Section 3(i) of Indian Patent Act, 1970:
Patent Eligibility of “Method of treatment Claims”
According to Indian Patent Act, 1970, every invention must fulfil the following criteria in order to be patentable, namely:
- It must not fall under Section 3 and Section 4 of Indian Patent Act and
- It must pass all the three prerequisites for ‘patentability’i.e.novelty, inventive step and industrial applicability.
The Patent (amendment) Act 2005, which came into force from January 1, 2005, brought major changes in the previous patent system of India wherein product patents were allowed for all subjects of technology related to chemicals, pharmaceuticals, food and even micro-organisms. Because of this amendment, the filing of patents at Indian Patent Office (IPO) has increased for inventions relating to new drug delivery system, new chemical entity, pharmaceutical formulations etc. However, the fate of all such patent applications pertaining to “method of treatment” claims will be decided by the sections mentioned in Indian Patent Act, especially section 3(i). “Method of treatment” claims are not patentable under this section since it is not capable of industrial application which is an important criterion for an application to get granted.
Provisions in different countries:
Since, patents are territorial in nature, “method of treatment” patents are allowed only in certain jurisdictions likes USAand Australia. Hence, construction or amendment of claims plays a vital role when enteringinto a particular jurisdiction. The status for “method of treatment” claim for different jurisdictions are given below:
| Jurisdiction | Status Under Section/Class/Article |
| India | Not allowed Under Section 3(i) |
| European Union | Not allowed Under Article53(C), 52(4) |
| USA | Allowed Under Class128, 239, 897 & 899 |
| New Zealand | Not allowed Under Section 16(2) |
| Australia | Allowed Under Section 18(1)(A) |
| Japan | Not allowed UnderArticle 69(3) |
| China | Not allowed UnderArticle 25(3) |
| Egypt | Not allowed Under Article 2 |
| Korea | Not allowed UnderArticle 32 |
| Pakistan | Not allowed UnderSection 7(4)(C) |
| South Africa | Not allowed Under Section 25(11) |
| Thailand | Not allowed Under Section 9(4) |
| Canada | Not allowed Under Section 2 |
| Singapore | Not allowed Under Section 16(2) |
What is patentable and what is not?
Now, Section 3 (i) of the Patents Act, 1970 states:
“any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their product”.
So as per Section 3(i), medicinal treatment includes a process of administering medicines orally (in form of tablets, capsules etc.) or through injectables, or topically or through a dermal patchand method of treatment by surgery for therapeutic or cosmetic purpose are not considered patentable. For instance, a stitch-free incision for cataract removal cannot be patented. Curative method includes a method of cleaning plaque from teeth whereas a prophylactic treatment includes a method of vaccination are not patentable. Also, “a method of sampling body fluid”, which comes under diagnostic purpose, can not be patented. As per the Manual of Indian Patent Practice and Procedure, the definitions of diagnosis and diagnostic are “Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of general physical state of an individual (e.g. a fitness test) is considered to be diagnostic”. For therapeutic method, process related to therapy either for prevention or treatment of disease may be considered as a method of treatment and hence cannot be patented2.
Also, as per section 3(i) and the draft of Manual of Indian Patent Practice and Procedure, 2008, “in-vivo” diagnostic procedures are not patentable. Further, “use of substance for treatment or therapeutic application” claims are not patentable. However, the method of diagnosis performed on tissues or cells or fluids outside human or animal body i.e. “in-vitro” diagnostic procedures and diagnostic kits are consideredpatentable. Also, manufacture of prostheses or artificial limbs and taking measurements thereof on human body are patentable. However, the application 4981/DELNP/2008 disclosing an in-vitro method for detecting fragmentation of an adiponectin receptor, where the presence or absence of certain soluble fragments of the adiponectin receptor in bodily fluids was construed as predictive of disease and hence categorised as hence considered as diagnostic method of treatment. IPO refused the application stating that the Act u/s 3(i) does not make discrepancy between in-vitro and in-vivo methods.
