Patents are important to the Pharma sector in India as they contribute to the recovery of investments in research and development and drug marketing. The invention can be secured by strict patent protection from possible infringers and cannot be used, created or transmitted without the permission of the patentee.
In India, pharmaceutical patenting has been of utmost importance not only to India, but also to the rest of the world with India's transformation into 'the pharmacy of the world.' India has been ranked third in Asia Pacific and in the world's top 12 biotechnology destinations. It is therefore the highest priority of the Indian Patent Office to ensure the uniformity and continuity of the review and the grant of patents in order to encourage innovation and technological growth in the country especially as the world recovers from the aftermath of the COVID-19 Pandemic
What is a patent?
A patent is a form of intellectual property right regulated by the Patents Act, 1970, which grants the inventor or patentee an exclusive right to use an invention commercially (products and processes but not services) for a limited period of 20 years from the date of filing of the patent application in India, in return for the complete disclosure of the invention. This grants the inventor the monopoly to possess, use, produce, sell, license or otherwise profit financially from the patented invention, while preventing others for a limited time from doing the same. Patents are meant to inspire inventors to create new inventions and to make scientific progress. Patents may be owned by the first inventors or their assignees alone or jointly. However, since this right is a territorial right, only within the jurisdiction of India is an Indian patent valid. Therefore, in several jurisdictions worldwide, corporations also opt for patent filings.
Patent protection in India
The protection of these patents could not be more important, given the considerable time and energy involved in biotechnology and pharmaceutical developments. However, in order for inventions to be qualified for such rights under the Patent Act 1970, they must qualify according to the following main criteria:
Article 27(1) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organization specifically states that patents should be issued without prejudice for innovations in any area of technology, subject to certain clauses. The third amendment to the Patents Act of 1970, which came into force on 1 January 2005, made the Patents Act completely compliant with TRIPS by omitting Section 5 of the Indian Patents Act to allow biotechnology and pharmaceutical inventions subject to patentability in India.
In the pharmaceutical and biotechnology industries, there are several patent forms that can be issued, such as Drug Compound Patents, Synergistic CombinationPatents, Invention Patents, Polymorph Patents, and Process Patents. It should be noted, however, that, under Indian law, no product patents can be issued on the substances themselves for substances generated by chemical processes or capable of being used as food, medicines or medicinal products. In these cases, only process patents can be issued in respect of the production process for such substances.
Types of patent applications
Having learned the fundamentals of patent protection, the next step is to consider, depending on different parameters, such as the legislation controlling it, the jurisdiction or the invention itself, the different forms of patents that may be registered for protection under patent law. There are different kinds of patent applications which an inventor may file:
Obtaining a patent in India
Now that we have understood the basic concepts of patent law, in order to obtain a patent, we can transfer to the practical procedure that needs to be followed.
Ideally, the first step towards filing a patent application should always be to perform a preliminary search by the inventor to ensure that the same invention was not previously made. In order to avoid wasting time and money, the prudent choice would be to perform such searches early on while designing the invention. It will also allow the inventor to draw up an application for his patent in such a way that, compared to similar inventions that have already been published or patented, the distinctive features of his invention will be highlighted. By accessing the Patent Office website, a patent search can be performed physically at the Patent Office or online. To ensure that a similar innovation has not been released or patented in another country, a similar quest should also be carried out on international databases such as Patentscope and Google Patents. Until it has been established that the invention at issue has not been patented anywhere before, the inventor may proceed to the filing of the invention's patent application.
Choosing Appropriate Patent Office
Currently, there are four patent offices in India located at New Delhi, Mumbai, Kolkata and Chennai respectively. The territorial jurisdictions of the patent offices are as follows-
An inventor is free to file a patent application in any such Patent office Branch under whose jurisdiction he/she:
Drafting the Patent Application
Ideally, the inventor and a patent attorney should draw up the patent application together in order to put together their technical and legal experience in the drafting of a concise and thorough application. As mentioned below, a patent application with different declarations and types has to be filed.
Although most of the above specifications are reasonably uniform, with the assistance of a patent attorney, the patent specification typically requires considerable customization and careful drafting. The main components of a specification for a patent are:
Provisional or Complete Specification
Whoever files a patent application first, irrespective of who invented the invention first, is awarded a patent for an invention. Therefore, before the completion of the creation of the invention, an inventor can choose to file a provincial patent application to ensure that nobody beats him in the race to the patent office. When the operation of an invention has been conceptualized but not actually produced or mastered for practical use, such a provincial specification for an application is filed. It does not require the disclosure of the minute details of the invention and only needs to provide a basic idea of the functionality of the invention to a fairly eligible individual in the relevant industry and is therefore much more abridged than the full specifications submitted after the product or method is ready for industrial use. In this case, within 12 months of the date of filing of the first application, the inventor is expected to file a full specification, thus allowing him time to secure funding on the basis of a possible patent and to develop the invention even after the invention in his name has been frozen.
Filing of the Patent Application
The full patent application, including all the forms and declarations referred to above, together with the related fees, as mentioned below, may be submitted by hand, by courier, or electronically with a digital signature to the appropriate patent office.
