India is granting

more patents than

before—but mostly
to non-Indians
REUTERS/SAVITA KIRLOSKAR
Clearing the backlog.

By Aria Thaker
Reporter
December 5, 2018
India’s patent office seems to be getting busier by the year.

The country granted over 50% more patents in 2017 than it

did in 2016, according to a report by the World Intellectual
Property Organization (pdf) of the United Nations.

In 2017, India’s patent office granted 12,387 patents—up

substantially from 8,248 in 2016 and 6,022 in 2015.
Worldwide, the WIPO estimates, there were 1.4 million
patents granted in 2017.

This increase has been a long time coming given that India has
been criticised for sitting on a large stack of pending patent
applications, as well as having a dismal ranking in the global
intellectual property index.

Perhaps among the changes leading to the increase in patents

has been the 2016 introduction of the National Intellectual
Property Rights Policy, which seeks to boost innovation by
simplifying procedures for granting patents, trademarks, and
copyrights.

However, despite the expedition, the lion’s share of patents

from India continue to go to foreigners.

While 1,712 patents were granted to resident individuals and

entities, 10,675 went to non-residents. The same has been true
in previous years, though the number of patents granted to
resident entities has increased over the years—from 1,115 in
2016 and 822 in 2015.

“Demand for IP (intellectual property) protection is rising

faster than the rate of global economic growth, illustrating that
IP-backed innovation is an increasingly critical component of
competition and commercial activity,” the WIPO director-
general, Francis Gurry, reportedly said at the release of the
report in Geneva.

India: Types Of Patents Granted And

Basis For Rejection
03 March 2020

by Tushar Kohli

Singh & Associates

1 Liked this Article

Types of patent applications granted in India

1. Ordinary or Non-Provisional Application

2. Convention Application
3. PCT International Application
4. PCT National Phase Application
5. Patent of Addition
6. Divisional Application
1. Ordinary or Non-Provisional Application
Ordinary or Non-Provisional application is filed if the applicant doesn't have any
priority to claim or in a case where the application is not filed in pursuance of any
preceding convention application. Non0 provisional application, when filed, must be
supported by a complete specification depicting the invention in detail.

2. Convention Application
A convention application is filed for claiming a priority date based on the same or
substantially similar application filed in any of the convention countries. The applicant
is required to file an application in the Indian Patent Office within a year from the date
of the initial filing of a similar application in the convention country.

3. PCT International Application

A PCT Application is an international application to streamline patent application
process in many countries at one go. It is governed by the Patent Corporation Treaty
and can be validated in up to 142 countries.

4. PCT National Phase Application

A national phase application is filed in each of the country wherein the protection is
sought. The national phase application must be filed within 30 or 31 months from the
priority date or the international filing date, whichever is earlier.

5. Patent of Addition
The applicant can file a patent of addition if there is a modification of the invention
which has already been applied for or patented. A patent of addition can only be
granted after the grant of the parent patent; hence, no separate renewal fee is to be
remitted during the term of the main patent.

6. Divisional Application
Divisional application is filed if the applicant wishes to divide an application to furnish
two or more applications if a particular application claims for more than one invention.
The priority date for divisional application is similar to that of the parent application.

