The last minute efforts of Indian pharmaceutical industry representatives to convince the union commerce minister Kamal Nath for changes in the Patent Amendment Bill, which is to be tabled before the Cabinet on August 25, 2004 seems to have met with little success. By all indications, the government is prepared to re-introduce the bill without any changes.

While industry associations like Indian Drugs Manufacturers Association
(IDMA) and Indian Pharmaceutical Alliance (IPA) have been asking for changes in at least two areas of the proposed bill, Organisation of Pharmaceutical Producers of India (OPPI) is known to have expressed satisfaction over the present structure of the bill. Even though the minister had given a patient hearing, the industry representatives feel that the government may not make any last minute changes in the bill.

According to sources, the government prefers to have the bill passed in its present form, with an option to make necessary amendments at a later stage.
The government sources however, denied that the bill was being planned to be introduced without any changes. They said that the government has made changes in the bill and were willing to make any relevant changes after hearing industry views.

Meanwhile, the IPA in its representation, expressed regrets over the
government's move to re-introduce the bill without any changes. "If this is so, we would find it extremely distressing as it would not only completely ignore our views, but more importantly, it would also amount to overlooking an opportunity to make a decisive use of the flexibilities under the TRIPS
Agreement," IPA said.

According to them, the government can minimize the burden on the consumer arising from higher pricing of patented medicines and create the conditions for the domestic industry to become a major player in the global
pharmaceutical industry by making just two changes in the bill.

Attracting the attention to the Section 3 of the Act, which defines inventions that are not patentable, IPA said that a further exclusion from patentability for new forms of previously patented compounds (polymorphs, metabolites, improved purity or stability, isomers and the like) would ensure that marginal changes or improvements in previously known compounds that merely serve to increase patent life and delay entry of generic would not be patentable.

Similarly, "Section 25 as it stands, provides the right of hearing in pre-grant opposition proceedings. The proposed amendment to Section 25 removes this right of hearing and provides it only post grant. The continuance of the present Act without change would assist the Patent Controller in ensuring that fraudulent, unlawful and frivolous patents are not granted even by mistake. It would also result in timely disposal of the patent applications as all parties to the dispute would not have any incentive to prolong the matter," the association stated.