Wednesday, January 19, 2005

NY Times editorial on Jan. 18 criticizes Indian patent policy

In an editorial on January 18, 2005, the New York Times criticized the Indian patent ordinance which became effective on January 1, 2005, which ordinance was for the purpose of India's compliance with WTO requirements.

One interesting thing about the editorial is that it criticizes the Indian government for not doing things that the United States has not done either.

For example, it criticizes the Indians for not making compulsory licenses easier to obtain, especially for AIDS drugs. The United States has not invoked compulsory licenses for AIDS drugs (though it did invoke them for airplane patents (eg, that of the Wright Brothers) during World War I.

It states Malawi, for example, could not import from India an inexpensive version of a medicine that is not under patent in Malawi. Can't import it from the US either, if the drug is under patent in the US.

It states that the decree would limit efforts to challenge patents before they take effect. It is talking about patent oppositions. There are no patent oppositions in the United States, either.

As to selling patented medicines to India's huge middle class, most of current consumption in India is of drugs patented before 1995, which are not covered by the Indian ordinance. This is more generous than in the United States, where in-force patents prior to 1995 do protect drugs.

So-called "evergreening" (as to polymorphs, enantiomers) currently exists in the United States.

There may indeed be some issues to discuss, but blaming India for taking actions similar to paths taken in the United States is absurdly inconsistent, a case of seeing the black pot but not the adjacent black kettle.

The editorial -->

For an AIDS patient in a poor country lucky enough to get antiretroviral treatment, chances are that the pills that stave off death come from India. Generic knockoffs of AIDS drugs made by Indian manufacturers - now treating patients in 200 countries - have brought the price of antiretroviral therapy down to $140 a year from $12,000.

That luck may soon run out. India has become the world's supplier of cheap AIDS drugs because it has the necessary raw materials and a thriving and sophisticated copycat drug industry made possible by laws that grant patents to the process of making medicines, rather than to the drugs themselves. But when India signed the World Trade Organization's agreement on intellectual property in 1994, it was required to institute patents on products by Jan. 1, 2005. These rules have little to do with free trade and more to do with the lobbying power of the American and European pharmaceutical industries.

India's government has issued rules that will effectively end the copycat industry for newer drugs. For the world's poor, this will be a double hit - cutting off the supply of affordable medicines and removing the generic competition that drives down the cost of brand-name drugs.

But there is still a chance to fix the flaws in these rules, because they are contained in a decree that must be approved by Parliament. Heavily influenced by multinational and Indian drug makers eager to sell patented medicines to India's huge middle class, the decree is so tilted toward the pharmaceutical industry that it does not even take advantage of rights countries enjoy under the W.T.O. to protect public health.

In November 2001, members of the World Trade Organization agreed that countries can issue compulsory licenses to permit generic production of patented drugs without the patent holder's agreement in order to protect public health, at home or abroad. But under the Indian decree, getting a compulsory license would be slow and difficult; each application would face a fight from multinational drug firms and the governments that do their bidding. India should adopt laws that expedite compulsory licenses, including allowing challenges to proceed after production begins instead of holding it up. In addition, India must close an important loophole affecting the sick overseas: under the current rules, Malawi, for example, could not import from India an inexpensive version of a medicine that is not under patent in Malawi. This needs to be changed.

Industry lobbyists managed to insert two noxious provisions in the decree that go well beyond the W.T.O. rules. The decree would limit efforts to challenge patents before they take effect. Also, it is uncomfortably vague about whether companies could engage in "evergreening" - extending their patents by switching from a capsule to tablet, for example, or finding a new use for the product. This practice, a problem in America and elsewhere, extends monopolies and discourages innovation.

While some drugs - those that existed before 1995 - will always be off patent in India, some widely used drugs are at risk. So are new generations of much more expensive AIDS drugs that will soon be needed worldwide as resistance builds to current medicines. If the decree is not changed before Parliament approves it, it will be very difficult for India to supply them. India's parliamentarians must keep in mind that this arcane dispute is actually a crucial battleground for the health of hundreds of millions of people in India and worldwide.


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