Call for product patent review

While accepting the fact that new chemical entities (NCEs) involves high cost and time, the justification for strong patent regimes does not hold true for other claims. As against an average of 50 NCEs developed a year, the number of patent claims runs into thousands.

This shows that NCE invention are only a very small fragment of total pharma research. Thus he argued that a law can not be designed to protect 50 NCEs’ and close the door to R&D of thousands of other innovations andimprovements.

During the 10 year period 1982 to 1991, patent protection which was progressively strengthened and R&D costs multiplied, in almost all advanced countries the number of NCEs brought out has decreased. Out of more than 80 countries having strong product patent regimes, during the last two decades or more only 8 countries developed NCEs’.

Patel said that modern patent regimes allows for the patenting of discoveries as well as inventions. This covers claims on products of nature and living beings including micro-organisms and animals. They also allow for patenting of new uses and new combinations of known drugs with insignificant changes in strengths and having virtually the same effects. Modern patents also allows for widest coverage for claims giving full scope to the `doctrine of equivalence’.

Herein millions of compounds are claimed just on the basis of the development and disclosure of only a couple of compounds.

Patel said that the impact of such a strong product patent regimes wouldblock efforts in pharma R&D. By granting exclusive rights, not only for an original molecule but also for thousands of compounds, all analogues, esters, salts, molecular substitutions, formulations and even their uses would be reserved exclusively for the patentee for both R&D and commercial use.

The patentee can keep on extending this monopoly, by successively and periodically claiming patents for molecular substitution products, salts, esters, formulations and their uses and even different forms. Ranitidine — form 1 and form 2 is a case in the point. Pressing on the point, Patel said that in the last 70 years research in modern drugs has progressed very fast with discoveries of important drugs like penicillin etc.