Criteria for a patent to be granted

 Novelty: According to Section 2(1)(j) of the Indian Patent Act, "invention" is a

new product or process involving an inventive step and capable of industrial
application. Further, Section 2(l) of the Act defines 'new invention' as any
invention or technology which has not been anticipated by publication in any
document or used in the country or elsewhere in the world before the date of
filing of patent application with complete specification, i.e., the subject matter
has not fallen in public domain or that it does not form part of the state of the
art.
 Inventive Step: According to Section 2(1) (ja) "inventive step" means a
feature of an invention that involves technical advance as compared to the
existing knowledge or having economic significance or both and that makes
the invention not obvious to a person skilled in the art.
 Industrial Application: The third criterion of patentability is that the invention
should be capable of industrial application. Section 2(1)(ac) of the Patents
Act, 1970, defines "Capable of Industrial application" in relation to an
invention as the invention is "capable of being made or used in an industry."
Therefore, to be patentable, an invention must be useful.
Basis for rejection of patents in India1
The rejections by the IPO are raised mostly in section 15 proceedings, which
accounts for 1637 rejections. Section 15 is not quoted in isolation and is often used in
conjunction with other sections, at times, the IPO calls for a hearing (under section
14), requesting the applicant for clarifications. In cases where the applicant fails to
clarify the objections raised under section 14, the Controller rejects the application
under section 15. In 54 cases, the Controller rejected the application solely based on
section 16, i.e. the application did not qualify as a divisional application under the Act.
Section 16 was otherwise quoted along with other sections in 117 cases.

Further, as illustrated in the table above, section 3 was used in 65% of cases either
singly or in combination with other sections to reject the patent applications. Out of
the total number of 1723 applications, 1113 applications were rejected by citing
section 3 as an objection.

Section 3 has many sub-sections out of which section 3(d) that deals with
patentability of known substances was used, either alone or in combination with other
sections in 771 cases (69%). In combination with other subsections like section 3(e)
and section 3(i), section 3(d) was used in 36% of cases where an objection of section
3 was raised.
REJECTION OVERVIEW: PHARMA VS OTHERS2

It is evident from the graph below that rejection of pharma were reduced as
compared to the non-pharma patents, wherein the rejections were increased.

As illustrated in the bar graph above, there was an increase in rejection of pharma
patents from the year 2013-2014 to 2014-2015. However, the number of rejections of
the same remained constant there through. On the contrary, there was an increase in
the rejection of other patents as compared to the pharma patents.

Footnotes

1 http://accessibsa.org/media/2017/12/Rejected-in-India.pdf

2. http://accessibsa.org/media/2017/12/Rejected-in-India.pdf

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.

AUTHOR(S)
Four Steps to Filing an
Opposition
There are four main steps to building your opposition. Each step requires research,
since you will be dealing with complex issues. We’ve included links to the resources
you’ll need as we go along.

Step 1: Fundamentals
Before you begin, it’s important to check two key issues:
 Is there no generic competition because the drug is protected by patents?
 Who is allowed to contest patents, when, and by what means?
These questions are fundamental. If you discover that patents are not the reason that
your drug of interest is not available in generic variants, then you will need to pursue
a different path.
And if you learn that patent oppositions are only allowed from researchers or
commercial entities, or can only be submitted within a specific timeframe, you may
have to adjust your plans.
Absence of generic competition
You know that there are no generic versions of your drug in the country you’re
working in — that’s why you’re considering a patent opposition in the first place.
But that might not always be because it’s protected by patents.
Action
Check if there are generic versions of the medicine commercially available in other countries. If so,
there may be a variety of reasons why your country does not have these versions available.

 Voluntary licence (VL) If you find a generic version in the international

market, this might mean that some generics producers have a VL
agreement with the originator company. There may be restrictions on
which countries the medicine can be sold in.
 Too small a market If your country has a small population, it may not
have been worth the effort for companies to market their generic
products there.
 Data exclusivity When the existing clinical data on a drug is ‘locked up’
for a period of years. This means that drug regulatory agencies can’t rely
on existing clinical data to register generic versions of a drug, and
generics companies can’t get approval to sell their own versions until data
exclusivity expires.
  Other factors Conditions of registration, or the government’s decision to
only buy from originator pharmaceutical corporations, can also impact
the availability of generic drugs.

Check the legislation in your country

You’ve identified that patents are the reason why there are no generic versions of the
drug in your country.
Now you’ll need to check the legislation in your country of interest to find answers to
the following questions, and consult our suggested resources, ask other people who
use this site for help, and, if all else fails, conduct your own research.
Resources
To check country legislation:

 WIPO Lex: A search mechanism covering national laws and treaties on

intellectual property (IP) of the World Intellectual Property Organisation
(WIPO) the World Trade Organisation (WTO) and United Nations (UN)
Members.

