Sunday, April 6, 2025

The right to health vs the right to patent

A need for harmonisation towards social justice - Part 7

by damith
March 10, 2025 1:00 am 0 comment 25 views

By Prof. S. Sarath Mathilal de Silva

Continued from last week

The petitioners’ contention is chiefly based on the position that the mitigating features, which were incorporated in the TRIPS Agreement, have not been included in the Present Bill. Following three (3) examples could be cited as important issues that should have been taken into consideration.

(A). Articles 30 and 31 of the TRIPS Agreement provide for a State to make provision for the use of the subject matter of a patent for the domestic market without the prior authorisation of the patent holder in certain situations such as national emergencies.

Article 30 of the TRIPS Agreement is an exception to rights conferred and reads as follows:

“Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.

Article 31 on the other hand deals with other use without authorisation of the right holder, and reads as follows:

“Where the law of a Member allows for other use of the subject matter of a patent without the authorisation of the right holder, including use by the Government or third parties authorised by the Government, the following provision shall be respected:

12 provisions are laid down under this Article”.

(B).The Doha declaration makes provision for compulsory licensing and parallel importing of pharmaceutical drugs to meet national health emergencies. This includes granting of compulsory licences in respect of pharmaceutical products with regard to public health crisis including those related to HIV/AIDS, Tuberculosis, Malaria and other epidemics.

(C).The TRIPS Agreement includes several mitigatory measures, which are allowed under the said Agreement.

None of these measures have been incorporated in the Bill on Intellectual Property. The provisions of the TRIPS Agreement specify that it has incorporated mitigatory provisions, as the Agreement would be applicable to developed countries as well as the less developed nations. In fact, the World Trade Organization (WTO) has recognised the inequality of nations in respect of the TRIPS Agreement by prescribing a staggered time frame for the implementation of the Agreement among countries of different economic levels.

Therefore, it is an accepted fact that the provisions of the TRIPS Agreement would be applicable to countries developed as well as developing, which cannot be treated as equals. Article 12(1) of the Sri Lankan Constitution not only guarantees equality before the law, but also provides for the equal protection of the law. It is a well settled law that just as much equals should not be placed unequally, at the same time unequals should not be treated as equals.

Equal protection means the right to equal treatment when similar circumstances are prevailing allowing no discrimination between two persons who are similarly circumstanced. Similarly, equal protection in terms of Article 12(1) guarantees protection not only from the executive, but also from the legislature. This Article is in line with Article 7 of the Universal Declaration of Human Rights (1948), which states that, “All are equal before the law and are entitled, without any discrimination, to equal protection of the law”.

Article 12(1) of our Constitution is similar in content and effect to the 14th Amendment to the Constitution of the United States of America and to Article 14 of the Constitution of India. As it has been decided by a series of cases in India, the guarantee of equal protection of the laws is an injunction issued by the framers of the legislature against enactment of discriminatory laws. Although the legislature has a wide choice in articulation of the subject matter of its laws, it should not treat unequals as equals and equals as unequals.

For the aforesaid reasons, Clauses 83 and 84 of the Bill are inconsistent with Article 12(1) of the Constitution. The Bill in its present form, therefore, requires to be passed by the special majority required under the provisions of paragraph 2 of Section 84 of the Constitution.

Clauses 90, 91, 92, 93 and 94

Clauses 90 to 97 are in Chapter XVII and deals with licence contracts. Clause 90 which is the interpretation Clause, defines the Licence Contract and is in the following terms:

“For the purposes of this part, licence contract means any contract by which the owner of a patent (hereinafter referred to as ‘the licensor’) grants to another person or enterprise (hereinafter referred to as ‘the licensee’), a licence to do all or any of the acts referred to in paragraph (a) of sub-section (1) and sub-section (3) of Section 84.”

