On 19th December, 2012 Indian Patent Office issued new guidelines for the examination of patent applications which are related to biotechnology. The biotech inventions includes products and processes of gene engineering technologies, methods of producing organism, methods of isolation of microorganisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, processes for making monoclonal antibodies, cell lines for making monoclonal antibodies etc. Biotech inventions have played a pivotal role in solving many problems related to different fields including medical sciences but they have been a topic of debate too because of the topics related to transgenic plants, animals and isolation of human genes for using them as medicaments.
In India, before 2002 patents were not allowed on living entities, biological materials, processes for production of living substances including nucleic acids but patents were granted for processes of producing non living substances by chemical processes, bioconversion and microbiological processes using microorganisms or biological processes.
The Patents Act, 1970 was amended in 2002 which made way for the grant of patents in the field of biotechnology. The Patents (Amendment) Act, 2002 added biochemical, biotechnological and microbiological processes to chemical processes for the grant of patent. With this a new definition of invention was also introduced which stated invention as any new product or process involving an inventive step and capable of industrial application and deleting the word manner of manufacture which was mentioned in earlier Patents Act.
Furthermore, India joined Budapest treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure on 17th December, 2001 and thus, section 10 of the Patents Act, 1970 was amended in 2002 to provide a center for deposition of the biological material and its reference in the patent application in case the invention relates to a biological material. The Patents Act, 1970 was amended to recognize the International Depository Authorities under the Budapest Treaty.
Biological Diversity Act
The BD Act came into force in 2004 and it provided a mechanism for access to the genetic resources and benefit from the same. Section 6 of the BD Act states that getting protection on biological resource in India; is subjected to the approval of National Biodiversity Authority.
To facilitate access of the genetic resources and benefits from the same and also to prevent unauthorized use of the biological resources of India, few amendments were made to the section 10 of the Patents Act, 1970. After this amendment disclosure of the source and geographical origin of the biological material was made mandatory 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.
1. Prior Art Search: It is mandated to 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 than as per Rule 9 (1) of the Patents Rule (2003), the same is to be filed in electronic form. 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.
2. Novelty: The novelty has to be determined in the same manner as that for other inventions. During the examination to ascertain novelty it is made necessary to interpret the prior art under section 13 (read with sections 29-34) of the Patents Act, 1970.
Novelty is to be ascertained by these parameters:
a) Product by process claims: A claim targeting a product should not be anticipated by a prior disclosure of that particular product per se, regardless of its method of production. The claimed product cannot be considered novel, if the process by which they are produced is novel. To establish novelty, technical evidences are needed which can show that modifications in the processes resulted in other products which are also distinct with regard to their properties over the products known in the prior art.
b) Sequence claims: If an applicant claims a polynucleotide which was available in library without even being determined than that nucleotide will not be considered as novel. 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.
c) Combination/composition claims: The claims of combination products escape the question of novelty which is than dealt with clauses of section 3 of the Patents Act, 1970. But it should be kept in mind while examining that the there may be a chance of the combination of invention falling into public domain and thus it is needed to be checked under novelty.
3. Inventive Step: 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. The court in a decision to Roche vs Cipla defined the test of evidence is:
- Whether, in the light of prior art, it was possible for a normal, but unimaginative person skilled in the art, to discern the inventive step of the invention on the basis of general common knowledge of prior art on the priority date.
- Whether the difference between the prior art would, without knowledge of the alleged invention, constitute steps that could have been obvious to the skilled man or whether they required any degree of invention.
If the answer to these questions is yes than the invention is said to have inventive step. The court also stated that invention should not be obvious to the person skilled in art.
Another situation is claiming of mutation in a known sequence of polynucleotide which doesn’t result in an unexpected property, then the claimed subject matter lacks inventive step.
4. Industrial Application: Section 2 (1) (ac) of the Patents Act, 1970 says “capable of industrial application”, it means that an invention is capable of being made or used in an industry. In context of gene sequences, it may be said that discovering a gene sequence doesn’t make a person entitled for patent protection and protein encoded with it unless its use is disclosed. Another important to be kept in mind is that the use of the claimed invention should not be only speculative but it should be specific, substantial and credible for establishing industrial applicability of the claimed subject matter.
