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In the name of R&D - Open invitation to deaths and suffering?

Narendra B Zaveri
Wednesday, June 29, 2022, 08:00 Hrs  [IST]

Frivolous patent threaten lives of millions. Pharma research has particularly for new drugs, having become prohibitively high risk and costly matter, Big pharma companies resort to repetitive, frivolous and fraudulent patent claims. As a direct inevitable result, even vital life saving drugs continue to remain patented priced sky high and consequently millions of citizens are denied access to them. How dangerous the situation has become, can be seen from the actual experience in respect of drugs, vaccines, etc for treatment of pandemic Covid-19. This has opened a flood gate of frivolous patent claims.

In a recent report published by WIPO gives the following information:

“Since the beginning of 2020 when Covid-19 began to spread quickly around the world, 5,293 patent applications related to Covid-19 have been published across 49 patent offices, including diagnostics, treatments, vaccines and any other references to either the SARS-CoV-2 virus or Covid-19 infection. Among these, 417 patent applications related to the development of Covid-19 vaccines were filed in 19 patent offices and 1,465 related to Covid-19 therapeutics filed across 31 patent offices.”

These are mere claims, not inventions; claims that can be killers, if not controlled.

The facts disclosed by WIPO in this statement need to be taken serious notice of, by the world community and more importantly by India, about the gross and most damaging use of the patent system by unscrupulous claimants.

The fact that within a short period of two years, 5,293 patent claim came to be filed in 49 patent offices reflects on the frivolous, repetitive and fraudulent patent claims. Apparently there was no R&D involved. These were nothing but mere experimental confirmation of the established scientific knowledge by person of ordinary skill in the pharmaceutical filed, being wrongfully claimed as patentable inventions.

What the world community and India in particular, need to take serious notice of, is the fact that it is such frivolous patent claims that are sought to be patented to monopolise vital life saving drugs, thereby denying/limiting access to such drugs to millions and millions of citizens, whose lives are threatened by the pandemic Covid-19.

Not only is gross abuse of the patent system involved, but even threat to the very lives of millions and millions of potential Covid victims are put at risk. This is nothing but profiteering at the cost of human life.

For India, these facts hold out a serious threat and warning, such claims do not qualify or satisfy the test of patentability, namely inventive step and non-obviousness, and must be rejected instantly and finally. India has been under constant pressure from big pharma and USTR to relax patenting standards and to delete Section 3(d) of Patent Act 1970 (PA’70).

In fact, WIPO’s statement is a serious warning to India against accepting such patent claims.

India needs to take serious notice and urgent amendments of patent act 1970 (PA70)
    i. To control and eliminate frivolous and fraudulent patents;
    ii. To make the provisions for opposition to grant of patents, more effective to eliminate frivolous, repetitious and fraudulent patent claims;
    iii. To provide for grant of Compulsory Licenses (CL) more effective;
    iv. To restrict remedies for infringement of drug patents only to monetary compensation.

This is not only a matter of fundamental and human rights of citizens, guaranteed by the constitution, but even more importantly, a matter of life and death for millions of citizens, which must be taken up urgently.

The amendments to Sections 22 to 25 of PA70 in 2005, are designed to defeat even genuine opposition to patent grant, and need to be reversed.

This being a matter not only of citizens fundamental right and even more of their lives and health, but also of sovereign functions and duties of the State, mandated by the constitution, particularly Article 47.

The gravity and urgency of the matter cannot be overemphasized. A reference to the actual experiences in USA of frivolous, fraudulent and repetitious patent claims and grants emphasizes the need of introducing the necessary amendments to avoid such patent claims and grants in India.

The statutory provisions of Sections 102 and 103 of US Patent Act contain provisions similar those in India and in compliance with Article 27 of TRIPS Agreement. However, taking advantage of tremendous pressure of work, at the US Patent Office, big pharma companies, acquire and hold thousands of patents for drugs and pharmaceuticals, which apparently do not satisfy the prescribe patenting standards several frivolous and repetitive patent claims have been claimed and acquired by them during last two decades. Few extracts from relevant report on the subject are reproduced below as warning for India against such patent claims.

Product hopping
The process or practice of extending patent protection, especially for a drug, medical device, etc., typically by making changes to a product whose patent is due to expire, in order to apply for a new patent for the updated product.

In the case of Mylan Pharmaceuticals Inc. vs. Warner Chilcott Pub Ltd dated 2015 the Court noted: - “involves allegations of one such way to defeat substitution laws called ‘product hopping’ - the practice of making trivial and non-therapeutic changes to existing drugs that make generic substitution laws inapplicable to the new formulation. The panel generally acknowledged that product hopping could amount to anti-competitive conduct----”

Such claims are strongly condemned by Eminent Former US Congress members – Ms Collins and Mr Brown – ploy by big companies, the relevant extracts are reproduced below:
    • “We heard in committee examples of the brand name manufacturer making extremely minor changes, such as in the color 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”. (Ms Collins Addressing US Senate on Bill S. 812 in 2002).
    • “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.---” {Mr Brown Source - Greater Access to Affordable Pharmaceuticals Act of 2001 – (H.R. – May 07, 2002)}

Multiple frivolous patent claims
A recent (December 2021) official report issued by a Committee on Oversight and Reform of US House of Representative, gives these most shocking information about repeated, frivolous patent claims.
    1. Pfizer has secured 69 patents in respect of its pain management drug Lyrica blocking competition for 32 potential years;
    2. AbbVie has secured 130 & 88 patents for its drug Humira & Imbruvica, blocking competition for 39 and 29 potential years respectively;
    3. Sanofi has secured 49 patents in respect of its drug Lantus, blocking competition for 37 potential years;
    4. Amgen has secured 39 patents in respect of its drug Enbrel, blocking competition for 47.5 potential years;
    5. Celgene has secured 109 patents in respect of its drug Revlimid, blocking competition for 40 potential years.

“Collectively, the companies in the Committee’s investigation have obtained over 600 patents on the 12 drugs examined, which could potentially extend their monopoly periods to a combined total of nearly 300 years. For just six of the drugs in the Committee’s investigation, the companies were issued almost 500 patents, collectively providing more than 200 years of potential market monopolies.”

Obviously, such patent claims and grants are in direct contravention of the statutory provisions and TRIPS Article 27.

An independent inquiry made at the Indian Patent Office will show that the patent claimed and acquired by big pharma in India after 2005 are also frivolous, fraudulent and repetitive.
 
(Author is an advocate based in Mumbai)

 

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