Patent error
A US governmental agency, the International Trade Commission (ITC), recently initiated an inquiry into allegations that India’s IP regime was flawed and at odds with US business interests. The present controversy highlights the US’s efforts to coerce India to amend its national IP regime to suit the former’s business interests.
Clearly, multinational pharmaceutical companies are upset with India’s rigorous patent threshold. In other countries, patent regimes are routinely gamed to protect and even promote the evergreening of drugs (that is, when an old drug that is off patent is modified ever so slightly so that an additional patent monopoply can be procured).
India, in its 2005 amendments to the patents act, sent a clear message that it would not suffer evergreening. The “notorious” Section 3(d) has been used to axe many an evergreening attempt, the most significant being Novartis’s anti-cancer drug, Glivec.
India, in its 2005 amendments to the patents act, sent a clear message that it would not suffer evergreening. The “notorious” Section 3(d) has been used to axe many an evergreening attempt, the most significant being Novartis’s anti-cancer drug, Glivec.
In similar vein, India went on to grant a compulsory licence to Bayer’s excessively priced anti-cancer drug (selling at Rs 2.8 lakh a month), paving the way for a cheaper generic to enter the market at Rs 8,800 per month. All of this was done in conformity with Indian patent law and WTO obligations. More importantly, the licence was issued after a rigorous judicial process.
The Bayer and the Novartis cases will no doubt take centrestage at this inquiry, triggered by senators who complained, among other things, that India “has applied its patent law in a discriminatory manner, particularly against innovative US pharmaceutical companies, so as to advantage its domestic industries”.
The Bayer and the Novartis cases will no doubt take centrestage at this inquiry, triggered by senators who complained, among other things, that India “has applied its patent law in a discriminatory manner, particularly against innovative US pharmaceutical companies, so as to advantage its domestic industries”.
In what appears to be a bid to show India in poor light at these hearings, the US Chamber of Commerce’s Global IP Centre (GIPC) issued a timely report ranking the IP regimes of a curious assortment of 25 countries. Unsurprisingly, the US topped the list and India came in last. The Chamber of Commerce has now gone on to demand that the US trade representative classify India as a “priority foreign country”, a status reserved for the worst IP offenders and one that could potentially lead to trade sanctions. Given that the GIPC report was authored by prominent members of a thinktank (Pugatch Consilium) who consult significantly with big pharma, it is reasonable to suspect its “independence”.
This is more than evident from a methodology that seems designed to make India look bad.
First, the report lumps together a diverse set of countries, without regard to their socio-economic status or their developmental imperatives. If history is any indication, almost every country had minimalist IP protection at the start of its technological trajectory and moved to a maximalist IP position when its indigenous units had built sufficient capacity. Indeed, as the American historian, Doron Ben Atar, reminds us, the US was once a “pirate” economy, with American enterprises being encouraged to “borrow” freely from European technology.
First, the report lumps together a diverse set of countries, without regard to their socio-economic status or their developmental imperatives. If history is any indication, almost every country had minimalist IP protection at the start of its technological trajectory and moved to a maximalist IP position when its indigenous units had built sufficient capacity. Indeed, as the American historian, Doron Ben Atar, reminds us, the US was once a “pirate” economy, with American enterprises being encouraged to “borrow” freely from European technology.
Second, there is no real mention of why the GIPC report picked the indicators they did or how it weighted them. For instance, the baseline value of the compulsory licencing index and the consequent ranking is extremely critical of any issuance of a licence, even when it is fully compliant with WTO-TRIPS norms.
Third, much of the ranking rests on “perception” and, conveniently enough, the perception of US multinationals that have faced difficulty extracting excessive patent rents from India. Relying on perception, particularly when patent numbers and “data” abound, is not just shoddy but dishonest.
Last, there is a delicious paradox underlying the flawed GIPC ranking and methodology. The report appears premised on the perception that an IP regime that offers more protection to inventions, even trivial ones, is a “strong” one. Countries such as India, which stands for genuine invention and will not suffer low quality evergreened varieties, are surprisingly labelled as “weak”. In fact, stretched to its logical limit, the GIPC index would suggest a score of “infinity” for any country granting an “eternal” patent or copyright term, pushing it right to the top of its rankings.
New Delhi: The health ministry has reopened the issue of waiving a global drug giant’s patent rights for Dasatinib, a cancer drug, arguing the move is needed to deal with an “emergency”. The latest development — which the ministry expects will go through — comes at a time when India has won a reprieve from the US over its intellectual property regime but is facing flak from the civil society, which is critical of the government “going soft” on affordability and availability of medicines for life-threatening diseases.
