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Patentability of Pharmaceutical products in India

Patents are the type of intellectual property which is granted to inventions. It protects inventions which are novel, contains an inventive step and has an industrial application. All of these three criteria go hand in hand in the patentability test i.e. for a product to fall under the definition of invention under the patent law; it should be new, should be a result of an inventive step and should have an industrial application[1]. These concepts will be further discussed as we go into this article.

Pharmaceutical Products
India, with its tag as the "pharmacy of the world" is expected to hold a significant 13% of the global Pharmaceutical market in the future[2]. It is already the largest supplier of generic medicines with a share of 20% in the global generic medicine market. With all these merits comes greater responsibility to contribute to the development of medical science through innovations for which enhanced patent protection is necessary.

India achieved this share in the global market of medicines through a rapid growth in the last few years in the field but the fact that India was late to comply with the pharmaceutical product patent requirement of TRIPS cannot be erased from its history. It was through the 2005 amendment to the patent act; India accommodated a vague definition of "pharmaceutical products", which defined pharmaceutical products to be "any new entity involving one or more inventive steps".

I feel the preciseness required in this definition, as expressed by some others cannot be the at the point of including the phrase "chemical substance" as that would bar electronic medical devices from falling under this definition but should pertain to the inclusion of a medical nature to this definition to define its purview. The fact that the Supreme Court has already defined the premises of efficacy of medicines to be "therapeutic efficacy" and not chemical efficacy[3] further advocates the inclusion of medicinal nature to the vague definition.

But nevertheless, the accommodation of both product and process patents in line with the TRIPS requirement[4] is a positive outcome of this amendment. Product patents are a mark of enhanced patent protection which will serve the purpose of the Patents which is to encourage inventions because such product patents ensure the maximum protection to the products invented as a result of investment in research by the R&D entities.

Provisions involved:
  • Section 2 (1) (j)
  • Section 2(1)(j)(a)
  • Section 2(1)(ac)
  • Section 3 (d)
Of the Indian Patents Act, 1970

Patentability of pharmaceutical products
The inclusion of pharmaceutical products into the ambit of The Patent Act naturally brings it into the three fold test discussed above, the novelty, inventive step, and industrial application test. To understand which pharmaceutical products can be patented, it is better if we get into the shoes of the examiner and understand the assessment procedure

Novelty, in the Indian patent regime, derives it definition from Section 2(l) of the act, which states that a "new invention" means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art.

This definition, if simply put, states that the subject matter of the patent claim should not be present in any publication or should not be something which is already in use somewhere in the world. The inventor or the claimant should come up with something more than a mere workshop improvement or verification of already existing knowledge.

In case of already known materials, the inventor should give an absolutely new diversion to the existing materials which would produce an outcome that is not an outcome which can be derived by merely carrying out what is already present in the publication. It is important to bear in mind that in order to be patentable an improvement on something known before or a combination of different matters already known should be something more than a mere workshop improvement and the improvement or the combination must produce a new result[5].

The examiner while assessing the novelty of the claim is neither permitted to combine separate items of prior art together nor is he permitted to combine separate items belonging to different documents together unless there is a suggestion that these items are linked with one another. Mosaicing of prior art documents cannot be done in determination of novelty.

Conclusively, the combination of completely new articles are compounds in producing pharmaceutical products hasn't got much to interfere with but in the case of already existing items, combination of them should produce a distinctive outcome as against the already existing outcome.

It is also a fact that usage of different and distinctive materials present in different prior art pieces cannot be contended by the examiner unless the materials cited is suggested to have connection, the defence of mosaicing prior art by the examiner can be invoked only when he uses completely unrelated prior arts to defeat the patent[6] provided that the outcome produces the distinctive or additive result. Mere aggregation of properties selected from various prior art wouldn't save the patent claim from being contended by the examiner[7]

It is a universally accepted principle that patents cannot prevent people from doing what they've already been doing which serves as the rationale behind the principle that products which are already in use in the world cannot be patented. The novelty of a claim is analysed or assessed by a person skilled in the art and hence, any implied disclosure on the claim as well as in the prior art are to be considered for the assessment. Therefore, the claim should escape from relating itself to any implied disclosure on the prior art in order to get patented.

The introduction and inclusion of product patents through the 2005 amendment came out with another type of assessment concern which is the product � by � process claim. These types of claims requests a definition of a product through the process involved to invent it.