To understand procedural requirements:

 IPpro: (English) - IPpro

Others:

 Standing Committee on the Law of Patents – Opposition systems (English,

French, Spanish) – WIPO

1. The system: Is there a framework for patent examination in your country of

interest?
Action
Use WIPO Lex to search for the relevant laws or treaties, and to find out what they include. (Note that
some countries have patent laws that differ by region).

2. The timing: Is it permissible to present a pre-grant opposition, a post-grant

opposition, or both?
Note that a country’s patent legislation may not necessarily use the specific terms
‘pre- or post-grant patent opposition’. It may use terms such as ‘representation’ or
‘observation’ for both pre- and post-grant oppositions.
Examples
In Brazil, Industrial Property Legislation Act #9.279/96, article 31, allows documents and information
to be presented in order to "support the examination" of a patent application. Although this is not
actually called a ‘pre-grant opposition’ and is considered limited from the procedural perspective, civil
society groups have used this as a basis to contest abusive patents on important medicines.

In China, Rule 48 of the Implementation Regulation of Chinese Patent Law allows any person to
submit observations to the patent office on a published patent application "with reasons therefore, on
the application which is not in conformity with the provisions of the Patent Law". This procedure is
called “observation”; it has been used by civil society organisations to challenge unmerited patent
application on medicines.

In some countries, including South Africa, pharmaceutical corporations can automatically register a
patent when a drug has already been patented in a developed country. In such cases, a pre-grant
opposition is not possible. Since South Africa is undergoing a patent law reform, you may need to
check once the reform is complete to see if and how the law allowing pre-grant oppositions has
changed.

Action
Check the fine details of what is permitted.

3. The letter of the law: How does the country interpret patentability requirements?
Countries who are members of the World Trade Organisation (WTO) adhere to the
general international patent rules that are in the WTO’s TRIPS Agreement.
However, TRIPS leaves the scope of interpretation of these terms open to each WTO
member country. As a result, WTO members have taken different approaches,
choosing definitions that best suit their needs. The flexibility to interpret also applies
to the detailed criteria on the three general requirements - so-called ‘patentability’ - to
patent protection: novelty, inventiveness and industrial applicability.
Crucially, to contest a patent, you will have to prove that it fails to meet the
patentability standards that are set out in the country or region’s own patent laws.
Validity may also be affected by other agreements that countries have signed, such as
free trade agreements.
Unfortunately, it is not always a simple matter to gain full understanding of a
country’s patent standards.
Just looking at the law may not be enough to determine how a country interprets
patentability requirements. You may also need to check relevant patent regulations,
patent examination guidelines issued by patent offices, and any court cases that can
provide critical information on how these provisions are interpreted.
Note: Keep an open mind as you do this research, and do not be dissuaded. Even
when a country has strict standards for patentability, there is no guarantee that they
have been adequately applied.
It’s also important to be aware that pharmaceutical corporations invest in clever
designs for their patent applications to claim novelty or inventiveness where they may
not exist as a way of dealing with legal requirements.
Resources
Article 27 of the TRIPS Agreement establishes that "patents shall be available for any inventions,
whether products or processes, in all fields of technology, provided that they are new, involve an
inventive step and are capable of industrial application".

To understand these key legal concepts, refer to ‘South Perspective - A Guide to Pharmaceutical
Patents (Volume 1 and 2)’
Examples
India, for example, has chosen a strict criteria where a patent on a new form or use of existing
medicines can only be granted if improved efficacy can be shown.

Argentina has recently issued guidelines for patent examiners on how to apply criteria to fight against
‘evergreening’ - a strategy used by pharmaceutical corporations to prolong their market monopolies by
applying for patents on petty changes to old medicines. For example, pharmaceutical corporations have
filed patent applications covering ‘formulation’ (e.g. heat stable tablets and syrups), dosage,
combinations, new use, and derivatives (salts, prodrugs, crystals, polymorphs) of the existing
medicines.

