IndiaContributing firm Krishna & Saurastri Associates

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The Patent Law’s exclusion of certain classes of invention can leave biotech inventions vulnerable to rejection on the grounds of non-patentability. However, careful drafting and strong arguments can help to overcome objections

By Mita Sheikh, Krishna & Saurastri Associates, India

The patentability of inventions in India is predicated on the criteria of novelty, inventive step and industrial applicability. In addition, the invention must not fall within the category of non-patentable inventions set out in Section 3 of the Patents Act. This is critical for biotech inventions, as out of 15 main classes, almost 10 govern the patentability of biotechnology inventions. The prosecution of biotech patent applications is thus challenging in India.

In order to establish uniform examination practice within and across its regional patent offices in Chennai, Delhi, Kolkata and Mumbai, the Indian Patent Office has published guidelines for the examination of biotechnological inventions. These clearly set out which biotech inventions are patentable and which are not, and have helped to promote consistent examination practice. Currently, the Patent Office is in the process of issuing fresh guidelines for the examination of biotech applications.

The guidelines – as well as the manual of practices and procedure followed by the Patent Office – do not have the force and effect of law, but serve only as practical guidance. Hence, it is worth thoroughly

understanding the provision that bars certain classes of biotech invention from patentability.

Frivolous inventionsOne category of non-patentable subject matter as per the Patents Act concerns frivolous inventions. This may relate to an invention in any field of technology and may not be particularly relevant to biotech inventions. An invention where only minor modifications are made - for example, nucleotide/polypeptide sequences - without resulting in any enhanced or unexpected activity or functional advantage could be deemed a non-patentable invention. It is likely that even if such an invention were found novel, it would lack inventiveness and would additionally be objected to for being trivial.

Inventions that are contrary to public moralityInventions whose commercial exploitation or use would be against public morality, or detrimental to human, animal or plant life, health or even the environment, are barred from patentability in India. Such exclusions are similar to those followed more or less universally, in particular in the European Union. Inventions that are excluded from patentability under these provisions might include processes for cloning human beings or for modifying the genetic identity of human beings. Inventions involving the commercial exploitation of human embryos would also be considered non-patentable in India.

Despite such exclusion, patents have been granted for inventions involving human embryonic stem cells. Subject matter for which patents have been granted has included: • Methods for culturing and propagating

Patenting biotech inventions in India: prosecution and claim drafting tips

Biotech protection in India

Co-published editorial

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property or use for a known substance is also considered not patentable. While these are more commonly used objections for chemical inventions, in some instances they may also be used to object to biotech inventions. For example, any modified substance (eg, polypeptides with minor modifications compared to those already existing in the art) without significantly improved property or efficacy would be considered non-patentable. However, if a significant or unexpected improvement in the property or efficacy of the modified substance can be established, such substance may be considered patentable. Again, it is important to provide data to show the enhanced activity in order to obtain protection for modified versions of known substances. AdmixturesInventions relating to compositions comprising known constituents (eg, enzyme cocktails) may be held non-patentable. In such cases the invention will be objected to if the activity achieved by the composition is equal to the sum of the activities of the individual constituents. However, if the activity is shown to be significantly enhanced, this may help to overcome such objections.

Agricultural and horticultural methodsInventions relating to agricultural or horticultural methods are not considered to be patentable in India. The subject matter that would be excluded from patentability may include methods of cultivating, breeding or propagating plants following the natural biological process. However, inventions claiming processes for improving characteristics of plants by transgenic methods and cultivating the resultant plant may not be excluded from patentability. Also, processes for making fertilisers, manures or plant growth regulators are not excluded, subject to meeting the other criteria of novelty, inventive step and industrial applicability – may qualify as patentable subject matter.

Medicinal, surgical, curative, prophylactic, diagnostic and therapeutic treatment methodsCertain categories of process are not considered to be inventions and hence are excluded from patentability. These include medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other methods for the treatment of human beings. Likewise, any process for the treatment of

human embryonic stem cells in a substantially undifferentiated state.

• Methods of culturing human embryonic stem cells for deriving a particular cell type or lineage (eg, cardiomyocytes, mesenchymal cells, osteoblasts or hepatocyte lineage cells).

The patentability of such inventions will depend on whether it can be established that the derivation of embryonic stem cells did not involve the destruction of embryos (eg, use of spare embryos donated by couples undergoing IVF). Further, the invention may be found patentable if it can be clearly shown that the invention pertains to embryonic stem cells that are incapable of developing into all types of human cell (ie, pluripotent stem cells).

Discovery of living or non-living entitiesThe mere discovery of a scientific principle or the formulation of an abstract theory is deemed non-patentable under the Patents Act. Likewise, the discovery of a living or non-living entity occurring in nature will also be deemed non-patentable. As per the Patent Office’s practice, finding a micro-organism or a new substance - such as nucleic acid sequences, proteins or enzymes - occurring freely in nature does not constitute an invention and therefore will not be considered patentable. However, processes to isolate these products are considered patentable.

Also, products which are isolated from nature after substantial human and technical intervention, which are characterised and whose uses are indicated should usually qualify as inventions. However, in certain instances examiners may construe such inventions as being non-patentable and object to them. This is more likely if the specification does not indicate or illustrate any practical way of using the isolated products - particularly gene/polypeptide sequences or expressed sequence tags of partial gene sequences. Therefore, it is necessary to disclose use of the product in the specification, if possible by way of examples, to establish evidence of industrial applicability in order to ensure that the product qualifies as a patentable invention.

