Since long this battle of patent linkage in india is going on between Bayer and Cipla and DCGI. After filing appeal in high court by Bayer the highcourt had dismissed the appeal by Bayer Corporation, seeking the introduction of patent linkage system in India. After this decision, Bayer raised his voice in supreme court, but same decision was given by supreme court and rejected the special leave petition filed by Bayer.
Patent linkage means if a product patent of any molecule is granted in india then DCGI should refuse or delay the approval of generic version of that drug until the expiry of the said product patent. If patent linkage system will be allowed the generic player can not come in the market early and due to that people have to pay high price of branded drugs. So ultimately people will suffer from this. Therefore the supreme court has also rejected the patent linkage system in india.
Showing posts with label Patent linkage. Show all posts
Showing posts with label Patent linkage. Show all posts
Thursday, December 2, 2010
Monday, September 20, 2010
Drug marketing approvals may be delinked from patent status
Marketing approvals for generic drugs may soon get delinked from their patent status, a long-standing demand of India’s pharmaceutical industry that depends heavily on the sale of generic drugs.
The health ministry is planning to remove a question on the patent status of a drug from the form that medicine companies fill in when applying to the Drug Controller General of India (DCGI) for regulatory approval, a ministry official said.
The proposal follows a meeting in Mumbai this month between Indian drug makers and health minister Ghulam Nabi Azad.
“Removal of the question of patent status was agreed to, in principle, at the meeting. But now, it has to go to the drug technical advisory board (DTAB, the highest advisory board for drugs) for approval,” the official said, requesting anonymity.
If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy.
For full article click here
The health ministry is planning to remove a question on the patent status of a drug from the form that medicine companies fill in when applying to the Drug Controller General of India (DCGI) for regulatory approval, a ministry official said.
The proposal follows a meeting in Mumbai this month between Indian drug makers and health minister Ghulam Nabi Azad.
“Removal of the question of patent status was agreed to, in principle, at the meeting. But now, it has to go to the drug technical advisory board (DTAB, the highest advisory board for drugs) for approval,” the official said, requesting anonymity.
If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy.
For full article click here
Monday, September 13, 2010
NGOs, patient groups alert PMO not to act on behest of OPPI on patent issues
A large number of patient groups, groups working on public health and HIV, public interest organizations, experts and concerned citizens have demanded to the Prime Minister's Office (PMO) to immediately withdraw the biased and one-sided notes which the PMO had reportedly circulated to the union ministries of commerce, health, legal affairs and chemicals at the urging of OPPI to amend key public health safeguards in the Patents Act including Section 3(d), and asking for patent linkages and data exclusivity.
The NGOs and experts in a letter to the PMO said that the OPPIs’ demands are contrary to the Indian Constitution and Indian law, and will severely undermine access and availability of affordable quality generic medicines. “We regret that the PMO circulated this biased note without any prior investigation into the legitimacy of the claims or the fact that several demands made by OPPI and US and European Pharmaceutical companies are either sub-judice or have been rejected by Indian Courts keeping in mind the Government’s constitutional obligations of life & health”, the letter said.
For full story click here
The NGOs and experts in a letter to the PMO said that the OPPIs’ demands are contrary to the Indian Constitution and Indian law, and will severely undermine access and availability of affordable quality generic medicines. “We regret that the PMO circulated this biased note without any prior investigation into the legitimacy of the claims or the fact that several demands made by OPPI and US and European Pharmaceutical companies are either sub-judice or have been rejected by Indian Courts keeping in mind the Government’s constitutional obligations of life & health”, the letter said.
For full story click here
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