Action
Search the Patent Opposition Database for examples of cases from the country you are focused on, to
see whether they contain any information about the grounds for analyzing and contesting patents.

Don’t forget to ask other people who use this site to help — they may already have the knowledge you
need.

4. The litigant: Who is entitled to file an opposition?

Some countries have legislation that restricts who can file an opposition to industry or
those involved in scientific research, such as universities and public institutions. Other
countries recognize the rights of any person, including patient groups, to file an
opposition by following some procedures of the local laws. The right to challenge a
patent by anyone at any time is extremely important, and should be added as a key
amendment in patent laws that do not include it. For example, a patent blocking
access to affordable medicines can injure people affected by a specific disease, so the
definition of who can be considered as third parties interested in the granting of a
patent must be as inclusive as possible.
Examples
In India, civil society groups can file pre-grant oppositions.

Patient groups in Thailand, Brazil and India have already filed a number of pre-grant oppositions on
applications claiming patents on important drugs, including tenofovir, sofosbuvir and linezolid.

5. Time limits: What is the period for filing an opposition?

In some countries, pre-grant oppositions must be filed within certain strict time limits.
Make sure you are aware of them — they can be crucial.
Examples
In Thailand, there is just a three-month window from the date when the patent application is published
for filing a pre-grant opposition.

In India, the window is far more flexible - an opposition can be filed at any time prior to the grant of
the patent.

6. Procedural requirements: What rules must be adhered to in submitting an

opposition?
Should your opposition be submitted in writing - and if so does it need to be a hard
copy on paper, or is email acceptable? What notifications are necessary, within what
timeframes? Are you required to work with a local lawyer or agent to submit the
opposition?
7. If all else fails: Does the system need fixing?
Some countries have procedural aspects that can make patent oppositions restrictive,
or costly.
In some cases, the answer to these questions may point to the need to improve the
local examination system, or to put one in place. For example, If the period for filing
an opposition is very short, if the patent office isn’t required to take the opposition
into account, or if civil society is excluded from filing an opposition, then it may be
necessary to improve the legislative framework, which includes the patent law and all
other patent-related regulations.
These restrictions and limitations could be addressed by advocating and campaigning
for changes in national patent laws, such as the current campaign led by the Treatment
Action Campaign and other civil society organisations to amend South Africa’s patent
laws. For more information on the campaign, visit fixthepatentlaws.org.
Examples
In Argentina documents must be officially translated; this can cost US$10,000, making it difficult for
patient groups to file pre-grant oppositions.

In Thailand, there is only a three-month window to file a pre-grant opposition; often, this deadline has
already expired before patient groups have found the relevant patent application relating to a drug.

Step 2: locate the patent(s)

Before considering a patent opposition to stimulate generic competition, it is
important to check two key issues: is the absence of generic competition a
consequence of patent protection; and, if so, which patent(s) cover this medicine and
are blocking generic competition.
Resources
Free, step-by-step guides are available to show people who are not legal experts how to undertake
preliminary patent searches.

 WHO: How to Conduct Patent Searches for Medicines: A Step-by-Step

Guide
 UNDP: Searching for Patents on Essential Medicines in Developing
Countries: A Methodology

Undertaking a patent search

After you’ve determined that access to your drug is restricted by patents, not the
factors listed above, and discovered that the path is clear for you to file an opposition,
the next step is to find out if patent applications have been filed in your country of
interest. This is done by undertaking a search at your local patent examination office,
where you can check to see whether patents are pending (the patent office has not yet
made a decision on the patent application), or have already been granted or rejected.
First, you will need some understanding of how and where patents are filed, and how
to read a patent application.
Resources
For more detail on this issue, see MSF’s report ‘Drug Patents Under the Spotlight’ and ‘Guidelines for
the examination of pharmaceutical patents: developing a public health perspective’.

