Patentability Requirements in India:
A patent is granted for an invention. An invention is defined in section 2(1)(j) as “a new product or process involving an inventive step and capable of industrial application.” Therefore, the criteria for an invention to be patentable are –
- It must be novel;
- It must have an inventive step; and
- It must be capable of industrial application.
Further, the invention should not fall under any of the categories of “Inventions Not Patentable” mentioned under sections (3) and (4) of the Patents Act, 1970. Also, the invention should be adequately disclosed.
Novelty of Invention: An invention is considered new (novel) if it has not been anticipated by publication in any document anywhere in the world or used in the country or prior claimed in an application for patent in India or form part of the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere before the date of filing of patent application or date of priority, that is, the subject matter has not fallen in the public domain or that it does not form part of the state of the art.
Example 1:
The invention relates to the fumarate salt of (2S)-1-{[1,1-Dimethyl-3-(4-(pyridin-3- yl))-imidazol-1-yl)-propylamino]-acetyl}-pyrrolidine-2-carbonitrile useful for the treatment of diabetes mellitus. Prior art specifically discloses methanesulfonic acid salt of (2S)-1-{[1,1-Dimethyl-3- (4-pyridin-3-yl-imidazol-1-yl)-propylamino]-acetyl}-pyrrolidine-2-carbonitrile. Further, it discloses “many pharmaceutically acceptable salts” of the said compound and also mentions many salt forming acids, among which fumaric acid was mentioned as one of the pharmaceutically acceptable salt forming acid.
Analysis of example 1: The subject-matter of the claimed invention claiming fumaric acid salt of a compound (2S)-1-{[1,1-Dimethyl-3-(4-pyridin-3-yl-imidazol-1-yl)-propylamino]-acetyl}-pyrrolidine-2-carbonitrile, the disclosure of prior art anticipates the novelty of claimed subject-matter.
Inventive Step (Non-obviousness): A patent may not be obtained though the invention is not identically disclosed or described, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Obviousness is a question of law and facts based on underlying factual inquiries. The factual inquiries enunciated are as follows:
- Determining the scope and content of the prior art; and
- Ascertaining the differences between the claimed invention and the prior art; and
- Resolving the level of ordinary skill in the pertinent art.
In India, as per the section 2(1)(j)(a) of Patents Act, an invention will have inventive step if the invention is (a) technically advanced as compared to existing knowledge or (b) having economic significance or (c) both, and that makes the invention not obvious to a person skilled in the art.
Skilled person: The meaning of a person skilled in the art is extremely important in the context of inventive step analysis. This hypothetical person is presumed to know all the prior arts as on that date, even non-patent prior art available to public. He has knowledge of the technical advancement as on that date, and the skill to perform experiments with the knowledge of state of the art. He is not a dullard and has certain modicum of creativity. Choosing a better alternative/substitute from the known alternative from the prior art to obtain the known results would not go beyond what may be normally expected from person skilled in the art.
Hindsight analysis: The ‘obviousness’ has to be strictly and objectively judged. To judge obviousness objectively, the skilled person needs to eliminate the hindsight analysis. The prior art needs to be judged on the date of priority of the application and not at a later date.
Reasonable expectation of success: With respect to what is obvious, it must be borne in mind that “the mere existence in the prior arts, of each of the elements in the invention, will not ipso facto mean obviousness. For after all most inventions are built with prior known puzzle-pieces. There must be a coherent thread leading from the prior arts to the invention, the tracing of the thread must be an act which follows obviously”. This “coherent thread leading from the prior art to the obviousness” or in other words, “the reasonable expectation of success embedded in the prior art which motivates the skilled person to reach to the invention, is the most crucial determining factor in ascertaining inventive step”. Obviousness cannot be avoided simply by showing of some degree of unpredictability in the art so long as there was a reasonable probability of success. Obviousness does not require absolute predictability of success. All that is required is a reasonable expectation of success. In the matter of pharmaceutical inventions structural and functional similarity of the product provides this motivation to combine the teachings of the prior arts. A surprising effect, synergistic outcome of the combinations, prior art prejudice etc. usually demonstrates the non-obvious nature of the invention.
Method for objectively analysing the inventive step:
- a) Identify the inventive concept of the claim in question
- b) Identify the “person skilled in the art”,
- c) Identify the relevant common general knowledge of the person skilled in the art at the priority date;
- d) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim;
- e) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of inventive ingenuity?
