National phase entry in India for Biomedical Engineering
Biomedical engineering is an up-and-coming profession that is of particular prominence due to the continually increasing intricate medical problems that need innovative signifies in the process of their solving. International applications for obtaining Patent applications under PCT through a single application are given under the Patent Cooperation Treaty or PCT. Within that context, this blog will discuss the particulars of entering the National phase entry in India, including the solicitor’s view on the operational requirements, time frames, and technicalities relating to biomedical engineering inventions. Knowledge about the PCT process and its national phase is essential for inventors and companies in this area to obtain proper protection for their inventions. Thus, understanding the main peculiarities of the Indian patent legislation allows inventors to protect their achievements in the sphere of biomedical engineering and grants them well-deserved recognition. During this guide, the reader will be introduced to the generalities of the procedure, as well as technical specifics, a manual to follow for the approach, and real-life cases to help the biomedical engineer have a smooth entry to the national phase entry in India.
PCT National Phase Application in India for Biomedical Engineering
PCT is an international patent procedure that enables applicants to apply for patents in several countries around the world using just one application. It entails the preparation and submission of an international application with the International Bureau of the WIPO; the Bureau conducts an initial examination. This treaty offers several advantages including it allows applicants to choose which country to seek patent protection in, is economical because it eliminates the need of having to make separate applications to different countries, and has a uniform attorney prosecution in different jurisdictions. The national phase entry in India is by filing applications within 31 months from the priority date and no renewal is allowed. The applicant must submit all the templates in the full specification, claims, abstract, and all the other necessary forms within this time. Compliance with the said requirements and timelines is important for the prosecution of patents in India.
Technical Aspects of Biomedical Engineering
Inventions in biomedical engineering must be innovative, inventive, and useful to qualify for Patent application under PCT. Examples of patentable inventions in this field include medical diagnostic devices, implantable devices, surgical instruments, and medical software. These innovations must meet the criteria of novelty, non-obviousness, and industrial applicability. The patent specification is a crucial document that must include a detailed description of the invention, claims, abstract, and any text matter of drawings. The format of the specification must match the one filed during the PCT stage at WIPO, ensuring consistency and comprehensiveness in the documentation of the invention. Applicants can make amendments during the PCT stage under Article 19 and Article 34, and they must include these amendments in the national phase application. However, the time of national phase entry does not permit new amendments.
Patent Amendment Rules, 2024
The Patent Amendment Rules, of 2024, brought changes in the patent process in India as faster examination times, lesser documentation, and lesser fees for startups and small entities. All these changes are designed to improve performance, foster innovation, and help businesses obtain Patent applications under PCT more easily.
What is patentable in India
The Patent Amendment Rules, of 2024, brought changes in the patent process in India as faster examination times, lesser documentation, and lesser fees for startups and small entities. All these changes are designed to improve performance, foster innovation, and help businesses in obtaining patent protection more easily.
Who Can Apply for a Patent
Anybody including individuals, companies, and legal persons can apply for the grant of a Patent application under PCT in India. The applicant may be the inventor, the assignee, or any other person entitled to protect the invention or claiming under the inventor or the assignee. It is also allowed for two or more inventors or companies to make a joint invention application.
Reply filed an application in the amended examination
After receiving an examination report, the applicant must respond by addressing objections or providing additional information within six months. Amendments to the claims or specifications may be required to overcome the examiner’s objections and proceed with the patent.
Step-by-Step Guide for National Phase Entry in India
Several aspects need to be paid attention to when entering or switching to the national phase entry in India, to meet the Indian patent laws requirements and promote a smooth further prosecution of the application. The process starts from the filing of the application within the set 31-month statutory period from the priority date. It affords the applicants sufficient time to time their study and compile all the relevant documents. Applying before this time is very essential since any application that is not filed within this period means that the patent right will be forfeited in India.
Documentation required for PCT National Phase Application in India
The necessary documentation is the full specification, claims, abstract, and essential forms. The preparation of each one of these components must be intricate, with particular attention to producing information that cannot be easily corrected or altered once submitted, to prevent delays or rejections during the examination of the application. Let it be stressed that while the full specification gives a comprehensive written description of the invention, the claims redefine the scope of legal protection and the abstract given is a brief description of the invention. Some of these forms could be Form 1 which is the form for application for grant of patent, Form 2 which is the form for provisional /complete specification and other: forms that the Indian Patent Office may prescribe.
Submission of Priority Documents for National Phase Entry in India
Once again, priority documents act to establish the earliest filing date and must also be filed within the 31 months in question. If the mentioned document is in English, there is no need to translate it. However, for documents that are not in English, it is necessary to provide the translated copy accompanied by the certification of translation. This has embodied the reality that the Indian Patent Office will be in a position to review the priority claims credibly. The verification certificate simply needs to affirm the authenticity of the translation as well as its compliance with translating all of the contents in the original document. As for the translation procedure, it is better to begin it immediately to eliminate any possible difficulties at the last moment.
Details Under Section 8 of the Indian Patents Act
Section 8 is another important requirement in which details of the corresponding Patent application under PCT filed in other countries must be included. This entails the bibliographic information like the country, filing date, application number, status of the application, publication date, and grant date. This information is useful for the Indian Patent Office to determine the patentability of the invention, considering other pending applications or patents in other countries. This information has to be current and correct during the entire procedure of patent prosecution.
Payment of Fees
Filing fees, examination requests, and other necessary fees vary based on the applicant category. The categories include natural person, startup, small entity, and others. Each category has different fee structures, and it is crucial to pay these fees within the prescribed deadlines to maintain the application’s validity. For instance, a natural person or startup might benefit from reduced fees compared to a large entity. Additionally, there are specific forms and declarations that startups and small entities need to submit to avail of these benefits. Ensuring timely payment of these fees is essential as non-payment can result in the application being deemed abandoned.
Requesting Examination
Once applicants file the application, they must request an examination by filing Form 18 (Request for Examination) within 48 months from the priority date or the filing date, whichever is earlier. The examination process involves a detailed review of the application by a patent examiner who assesses the patentability criteria, such as novelty, inventive step, and industrial applicability. If there are any objections or requirements for additional information, the patent office will issue an examination report, and the applicant must respond within six months to address these issues.
Case Studies and Examples
Examples from the real world can be quite instrumental in throwing light on the process. A successful application includes a diagnostic tool for detecting a certain disease in patients. Therefore the PCT was filed on June 1, 2022, While the national phase entry was entered in India on March 1, 2024, Although the actual priority date of March 1, 2022, was provided. All the deadlines have to be achieved and much emphasis has to be put on the correctness of all papers as was done in this case. Another example includes an implantation device for the treatment of a chronic ailment, with the priority date being from the 1 of January 2023, PCT filing from the 1 of April 2023, and the national phase entry in India from the 1 of October 2024. The above-mentioned examples explain both the processes and temporalities of obtaining patent protection for biomedical engineering innovations in the India context and reaffirm that the innovation process is not a one-step drive rather it requires a lot of groundwork coupled with legal compliance.
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Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.
Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filings, patent services in India and global patent consulting services.
