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A Case Law on Patenting of Microbiological Invention

A landmark decision has been awarded by the Calcutta High Court on 15th January, 2002 in respect of patenting of inventions involving micro-organisms in a case filed by Dimminaco A.G. against the decision of the Controller General of Patents, Designs and Trademark.

The Appellant had filed a patent application for an inventive process of preparing infectious Bursitis vaccine. The application was turned down by the Patent Office on the ground that the process did not constitute an invention under the Act. No reason(s) was assigned for this decision. The Court took a serious note of the fact that quasi-judiciary duties of the office had not been adequately discharged.

During the arguments before the Court, the Patent Office maintained that an inventive process must lead to an article or a substance. An article according to the Patent Office implied material thing, item, a thing of a particular class or kind as distinguished from a thing of any class or kind. It was further argued that only an inanimate object can be denoted as a thing or item and not a living one. It was therefore concluded that a vaccine with the living organism could not be considered substance. Hence, the process of preparing a vaccine having a living entity cannot be considered ‘manufacture’. The appellant argued that the terms ‘manufacture’ and ‘substance’ had not been defined in the Act and therefore one would have to rely on the meaning provided in a dictionary. The appellant also brought to the notice of the Court that the Patent Office on earlier occasions had accepted applications in respect of new processes which included cells, virus and other microorganisms.

The Patent Office submitted that all the patents mentioned above involved lyophilizing which means freeze drying which was interpreted by the Patent Office as death of the microorganism. However, it was found that the lyophilizing put the microorganisms in dormant state which did not necessarily mean death of microorganisms.

The Court held the following:-

Controller erred himself in law by holding that merely because  end product contains live virus, process involved is not an invention. And as there is no statutory meaning of ‘manufacture’, dictionary meaning should be accepted which does not exclude a vendible product containing living organism from it.
The claims of the patent should have been considered by Controller on principle of Section 3 of Patent Act. No objection was raised by the Examiner under Section 3.
The order passed by the Controller that the process does not lead to manufacture of substance also cannot be accepted  as it leads to vendible product. It is certainly a substance after going through the process of manufacture.
From the records placed it is already clear that patent has been granted by authorities where end product contains living virus. But the respondent’s stand that lyophilizing means killing of living cells cannot be accepted. As even the dictionary meaning explains it as freeze drying. It is a preservation technique in which nothing is killed or destroyed. (Ref. Willey’s Encyclopedia of Food Science & Technology, Vol. II pg., 1106 &1107 and Vol. III pg., 1633).
Learned counsel for respondent had argued in desperation that if on investigation it is found that end product of patents so granted contain living virus, Controller will take steps for revocation of grant of aforesaid patents. However the said stand is contrary to law as revocation of grant of patent is governed under Section 64. According to it, procedure for revocation can be initiated on: a) petition by an interested party, b) petition by central Government, c) on a counterclaim in a suit for infringement of patent.
Therefore, this submission is not acceptable to Court. In light of this the Order of Controller is quashed and appeal allowed.
Court also said that the application of the petitioner may be reconsidered for grant of patent as early as possible, but no later than 2 months from production or service of this judgment on them.

The judgement opens up new opportunities for obtaining patents in India on microorganism related inventions which were hitherto not granted. Further, the importance of definitions in the Act has been clearly brought out. The law cannot be left to the interpretation of individuals. There has to be a consistent interpretation which should follow some logic.

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