This article looks into the challenges faced in the patenting of therapeutic antibodies in India. However, before going any further it is worthwhile to understand a little bit about the existing patenting process and practices followed in India in general and pharmaceuticals in particular.
The Indian Pharmaceutical industry is a successful and technology-oriented competent space that has seen some consistent growth over the last three decades. The current space comprises several private players who have captured substantial domestic market share and also benefit from factors such as favorable government policies and limited competition from overseas. However, as India gears up to be a global player, the dynamics of this industry are also changing where the domestic players will need to match the standards of the global market going forward. To this end efforts are being made in India to curb the problems of weak enforceability of existing intellectual property legislations and moving towards establishing a process that aims at creating a conducive environment for technological advances. Under the current patent laws in India, 'Molecules' which are the result of a chemical reaction are non-patentable. Additionally, any chemical agent or admixtures resulting in aggregation of properties but non-synergetic behaviour are also treated as non-patentable in India. Irrespective of whether such agents or molecules exhibit functional properties, they are still considered non-patentable. Only the process or the method of synthesizing such molecules/agents is considered patentable.
This lack of protection for product patents has had a tremendous impact on the domestic pharmaceuticals industry in the last three decades. In a manner, this handicap has encouraged an entire generation of pharmacists and scientists in India to develop novel methods to reengineer "Molecules' that were protected and patentable throughout the world but unprotected in India. Also, once the patent for these drugs expired in the international market, Indian players would flood the market with cheap and generic versions of the same drug, thus, bagging a hefty profit. However, with introduction of TRIPS and India realizing the need to be a responsible global partner, the Indian government is working towards establishing a new patent regime which on one hand can ensure the same level of technological advances as seen by industry in past few years, and on the other also, keep the country honest to her global commitments.
Coming to the subject of patenting therapeutic antibodies in India, the same law applies as described above in general, provided, one were able to prove that the antibody in question is novel, inventive and useful. Additionally, the claimed antibody must be structurally and functionally different from an antibody occurring in nature. In case a new life form of an existing antibody needs to be patented, the application should prove that this newer version is more efficient and productive than its original counterpart. Based on recent experiences, it can be noted that the Indian Patent office has been a little inconsistent in awarding patents to antibodies in India. One of the main reasons for this might be the sheer complexity involved in defining characteristics of an antibody, such that they are able to demonstrate both structural and functional distinctions, so that it is able to assure the IPO of its novelty. The claims defining the antibody by only functional features, are often objected to and might end up getting rejected.
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