The US-India Business Council (USIBC), the premier business advocacy organization comprised of America’s and India’s top-tier companies, has expressed concern that the draft 'Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals', issued by the Indian Patent Controller recently, could lead to an unnecessary bias against pharmaceutical patent applications.

Besides, the guidelines may impose unnecessary burden on pharmaceutical patents, driving up the costs and risks of innovation, the USIBC said.

In response to the draft guidelines, the USIBC said that the draft guidelines recognize that good patents are essential for promoting innovation and technological development in the country. However, other provisions of the 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, the USIBC commented.

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, it 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 recognize 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,” the USIBC in its comment said.

It further said that the draft guidelines may impose unnecessary burdens on pharmaceutical patents, driving up the costs and risks of innovation as several of the draft guidelines relating to tests, claim terms and source and location of biological materials impose requirements that would substantially increase the burdens on pharmaceutical patent applicants, thereby increasing the costs and risks of innovation.