Mere discovery of new form of known substanceAnother class of invention considered non-patentable would be the mere discovery of a new form of a known substance which does not enhance its known efficacy. Similarly, the mere discovery of any new

Mita SheikhPatent associate Krishna & Saurastri AssociatesIndiaTel: +91 22 2200 6320Fax: +91 22 2200 6326mita@krishnaandsaurastri.com Mita Sheikh has extensive experience of drafting patent applications and strategising the worldwide prosecution of patent applications, mainly in the life sciences, including biotechnology, biochemistry and pharmaceuticals. She also has expertise in due diligence, freedom-to-operate analyses, and IP and technology watches. With more than 15 years of experience, she has primarily worked with clients right from the inception stage, helping them to create, manage and strengthen their patent portfolios in India and abroad. Mita has also lectured at numerous events addressing industry and academia on various aspects of building and managing strong patent portfolios.

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Biotech protection in India

Besides meeting the criteria of novelty, inventive step and industrial application, the patentability of a biotech invention will depend on the extent to which its subject matter constitutes a non-patentable invention

animals to render them free of disease or to increase their economic value or that of their products would also be deemed non-patentable. As per Indian patent practice, any process that involves administering medicine, vaccination or therapy practised on the human body, or any method for treating, curing or preventing disease, will be construed as the medicinal, therapeutic, curative or prophylactic treatment of human beings, and claims with such subject matter will be objected to by the examiner. In case of animals, not only methods of treating disease, but also methods of treatment to increase their economic value or that of their products are excluded from patentability. Examples of methods found non-patentable on these grounds might include:• A method for treating cows or buffalo

to increase their milk yield. • An invasive process or operation

carried out on the body of a subject by a surgeon – this would be considered to fall within the ambit of surgical treatment.

• Methods for identifying the nature of a medical illness, usually by investigating its history and symptoms. In order to refute and overcome the

objections set out above, one could adopt a case-specific approach. In certain cases where methods are categorically considered to be non-patentable inventions (eg, those relating to therapeutic treatment

methods), it would be prudent to omit such claims. Similarly, claims specifically directed to surgical treatment methods should be withdrawn from the examiner’s consideration. However, often claims may not actually be directed at one of the aforementioned non-patentable categories, but would merely include a step that falls within the ambit of non-patentable subject matter. Claims may then be amended either by deleting this step or by rewording without the spirit and scope being affected. With regard to diagnostic methods, those carried out on the body of a subject to identify an illness are excluded from patentability. However, as a long-followed practice, methods carried out in vitro using a sample are usually not excluded from consideration for patentability. Further, there are instances where claimed methods are not directed to a classic diagnosis per se – that is, to identify disease or illness – but are rather applied for different purposes (eg, in drug screening). In any case, claims either directed to diagnosis or for other purposes may be amended and accompanied by a detailed explanation in order to overcome the examiner’s objection.

Plants, animals, seeds and essentially biological processesOther than micro-organisms, plants and animals - either in whole or any part thereof - seeds, varieties and species are excluded from patentability in India.

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Accordingly, essentially biological processes for production or propagation are also excluded. Under the Patents Act, new varieties of plants are not patentable. However, new plant varieties are protected in India under the Protection of Plant Varieties and Farmers’ Rights Act 2002. Also, transgenic animals or tissue models developed for in vitro experimental studies are not considered patentable subject matter in India. However, processes for the production or propagation of plants and animals that are not essentially biological, but are carried out with substantial human intervention may be considered patentable, provided that the other requirements of patentability are met. As per Indian patent practice, finding a micro-organism occurring freely in nature constitutes a discovery. Accordingly, micro-organisms that are not merely discovered, but are invented with significant human intervention, and whose utility is established, may be patentable, subject to other requirements.

Mathematical methods, algorithms and computer programsAnother category of invention that may be excluded under the Patents Act relates to bioinformatics. For instance, inventions relating to a mathematical or business method or a computer program per se, and algorithms, are not patentable. Bioinformatics inventions, which involve biotechnology as well as information technology, may be considered under this provision. When deciding such cases, the examiner may take into account the extent of technical implementation or invention leading to a real product, and whether this product can be considered patentable.

Inventions based on traditional knowledgeBiotech inventions that in effect are traditional knowledge are excluded. An invention that aggregates or duplicates known properties of traditionally known components would also be considered non-patentable.

It is thus desirable to draft claims which can be pursued in India. Nonetheless, if claims are drafted bearing in mind the requirements of different jurisdictions, which would usually be the practice for Patent Cooperation Treaty international applications, they may be amended as appropriate in India - preferably during prosecution - to address objections raised by Indian examiners and to bring the claimed subject matter outside the scope of

non-patentable inventions. It is also crucial to provide data to enable claims sufficiently.

ConclusionBesides meeting the criteria of novelty, inventive step and industrial application, the patentability of a biotech invention will depend on the extent to which its subject matter constitutes a non-patentable invention. However, providing information about significant improvements in the activity or property to establish industrial applicability, as well as sufficient enablement of the claims, may help to support its patentability. Most importantly, the possibility and scope of amendments to claims, along with strong arguments, can help to overcome objections raised during the prosecution and establish the patentability of biotech inventions.