Draft guidelines for examining pharma patent applications

On February 28 2014 the Indian Patent Office issued draft guidelines for the examination of patent applications in the pharmaceuticals field, inviting public comments by March 21 2014. The guidelines are intended to assist examiners and controllers at the Patent Office in achieving uniform standards of patent examination in the pharmaceutical sector. However, perhaps recognising that they have no statutory basis, the guidelines clearly state that in case of any conflict with the Patents Act 1970 or the Patent Rules, the act and the rules prevail.

As their name suggests, the focus of the draft guidelines is essentially on the assessment of novelty, inventive step and industrial applicability in relation to products and processes in the pharmaceuticals field. They also discuss non-patentable subject matter. Most sections of the guidelines are explained by means of illustrative examples. There is also some assistance in terms of assessing the sufficiency of disclosure and unity of invention.

Use of such illustrative examples is in line with other guidelines previously issued by the Patent Office. While such illustrative examples may assist the examiners in better understanding the application of the guidelines, there is also a concern that the examiners and controllers might perceive these illustrations to have the nature of a rule and might try to fit claims into such illustrations rather than attempting to analyse claims on their own merit. To avoid such unintended consequences, it would be helpful if the guidelines included a caveat that these examples are merely illustrative and by no means exhaustive. 

Even though the draft guidelines are non-binding, it may be prudent for applicants and practitioners alike to provide comments on them. It is important to assess the extent to which the guidelines conform to the text of the legislation and resemble those applied by other major patent offices.

For instance, in relation to Markush claim structures, the draft suggests that the complete specification disclose all possible embodiments covered under the claimed Markush formula, and that the complete specification provide details of tests conducted with regard to each embodiment. Some may consider this to frustrate the purpose of a Markush claim; therefore, the language used may have to be fine tuned  to allow for assessment on a case-to-case basis.

Another instance would be the definitive statement by the Patent Office that any compound isolated from nature is not patentable subject matter. Essentially, the position of the Patent Office under the biotech guidelines not to allow patents on isolated nucleotide sequences has been extended to chemical/pharmaceutical compounds. The illustrations essentially prevent applicants from trying to patent cerebrospinal fluids and cardiac glycosides isolated from living things. While the US Supreme Court decision in Myriad may have strengthened the Patent Office's position, it remains to be seen how a court would interpret the relevant statutory provision. Indian law prohibits patenting the discovery of a living or non-living thing or substance, and whether isolation through a technical process would be considered as falling within the scope of discovery has yet to be discussed in the Indian context.  

With regard to controversial Section 3(d) of the act, the guidelines emphasise the interpretation of the term 'efficacy' as interpreted by the Supreme Court in Novartis AG v Union of India ((2013) 6 SCC 1) to mean therapeutic efficacy. Interestingly, the Patent Office appears to have a more comprehensive understanding of this controversial decision, compared to many of the commentaries available. The guidelines emphasise the Supreme Court's decision that an increase in bioavailablity of the drug could be linked to an enhancement of therapeutic efficacy of that drug by means of appropriate research data. Prudently, the Patent Office has also made no limiting statement as to the type of evidence needed to show enhanced efficacy. At the same time, there is no illustration provided of where a claim may be allowed under Section 3(d); providing at least one such example would help examiners to have a balanced view. Based on the IP Appellate Board order in Ajantha Pharma v Allergan Inc (Order 173/2013), the guidelines also clarify that the term 'combination' used in Section 3(d) of the act pertains only to a combination of one or more of the derivatives mentioned in the explanation to the provision or a combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to efficacy. This appears to settle the position that combinations of unknown substances or known substances that are not derivatives of a common substance or of each other do not fall foul of Section 3(d).

Although these guidelines do not have the force of law, they reflect the thinking of the Patent Office. Once finalised and issued, the guidelines will have some influence on examiners and may impose an extra burden for patent applicants to overcome during prosecution. Hence, it may be crucial to flag up any relevant issues, especially where the guidelines appear to go beyond the language used in the law. It will be interesting to see whether representatives of the pharmaceutical industry and the public in general agree with the Patent Office's interpretation of the law.