India has been in the centre of IP debate worldwide quite often and now another issue seemingly is making an entry i.e. section 4 of the Indian Patents Act, 1971 which deals with the inventions relating to Atomic Energy being not patentable. Off lately there has been a significant rise at the Indian Patent office in raising objection under section 4. Originally section 4 find its root in the Interim report submitted by the Ayyangar committee in April 1959. An "urgent necessity" was foreseen by the committee members then, which made them submit said interim report when their complete report on revisions of the Law of Patents in general was nearing completion! And the complete report was submitted soon after few months i.e. in September 1959.
The emerging issue of applicability of section 4 on an invention, allowability of applications and other related issues need to be analysed, keeping in view the "urgent necessity" of the world then and now.
The first legislation in India relating to patents was the Act VI of 1856. The objective of this legislation was to encourage inventions of new and useful manufactures and to induce inventors to disclose secret of their inventions. The Legislative History of India's patent law has seen several stages staring as early as 1832 and arriving to the Indian Patents Amendment Act, 2005. On its evolution path two committee reports made mark in shaping the patents law. Firstly, the Tek Chand Committee Report which made recommendation for prevention of misuse or abuse of patent right in India and that the Patents Act should contain clear indication to ensure that food and medicine and surgical and curative devices are made available to the public at the cheapest price commensurate with giving reasonable compensation to the patentee. Second, The Aayynagar Committee Report. The development of patent law in India owes much to the Report of Justice Rajagopala Ayyangar, as majority of recommendations of the Committee found their way into the Act.
In 1957, the Government of India appointed Justice N. Rajagopala Ayyangar Committee to examine the question of revision of the Patent Law and advise government accordingly. The interim Ayyangar committee report analysed the law governing inventions in the field of atomic energy in the two major countries i.e. U.S.A. and U.K.. After taking into consideration the socio-economic challenges of India made their recommendations. The main basis of their recommendation was of national security and to secure publication/accessibility of such sensitive information to public.
Atomic Energy and the Indian Patents Act
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.
Further, Section 39 of the Act1 creates an embargo on Indian Residents applying for patents relevant for defence purposes or atomic energy outside India without prior permission.
The understanding of Section 39 of the Act also has to be read with Article 65 of the patent Co-operation Treaty, for gradual International Applications so made as well, which was as follows; (1) If the agreement with any International Searching or Preliminary Examining Authority provides, transitionally, for limits on the number or kind of international applications that such Authority undertakes to process, the Assembly shall adopt the measures necessary for the gradual application of this Treaty and the Regulations in respect of given categories of international applications.
Any act in contravention of the secrecy directions or provisions of Section 39 of the Act, shall lead to the application for patent under this Act deemed to have been abandoned and the patent granted, if any, shall be liable to be revoked. Section 157A2 of the Act is a non-obstante clause which empowers the Central Government to not to disclose any information prejudicial to the interest of security of India. The explanation appended to the Section defines "security of India" to include any action necessary for the security of India which relates to, inter alia, fissionable materials or the materials from which they are derived.
The Ayyanger Committee Report referred to the Patent Laws of U.S.A. and Australia and observed:
- Having notified clauses which shall be prohibited uses of atomic energy would make the Controller's Role merely mechanical.
- Giving the Controller more power and discretion would warrant the need for an assistive committee to make up for the lack of know-how.
- Military science and defence needs are changing at such a rate that the civil Patent office cannot keep up with the evolution so there is not much the assistive committee can do.
While no direct words to the effect were used, the report warranted the implementation of Section 4 of the Patents Act which read with the strict wording of section 20 of the atomic energy act makes it crystal clear that the intention of the legislature was not to allow for patenting of inventions relating to atomic energy. Even if a patent is granted for an invention relating to atomic energy, the same may be revoked under Section 65 of the Patents Act.
It is also pertinent to note that presently, Indian law makes no distinction between atomic weapons and atomic energy. The security reason of the country appears to be the rationale for disallowing patents for atomic weapons.
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 (DAE) of the Government of India. Ultimately, the decisive power regarding whether an invention relates to atomic energy or not rests with the Central Government. On an affirmative finding of DAE the application would be refused by the Controller of Patents directly without even giving an opportunity to the applicant of hearing. More so, there is no provision or mandate of giving the applicant an opportunity of being heard before the DAE. The application denied/refused under section 4 is non-appealable.