In a letter to the department of industrial policy and promotion (DIPP) last week, the health ministry has answered the concerns raised earlier and said the cost of the drug produced by pharma major Bristol-Myers Squibb (BMS) will be met through government schemes. Many experts see BMS along with Pfizer at the forefront of the battle to get the US authorities to downgrade India’s patent regime by a notch and open it to possible punitive action.
Officials in DIPP refused to comment on the latest move, but health ministry sources said they plan to use around half-a-dozen schemes to fund the cost of making the drugs available to patients for what is called public non-commercial use and the position has been made clear in last week’s letter. Dasatinib is used to treat chronic myeloid leukemia.
If the move goes through, it will be the first instance of the government invoking emergency provisions in the law to waive the patent rights. So far, the compulsory licence provisions have been used by the Patents Office, which waived Bayer Corporation’s patent rights over Nexavar, a renal cancer drug, allowing Natco Pharma to manufacture and sell it at a fraction of the cost. Natco had offered to sell the medicine at Rs 8,800 for a month’s therapy, compared to Bayer’s Rs 2.8 lakh.
But unlike last time, this time the government will itself have to issue the compulsory licence, which is provided for in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips). Even in this case, the sources said, the government will have to hear the arguments put forward by BMS to “follow the principles of natural justice”. Once the government issues its order, the Patents Office will be required to notify the availability of a compulsory licence for the drug and will be required to go through another round of hearing.
Initially, the health ministry was pushing for compulsory licence for three cancerdrugs, but had to drop plans for two of them.
Given the international scrutiny, the government is treading with caution and had earlier turned down health ministry’s plea that the government issue a compulsory licence under section 84 of the Indian Patents Act on the grounds of affordability and had suggested an application be made with the Patents Office. DIPP is extra cautious over the issue as it will undergo the legal process and it does not want to be caught doing something which is against the law.
Last October, the Patents Office had rejected an application from BDR Pharma to make a generic version of BMS’s Dasatinib, which is sold under the Sprycel brand. The proposal was rejected on the grounds that the Indian company did not make enough efforts to obtain a voluntary licence for the anti-cancer drug.
New Delhi: The US government is coming under intense pressure from lawmakers to act against India at the World Trade Organization (WTO) for what they say are violations of patent rules. The tough stance adopted by US lawmakers raises the pressure on the new Indian government to swiftly swing into action to check against potential damage to bilateral trade ties, which have taken a knock in recent months.
The demand to move the WTO was made during a meeting of the Senate finance committee on the US administration’s trade policy agenda last Thursday, a day after the US Trade Representative released a report where it refused to downgrade India for its intellectual property rights (IPR) regime.
Clearly, the US senators were not satisfied with the response and attacked their government for letting several developing countries, including India, China and Brazil, steal a march. “In 1990s, India and China had limited technical capacity. Now, they can use highly technical standards to advantage their domestic firms and extract American company’s intellectual property for their own use. And it’s a shakedown, plain and simple,” said Ron Wyden, who chairs the US Senate finance committee.
Some others went a step further and attacked India. “India’s been pursuing trade policies that undermine US intellectual property to promote its own domestic industries. What they are doing seems to me to be a clear violation of their WTO obligations…enforcement action at the WTO may be the most effective tool that we have to get India to change its behaviour,” said Orrin G Hatch, a Republican from Utah. Similarly, Democrat Robert Menendez pointed to specific concerns over “India’s pharmaceutical patent violations”.
In response, USTR Michael Froman said the authorities were concerned “about the deterioration of the innovation environment in India” but was awaiting a dialogue with the new government so that the concerns could be addressed.
He specially flagged two concerns, patents and compulsory licensing, issues that are of special interest to global pharmaceutical giants, which have been lobbying with the US authorities as well as with lawmakers. “We’ve been encouraging them to enter into a dialogue about other mechanisms for addressing legitimate concerns about healthcare in India and about access to medicines that do not violate our IPR,” Froman said.
Although the Indian government has indicated that it is open to a dialogue, it wants the agenda to include other areas of interest as well. At the same time, officials have ruled out any violation of India’s international commitments on IPRs, arguing that it issued a compulsory licence, which means it waived a company’s patent rights, over a cancer drug for affordability.
Similarly, the government maintains that denial of patents was allowed under section 3(d) of Indian Patent Act and did not violate WTO’s Agreement on Trade-Related Aspects of IPR (Trips) if there was no genuine invention or discovery and there was an attempt to merely tweak an existing product to continue with the patents.
