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Intellectual property rights: US set to punish India

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Oooookay interesting timing
nick, @Bang Galore
the recent dent in the U.S/India ties is a quiet confusing one to be honest, the "reason" is what is puzzling in this case as it doesn't make much sense to honest , however one analysis is that of India's reluctance or hesitation regarding its role in the pivot to Asia policy ( the China factor), or sort of a lack of will or a hesitation to any firm commitment particularly from India's side might be the reason for the U.S discomfort from a geo-strategic point of view, this is the only reason which makes sense
your take on this issue ?
 
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@drunken-monke Compulsory licensing is within the law, so are generic drugs, and ever-greening practiced by MNC pharma companies is blatantly illegal & unethical, I think India will win if these cases go to international court.




That's because China is increasingly acting like a western bully.
Compulsory licensing is within the law (of India) for life saving drugs required in a pandemic.. Not all..
Unless the patent/exclusivity is expired, generic is not allowed to register/file or market the drug product..
Go this has been discussed till death in the thread started by @halupridol ...
MNCs are not unethical.. Copying their drugs before patent expiry and exclusivity expiry is unethical.. India wont win a single case in this regard.. Believe me I am a project manager and litigator in this regard... Please go through post #488 on this thread..
Developed cancer drug for 'western patients' who could afford, not 'for Indians': Bayer's CEO | Page 33
 
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You are referring to the case of Gleevec the anticancer agent... It was right of Novartis to file and get patent of the same in India, but it was immoral to price the medicine about 30$ per pill. The total cost could go up to 30000$ per year... The Honorable supreme court upheld the decision of of Patent office which rejected the Novartis application.. This decison was welcomed by generic manufacturer and general public.. But is it moral to deprive one of its right?? Novartis should have lowered the cost of medicine..

India is a signatory of WTO by virtue of which it is abide by worldwide intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect

Yes, the gleevec case, it was a case of attempted ever-greening, I am on mobile, will give a detailed answer later, but our court rightly rejected their attempt to secure a fresh patent for an old patent expired drug, just for some superficial changes.
 
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Yes, the gleevec case, it was a case of attempted ever-greening, I am on mobile, will give a detailed answer later, but our court rightly rejected their attempt to secure a fresh patent for an old patent expired drug, just for some superficial changes.
Any sane argument welcomed...
 
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good, more USA pushes us, regional alliance formation possibility in this region will increase more

Regional players are just **** bhoonkanay walay either Pakistan or India... buying Weapons from US and unhe ko aankhain nikaalna ? HAHAHHAHAHAHHA
 
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Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP
NEW DELHI: The Indian arm of Swiss pharma major Roche, which unexpectedly gave up its patent on it s $6 billion breast cancer drug Herceptin (Trastuzumab) in India last year, has sued Bangalore based Biocon and US generic giant Mylan Inc in Delhi High Court (HC) for launching world's first biosimilar version of the original drug in India.
It has also sued the Drug Controller General of India for giving permission for such a launch.

The Delhi High Court has restrained Mylan and Biocon from "relying upon" or "referring to Herceptin" or any data relating to it for selling or promoting their brands Canmab (Biocon)and Hertaz (Mylan) till the next hearing, according to an order reviewed by ET. Trastumab was being considered for a compulsory license, but Roche pre-empted the move by not renewing the patent here.

Roche has told the court that the drugs of Biocon and Mylan are being misrepresented as 'biosimilar Trastuzumab' and 'biosimilar version of Herceptin' without following the 'due process in accordance with the guidelines on similar biologics' for getting approvals in India.

The Swiss company argues that there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

Roche further contests that guidelines on similar biologics were only issued in 2012, which laid down 'a detailed and structured process for comparison of biosimilar with the original product and "all the applications for manufacturing and marketing authorization" of biosimilars have to follow that path before getting an approval. Roche also claims that DCGI has approved Biocon's "protocol and design study for testing" related to the proposed drug even before its own regulatory guidelines were firmed up.

"As per the annual report for the year 2012 of the defendant No 2 (Biocon), in June 2012 much before the guidelines became effective, the defendant No 2 was already conducting Phase III clinical trials (for the drug candidate)" Roche has pleaded, according to a copy of the Delhi HC order.

Roche has cast doubts in its submission saying the Indian drug regulator's approval for biosimilars couldn't have come about in 'such a short period' when its 'prescribed procedure' in the guideline is so long.

Three months after Roche announced that it would no longer pursue a patent on breast cancer drug Herceptin in India, Biocon in October last year got an approval for making the drug from the central drug regulator.

