Reader response: patents and India

The Economic Times web site carried an article from Tapan Ray [director-general designate, Organisation of Pharmaceutical Producers of India].

This has set a reader thinking and he has given his views on the article. Below is the article and his comments [as is]. Sensing that this is a potentially explosive situation, I have been requested to NOT share the identity and accordingly, I only set the text.

I invite you all to share your views on this matter.

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http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotech/Towards_better_medicines_Need_for_incentives_to_innovate/articleshow/2573985.cms

The Reader’s comments are in BLUE, while the article text is in black.

Towards better medicines: Need for incentives to innovate
By Tapan Ray

Ever since the passing of the Third amendment to the Patents Act, increasingly strident voices have been raised against pharmaceutical patents. The discourse on pharmaceutical innovation and patents has often been hijacked by emotive voices confusing the debate by raising accessibility and affordability of medicines.
Yes, I agree that there has been hijacking. But this hijacking has been done by both sides - so called Innovator companies and the generic companies/ NGOs.

Pharmaceutical companies have been accused of filing “frivolous patents” or “bogus patents” over “small” or “trivial” inventions in order to maximise market exclusivity. These allegations are unfounded and stem from a naive approach towards patents in general and pharma patents in particular.
These allegations are NOT frivolous and the approach not necessarily 'naive'. The Patent Office has issued rejections for applications only after the NGO/ generic company has convinced that there is no patentability in the specific application.
More so the fact that 'Innovator' companies are withdrawing their applications is also a testament that they too feel their "inventions" are not water tight.

There is either a paucity of understanding of the process of pharmaceutical inventions or else the concerns over pharma patents are guided more by ulterior motives than by logic and objective factual analysis.
There may be some paucity amongst the general public. But the people who are opposing the patents have a strong sense of Indian patent law.

Inventions in high technology areas like pharmaceuticals almost never happen through a “eureka” moment or flash of genius by an isolated inventor. Instead, inventions usually come from a team of scientists and technologists working together, resulting in a series of seemingly small steps advancing from the existing knowledge – the prior art - all contributing to the ultimate innovation. This is certainly the case in pharmaceuticals and in most high technology sectors, for example automobiles, computers, mobile phones, televisions, cameras, printing inks, composites, pesticides etc.
Yes, inventions increasingly are not a result of a eureka moment but that does not impact the patentability of the same. If the invention passes the muster of our legal standards, then it should merit grant of a patent, else not. Merely the fact that is an application filed on behalf of 5 inventors should not make any difference.

The simple invention of the wheel thousands of years ago was the starting point for innovation in land transportation which developed stepwise in small incremental advances to the sophisticated innovatory transport systems we have today. Innovatory development is no different in the case of pharmaceuticals, building stepwise on existing knowledge and experience with additional creative/scientific thinking, research and trials to produce the valuable end-product.
Each advance over the existing art requires strenuous research and development and financial investment since the success of the work cannot be guaranteed – in the case of new drugs where the development takes place over many years, the investment is at risk right up to the point of launch for lack of safety or effectiveness. Such financial risk and efforts must be incentivised and rewarded by effective patent protection.
During any pharmaceutical development a number of problems inevitably have to be solved and the solutions may well involve patentable inventions such as improved or alternative processes and new formulations and presentations of the active ingredient.
None of these can be considered ‘frivolous’ if they satisfy the globally accepted standards of patentability, viz. newness and inventive step over what is already known and industrial applicability. It should not then be a surprise that companies have filed several different patents covering a new product development. The same practice is followed in other technology areas with analogous families of patents protecting different aspects of the product, for example computers and mobile phones.
In all areas of technology many inventions can look “trivial” once someone else has made them. Consider for example safety pins, ball point pens, flip-top mobile phones etc. which although relatively simple in relation to the prior art are now regarded as truly innovatory by virtue of their impact on society. Even experts find it difficult to categorise inventions as “breakthrough” or “fundamental” on one hand, or “adaptive”, “cumulative” or “incremental” on the other.
No patent systems in the world now attempt to use such an impossible standard in the process of deciding whether to grant a patent on a particular invention. No patent systems in the world have introduced an extra hurdle denying patents to inventions which lack “improved efficacy” – whatever that means – over any known counterparts like India which did so through the Section 3(d) exclusion. Other patent systems simply require that the invention involves an inventive step however apparently small over what is already known in the prior art – often referred to as the “scintilla” of invention.
There are no globally accepted 'gold standards' of patentability. Even the US has now re-looked at its stand on obviousness/ patentability and turned/ invalidated patents on salts [Amlodipine] and pure forms [Ramipril]. This new US view will be tested further as important cases on enantiomers [Esomeprazole] also come to judgment. So criticizing 3[d] is not the solution. I do believe that the present situation of 'increased efficacy' may cause heart burn, but the at least the part relating to non recognition of salts/ esters/ polymorphs/ particle sizes etc as patentable inventions, is definitely the right standard for arguing obviousness.