Publication of the Application
It shall be published in the journal published by the Patent Office for public review within 18 months of filing, following the filing of the patent application. The particulars of the application shall be published, including the date of the application, the number of the application, the name and address of the applicant, and the abstract of the invention in respect of which the patent is sought. The inventor may also request early publication, together with the prescribed fees, by means of Form 9, in which case it shall be published within one month of the date on which that request is made.
Under Section 11A of the Patents Act, 1970, any person may, on any of the grounds provided for in Section 25(1) of the Patents Act, file an opposition within 6 months of the publication date of the application. This opposition shall be taken into account until an application for review has been submitted by the claimant, and not otherwise.
Filing Request for Examination of Application
After the application has been issued, the inventor is obliged to file an application for review (in order to initiate examination of the application by the patent examiner) within 48 months of the filing of the application by means of Form 18, along with the specified fees, either physically or electronically, unless the application is deemed to have been withdrawn.
First Examination Report
Subsequently, in order to ensure that there are no grounds for challenge to the grant of the patent, the patent application is reviewed by a patent examiner employed by the Patent Office. The examiner shall then, within a maximum duration of 3 months, prepare a First Review Report, in which his remarks on the application are reported along with any deficiencies in the application. Subsequently, within 1 month of receipt of such a report from the examiner, the report must be disposed of by the Controller and a Declaration of Objections must be released within 1 month of the disposal of the report.
Grant of Patent Certificate
Until the conditions issued by the Patent Office have been complied with and the defects have been corrected, the particulars of the patent shall be registered in the Patent Register and published in the Official Journal of the Patent Office and the applicant shall be issued a patent certificate in the format specified.
Any individual can file a post-grant objection within 12 months of the date on which the grant of the patent is published in the official journal of the Patent Office.
Obtaining a patent abroad
Applicants seeking international patent rights in multiple jurisdictions have two choices under which they can, depending on the number of countries in which they wish to apply and the costs involved, choose to file an application. The Paris Convention and the Patent Cooperation Treaty are the two international conventions which are important (PCT). It is necessary to make sure, before filing a patent application in a specific foreign country, that the country in which the patent is sought is a member of the international conventions referred to above. In both foreign agreements, the applicant is obliged, after paying the required fees under Section 39 of the Patents Act, 1970, to seek authorisation from the controller by means of Form 25.
Filing under the PCT
The alternative route of application for a patent is the PCT, with 146 Member States, where the defense sought is in more than 3 countries. In several jurisdictions, this helps reduce the extensive costs of filing applications. The application must be sent to the International Bureau of the World Intellectual Property Organization (WIPO) in two stages, the international phase and then the national phase, within 12 months of the filing of the request in India.
The international phase is made up of 5 stages as follows:
Filing under the Paris Convention
If a patent is requested in less than three nations, the Paris Convention, which has 174 members, is chosen. In this case, the PCT filing process can be overly lengthy and costly. Instead of a common international application procedure for multiple countries, the applicant files directly with the domestic patent authorities of the countries in which it seeks protection under the Paris Convention, which is a faster and more cost-effective process than the PCT. Since certain African and Middle Eastern countries are only members of the Paris Convention, applicants seeking immunity in these countries have no other options.
Other important actions regarding patent
Patent of Biological Material
If, prior to the filing of an application in India, a new biological material has been used in an invention, the same must be deposited with the International Depositary Authority (IDA) (known as the Institute of Microbial Technology (IMTECH) in India) to supplement the definition.
Periodic Renewal Fees
An annual renewal fee (in installments or as a lump sum) must be charged after the patent has been issued, with the first payment due after the expiration of the first two years, in the absence of which the patent would become invalid.
Opposition to Similar Patent Applications
Patent holders may object to any current or pending patent applications which may infringe their exclusive rights on the ground that they are too close to their inventions or hamper the potential use of general technology by the proprietor.
Legal issues regarding pharmaceutical and biotechnology patents
In India, pursuant to Section 3(d) of the Act, only inventions are subject to patentability and not merely findings of a new type of a known substance, unless the efficiency of the substance, as held in the Novartis case, is substantially increased. However, when applying for a patent, the lack of a defined distinction between unpatentable discovery and patentable invention creates considerable uncertainty and struggle.
As the patenting of new drug formulations is advised against, the obstacle to meeting the condition of an inventive phase and/or non-obviousness presents a huge difficulty for pharmaceutical patents, assuming that' patent applications on compositions, i.e. formulations, would usually face an opposition of lack of inventive step'
However, new formulations of existing medicinal products will offer substantial benefits to patients, improve the convenience of prescribing the medicinal product, minimize side effects, and the research required to produce new formulations should not be discouraged by the need for an improperly increased intellectual leap for a patent.
In addition, the Indian Patent Office's guidelines concerning biotech patents are grossly insufficient and inconsistent with the absence anywhere in the Patent Act of simple terms such as DNA or gene. The law also does not differentiate in India between goods changed or isolated from nature and products of nature, further blurring the boundaries between innovation and discovery.
In addition, pharmaceutical and biotechnology patents are also subject to compulsory licensing if the public requirements of the invention have not been satisfied or are not available to the public at a fair price, in which case the patentee loses his monopoly and is ordered to license the invention under often unfair conditions.