“Method of treatment” claims are not allowed in European countries under Article 52(4) of European Patent Convention. However, swiss-type claims are allowed in European Patent Convention such as “Use of a substance or composition for the manufacture of a medicament for therapeutic application”. However, such “use” claims are not acceptable in India3.
Under section 3(i), IPO rejected the following casessince the claims of the inventionwere considered as “method of treatment”:
However, there are certain exceptions that have been made to section 3(i) by IPO such as:
| Application Number | Applicant, Title& Claim |
| 267/KOLNP/2007 | Applicant: ID Biomedical Corporation of Quebec and The Brigham and Women’s Hospital, Inc |
| Rejected Claim: A method of treating a neurological disease or disorder in a mammal, which method comprises administering to said mammal in need of such treatment a therapeutically effective amount of a proteasome-based composition Granted Claim: A composition in the form of a medicament for a neurological disease or disorder comprising a proteasome-based composition | |
| 5856/CHENP/2007 | Applicant:Queen Mary & Westfield College |
| Rejected Claim:The use of a calcitonin and a glucocorticoid in the preparation of amedicament for the treatment of an inflammatory disease or condition Granted Claim:A pharmaceutical composition comprising a calcitonin, a glucocorticoid and apharmaceutical acceptable carrier | |
| 202/DELNP/2012 | Applicant:Novartis |
| Rejected Claim:A method for treating a Plasmodium related disease in a subject to prevent, inhibit orameliorate the pathology and/or symptamology of the Plasmodium related disease Granted Claim:A compound as and when used in a medicament for treatment of Plasmodium related disease | |
| 861/CHE/2007 | Applicant: Stempeutic Research Pvt. Ltd. |
| Rejected Claims: A process for isolation of mesenchymal stem cells (MSCs) from a sample Granted Claim:An in-vitro process of isolation of mesenchymal stem cells (MSCs) from a heterogenous cell population |
(i) Application of substance to the body purely for cosmetic purpose is not considered as a therapy. So, any method of treatment for cosmetic purpose i.e. which improves the physical appearance of an individual and does not cures any disease, is patentable. However, the decision of the Controller to accept or reject the application depends on the case per se.
E.g. A patent application 1376/DELNP/2007was filed for a method to modify the eye colour by forming annular channel in human eye by surgical blade or laser technique by slitting the cornea of the eye. In the application, it was claimed that the procedure was not surgical as it was done only to improve the aesthetic appearance of a person and that it did not cure the person from any disease. However, upon detailed assessment, the application was refused on the ground that the claimed method needs a lot of precision to carry out such a complex procedure by anexpert surgeon. Thus, before deciding whether a process is merely cosmetic or not, it is necessary to read the specification for better understanding of the invention.
(ii) Medical devices, apparatus, instrument or products for diagnostic, surgical or curative purposes are patentable in India. Using standard product claim format, pharmaceutical or medical devices can normally be claimed. For instance, a patent application1553/DEL/1996 claiming “a device for detection of antibodies to HIV in human serum” was considered only for the structural features of the device rather than its operating principle/method of using the device for detection of antibodies which does not come under the scope of the claims.
As per section 3(i), a process or a method of treatment of human beings or animals to render them free of disease is non-patentable. However, the “disease”, mentioned in the section, is not clearly defined under the patent act. Certain disorders like obesity, depression or osteoporosis etc. should be categorized under lifestyle disorder or a disease is still a question. So, at present, there is no concrete list of diseases or conditions which can be considered under the definition of “disease”.
