By Excelon IP
A patent is a right or licenses conferred to the patentee by the government authority for a period of 20 years to exclude others from making, using, or selling an invention.
Indian patent system defines three criteria for patentable subject matter: Novelty, New Invention, and Industrial applicability. The patent system allows patent protection to be obtained for products, processes, and methods of use. However, the Indian Patent Act under section 3 and section 4 inventions are not patentable.
Section 3(j) states plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties, and species and essentially biological processes for production or propagation of plants and animals are not patentable.
Biotechnology covers a wide area of biological sciences ranging from molecular and cellular level to an expanded industrial production scale. Augmentation on the molecular level using DNA modifying techniques in prokaryotic or eukaryotic cells leads to various applications in a wide array of industrial productions. Such modifications with the genetic information lead to advantageous leaps in various fields like beverage, food, medicinal, and environment.
Patent rules for this specific faucet of biotechnological products and processes involve various intricacies, which may not exist for other areas of technological advances. However, there are some serious concerns to the Indian Patent system relating to the patentability of biotechnological inventions such as the one relating to environmental safety, moral and ethical issues, issues relating to cloning of farm animals, stem cells, gene diagnostics, ESTs (Expressed Sequence Tags) of partial gene sequences. Hence patenting the biotechnological inventions poses various challenges to the applicants.
The Indian patent system before 2002 didn’t grant patents for inventions relating to living entities of natural or artificial origin, biological materials, or any processes for the production of living substances or entities including nucleic acids. However, patents related to processes producing non-living substances by chemical processes or microbiological processes were granted.
But a decision made in the year 2002 by the Calcutta High Court in case DIMMINACO A.G.VERSUS CONTROLLER OF PATENTS AND DESIGNS & OTHERS played a significant role in the evolution of Indian biotechnology patent, wherein the end product is a living organism is a new article, then the process leading to the product can be considered as a new invention. In DIMMINACO A.G.VERSUSCONTROLLER OF PATENTS AND DESIGNS & OTHERS, Dimminaco A.G case was related to an invention relating to a process for the preparation of bursitis vaccine responsible for contagious bursitis infection in poultry. The vaccine was a live vaccine for protecting poultry against Bursitis infection. Now due to the prevailing patent legislation at that time, the IPO noted that for an invention to be patentable, it must be “new and useful”, but preparing a vaccine containing a living virus cannot be considered as a new invention as the process has to result either in an article or a substance and the present invention was only a natural process devoid of any manufacturing activity and a living organism, hence the patent office rejected Dominica’s application. On appeal, the court applied the vendibility test which stated that the product should be a commercial entity, and so the invention was new. This judgment gave a new definition to biological patents in the Indian Patent system. Further the Patents (Amendment) Act, 2002 opened the arena of a grant of patents in the field of biotechnology, where biochemical, biotechnological, and microbiological processes were included within the scope of chemical processes as patentable subject matter. The Patent Amendment Act 2005 paved a way for the grant of product patents including biotechnology patents with certain exceptions for the national policy to protect the public interest.
What can be patented?
- Polypeptides, nucleic acids, cell lines, vectors
- gene delivery systems
- micro-organisms (if modified through human intervention)
- genetically modified plants and animals
- antibodies and vaccines
- methods such as diagnostic assays, therapeutic methods, screening methods, purification protocols, sequencing protocols, and cell culture techniques.
Formal requirements for biotechnology patent applications:
Under Section 10(4) of the Patent Act after India entered the Budapest Treaty, an applicant must deposit the biological material which is mentioned in the specification if it is unavailable to the public and cannot be described adequately as per the provisions of the act. Under the Budapest Treaty, the material must be deposited with international depositary authority.
The applicant must mention the sequence listing for genes, nucleotide sequences, and polypeptide sequences, in electronic form in the complete specification, along with a gene accession number.
Conclusion:
Biotechnology is a field of fast innovation and knowing the complications and limitations of biotechnology patents it becomes essential to make sure that technologies that can save lives and improve the world are properly protected with due consideration to ethical and moral rights.