Ever since India opened up its patent regime in January 2005 to
include product patents in the field of pharmaceuticals, the patent
law in this domain has kept alive the interest of various
stakeholders. This is rightly so, since India is also known as the
pharmacy of the world and is a global market leader in the export
of generic drugs to the United States and Japan, as well as to
countries in Africa and Europe. The Indian generic pharmaceutical
industry had a turnover of US$11 billion in 2010, registering a
growth rate of 22 per cent.1 During 20132014,
pharmaceutical exports stood at Rs 90 000 crores (US$14.55
billion).2 Also, India is one of the largest consumers
of medicines in the world, even though accessibility of medicines
across economically weaker sections remains an issue. The Indian
patent regime is well equipped to balance the quid-pro-quo
requirement of patents. Even though jurisprudence in this field is
still evolving, recent judicial precedents have reaffirmed that
this is so.
In 2013, the Indian Patent Office (IPO) proposed a requirement
of disclosure of International Nonproprietary Names (INNs) in
patent applications relating to pharmaceutical
inventions.3 Thereafter, the IPO organized a meeting
with different stakeholders to discuss the proposal and receive
feedback on the feasibility and implementation of this policy. The
proposal was to make the disclosure of INNs mandatory and for the
Patent Rules to be amended to provide the necessary basis for this.
The stakeholders put voiced their concerns both for and against the
proposal. The IPO finally decided to reject the proposal at least
of making this a mandatory requirement, so the Patent Rules remain
unchanged. It goes to IPO’s credit that the proposal of
mandatory disclosure of INNs in the patent specification was
removed from the recently issued guidelines for examination of
pharmaceutical applications. However, the guidelines instruct the
examiner to search prior art based on any INN disclosed in the
specification. Further, in the case of second medical
use4 inventions, the examiner is directed to ask the
applicant to disclose the INN of the known substance where second
medical use is claimed. In the event that the applicant does not
give such information even upon request, the examiner is required
to seek to ascertain the INN and to search prior art based on
In this article, we attempt to explore the use of INNs as a
proposed tool for searching prior art and examine whether INNs
would indeed make things simpler for patent examiners in India.
Some of the issues were discussed during various stakeholder
meetings held at the IPO, before this proposal was finally
General background of INNs
The INN or generic name is an official name given to a
pharmaceutical substance, as designated by the World Health
Organization (WHO). An INN identifies a pharmaceutical substance or
active pharmaceutical ingredient by a unique name that is globally
recognized and easy to remember, unlike International Union of Pure
and Applied Chemistry (IUPAC) nomenclature. Apart from INN
nomenclature, there are also various systems of nomenclature across
different countries, such as British Approved Names (BANs) and
United States Adopted Names (USANs) to identify pharmaceutical
substance with an official nonproprietary name.5 Table 1
provides examples of INNs.
The proposal for using INN as a search tool raised a number of
questions, including the following: What makes INNs suddenly a
sought-after tool for searching prior art patents? Would it be
beneficial for the patent examiner to have a disclosure regarding
INNs? Might it not be an extra burden on applicants seeking patents
in India? Is there any vested interest of any group or agency in
fueling the sudden need for such disclosure in Indian applications?
Would this requirement be TRIPs-compliant?
INNs as a tool for searching earlier patents
The proposal to disclose INNs was based on the premise that this
would help the examiner to conduct a search of prior patents more
To examine this hypothesis, we designed a sample prior patent
search5 related to the method of synthesis for aspirin.
The results are shown in Table 2.
We found that search string B, which used the IUPAC name of
aspirin, found two relevant results out of four documents in the
domain of method of synthesis of aspirin. In fact, string A
appeared to have missed two most relevant results which were found
by string B (as there are no common patents between string A and B
as shown above). Thus INNs did not prove to provide an effective
search tool in this instance.
Further, to confirm this provisional conclusion, we designed
another study for prior patent search6 in the domain of
composition of rotigotine. Rotigotine is a drug that was approved
in Europe for the treatment of Parkinson’s disease and restless
legs syndrome in 2006. For this trial, we changed the subject
matter of the search (from ‘method of synthesis’ to
‘composition’), the name of drug molecule (from
‘aspirin’ to ‘rotigotine’) and the search field
(from ‘title’ to ‘title, abstract or claims’ to
broaden the patent search), as there may be a presumption that
aspirin is a too old a drug, and String A would nevertheless miss
patents in the domain of method of synthesis (where generally the
IUPAC name is disclosed in synthesis patents). However, we reached
the same conclusion as mentioned above. The results are shown in
Out of four documents captured by String F, three documents
belong to same patent family which discloses composition comprising
acid addition salts of rotigotine, while one remaining document
talks about novel rotigotine salts. In other words, these patents
or applications were not relevant to our search, as they related to
salts of rotigotine and its composition but not to the composition
of rotigotine as such.
