Protection of biotech inventions

Source: The Hindu

8 Sep 2014

This is the fourth in a series of occasional articles by N. R. Subbaram in the form of questions and answers on Intellectual Property Rights and Patents.

QUESTION: What is the position of patent protection relating to and /or involving living things?

ANSWER: For an invention to be patentable, the patent law requires the invention to be new, to have an inventive step (non-obvious) and to be industrially applicable (utility). In addition, the invention must be repeatable. In other words, it must enable others to repeat the invention described.

As for the condition of novelty, an invention is not new if it has been disclosed to the public either in writing or orally, by use or otherwise, before the filing date or priority date of the patent.

In addition, the patent law distinguishes between discoveries and inventions and stipulates that discoveries are not patentable.

In many countries, especially developing countries including India, the patent law also makes a distinction between living and non-living things and stipulates that patents relating to and / or involving living things cannot be secured.

Q: What are the difficulties in protecting inventions in the area of biotechnology?

A: A question, therefore, arises as to whether patent protection can be obtained for inventions in the area of biotechnology, which usually relates to and / or involves living things. Furthermore, what is the position of substances like microorganisms or other biological materials present in nature? Do they fall under the category of discovery or invention? If they are considered inventions do these materials fully satisfy the important patentability criteria of novelty, as they are already available in nature?

As in the case of other technological fields, the requirement of satisfying the criterion of inventive step (non-obvious) constitutes one of the most complex questions in the field of biotechnology. The consideration of industrial application is yet another obstacle for securing patents for inventions in biotechnology.

Another problem in protection of inventions in biotechnology is the difficulty of satisfying the mandatory requirement of the condition of `sufficient disclosure’. This is due to the fact that inventions in this field relate and / or involve, as explained above, living entities (biological materials). Such materials are difficult to describe in words.

Therefore, it is important to know clearly how inventions in biotechnology are accommodated within the general framework of the patent system.

Q: What are the solutions for the protection of inventions in biotechnology?

A: As regards protection of living things such as unicellular organisms like microorganisms, in most countries, protection is available for such microorganisms if they satisfy the cardinal requirements of the patent law. For example, if the a microorganism is isolated from nature by the application of human intellect and if such a microorganism is not known prior to the date of filing of the application for patent, such a work is considered an invention and not a discovery. Since such a microorganism is not known prior to the filing of the application for patent it is treated as novel.

To satisfy the patent law requirement `sufficiency of description’ in biotechnology, a practice has been developed now, to deposit the sample of the living entity microorganism / biological material involved in the invention with an authorised depository authority. This authority is known as the International Depository Authority (IDA). On deposition of the microorganism / biological material involved in the invention, in the prescribed manner, such an Authority provides an accession number which, when quoted in the patent document (specification), is considered the equivalent description of the microorganism / biological material thereby satisfying the requirement of `sufficiency of disclosure’. It is also beneficial to provide the written description of the microorganism / biological material wherever possible in addition to mentioning the accession number. The deposit supplements the description of the biological materials so that a person in the art is able to identify the type of material involved in the invention.

The reference made to the accession number, provided by the depository institution for the biological material, in the specification is considered part of the description of the invention. It should be noted that the sample of the biological material involved must be deposited with the depository authority at the latest on the date of filing the application for patent or, if priority is claimed, on the date of the priority.

There is an international treaty called Budapest Treaty on the international recognition of the deposit of microorganisms for the purpose of patent procedure. The membership to this treaty is open only to members of the Paris Convention. India is a member of both. In India, IMTECH, Chandigarh, a constituent laboratory of CSIR, has been notified by the Government as the depository authority for depositing microorganisms and / or biological materials for purposes of the Patents Act 70.

Q: What is the scope of protection in India for inventions relating to biotechnology?

A: The following inventions involving and / or relating to microorganisms are patentable in India:

(i) Process for producing a new microorganism

(ii) End products of biosynthesis, for example, a new microorganism

(iii) Synergistic composition containing the microorganism (new or known)

(iv) Use of microorganisms, as for producing antibiotics.

Similarly, in other areas of biotechnology such as plasmids and DNA and processes for the preparation of such substances as well as their applications in developing diagnostics kits / drug delivery systems, patents can be secured.

However, it should be noted that since product protection has not yet come into force in India no protection is possible for the new products, including new microorganisms. But applications containing claims for such new products can be filled as the date of bringing the product patent regime into force is not far away.

In India, plants and animals, in whole or in part thereof, including seeds varieties and species and essentially biological processes for the production or propagation of plants and animals are not patentable.

Q: What are the TRIPS provisions of WTO relating to protection of inventions relating to biotechnology?

A: According to the TRIPS provisions of the WTO Agreement, it is essential for member countries to provide, in the area of biotechnology, at least protection for microorganisms per se if they satisfy the novelty, inventive step and utility requirements of the patent law and for the protection of plant varieties. In the case of microorganisms member countries have no options meaning that the protection should be by way of grant of patents. But in the case of plant varieties, there are options, namely, either by patents or by a sui generis system. India has opted for the latter.

Summing up, it may said that there are many gray areas in respect of securing protection for inventions in biotechnology. In spite of this position, there is ample scope for the protection of inventions falling within the area of biotechnology.

(The author is former head of the Intellectual Property Management Division of CSIR)

This entry was posted in Biologics/Biosimilars, Patents. Bookmark the permalink.

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