Intellectual property is the intangible property or assets of a person or company that has been created by the mind of people. Intellectual Property Laws are the exclusive rights that are provided to the owner to protect the creations for a certain period and provides exclusive rights within the market usually to produce or sell the output of creation which can be a product or service or technology which can further be extended for the specific requirements. The IP sector’s ambit lies in a plethora of areas like Copyrights, Patents, Trademarks, Geographical Indications, Trade secrets, etc. The pharmaceutical industry has been a prominent economic sector in India and contributes to the Indian commercial sector. There had been patent infringement issues and generic medicines that act as a prominent issue in this field.
EMERGING TRENDS OF PATENTS IN THE PHARMACEUTICALS: According to WIPO, patents are defined as “ A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem 1”. Patents are the rights that have been conferred on the owner or inventor on using the potential of his invention for the betterment of society and his monetary benefits.
It actually balances around the two concepts –the fruit of the inventor’s hard work and social welfare. The major criteria for the invention’s patentability are novelty, inventive steps, and industrial applicability. The major hurdles in this arena of pharmaceuticals are the restrictions on the subject matter regarding Section 3d of the Indian patent Act2 and generic medicines.
Section 3(d) of the Indian Patent Act is a peculiar sui generis provision under Indian law. Any new use of a known substance is not patentable unless there is enhanced known efficacy over the known substance.
It is to be seen that while dealing with objections under section 3(d) of the Act, it has to be borne in mind that section 3(d) does not ipso facto apply to all chemical or pharmaceutical inventions.
To apply section 3(d), it has to be established that the invention is a ‘new form of a known substance,’ meaning that there has to be a known substance, and the examiner has to identify the same.
In the case of I.G. Farbenindustrie A. G, it was stated that
“while setting down three conditions that must be satisfied for a patent to be valid
- There must be a substantial advantage to be secured or disadvantage to be avoided by using the selected members.
- The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question.
- The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.”
This case describes the conditions for the patentability and the relevance of the inventive steps necessary for the pharma industry.
In the case of Eli Lilly Canada Inc. v. Novopharm Limited 4it, the court stated that “A patent is granted for making an inventive choice of selection from a prior known field. Selection inventions normally involve the selection of individual elements, subsets, or sub-ranges, which have not been specifically disclosed previously, within a larger known set or range.”
The court had iterated the meaning of anticipation in Farbewerke Hoechst Aktiengesellschaft Vormals Meister Lucius v. Unichem Laboratories which is as follows:
“to anticipate a patent, a prior publication or activity must contain the whole of the invention impugned; i.e., all the features by which the particular claim attacked is limited. In other words, the anticipation must be such as to describe, or be an infringement of the claim attacked.”
However, if the invention does fall under section 3(d), then enhanced efficacy data of a modified/derivative antibody over the prior known substance should be provided. Examiners generally accept comparative data showing improved efficacy of the new substance/method vis-à-vis the closest prior art. The Indian Patent Office (IPO) usually accepts additional comparative data submitted during prosecution to overcome the objection under Section 3(d). Thus, on a case to case basis, the Examiner applies the test as to what constitutes such salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives to differ significantly. The complete specification may bring out clearly and categorically how the subject matter differs significantly in properties about efficacy from the known substance in properties concerning efficacy from the known substance.
Selection inventions are quite important for the competitive situation in the pharmaceutical sector. A typical product patent for a pharmaceutical takes the form of a Markush claim. If the Markush claim has eight substituents, the number of individual substances included in the claim can be obtained by multiplying the substituents in each of the eight molecule positions.
CONCLUSION
The pharmaceutical industry patent has the most hurdles in overcoming the objections of Section 3(d) as in the case of being held in the concept of the selection patent and the species
structure from the genus patent. The novelty requirement alone is not a sufficient condition of patentability. Normally the assessment of novelty is overshadowed by the requirement of inventive steps. This complicates the novelty requirement because the relevant economic question is whether or not the invention is patentable. This is the case with novelty assessment of selection patents, but in a few other situations within the novelty requirement. Inventions of doubtful novelty usually lack inventive steps.
