This article is written by Aditi Lahiri, pursuing a Diploma in Business Laws for In House Counsels from Lawsikho.com.

Introduction

With the evolution of India into ‘the pharmacy of the world’, pharmaceutical and biotechnology patenting in India has become of utmost concern not only to India, but also for the rest of the world. India has been ranked third in Asia Pacific and in the top 12 destinations for biotechnology worldwide. Hence, to promote innovation and technological development in the country, it is the highest priority of the Indian Patent Office that the uniformity and consistency of examination and grant of patents be maintained. 

What is a patent? 

Governed by the Patents Act, 1970, a Patent is a sort of intellectual property right that grants the inventor or the patentee the exclusive right to economically exploit an invention (products and processes but not services) 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. This gives the inventor the monopoly to own, use, make, sell, license, or otherwise financially benefit from the patented invention, while excluding others from doing the same during the limited period. The purpose of patents is to incentivise inventors towards developing new technology and making scientific progress. Patents can be held alone or jointly by first inventors or their assignees. However, this right being a territorial right, an Indian patent is only applicable within the territory of India. Hence, businesses often opt for filing for patents in multiple jurisdictions internationally. 

Patent protection in India

Considering the significant time and resources that go into biotechnology and pharmaceutical inventions, the protection of these patents could not be more important. However, to be eligible for such protection under the Patent Act, 1970, the inventions have to qualify under the following key criteria:

• Patentable subject matter – the invention should not fall under the Sections 3 and 4 of the Patents Act, 1970;
• Novelty of the invention – the invention should not have been published in India or anywhere else in the world before the date of filing the patent application;
• Non-obviousness/Inventive step – the invention cannot be obvious and should have a significant leap of scientific progress;
• Industrial application – the invention should possess some sort of practical utility that can be applied in real-life, it cannot be an abstract theory.

Article 27(1) of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement clearly states that, subject to certain clauses, patents should be granted for inventions in any field of technology without discrimination. The third amendment of the Patents Act, 1970, which came into effect from 1st January 2005, made the Patents Act fully TRIPS compliant as it omitted Section 5 of the Indian Patents Act bringing biotechnological and pharmaceutical inventions under the purview of patentable subject matter in India. 

There are many types of patents that can be granted in the pharmaceutical and biotechnology industry like Drug Compound Patents, Synergistic Combination Patents, Technology Patents, Polymorph Patents and Process Patents. However, it should be noted that under the Indian law, for substances produced by chemical processes or capable of being used as food, drugs or medicines, no product patents can be granted for the substances themselves. In such cases, only process patents can be granted for the procedure of manufacture of such substances. 

Types of patent applications

Having understood the basics of patent protection, the next step is to understand the various types of patents that may be filed to be protected under patent law depending on various parameters like the statute governing it, the jurisdiction, or the invention itself. These are various types of patent applications that can be filed by an inventor:

• an ordinary patent application under the Patents Act, 1970, 
• a divisional application that may be filed in case of many inventions disclosed in the main application, 
• a Patent of Addition, to be filed post the filing of the main application of patent, for an improvement or modification in the invention, 
• a Convention Application, which is filed for patent in a convention country within 12 months from the date of basic application and 
• a National Phase Application under the Patent Cooperation Treaty (PCT), which 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

Now that we have understood the foundational concepts of patent law, we may shift to the practical process that is required to be followed in order to obtain a patent. 

Patent Search

The first step towards filing an application for a patent should ideally always be conducting a preliminary search by the inventor to confirm that the same invention has not been made previously. The wise choice would be to conduct such search early on while developing the invention to avoid wastage of time and resources. This will also help the inventor in drafting an application for his patent in such a way so as to highlight the unique features of his invention compared to similar inventions that have already been published or patented. A patent search may be conducted physically at the Patent Office or online by visiting the website of the Patent Office. A similar search should also be conducted on international databases like Patentscope and Google Patents to ensure that a similar invention has not been published or patented in a different country. Once it has been confirmed that the invention in question has not been patented anywhere before, the inventor can move on to filing a patent application for the invention.  

Choosing Appropriate Patent Office

Presently, 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-

• New Delhi Branch – Delhi, Haryana, Jammu and Kashmir, Himachal Pradesh, Punjab, Uttar Pradesh, Rajasthan, Uttaranchal and Chandigarh;
• Mumbai Branch – Maharashtra, Madhya Pradesh, Gujarat, Nagar Haveli and Daman and Diu and Dadra;
• Chennai Branch – Tamil Nadu, Kerala, Karnataka Andhra Pradesh, Lakshadweep and Pondicherry;
• Kolkata Branch – the rest of India. 

