Protect lives, and law

: Mix two complex subjects (patent law and pharmaceutical chemistry), add one seemingly obvious statement (lifesaving drugs must be “affordable”), shake vigorously to produce public indignation, and you get a dangerous solution. That solution is: patents are anti-patient. So, following the Delhi high court’s interim order in Roche versus Cipla, there’s already happy talk of a new paradigm where Big Pharma will not be able to gouge little people. Let us all wait for the court’s final order. But while waiting let’s stop bashing Big Pharma for a bit and ask the Big Question.

The Big Question is this: is busting patents the best way to increase access to lifesaving drugs?

Indian law allows pre and post-grant challenge to a patent. It also says if a patented drug was produced and marketed before 2005, a generic manufacturer can reverse engineer the product after paying “reasonable” royalty to the patent-holder. There’s also a compulsory licence provision that allows the patent-holder’s exclusive right to be challenged three years after the patent date. The provisions under which this clause can be invoked include public availability at reasonable price. The three-year wait can be suspended in case of a public health emergency.

Now consider the Roche vs Cipla case. Roche was granted marketing rights for its anti-cancer drug, Tarceva, in July 2005. That means Cipla couldn’t use the pre-2005 exception to sell a generic version. The Tarceva patent was granted in July 2007. Cipla didn’t challenge the patent pre or post-grant with the patent authority. Pre and post-grant challenges are common. Indian pharma companies like Ranbaxy, Ajanta Pharma and Torrent have challenged patents granted to MNCs like Eli Lilly, Pfizer and

AstraZeneca. Wockhardt has issued a post-grant challenge to Roche’s hepatitis C drug, Pegasys.

All this is unexceptionable.

But Cipla has manufactured a generic version of a newly patented drug, therefore invited litigation and only then challenged the validity of the patent. So it has questioned a patent by violating it. And since it is already marketing its anti-cancer generic drug, the question about Roche’s patent has now got linked with market price in popular discourse. Prices of lifesaving drugs are not a non-issue. But it has to be understood that the validity of Roche’s Tarceva patent is a matter of chemistry, not economics.

Let us clarify here that we have no position on whether Roche’s Tarceva patent is scientifically valid or not; the court will decide that....

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