While German firm Bayer has adopted a ‘try till you succeed’ stance on pursuing patent linkage in India, on the other hand, a European parliamentary group is planning to call on the EU and European Commission, the executive arm of the EU, to not push for provisions such as patent linkage in developing countries.
This system is believed to delay early entry of generics.
Despite Bayer’s appeal, to introduce patent linkage in India, being dismissed by the Delhi High Court last week, the firm is keen on chasing the matter, with a company spokesperson saying that they would consider its legal options in this regard.Though Bayer hasn’t specified what its legal options would be, there is a strong likelihood of the company approaching the Supreme Court regarding this matter.
Meanwhile, the European parliament working group on innovation, access to medicines and poverty related diseases, the parliamentary group formed last month, believes provisions such as patent linkage can impact access to medicines.
“The decision by the Indian court to reject Bayer’s attempts to introduce patent linkage is crucial. The group indeed recognises and stresses the importance that public health safeguards can be used to open generic production of life saving medicines for millions in India and beyond,” says Alexandra Heumber, EU and intellectual property policy advisor, Medecins Sans Frontieres, who is working closely with the parliamentary group.
The parliamentary group will also organise roundtable or hearings to call on the EU to support policies that improve access to medicines through competitive supply of drugs, such as compulsory licensing, also bolar exception, etc.
While a compulsory license is issued if patented drugs are unavailable or unaffordable. “Patent linkage could block marketing approval of generics, thereby rendering compulsory licenses useless and neutralise Bolar exception,” says BK Keayla, convenor, National Working Group on Patent Laws.
The EU currently does not allow patent linkage, and according to the European Generic Medicines Association, the system is contrary to EU regulatory laws and hinders quick access to generic medicines.
Heumber says patent linkage is a provision that goes beyond what is required by the trade-related aspectsof intellectual property rights (Trips) agreement of the World Trade Organisation (WTO), which India is a signatory to. “Nowhere in Trips is there a reference to an obligation to link patent protection and drug registration.The group is clear, ‘No Trips plus provision’.”
Why then is Bayer so keen on pushing for patent linkage in India, when EU itself is against it? “No comments,” was all the Bayer spokesperson could say.
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