Maximizing Innovation and Protection in India’s Med-Tech Sector
India’s medical technology (med-tech) device sector, crucial to its healthcare system, offers a wide range of products such as catheters, needles, syringes, cardiac stents and orthopaedic implants.
Valued over 900,000,000,000 Indian rupees (approximately £8,532,661,146) in 2022, it is projected to grow at a CAGR of 16.4%, reaching $50 billion by 2030. This positions India as Asia’s fourth-largest medical devices market (behind Japan, China and South Korea) and among the top 20 globally, propelled by growing medical demand and higher public health spending.
To promote the med-tech sector’s growth, the government has enacted policies like the National Health Policy 2017, permitting 100% foreign direct investment and the National Medical Devices Policy 2023, aiming to enhance access, affordability and innovation. Additionally, initiatives like the establishment of an export promotion council and schemes such as the Production Linked Incentive and Promotion of Medical Devices Parks are in place to boost the sector’s growth and establish India as a global hub for medical device manufacturing and innovation.
Design Protection can be a Game-Changer for India’s Med-Tech Boom
Synergy between design innovation and legal protection will be instrumental in shaping a healthier future
India’s medical technology (med-tech) device sector, crucial to its healthcare system, offers a wide range of products like catheters, needles, syringes, cardiac stents, and orthopaedic implants. Valued over Rs 90,000 crore ($11 billion) in 2022, it is projected to grow at a CAGR of 16.4%, reaching $50 billion by 2030. This positions India as Asia’s fourth-largest medical devices market (behind Japan, China, and South Korea) and among the top 20 globally, propelled by growing medical demand and higher public health spending.
To promote the med-tech sector’s growth, the Indian government has enacted policies like the National Health Policy 2017, permitting 100% foreign direct investment, and the National Medical Devices Policy, 2023, aiming to enhance access, affordability, and innovation. Additionally, initiatives like the establishment of an export promotion council, and schemes such as the Production Linked Incentive (PLI) and Promotion of Medical Devices Parks are in place to boost the sector’s growth and establish India as a global hub for medical device manufacturing and innovation.
Draft Patents (2nd Amendment) Rules 2024 to implement the changes enacted by the Jan Vishwas Act, 2023
The Ministry of Commerce and Industry announced the Draft Patents (2nd Amendment) Rules (draft Rules), 2024 on January 2, 2024.
The draft Rules propose to amend Section 120, 122, 123, and 124 of the Patents Act, 1970 (the Act), to implement the Jan Vishwas (Amendment of Provisions) Act, 2023, which decriminalized about 40 plus Indian legislations, including the Patents Act. Read our earlier update on this here.
Key Aspects of the draft Rules:
- Adjudication of Penalties: The draft rules establish a framework for the adjudication of penalties related to patent infringement, focusing on unauthorized patent claims (Section 120), failure to supply information (Section 122), and practices by non-registered patent agents (Section 123).
- Filing Complaints: The newly proposed Form 32 allows any person to file a complaint with the adjudicating officer against any violations of the above-listed provisions. The complaint must include a statement and supporting evidence. The adjudicating officer will assess the maintainability of the complaint, notify the alleged violator and provide them requisite time to file a reply statement along with Form 14.
- Hearing and Final Order: The adjudicating officer will conduct a hearing based on the complaint and the alleged violator’s response. If a violation or non-compliance of sections 120, 122 or 123, is confirmed, a final order will be passed within 3 months along with a suitable compensation as decided by the officer. The draft provides the factors to be considered by the adjudicating officer while adjudging the quantum of compensation.
- Appeals Process: Aggrieved parties can appeal against the adjudicating officer’s order under section 124A of the Jan Vishwas Act.
- Appeals Time period: Appeals can be filed with appellate authority within 60 days on Form 33, extendable by one additional month. The appeal should include grounds of appeal along with a copy of the order of the adjudicating officer.
- Procedure for Appeals: After registering the appeal, the appellate authority will notify the adjudicating officer, who must reply within 21 days. Both parties will present their arguments during the hearing, after which the appellate authority may confirm, modify, or annual the original decisions, or order a re-evaluation. Wherever possible, the proceedings should be concluded within six months.
