Patentability of methods for treatment has been objected under multiple jurisdictions. Similarly, the provision of section 3(i) of the Indian Patent Act, 1970 prohibits grant of Patent to any invention relating to “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 products.”
From break-up of above provision, one would note that present section renders following as non-patentable:
- Medicinal methods: As for example, a process of administering medicines orally or through injectable, or topically or through a dermal patch;
- Surgical methods: As for example, a stitch-free incision for cataract removal;
- Curative methods: As for example, a method of cleaning plaque from teeth;
- Prophylactic methods: As for example, a method of vaccination;
- Diagnostic methods: Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of the general physical state of an individual (e.g. a fitness test) is considered to be diagnostic;
- Therapeutic methods: The term “therapy’’ includes prevention as well as treatment or cure of disease. Therefore, the process relating to therapy may be considered as a method of treatment and as such not patentable;
- Any method of treatment of animal to render them free of disease or to increase their economic value or that of their products. As for example, a method of treating sheep for increasing wool yield or a method of artificially inducing the body mass of poultry;
Present provision has been limited only to process / method of treatment. Therefore, claims related to method / process of treatment by medicinal, surgical, curative, prophylactic, diagnostic, therapeutic are statutorily non-patentable. Further, treatment to free an “individual” (including human beings and animals) from disease or treatment of animals for increasing economic value of an animal is also non-patentable. Thus, if an invention is claiming a method which directly or indirectly makes a reference to a medical condition it generally falls under the ambit of the mentioned section and become statutorily non-patentable.
However, following exceptions have been made to section 3(i) by way of guidelines issued by IPO and precedents set by previous decisions:
- Application of substances to the body for purely cosmetic purposes is not considered as therapy.
- Patent may however be obtained for surgical, therapeutic or diagnostic instrument or apparatus. Also the manufacture of prostheses or artificial limbs and taking measurements thereof on the human body are patentable.
Cosmetics – an exception to section 3(i)
As per the first exception, any process or method of treatment for cosmetic purposes i.e. something that improves the physical appearance of an individual and not cures any disease per se is patentable.
But, are all cosmetic treatments patentable?
When any application is made for any medicinal product, the defense of the method being for “purely cosmetic purpose” is generally taken.
In one of the case, a patent application was filed for a method for modifying eye color by forming annular channel in human eye by surgical blade or laser technique; slitting the cornea of the eye. Wherein, it was claimed that the procedure was not surgical as it was only to improve the physical appearance of a person and it did not cure him of any disease. Reference was drawn decision of the Board of Appeal of European Patent Office, wherein it was stated that “The claims are directed to a “cosmetic method” in order to emphasize that the purpose of the claimed method is to improve the aesthetic appearance of the person treated rather than to cure the underlying malady“. However, upon detailed review, the application was refused on the ground “the claimed method needs lot of precision & can only be carried out by a surgeon who has expertise to carry out such complex method”.
Thus for deciding whether a process is merely a cosmetic process or not, it is important to understand what has been described in specification. For a process, which requires the skill and knowledge of a surgeon and includes cosmetic treatment, may still be refused.
Surgical, therapeutic or diagnostic instrument or apparatus
Furthermore, the second exception allows the products involved in treatment to be patented. This could be pharmaceutical or medical devices such as scalpels, staplers, surgical sutures, stents, reagents, diagnostic kits, etc. It could also include medico-physical devices for use in therapy and surgery, as well as to pharmaceuticals and diagnostic kits. When such devices are novel (and independently meet other requirements of patentability), their patentability is generally not affected by the prohibition on patenting method of treatment. The pharmaceutical or medical devices may normally be claimed as such, using a standard product claim format.
For example, in an application for patent claiming a device for detection of antibodies to HIV in human serum” it was held that the application related to a device as only the physical constructional feature had been claimed, the method of using the devise was not under the scope of the claim.
But do instruments and apparatus’ enjoy blanket cover?
Re-wording of claims to claim a kit should go hand in hand with what specification describes. For example, in one of the case, the claims were objected under section 3(i). Subsequently, they were reworded to ‘a kit comprising an orthodontic fastening part, a protector, and an applicator’. It was held that the description referred only to the method for the correct application of the device and therefore, the application was refused and the exception of it being an instrument or apparatus was not accepted.
Treatment of Diseases – but what is a disease?
Another aspect of Section 3(i) is that it makes any treatment that frees an individual of a disease non-patentable. However, what would constitute as a disease is still not defined under a patent act. In a patent application, the invention claimed treatment of prophylaxis of obesity, which was projected as a lifestyle disorder and not a disease. After detailed review of specification, it was held that this method is nothing but diagnosis and therefore, non-patentable.
A strong defense was taken up in another application for patent wherein the application claimed a repressing, delaying or otherwise reducing the expression of a target gene in a vertebrate cell by introducing one or more dispersed nucleic acid molecules which fell within the ambit of Section 3(i) of the Act. However, it was claimed that the entire procedure is conducted Ex-Vivo i.e., outside the body of human being or animal. What the applicants do with the processed cell is not part of the claimed invention. Therefore, the application was accepted.
At present an exhaustive list or guidelines to what can be construed as a disease has not been defined. Answer to questions whether hair-loss, skin pigmentation, etc. should be considered as a mere lifestyle disorder or a disease is ambiguous and may vary from case to case and prevalent circumstances in the society. Skills required for performing such method, requirement of medical supervision and / or medical necessity to perform such method and steps described in specification may act as guiding attributes to decide if method performed is to cure a disease or a lifestyle disorder.
Contributors to present article are Ankush, Abhilasha and Sunidhi.
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