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Pharma should not ignore India

It’s complicated, but multinational pharma cannot ignore a market with one billion plus people
India

At a recent healthcare conference in San Francisco, I had the chance to sit down with four executives from different healthcare companies and we talked about current 'hot topics' in life sciences. The dialogue quickly turned to India's recent spate of patent 'strikedowns' and the implications of this for both the subcontinent and beyond.

The list of drugs that have lost exclusivity in India is staggering - Herceptin, Glivec, Iressa and Pegasys - just to name a few. And there are more to come as India looks to generics and biosimilars to provide financial relief for life-saving drugs for the country's poor. And this, without question, is the issue. India's battles with multinational pharmaceutical companies have nothing to do with intellectual property protection per se, but rather this is an attempt to reign in the spiralling cost of healthcare in a country where the rupee's valuation has taken an immense hit in the past year. The rhetoric between India and multinational pharmaceutical companies has become nasty in recent months with Fortune 500 CEOs and US government officials getting involved and exchanging barbs in the media and expressing grave concern during official state visits.

India's position on this matter is that some of the patent extensions being filed in their country on drug molecules are nothing but shameless attempts to squeeze generic manufacturers out of the picture so that they can enjoy unabated exclusivity on product at price levels that are prohibitively high for the average Indian patient. The truly fascinating tangential issue that has been brought forth as a result of this situation is India's interpretation of what actually constitutes 'innovation' insofar as pharmaceutical molecules are concerned.

There is no surprise to anyone that India, like most nations, is concerned about providing access to drugs that are cost-effective. And there is no surprise that India, like most nations, is struggling deeply with how to control an increasingly high level of healthcare spending as a proportion of GDP. A recent US trade report stated that “India's prohibition on patents for certain chemical forms absent for showing of 'enhanced efficacy' may have the effect of limiting the patentability of potentially beneficial innovations”. With specific reference to Novartis' Glivec, the Indian Supreme Court ruled that, in its view, there was no new invention and no new substance used in the drug. The same report went on to add that “the decision appears to confirm that India's law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application”. 

So India's highest courts are capable and confident in characterising that a pharmacokinetic modification resulting in a drug's absorption through the GI tract as opposed to the liver, or that a change in a drug's dosing from once-a-day to twice-a-day, or that a change in a drug's delivery system are not all individually true innovation? To be clear, this is not the issue that resulted in the denial of patents in the Glivec case, however, these are all inventive steps with industrial application.

Further complicating this issue is that it appears to some who have reported on this ongoing situation that the decisions made by India's highest courts appear, in part, to be based on innovator company decisions to import their products into India as opposed to manufacturing them locally. So, in order to protect their innovation and intellectual property, manufacturers could be forced to set up manufacturing operations in India or face the prospect of giving up their licence to local Indian generic manufacturers.

The rhetoric between India and multinational pharma companies has become nasty in recent months

As always, the expression 'follow the money' holds true. Multinational pharmaceutical manufacturers cannot ignore a market with one billion plus people. The Indian government, faced with spiralling drug costs and looking for ways to control spending, cannot ignore the fact that by striking down patents and allowing local manufacturers to manufacture drugs they will save the health system money. Local manufacturers, with the help of the Indian government, cannot ignore the fact that they stand to reap great financial reward by virtue of forced partnerships with multinationals and/or the opening up of pharmaceutical blueprints for production of biosimilars. 

The larger question will be what other jurisdictions do in the face of this approach by the Indian government and courts and whether they, too, decide that a reinterpretation of what constitutes innovation is in order. Surely, many nations are watching and waiting.

Article by
Rohit Khanna

managing director of In Vivo, a communications, advertising and strategy agency. He can be reached at rohit@nvvo.ca

27th November 2013

From: Sales, Regulatory, Healthcare

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