The journey of this blockbuster drug, which earns its parent company over $6 billion in annual sales globally, has been particularly intriguing in India as it was the first drug candidate, which was being considered for grant of a compulsory license by the government under section 92 of Indian Patents Act. The case for grant of compulsory license was buried after Roche in August unexpectedly dropped claims for a patent on drug by not applying for a renewal of its existing patent in India.

While Roche and Mylan couldn't be reached for their comment immediately, a Biocon spokesperson refused to comment saying the company was not appraised of the matter yet.
Biocon has developed this biosimilar in partnership with US generic giant Mylan and both launched their brands early this year with much fanfare.

Roche which markets Trastuzumab in India under the 'Herceptin', commands a near monopoly in this market here. Roche had launched the drug at over 1 lakh per vial. However, following India's decision to grant its first compulsory licence on liver cancer drug Sorafenib (Nexavar), Roche in March 2012 announced a cut of over 15% in the price of Herceptin per dose to 92,000. It also tied up with Indian drug maker Emcure Pharma, which started offering the drug under brand Herclon at 72,000 per dose. While Roche, known for aggressively defending its patents, it didn't give a specific reason for dropping its patent on this drug here, sector analysts read this as a change in its India strategy.

Patient groups, however, alleged that the company made such a move because it was on weak ground with regards to this drug patent in India.

Roche sues Biocon, Mylan, DCGI over breast cancer drug - Economic Times
 
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nick, @Bang Galore
the recent dent in the U.S/India ties is a quiet confusing one to be honest, the "reason" is what is puzzling in this case as it doesn't make much sense to honest , however one analysis is that of India's reluctance or hesitation regarding its role in the pivot to Asia policy ( the China factor), or sort of a lack of will or a hesitation to any firm commitment particularly from India's side might be the reason for the U.S discomfort from a geo-strategic point of view, this is the only reason which makes sense
your take on this issue ?

China is India's neighbour. If given a chance to sort out our differences with China we will enthusiastically grab it because we need peace and stability to grow.

US strategy is to destabilize the whole APAC region so that US and it's NATO allies get a chance to poke their nose here. China is their target today, but tomorrow it will be us who will be under their cross-hair. If US wants to fight a war let it fight using it's own resources, let it sacrifice it's own population.

Back on topic, if we are not breaking any law the we can drag the US to WTO in case it decides to take any punitive action against us.
 
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Back on topic, if we are not breaking any law the we can drag the US to WTO in case it decides to take any punitive action against us.

Yes we breaking the laws.. India is a signatory of WTO by virtue of which it is abide by worldwide intellectual property standards under the TRIPS agreement.
 
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U.S. launches new trade action against India over solar program
(Reuters) - The United States on Monday said it would take India to the World Trade Organization to gain a bigger foothold for U.S. manufacturers in its fast-growing solar products market, adding another irritant to an already strained relationship.

The Obama administration said it was filing its second case at the WTO over the domestic content requirements in India's massive solar program, which aims to ease chronic energy shortages in Asia's third-largest economy.

U.S. Trade Representative Michael Froman said making Indian solar developers use locally made equipment discriminated against U.S. producers and could hinder the spread of solar power.

"Domestic content requirements detract from successful cooperation on clean energy and actually impede India's deployment of solar energy by raising its cost," Froman said.

It is the second time in a year that Washington has sought a consultation at the WTO - the first stage in a dispute process that can lead to sanctions - over India's Jawaharlal Nehru National Solar Mission.

The ongoing trade spat between the two allies follows the recent arrest and strip search of a female Indian diplomat in New York in connection with visa fraud charges.

The arrest sparked fury in India, prompted retaliatory measures against U.S. diplomats there and plunged U.S.-India relations to their lowest point since India tested a nuclear device in 1998.

The USTR issued its first challenge to India's solar program last February when it formally requested consultations over its first stage. The program aims to double India's renewable energy capacity by 2017.

U.S. officials had hoped a second phase of the program would address Washington's concerns, but now fear the harm to American producers would likely be even greater because the rules were expanded in October to cover so-called thin film technology that comprises the majority of U.S. solar product exports to India.

India hit back at the initial U.S. accusations in April, asking Washington to justify its own incentives offered to U.S. companies that use local labor and products in renewable energy and water projects. The Indian embassy in Washington was not immediately available for comment on the latest trade action.

India has argued its solar policies are legal under WTO government procurement rules that permit countries to exempt projects from non-discrimination obligations.

YEARS IN THE MAKING

Froman said the action did not undermine the value that the United States placed on its relationship with India, saying: "Today's action addresses a specific issue of concern and in no way detracts from the importance we attach to this relationship." Attorneys for the USTR said later such cases took months to prepare.

