SC to decide pharma patent, take up marines case

In a judgment that would have a far-reaching implication for the Indian pharmaceutical industry, the court will rule on Novartis AG plea seeking a patent for the beta-crystalline form of imatinib mesylate, which is used in the treatment of chronic mycloid leukaemia.

International drug makers are critical of Section 3(d) of the Indian Patent Act which says that mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance does not qualify for patent protection.

The Supreme Court. File Pic

Novartis has contended that there could be a situation where a product which is an innovation under 2(j) and 2(j)(a) of the Patent Act is sought to be denuded of invention under 3(d) in terms of pharmaceutical "efficacy".

Section 3(d) of the Patent Act seeks to thwart the "ever greening" of the pharmaceutical products with minor changes in the content and form without any innovation. Section 2(j) and 2(j)(a) deal with the grant of innovation to the product claimed to be original and a novelty.

The global drug makers have contended that Indian patent law does not encourage innovation and criteria of efficacy under Section 3(d) are not clearly defined.

The next important judgment will be on Tuesday on the plea by Sterlite Industries India Limited challenging the Madras High Court order directing it to close down its Tuticorin copper-smelting plant for violating environmental norms.

The Madras High Court, by it Sep 28, 2010 order, had directed the immediate closure of the plant. The apex court, by its interim order of Oct 1, 2010, had stayed the operation of the high court order.

However, the Tamil Nadu Pollution Control Board (TNPCB) Friday ordered closure of the plant with immediate effect, and power supply to the plant was cut off. The TNPCB order comes after the leakage of noxious gas from the plant March 23.

The case of two Italian marines Massimiliano Latorre and Salvatore Girone, which had become a hot diplomatic and legal issue after Italy reneged on the undertaking given by its Ambassador Daniele Mancini on their return, is listed before the court of Chief Justice Altamas Kabir Tuesday.

The court may have a fresh look on its earlier order restraining Italian ambassador Mancini from leaving the country. In the course of the last hearing of the case, the court had clarified that its orders for the promised return of two maries has not been violated as they were to be back by March 23, 2013.

It may also deal with the status of the charge sheet pending before the Kerala trial court as it had already ruled that Kerala Police had no jurisdiction over two marines.
u00a0