World Wide Legal Status Of Medical Method Patents: An Overview

Therapeutic, surgical and diagnostic methods (collectively, "medical methods") produce effects on human (or animal) body, and they don't have an industrial effect. Therefore, they may be deemed not patentable because of non-compliance with the industrial applicability requirement provided for in most patent laws, even in the absence of a specific exception. The norms of medical profession as expressed in Hippocratic Oath and medical codes of ethics mandate that physician share medical knowledge for benefit of their patients and not for personal gain. The medical profession finds itself in a unique position because it forms part of the scientific community where innovation is encouraged but it also specifically imposes a code of ethics on its members prohibiting them from patenting medical procedures.

More than 80 countries, including most Trans-Pacific Partnership (TPP) negotiating parties, exclude medical procedures from patentability. Medical methods are expressly excluded from patentability in Brunei Darussalam (Section 16 of the new Patents Act (2011)), Chile (Article 37 of Chilean Law No. 19.039 on Industrial Property), Malaysia (Section 13 of the Malaysia Patents Act (291 of 1983)), Mexico (Article 19 (VII) of the Industrial Property Law), Peru, (Article 20 of Andean Community Decision 486 "Common Intellectual Property Regime" , as authorized by Article 16.9.2 of the US-Peru TPA), Singapore, (Section 16(2) of the Patents Act (No. 24 of 2001, as amended by Act No. 2 of 2007), as authorized by Article 16.7.1 of the US-Singapore FTA), and Vietnam (Vietnamese Law on Intellectual Property (50/2005)). In Canada, Section 2(d) of the Canadian Patent Act does not exclude medical procedures from patentability, but case law prohibits patents on surgical and therapeutic methods, while allowing patents on diagnostic methods. In New Zealand, while medical procedures are not statutorily excluded from patentability, case law has generally rejected such patents. Only Australia—even though it maintained the flexibility to do so in the AUSFTA (Article 17.9.2)— the Patents Act of 1990 doesn't specifically exclude medical procedures from patentability, and case law suggests that they are in fact patentable.1

TRIPS AGREEMENT:

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)2 under Paragraph 3 of Article 27 allows members to exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals from the scope of patentable subject matter.

INDIAN STATUS:

Section 3 (i) of India's Patent Act, 1970 excludes from patentability "any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products".

This provision rules out the patentability of methods used for the treatment of not only human beings, but also animals and plants. Although with the advent of The Patents (Amendment) Act, 2002, any process for treatment of plants has now become patentable, still the diagnostic or therapeutic processes are not...