Biotechnology inventions, like inventions in any other field of technology are capable of receiving patent protection provided they fulfil the three basic criteria for obtaining a patent i.e. Novelty, Inventive Step and Industrial applicability. Gene and DNA sequences being neither new, as they have always existed in the bodies of organisms nor inventive since they are discoverable due to their prior existence, posed peculiar legal problems for Patent Offices due to their characteristics of being products of nature. However, to advance the cause of Research & Development in the area of Biotechnology, many patent granting jurisdictions have come up with specific guidelines and laws for grant of patents to inventions involving gene sequences. One such example is the ‘DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998’. The directive, provides that biological material which is isolated from its natural environment … may be the subject of an invention even if it previously occurred in nature. As of January 15, 2007, all of the 27 EU member states have implemented the Directive.
The Indian Patent office guidelines with regard to Biotech related patents can be best described as inconsistent and grossly inadequate. The word gene or DNA does not appear anywhere in the Indian Patent Act nor there is any special directive issued by GOI for according legal protection to Biotechnology related inventions. The only reference for the same can be found in the Examination Manual Chapter 8 which deals with Examination and Grant of Patent applications. The Manual is currently in its third edition and has undergone substantial changes since the time it was introduced. The manual is not a binding document as it is not issued under any provisions of the Patent Act, but serves as an informal written guidance for the Examiners at the Patent office. The current as well as the 2008 edition of the Manual regards claims to ‘genetically modified Gene Sequence/ Amino Acid Sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence’ as having a single inventive concept and capable of being granted a patent. The above text can be found under the explanation for section 10(5) Unity of Invention. The Patent office indeed does consider claims to genetically modified sequences for grant of Patent, something which I can confirm from the experience of handling prosecution of numerous patent applications claiming DNA and protein sequences. The term ‘Genetically Modified Sequence’ however restricts smooth prosecution of only those inventions which relate to modifying known genes sequences or synthesis of a completely new gene sequence in the lab. To meet the novelty and inventive criteria, the modified gene sequence should not have existed in nature or should differ in at least one aspect from its identical copy in the nature. The difference can be a change of a single base pair which could provide new function, property or configuration to the protein molecule encoded by the gene sequence.
The manual issued in 2005 however spoke a different story altogether. For analysis, excerpts from the Manual of 2005 relating to Unity of Invention and inventive step requirements for gene patents is produced below;
- Explanation to section 10(5): “•New gene sequence A •A method of expressing sequence A •An antibody made to the protein of sequence A •A kit made from the antibody to sequence A; All of these claims are linked by the inventive concept that sequence A is new and inventive.”
- Inventive step requirement for Biotechnology related invention: “Gene sequences, DNA sequences without having disclosed their functions are not patentable for lack of inventive step and industrial application.”
According to the 2005 guidelines a new gene sequence modified or unmodified was considered as novel invention, and providing the function of the gene sequence was sufficient to meet the inventive step and industrial applicability requirement for such inventions. The word genetically modified is not present in the explanation to section 10(5) and grant of patents was not restricted to only those inventions which claimed genetically modified sequences.
Though the text of the Patent office Manual is not binding and only serves as a guiding principle for Examiner, it nevertheless leads to major delays in the prosecuting Biotechnology related applications e.g. inventions claiming cDNA sequences. A cDNA sequence is formed from a mRNA sequence using a reverse transcriptase enzyme, a DNA polymerase enzyme and a PCR machine. A cDNA sequence is an identical copy of chromosomal gene sequence minus the introns. Thus they cannot be regarded as truly existing in nature but nevertheless cover the complete functional gene sequence when claimed in a patent.
With India being promoted as a hub for clinical research, contract manufacturing and basic R&D in Biotechnology led drug development, there is an immediate need for legislation and concrete guidelines for biotechnology related inventions else delays and road blocks will be a major issues working against the Government efforts of promoting Research & Development in this industry.