How to Obtain a patent for pharmaceutical products in India

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  divisional application is filed in case many many inventions disclosed in the main application, 

l  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 Convention Application, which is filed for a patent in a convention country within 12 months from the date of the basic application

l  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.