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.
With India's transformation into "the pharmacy of the world," pharmaceutical patenting has become critical not only for India, but also for the rest of the world. India is ranked third in Asia and among the top 12 biotechnology destinations in the world. As a result, the Indian Patent Office has made it a top priority to ensure uniformity and consistency in the review and grant of patents in order to promote innovation and technological growth in the country, particularly as the world recovers from the COVID-19 Pandemic.
A patent is a form of intellectual property right governed by the Patents Act of 1970, which grants the inventor or patentee the exclusive right to use an invention commercially (products and methods, but not services) for a duration of 20 years from the date of filing the patent application in India, in exchange for full disclosure of the invention. This gives the inventor a monopoly on possessing, using, producing, selling, licencing, or otherwise profiting financially from the patented invention for a limited time, thus prohibiting others from doing so. Patents are intended to motivate inventors to develop new technologies and advance science. Patents may be held individually or collectively by the first inventors or their assignees. However, since this is a territorial privilege, an Indian patent is only valid within India's jurisdiction. As a result, companies want to file patents in a number of jurisdictions around the world.
Given the significant time and energy invested in biotechnology and pharmaceutical production, the security of these patents is critical. However, in order to be eligible for certain rights under the Patent Act of 1970, inventions must meet the following key requirements:
Patents should be granted without discrimination for inventions in any field of technology, according to Article 27(1) of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), subject to certain conditions. The third amendment to the Patents Act of 1970, which took effect on January 1, 2005, made the Patents Act fully TRIPS compliant by removing Section 5 of the Indian Patents Act, which made biotechnology and pharmaceutical innovations patentable in India. There are many types of patents that can be granted in the pharmaceutical and biotechnology industries, including Drug Compound Patents, Synergistic Combination Patents, Invention Patents, Polymorph Patents, and Process Patents. It should be noted, however, that no product patents can be granted on substances produced by chemical processes or capable of being used as food, medicines, or medicinal products under Indian law. Only process patents for the manufacturing process of such substances may be granted in these situations.
After learning the fundamentals of patent protection, the next step is to consider the various types of patents that may be registered for protection under patent law, depending on various factors such as the legislation that governs it, the jurisdiction, or the invention itself. An inventor may file a variety of patent applications, including:
Ideally, the inventor can conduct a preliminary search before filing a patent application to ensure that the same invention has not been produced previously. To avoid wasting time and resources, it's best to conduct such searches early on in the design process. It will also allow the inventor to draught a patent application in such a way that, when compared to similar inventions that have already been published or patented, the unique features of his invention will stand out. A patent quest can be done either physically at the Patent Office or online by going to the website of the Patent Office. A similar search should be conducted on international databases such as Patentscope and Google Patents to ensure that a similar invention has not been published or patented in another country. The inventor may continue with the filing of the invention's patent application until it is known that the invention at issue has never been patented before.
In order to combine their technological and legal expertise in the drafting of a succinct and detailed application, the inventor and a patent attorney should draught the patent application together. A patent application with various declarations and types must be filed, as described below. While most of the above specifications are fairly standardised, the patent specification usually requires significant customization and thorough drafting with the help of a patent attorney. The following are the key elements of a patent specification:
A patent is granted to the person who files a patent application first, regardless of who invented the invention first. As a result, an inventor can opt to file a provincial patent application before completing the development of the invention to ensure that no one beats him to the patent office. A provincial specification for an application is filed when the operation of an invention has been conceptualised but not actually developed or perfected for practical use. It is much more condensed than the full requirements submitted after the product or process is ready for commercial use since it does not include the disclosure of minute information of the invention and only needs to provide a clear understanding of the invention's functionality to a reasonably qualified person in the relevant industry. In this situation, the inventor is required to file a complete specification within 12 months of filing the first application, giving him enough time to obtain funding on the basis of a potential patent and continue developing the innovation even after the invention in his name has been frozen.
The full patent application, including all of the forms and declarations described above, as well as the fees listed below, may be sent to the appropriate patent office by hand, by courier, or electronically with a digital signature.
Following the filing of the patent application, it must be published in the Patent Office's journal for public review within 18 months of filing. The application's details, including the date of the application, the number of the application, the applicant's name and address, and the abstract of the invention for which the patent is requested, must be made public. The inventor may also submit a Form 9 request for early release, along with the required payment, and it will be published within one month of the date on which the request is made.
Any individual may file an opposition under Section 11A of the Patents Act, 1970, within 6 months of the application's publication date, on any of the grounds specified in Section 25(1) of the Patents Act. This opposition will be considered before the complainant files a request for review, and then it will be ignored.
Unless the application is considered to have been withdrawn, the inventor must file an application for review (in order to initiate evaluation of the application by the patent examiner) within 48 months of the filing of the application using Form 18, along with the required fees, either physically or electronically, within 48 months of the filing of the application.
The patent application is then examined by a patent examiner employed by the Patent Office to ensure that there are no grounds for challenging the patent's award. The reviewer must then prepare a First Review Report, which includes his comments on the application as well as any flaws in the application, within a period of three months. Following that, the Controller must dispose of the report within one month of receiving it from the examiner, and a Declaration of Objections must be issued within one month of the report's disposal.
The details of the patent shall be registered in the Patent Register and published in the Official Journal of the Patent Office until the conditions imposed by the Patent Office have been met and the defects have been corrected, and the applicant shall be issued a patent certificate in the format specified.
Any person has 12 months from the date the patent grant is published in the Patent Office's official journal to file a post-grant objection.
Applicants seeking international patent rights in several jurisdictions have two options: file an application in one or more countries, depending on the number of countries in which they wish to apply and the costs involved. The Paris Convention and the Patent Cooperation Treaty are two relevant international treaties (PCT). Before filing a patent application in a foreign country, make sure that the country in which the patent is sought is a signatory to the above-mentioned international conventions. After paying the necessary fees under Section 39 of the Patents Act of 1970, the applicant is required to obtain authorization under both foreign agreements.
If a patent is sought in less than three countries, the 174-member Paris Convention is selected. In this scenario, the PCT filing procedure can be excessively time-consuming and expensive. The applicant files directly with the domestic patent authorities of the countries in which it requires immunity under the Paris Convention, which is a simpler and more cost-effective mechanism than the PCT. Applicants seeking protection in many African and Middle Eastern countries have no other choices since these countries are only members of the Paris Convention.
The legal inadequacies in Indian patent law could have a detrimental impact on research and development in the long run. Others, on the other hand, claim that current regulatory provisions prioritise public health and maintain a higher threshold for an innovative monopoly leap, which raises the bar for the pharmaceutical and biotechnology industries in terms of innovation.