U.S. solar trade groups cheered the move and said the United States had been patient in its discussions with India.

"The U.S. government spent two years talking with India trying to encourage them to move away from the local content requirement before initiating the first action roughly a year ago," said John Smirnow, vice president of trade and competitiveness for the Solar Energy Industries Association.

"We are almost three years in the making of the U.S. trying to get India to move back from this local content requirement."

U.S. environmental groups have urged the Obama administration to back off any WTO action, arguing that building up India's solar power industry will help it cut high greenhouse gas emissions.

But the administration has come under growing pressure from lawmakers and business groups to take a tougher stance on perceived Indian protectionist measures and intellectual property rights abuses by Indian drug companies.

India is widely perceived in Washington as a serial trade offender, with U.S. companies unhappy about imports of everything from shrimp to steel pipes they say threaten jobs.

The U.S. International Trade Commission is scheduled to hold a hearing into complaints of trade barriers erected by India on Wednesday and Thursday.

There are 14 past or current World Trade Organization cases between India and the United States, whose bilateral trade in goods measured $63.7 billion last year, not including the latest case.

U.S. launches new trade action against India over solar program| Reuters

Double standards by US...:usflag:
 
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U.S. launches new trade action against India over solar program
(Reuters) - The United States on Monday said it would take India to the World Trade Organization to gain a bigger foothold for U.S. manufacturers in its fast-growing solar products market, adding another irritant to an already strained relationship.

The Obama administration said it was filing its second case at the WTO over the domestic content requirements in India's massive solar program, which aims to ease chronic energy shortages in Asia's third-largest economy.

U.S. Trade Representative Michael Froman said making Indian solar developers use locally made equipment discriminated against U.S. producers and could hinder the spread of solar power.

"Domestic content requirements detract from successful cooperation on clean energy and actually impede India's deployment of solar energy by raising its cost," Froman said.

It is the second time in a year that Washington has sought a consultation at the WTO - the first stage in a dispute process that can lead to sanctions - over India's Jawaharlal Nehru National Solar Mission.

The ongoing trade spat between the two allies follows the recent arrest and strip search of a female Indian diplomat in New York in connection with visa fraud charges.

The arrest sparked fury in India, prompted retaliatory measures against U.S. diplomats there and plunged U.S.-India relations to their lowest point since India tested a nuclear device in 1998.

The USTR issued its first challenge to India's solar program last February when it formally requested consultations over its first stage. The program aims to double India's renewable energy capacity by 2017.

U.S. officials had hoped a second phase of the program would address Washington's concerns, but now fear the harm to American producers would likely be even greater because the rules were expanded in October to cover so-called thin film technology that comprises the majority of U.S. solar product exports to India.

India hit back at the initial U.S. accusations in April, asking Washington to justify its own incentives offered to U.S. companies that use local labor and products in renewable energy and water projects. The Indian embassy in Washington was not immediately available for comment on the latest trade action.

India has argued its solar policies are legal under WTO government procurement rules that permit countries to exempt projects from non-discrimination obligations.

YEARS IN THE MAKING

Froman said the action did not undermine the value that the United States placed on its relationship with India, saying: "Today's action addresses a specific issue of concern and in no way detracts from the importance we attach to this relationship." Attorneys for the USTR said later such cases took months to prepare.

U.S. solar trade groups cheered the move and said the United States had been patient in its discussions with India.

"The U.S. government spent two years talking with India trying to encourage them to move away from the local content requirement before initiating the first action roughly a year ago," said John Smirnow, vice president of trade and competitiveness for the Solar Energy Industries Association.

"We are almost three years in the making of the U.S. trying to get India to move back from this local content requirement."

U.S. environmental groups have urged the Obama administration to back off any WTO action, arguing that building up India's solar power industry will help it cut high greenhouse gas emissions.

But the administration has come under growing pressure from lawmakers and business groups to take a tougher stance on perceived Indian protectionist measures and intellectual property rights abuses by Indian drug companies.

India is widely perceived in Washington as a serial trade offender, with U.S. companies unhappy about imports of everything from shrimp to steel pipes they say threaten jobs.

The U.S. International Trade Commission is scheduled to hold a hearing into complaints of trade barriers erected by India on Wednesday and Thursday.

There are 14 past or current World Trade Organization cases between India and the United States, whose bilateral trade in goods measured $63.7 billion last year, not including the latest case.

