Continued from last week
Apatent expires 20 years after the date of application for its registration (Section 83 (1) of the Act).
Where a patentee intends, at the expiration of the second year from the date of grant of the patent, to keep the same in force, the patentee must, 12 months before the date of expiration of the second and each succeeding year during the term of the patent, pay the prescribed the annual fee for the renewal of the patent.
Rights of the owner of a patent
The owner of the patent is subject and without prejudice to other provisions of the Act relating to patents, entitled to the following exclusive rights in relation to the patented invention – (a) to exploit the patented invention; (b) to assign or transmit the patent; and (c) to conclude licence contract (Section 84 (1) of the Act).
The expression ‘exploitation of a patented invention’ means any of the following acts in relation to a patent:
when the patent has been granted in respect of a product –
(i) making, importing offering for sale, selling and using products and
(ii) stocking such product for the purpose of offering for sale, selling or using
when the patent has been granted in respect of a process – (i) using the process, (ii) doing any of the acts referred to in the above paragraph (a), in respect of a product obtained directly by means of a process and (iii) preventing any person from using that process or using, selling or importing any product obtained directly by means of that process unless such person is authorised to do so (section 84 (3) of the Act.
The law prohibits every person from doing any of the acts referred to above under the rights of an owner of a patent within the consent of such owner (section 84(2)).
Limitation of protected rights
Section 86 makes provisions with regard to the limitation of the patented rights of the owner of a patent which are referred to below.
Non-industrial or commercial purposes.
Rights derived from prior manufacture or use or from a licence.
The presence or use of products on foreign vessels, aircraft, spacecraft or land vehicles. The protected rights accordingly do not extend to the presence or use of products on foreign vessels, aircraft, spacecraft or land vehicles which temporarily or accidentally enter the waters, airspace or territory of Sri Lanka
Exhaustion
The protected rights do not extend to the acts performed in respect of the articles which have been put in the market by the owner of the patent or with his written consent.
Compulsory licences
Any person, body of persons, Government department or statutory body may make an application to the Director General for obtaining a compulsory licence (non- voluntary licence) to exploit a patented invention.
The Director – General may issue the compulsory licence upon being satisfied that (i) the applicant has made efforts to obtain approval to exploit the patented invention from the right holder on reasonable commercial terms and conditions and (ii) that such efforts have not been successful within a reasonable period of time.
The Director – General may waive these two requirements (i) where a national emergency or any other circumstances of extreme urgency exist, or (ii) in case of public non-commercial use for the purposes such as national security, nutrition, health or (iii) for the development of other vital sections of the national economy.
The exploitation of a patent under a compulsory licence must be limited in scope and duration to the purpose as is specified in the licence. Such exploitation is permitted predominantly for the purpose of supply to the domestic market. The Director – General is required to consider each application on its individual merits before granting a compulsory licence to exploit a patent.
A compulsory licence must be non-exclusive and subject to the payment of adequate remuneration to the owner of the patent taking into consideration the economic value as determined by the Director – General and where applicable, the need to correct anti-competitive practices.
The registered owner of a patent may surrender the patent by a declaration in writing signed by him or on his behalf and submitted to the Director – General (Section 98 (1) of the Act). The surrender of a patent may be limited to one or more claims of the patent.
The surrender takes effect from the date that the Director – General receives the declaration of the surrender. The Director – General is required on the receipt of the declaration to record it in the Register of Patents and cause such record to be published in the Gazette.
Nullity of a patent
The Court is competent, on an application of any person showing a legitimate interest, or of any competent authority including the Director – General to which the owner of the patent and every assignee, licensee or sub-licencee on record are made party, to declare a patent null and void on any – or more, of the specified grounds in the Act (Section 99 (1) of the Act).
Upon a final decision of the Court declaring total or partial nullity of a patent, the patent is deemed to have been null and void totally or partially, as the case may be from the date of grant of the patent (Section 100 (1) of the Act). Upon a declaration of the nullity becoming final, the Registrar of the Court is required to notify the Director – General accordingly. Then the Director – General records the declaration of nullity in the Register of Patents and causes it to be published in the Gazette.
Impact of IPR on the right to health
The relationship between human rights and Intellectual Property Rights (IPR) has been the topic of many debates in the recent past all over the world. Socio-economic rights having been repeatedly recognised as an indivisible aspect of human rights pose a great challenge to many States.
