRs, and ensure that use and sharing of knowledge for purposes such as research, education and access to medicines are not overridden by IP rightholders’ claims. The Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS), which is the largest international agreement governing countries’ IPR regimes also promotes the use of these flexibilities to build balanced regimes. The policy does occasionally state its commitment to the TRIPS agreement and the Doha Declaration, but does not commit or spell out any new concrete steps. Thus, it fails to show any seriousness about upholding and promoting a ‘balanced’ regime – in stark comparison to the detailed and surgical manner in which it aims to raise awareness about IPRs and commercialise them.

Unfortunately for the policy, a myopic rationale captures the ambition of the document. The policy document states that, “The rationale… lies in the need to create awareness about the importance of IPRs as a marketable financial asset and economic tool. As such, the policy fails to recognise the philosophy of welfare and balance embedded in IPRs: to ensure innovation, social, scientific and cultural progress and furtherance of access to knowledge. In all fairness, while the document pays a salutary tribute to objectives such as achieve economic growth and socio-cultural development, while protecting public interest; also of advancing science and technology, arts and culture, traditional knowledge and biodiversity, transforming knowledge-owned into knowledge shared, it never rises above its treatment of IPR as a tool to solely serve the interests of rights-holders.

The policy’s attempts to ‘create awareness’ about IPRs through massive outreach and promotion would perhaps be justified, if the singular aim was not the glorification of IPRs. This section implements several steps to induce positivity around IPRs in society to the extent of teaching young students about the benefits of IPRs, which is excessive. While I am of the opinion that awareness building may be important at research centres and industries, a lopsided rights-centric positive view of IPRs should not pass off for ‘awareness’. This is a dangerous view, and will only create a mad race to generate IP and acquire rights.

Chinese copycat?

Unfortunately, it appears that the government is indeed on board with this. I say this because the lopsided view was endorsed by senior Indian Patent Office and DIPP officials at a recent national conference. It is likely that the idea to use the IPR policy as a tool for ‘IPR indoctrination’ to result in staggering IPR generation came to the Indian government from their Chinese counterparts. In 1995, China started conducting elaborate training of its officers, researchers and students to popularise a generation of IPRs and last year the country received 10 lakh patent filings – an international record. At the conference, the officials were in awe of the Chinese statistics, and they were confident of catching up in the next few years. This despite the fact that in China, the race to patent innovations has only led to a proliferation of low value innovations in high numbers. Less than 1% of China’s patents are of intermediate or high value. Thus, China despite its high patent filings shows only a weak innovative performance. Globally, there is enough evidence to show that there is no positive correlation between patent filings and cumulative innovative performance of a country.

Further, the policy in its bid to maximise IPR generation goes to the extent of encumbering public-funded research by IPRs. It suggests that R&D institutions and academia reward researchers based on the degree of IPR creation, which would obviously lead to IPR-driven research. Such an approach would mean that research on less profiteering sectors in terms of IPR revenues would be neglected. Is this how we want our fledgling research and development sector to shape up?

It is disappointing to see how the DIPP has used the policy to strengthen administrative, enforcement and adjudicatory mechanisms for only trade protectionist purposes. The policy is also in contrast with steps taken by other government departments to foster access to knowledge and openness in domains traditionally encumbered by various barriers, including IPRs. For instance, the Department of Biotechnology, Department of Science and Technology has adopted an open access policy applicable to all researchers – this policy ensures that all publications resulting from publicly funded research will be made freely accessible. The Ministry of Law and Justice is in the process of finalising a suitable licence to enable the distribution and sharing of government data. This policy seems at odds, therefore, with other commons-oriented approaches adopted within the government itself.

Next up, pharma

India’s generic drug industry has been a saviour for providing affordable drugs worldwide. The most critical provision to ensure a check on ‘evergreening’ of patents is section 3(d) of the Patents Act, 1970. This provision along with compulsory licensing mechanism has been regularly attacked by big pharma. However, the policy does not mention or affirm its commitment to using such tools effectively. Moreover, the policy also misses an opportunity to stress on enforcement of form 27 filings by patent-holders. Form 27 filings demonstrate if a patent is being ‘worked’ in a territory or not, and if it is not worked adequately, a third party can apply for a compulsory licence. Both the Indian Patent Office and patent holders have largely neglected providing form 27 in a timely manner. The policy also over-reaches in certain areas. It mandates the creation of a separate offence for illegal duplication of films – which is completely unwarranted and redundant. The creation of a new criminal penalty for what essentially is infringement and already punishable (under Indian Copyright Act, 1957) comes directly from lobbying by movie studios.

Finally, while it is laudable that the policy aims to step up the efficiency of all concerned IPR offices, there is little to suggest that the policy is capable of nurturing and protecting a balanced IP regime. The flawed assumption of a linkage between IPR generation and cumulative innovation underpins the document, which should have no place in any national IPR policy. It is common knowledge that India had been under pressure from western governments and industry lobbies to ‘strengthen’ its IPR regime to the likes of matured economies and societies. India, a fast developing country, could have secured its unique developmental needs through a more balanced and nuanced IPR policy. But the changes that have taken place will largely benefit a small fraction of the ecosystem, one with deep pockets and great power.

Anubha Sinha is a programme officer at CIS. She works primarily on the Pervasive Technologies Project, and on other issues involving intellectual property law and openness.