FEELING THE HEAT
The tough stance by US lawmakers has increased the pressure on the new govt to check against potential damage to bilateral trade ties
Natco wins Indian patent dispute case
Natco Pharmaceuticals, the Hyderabad-based drug manufacturer, has won a patent case against Teva Pharmaceuticals of Israel.
The New Delhi High Court, on February 28, dismissed Teva’s suit seeking an injunction over the marketing of a generic version of multiple sclerosis drug, copaxone (glatiramer acetate) in the U.S. While Teva does not have a patent on the drug in India, the injunction sought to prevent Natco exporting it.
The decision could allow Natco to launch generic version of Teva’s Copaxone in the U.S., subject to approval from the U.S. Food & Drug Administration (USFDA).
The patent on the $4 billion sales drug, expires in the U.S. on May 24, 2014.
Natco has been selling it in India since 2007, and plans to market it with partner U.S.-based pharma giant Mylan with whom it has a global marketing alliance since 2008.
Teva sued Natco, seeking an injunction as it alleged Natco’s move infringed on its process patent.
Natco took on big global pharma in the past having won a case against Novartis for its blood cancer drug, Glivec last year and also receiving India’s first compulsory license (CL) on the kidney cancer drug Nexavar made by Bayer.
Natco took on big global pharma in the past having won a case against Novartis for its blood cancer drug, Glivec last year and also receiving India’s first compulsory license (CL) on the kidney cancer drug Nexavar made by Bayer.
Govt mulls cancer drug patent waiver
Health Min Writes To DIPP On Ending Protection For Bristol-Myers’ Dasatinib
Sidhartha TNN
New Delhi: The health ministry has reopened the issue of waiving a global drug giant’s patent rights for Dasatinib, a cancer drug, arguing the move is needed to deal with an “emergency”. The latest development — which the ministry expects will go through — comes at a time when India has won a reprieve from the US over its intellectual property regime but is facing flak from the civil society, which is critical of the government “going soft” on affordability and availability of medicines for life-threatening diseases.
In a letter to the department of industrial policy and promotion (DIPP) last week, the health ministry has answered the concerns raised earlier and said the cost of the drug produced by pharma major Bristol-Myers Squibb (BMS) will be met through government schemes. Many experts see BMS along with Pfizer at the forefront of the battle to get the US authorities to downgrade India’s patent regime by a notch and open it to possible punitive action.
Officials in DIPP refused to comment on the latest move, but health ministry sources said they plan to use around half-a-dozen schemes to fund the cost of making the drugs available to patients for what is called public non-commercial use and the position has been made clear in last week’s letter. Dasatinib is used to treat chronic myeloid leukemia.
If the move goes through, it will be the first instance of the government invoking emergency provisions in the law to waive the patent rights. So far, the compulsory licence provisions have been used by the Patents Office, which waived Bayer Corporation’s patent rights over Nexavar, a renal cancer drug, allowing Natco Pharma to manufacture and sell it at a fraction of the cost. Natco had offered to sell the medicine at Rs 8,800 for a month’s therapy, compared to Bayer’s Rs 2.8 lakh.
But unlike last time, this time the government will itself have to issue the compulsory licence, which is provided for in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips). Even in this case, the sources said, the government will have to hear the arguments put forward by BMS to “follow the principles of natural justice”. Once the government issues its order, the Patents Office will be required to notify the availability of a compulsory licence for the drug and will be required to go through another round of hearing.
Initially, the health ministry was pushing for compulsory licence for three cancerdrugs, but had to drop plans for two of them.
Given the international scrutiny, the government is treading with caution and had earlier turned down health ministry’s plea that the government issue a compulsory licence under section 84 of the Indian Patents Act on the grounds of affordability and had suggested an application be made with the Patents Office. DIPP is extra cautious over the issue as it will undergo the legal process and it does not want to be caught doing something which is against the law.
Last October, the Patents Office had rejected an application from BDR Pharma to make a generic version of BMS’s Dasatinib, which is sold under the Sprycel brand. The proposal was rejected on the grounds that the Indian company did not make enough efforts to obtain a voluntary licence for the anti-cancer drug.
US under pressure to act against India
Senate Panel Wants Action At WTO For Violation Of Intellectual Property Rights
Sidhartha TNN
New Delhi: The US government is coming under intense pressure from lawmakers to act against India at the World Trade Organization (WTO) for what they say are violations of patent rules. The tough stance adopted by US lawmakers raises the pressure on the new Indian government to swiftly swing into action to check against potential damage to bilateral trade ties, which have taken a knock in recent months.
