A problem with the prosecution of Indian patent applications relating to pharmaceutical subject matter has been the inconsistent and non-uniform approach that has been adopted by the four offices of the Indian Patent Office (IPO). To address this issue, in February 2014 the IPO had published a set of draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (the draft Guidelines), with the objective of providing both Examiners and Applicants clearer guidelines for the examination of pharmaceutical subject matter patents in India. The draft Guidelines were open for public review and comment. This article summarizes what we believe to be the most important aspects of the draft Guidelines from an Applicant’s standpoint.

Non-patentable subject matter

  • The most pertinent review points being discussed are:Sec. 3 of the Indian Patents Act defines what constitutes non-patentable subject matter in India, which includes the “mere discovery […] of any living thing or non-living substance occurring in nature”.The draft Guidelines have in our view gone further by stating that any compound “isolated from nature” falls foul of Sec. 3 and is therefore not patentable. This conclusion may have a major impact on pending Indian patent applications as active compounds in many pharmaceutical compositions are isolated from nature, e.g. isolated nucleic acid and protein sequences.
  • Sec. 3d states that inventions that claim a “mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance” are not patentable. The draft Guidelines state that the onus is on Applicants to furnish adequate proof of enhanced efficacy of a claimed substance compared to the known substance.  Frustratingly, the draft Guidelines do not state what form of evidence is required to traverse a Sec. 3d objection. There has always been a question in Indian law as to the scope of Sec. 3d: is the term “efficacy” limited to therapeutic efficacy as suggested in some case law or can a broader meaning being applied to the term?  It is disappointing that the draft Guidelines have not addressed this issue.
  • The draft Guidelines address the patentability of known compounds for the treatment of new diseases. Until now, a new use of a known compound was only claimable when worded according to the EPC2000 claim format, in India also known as an application claim. If approved, the draft Guidelines means that such claims will not be allowed by the IPO.

Markush claims

When claiming compounds in the form of Markush claims, it has generally been sufficient to provide experimental data and support for only one representative embodiment of one of the claimed compounds in the specification. The draft Guidelines now require that the specification of a patent application be assessed to see if:

the complete specification discloses all the possible embodiments covered under the claimed Markush formula; and [if] the complete specification provides details of tests conducted with regard to each embodiment.”

This requirement puts a tremendous onus on Applicants of providing experimental data for all possible embodiments expressly covered in their Markush claims. Our concern is that should the draft Guidelines be adopted, the IPO is likely to issue pharmaceutical patents of limited scope compared to rights that would be acquired in corresponding patents in other jurisdictions which do not adopt such an onerous stance for Markush claim support. The proposed approach to examination of Markush claims has been challenged by Indian Patent Attorney practitioners and it is hoped that this section will be reformulated to be in alignment with the approach taken in other jurisdictions.

Connecting / transitional terms

The use of connecting or transitional terms such as “comprising” and “including”, are an internationally accepted means of indicating essential but non-limiting components of an invention as defined by the claims. However, section 11.12 of the draft Guidelines state that these connecting terms, along with non-definitive terms such as “approximately” and “near to”, are to be objected to, as they allegedly lead to confusion regarding the scope of the claims. Having said this, no alternative terms have been suggested in the draft Guidelines. Should the IPO begin to object to the use of such terms, this section of the draft Guidelines would have a palpable effect on the claim drafting process as it would make pharmaceutical claims for acceptance in India unnecessarily verbose.  Applicants would no longer be allowed to group essential components of an invention together in a claim but would have to include all features which are part of the product in the claim. The value of such a claim for enforcement purposes would be more than questionable.

Industrial Applicability

It is generally understood that in order for an invention to be deemed industrially applicable, it needs to be capable of exploitation or use in the respective industry.

The draft Guidelines have taken this broad understanding and narrowed it further by adding a requirement that a pharmaceutical invention also has to show “usefulness” in a “distinct and credible manner”, in order to qualify as being industrially applicable. This places the onus on the Applicant to prove the “usefulness” of their invention. Neither examples nor the definition provided in the draft Guidelines help Applicants to understand what is useful in a distinct and credible manner. The Indian Patent Attorney profession did ask for more clarity on this issue as part of the submission that were made in response to the public review and comment of the draft Guidelines.

Deposition of Biological Material

Sec. 10 (4) states that when an invention refers to biological materials, samples of the material only have to be deposited at the time of filing the application if, and only if, it is not possible to sufficiently describe the biological material in writing and if samples of the material are not available to the public. While this is understood to take place on occasion, over time it appears to have become a regular occurrence, much to the chagrin of Applicants who frequently find themselves invited to deposit biological materials, in spite of having submitted a thorough and detailed specification.

Now the draft Guidelines, in addition to the requirement above, inform the Applicant of the need to disclose the “source and geographical origin” of the biological material used in the invention. Not only does this requirement lack legal basis in the Patents Act, it also leaves the Applicants guessing as to how the source and geographic origin is to be determined.

As the draft Guidelines await review and final release by the IPO, it remains to be seen which points, and it what form, will make it into the final version of the Examination Guidelines that will be used by Indian Examiners to examine inventions in the pharmaceutical arts.