One medicine, many patents

Many people assume that a patented medicine is protected by one particular patent.
Unfortunately, it is not that straightforward.
Patents do not protect medicines, but ‘inventions’. In the pharmaceutical sector, to
postpone the date that their products will go off-patent, companies file numerous
applications around their invention.
So, suppose that the medicine’s formulation includes a specific molecule, the
‘invention’ that is central to the patent. In addition to a patent on the molecule itself,
patents can also cover ‘process’ (the means by which the molecule is manufactured),
‘formulation’ (the form the medicine takes, e.g. powders, tablets and capsules, etc.),
dosage (route, regimen), combinations (e.g. a fixed-dose combination when different
drugs are combined in the same pill), new use (i.e. an existing medicine for which a
new use has been found), and derivatives (salts, prodrugs, crystals, polymorphs).
Not all of these patents may prevent generic competition. Some patents can be easily
worked around to launch generic products without infringement: imagine, for
example, a new way to manufacture the same molecule.
So it’s important to locate each patent that covers your medicine: you can analyse
them later, to check whether any of them actually do block generic competition.
Dealing with a lack of transparency
Patent information should be transparent, but it often isn’t.
Sometimes it isn’t obvious that the patent application refers to the medicine you’re
researching.
A company only has to describe the subject matter of the invention (e.g. the chemical
formula of a molecule), and they seldom use the chemical or international non-
proprietary name (INN) or the brand name of the medicine.
In any case, a patent on a new compound is filed before the medicine is formally
registered and has a proper INN assigned to it. So don’t give up if a search if the
medicine’s name doesn’t yield results. Instead, look for the chemical formula or other
invention that the patent is likely to refer to.
Example
The antibiotic linezolid is used to treat pneumonia, skin infections and drug-resistant tuberculosis (DR-
TB). It has a complex chemical name S)-N-({3-[3-fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-
oxazolidin-5-yl}methyl) acetamide, Most patents refer to linezolid by the chemical name.

Be prepared for setbacks

Pharmaceutical corporations are not willing to disclose all of the patent applications
related to a medicine, often keeping this information confidential.
Access to commercial databases and information services that provide overviews of
patent applications and the patents that are related to specific medicines can be
expensive.
Patent offices in developing countries generally have information on which patent
applications are pending or which patents are still in effect, although it may not
always be up-to-date or accurate. Information and source documents are often not
made public - or even disclosed on request. Requests for patent searches in patent
offices are not always free and can be expensive in some countries; in developing
countries, some patent offices lack the capacity to respond to requests for information.
All of this can make your task more difficult, so be prepared for setbacks.
Here in the Patent Opposition Database, the search engine on the homepage was
designed to overcome some of these barriers. By typing the name of a drug, you may
find corresponding patent information already uploaded by other users, or links to
other sources where patent information on medicines is collected.
Anyway, looking at your country databases is essential, to ensure you have an
accurate picture of the patent situation.
Example
In India, treatment activists have used various means to access information concerning patent claims
filed by pharmaceutical corporations; this information should be in the public domain - but it is not.
Information has been sought through interactions with patent office staff, filing applications under the
Right to Information Act, 2005, and consulting with generic companies having interest in producing
these medicines.

Action
Start researching the patent(s) on your drug.

Resources
Patent landscapes

 World Intellectual Property Organization Patent Landscape Reports

 Medicines Patent Pool. MedsPal: Although not exhaustive, the Medicines
Patent Pool’s licensing and patent database provides information on the
patent status of selected drugs for HIV/AIDS, hepatitis C and tuberculosis
(TB) in a large number of low- and middle-income countries. It enables
users to search by country/region and by medicine for information on key
patents relating to each medicine. Wherever a patent has been applied for
or granted in a given jurisdiction, the relevant patent number is also
provided, if it is available.
 I-MAK: The Roadmap: The HIV Drug Pipeline & its Patents (PDF)
 I-MAK: HIV drug patents in China (PDF)
 Lawyers Collective: Drug Patent Status - India