So innovation is itself fundamentally incremental in nature and only becomes really apparent after the introduction of inventions to the marketplace. The attempts to classify inventions (and the innovations that result) as “frivolous” or “bogus” and so not deserving of recognition and encouragement simply because they are incremental is illogical and guided by ulterior motives.
Such a move will limit further progress in the pharmaceutical arts and must be resisted if serious damage to India’s knowledge economy is to be avoided.
Pharmaceutical arts are already in the dumps, not because the standards of obviousness are high [or impossible as per Mr. Ray] but because less money is now being focused on basic NCE research and a much larger amount is being spent on finding me - too drugs
Closing down R & D sites/ creating hype around diseases is possibly all that big pharma is doing these days. The data relating to each company's drug pipe line is in public domain. How many of these innovator companies are working on totally new drug therapy areas?

People worldwide have benefited enormously from stepwise innovation in medicines used to treat a variety of acute and chronic diseases. It may be unnecessary to develop several drugs for use in the same class such as those for use in treating particular heart disease or infections. Yet the existence of a range of drugs with a similar medical action enables physicians to treat the individual needs of diverse patients with greater precision and certainty of outcome.
I seriously beg to differ. Using human drugs for depression for animals/ finding drugs for diseases which are not even scientifically quantifiable are being touted as the benefits to mankind. The data on how one SSRI drug was earlier touted as the best and how it later came to be known that there difference was hyped is there for every one to read. Let us face it: Both Innovator and generic lobbies have their short comings.
Innovator' are not doing interesting research and generics, all said and done, are copy cats. Business is impacted for both and hence both sides are crying hoarse with out showing the full picture.

Incremental drug treatment innovations can bring benefits in many different forms. A new medicine may be more effective in treating a particular medical condition. It may improve patient compliance through improved dosage and forms of administration. It may be more stable and no longer need to be stored in a refrigerator. It may cause fewer side effects by releasing the active ingredient in a more carefully controlled manner.
Incremental medical innovation may often result in greater overall efficiency by reducing the need for close medical supervision or hospitalisation, improved patient responsiveness, reduced side effects etc, adding up to one outcome: better value for money.
Incremental innovation may be good. But the key question is whether it is passing the standard of patentability. As we saw in Amlodipine, specific salt selection was touted on account of manufacturing advantage by the innovator. But later in the judgment, mere salt selection from a known set of possible salts was held as not being inventive. Similarly, in Ramipril, creating of purer form would be an incremental innovation. But would that be patentable? The US law itself does not seem to think so.

India now has the necessary skills to engage in all aspects of pharma R&D. This is especially the case with the development of new dosage forms and drug delivery systems, which are well suited to the Indian industry’s stage of development and capacity to spend on R&D. However such expensive R&D won’t be undertaken by anyone unless it is actively encouraged by providing adequate strong IPR protection for all classes of invention.
This is not the case. Every major Indian company [which today does a majority generic business] is investing a huge amount in novel drug/ formulation research. Also, the Innovators must acknowledge that if today their 'incremental innovations' are being attacked, tomorrow, these Indian companies will also face the same heat... possibly by today's Innovators.

The nature and importance of patents as an essential enabler for a growing pharma industry in a developing country like India and objectively assess the actual role that patents play in the entire healthcare scenario. Misconceptions based on extrapolated emotive issues are detrimental both for public health and pharmaceutical innovation.
The recent changes in Indian patent law in 2005 will mainly affect new medicines which are yet to be introduced rather than existing medicines which are already marketed. Attacking drug patents will simply damage the process of innovation, which is inherently incremental in nature, and the ability of India’s own pharma industry to participate in the sector. Why consider denying pharmaceutical inventions patents because they involve seemingly small incremental changes when allowing them in other technology sectors? Is a new medical development not at least as important to India as a new mobile phone or personal stereo?
No point in comparing stereos versus medicines. The key issue here is whether present S.3d is too restrictive. As said earlier, salts etc do not necessarily cross the thresh hold of obviousness.

(The author of the ET article is director-general designate, Organisation of Pharmaceutical Producers of India)