India – Patent Office considering the requirement of disclosure of INN (generic name of the drug) in patent applications -holds regional consultations and invites submissions
All four patent offices of India (Delhi, Mumbai, Chennai and Kolkata) are holding consultations on “Disclosure of the International Non-Proprietary Names or INNs, in patent applications related to the pharmaceutical inventions”
The consultations are being held to “gather views of stakeholders as to whether it should be made mandatory for the inventors or applicants to disclose INN in the description of the invention since such disclosures will benefit not only patent examiners but public at large as well. It may be noted that such International Non-proprietary Names (INN) identify pharmaceutical substances or active pharmaceutical ingredient in the claimed product”.
The consultation in Delhi was held on 9 October 2013. See below highlights of the consultation:
It was attended by mostly law firms that represent multinational pharmaceutical companies. Patent office officials made it clear that in their introductory speech that use of INN in the patent applications would be beneficial for the users of the patent office, including those doing academic research.
Views of Law firms (mostly Big Pharma’s) on the issue:
The law firms (KNS, Remfroy &Sagar, Corporate Law Group) oppose the introduction of a mandatory requirement as it would be a burden on the patent applicant. Already too much burden in India – section 8 and 3(d). This job of linking INN to patent applications should be shifted to the drug regulatory authority (basically patent linkage).
(Note – it will have to be a mandatory requirement as no one will comply. There is no extra burden on the applicant as they have the information already at their disposal as to which INN is within the scope of the claims. The drug regulatory authority has no capacity to do this job and this will be TRIPS Plus)
They oppose the requirement as they felt that the INN may not be available when they apply for the patent. The INN may be granted after the patent application is filed and even examined.
(Note – majority of applications are secondary applications and applicant can easily disclose the INN in the abstract/summary as information available to it at the time of filing. For those few applications covering NCEs for which WHO is still to allocate a INN, it can be submitted later – when the applicant receives it through a amended abstract). They felt it was not TRIPS compliant – no other country had such a requirement
(Patent office – TRIPS gives you minimum standards and you have flexibility to include the disclosure of INN)
The law firms felt it will enable third party searches and open the flood gates to abusive patent oppositions.
(Note – this information is important to procurers of medicines, researchers and other stakeholders. Also patent oppositions are done on the basis of patent claims and not just preliminary searches of applications.)
The law firms pushed for a parliamentary amendment if this requirement of INN was to be brought in.
(Note– This can be done through rule making as section 10 and other provisions enable the patent controller to require disclosure of material facts related to the working of the patent)
The patent office also noted that the disclosure of the INN would also benefit examiners as it would strengthen the search procedure at the time of examination. Particularly in the area of biotech application it is relevant for the examiner to know which product the application covers as there are many related to the same one.
(Note – It would be relevant for the examiner to know which other applications are pending on the same product.)
Written suggestions if any may be sent to Shri Hardev Karar, Deputy Controller of Patents and Designs at email@example.com and Dr S.S. Singh Assistant Controller of Patents and Designs at firstname.lastname@example.org in this regard.