The Indian Patent Office is presently considering a proposal that would make it mandatory for drug firms to disclose the WHO-assigned INN (International Non-proprietary names) in the pharma patent applications. This proposal has been mooted, according to the Patent Office, as it would help ensure that frivolous patents, which do not provide any enhancement of efficacy of a therapy, are not granted.
In order to contextualise this proposal better, the working of an INN needs to be understood. An INN is the generic name of a pharmaceutical drug assigned to it by the WHO. However, it can also refer to the common functional group or active ingredient in a particular class of pharmaceutical drugs. The relevance of an INN has been described by the WHO itself thus: “Another important feature of the INN system is that the names of pharmacologically-related substances demonstrate their relationship by using a common “stem”. By the use of common stems the medical practitioner, the pharmacist, or anyone dealing with pharmaceutical products can recognize that the substance belongs to a group of substances having similar pharmacological activity.” (For Prashant’s posts on INN’s with respect to trademarks and the importance of generic names see here, here and here).
There are three main steps in an INN selection process. First, a request or application has to be made by the manufacturer or inventor, secondly, there is a thorough review by the WHO Secretariat for conformity with general rules as well as similarities and conflicts with published INN’s and existing trademarks. A note summarizing the results of this review is forwarded to a Committee of Experts. Once the Experts agree on a name, the selected INN is published for comments and objections in WHO Drug Information with a four month objection period. Thirdly, after the lapse of the four month objection period, the proposed INN will receive the status of a recommended INN and will be published as if no objection has been raised. Once a name has been published as a recommended INN, it is ready for use in labeling, publications, in drug information. The recommended INN will usually not be modified.
It is important to understand that INN is just one of the many naming systems. The more prominent one is the IUPAC names which are more commonly known as the chemical names of drugs. For example, Crocin is the brand name of a drug whose generic name is Paracetamol. The INN is also Paracetamol while the IUPAC name of the same is N-(4-hydroxyphenyl)ethanamide.
The proposal put forward by the Patent Office mandates that patent applications must disclose the INN of the drugs as well. The proposal, it is argued is beneficial as it is expected to limit the practice of evergreening in India where multiple patent applications are filed for the same drug, as argued by Leena Menghaney, who works with global public health group Medecins Sans Frontieres in the Economic Times.
However, objections have been raised against this proposal as well. At the consultation held by the Patent Office in Delhi to gauge the reactions of the various stakeholders to the proposal, law firms which represented multinational organizations stated that such a move would make the patent process in India exceedingly onerous. They opined that India’s patent process is already too cumbersome (courtesy Section 3(d) and 8, Patents Act) and is facing serious criticism for the same from the West. India’s proposal to include the INN, making it the first country in the world to place such a restriction, would not only be adding an additional requirement and thereby placing too much burden on the applicant but also violative of the country’s obligations under the TRIPS regime. They state that this burden, if required at all, must be on the drug regulatory authority. Moreover, they also argue that INN’s may not available at the time of patent applications and may be issued after the patent has been examined and granted. Further, the presence of INN, it is argued will enable third party searches and open the floodgates for abusive patent oppositions. Finally, it is argued that if at all the INN requirement is to be brought in, it must be by the Parliament in the form of an amendment and not by the Patent Office.
There are two main concerns that need to be addressed with respect to the proposal. First, the competence of the Government to issue such a proposal and secondly, the issue of whether the INN requirement would be beneficial.
Addressing the competence issue first, the relevant Section is S.159, Patents Act which deals with the power of the Central Government to frame rules for carrying out the purposes of the Act. On one hand, it is argued that the INN proposal can be included within the general rule making powers of the Central Government under S.159(1) as it is necessary to fulfil the purposes of the Act. The counter-argument is that the rule making power under S. 159 extends only to prescribing the form of specifications. The Executive cannot use the power under S.159 to create substantive new policy, which in the opinion of many, is exactly what the INN requirement is doing. The issue of constitutionality of this proposal is therefore, in our opinion, one that merits much discussion.
On the second ground, the INN is undoubtedly a simpler name than the IUPAC which would make it easier for patent examiners to curb evergreening. (See this compilation of WHO for a comparison of INN and chemical names) INN’s will also be particularly helpful in cases of drugs with complex biologicals which have no fixed chemical entries of the nature of those in the Orange Book. However, on the flipside, in cases of Markush claims which involves several compounds, INN’s may not be feasible or helpful. This issue rises to prominence in the context of lack of clarity within the proposal of whether there is a mandate on the patent applicant to apply for an INN if none already exists. This is problematic on two levels: first, the procurement of an INN is quite a rigorous procedure which is time-consuming (around 26 months on average) and involves costs. Secondly, particularly, in cases of Markush claims that involve several compounds, the INN requirement would not be feasible if some of those several compounds do not have an INN and there is a requirement on the applicant to obtain an INN for all those compounds before making such a claim.
Therefore the question to be considered is whether the benefits of an INN in bringing about drug information transparency and curbing evergreening outweighs the various costs involved, which include a possible TRIPS violation, impossibility of performance due to non-availability of INN, consequent difficulties in obtaining an INN (if required) as well as global criticism for an exceeding onerous patent regime, assuming that the Central Government has the competence to issue such a proposal in the first place.
Readers who have suggestions in this regard can send it to Shri Hardev Karar, Deputy Controller of Patents and Designs at [email protected] and Dr S.S. Singh Assistant Controller of Patents and Designs at [email protected].
(A bunch of thanks to Madhulika, Prashant and Shamnad Sir for all the help with this post!)