Patent searches

 WIPO PATENTSCOPE Chemsearch, which has not officially launched; to

gain access, set up a free account and log in. Go to ‘search’ and select
‘chemical compound’. You will find three buttons: structure editor,
 convert structure and upload structure. If you are not an expert on on
chemical structure, choose 'convert structure', and select INN from the
menu. Enter the INN name you are looking for, and start searching.
 United States Patent and Trademark Office
 FPO: IP Research & Communities
 Google Patents
 Patent Lens
 Intellectual Property Library
 Prior Smart
 US FDA
 Health Canada

1. Use the ‘patent landscape’.

Explore previous searches and studies that others have made on medicines.
Try the resources listed above. You can also use the drug pages of this database to see
if there are materials relating to your medicine. Previous oppositions on the same drug
can also provide information on relevant patents: find them on each drug page by
clicking on ‘patent oppositions’.
2. Learn how to conduct a patent search.
If there is no patent landscape for a medicine, it is worth exploring the possibility of
conducting a patent search. We recommend that you read the World Health
Organisation’s Guide to Patent Searches [PDF] before continuing.
Even if there are patent landscapes available, a patent search will often yield valuable
local information, and is worth the effort. Most guides will refer to the US Food and
Drug Administration (FDA) and Health Canada online patent registries as a starting
point, since many key patents are listed on these sites (with their INNs).
The information you get from these sites can be used at your local patent office, to ask
for the corresponding applications in your country.
The World Intellectual Property Organization (WIPO) also has a searchable online
database for patent applications that can provide information on where patents
applications may have been submitted; this may help you to find the corresponding
patent applications that are pending or have been granted in your own country.
3. Share your findings.
As you can see, the Patents Opposition Database works best when users share their
resources — so if you discover useful patent information, or a patent landscape that is
not yet included here, please submit it for inclusion.
Resources
These public interest organisations have worked with patient groups. Their websites contain useful
information.

 ABIA: Associaçã o Brasileira Interdisciplinar de AIDS (Brazilian

Interdisciplinary AIDS Association) (ABIA) is a non-governmental, non-
 profit organization fighting for access to care and treatment for people
living with HIV and AIDS.
 Lawyers Collective: A public service interest provider in India, Lawyers
Collective works in human rights advocacy, legal aid and litigation.
 I-MAK: Initiative for Medicines, Access & Knowledge: I-MAK is a team of
lawyers and scientists increasing access to affordable medicines through
an efficient patent system.
 Public Patent Foundation: The Public Patent Foundation at Benjamin N.
Cardozo School of Law (‘PUBPAT’) is a not-for-profit legal service
organization that works to strengthen the patent system by introducing
non-patentee input to help the system achieve high quality and balanced
policies.

Step 3: Searching and analysing

Resources
To better understand the anatomy of a patent, see page 34 of MSF’s report, Drug Patents Under the
Spotlight.

If you’ve completed Steps 1 and 2 (Fundamentals and Locating the Patent), you now
have a good overview of what’s legally possible in your country of interest. You’ve
located the relevant patents, and found materials that may help you to contest them.
Now it’s time to build your opposition.
This is the stage when you will almost certainly need help from someone with a legal
or pharmaceutical background. As you’ll see, this site can help you find them.
Building arguments for an opposition
You’ll be trying to prove one or more of the following:

 That the patent application does not fulfil one or more of the requirements
(novelty, inventiveness and industrial applicability);
 That the drug or medical product is non-patentable in other ways;
 That the patent or application fails to meet other requirements set out in the
laws of your country of interest (e.g. sufficient disclosure of the invention).

