The biotechnological inventions majorly include products and/or processes of gene engineering technologies, methods of isolation of micro-organisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, processes for making monoclonal antibodies, etc.,1 Often, the focus is laid on controversial issues surrounding biotechnology patenting such as criteria for patenting plants and animals, the patenting of gene sequences and related morality issues. Contrary to the aforesaid issues, majority of biotechnology patent applications are decided on serious issues of patent system such as novelty, inventive step and industrial application as well as the sufficiency of disclosure and support of the description to the claims.
Biotech inventions are considered in the same light as the other inventions. The Patents Act, 1970, seeks to help the applicants as well as the examiners of patents as it covers not only at how the basic issues of protecting biotechnological inventions have been applied in the past but also at how they should be applied, subject to guidance from courts and the Intellectual Property Appellate Board (IPAB) in the context of recent developments in the technology. This article endeavors to throw light of such aspects and explicitly discusses the provisions with regard to patenting of biotechnological inventions.
Prior Art Search
The draft guidelines issued by the Indian Patent Office on 25th March 2013 mandates the examiner to design a comprehensive search strategy by combining various search parameters including key words, IPC, sequences etc., and thorough search should be carried out in patent as well as non-patent literature. If a patent application consists a sequence listing of nucleotides or amino acids then Rule 9 (1) of the Patents Rule (2003), specifies that the same is to be filed by the applicant in electronic form2. A thorough search of the sequence has to be carried out by the examiner on the commercial databases available to the office using BLAST, FASTA, etc.
It is mandated that novelty has to be assessed in the same manner as that for other inventions. Novelty has to be interpreted vis-à-vis prior art as provided under Section 13 of the Act. To ascertain novelty as per Sec 2(1)(j) of the Act, the following different kinds of claims can be evaluated namely,
- Product-by-process claims: A claim describing a product should not be anticipated by a prior disclosure of that particular product per se regardless of the method of production of the product. The claimed product cannot be considered as novel, if the process by which it is produced is novel. In order to establish novelty, technical evidences are required to show that the modifications in the processes result in other products which are distinct with regard to their properties over the products known in the prior art.
- Sequence claims: If any applicant claims that a polynucleotide sequence which was already available in a library is not novel, even if the function of that particular sequence was not previously characterized. If any sequence of a polynucleotide from a prior art doesn’t match exactly to the claimed sequence of polynucleotide, then the subject matter is considered novel. The same applies to a polypeptide sequence.
- Combination/Composition claims: The claims of combination of products of biotechnology are often missed out while assessing novelty instead is dealt under the inventive step or other relevant clauses of Section 3 of the Act. However, since combination/ composition claims have already fallen into the public domain, they have to be dealt under novelty.
According to the Patents Act, 1970, an invention will have inventive step if it is technically advanced or economically advanced when compared to the existing knowledge and it should be non-obvious to a person with ordinary skilled in that art. Example, structurally and functionally similar polynucleotide/polypeptide sequences are considered to be obvious. Similarly claim for a sequence with minor variations/mutations in the amino acid sequences which do not alter the activity and function of a protein sequence which is already in public domain cannot be patented due to the lack of inventive step. Therefore, the applicant should provide evidences to highlight the difference between the encoded protein disclosed in the prior art and that encoded by the claimed DNA for which a patent is being sought.
As per Section 2(1) (ac) of the Act, “Capable of industrial application” in relation to an invention, means that the invention is capable of being made or used in an industry. Mere discovering a gene sequence and the protein encoded by it doesn’t ensure patent protection unless a distinct and credible use of the gene sequence is specified. To establish industrial applicability of a gene sequence, the use of the sequence and the significance of the product encoded by it has to be stated. Section 64(1) (g) of the Act provides that if the invention do not meet the criteria of industrial applicability, it is deemed to be revoked.
Fragments /Expressed Sequence Tags (ESTs)
Fragments/ESTs are allowable only if they satisfy the question of usefulness and industrial application. A credible and substantial use of the EST should be disclosed. For Example, use of ESTs as a probe or chromosome marker to diagnose a specific disease condition.
It is mandated that adequate care has to be taken while examining inventions whose commercial exploitation is speculated to be contrary to public order, morality or causes serious prejudice to human, animal or plant life or to the environment as per the provisions mentioned in Section 3(b) of the Act. (e.g., cloning of mammals, modifications in the germ line and genetic identity of living organisms, terminator gene technology and use of human embryos)
As per Section 3(c) of the Act, the products such as microorganisms, nucleic acid sequences, proteins, enzymes, compounds, etc., which are directly isolated from nature are not patentable subject matter. However, the exception to this provision is the processes of isolation of these products can be considered subject to requirements of Section 2(1) (j) of the Act.
