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The US-India Business Council (USIBC) has stated that the Draft 'Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals' issued recently by the Indian Patent Controller could lead to an unnecessary bias against pharmaceutical patent applications.
In its response to the draft Guidelines, the USIBC, a business advocacy organization comprising of America’s and India’s top-tier companies to deepen two way TRADE and strengthen commercial ties, pointed out that provisions of the Draft Guidelines may suggest to examiners that, unlike other technologies, pharmaceutical patents are presumptively disfavored or even “bad.”
For example, the Draft Guidelines identify the benefits of “good patents,” generally speaking, without mentioning the value of pharmaceutical patents in particular. On the other hand, the Draft Guidelines single out “bad” pharmaceutical patents as “a burden to society,” without acknowledging that a “bad” patent in any area of technology is a burden to society. Differentiating between “good” and “bad” patents could lead to inappropriate biases on the part of the examiners, it said.
It further pointed out that there are also several statements that would be helpful to have some clarification. For example, we believe there are only certain instances where pharmaceutical patent claims are unduly broad. Statements that allude to pharmaceutical patents are unduly broad could create the distinct impression that the Draft Guidelines are bias against pharmaceutical patents when, instead, they should provide objective guidance for patent examiners to fairly and accurately apply the relevant law, the USIBC said.
Onerous requirements for pharmaceutical patents could also discourage innovation and erode India’s stated goal of maintaining its status as “the pharmacy of the world.” As viruses, bacteria, fungi and other pathogens continue to evolve, there will be pressing needs for technological innovation and development to address these emerging health concerns. The Draft Guidelines in fact recognise that patents are an important incentive for that innovation and development in India and elsewhere in the world. And, without the innovation and development that lead to pioneering pharmaceuticals and therapies, there could be no generic versions that enable India to serve as the “pharmacy of the world,” it further said.
The Indian Patent Controller had last month released the revised “draft guidelines for examination of patent applications in the field of pharmaceuticals” which would help the examiners and the controllers of the patent office in achieving consistently uniform standards of patent examination and grant of patents.
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