A section of pharmaceutical experts feel that the government has incorporated enough provisions in the patent ordinance to protect the interests of the domestic pharmaceutical industry. The new product patent regime, therefore, is unlikely to cause much damage as feared by the Indian industry.
The provision in the ordinance -not to allow patents on new use and new therapeutic properties of existing molecules -will help to safeguard the existing brands of Indian manufacturers. Further, the condition on mailbox applications stipulating patent rights in respect of the mailbox shall be available only from the date of grant of patent and not retrospectively from the date of publication, further ensures life for the existing brands.
Earlier, there was fear that the Indian manufacturers will have to withdraw several brands of molecules worth many crores of rupees. However, in the emerging scenario, it is expected that the need for withdrawals will be minimum, i.e., brands of maximum five to six molecules like rabiprazole or etricoxib. However, a clear picture will emerge only when the mailbox applications are scrutinized.
"We are happy that the government has agreed on the constant demands of IDMA to protect the interests of Indian manufacturers. Three months time for pre grant opposition is one such provision. They also have conceded most of our other demands. Though India also has moved into the product patent regime, the impact will be visible only later, say after one year," says S V Veeraamani, vice president (South Zone), Indian Drug Manufacturers Association.
According to T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industries (CIPI-ssi), a clear picture and the impact would be on the industry only by 2008, when around 200 odd molecules become off patent by that time. Unlike as happened in the past, the new patent regime shuts out the opportunities and aspirations of small companies to grow and become medium and large companies.
"Numerous small companies, started a few decades ago or so became medium and large companies in the past. This opportunity will not be there for the SSIs in future. Adjustments in business modules to specialize in specific areas are the only option for them now. Outsourcing and contract manufacturing opportunities will be more for SSIs in future provided they have knowledge and specialized capabilities with necessary capacities," said Jaishankar.
According to Advocate K Radhakrishnan Nair, president of IPR Awareness Forum, a Kochi-based NGO into IPR issues, the ordinance should auger well for the Indian drug industry, as well as the public, as huge increase in drug prices are unlikely to happen as feared by many people. "We are a signatory to WTO and have to oblige with those conditions. I think enough provisions have been incorporated in the amendment to protect the interests of Indian manufacturers and the public," said Radhakrishnan Nair.
The industry also says increase in drug prices are unlikely to happen, as portrayed by a section of NGOs and political parties. "IDMA's new slogan itself is 'people first, patent next'. With the percentage of patent protected drugs are minimum in the present context, the impact will be bare minimum. Prices may rise as the percentage increase, but this scenario may happen only after many years. Further, the IDMA and the government is committed to the public to see that the drug prices are not increasing. We are also socially committed," said Veeraamani.
"The drug prices of newer molecules, mainly for therapeutic areas like AIDS, CVDs, cancer, will increase as the inventor companies have monopoly. However, older molecules like Limovidine or Stavidine are there to stay in cancer treatment, and it is up to the doctors to decide which to be prescribed. In a country like India, people are ready to even sell their house and get cured. There should be some mechanism to control the options for drug companies exploiting the public in these kind of important therapeutical areas," note Jaishankar.
According to Radhakrishnan Nair, the government should concentrate on subsidizing drugs for AIDS and cancer, as there are numerous agencies worldwide offering free charity funds to fight such diseases.