Further, string D missed a few results that are highly relevant
to the field of study, already captured in String E. We found that
search string E, which used the IUPAC name of rotigotine, found
four relevant results (US7413747B2, US20080138389A1, US6884434B1
and US20050033065A1) among 26 documents in the domain of
composition of rotigotine as such. In fact, among four relevant
documents, there are patents US7413747B2 and US6884434B1 listed in
the Orange Book. Orange Book-listed patents are highly relevant
patents that are published by the Food and Drug Administration (the
US drug approval agency). Thus INNs appeared to fail as an
efficient search tool to obtain the relevant prior art.
In addition, we designed one more study in the domain of the
polymorph (crystalline) form of axitinib and found the same
conclusion as mentioned above. The results are shown in Table
Two documents captured by String I were not relevant to our
domain of search. Further, string G missed a few results which are
highly relevant to the field of study, already captured in String
H. In other words, we found that search string H, which used the
IUPAC name of axitinib, captured one Orange Book-listed patents
US8791140B2 disclosing the crystalline form of axitinib and its
corresponding EP and WO patent applications which was missed by
The currently available searching tools, such as molecular
formulae, structural diagrams, clinical trial codes and systematic
names under the IUPAC nomenclature, Chemical Abstracts Services
(CAS) registry numbers etc, have been well tried and tested. These
well-established tools have been recognized worldwide to be
effective in searching prior art data, and no major patent office
requires disclosure of INNs in the patent application.
Sometimes, there may even be a conflict between substances still
being referred to with national names such as BANs,
Denominations communes francaises (DCFs), Japanese
Adopted Names (JANs) and USANs, which are similar in purpose to the
INN. There may be cases where there will be a difference between
INNs and other approved national names such as BANs, JANs or USANs.
For example, Flurothyl is an approved USAN, whereas its INN is
Flurotyl.8 This could lead to confusion. It is thus
concluded that the requirement of disclosing INNs may create
confusion in patent prosecution.
Why link patents to INNs?
Was it a good idea to link patents to INN? If it was, who should
take on the burden of linking patents to INNs? Would the applicant
have found it unnecessarily cumbersome to disclose the INN before
filing the patent application? At best, any link between the patent
and the INN should be the responsibility of regulatory bodies
during the drug approval stage.
Including INNs at the time of filing the patent
Drug patents are filed as soon as the pharmaceutical research
and development (RD) shows promise in an invention.
Accordingly, compounds of interest are unlikely to have an INN at
the patenting stage. Some patents actually use laboratory acronyms
for naming these compounds. It is therefore a practical challenge
to include the INN at the time of filing of a patent application,
which is why patent applications almost never use INNs. Besides,
since the international patent system does not allow for adding
subject matter once the application has been filed, the inclusion
of an INN does not present a viable approach.
Internationally, linking patents to INNs is done at the
regulatory stage when applying for drug approval and not at the
patenting stage itself. Patent linkage at the product approval
stage is meant to prevent patent infringement by generics and is
followed by several countries that are members of the World Trade
Organization. Further, such linkage requires a closer collaboration
of health regulators and the patent office.
The US Food and Drug Administration (FDA) used to link approved
drug products (which had an INN) to patents on their website using
a repository known as the Orange Book.9 We performed the
search for ‘rotigotine’ (an FDA-approved drug acting as
dopamine agonist indicated for the treatment of Parkinson’s
disease and Willis-Ekbom disease) as an INN in the Orange Book. The
search results are presented below in Table 5.
Patent information corresponding to a drug product is submitted
by the sponsor/applicant to the FDA, depending on the approval
status of the product application. Following the product’s
approval, the FDA publishes the list of patents mapped with that
product (which has an INN) in the Orange Book.
