India does respect patent laws, its just that we don't respect the malpractice of "Ever Greening". Exclusive patent rights are awarded for a period of 20 years, companies can recover the R&D costs in those 20 years. But after each 20 year period these companies make some superficial changes in the existing medicine and claim for a fresh patent for another 20 years. Such practice will ensure a lifetime guarantee of exclusive patent rights for any medicine. We think that this is actually the violation of patent laws. And India is not against patent rights of Life Saving Drugs also, any new life saving drugs can surely be patented, and such patents will be respected here, but for 20 years only....no "Ever greening" please! We are not fools to not understand what these companies are trying to do.
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. Does that sound logical? In fact, EU, Australia, Canada may follow India’s Patent Law, here are some points:
•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.
•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.
•”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.
