EVERGREENING OF PATENT IN PHARMACEUTICAL INDUSTRY WITH SPECIAL REFERENCE TO LEAST DEVELOPED COUNTRIES
A patent is a right which is provided by the intellectual property (IP) authority of a state to the inventor. It is provided for a limited period of time of 20 years of disclosure of an invention for the benefit of mankind. Nowadays it’s is being used by number of innovator companies so that they exclude others from making or selling there invention. The extension of monopoly term ‘Evergreening’, is a chief aspect of pharmaceutical patenting.
‘Evergreening’ refers to distinct ways wherein patent owners take imprudent advantage of the law and associated regulatory processes to extend their IP monopoly mainly over highly advantageous ‘blockbuster’ drugs by filing crafty patents on an already patent-protected invention shortly before due date of the ‘parent’ patent. These crafty patents have tendency to protect delivery profiles, secondary, and isomeric forms, method of action, dosing procedure, and dosing extent, and dosing way, various procedures of treatment, combinations, screening methods, biological targets and criteria of use for the same old molecule. This provides, the innovator companies have enough time to recover their disputedly estimated ‘research and development’ costs.
The TRIPS conformity has forced pharmaectual industries of the under developed countries to innovate in order to serve to the Needs of present and future drugs.
The interplay among patents and access to medicines occurs usually in two ways;
1. patents are designed to remunerate transformation by providing a temporary ownership over medicines that meet the patentability criteria of unfamiliarity, inovative step and industrial application. Transnational research and development based pharmaceutical firms undertake little research and development on diseases that primarily affect people in developing countries. The World Health Organisation Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (2008), recognize the limitations of patent stimulants to address the public health issues of developing countries.
2. where a medicine is protected by patent, the rates of the medicine are usually higher, unless the patent holder provides distinctive cost or grants a license with favourable terms, taking into account the accessability of medicines. Costly medicines affect the budget for government acquirement and the excessive expenditure of consumers, and may prevent access to medicines.
Developing countries with low research and development investment, pharmaceutical manufacturing capacity, and an underdeveloped health financing system face censorious challenges in protecting access to medicines.
‘Evergreening’ is an feature of patenting which leads to patent life cycle strengthen technique’ employed by the pharmaceutical companies to Grow ‘bullet proof’ patent memento around profitable drug molecules .This is done in an crafty way by saving a large number of inventive Feature over the general invention by avoiding any impending dual patent rejection and slowly leading to extension of patent terms to the next 20 year term for a single drug product. Safeguard on such family of so called ‘profitable molecules’ can at times act as a bonanza to the multinational pharmaceutical companies and continue to retain market monopoly. Nevertheless,‘Evergreening’ perspective guide to the addition of patent terms provided the national patent law allows such pliabilities.
In respect to ‘BHUTAN’
The intellectual property division (IPD) of the ministry of economic affairs (MoEA) has finally confirmed a registry for patents as authorized by the Industrial Property Act of the kingdom of Bhutan, 2001. This means inventors are granted with an productive means to safeguard and promote their inventions. Patent rights are available here only after 2 years of invention as it needs to go through various phases. Upon receipt of the request by WIPO, it will be inspected by another institute and diligent examination will follow till registration or disqualification of the patent.
Statistics show that at present there are more than 10,000 trademarks registered with the IPD. Three designs have been registered out of which two are under testing process. Two patent applications have been received and are under inspection.
Bhutan is in the way of drafting the National Intellectual Property policy. A two-page concept paper has also been developed by consultants from WIPO. Kencho Palden said there will be rigorous consultations before any of the provisions come into effect.
In respect to ‘BANGLADESH’
Bangladesh’s pharmaceutical production is quirky among least developed countries (LDCs). Driven by active government policies, output has increased a thousand times since 1982, to US$2 billion, or about 1% of GDP, making it the biggest white collar workers in the country. The industry provides almost the entire domestic market and more than 100 other countries as well as the United States.
Weak intellectual property protection has also allowed Bangladeshi organisations to construct their technological base by copying or de-compiling foreign technologies. Imitating and de-compiling critical to economic catch-up in a range of industries, not just pharmaceuticals. Instead they start from scratch, developing-country organisations can take advantage of what others have learned.
Bangladesh would have to renovate its patent law, by increasing patent terms to 20 years, increasing patents to pharmaceutical products and processes, and agreeing patent protections on animal and plant varieties. Patents could no longer be abandoned simply because they are foreign-registered, and importantly licenses could only be granted by the government.
Limiting the activities of pharmaceuticals strategies could increase prices for Bangladeshis who couldn’t otherwise offer vital drugs – as well as buyers around the world. Life-saving medicines would no longer be accesible for poor people in Bangladesh, LDCs and other least developed countries.
Patent evergreening fosters development of biased means of competition and related abuse. Upgraded IP scan may remove the imprecation of these unfair practices which are largely followed by the innovator firms to create a barrier for generic firms that are trying hard to provide safe and effectfual medicines to the public at large at effective prices. There is a need for developing countries to develop and promote effective mechanisms to reverse evergreening practices of innovators. It is important to promote innovations of big organisations and at the same time respective efforts put down by the generic firms so that with equal Stability, cost effective, affordable products are launched in the market, thereby benefiting the public at large.
Author: SAMEER AFZAL ANSARI,
GURU GOBIND SINGH INDRAPRASTHA UNIVERSITY , THIRD YEAR , SIXTH SEMESTER , BACHELORS OF ARTS AND BACHELORS OF LEGISLATIVE LAWS