The patentability of such products depends both on the novelty of both the process as well as the product, mere novelty in the process involved to obtain a product with no novelty, or a product which is already present wouldn't attract this "product - by � process claim", there should be novelty in both the product and the process[8]

Inventive step
Inventive step has its premise laid down in Section 2(ja) of the Indian Patents Act,1970 which says that an "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

Inventive step as defined under the Indian patents act, 1970 has three criterion again, one, it has an additional technical advancement over what is existing in the field, two, it has economic significance autonomously or as a result of such technical advancement, and, it should be non obvious to a person skilled in the art. A product is said to have an inventive step when it makes a positive difference in the respective field changing the status quo.

Alternatively, the step should have an economic impact i.e. making the existing product a "cheaper article then before"[9] and if the technical advancement or positive difference results in such an economic significance, the product falls in place of such inventive step provided it satisfies the other criteria of "non-obviousness".

Imagine there's an express train which is scheduled to start from Chennai and reach Mumbai, it will be known to the background employees of Indian Railways that this train will reach Mumbai anyway, regardless of stops and stations, but, what if the train changes track, what if it diverts itself to reach Hyderabad at some point without any announcement.

This unprecedented move of the train wouldn't be anticipated by the employees and therefore it arrives at a new destination which is not anticipated by even the people involved in it. This is non- obviousness, the diversion of the train which is not anticipated by its own employees (person skilled in the art) is that inventive step the patent act is looking for in an invention.

The test of inventive step is derived from the non- obviousness principle i.e. if a skilled person in the same field with all the knowledge available to him before the priority date would come up with the subject matter of the invention, then it can be said that the invention is obvious[10] . Mosaicking of prior art is allowed while the examiner assesses inventive step because unlike novelty which is a quantitative requirement, inventive step is a qualitative requirement.

The inventive step is expected to be absolutely non- obvious to a person skilled in the art. Now every time legislation comes up with such a requirement, the definition of the same will be sought through precedents. The IPAB has clarified in the case of Enercon v. Alloys Wobbens that it does not intend to visualize an extremely skilled person but a person who is skilled to carry out basic instructions as the skilled person.

The pharmaceutical inventions derive their energy from the teachings of the prior art, permutations and combinations of the same, any surprising or contrary outcome of the prior art from these permutations and combinations would explain non-obviousness but however, mere substituting of compounds with alternatives which are known to the skilled person will not stand its claimed position as non-obvious.

Industrial applicability
This requirement is defined under Section 2 (ac) of the Indian Patents Act, 1970, it says that the invention is patentable only when it is capable of being made or used in an industry. The usefulness of the invention is a prima facie factor in determining the patentability of the invention. It is very simple and straightforward as it is also envisaged in Section 64 (g) of the act that a patent is liable to be revoked when the invention is not useful. As already stated, the therapeutic efficacy is the determining factor of pharmaceutical with respect to these criterions. A mere medicinal property of a product or a scientific interest cannot equip a product to obtain a patent, specific utility is what matters.

Section 3 (d)
In Section 3 of the act which lists subject matters which are not patentable, 3 (d) is the closest and the most relevant provision to the field of Pharmaceuticals, it states the following

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.

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

This purpose of this specific provision is to deal with the chemical substance and more specifically pharmaceutical substances[11], this provision states that a mere discovery of a now form or new property of a chemical substance which doesn't result in therapeutic efficacy cannot be patented, this provision is useful to curtail the piling up of patents of like products and substances which will make the Indian Patent base complicate as that of the US and also protects the genuine inventions, repetitive patenting etc.

In the case of pharmaceuticals, development of existing knowledge of prior art is common, not many times do the inventors come up with absolutely new product with absolutely new substances and processes. In such an occurring field, the grant of patent depends on the amount of distinctiveness arising out of new, inventive steps taken in such production which result in the therapeutic efficacy of the products. A strong patent regime is one of the most essential requirements to sustain the stability of the Indian Pharmaceutical market and there is no hesitation in stating that India is in the right direction.

  1. Section 2(j) of Indian Patents Act
  3. Novartis v. Union of India, 2013
  4. Article 27 of TRIPS
  5. Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries, 1978
  6. Sterlite Technologies Ltd. v. HCL Limited, 2002
  7. Bhabha Atomic Research Centre vs Union Of India, 2013
  8. The Research Foundation Of State University Of New York Vs Assistant Controller Of Patents
  9. Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries, 1978
  10. Farbwerke Hoechst & B. Corporation v. Unichem Laboratories
  11. Novartis AG Vs. Union of India (UOI) and Ors, 2013

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