An inventor is free to file a patent application in any such Patent office Branch under whose jurisdiction he/she:

1. normally resides;
2. has a place of business; or
3. the invention was originally created. 

Drafting the Patent Application

The patent application should ideally be drafted together by the inventor and a patent attorney so as to bring their technological and legal expertise together in drafting a clear and detailed 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)

While most of the above requirements are fairly standardised, the patent specification usually requires significant customisation and careful drafting through the aid of a patent attorney. The main components of a patent specification are:

1. Title of the Invention – this will indicate a phrase indicating the new product or the process depending on the nature of the invention.
2. Abstract – this should provide the technical field the invention belongs to, the problem it has attempted to address, the solution provided by the invention and its usefulness, within 150 words. 
3. Background – this explains the prior art existing before the new invention, the deficiencies therein, a brief description of the new invention (along with drawings, if any) and its usefulness in solving the deficiencies of the prior art. This helps in demonstrating the inventive step in the new product or process described later.
4. Drawings and Detailed Description – this part contains systematically numbered drawings to explain and demonstrate the working of the new invention, making it easier to describe and comprehend the details of the different components of the invention. Accordingly, the drawings must be explained in detail as to how all the different parts function together to give the desired results. 
5. Claims – this describes the scope of the patent that the applicant seeks and can be as broad or narrow as the inventor desires. The technical features of the invention for which protection is sought should be mentioned without including non-technical matters like commercial advantages. 

Provisional or Complete Specification

A patent for an  invention is granted to whoever files a patent application first, regardless of who developed the invention first. Hence, an inventor may choose to file a provincial application for the patent before the completion of the development of the invention to ensure that nobody beats him in the race to the patent office. Such a provincial specification for an application is filed when the working of an invention has been conceptualised but hasn’t necessarily been created or perfected for practical use. It does not require the disclosure of the 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 and is hence much more abridged than the complete specifications filed after the product or process is ready for industrial use. In this case, the inventor is required to file a complete specification within 12 months from the date of filing of the first application, thus giving him time to obtain funding on the basis of a potential patent and improve the invention even after freezing the invention in his name. 

Filing of the Patent Application 

The complete Patent Application including all the forms and declarations as specified above, along with the relevant fees as described below, may be delivered to the appropriate patent office by hand, through courier or electronically with a digital signature. The appropriate fees in INR for filing a patent are as follows:

Publication of the Application

After filing the Patent application, it is published in the journal released by 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. The inventor may also request an early publication through Form 9 along with the prescribed fees, in which case, it shall be published within a month from the date of making such request. 

Pre-grant Opposition

Under Section 11A of the Patents Act, 1970, any person 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. This opposition is taken into consideration once the applicant files a request for examination and not otherwise. 

Filing Request for Examination of Application

Post publication of the 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 filing the application through Form 18 along with the prescribed fees, either physically or electronically, failing which, the application will be considered to have been withdrawn. 

First Examination Report

Subsequently, the patent application is scrutinised by a patent examiner employed 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 where his observations on the application are recorded along with any deficiencies in the application. Following this, the report has to be disposed off by the Controller within 1 month of receipt of such report from the examiner and a Statement of Objections has to be issued within 1 month of disposal of the report. 

Handling Objections 

The applicant is given the opportunity of complying with the requirements and correcting any Procedural/Formal or Substantive objections raised in the First Examination Report within 6 months of the issuance of the report, which may be extended for another 3 months on request by the applicant, failing which, the application will considered to have been withdrawn. In case the applicant does not agree with the Substantive objections that have been raised, he may contest the same by sending a written reply to the Controller or request a hearing to explain his disagreement to the examiner and the controller. 

Grant of Patent Certificate

Once the requirements issued by the Patent Office have been complied with 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. 

Post-grant Opposition

A post-grant opposition may be filed by any person within 12 months from the date of the grant of patent being published in the official journal of the Patent Office.

Obtaining a patent abroad 

Applicants seeking to claim Patent protection in multiple jurisdictions internationally, have two options under which they can choose to file an application, depending on the number of countries they want to apply in and the costs involved. The two relevant international conventions are the Paris Convention and the Patent Cooperation Treaty (PCT). Before filing a patent application in a particular foreign country, it is important to ascertain that the relevant country where the patent is sought, is a member state of the abovementioned international conventions. Under both the international arrangements, the applicant is mandatorily required to obtain permission of the Controller through Form 25 after paying the prescribed fees under Section 39 of the Patents Act, 1970. 

