Authored By – Dr Niti Dewan & Ms Megha Kathuria
Biotechnology may be defined as the combined use of science and technology to exploit biological processes. Biotechnology contributes to advancement in the life sciences and offers tremendous scope for improving human health and furthering a nation’s economic development.
Many biotechnology inventions involve sequencing genes, systems to selectively express, regulate or silence genes, gene mutations, expression of protein structures by mutated genes and analysis of genetic make-up on metabolism of an organism. In general, patent specifications for biotechnology inventions require description by reference to the sequence of a gene or protein. A gene comprises a polynucleotide chain/s composed of the nucleotides adenine (A), thymine (T)/uracil (U), guanine (G) and cytosine (C) that code for amino acids. A protein is composed of amino acids and there are twenty naturally occurring amino acids. Each amino acid is given a unique one letter code. A sequence listing identifies the gene or protein by a “SEQ ID NO.” (Example, SEQ ID NO: 1), and provides the entire sequence.
Electronic Filing of Sequence Listing
Generally, inventions related to isolation and purification of DNA, mRNA, cDNA and oligonucleotides, and inventions related to genetically modified organisms such as fungi, bacteria, plants and animals require the disclosure of nucleotides and/or amino acid sequences in the patent specification.
In the United States, prior to January 2001, applicants were required to submit the sequence listing of nucleotides and/or amino acids in electronic form as well as on paper for examination and description purposes respectively. Thereafter, the USPTO in compliance with the PCT, started to accept the sequence listing of nucleotides and amino acids in patent applications in electronic form only and has done away with the obligation as to filing of sequence listing in paper (hardcopy) format.
The 2005 amendment of The Indian Patents Act, 1970 aimed at bringing the Indian patent law in tune with the TRIPS agreement, particularly Article 27 of the agreement. As per Rule 9, Proviso 1 of the Patent Rules 2003 (India), if a patent application discloses the sequence listing of nucleotides and/or amino acids, the same shall also be filed in electronic form. To facilitate the processing of patent applications, the sequence listings should be filed in computer readable format. The examiner may carry out a sequence search on commercial databases available to the office and freely available databases using diverse search tools such as BLAST, FASTA, etc. The above mentioned rule has recently been supported by the ‘Guidelines for Examination of Biotechnology Applications for Patent’ issued by the Controller General of Patents, Designs and Trademarks (CGPDT) in March 2013.
Both Standard 25 of WIPO (Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in Patent Applications) and Part 8 of PCT Administrative Instruction (Al) affirm the requirement of filing sequence listing of nucleotides and/or amino acids in electronic format.
The acceptance of sequence listing in electronics format offers the following advantages:
Disclosure of sequencing in electronic form makes it easier for the examiner to process the patent application.
It is easier for the applicant to comply with the obligation by submitting the nucleotide sequence listing in a computer readable format.
The above declaration on the part of the CGPDT brings the patent registration process of nucleotides in India at par with most of the European nations as well as USA which accept the sequence listing of nucleotides and/or amino acids in electronic format.
The submission of nucleotide and amino acid sequences in electronic form increases the correctness and presentation of nucleotide and/ or amino acid sequences which is helpful for the public at large to understand.
Maintenance of the nucleotide sequence in an electronic database is easier and facilitates easy searching and exchange of sequence data by the Patent Offices.
Public at large including Research institutions may have an easy and uninterrupted access to the sequences for various purposes such as research, information etc.