drunken-monke
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"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."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.
This sums up everything from your post and agree to this fully...
Provided, you have able government which was Atalji's at that moment.. If it would have congress's government or someone like mulayam or any third front maniac, then god helps in that case...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.