Developed and Developing States tend to neglect the protection of socio-economic rights on the grounds of resource constraints. The real problem, therefore, seems to be that of reasonable prioritisation. It is also doubtful whether the limited funds available for the protection of socio-economic rights including health system/rights would be allocated properly and even if properly allocated whether it would be used in an optimal manner untainted by bribery and corruption.
IPR too have increasingly come into conflict with socio-economic rights, especially the right to health.
The General Comment on the Right to Health (Committee on Economic, Social and Cultural Rights, General Comment No.14. The Right to the Highest Attainable Standard of Health; UN Doc.), recognises certain essential rights of the right to health such as availability, accessibility and quality of health care.
Considering the resource constraints faced by countries in implementing these obligations, the International Covenant on Economic, Social, Cultural Rights (ICESCR) recognises that a State has a duty to take all measures to the ‘maximum of its available resources, with a view to achieving progressively the full realisation of the right recognised in the present Covenant by all appropriate means’ (Article 2 of ICESCR).
The phrase (in Article 2 of the ICESCR) – progressive realisation cannot be used to evade the obligations under the Covenant. Article 2 of the General Comment on Health states: ‘The progressive realisation of the right to health over a period of time should not be interpreted as depriving States Parties’ obligation of all meaningful content.
Rather progressive realisation means that States parties have specific and continuing obligation to move as expeditiously and effective as possible towards the full realisation of Article 12 (elements of the right to health).
There are certain aspects of the right to health that must be realised immediately. Such obligations are called ‘minimum core obligations’. States are bound to comply with them immediately upon the ratification of the Treaty.
The General Comment on the Right to Health states that the minimum core obligations at the very least include the provision of essential drugs.
These obligations, in certain instances come into conflict with the obligations under the IPR regime. Patented drugs (as opposed to the cheaper generic drugs) produced by the global pharmaceutical giants are usually priced at a level that is beyond the reach of millions of people living in poor countries.
On the other hand, the generic versions of these drugs, which are mostly produced by Indian or Brazilian pharmaceutical companies are priced at much lower levels, which are at times less than one fifth of the price of the patented drugs. Because of the pressures brought to bear on them by multinational drug companies and some Northern Governments, poor countries with limited health budgets are generally compelled to protect IPR and not the health rights of the people.
Many rich countries have exerted much pressure on developing countries to strengthen protection given to IPR and the process is still continuing. Developed countries also use pressure tactics to prevent developing countries from purchasing drugs from manufactures who are not the patent holders.
The difference in the costs incurred in purchasing branded drugs as opposed to generic drugs is staggering, especially with some drugs needed for life prolonging treatment.
From the point of the view of the pharmaceutical industry, the patents are of special significance. The marginal cost or the cost of manufacturing a drug is usually very low. But these companies have incurred very much ‘sunk costs’ or initial investments for the research and development of these drugs. Multinational companies protect their drugs through patent and they protect themselves from competition and can recoup the costs of research and development. Indian based pharmaceutical companies which have not issued such massive sunk costs can offer the same drug at a cheaper price.
According to health rights activists, patents and profits need not be a consideration in catering to the health needs of the poor. It is not the main obligation of the pharmaceutical companies to provide for health needs of the poor. It is the sole obligation of the State assisted by the private sector. Therefore, the State must ensure that at least the minimum core obligations are fulfilled.
If the Government enacts tougher patent laws, it results in the continued profitability of these companies. Then the tougher patent laws will increase the extent of State obligations with regard to the provision of health care, necessitating an increase in State expenditure on drugs. Therefore, State expenditure on health must increase with the introduction of tougher patent laws. There is no doubt that we need IPR with patent laws.
It is then the responsibility of the State to introduce a properly planned system of State financing or compulsory licensing to prevent escalation of drug prices in countries such as Sri Lanka, at the very least for essential drugs.
The challenging task is to ensure at least a basic level of harmonisation with human rights that are imperiled by these laws. The need for mitigatory measures in implementing patents is recognised in two ways. Firstly, the IPR regime itself has created certain provisions which may be used for this purpose. Secondly, within international human rights law, there exist certain legal and moral justifications for the preservation of the human rights of the people.
The TRIPS agreement and the Doha Declarations contain certain mitigatory provisions which can be used to further the protection of human rights in certain instances. These mitigatory provisions were not initially included in the Intellectual Property Bill and were later incorporated after the Court determination to that effect. To be continued next week
