Media reports are now abuzz with various stories related to intense pressure being created by Big Pharma on the United States Government to declare India as a ‘Priority Foreign Country’ for initiating ‘Trade Sanctions’.

As we know, ‘Priority Foreign Country’ is the worst classification given by the United States to “foreign countries” that deny “adequate and effective” protection of Intellectual Property Rights (IPR) or “fair and equitable market access” to the US.

One of the key factors that infuriated Big Pharma is the ‘patentability’ criterion of the Indian Patents Act 2005 captured in its section 3(d).  This denies grant of patent to those inventions, which are mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy, offering no significant treatment advantages over already existing drugs.

A brief perspective:

The sole requirement for any company to enjoy market monopoly with a medicine, for a specific period, with its associated commercial advantages, is obtaining a valid patent for that new drug substance from a competent authority of the concerned country. Marketing approval process and other requirements for the same of the drug regulators do not come in the way of the market monopoly status granted to patented products.

This is mainly because the drug regulators do not require to be convinced that a new drug is an improvement or more effective than the existing ones. As a consequence of which, there has been no compulsion for the Big Pharma to bring to the market only those New Molecular Entities (NMEs) that would significantly improve efficacy of a disease treatment benefitting the patients.

Choosing the easier path:

Developing any NME that is a breakthrough in the treatment of a disease is not just difficult and time consuming, it is very risky too. For this reason, once a new innovative drug gets well established in the market, many companies decide to produce their own versions of the same and obtain patent rights for the new ‘tweaked’ molecules, as is generally believed by many.

This approach of bringing ‘me-too’ types of so called ‘innovative’ drugs into the market is considered much less risky, takes lot lesser time in the R&D process, not as expensive and most importantly, enjoys all the commercial benefits that a break through NME would otherwise derive out of its invention, especially the market monopoly with free pricing.

In his well-known book titled ‘Bad Pharma’, Ben Goldacre stated that, as very often these ‘me-too’ drugs do not offer any significant therapeutic benefits, many people regard them as wasteful, an unnecessary use of product development money, potentially exposing trial participants to unnecessary harm for individual companies commercial gain, rather than any medical advancement.

‘Innovation’ of ‘me-too’ molecules:

Examples of some of the ‘me-too’ molecules are as follows:

• Cemetidine – Ranitidine – Famotidine – Nizatidine – Roxatidine (to treat Acid-peptic disease)

• Simvastatin – Pravastatin – Lovastatin – Pitavastatin – Atorvastatin – Fluvastatin – Rosuvastatin (to treat blood lipid disorder)

• Captopril – Enalepril – Lisinopril – Fosinopril – Benzapril – Perindopril – Ramipiril – Quinalapril – Zofenopril (Anti-hypertensives)

Goldacre further highlighted in his book that despite this fact, pharma market does not behave accordingly. Unlike usual expectations that multiple competing drugs in the same disease area would bring the prices down, a Swedish data showed that the drugs considered by the US-FDA as showing no advantages over the existing ones, enter the market at the same or even at higher prices than the original ones. Consequently, the outcome of such innovations adversely impacts the patients and the payor including the government, as Big Pharma takes full advantage of market monopoly and free pricing for such drugs in the garb of innovation.

‘Innovation’ of ‘me-gain’ molecules:

Unlike the above ‘me-too’ drugs, which are new molecules, though work in a similar way to the original ones, another kind of patented drugs have now come-up in a dime a dozen.

Goldacre defined those drugs as ‘me-again’ drugs. These are the same molecule re-launched in the same market at the same price with a different patented ‘enantiomer’. Each of a pair of such molecules is a mirror image of each other e.g. esomeprazole (Nexium) is the left-handed version of the omeprazole molecule (Prilosec), which is a mixture of both left and right handed forms.

There is no dramatic difference between omeprazole and esomeprazole in any respect. Moreover, it is worth noting that concerned constituents of Big Pharma come out with ‘me-again’ drugs only at the end of the patent lives of the original ones. What then could be the reason?

Some examples of ‘me-again’ drugs are as follows:

Enantiomer/Brand	Medical Condition	Original Drug/Brand
Levocetirizine (Vozet)	Allergies	Cetirizine (Zyrtec)
Escitalopram (Lexapro)	Depression	Citalopram (Celexa)
Esomeprazole (Nexium)	Acid reflux	Omeprazole (Prilosec)
Desloratadine (Clarinex)	Allergies	Loratadine (Claritan)
Pregabalin (Lyrica)	Seizures	Gabapentin (Neurotonin)

Why do the doctors prescribe such drugs?

