Protection of Inventions Relating to Pharmaceutical and Like Products
04 October 2012
The provisions of Section 3(d) of the Indian Patents Act excluding the grant of patents on inventions relating to 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” have generated certain myths about processing of such patent applications in India.
The provisions are explicitly clear on what can be patented and what cannot be patented.
To secure the grant of a patent on pharmaceutical, agrochemical, food, chemicals and like substances in India, the applicant needs to establish, with “clear and unambiguous support” from the “originally filed specification including examples” that the invention as claimed in the claims has better or enhanced efficacy when compared to the base or prior existing substance or its other form.
For example, if invention intends to claim salt, ester, ether, polymorph, metabolite, isomer, a mixture of isomers, complex, combination or any other derivative, or pure form or particle size of the substance, the description including examples should satisfy that the invention as claimed unexpectedly has one or more of the following properties:
• enhanced bioactivity, solubility, transport rate, bioavailability or bioabsorption; or
• enhanced biostability, that is, it does not demonstrate unwanted in-vivo transformation; or
• improved cosmetic, therapeutic efficacy, etc.; or
• the same physio-chemical properties as that of the cell membrane; or
• ease of oral administration; or
• easy and quick penetration in cell membrane or skin; or
• reduced variability, that is inter- and intra-patient bioabsorption variability is reduced; or
• no or reduced side effects for example the active ingredient becomes available very slowly; or
• enhanced capability of making early bioavailability of an active ingredient in a particular part of the body; or forming a microemulsion of a particular particle size; or a clear solution; or rupturing the shell; or being stored, that is having enhanced shelf life; or forming thermodynamically stable compounds or emulsions; or releasing the drug in reduced time with reduced toxicity and variability; or meeting stringent clinical requirements; or
• the like.
It may be noted that a mere statement in the description may not be sufficient. It should, instead, be sufficiently supported by comparative examples. In case originally filed specification does not have sufficient support by way of examples to establish enhanced efficacy, comparative experimental data may be submitted during prosecution by way of explanation. It is not required to give clinical data at the time of filing or during prosecution of application; laboratory and animal data may suffice for meeting this requirement.
If the invention intends to claim process for preparing a pharmaceutical substance, the applicant needs to establish as above that the invention as claimed in the claims:
• either employs a new reactant; or
• results in the formation of the desired product via a new intermediate; or by saving process time and energy and cost; or
• results in a product having enhanced bioactivity or purity or optical activity or having a particular particle size or any of above described property which is proven to be crucial for its desired application by comparative supporting examples.
Therefore, there is neither any ambiguity nor any bias in processing of applications relating to pharmaceutical and like products.
Section 3(d) of the Indian Patents Act reads as follows:
[The following are not inventions within the meaning of the Act.] 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.
Mehta & Mehta Associates
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Gurgaon – 122002, NCR,
India
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