A few years back, a decree was published in the official Gazette
of the Federal Government of Mexico, which amended the Regulations
of the Health Law as well as the Regulations of the Law on
Industrial Property. This new amendment imposed upon the Mexican
Institute of Industrial Property (IMPI) an obligation to publish a
special gazette listing those patents relating to allopathic drugs
and their corresponding INNs. This new regime was brought in to
benefit patent owners, as following this amendment, the Mexican
health authorities would not grant health registrations for
products covering the active ingredients as published in the
gazette, until the expiry of the patent.10 In this case,
applicants for marketing approval of pharmaceutical products are
required to inform the health regulatory authorities whether or not
they are the patent holder or licensee for any existing patent
relevant to that product. An the applicant who does not have a
patent or licence must provide a declaration that the product
application does not infringe the rights of the patent holder.
The health authorities work with the IMPI to determine the
patent status of the product for which there is a pending marketing
application. If the search indicates that a valid patent would be
infringed, the health authorities will give the applicant an
opportunity to demonstrate that it has the rights to the product.
In the alternative, the health authorities will reject the product
Similarly, in China, the State Food and Drug Administration
(SFDA) maintains two separate tracks by which it provides patent
linkage for compound/composition patents:
- The SFDA requires all applicants for
marketing approval to check patent status prior to making an
application, and to certify that their products do not infringe any
existing patents; they must also acknowledge liability for damage
resulting from any future finding of patent infringement.
- The SFDA maintains a list of all drug
product registrations by chemical names (INNs), which is available
for frequent inspection by patent owners, who can check whether
there are applications for marketing approval for new products that
may infringe any existing patents.12
In the interest of the patent owners and in order to avoid
copying of a patented drug, such linkage between patent and INNs at
the regulatory stage does appear justified. The aim of the INN
system has been to provide health professionals with a unique,
universally available, designated name to identify each
pharmaceutical substance. The existence of an international
nomenclature for pharmaceutical substances, in the form of INNs, is
for identification, safe prescription and dispensing of medicines
to patients, and also for communication and exchange of information
among health professionals. The role of INNs is mainly for
regulatory and commercial purposes and not for patenting issues.
Readers may also recall that, in Bayer v
Cipla,13 the Indian High Court and the Indian
Supreme Court clearly ruled that there can be no overlap between
regulatory and patent law. This would also apply in the present
context where the regulatory and commercial role of INNs should not
overlap with the patent by disclosing an INN in a patent
What would it take to disclose an INN in a patent
INNs are allocated by the WHO on the advice of experts from the
WHO Expert Advisory Panel on the International Pharmacopoeia and
Pharmaceutical Preparations. The process of INN selection follows
three main steps:
- a request/application is made by the
- after a review of the request, a
proposed INN is selected and published for comments;
- after a time-period for comments and
objections has lapsed, the name will obtain the status of a
recommended INN and will be published.
Importantly, the rules relating to the application for an INN
specifically state that an INN for a substance should only be
applied for once it has been tested on human subjects.
Concerns of the patent applicant
Patent applicants seeking a drug patent in India have had
substantial concerns with regard to the inclusion of INNs in the
patents’ description. These concerns include the risk of losing
novelty due to delay in obtaining an INN from the WHO; the lack of
clarity as to the consequences of not including an INN in the
description (even though the recent examination guidelines on
pharmaceutical inventions issued by the IPO do not mandate the
disclosure of INN now); possible loss of patent term, where the IPO
decides to withhold the grant of a patent for want of INN
disclosure; misuse by third parties due to frivolous oppositions or
invalidation proceedings, particularly on the ground of s 3(d) of
Indian Patents Act; and practical difficulties in specifying INNs
for all possible components of a claimed composition or a Markush
Section 10(4) of the Indian Patents Act clearly defines what the
specification of the patent application shall contain. The
‘best method of performing the invention’ requirement under
s 10(4) (b) of the same Act clearly states that the
applicant/inventor is entitled to protection by disclosing the best
method of performing the invention. The disclosure of an INN does
not appear to be a reliable source of describing an invention; nor
does it provide any aid in enabling a person skilled in the art to
carry out or apply the invention. It is only wise that this
requirement should be dropped: it imposes a burden on the
applicant, who in any event must overcome other important legal
barriers before obtaining a drug patent in India.
Legally speaking, under Article 27 of the Agreement on
Trade-related Aspects of Intellectual Property Rights (TRIPS),
members of the said agreement cannot discriminate between different
fields of technology in their patent regimes. By rejecting the
proposal for mandatory requirement of disclosing an INN in the
specification, India has saved itself from being potentially
accused of discrimination between other technologies and
pharmaceuticals, which would be contrary to TRIPS.