That is indeed a good question, why do the doctors prescribe such costly, avoidable and so called ‘innovative’ drugs? Well, don’t we know that already?

Section (3d) plugs the loophole:

To discourage market entry of high priced and avoidable ‘me-too’ and ‘me-again’ types of drugs that are also an outcome of so called pharma ‘innovations’, the Indian law makers very wisely introduced the section (3d), while amending the Indian Patents Act in 2005. This section, as indicated above, categorically states that inventions that are mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable. This law has also passed the scrutiny of the Supreme Court of India in the Glivec case of Novartis.

With this Act, India has unambiguously reiterated that it does not support the grant of patents for inventions that are minor modifications of the original ones, effectively blocking the usual path of patents grant as followed by Big Pharma across the world to enjoy monopolistic commercial advantages of ‘frivolous’ innovations, as called by many experts in this area.

Consequent ire of Big Pharma:

This above action of Indian law makers has raised the ire of Big Pharma, as it has a huge commercial interest to protect ‘me-too’ and ‘me-again’ types of innovations in India, even if that comes at the cost of patients’ health interest.

Section (3d) of the Indian Patents Act, therefore, became a major hindrance in meeting the commercial goals of its constituents in India, as such molecules constitute a large majority of the total number of NMEs innovated globally.

As intense power-packed advocacy campaigns of the global pharma companies with the Government of India did not yield any meaningful result to get the section 3(d) amended, it unleashed the might of its well funded lobby groups having free access to the corridors of political power to play hardball with India, riding the horse of innovation and pooh-poohing patients’ interests.

Playing hardball:

The question therefore arises, would India tactfully reciprocate playing hardball or give in to the pressure of trade sanctions under ‘Priority Foreign Country’ categorization of the United States?

I reckon India would not give in. To state more emphatically, India just cannot give in now, under any circumstances.

Come May 16, 2014, the new Union Government of India would almost be ready take its position on the saddle. Thereafter, even if it prefers to give in to intense US political pressure just to avoid trade sanctions, in all practicality that would virtually be a non-starter. This is because, the new Government would unlikely to be in a position to garner enough votes in the Parliament to amend the section (3d), ignoring the general sentiment on this important public health related issue and political compulsions of many of its constituents on the subject.

Would America go to WTO?

Would the United States of America ultimately complain against India in the multilateral forum of the World Trade Organization (WTO) for alleged violation of the TRIPS Agreement? That is exactly the question that many people are asking today.

In this context it is worth noting, India has reiterated time and again that Indian Patents Act 2005 is in full compliance of the TRIPS Agreement and the Doha Declaration of 2001.

Since, no country has complained to WTO against India on this issue, as yet, despite so much of posturing and the noise generated the world over, it appears improbable that the US would now do so, though Big Pharma would continue playing hardball raising the same old bogey of protection of ‘innovation’ in a much higher pitch, cleverly camouflaging its hardcore vested commercial interests.

What happens, if WTO decides in favor of India?

In the multilateral forum, if the WTO decides in favor of India, there is much to loose for Big Pharma.

In that scenario, the Indian example would encourage a large number of countries to enact similar model of Patents Act fully complying with the TRIPS agreement, as vetted by the WTO.

Some has termed it as a refreshingly fresh “Alternative Model of Patent Law’, going away from the dominant IP model as is being propagated by the US.

As I had indicated in the past, countries like the Philippines, Brazil and South Africa have either emulated or strongly favoring this alternative model that favors protection of Intellectual Property (IP) and at the same time promotes access to new inventions to a large majority of the global population.

Conclusion:

I reckon, Big Pharma’s playing hardball with India, riding the horse of ‘innovation’, could ultimately boomerang.

The Government of India, irrespective of any political color, lineage or creed, is unlikely to be bullied by Big Pharma constituents any time soon.

More importantly, even in a worse case scenario, the Government would be incapable of getting the section (3d) amended by the Indian Parliament garnering majority of the lawmakers’ support and going against strong political and public voices on this issue.

Nevertheless, Big pharma would continue to wish it to happen… and that drags me to the good old saying:

“If wishes were horses, beggars would ride.”

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.