To do this, you’ll need to assess the claims in the patent application documents. This
is a technical task: claims are complex, and understanding them often requires a legal
and chemical background to properly judge the merits of the invention.
If you do not have access to such expertise, our ‘call for help’ feature can be useful. It
allows you to ask other users of the site to share their expertise.
You can use the Patent Opposition Database search tool to find patent oppositions
relating to specific drugs or types of patent applications. These can be used to identify
similarities between the arguments used in different oppositions.
Adapting an existing opposition to your country
In step 2, you researched the patent landscape. If you found oppositions from other
countries, you’re in luck. Understanding the claims that were contested - whether
successfully or not - will help to inform your own argument.
Finding an existing opposition will save a lot of work, although you’ll still need to use
the research you did in Step 1 (when you found out about laws governing patent
oppositions in your country of interest). You may find that the grounds on which the
claims were contested are not allowed by your country’s laws.
Even if you are not able make similar arguments, existing oppositions can be a great
help. The rationale used in other countries can be a good starting point and reference
when you come to formulate your own opposition.
Identify the description, claims and subject matter
To draft an opposition, you will need access to a) the description and b) claims in the
patent application. The description opens by ‘setting the scene’ for the invention,
while the claims define the scope of the patent protection that the applicant asked for.
Next, identify the subject matter of the patent protection: it could, for example, be a
molecule or group of molecules; a salt; a process; a formulation; a combination; a
dosage form — or something else.
Resources
Access to patent opposition stories can also help building arguments against weak claims.

These services contain helpful information about prosecution and access to case files: the USPTO
Patent Application Information Retrieval (PAIR) and European Patent Office’s epoline.

Also, check whether there is an International Search Report (ISR) or International Preliminary
Examining Authorities (IPEA) report for patent applications made under the Patent Cooperation Treaty
procedure. This can be found through the WIPO Patentscope database.

Such reports may help build a case that a particular patent claim is not novel, as they show what other
search authorities have found in relation to ‘prior art’ i.e. what was already known and in the public
domain.

If the prior art covers the same subject matter as a claim, then this can be used to argue that the claim
should be rejected for failing to pass the novelty ‘test’ for the grant of a patent.

Examples
Examples of oppositions on typical patent claims:

 Patent opposition on formulation and composition: pre-grant opposition

by I-MAK against patent on LPV/r(339/MUMNP/2006)
 Patent opposition on fixed dose combination: pre-grant opposition by
INP+ & MNP+ against patent on AZT/3TC (2044/CAL/1997)
 Patent opposition on salts, ethers and esters: pre-grant opposition by
INP+ & DNP+ against patent on TDF (896/DEL/2002 - divisional to
2174/DEL1998)
 Patent opposition on polymorphs: pre-grant opposition by INP+ & DNP+
against patent on ritonavir (PCT/2001/00018/MUM)
  Patent opposition on selection patent application: pre-grant opposition by
INP+ against patent on abacavir (872/CAL/98)
 Patent opposition on process: pre-grant opposition by Matrix against
patent on lopinavir (259/MUMNP/2003)
 Patent opposition on active metabolite and pro-drug: pre-grant
opposition by ABIA/Sahara against patent on TDF (2076/DEL/1997)

Step 4: File your opposition

Once you have gathered all the information and formulated your arguments, you need
to compile them into a written document that complies with the rules on patent
opposition in your country of interest.
Then, opposition can be filed. Every country has its own filing procedures. Patent
oppositions may be an administrative procedure, dealt with by the patent office, a
judicial office, or dealt with by the court. Consult your country’s patent authority
website to see exactly what they require.
At a minimum, most authorities will require the following information:

 Name and legal information of the opponent(s);

 Reference to the law allowing for opposition;
 Reference to the legal standing of the opponent(s);
 Summary of the arguments that justify the request for refusal;
 Summary of the claims made by the applicant;
 The grounds for the opposition (in detail);
 Request for subsequent actions to be taken by the court or patent office such as
revoking or refusing to grant the patent

At this stage the inventor and the patent agent create and send a response to the
examina
-
�on that tries to prove to controller that his inven�on is indeed patentable and sa�sfies
all
patentability criteria’s.
Step 8: respond to objec�ons
This communica�on takes place between the controller and the patent applicant to
ensure
that all objec�ons raised in the patent applica�on are resolved. (if not the patent will not
be
granted ) and the inventor gets a fair chance to prove his point and establish novelty and
inven�ve step over exis�ng prior arts.
Step 9: clearing all objec�ons
The applica�on is placed in order for grant once it is found that all patentability require
-
ments are being fulfilled.
The grant of patent is no�fied in the patent journal which is published from �me to
�me