It’s sometimes better to think about the things that cannot be patented to get a sense of the contours of patentability. Article 27.1 of the TRIPS Agreement states that patents must be available for the subject matter patentable “for any inventions, whether processes or products, in all technical fields”. Since products or processes used in the course of medical care do not ipso facto represent “methods of treatment,” the Agreement makes it clear that they are patentable in their own right.”
However, not everything made by man is patentable, according to each country’s patent laws; in most nations, certain subject matters are not patentable. Some countries, especially in the field of life sciences or medical treatment provide for exceptions in their domestic laws based on the provisions of TRIPS articles 27.2 and 27.3.
Patent law in India is governed by the Indian Patents Act of 1970.It was eventually amended between 1999 and 2005 to meet India’s international obligations towards TRIPS Agreement. TRIPS aims to eliminate potential obstacles to ‘free trade’ by setting global minimum IPR requirements. It mandates that member countries grant product patents to all technologies and microorganisms. It also allows non-compliance with WTO laws subject to punishment and harsh penalties, such as fines or sanctions.
Despite the protections and other flexibilities offered in the form of preferential treatment for emerging and least developed countries, most developing participants consider the TRIPS patentability spectrum to be much too wide. They claim that excessively strong IPR with expanded reach and period of protection is proving to be counterproductive to the TRIPS Agreement’s very object and intent, as stated in Article 7’s objectives. India like other developing countries has always maintained that ‘Patent rights should be exercised in a way that is consistent with the goals of reciprocal benefit for patent holders and users of patented medicines, as well as the balancing of rights and responsibilities.
Developing countries like India, choose a broad interpretation of eligibility exclusions to represent their national priorities. Patentability, in the case of developing countries such as India, refers to the idea of access to technology products as well as innovation and advances. The term “access” is most often associated with pharmaceuticals and public health.
The concept of exempting surgical, medical, and therapeutic methods from patentability is based on human rights values. A person’s constitutional right to life must be given priority. From the beginning, a person’s right to fair and proper treatment becomes a universal human right to every human being.
Are there any restrictions in the UK?
Patenting medical treatment methods is not allowed in the United Kingdom, allowing physicians to give the best possible service to patients without risk of infringing on patent rights. However, when a potential use for an existing drug is discovered, a patent can be secured using the so-called claim of “second medical use”. Even if the drug and the disease it is intended to treat were already established, a patent can be sought if a new and effective dosage arrangement is discovered.
Diagnostic methods can be protected as long as they do not have a step that is performed on the body.Like a procedure that includes in vitro testing of a blood sample for the presence of a biomarker, for example, is patentable as long as the step of taking the blood sample is omitted from the scope of protection.Further, those biotechnological inventions, such as those that use human embryos and those that depend on natural crossing and selection to produce plants and animals, are not protected by patents.
Position in India
Since the mode of the treatment interferes with human/animal life, the legislator has taken particular care to ensure that these inventions do not have exclusive commercial use. The method of treatment is not patentable except in the United States, Australia, and New Zealand. The exclusion of method of treatment from patent rights is found in Section 3(i) of the Indian Patent Act, 1970.The Indian Patent Act, 1970, states in section 3(i) that:
“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.”
However, the Indian Patent Act of 1970 does not prohibit the patenting of products used in treatment, whether they be medical instruments or pharmaceuticals.
Section 3(i) of the Patent Act, 1970 excludes any product intended for use in the medicinal, surgical, curative, prophylactic, diagnostic, or medicinal care of human or animal bodies. Therefore a medico-physical instrument used in treatment and surgery, as well as pharmaceuticals and medical kits, can be covered by patent law. When such devices are novel & the restriction on patenting methods of treatment has no impact on their patentability. Using a common product claim format, the device and pharmaceuticals can usually be claimed as such.
Indeed because of several political, technological, and social considerations, it is impractical to formulate a standard exclusion scheme in the patent system for medical, diagnostic, and therapeutic methods. However, a positive interpretation of an exclusion clause and integration of it into national public policy doctrines would at the very least put an end to major inconsistencies in this area.
Author: Siddhesh Birajdar a 3rd year student of University of Mumbai, intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at aishani@khuranaandkhurana.com.
