The Pharmaceutical Research and Manufacturers of America (PhRMA) has criticised the Indian Patent Controller for showing bias against pharmaceutical sector in the draft 'Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals' issued by the Indian Patent Controller on February 28, 2014.

In its response to the draft Guidelines, the PhRMA, a nonprofit association that represents leading global pharmaceutical research and biotechnology companies, pointed out that some provisions of the Draft Guidelines appear to indicate to examiners that, unlike other technologies, pharmaceutical patents are presumptively disfavored or even “bad.”

This language is misleading and subjective. 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, i.e., a patent that does not meet traditional patentability criteria of novelty, inventive step, and industrial applicability, in any area of technology may be a burden to society. This kind of language, which appears to disparage or single out pharmaceutical patents, runs throughout the Draft Guidelines and should be eliminated, PhRMA's associate vice president Amiee Adasczik said in the comments to Draft Guidelines.

There are also several specific misstatements in the Draft Guidelines that warrant correction. For example, there is no evidence to support statements in the Draft Guidelines that pharmaceutical patent claims are unduly broad. Such statements accordingly create the distinct impression that the Draft Guidelines are imbalanced and negative toward pharmaceutical patents when, instead, they should provide objective guidance for patent examiners to fairly and accurately apply the relevant law, PhRMA said.

The Draft Guidelines rely extensively on examples to provide guidance, but they do not appear to be balanced. For example, each of the examples concerning novelty or sufficiency of disclosure concludes that the invention is not patentable. This could suggest to examiners that there is a preference for denying applications on these grounds, when the Patents Act requires careful, objective, and balanced examination and evaluation. The Draft Guidelines should also include examples, perhaps taken from actual applications, that demonstrate compliance with each of the requirements for allowance of claims.

Onerous requirements for pharmaceutical patents, and bias against them, would discourage innovation. 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, at least nominally, 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 new generic drugs.

Not only are distinctions in the Draft Guidelines between pharmaceutical patents and patents on other technologies unwarranted, they also appear inconsistent with India’s obligations under TRIPS.

By singling out pharmaceutical patents for requirements in addition to novelty, inventive step, and industrial application, the Draft Guidelines, if adopted, would be inconsistent with these important provisions.