Certain examples where patent applications were granted after rejection under Section 3(i) of Patent Act during the examination phase:
| Application Number | Applicant, Title& Claim |
| 267/KOLNP/2007 | Applicant: ID Biomedical Corporation of Quebec and The Brigham and Women’s Hospital, Inc |
| Rejected Claim: A method of treating a neurological disease or disorder in a mammal, which method comprises administering to said mammal in need of such treatment a therapeutically effective amount of a proteasome-based composition Granted Claim: A composition in the form of a medicament for a neurological disease or disorder comprising a proteasome-based composition | |
| 5856/CHENP/2007 | Applicant:Queen Mary & Westfield College |
| Rejected Claim:The use of a calcitonin and a glucocorticoid in the preparation of amedicament for the treatment of an inflammatory disease or condition Granted Claim:A pharmaceutical composition comprising a calcitonin, a glucocorticoid and apharmaceutical acceptable carrier | |
| 202/DELNP/2012 | Applicant:Novartis |
| Rejected Claim:A method for treating a Plasmodium related disease in a subject to prevent, inhibit orameliorate the pathology and/or symptamology of the Plasmodium related disease Granted Claim:A compound as and when used in a medicament for treatment of Plasmodium related disease | |
| 861/CHE/2007 | Applicant: Stempeutic Research Pvt. Ltd. |
| Rejected Claims: A process for isolation of mesenchymal stem cells (MSCs) from a sample Granted Claim:An in-vitro process of isolation of mesenchymal stem cells (MSCs) from a heterogenous cell population |
Most referred case study of European Patent Office (EPO):
T 0383/03 case of the General Hospital Corporation describes a method of hair removal by Virulite wherein the invention relates to a method of hair removal from skin by applying short bursts of light of selected wavelength to the skin4. This case was considered by the Technical Board of Appeal of EPO since it was argued that excess hair was removed from the body and was not done to treat any underlying cause which can be because of malignancy or endocrinological disease. The treatment will only result in improvement in the physical appearance of the person. Also, claims are directed towards “cosmetic method” to specify that the claimed method is not for curing the underlying condition. Specifically for this case, the following two-steps were considered for determining whether the method is a “method of treatment” or not:
- Whether there is non-insignificant intentional physical intervention
- Whether the treatment is suitable or potentially suitable for maintaining or restoring health, the physical integrity, or the physical well-being of human beings or animals
A method is a “method of treatment” if the response to both is the question is positive. However, even if one response is negative, said method does not fall under “method of treatment”.
Conclusion:
The patent eligibility criterion under section 3(i) has been analysed in various manners over the years by IPO. A method for detecting an analyte in a biological sample removed from a body may be construed as an in-vitro method if it is supported by the specification and not as a diagnostic method of treatment. So, depending on the disclosure of the invention in the specification, the application may either get rejected or accepted.
In the inventions relating to genetic material disposed in a medical device, it is desirable that the applicant amend claims to recite only the variant form having new substitutions. BLAST search result of the claimed variant can also be submitted to validate that the claimed sequences are variant from the known natural sequences having new substitutions or modifications. Also, source of each claimed sequences should be present in the specification. This information will help the Controller during the prosecution of the application. So, such strategies can be implemented to successfully prevent our invention from getting rejected u/s 3(i) by the Controller.
Application of cosmetics to the body purely for changing/improving the aesthetic of a person does not come under therapy. Hence, such applications are accepted.
Also, the probability of medical and pharmaceutical patents getting accepted is uncertain in IPO since the act does not clearly define the scope of disease. Therefore, by considering all the examples mentioned above, the most important thing to remember is to draft the claims judiciously to avoid objection u/s 3(i) and even if the application gets rejected u/s 3(i), the claims should be amended accordingly or should present clever legal argument.
References:
- http://shodhganga.inflibnet.ac.in/bitstream/10603/21666/9/chapter-vi.pdf
- http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_34_1_guidelines-draftSearch-examination-04march2015.pdf
- http://www.asiaiplaw.com/article/41/475/
- https://www.epo.org/law-practice/case-law-appeals/recent/t030383ex1.html
- http://www.mondaq.com/india/x/586550/Patent/Finding+Escape+Routes+Can+Your+Invention+Avoid+Or+Overcome+Section+3+i+Of+Indian+Patents+Act+Method+Of+Treatment
- https://www.lakshmisri.com/News-and-Publications/Publications/Articles/IPR/scope-of-section-3i-an-analysis-on-diagnostic-methods-of-treatment
