Section 3d Of India Patents Act
Section 3d Of India Patents Act
History of Patent Law in India
- In 1911, the Indian Patents and Designs Act was enacted, providing basic protection to patents.
- The Patents Act, 1970 is the legislation that till date governs patents in India. It first came into force in 1972.
- The Patents Act has been repeatedly amended: 1999, 2002, 2005, 2006. These amendments were required to make the Patents Act TRIPS-compliant
- The major amendment was in 2005, when product patent was extended to all fields of technology like food, drugs, chemicals and micro organisms. 2005 was the final deadline for complete compliance with TRIPS. The Rules under Patent Act were also amended in 2012, 2013, 2014.
2005 Amendment of the Patent Law
Salient features of the Patents (Amendment) Act 2005 related to product patents:
- Extension of product patent protection to products in sectors of drugs, foods and chemical.
- Term for protection of product patent shall be for 20 years.
- Introduction of a provision for enabling grant of compulsory license for export of medicines to countries which have insufficient or no manufacturing capacity; provided such importing country has either granted a compulsory license for import or by notification or otherwise allowed importation of the patented pharmaceutical products from India (in accordance with the Doha Declaration on TRIPS and Public Health)
- Section 3 (d) regarding patentability
Section 3 of the Indian Patents Act
- Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. Thus, the Indian Patent Act does not allow evergreening of patents.
- Section 3(d), covers “combinations and other derivatives of known substance”. In this case, the applicant has to submit “efficacy” data to get the patent.
- Section 3(e), covers “substance obtained by a mere admixture resulting only in the aggregation of the properties of the components or a process for producing such substance”. In this case, the applicant has to submit data for “synergism”. Synergism means that the combined effect of two or more medicines will be greater than their individual effects.
- Section 3(i) of the Act categorically excluded methods of treatments from the purview of patent protection.
Issues around Section 3(d) | Section 3d Of India Patents Act
- Section 3 of the Patents Act speaks of inventions which are not patentable
- Section 3(d) of the Patents Act was introduced by the 2005 Amendment. The section sets a ‘novelty’ standard.
- For a product to be patentable, something genuinely new should have been discovered or added to an existing product.
- The section stipulates conditions under which the product will not be patentable:-
- If the alleged ‘new product’ just involves the discovery of a new form of an existing substance, AND it does not enhance the efficacy of the older form of the product
- Mere discovery of a new use for an already known substance
- Mere discovery of any new property
- Modified usage of an already existing and known process, machine or apparatus without it resulting in a new product or employing at least one new reactant
- The part of section 3(d) that has been controversial is the part which prohibits granting of patents for mere discovery of new usage of known substance. To better illustrate through an example, Aspirin was initially used to alleviate headaches and other ailments.
- However, it was later discovered that Aspirin also serves as a blood-thinner and can be used in the treatment of cardio-vascular diseases. Now, a new patent for Aspirin cannot be filed just because a new use was discovered for the same product.
- The above portion of section 3(d) along with the part prohibiting granting of patents for discovery of new form of a known substance has been exploited by pharmaceutical companies to evergreen patents.
Conclusion | Section 3d Of India Patents Act
- If the Section 3(d) is reviewed and amended then a lot of non-patentable products will squeeze into the Indian market with a monopoly.
- Till Section 3(d) is there, global Pharma companies cannot market drugs which are not novel. Simple physical modifications will not be patentable in presence of Section 3(d) the pharmaceutical industries reluctant towards further improvement of a known drug or discovery of new therapeutic use of a known substance.
- It is clear from the above paragraphs and discussions, that pharmaceutical research does not halt on patenting of one pharmaceutical activity mainly due to ongoing research the same drug may be found to have other beneficial properties which was previously unrecognized.
- Therefore, from the viewpoint of a pharma industry the exemption of swiss-type claim format in India is unwelcoming and would rather harm to the Industry.
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