How To Obtain A Patent For Pharmaceutical Products In India
India ranks third in Asia pacific and the top
12 destinations for biotechnology worldwide. With the evolution of
pharmaceutical technology in India, it has become an utmost concern for Indian
Patent Office that the uniformity and consistency of examination and grant of
patents be maintained.
What is Patent?
The Patent Act, 1970 govern patents in India.
A patent is an intellectual property which grants the inventor or the patentee
the exclusive right to exploit the invention economically for a limited period
of 20 years from the date of filing the patent application within India, in
exchange of full disclosure of his invention. The purpose of granting a patent
right is to incentive inventors towards developing new technology and making
scientific progress.
Patent Protection in India
A pharmaceutical invention requires
significant time and resources. Thus, the protection of these inventions and
their patents could not be more critical. However, to apply for a patent under
the Patent Act, 1970, an invention must qualify the following criteria:
l Patentable subject matter: The invention
should not fall under section 3 which defines “what are not invenetions” and
section 4 of Patent Act, 1970 which says “Inventions relating to atomic energy
not patentable.”
l Novelty of the invention: the invention should
not be have been published in India or anywhere else in the world before the
date of filing the patent application.
l Non-obviousness/Inventive
step – the
invention cannot be obvious and should have a significant leap of scientific
progress.
l Industrial Application: the invention should
have some practical utility and industrial application that can be applied in
real life; it cannot be an abstract theory.
According to article 27(1) of the World Trade
Organization’s Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPs) Agreement, patents should be granted for inventions in any field
of technology without discrimination. The third amendment of the Patents Act,
1970 bring biotechnological and pharmaceutical inventions under the purview of
patentable subject matter in India.
Types of Patent Application
Various types of patents are filed under
patent law depending on various parameters like the statute governing it, the
jurisdiction etc. These are various types of patent applications that can be
filed by an inventor:
l an ordinary patent application under
the Patents Act, 1970,
l a divisional application is
filed in case many many inventions disclosed in the main application,
l a Patent of Addition is
filed in the post the filing of the main application of patent, in case of
improvement or modification in the invention,
l a Convention Application,
which is filed for a patent in a convention country within 12 months from the
date of the basic application
l a National Phase Application
under the Patent Cooperation Treaty (PCT), that allows a national
or resident of a PCT country (like India) to enjoy the benefit of patent
holdings in all or any of the PCT countries.
Obtaining a Patent in India
1. Patent Search: The first step while filing for a patent
application is to search by the inventor to confirm that the same invention has
not been made previously. This step is essential and helps the inventor to
avoid wastage of time and resources. This would also help the inventor in
drafting the application in such a way that it highlights the unique features
of his invention compared to similar inventions that have already been
published or patented. A patent search may be conducted at the patent office or
online by the website of the Patent Office. A similar search for patents should
also be conducted on an international database like Google Patents to ensure
that a similar invention has not been published or patented in a different
country.
2. Choosing Appropriate Patent Office- There are four patent offices in India located
at New Delhi, Mumbai, Kolkata and Chennai, respectively. The territorial
jurisdiction of the patent offices are as follows-
l New Delhi Branch – Delhi, Haryana, Jammu and Kashmir,
Himachal Pradesh, Punjab, Uttar Pradesh, Rajasthan, Uttaranchal and Chandigarh;
l Mumbai Branch – Maharashtra, Madhya Pradesh, Gujarat, Nagar
Haveli and Daman and Diu and Dadra;
l Chennai Branch – Tamil Nadu, Kerala, Karnataka Andhra
Pradesh, Lakshadweep and Pondicherry;
l Kolkata Branch – the rest of India.
3. Drafting the Patent Application- A patent application has to be filed with
various declarations and forms as described below:
1. Application for Patent (Form 1)
2. Proof of right to file the application from
the inventor (Form 30)
3. Provisional or Complete specification (Form 2)
4. Statement and undertaking within 6 months
of application (Form 3) (in
case of filing abroad in addition to filing in India)
5. Declaration as to inventorship (Form 4/5)
6. Power of authority (Form 26) (in case of filing
through a patent agent)
7. Priority document within 18 months of
application (in case of Convention or PCT applications)
4. Provisional or Complete
Specification- A
patent is granted to whoever files a patent application first. Hence, an
inventor may file a provincial application for the patent before the completion
of the invention. It does not require to disclose minute details of the invention
and only needs to give a reasonably skilled person in the relevant industry a
basic idea of the functionality of the invention. In this case, the complete
specification is required to file within 12 months from the date of filing of
the first application, thus giving him time to obtain funding based on a
potential patent.
5. Publication of the Application: After filling the application, it is published
in the journal of the Patent Office for public inspection within 18 months of
filing. The details of the application, including the date of application,
application number, name and address of the applicant and the abstract of the
invention for which the patent is sought are published.
6. Pre-Grant Opposition: Any person under Section 11A of the Patents Act, 1970 can file
an opposition within 6 months from the date of publication
of the application on any of the grounds provided under Section 25(1) of the Patents Act.
7. Filing Request for Examination of Application:
Post-publication
of the patent application the inventor is required to file a request for
examination (to initiate the examination of the application by the patent
examiner), within 48 months of applying Form 18.First Examination Report- The
patent application is examined and scrutinised by a patent examiner under the
patent office to ensure that there are no grounds for objection to the granting
of the patent. The examiner then prepares a First Examination Report within a
maximum period of 3 months. Following this, the report has to be disposed off
by the Controller within one month of receipt of such report from the examiner
and a Statement of Objections has to be issued within one month of disposal of
the report.
8. Grant of Patent Certificate- Once the requirement issued by the Patent Office has been met and the deficiencies have been rectified, the details of the patent are recorded in the Register of Patents and the same is published in the Official Journal of the Patent Office and a patent certificate in the prescribed format is issued to the applicant.