Patents On Medical Use Of Radioisotopes
17 October 2012
Radioisotopes or radionuclides are atoms of elements which behave chemically in the same way as their neighbours, but have different atomic masses and have the additional property of emitting energy in one or more forms such as alpha, beta or gamma radiation. Radioisotopes with suitable half-lives and radiation characteristics play an important part in the field nuclear medicine.
Considerable medical research is being conducted worldwide into the use of radioisotopes for medical diagnosis. However, radionuclides can also present both real and perceived dangers to health, particularly if they are excessively used during treatment or in other ways applied to living beings. This is called radiation poisoning. Consequently, when it comes to intellectual property protection of inventions based on such radioisotopes, the problem of the unpatentability of such subject matter arises on the grounds of protection of national security.
Exclusions on the grounds of protection of national security are outlined under Article 76 of the World Trade Organization’s Trade Related Intellectual Property Rights (TRIPS) Agreement. A number of countries have used this exception for defence-related inventions. Inventions related to substances by means of nuclear transformations, i.e. radionuclides, can also be excluded and such exclusion provisions have been incorporated in patent laws by a number of countries.
In India, Section 4 of the Patent Act, 1970, provides that no patent shall be granted in respect of an invention relating to atomic energy falling within subsection (1) of Section 20 of the Atomic Energy Act, 1962. Section 20(1) of the Atomic Energy Act provides that no patent shall be granted for inventions which in the opinion of the Central Government are useful for or relate to the production, control, use or disposal of atomic energy or the prospecting, mining, extraction, production, physical and chemical treatment, fabrication, enrichment, canning or use of any prescribed substance or radioactive substance or the ensuring of safety in atomic energy operations.
According to the Atomic Energy Act, “atomic energy” means energy released from atomic nuclei as a result of any process including the fission and fusion processes. Under this Act, “prescribed substances” means any substance including any mineral which the Central Government may, by notification, prescribe, being a substance which in its opinion is or may be used for the production or use of atomic energy or research into matters connected therewith and includes uranium, plutonium, thorium, beryllium, deuterium or any of these respective derivatives or compounds or any other materials containing any of the aforesaid substances. The Act defines the term “radioactive substances” or “radioactive material” as any substance or material which spontaneously emits radiation in excess of the levels prescribed by notification by the Central Government.
Accordingly, if the Patent Office finds any reference to any radioactive material in a patent application, such an application is likely to attract section 4 of the Indian Patent Act and, prima facie, a patent cannot be granted for such an application. The patent application is then communicated to the Department of Atomic Energy of the Government of India. Ultimately, the decisive power regarding whether an invention relates to atomic energy or not rests with the Central Government. If, in the opinion of the Central Government, the invention does relate to atomic energy, the Patent Office is then directed by the Department of Atomic Energy that the said application should not be entertained. Such an application is then refused by the Controller of Patents on that ground.
Thus in order to get patent protection, it is prudent to remove any references to any radioactive substances or materials which may attract section 4 of the Indian Patent Act. In various instances of inventions related to tissue specific disease imaging for diagnostic purposes or image guided therapies which used radionuclides, the patent applications were allowed once all references to radionuclides were deleted while the other components of the invention were retained.
One may question the rationale behind the exclusion of inventions in the field of nuclear medicine which employ radioisotopes on the grounds of national security. Though it is agreed that excessive exposure to radionuclides which causes irreversible damage by way of radiation poisoning poses threat to life and environment, the benefits of controlled use of medical radioisotopes far outweigh these perceived dangers. More than 10,000 hospitals worldwide use radioisotopes in medicine, and about 90% of the procedures are for diagnosis. Millions of the diseased worldwide are benefiting from inventions employing radioisotopes. The field of nuclear medicine has turned out five Nobel Laureates already. Commonly used diagnostic radioisotopes such as chromium-51, cobalt-58, gallium-67, iodine-123, iron-59, sodium-24, thallium-201 and the most widely used technetium-99 are all relatively safe, having very short half lives and are used in small amounts in such diagnostic and therapeutic procedures.
On a closer reading of the Atomic Energy Act, the term “radioactive substances” or “radioactive material” are defined as any substance or material which spontaneously emits radiation in excess of the levels prescribed by notification by the Central Government. Thus, if an invention employs radioisotopes in minute quantities for medical purposes, which emit radiations below the prescribed levels and hugely benefit mankind, why shouldn’t such patent applications be allowed? Caution has to be exercised in so far as production, handling, storage and transportation of such radioisotopes is concerned, but regulatory measures by way of exclusion from patent protection does not seem to be an answer to this perceived problem.
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