INN is no stranger to pharmaceutical industry. International Non-proprietary Names, designated as INN facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients (APIs) popularly known in India as bulk drugs. Each INN is a unique name that is globally recognized. Once a name is chosen as INN, this becomes a public property. INNs cannot be appropriated by anyone as proprietary name statutorily or cannot be protected as IP (Intellectual Property) in any form. In recent times, when IP wars are at its peak, there are extensive and excessive attempts to claim monopoly through IP protection on INNs. WHO, who has a constitutional mandate to develop, establish and promote International standards on these related products, collaborates closely with INN experts and bodies to select names and chooses INN based on the chemical as well as therapeutic groups.
To avoid confusion (and to prevent abuse) which could jeopardies patient safety and prescription errors, it is made mandatory by WHO that trademarks should neither be derived from INNs nor certain common names used in INNs.
India has made provisions in its laws in line with WHO guidelines. Sec.13 has provided that INN should not be abused through trademark (TM) protection, the relevant portion of the provision commencing with “Prohibition of registration of names of chemical elements or international non-proprietary names” (Sec.13 of the Trade Marks Act, 1999) (incomplete – For full provision, refer to the Trade Marks Act, 1999). However, there is a trend to register TM similar to INN to help prescribing physicians as well as patients to identify and remember the TM with the disease or generic name (INN). This trend is alarmingly growing in India. A recent case, though not exactly an INN, relates to the very popular nomenclature ORS which is used for Oral Rehydration Salt. To prevent abuse “ORS” word which belongs to WHO, is protected in India by the Ministry of Health by registering the TM in their name. However, a mark “ORS-L” has been registered by the Trade Mark Office in India as a private proprietary mark, for a liquid form of ORS. There are many such examples in India, which will need to get resolved only in due course of time. Registering of brand names which are very similar to generic names or INNs makes the brand “descriptive” and not “distinctive”, whereby it becomes difficult to retain the brand identity and increases the likelihood of brand replacement in the market place.
Recently “INN” has also found a place in another form of IP i.e. patents. Through a recent background note issued by the Patent Office, the Patent Office is calling for views on making mention on INNs compulsory in the Patent Specifications (Description of the invention in Patent Applications). This is a welcome initiative, however, with a few exception and teething problems. The background note makes out a case for making declaration of INN compulsory for patent applications. The benefit of such a proposal is explained in this note from the Patent Office. The proposal has been mooted at the instances of the UNDP, ref:Patent Information and Transparency: A Methodology for Patent Searches on Essential Medicines in
Developing Countries, Published by United Nations Development Programme, First Edition, July 2012.
As per this paper, declaring INN in patent applications will help patent examiners and patent practitioners as well as researchers in felicitating prior art search and consequent patent mapping and landscaping as well as data co-relation for technology transfer, compulsory licensing and post-grant opposition. According to the note, this proposal is in line with compliance of Art. 29 of TRIPs regarding need for technical disclosure in patent specifications to be sufficiently clear and in an enabling manner. The methodology and procedure for implementation of the proposal is also elaborated in this Note. A new sub-rule 2(h) is proposed to be introduced to define INN alongwith a new sub-rule in Rule 13 of Patent Rules, 2003, as Rule 13(4)(a) and an amendment to Rule 13(7)(b). Amendment to Rule 24(A) as well as in Form 1 under Serial No.9 (declaration) to be inserted as a third bullet point, is also proposed.
It is worthwhile to see the background for such a proposal. It has been common for even the innovator companies, for decades, not to refer to their prior arts (earlier patents, patent applications or publications). There have been innumerable patents granted repeatedly for the same inventions, unintentionally by the patent offices because the innovator has failed (mostly intentionally) to disclose his earlier camouflaged applications or publications, most of which used to escape the search by the examiner. This has led to extensive abuse of the patenting system. Such abuses were termed as “double patenting”, “ever greening” etc. Of late, WIPO (World Intellectual Property Organization) and WHO (World Health Organization) and respective patent office administrations such as USPTO (United States Patent and Trademark Office) and IPO (Indian Patent Office) and others have addressed this issue and have taken laudable initiatives if not eliminate this practice, but at least substantially diminish such exploitation. USPTO has made it compulsory to make IDS (Information Disclosure Statement) for all the patent applicants. Better late than never. The obligation of all patent applicants to make all disclosures relating the invention, as known to them being relevant has helped to reduce such malpractices. WIPO has also contributed extensively in achieving this goal. PCT search by ISA (International Search Authority) have substantially improved over the years with databases being better equipped and accessible.
As per suggestion of WHO, the Indian Patent Office has also started making “roadshows” at the patent offices to popularize and seek opinion from users, such as inventors, patent applicants, patent practitioners and others for better disclosure of the INN (International Non-proprietary Names) in the patent specifications. This practice once made mandatory, will substantially help “patent searchers” transparent and productive. In recent times, especially in last two decades, more and more “innovative” abusive practices have been introduced by “creative” patent practitioners and specification draftees. Among them were “markush” structures, assisted by designed with “bioinformatic” or “insilico” models of computational drug design. Such “markush” structures in specification and claims often runs into many pages and even hundreds of claims. Such patent applications merit rejection, because the “industrial utility” which is a prerequisite for grant of a patent, is not established in these claims. However, thousands of patents got granted and ‘enforced’ in last 20 to 30 years, through ‘markush’ claims. This has happened because examiners, controllers and judges (and juries, where the system exists) got overwhelmed by the superficial glitter of scientific claims (based on computer-software based molecular designs).
INNs in Patent Specifications can be used on later patent applications, filed after the ‘INN’ naming ceremony is over, i.e. after an ‘NCE’ becomes a “New Drug”. When such subsequent applications are being filed, the background and prior art therein, could be made mandatory to refer to earlier (pre INN) patent applications or granted patents where the related disclosures to the chemical entities are made.
This proposal for ‘INN’ disclosure in patent specifications will substantially help “Patent Prior Art Search” being smooth, highly responsive and user friendly.
(The author is CEO, Gopakumar Nair Associates)