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KOLKATA, Feb. 3

THE Calcutta High Court, in a landmark judgment, has clarified the law on patentability of biotechnology inventions, particularly a process of manufacture involving a living end-product.

In a case pertaining to a Swiss company's application to patent a process of manufacturing a vaccine for infectious bursitis in poultry, Mr Justice Asok Kumar Ganguly quashed the impugned order of the Controller of Patents and Designs rejecting the patent application of the petitioner company. He directed that the application be reconsidered for grant of patent not later than two months from the date of production or service of the said judgment. A prayer for stay of operation of the judgment and order was considered and rejected.

In India, till date, no patent has been granted for any process of preparing a living organism.

The judge held that the word "manufacture" had not been defined in the Patent Act, and the dictionary meaning of the word or the meaning attributed to it in the particular trade or business must be accepted if the end product was a commercial entity.

The Assistant Controller of Patents and Designs had refused to accept the patent application (filed in 1998) by Dimminaco AG, a Swiss subsidiary of American Home Products Inc, on the ground that it did not constitute an invention, and that since the end product of the subject-process contained a living organism, the process could not be called a manner of manufacture.

The statutory appeal against rejection of the application was preferred by D.P.Ahuja & Co, a firm of Patent and Trademark attorneys.

Talking to newspersons, Mr Sudhir D. Ahuja, after reading the full text of the judgment, said the verdict had not only clarified the position of Indian law on the patentability of biotechnology inventions, but also broken the restrictive and "statutorily unsupported stand of the Patent Office with regard to such biotech inventions".

He said the Patent Office, by turning down the application for a biotechnology process, had violated the provisions of the Indian Patents Act, "which does not deny patentability to biotech inventions".

Mr Samarash Chakraborty, Senior Patent Attorney who appeared for the petitioner, said it may now be expected that this path-breaking decision would "caution the Patent Office from further use of obscure administrative policies to override statutory provisions".

Patent offices all over the world encouraged inventive activity with regard to new and useful biotechnology subject matter, he pointed.

Analysing the case, Mr Ahuja said while the client had virtually given up the matter, the company decided to pursue the appeal with its own resources as the matter involved public interest.

In the instant case, the judgment concluded that the novel process claimed in the application was a new process for preparing a vaccine involving chemical steps under specific scientific conditions. "The said vaccine is useful for protecting poultry against contagious bursitis infection, and where the end-product is a new article, the process leading to its manufacture is an invention."

Conceding that the Patent Office may appeal to the Supreme Court, Mr Ahuja said at least the long-pending doubts over the patentability of such inventions in the area of frontier-sciences had now been laid to rest.

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