Section 3(d) of the Act provides that any minor modifications in the already existing substance in the prior art are not patentable unless the improved property or efficacy of the modified substance is established. With respect to biotechnology patent applications, section 3(d) is applicable to those inventions relating to a three-dimensional or crystal structure of a polypeptide unless it is proved that such polypeptide differs significantly in properties with regards to therapeutic efficacy.
Further, Section 3(e) establishes that a composition comprising a combination of substances naturally occurring in nature is not patentable subject matter unless the synergistic effect of the components is established. In the light of chemical and biotechnological sciences, Section 3(e) of the Act reflects the legislative intent on the law of patenting of combination inventions.
According to Section 3(h) of the Act, a method of agriculture (a method of spraying insecticide for controlling pests) or horticulture is not considered as patentable subject matter. Conventional methods performed on actual open fields should be construed as method of agriculture/horticulture.
Section 3(i) of the Act emphasizes that any method of treatment including diagnostic procedures or method of drug administration either to humans or animals are not patentable. Some inventors draft composition of drugs in certain dosage forms and claims that subject matter relates to application or administration of individual drugs. In such cases, although the claims are directed to a combination of drugs, but the claimed invention resides in the method of administration of individual drugs in the said manner and thus, it falls within the scope of Section 3 (i) of the Act. Patenting on gene based diagnostics is completely ruled out.
As per Section 3(c) of the Act, it is mandated that microorganisms are not patentable. It is implied also that only modified microorganisms are patentable subject matter under the Act. Claims relating to basic biological processes of growing plants, germination of seeds, of development stages of plants and animals are not patentable. In relation to biotechnological inventions, bio-informatics is relatively a new science that has evolved from the combination of information technology and biotechnology. Determination of patentability of inventions pertaining to bio-informatics is examined vis-à-vis the provisions mentioned under section 3(k) of the Act.
Section 10(4) of the Act requires that every complete specification shall fully and particularly describe the invention and its operation or its use and by the method by which it is to be performed. In case of biotechnological inventions, it is possible that the gene may play a vital role in the treatment of one or more of the listed diseases. But it is very unlikely that the gene or the protein it produces will have a role in all of the diseases. Such claims are made when the function of the protein is not fully characterized. Therefore the potential uses of the protein claimed are speculative. It is hence evident that if there is no evidence in the complete specification as filed that the gene/ polypeptide is of therapeutic or diagnostic use in the laundry list of different diseases listed, then the specification is insufficient.
Claims to antibodies that may have therapeutic or diagnostic potential are not valid if a role for the target protein in a specific disease has not been identified and proved by sufficient data.
Section 10(5) of the Act, provides that the claim(s) shall be clear and succinct and shall be fairly based on the matter disclosed in the specification. Also, the claim(s) of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept. In case of genetic engineering patent applications, it is very frequently observed that an application claim a large number of polynucleotide/polypeptide sequences. Lack of unity create problem during publication, examination and searching stage. Further, it is unclear whether the claimed sequence relates to a single invention or to a group of inventions linked so as to form a single inventive concept.
Deposit of biological material
The draft guidelines mandate that the biological material which cannot be described in a sufficient manner and which is not available to the public has to be deposited to an International Depository Authority (IDA) under the Budapest Treaty. The deposit is to be made before filing of the patent and a reference of the deposit is to be submitted within three months from the date of filing of the patent application in India. It is necessary for the inventory to correctly identify and indicate the characteristics which are to be included in the specifications and it should also include name, address of the depository institute and the date and number of the deposit. In India, Microbial Type Culture Collection (MTCC), Chandigarh is the International Deposit Authority (IDA).
The Biodiversity Act , 2002
The BD Act came into force on 1st July 2004.The BD Act provides a mechanism to prevent the misappropriation of biological resources and traditional knowledge by introducing provisions for mandatory prior permission from the National Biodiversity Authority by the applicant for any patent application based on research or any information related to biological resources obtained from India.
According to this Act, the applicant has to provide a mandatory disclosure of the source and geographical origin of the biological material in the patent application. An applicant has also to provide a declaration in Form 1 of the Patent Rules, 2003 about the permission from the competent authority.
In addition to the basic patenting issues, special issues such as moral and ethical concerns, cloning of farm animals, stem cells, gene therapy, patenting of DNA and ESTs of gene sequences, etc., have also evolved. Therefore, setting norms and protocols for assessing biotechnological inventions poses challenges to the applicants for patents as well as to the Patent Office. In view of the aforesaid, the biotechnology and allied sciences patent provisions in India serves as a potential guide in order to establish uniform and consistent practice with regard to the patent applications made in the said technologies.