The Hindu : National : Review patents ordinance: drug companies

Online edition of India's National Newspaper
Friday, Dec 31, 2004

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National

Review patents ordinance: drug companies

By Our Special Correspondent

NEW DELHI, DEC. 30. The drug industry has urged the Government to review the recent ordinance amending the existing patents law and ensure that crucial safeguards are introduced when it is considered in Parliament. These include retaining the right of pre-grant opposition and allowing generic production of crucial drugs which may be affected by the mail box patents.

In a statement here today, the Indian Drug Manufacturers Association (IDMA) says: "the era of inexpensive medicines due to earlier process patent is becoming history and new patented medicines now will be sold at the monopoly price laid down by their patent holder owner."

It notes that the product patent system in pharmaceuticals, food and agro-chemicals is now operative as the country has issued the expected patents' ordinance to fulfil commitments under the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS).

The drug industry has expressed concern that some crucial points in the ordinance have either been left out or have been treated in a "half-hearted manner".

It has also pointed out that the issue of a three-month period for an appealable pre-grant opposition or insistence on local working does not appear in the ordinance. Hopefully, it says, these will be covered in rules expected to come out soon.

Stipulations

Among the provisions which need to be included in the final amendment, according to IDMA, are stipulations that salts, esters, polymorphs, hydrates, isomers, metabolites or changes in purity level, particle size and blood levels are not patentable being not substantially different from the original product. This will avoid litigation, it feels, and prevent "evergreening" by unscrupulous patent applicants.

Besides, it has sought retention of the right of pre-grant opposition as contained in the original Patents Act 1970. It has also proposed continued generic production of crucial drugs which are expected to be affected by the mail box patents in the interest of patients by allowing statutory royalty payment to the patent holder.

Procedures of issuing compulsory licences will have to be simplified so that such licences needed for urgently required medicines are issued expeditiously to other parties in public interest, it has stated. This will be subject to payment of reasonable compensation to the patent holder.

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