Drug Regulation Patent

Split Wide Open: Patent on Stomach Medicine effectively monopolised.

In a revelation that has sent shockwaves in the Pharma industry, Reckitt Benckiser was allegedly found to have extended the monopoly they had on the stomach medicine “Gaviscon”!

Internal documents that were recently leaked to the public, indicate that the Company had schemed with NHS to avoid releasing a generic name for the product in 2000. This was achieved by extending influence over the regulatory bodies. Therefore, on payment of an exorbitant amount (incidentally, three times higher than for any generic drug) to the NHS, the Company still enjoyed effective monopoly over this market.

As if this was not indication enough of the dishonesty of the Company, it has also been reported that the same procedure was used in 2003 and 2005 to avoid releasing a generic name. In each case, Reckitt cited health and patient safety as the reason for its objections, however excerpts from the internal documents are testament to the fact that top executives favoured such practice for profit.

In what is probably more shocking:

  1. Gaviscon enjoys about 88% of the market monopoly to date- still without a generic name.
  2. Generic copies of the drug would have saved the budget of about £ 40 million since 1999
Reckitt has however denied all charges and still claims to be a responsible company, with no control over the timetable of the issue of the generic name. The matter is now to be put before the Parliament.

However, what does this mean for the Indian patent scene? The implication is at least to learn from mistake of others. The time has come for India to expand the ‘patentability criteria’ in Section 3 (see especially 3 (d) included by amendment in 2005) to curb evergreening of patents. A look at the current laws would show us that focus on drug regulation is abysmal and the time is now to prevent the same from happening in our country.

Find reports on this story here, here, here and here.

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  1. Anonymous

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