From sudden interest to careful thought
The sudden interest of the Indian Patent Office in require
disclosure of INN in a patent application came as a surprise to
patent applicants in the pharma domain. Given that debate over the
patenting of pharmaceutical inventions in India is no longer
restricted to legal issues but evokes serious emotive issues, the
IPO was certainly faced with dilemma of having to address both.
Admirably, the IPO took a reasonable and balanced view on this
issue pursuant to elaborate discussions on this issue with various
stakeholders. It may augur well for the patent fraternity if the
IPO thoroughly researches the need and usefulness of such
proposals, which have a great impact on all the stakeholders before
initiating any nationwide debate.
The patent search outlined in Table 6 was performed in Total
Patent Database on 15 April 2015. The Search field remains the same
as Title, Abstract or claims in US, EP and WO. The same conclusion
was drawn as mentioned above, ie that the strings based on INN
missed the relevant results which were captured by the strings
based on the IUPAC name.
* The authors thank Dr Deepa Kachroo Tiku, Partner, K
S Partners, Gurgaon, India for providing her unconditional
guidance and critical comments without which this paper could not
be written to its fullest. The views expressed in this article are
solely those of authors alone and do not in any way represent the
views of K S Partners.
1. Aiswariya Chidambaram, ‘Market Insight, Indian
Generic Pharmaceuticals MarketA Snapshot’ SOURCE (27
July 2012). Available at http://www.frost.com/sublib/display-market-insight-top.do?id=264038078
(May 05, 2015).
2. India in Business, Ministry of External Affairs,
Government of India, Investment and Technology Promotion Division
“Pharmaceuticals”. Available at http://indiainbusiness.nic.in/newdesign/index.php?param=industryservices_landing/347/1
(June 03, 2015).
3. Office of the Controller General of Patents, Designs
Trade Marks, Guidelines for Examination of Patent
Applications in the Field of Pharmaceuticals (October 2014)
paras 5.3 and 5.4. Available at http://ipindia.nic.in/iponew/Guidelines_for_Examination_of_Patent_applications_Pharmaceutical_29Oct2014.pdf
(May 03, 2015).
4. New therapeutic uses for known active
5. World Health Organization, ‘Guidance on INN’.
Available at http://www.who.int/medicines/services/inn/innquidance/en/
(April 05, 2015).
6. The patent search was conducted using the Total Patent
database on 23 December 2014. ‘w/n’ is a search operator
used in Total Patent database that finds search terms that appear
within n-number of words of each other.
7. A similar exercise was conducted with several drugs
and the same conclusion was obtained. The results are presented in
8. Kyoto University Bioinformatics Center (GenomeNet),
“DRUG: D04236″ Available at http://www.genome.jp/dbget-bin/www_bget?drug+D04236
(June 14, 2015).
9. US Food and Drug Administration, ‘Orange Book:
Approved Drug Products with Therapeutic Equivalence
EvaluationsActive ingredient search engine’. Available
(April 22, 2015).
10. D Sanchez, ‘Drugs Patent Reforms
Introduced’, Managing Intellectual Property (April 2004).
Available at http://www.olivares.com.mx/En/Knowledge/Articles/RegulatoryLawArticles/Drugspatentreformsintroduced
(March 21, 2015).
11. Finston Consulting, LLC, ‘Patent Linkage Case
Studies’, Report (8 October 2006) 34. Available at http://report.nat.gov.tw/ReportFront/report_download.jspx?sysId=C09602410fileNo=004
(March 15, 2015).
12. Report of US-China Joint Commission on Commerce and
Trade, Medical Device and Pharmaceutical Subgroup, Pharmaceutical
Task force Meeting, August 20, 2005, Beijing, China. Available at
(June 03, 2015).
13. Bayer v UOI, Case Nos 7833/2008 and LPA 443/2009,
Delhi High Court WP(C), paras 3941 (Judgement pronounced on
August 18, 2009); Bayer v UOI, Case No 6540/2010, Supreme Court of
India Appeal (Civil) (Disposed on December 01, 2010).
14. Herein, Markush representation are chemical symbols
used to indicate a collection of chemicals with similar structures.
They are commonly used in chemistry texts, and also in patent
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Article source: http://www.mondaq.com/india/x/432094/Patent/To+Keep+INN+Or+Out