Filing under the PCT 

The PCT, having 146 member states, is the preferred route of applying for a patent if the protection sought is in more than 3 countries. This helps in cutting down the extensive costs of filing applications in multiple jurisdictions. The application has to be filed in two phases – the international phase and then the national phase, in the International Bureau of world Intellectual Property Organisation (WIPO) within 12 months of filing the application in India. 

The international phase comprises of 5 stages as follows:

• The domestic patent office of the relevant country receives and processes the application;
• An international search authority conducts a search process to determine the standard for prior art and prepares a written opinion and a search report;
• The International Bureau publishes and communicates the application and the search report to the national patent offices of the countries where the patent is sought;
• A different International Search Authority conducts another supplementary international search and prepares a supplementary international search report;
• An International preliminary Examining Authority conducts a preliminary examination and publishes an international preliminary report on whether the invention is patentable and the same is intimated to the domestic Patent Offices. 

Subsequently, the application enters the national phase which commences with the furnishing of a translated copy, the details of the inventor as well as the domestic fee payable to the national Patent Offices. In this phase, the application for the patent is scrutinised by the domestic patent offices of the specific countries where protection is sought within 30 months of the date of filing the application in India, unless a specific request for early examination is made by the applicant in the relevant office. 

Filing under the Paris Convention

The Paris Convention, which has 174 members, is opted for if a patent is sought in less than three countries, in which case, the filing process under PCT might be unnecessarily extensive and expensive. Under the Paris Convention, the applicant is to directly file before the domestic patent authorities of the countries it seeks protection in, instead of a common international application process for multiple countries and is a quicker and cost-effective process compared to the PCT. As some African and Middle Eastern Countries are only part of the Paris Convention, this is the only option for applicants seeking protection in these Countries. 

Other important actions regarding patent

Patent of Biological Material

If a new biological material has been used in an invention, before the filing of the application in India, the same has to be deposited in the International Depository Authority (IDA) (known as Institute of Microbial Technology (IMTECH) in India) in order to supplement the description. 

Periodic Renewal Fees

After the patent has been granted, an annual renewal fee has to be paid (in instalments or as a lump sum amount) with the first instalment being due after the completion of the first two years, failing which the patent will become invalid. 

Opposition to Similar Patent Applications

Patent holders should file oppositions with respect to any existing or pending patent applications that may infringe upon their exclusive rights due to being too similar to their inventions or hindering the holder’s use of a general technology in the future. 

Legal issues regarding pharmaceutical and biotechnology patents 

In India, under Section 3(d) of the Act, only inventions are patentable subject matter and not mere discoveries of a new form of a known substance, unless it significantly increases the efficiency of the substance as held by the Supreme Court in Novartis AG v. Union Of India. However, the absence of a defined distinction between unpatentable discovery and patentable invention causes significant confusion and struggle while applying for a patent. 

The hurdle of meeting the condition of an inventive step and/or non-obviousness poses a huge difficulty for the pharmaceutical patents as the patenting of new drug formulations is advised against, opining that “patent applications on compositions i.e., formulations, will normally confront an objection of lack of inventive step.” 

However, new formulations of existing drugs can provide significant benefits to patients, increase convenience of administering the drug, reduce side effects, and such research necessary to develop new formulations should not be disincentivized by the requirement of an inappropriately heightened intellectual leap for a patent. 

Further, the guidelines by the Indian Patent Office regarding biotech patents are grossly inadequate and inconsistent with the absence of basic words like DNA or gene anywhere in the Patent Act. The law in India also does not discriminate between products modified or isolated from nature and products of nature, further blurring the lines between invention and discovery. 

Pharmaceutical and biotechnology patents are also often subject to compulsory licensing, in case public requirements of the invention haven’t been met or if it is not available to the public at a reasonable price, in which case the patentee loses his monopoly and is ordered to license the invention on sometimes unreasonable terms. 

Conclusion

The legal inadequacies in Indian Patent law may negatively affect research and development in the long run. However, some are of the opinion that the current legal provisions prioritise public health and maintain a higher threshold of inventive leap for granting monopoly, which in turn sets higher standards for innovation in the pharmaceutical and biotechnology industry. 

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