Joining the ongoing debate on patent laws in India, drug manufacturers in the United States are putting further pressure on the government of the India to bring in some drastic changes to the existing laws to revise the standards of patentability and eliminate pre-grant oppositions, besides seeking an early decision on data protection.

The Pharmaceutical Research and Manufacturers of America (PhRMA) asked the government to amend the standards of patentability to conform to the obligations in the TRIPS Agreement and international practices.

"India was required to provide protection for certain pharmaceutical test and other data by TRIPS Article 39.3, but hast yet to do so. To obtain marketing approval of a pharmaceutical product that was first marketed outside of India, applicants must prove that the product was approved and marketed in another country and must provide test and other data from clinical studies on 100 Indian patients. Thus India is using other countries as its agents,'' PhRMA alleged in its special 301 submission 2007.

They also wanted India to provide procedure for linking the patent system with the system of granting marketing approval for generic pharmaceutical products. On the standards of patentability, they claimed that norms were inconsistent with TRIPS Agreement and departing from the mainstream practices at the international level, besides lacking transparency.

"First, Indian law does not allow second use and method of treatment patents. Section 3(d) of the Act, as amended in 2005, further creates additional hurdles for pharmaceutical patents. Salts, esters, ethers, polymorphs and other derivates of known substances are considered the same substance and not patentable unless it can be shown that they differ significantly in properties with regard to efficacy. These additional requirements are inconsistent with the TRIPS Agreement," the submission said.

This is contrary and going beyond the TRIPS, it added. "The concepts in Section 3(d) are nebulous and potentially have a broad impact, thus undermining incentives for innovation, the submission said.

Referring to Section 3(i), the PhRMA observed that WTO members were permitted to exclude diagnostic, therapeutic or surgical methods from patentable subject matter under TRIPS Article 27.3 and are considered inventions. These should be encouraged and not excluded from the patent system, while Indian law does not consider it as invention.

They also wanted India to promulgate guidelines for applying concepts used in determining patentability such as inventive step, technical advance and economic significance, to bring more transparency.

PhRMA wanted India to rectify the provision for mandatory compulsory licensing for mailbox patents, which does not allow the patent holder of a mailbox patent to preclude generic manufacturers manufacturing the patented product. In cases of compulsory license for exports, India should ensure that proper anti-diversion measures be taken and that the compulsory license itself was granted for humanitarian, non-commercial use, it further added.

Taking exception to the current practice of pre-grant oppositions which they claimed, usually caused delays in granting of a patent, they called for regulations to make it time-bound and curb the oppositions filed by competitors sequentially.