The demand to move the WTO was made during a meeting of the Senate finance committee on the US administration’s trade policy agenda last Thursday, a day after the US Trade Representative released a report where it refused to downgrade India for its intellectual property rights (IPR) regime.
Clearly, the US senators were not satisfied with the response and attacked their government for letting several developing countries, including India, China and Brazil, steal a march. “In 1990s, India and China had limited technical capacity. Now, they can use highly technical standards to advantage their domestic firms and extract American company’s intellectual property for their own use. And it’s a shakedown, plain and simple,” said Ron Wyden, who chairs the US Senate finance committee.
Some others went a step further and attacked India. “India’s been pursuing trade policies that undermine US intellectual property to promote its own domestic industries. What they are doing seems to me to be a clear violation of their WTO obligations…enforcement action at the WTO may be the most effective tool that we have to get India to change its behaviour,” said Orrin G Hatch, a Republican from Utah. Similarly, Democrat Robert Menendez pointed to specific concerns over “India’s pharmaceutical patent violations”.
In response, USTR Michael Froman said the authorities were concerned “about the deterioration of the innovation environment in India” but was awaiting a dialogue with the new government so that the concerns could be addressed.
He specially flagged two concerns, patents and compulsory licensing, issues that are of special interest to global pharmaceutical giants, which have been lobbying with the US authorities as well as with lawmakers. “We’ve been encouraging them to enter into a dialogue about other mechanisms for addressing legitimate concerns about healthcare in India and about access to medicines that do not violate our IPR,” Froman said.
Although the Indian government has indicated that it is open to a dialogue, it wants the agenda to include other areas of interest as well. At the same time, officials have ruled out any violation of India’s international commitments on IPRs, arguing that it issued a compulsory licence, which means it waived a company’s patent rights, over a cancer drug for affordability.
Similarly, the government maintains that denial of patents was allowed under section 3(d) of Indian Patent Act and did not violate WTO’s Agreement on Trade-Related Aspects of IPR (Trips) if there was no genuine invention or discovery and there was an attempt to merely tweak an existing product to continue with the patents.
FEELING THE HEAT
The tough stance by US lawmakers has increased the pressure on the new govt to check against potential damage to bilateral trade ties
U.S. government panel puts India on piracy watch list
India acquired yet another dubious honour on Wednesday, after it was named to an ‘International Piracy Watch List’ by a U.S. government panel that is looking to highlight countries that are doing little to address high rates of digital piracy.
Being put on this Congressional caucus list may have an impact on the ‘out-of-cycle’ intellectual property review that the Office of the U.S Trade Representative will conduct on India later this year.
“That’s why we started the Watch List – to alert those who are profiting by stealing the hard work of American creators and the countries helping them that we are paying attention and we expect our trading partners to protect intellectual property rights,” said U.S Representative Adam Schiff, who is a member of the Congressional caucus, in a statement. The watch list, which also highlights concerns in China, Russia and Switzerland, points out that India continues to present a “seriously flawed environment” for the promotion of copyright and intellectual property.
“The Special 301 Report again lists India as a priority watch nation. Despite a large domestic creative industry in film, music and other copyright intensive industries, India continues to lag badly in both the legal framework for IP protection,” the report said.
“Among continuing issues in India are extremely high rates of camcording piracy, high levels of unlicensed software use by enterprises, and a lack of effective notice-and-takedown procedures for online piracy,” it added.
A new study recently pointed out that online piracy levels in India remained at 60 per cent, with nearly $2.9 billion of unlicensed software being installed in 2013.
According to non-profit organisation BSA, India is second only to China (over $8.7 billion) in the Asia Pacific region in terms of commercial value of unlicensed software sold in 2013.
India ratifies Marrakesh Treaty for visually impaired
India has become the first country to ratify the Marrakesh Treaty to facilitate access to published works for persons who are visually impaired, or otherwise print disabled. The Treaty was adopted by 79 member countries of the World Intellectual Property Organisation (WIPO) on June 27, 2013, and India ratified it on June 24 this year.
India handed over the Instrument of Ratification to WIPO at the 28th session of the Standing Committee on Copyright and Related Rights in Geneva.
The Marrakesh Treaty will come into force once 20 countries ratify it. The treaty requires signatories to adopt national law provisions that facilitate the availability of published works in formats like Braille that are accessible to the blind and allow their exchange across borders by organisations working for the visually impaired.
The treaty will facilitate import of accessible format copies from the member states by the Indian authorised entities such as educational institutions, libraries and other institutions working for the benefit of the visually impaired. This will also facilitate translation of imported accessible format copies and export of accessible format copies in Indian languages.
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