Example 2:
The claimed invention in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to the amlodipine besylate drug product, which was sold in tablet form in the United States under the trademark Norvasc. Amlodipine and the use of besylate anions were both known at the time of the invention. Amlodipine was known to have the same therapeutic properties as were being claimed for the amlodipine besylate, but Pfizer discovered that the besylate form had better manufacturing properties (e.g., reduced “stickiness”).
Pfizer argued that the results of forming amlodipine besylate would have been unpredictable and therefore nonobvious. The court rejected the notion that unpredictability could be equated with non-obviousness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties.
The court found that one of ordinary skill in the art having problems with the machinability of amlodipine would have looked to forming a salt of the compound and would have been able to narrow the group of potential salt-formers to a group of 53 anions known to form pharmaceutically acceptable salts, which would be an acceptable number to form “a reasonable expectation of success.”
Industrial Application: In India, Section 2 (1) (ac) “Capable of Industrial application”, in relation to an invention, means that the invention is capable of being made or used in an industry.
Example 3:
The invention relates to synthetic analogues of a steroid. The steroids possess certain medicinal properties. However, the compounds of the invention, as asserted, are subjects of serious investigation, being the analogue of compounds known for medicinal properties.
Analysis: The claimed compounds are not patentable as they lack any credible and specific utility. A mere scientific interest does not make something eligible for patentability.
Adequate disclosure: A written description requirement issue generally involves the question of whether the subject matter of a claim is supported by [conforms to] the disclosure of an application as filed. If the examiner concludes that the claimed subject matter is not supported [described] in an application as filed, this would result in a rejection of the claim on the ground of a lack of written description.
Subject Matters Not Patentable in India: Section 3 of Indian Patent Act deals with subject matter not patentable as follows:
Section 3 . What are not inventions:
(a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;
Example: A machine alleged to be giving output without any input.
(b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;
Example: Any machine or method for counterfeiting of currency notes.
(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;
Example: An extract obtained from cerebrospinal fluid of horseshoe crab for cardiac activity
(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;
Example: A composition of two drugs, i.e. Paracetamol and Ibuprofen for curing fever and pain or process of preparation thereof is not patentable for the reason that the composition is a mere admixture of two drug components resulting into aggregation of properties thereof; since Paracetamol is well known for treatment of fever and Ibuprofen for treatment of pain. However, if the mixture of drugs exhibits some unexpected results or synergistic properties in their action , then such composition is considered as patentable subject matter.
(f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;
Example: Play-cum-educational device (1532/Cal/76). The device comprises of a chart, a set of tokens for players and one or more dice. It was held not patentable under the provisions of this section since the chart, token and dice, all are working independently of each other and there is no interrelation between them.
(h) a method of agriculture or horticulture;
Example: A method of producing improved soil from the soil with nematodes by treating
the soil with a preparation containing specified phosphorathioates is not patentable under this Section.
(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.
Example: A method of treatment of malignant tumour cells.
(j) plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
Example: A genetically modified seed of neem plant.
(k) a mathematical or business method or a computer programme per se or algorithms;
(l) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions;
Example: Writings, music, works of fine arts, paintings, sculptures etc.
(m) a mere scheme or rule or method of performing mental act or method of playing game;
Example: A method of learning a language.
(n) a presentation of information;
(o) topography of integrated circuits;
(p) an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.
Example: The anti septic property of turmeric for wound healing. Another example is the pesticidal and insecticidal properties of neem
References:
Manual of Patent Practice India.
O my friend — but it is too much for my strength — I sink under the weight of the splendor of these visions! A wonderful serenity has taken possession of my entire soul, like these sweet mornings of spring which I enjoy with my whole heart. I am alone, and feel the charm of existence in this spot, which was created for the bliss of souls like mine.
I am so happy, my dear friend, so absorbed in the exquisite sense of mere tranquil existence, that I neglect my talents. I should be incapable of drawing a single stroke at the present moment; and yet I feel that I never was a greater artist than now.
When, while the lovely valley teems with vapor around me, and the meridian sun strikes the upper surface of the impenetrable foliage of my trees, and but a few stray gleams steal into the inner sanctuary, I throw myself down among the tall grass by the trickling stream; and, as I lie close to the earth, a thousand unknown plants are noticed by me: when I hear the buzz of the little world among the stalks, and grow familiar with the countless indescribable forms of the insects and flies, then I feel the presence of the Almighty, who formed us in his own image, and the breath of that universal love which bears and sustains us, as it floats around us in an eternity of bliss; and then, my friend, when darkness overspreads my eyes, and heaven and earth seem to dwell in my soul and absorb its power, like the form of a beloved mistress, then I often think with longing, Oh, would I could describe these conceptions, could impress upon paper all that is living so full and warm within me.
