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It is simply outrageous, cruel and inhuman. What is involved is deaths and sufferings of lakhs of citizens, who are denied access to life saving drugs by gross abuse of the patent system. This is preventable and must be prevented. People must rise in protest.
The problem is created and inflicted on the people of India by multinational pharma companies (the Big Pharma) as a part of their Common Corporate Policy (CCP). The CCP is aimed at controlling and containing the excellent all round progress of the Indian Drug Industry (IDI). The big question is should the people be made to suffer and die untreated in implementation of CCP?
This article, based on facts and actual experiences, is intended to place before the people of India and the Government, the true facts of the matter and gravity of the problem for immediate corrective measures. Urgent actions are necessary to ensure availability of all recently developed drugs access to which is being denied to people by abuse of the patent system enforced by statutory provisions.
The forth coming general elections will ensure a prompt favourable response from the government. Now is the time for the people to raise their voice in protest for urgent actions.
R&D of new drugs having become a high cost, high risk matter is virtually abandoned even by Big Pharma. The patent claims made by them in respect of repetitive, false, frivolous and fraudulent claims which do not satisfy the requirements of novelty and inventive step (or non-obviousness) mandated by Patent Act 1970 (PA70) and TRIPS Agreement.
This problem is not recent it has been there since 2002-03. In her speech in support of Bill number S.812, the then US Senate, Senator Ms Collins complained:
“We heard in committee examples of the brand name manufacturer making extremely minor changes, such as in the colour or the design of the packaging or the scoring of the pill that really did not indicate a different or improved use for the product, but, rather, were devices intended to keep the generic off the market for a while longer”.
In 2003, Mr Brown a member of US House of Representative in his speech shocked the House by reporting:
“A patent, for example, was filed on a pill that could be divided into three parts instead of in half, instead of in two parts. - While the generic company fights this outrageous patent in court, the brand name company, the big drug company, retains its market exclusivity at the cost of tens of millions, sometimes even billions of dollars, to consumers. -”
Frivolity a problem also in India
Complains about such claims been made in India was pointed out by the Supreme Court in the Novartis case.
In this context reference is invited to the Supreme Court judgement in the Novartis case, in which the Court has quoted with approval (Para 80) the following statement of an MP:
“India has benefited from the low-cost generic industry to dominate 30% of the low-cost drugs in the world”.
Secondly, it (the Bill) is vague about the evergreening effect in which companies extend their patent rights by switching from capsules to tablets, for instance. This extends monopolies. Parliament must make sure that it protects the rights of India to make these generic drugs. We should remove the provision that allows this evergreening.
It is simply outrageous and shocking to think that a patent claimed and granted for insignificant modification of capsule instead of tablets, would be use to deny access to life saving drugs, leaving thousands of patients to suffer/die untreated.
However, even more shocking aspect is that the Big Pharma companies deliberately and as a matter of CCP avoids producing, importing, marketing or licensing the frivolous drugs patented by them even in India during the entire patent term. This is because the Big Pharma do not want to disclose their cost data of their patented drugs required to be submitted under the Drug Price Control regulation. They also want to avoid having to market the drug at statutory prices fixed under statutory price control order. In fact, though they have acquired about 7000 product patents in India since 2005, they have deliberately avoided producing, importing or marketing such drugs. They only use of the patent system to prevent IDI from producing and marketing the drugs patented by them.
This is not only a case of fraud on the people or denial of fundamental right to life guaranteed by Article 21 of the Constitution, but even worse leaving people to suffer/die untreated.
It is all the more shocking to know that such fraud is being practised by Big Pharma companies since introduction of product patent system in 2005, and that too with the help of Patent Act amendments introduced in 2002 and 2005. With a view to encourage the Big Pharma companies to establish productions in India and to invite Foreign Direct Investment (FDI), the PA70 was amended in 2002 (Section 87) & 2005 (Section 25). However, the actual experience during last 17 years, has been that Big Pharma companies have not only fail to bring in any new investment, but have even abuses these provisions to deny access to many life saving drugs, leaving thousands of citizens to suffer/die untreated. People must rise in protest against such abuses of the patent system and consequent deaths and sufferings of millions of citizens.
The PA70 should be immediately amended to prevent such abuses, deaths and sufferings. The people and the govt need to know the absurdity and abuses being made by Big Pharma of Sections 87 and 25 of PA70, for immediate corrective actions.
Section 87 as amended in 2002, gives a right to the patentee to oppose the grant of ‘compulsory’ licenses. How can a license which is ‘compulsory’ be permitted to oppose. It is like a bank watchman handing over keys of safe deposit vault to the bank robber leaving him free to rob.
The grant of compulsory license (CL) is provided in patent system as part of give and take bargain. In absence of CL a patent would become a grant of monopoly, prohibited by Article 14 of the Constitution. The CL provisions are intended to be consideration and a matter of right for the other citizens and interested parties for the restriction impose on them by grant of patent. The patentee cannot object to the grant of CL. It is matter of right and remedy for the other citizens.
Section 25 as amended in 2005 creates an absurd and untenable situation. In fact, in its application to patents for drugs and medicine the provision, is simply revolting and it has to be rejected. It is like a bank cashier accepting the check and making payment against it without verifying the signature or bank balance. The law accepts by clauses of Section 25 of ‘e’ and ‘f’ that the patent claim is questionable and liable to be cancelled, and yet it allows the patentee to enjoy the patent right even if it result in denial of access to life saving drugs to thousands of citizens, leaving them to suffer/die untreated. This is not a mere hypothetical possibility.
It is simply absurd that Section 25 as amended in 2005 virtually denies rights of other citizens to oppose the grant of patent, while Section 87 allows the patentee to oppose the grant of CL. In both cases it is the Big Pharma which is favoured, not only at the cost of right to trade of IDI but even worse, at the cost of health and lives of citizens.
On the other hand, the Big Pharma have been very active in obstructing – in fact, ‘blocking’ – the IDI producing such drugs. The only result of such policies statutory provisions, as been blockade of production of such drugs by IDI, and even worse deaths of sufferings of millions of citizens during last 17 years by denial of access to the drugs, the original patents of which, have long since expired.
It is now urgent and imperative that the people, the Parliament and the Government review the matter and adopt urgent corrective measures particularly by amendment of PA70 – preferably by an ordinance. Delay of everyday costs sufferings and lives of thousands of citizens. It is not only a matter of denial of Constitutional rights of citizens (Articles 14, 19 (1) (g) and 21), but also of the sufferings and lives of thousands of citizens it brooks no delay. Any delay is not only unpardonable criminal but even dangerous. The fact that the offending provisions of PA70 are also in violation of the provisions of TRIPS Agreement.
Delay of everyday in taking decisions and corrective actions costs lives of citizens. This is not only a fit case but also a part of sovereign function and duty of State for issue of an Ordinance by the Government.
The law cannot be framed and administered to suit the business policies of Big Pharma. The law must serve the needs of people of India and comply with the Constitution and the Trips Agreement.
(Author is an advocate based in Mumbai)
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