As the Indian patent regime is continually evolving, applicants seeking to protect their inventions in India must pay careful attention to the legislation and Patent Office guidelines.The life sciences industry has the potential to offer many innovative products for the betterment of society, especially in relation to healthcare. This has led many companies – both start-ups and large organizations – to invest in the sector and implement measures to protect their innovative products and processes. Most innovations in the global life sciences industry relate directly to human health and therefore come under close scrutiny from both governmental and non-governmental bodies. This poses a number of challenges when protecting such innovations through patents. This article discusses some of the issues faced by patent applicants in the life sciences sector in India (especially for inventions related to drugs, medicines and vaccines), examines the relevant provisions of the Patents Act 1970 and describes the possible actions that applicants may consider to protect their innovations in the country.
– Criteria of Patentability in Biotechnology
– Traditional Knowledge
– Patenting already known substance
– Permission from National Biodiversity
General Patenting Issues –
1) Claim Language 2) Method of treatment 3) Unity of Inventor
Criteria of Patentability in Biotechnology:
Novelty- New challenges are being faced in the form of identifying the novelty in the living matters, which is a very difficult task, if not impossible. This is because, the living things like, animals and gene sequences exist naturally, and as some rightly argue it is impossible for such living matter to be novel.
Non-Obviousness- Obviousness has been a sticky subject in the realm of biotechnology because scientists use similar techniques to isolate different gene sequences, been through the gene sequences may be new. Non-obviousness precludes patentability, if given the prior available technology ‘prior art’, the invention would have been obvious to someone of ordinary skill in the art 20.
Patenting new form of already known substances:
The most discussed provision of the Patents Act is Section 3(d), which prohibits patenting of “a new form of a known substance which does not result in the enhancement of the known efficacy of that substance”. Earlier “efficacy” was not mentioned in patent act it came into notice only after the Novartis vs Union of India (2013).
Some of the objections raised by Section 3(d) may be overcome either by establishing that the claimed product is not a new form of a known substance or by providing evidence that the claimed product has better or enhanced efficacy than the known forms.
If a product claims a particular function, its utility or function must also be shown in the application, by way of examples. Applicants that intend to obtain patent protection in India for their products must consider performing tests that compare the effects of the claimed product with those of the closest available prior art products. This will generally help in establishing the patentability of the invention, including inventive step, and overcoming any objections under Section 3(d).
Permission from National Biodiversity Authority:
Another typical requirement under the Patents Act relates to use of biological resources, or information based on such resources, obtained from India in the invention. The Patent Office has recently started taking into account the requirements of the Biological Diversity Act 2002 in relation to patent applications. Section 6 of the act requires applicants whose inventions or applications are based on research or information relating to ‘biological resources’ – defined in
Section 2(c) of the act as “plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value but does not include human genetic material” – originating from India to obtain permission from the National Biodiversity Authority (NBA) when applying for IP rights.
Breach of these provisions can result in penalties, including imprisonment for up to five years or a fine of up to Rs1 million (approximately $16,000). In cases where the damage caused exceeds Rs1 million, such fine may be commensurate to the damage caused.
Traditional Knowledge:
The Patents Act prohibits the patenting of inventions that are in effect traditional knowledge. In this regard, there is no restriction on the particular community or geographical area to which such knowledge pertains; traditional knowledge from anywhere in the world will be considered. Even the aggregation or duplication of known properties of traditionally known components cannot be patented.
To assist applicants in checking whether their invention will be considered traditional knowledge, a traditional knowledge digital library has been established by the Council of Scientific and Industrial Research in collaboration with the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy.
General Patenting issues:
Although these are the basic problems that we face in filing patents in life sciences field but few other conditions also persist, those are:
Claims Language- One of the most frequent objections in India for inventions in the life sciences sector, especially in biotechnology, is non definitiveness of claims. In biotechnology, the product (eg, an antibody) is often described by its function, rather than by its composition or construction. Such claims are usually considered vague and indefinite by the Patent Office. Applicants may therefore need to highlight those aspects of the application that demonstrate the definitiveness of their claims. Explaining the claim and showing how it has a defined scope will often help in such a claim being accepted.
Method of treatment- Some patent offices (eg, the US Patent and Trademark Office) allow claims related to method of treatment, but others (eg, the European Patent Office and the Indian Patent Office) do not. The Indian Patent Office does not allow even second medical use claims, which are generally allowed by the European Patent Office. Section 3(i) of the Indian Patents Act excludes “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for the similar treatment of animals to render them free of disease or to increase their economic value or that of their products”.
This exclusion exists more as a policy that skilled professionals practicing in these areas who use these methods as a part of their duties should not be restricted as a result of patent protection arising from these methods or treatments.
Unity of Invention- In the life sciences sector, especially in biotechnology, it is usual practice to include multiple independent claims directed towards multiple related inventions. The Indian Patent Office is usually rigorous in its assessment of the plurality of distinct inventions and often tends to discourage multiple inventions submitted in a single application.
However, the Patents Act does allow multiple inventions if it can be established that the distinct inventions are linked so as to form a single inventive concept. If a single inventive concept cannot be established, the applicant can seek protection for the non-accepted inventions in one or more divisional applications. However, the applicant must take care with regard to the timing of such applications: any divisional application must be filed before grant of the first parent application.
Conclusion: The Patents Act 1970 has undergone numerous changes since its introduction. Along with the changes in law, the practices of the Indian Patent Office are constantly developing and it is well on the way to achieving digitisation, transparency and consistency in practice. The Patent Office has already issued guidelines for the examination of inventions related to biotechnology and traditional knowledge, and the draft guidelines for the examination of inventions related to pharmaceuticals are open for public comment.
Applicants that hope to protect their inventions in India – a sought-after market for products from the life sciences sector – are therefore advised to consider the Patents Act when writing their applications. Most information related to patent applications, controllers’ decisions and examination guidelines is made available online by the Patent Office. Such developments pave the way for the development of consistent patent practice, which should help applicants to protect their inventions effectively.
