The European Commission (EC) has expressed concern over the interpretation of Section 3(d) as additional patentability criteria in India's Patent Act and has sought further clarification on Section 3(d) such as what type of inventions, including new forms or uses of known substances, would fulfil the patentability criteria in India.

In response to the draft 'Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals' issued by the Indian Patent Controller recently,  EC's directorate-general for trade Anders C. Jessen said that the interpretation of Section 3(d) of India's Patent Act introduces a patentability criterion ("enhanced therapeutic efficacy") additional to the three provided for under TRIPs and could thus conflict with it.   TRIPs requires "any inventions ... in all fields of technology" to be patentable "provided that they are new, involve an inventive step and are capable of industrial application." The agreement leaves no room for additional patentability criteria, the EC said.

The Guidelines note that after having established that an application involves an inventive step, Section 3(d) sets an additional hurdle "the amended portion of Section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products" (Point 10.5).   “This interpretation of Section 3(d) therefore appears to set an additional patentability criterion rather than giving guidance regarding the assessment of the inventive step”, the EC lamented.

This additional patentability criterion would appear to result in an exclusion from patentability for so-called inventions of second medical or non-medical use. However, those inventions are potentially valuable, patentable inventions.  European patent law also requires for a new form of a known substance to be patentable that it involves an inventive step, i.e. that a specific technical problem is solved in a novel and non-obvious way, but allows these second use inventions to be patented, it said.

In addition there appears to be an overly extensive interpretation of the therapeutic efficacy criterion restricting patentability of pharmaceutical inventions. The Guidelines appear to exclude inventions whose main benefit relates e.g. to increased resistance to heat or humidity. Under European patent law the inventive step can relate to other aspects than efficacy such as improved application or storage, the EC further said.

Supporting the incremental innovation, the EC said that the basis for excluding inventions relating to other features in view of the fact that these can fulfil the three patentability criteria of novelty, inventive step and being capable of industrial application. Incremental improvements based on existing knowledge and products are the norm rather than exception in the process of innovation. In pharmaceutical technology completely new chemical entities are the exception rather than the rule. Numerous pharmaceuticals inventions are incremental improvements that may be of tremendous value such as improved application, storage or manufacturing properties. Since these compounds fall under the exceptions of Section 3 (d) these would appear not to qualify for protection in India. It is important to use the patent system to incentivise this incremental innovation, including new forms or uses of known substances.

If the Guidelines' aim is to prevent undue extension of a patent monopoly, achieved by insignificant changes to an already existing patented product, sometimes referred to as 'ever-greening', this can be done by a strict application of patentability criteria, the EC opined.