Section 84, as referred to earlier, deals with the rights of an owner of a patent. It was contended on behalf of the petitioners that, a patent which is a statutory grant of a right to an inventor on his invention from which others are excluded as long as the grant runs, will give the inventor a monopoly to exploit the invention at the exclusion of all others. This will detract any opportunity available for the use of the patented product by any other user. This in effect would be a disincentive and an obstacle to the development of the local pharmaceutical industry, which would in turn be unequal treatment and violation of equal protection for the persons who are engaged in such industry.

We, therefore, determine that Clause 90,91,92,93 and 94 are inconsistent with Article 12(1) of the Constitution.

The petitioners contended that Clause 87 of the Bill is inconsistent with Articles 12(1) and 14(1)g of the Constitution for the following reasons:

Clause 87

Clause 87 deals with the rights derived from prior manufacture or use and, reads as follows:

‘Where a person at the filing date or where applicable, the priority date of the patent application.

(a) was in good faith making the product or using the process in Sri Lanka which is the subject of the invention claimed in such application:

(b) had in good faith made serious preparation in Sri Lanka towards the making of the product or using the process referred to in paragraph (a).

he shall have the right, despite the grant of the patent to exploit the patented invention:

provided that the product in question is made or the process in question is used by the said person in Sri Lanka:

provided further, if the invention was disclosed under circumstances referred in paragraphs (a) or (b) of subsection (3) of Section 64, he may prove that his knowledge of the invention was not as a result of such disclosure’

Clause 64 deals with ‘Novelty’ and refers to ‘Prior Art’ which is defined in Clause 64(2) in the following terms:

‘Prior Art shall consist of –

(a) everything disclosed to the public, anywhere in the world by written publication, oral disclosure, use or in any other way prior to the filing or, where appropriate, priority date of the patent application claiming the invention’.

However, in terms of Clause 87(1) read together with Clause 64, a Sri Lankan, who had already been making a product or using a process in respect of which another party has applied for the patent, may end up only with the right to exploit the patented invention or process. If the purpose of the inclusion of Clause 87 was to protect the Sri Lankan who is already making a product or using the process, where another party had applied for a patent, then the Sri Lankan should be entitled to it and the application made by the other party for the patent should be refused on the ground that the invention has already been anticipated by Prior Art. Clause 87, therefore, is not granting the equal right or the equal protection to an inventor, who had already made a product or uses a process and thereby is inconsistent with Article 12(1) of the Constitution.

Clause 62

Clause 62 deals with definitions and Clause 62(3)b refers to the items, although they are inventions, which are not patentable within the meaning of Sub-Clause (1) of Clause 62. These are

(b) Plants and animals other than microorganism and an essentially biological process for the production of plants and animals other than non-biological of plants and animals other than non-biological and microbiological processes’ (emphasis added).

This Clause has excluded microorganisms by excluding them from living organisms thus allowing them be to patented.

Petitioners contended that in terms of the TRIPS Agreement, although it is necessary for a country to give patents to microorganisms, there is no definition given to this term. This has created a situation where it is possible to have a broad scope of patent protection, which could in turn be detrimental to the interests of the country. Examples were given of the pure culture of the microorganism sreptisporangium fragile that is capable of producing the antibiotic complex containing Frajilomycin A which has been found in a paddy field in the village of Anaikota, about five miles from Jaffna in the Northern Province.

Reference was also made to microorganism known as pathogens. It was submitted that due to the fact that there is no definition for the term ‘microorganism’, it makes possible for a variant of pathogens to be patented. This will pave the way for a patent holder to carry out research for the purpose of diagnosis and finding cures, which in effect will increase the prices of diagnosis and cures. Therefore, the petitioners contended that, the non-inclusion of the definition of microorganism is inconsistent of Article 12(1) of the Constitution which guarantees equal rights and equal protection to person, with which we agree.

It is, however, suggested that if the words ‘and microorganism other than transgenic microorganism’ is added after the word animals in Clause 62(3) b thereby amending the said Clause, it would cease to be inconsistent with article 12(1) of the Constitution.

Concluded

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