Further, the recent trends show that from 2013 to February 2017 there has been several applications which were refused under section 4. A sudden emergence of awareness on atomic energy related inventions at the Indian Patent office where as the issue and the provision find its roots in interim Ayyangar committee report i.e. in April 1959, do certainly point towards a brewing storm.
Now, a prudent question which arises is whether all inventions using atomic elements/energy would attract section 4 of the Indian Patents Act? In particular, 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. 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. 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.
Patent Application Status Under Section 4 of the Act: An Understanding
During the five year period 2013- February 2017, the Indian Patent office has issued 43 orders under section 4, which is the highest since the incorporation of said provision.
Whenever an application was considered as coming within the scope of Section 4 of the Act, the same was referred to the DAE to confirm whether it the invention being claimed is under section 20 (1) of the Atomic Energy Act or not. Further, the question may arise that whether the controllers are blindly referring the applications to the DAE or are analysing them before referring? Also, whether all four patent offices in India are uniformly sensitised on section 4 and are raising objections under section 4? The answer to the above questions are interesting, as Kolkata patent office of India has issued about 70% of the order in the last 5 years under section 4. Further, based on the information available it was found that about 10% of the decided applications were not referred to DAE.
(Out of the total 43 Patent Application so filed only, 39 Applications i.e. 90% of the Applications were referred to the DAE, and remaining 4 i.e. 10% were not referred to the DAE by the Patent Controller)
Out of the 10 % of the Applications that were not referred by the Patent Controller the 'claims' that were found to be in conflict were removed or amended as per Section the 20 (1) of the Atomic Energy Act, i.e. the elements were generally found to be in conflict with the list of 'prescribed substances' and/or 'radioactive substances', were removed, on the basis of which no reference to the DAE was sought, by virtue of amended claims the patent were allowed. Most commonly used Industrial elements such as Gd, Hf, Zr, generally fine their use in Industrial Application.4 Whereas the DAE in 41.80% cases has refused grant of the Patent Application and ruled that applications were falling under the scope of Section 20 (1) of the Atomic Energy Act.
Generally the Patent Applications involved use of the substances falling under the category of 'prescribed substances' and/or the 'radioactive substances' or various genus of the same in the form of derivatives, isotopes and/or isomers,5 beyond the limit exceeding as notified by the Central Government. One of the applications was refused on the ground that the use of a 'radioactive element' was deliberately found not to be mentioned in the patent application based on the nature of Invention, observing which the DAE observed that Patent should not be granted.6
Applications consisting of the use of radioactive isomers for detection purposes were also refused by the DAE and the Patent Office, by virtue of the 'radioactive elements' that were being used in the invention. One of the Patent Applications was also rejected because of the use of 'radiopharmaceuticals'.7 In one such application use of 'radioisotope-mediated radiation therapy' in the Magnetic resonance imaging (MRI was found to be a persuasive argument, in granting of the patented application.8
Generally the grounds of refusal and the reason for refusal by the DAE are very clear; i.e. when there is a clear indication of notified substances not being used as per notification or if falling under the category of Radioactive substances. In case of patent application falling under Section 4 of the Patent related to medicinal uses and Research & Development (R & D), there has been a mixed response from the Indian Patent office and the DAE.
The main issue in patenting Atomic Energy Using Patent Inventions are looked at by the DAE and the Indian Patent Office is:
- The Purpose of Atomic Energy; Educational, Medical9 or for R & D
- The Radioactive element and/or its derivative used
- National Security threat faced i.e. defence purposes10 if any.
The most common pattern is that when the patented invention is not covered Under Section 4 then patent application is generally considered to be in order of grant, unless there are other objections related to novelty, inventive step etc. attached to it as well.
In one such patent application a radioactive compound was being used known as 18F-fluorine as a radioactive tracer which has a short half-life (i.e., 110 minutes) and was claimed to be used for medical purposes only. The patent application in such a case was found to be in order for grant.11 But this is an exception and not the pattern, and has to be looked at in the same way.