Fragments/Expression Sequence Tag (EST) is allowed for patenting if they satisfy the condition of usefulness and industrial application. For EST a credible, substantive and specific use have to be disclosed e.g. use as a probe to diagnose a specific disease.
5. Section 3 (b): Adequate care is to be taken while examining the inventions with respect to their commercial exploitation and it should be carefully dealt so that the subject matter is not contrary to public order, morality or causes serious prejudice to human, animal or plant life or health or to the environment.
6. Section 3 (c): Products such as microorganisms, nucleic acid sequences, proteins, enzymes, compounds etc. which are directly isolated from nature, are not patentable.
7. Section 3 (d): Any minor modification in the already existing substance in the prior art are not patentable unless there is improvement in efficacy of the modified substance is established. The inventions relating to three dimensional or crystal structure of a polypeptide attracts the provision of section 3 (d) of the Patents Act, 1970 unless it is proved that such polypeptide differs significantly in the properties with regards to the therapeutic efficacy.
8. Section 3 (e): When old integers are placed together and have some working interrelation producing a new or improved result, then that combination is patentable subject matter. This section reflects the legislative intent of patenting of combination inventions in the field of chemical as well as biotechnological inventions.
9. Section 3 (h): According to this section, a method of agriculture or horticulture is not considered as patentable subject matter.
10. Section 3 (i): There are chances of biotech invention involving a method of treatment but he exclusivity in method of treatment through patenting may interfere in the freedom of medical practitioner.
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 Patents Act, 1970.
11. Section 3 (j): As we all know that microorganisms are not patentable under Indian law. But when conjoined with Section 3 (c) of the Patents Act, 1970, genetically modified microorganisms can be patented under the Patents Act, 1970. Also claims related to essential biological processes of growing plants, germination of seeds, of development stages of plants and animals can be objected under Section 3 (j) of the Patents Act, 1970.
12. Section 3 (k): According to this section mathematical or business methods are not patentable. In biotechnology, bioinformatics is a new field and is emerging as a combination of information technology and biotechnology. Thus, bioinformatics’ inventions require special attention relating to patenting.
13. Section 3 (p): For this section guidelines have been discussed in a different article. Click here to read those guidelines.
14. Sufficiency of disclosure, Clarity and Support of the claims and unity of inventions: It has been asked to the examiner to ensure that atleast one method of performing the invention is given in the description as such that the whole claimed matter is claimed in the claims and not just a part of it. Another thing that an examiner has to ensure is that the written description enables a person with the skilled art to make that invention without carrying out undue experimentation.
Examiner has to find out that what does that invention tends to do and if its related to therapeutic effect than he has to ensure that the specifications doesn’t discloses a list of a wide range of unrelated diseases as potential future therapeutic or diagnostic features of the invention.
Another thing that an examiner has to check is embodiments. Examiner has to ensure that the complete specifications describe an invention’s embodiment claimed in each claim and it should be easy to follow.
Claims to antibodies that are having therapeutic or diagnostic the Patents Act, 1970ivities are not patentable if target protein in a specific disease has not been identified and proved by sufficient data.
Unity of Invention: It is mandated under section 10 (5) of the Patents Act, 1970 that the claim or claims of a complete specification should relate to a single invention or to a group of inventions which are linked to form a single inventive concept. For gene technology it is possible for one patent application to claim a large number of polynucleotide or polypeptide sequences which results in problems at the various phases of patent filing procedure. This is because it is never clear that the claimed sequence relates to a single invention or to a group of inventions which may have been linked to form a single inventive concept. For this examiners have been given these two ways to determine lack of unity:
a. A priori which is before consideration of prior art: If `the claims are falling in different groups and are not sharing a same or corresponding technical feature.
b. A posteriori which is after the search of the prior art: If the technical features of new invention fail to make a contribution over the prior art.