U.S. launches new trade action against India over solar program| Reuters

Double standards by US...:usflag:


These are not retaliation of Khobdagade case, actually differences were growing between USA & India in every sphere, be it free trade, foreign policy, or Govt. purchases. Actually US version of 'friendship' is being a 'yes man' of US, they wanted a free (not fair, only free) trade in India; we said you have to follow restrictions like local content, they thought we will buy nuclear reactors and big ticket military equipment at their terms; we got it from France & Russia, they thought they will control our foreign policies from White House; we did make some compromises but certainly far less than they expected, and then the Khobdagade case, US is not getting the kind of leverage in India that they thought we will gleefully grant them being a third world developing country. Our spine is stronger than they expected, and hence the attempt to soften that spine, but I think this retaliatory policy will backfire on them.
 
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Any sane argument welcomed...


About the Glivec case, do you think India is at wrong there? Ever-greening is not only illegal in Indian law, it is illegal as per international laws also, it's just that the big MNCs with their huge money power and political clout always try to get fresh patent rights by ever-greening, and many a times succeed to get patent perpetually.

"Glivec was already on the market, however, so Novartis decided to seek a patent on a slightly altered version, potentially giving it a longer period of market exclusivity. The supreme court has thrown out the application, saying the new drug is not significantly different from the old version, and ordered Novartis to pay costs."

"The case hinged on the interpretation of section 3(d) of the Indian Patents Act, which does not allow patents of new versions of known drug molecules, unless they make the medicine significantly more effective than before.

Novartis argued that better physicochemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.

But the court decided that the changes were simply an attempt at "evergreening" – refreshing the drug so that a new patent would be granted – which is common practice in Europe and North America."


"By refusing patent monopolies on minor changes to known molecules, this judgment will facilitate early entry of generic medicines into the market for other medicines and diseases too. The impact will be felt not only in India, but also across the developing world."

Novartis denied cancer drug patent in landmark Indian case | World news | The Guardian


Section 3(d) of Indian patent law reads: "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;"


Essentially, it says that you can't tweak something that already exists and then patent it, if it doesn't enhance the known efficacy of that thing, or result in a new product. Novartis tried to do the same thing with Glivec which is an old drug. In fact, there are rising voices in EU, Australia, Canada, and they may follow India's Patent Law, here are some points:

1. Australian government body, IP Australia, asked for changes in its patent laws relating to drugs suggesting that the indiscriminate grant of patents to incremental innovations should be checked and that an independent review should be set up to examine these proposals, as reported The Times of India.

2. Canadian lawyers and health industry officials are also reportedly discussing tighter standards.
A clause in Indian law introduced in 1995 forces the patent applicant to prove the medical or therapeutic efficacy of any incremental innovation for which it is seeking a patent. The Indian law and the Supreme Court ruling recently denied patent protection to Novartis Glivec.

3. What the Novartis decision does is give other countries an imprimatur from a highly respected court that restricting ever greening is an important public policy, said Brooke Baker, Northeastern School of Law professor, who advised the Uganda government in drafting its patent law.


Chapter II of the The Patents Act, 1970 on 'Inventions not patentable' reads as:

3. What are not inventions. The following are not inventions within the meaning of this Act:

(a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;

(b) an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;

(c)the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;

(g) Omitted by the Patents (Amendment) Act, 2002

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.
 
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These are not retaliation of Khobdagade case, actually differences were growing between USA & India in every sphere, be it free trade, foreign policy, or Govt. purchases. Actually US version of 'friendship' is being a 'yes man' of US, they wanted a free (not fair, only free) trade in India; we said you have to follow restrictions like local content, they thought we will buy nuclear reactors and big ticket military equipment at their terms; we got it from France & Russia, they thought they will control our foreign policies from White House; we did make some compromises but certainly far less than they expected, and then the Khobdagade case, US is not getting the kind of leverage in India that they thought we will gleefully grant them being a third world developing country. Our spine is stronger than they expected, and hence the attempt to soften that spine, but I think this retaliatory policy will backfire on them.

It depends how far the US is willing to go to soften that Indian spine. If the US really wanted to they could cripple the entire Indian economy. Financial sanctions and the Rupee will collapse and inflation will be skyrocket.
 
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It depends how far the US is willing to go to soften that Indian spine. If the US really wanted to they could cripple the entire Indian economy. Financial sanctions and the Rupee will collapse and inflation will be skyrocket.


We have already successfully survived a major US sanction after Pokhran nuclear tests, ours is not an export driven economy, and any attempt to cripple Indian economy will create negative repercussions for world economy. Coercive measures are not the way to go if anybody want any kind of cooperation with India.
 
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