In one such Patent application despite conformation from the DAE that the invention did not relate to use of Atomic energy despite that the Patent Application was refused on grounds of lack of inventive step and the fact that the same was relevant purpose.12
In one such Patent Application the fact that usage of elements involving Zirconium and Titanium was objected saying it may fall under the scope of Section 4, the DAE had at that time notified it as an 'radioactive substance', the applicant contended such a notification which led to the DAE subsequently de-notifying these elements from the list of notified substances.13
In 3 such patent applications that were filed wherever an objection was raised in the First Examination Report, in relation to Section 4 of the act, the Applicant himself amended the Claim in relation to which objections were raised under section 4, seeing which the Patent was granted without referring the same to the office of the DAE, as the entire claim which objection under Section 4 was raised was removed.
Also the fact that similar patent applications have been accepted for grant in counterpart jurisdictions cannot be used as a defence by the Applicant in relation to the refusal of grant by the DAE. This order so given by the Controller limited the persuasive value of foreign statutory implications and that of foreign orders in relation to grant of patents being done on the same subject matter (i.e. atomic energy related patents) being done in India.
In another very important patent application filed by MERCK & CIE's having application no. 2996/KOLNP /2OO9 section 4 objection was raised. The application was granted in other major jurisdictions. Said invention relates to novel folate conjugates and the corresponding metal-chelate complexes as well as pharmaceutical compositions thereof, their methods of production and use in diagnostic and therapeutic medical applications, such as in diagnostic imaging and radiotherapy. The applicant made the submission that the invention has no relevance or use in the field of atomic energy and do not attract the provisions of Section 4 of the Patents Act. Applicant even made reference to similar patent applicants which were granted by the Indian patent office. Finally, patent office based their decision on the findings of DAE only and refused their application.
In the case of Raytheon Company Vs The Controller Of Patents & Anr. The scope of the Central's Governments power vis-a vis Section 4 was disputed and the extent to which the Central government can exercise power under the Act. The Judge in relation to scope of Section 4 of the Act and Power of Central Government under it observed that:
- The Central Government shall have the power to inspect at any time any pending patent application and specification before its acceptance and if it considers that the invention relates to atomic energy, to issue directions to the Controller of Patents and Designs to refuse the application on that ground.
- Any person, who has made an invention which he has reason to believe relates to atomic energy, shall communicate to the Central Government the nature and description of the invention.
- The Controller of Patents and Designs shall have the power to refer any application to the Central Government for direction as to whether the invention is one relating to atomic energy and the direction given by the Central Government shall be final.
From said ruling one can clearly understand that the judiciary is certainly not inclined to interfere with any matters related to atomic energy or national security.
In 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, but such patent applications are not being allowed as 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.14 In US, there continues to be a bar on patents for inventions related solely to atomic weapons, patents for other inventions related to atomic invention may be granted after scrutiny by the Department of Energy in the US.
Some say to determine a pattern for the patent orders so given under Section 4 might be too soon, but one can safely presume that in light of the sudden surge if nuclear related development and usages, especially in the fields of medicine and R & D such applications are only going to increase. The Granting/Refusal might be a borderline, but taking into consideration the abandoned patent applications as well, one can safely say that the tendency lies towards generally rejecting the applications and not to grant such patent applications. The burden to show that the Patent Application is beyond the scope of Section 4 is on the defendant and as analysed from the above orders depends more on the function and usage of the prescribed substance/radioactive substance subject to the decision of the DAE, rather than the fact that such usage is has been granted in other jurisdictions or not or any other procedural aspect related to grant or such patents. Merely claiming that Section 4 will not apply is not enough.
- Section 39 of the Act: Residents not to apply for patents outside India without prior permission. (refer bare text)
- Section 157A of the Act ‘Protection of Security of India’ (refer bare text)
- graph depicting an increase in number of orders under section 4 at the Indian patent office in last five years.
- Patent Application No. 4222/KOLNP/2008 and Patent Application No. 5365/DELNP/2006
- Patent Application No. 4202/DELNP/2007
- Patent Application No. 2996/KOLNP/2009
- Patent Application No. 2047/KOLNP/2009
- Patent Application No. 3155/KOLNP/2009
- Patent Application No. 1245/KOLNP/2005
- Patent Application No. 4001/DELNP/2008 and 2996/KOLNP/2009
- Patent Application No. 4222/KOLNP/2008
- Patent Application No. 2026/MUMNP/2007