- Enhancement of Penalties: If the appellate authority considers enhancing penalties, a reasonable opportunity for a fair hearing will be provided to the appellant.
- Ex-parte Hearings: In case of ex-parte hearing, the appellate authority may dispose the appeal. However, if the appellant provides a sufficient cause for their absence, the appellate authority may set aside ex-parte order; the appeal may be reinstated within one year.
- Costs and Timelines: Filings fees for Form 32 and 33 costs is proposed as INR 10,000 (~ USD 120) for individuals, startups, MSMEs, and educational institutions, and INR 15,000 (~ USD 180) for others. The adjudicating officer and Appellate Authority may adjourn hearings for reasons with sufficient cause and with the prescribed fee.
- Documentation: The order of adjudicating officer as well as Appellate Authority shall be in writing, reasoned, dated and signed.
Stakeholders have been invited to submit their suggestions or objections to these rules by February 2, 2024.
To share your suggestions and comments with us, if any on the Draft Rules, please reach out directly to your K&S Partners contact or write to us at patent@knspartners.com by January 31, 2024.
Draft Trade Marks (1st Amendment) Rules, 2024
The Department of Promotion of Industry and Internal Trade (DPIIT), under the Ministry of Commerce and Industry, Government of India, has notified the draft Trade Marks (1st Amendment) Rules, 2024 (draft Rules) and invited public suggestions and comments before February 9, 2023.
The draft Rules introduce two prospective provisions, Section 112A and 112B, to the Trade Marks Act, 1999 (Act) by Item 30(D) of the newly enacted Jan Vishwas (Amendment of Provisions) Act, 2023 along with related procedural guidelines. Additionally, also it suggests incorporating three new forms, namely Form: TM-D, TM-OPP and TM-DA, into the Second Schedule of the Act.
The key proposed amendments in the draft Rules include:
- Filing of Complaint (Form TM-D): Any person may file a complaint using Form TM-D against a false representation trademark under section 107 of the TM Act. [Rule 105A]
- Quashing and Dismissal of the Complaint Summarily: If no prima facie case for the maintainability of the Complaint has been made, the complaint shall be quashed and dismissed by the appointed Adjudicating Officer. [Rule 105B & 105C]
- Summary Proceeding: In a prima facie case, the alleged violator is served a notice and a complaint, and must respond with a written submission on Form TM-OPP within 15 days from the date of the issuance of the notice. [Rule 105D (a) & (b)]
- Manner of Holding Inquiry: A show cause notice shall be issued to the alleged violator and thereafter a final order shall be passed within 60 days. The draft proposes that while adjudging the quantum of compensation, three factors should be taken into consideration: (a) the amount of gain of unfair advantage, wherever quantifiable; (b) the amount of loss caused to any person; and (c) the repetitive nature of the default. [Rule 105D (c)]
- Time-Period Extension: The time period for responding to the show cause notice can be extended on showing sufficient cause and the payment of fees. An adjournment order may also be passed at the hearing. However, the proceeding must be completed and the penalty or compensation must be imposed or awarded, respectively, within 90 days. [Rule 105D(d)]
- Appeal: Aggrieved parties can appeal, using Form TM-DA within 60 days of receiving the order, accompanied by a fee of INR 5,000 (~ USD 60) in favour of the Appellate Authority. [Rule 105E]
- Registration and Disposal of Appeal: General rules as to registration, admission and serving a copy of the appeal shall be followed. The responses need to be filed within 21 days, extendable by another 21 days. The hearing will be scheduled no earlier than 30 days after notifying the parties about the same, shall be fixed for hearing the appeal and on which the Appellant Authority may pass any order including an order of adjournment. [Rule 105F & 105G]
- Procedure in Appeal: The Appellant can plead on other grounds also, not specified in an appeal if the omission was not wilful or reasonable. The Appeal shall be heard and decided within 60 days from the filing date, where possible. One adjournment may also be granted to the parties. Further, the appeal may be disposed of ex-parte also, however, this order may be set aside and the appeal may be restored, not beyond 1 year, on showing sufficient cause of the absence by the opposite party. [Rule 105H]
Stakeholders are invited to submit their suggestions or objections to these rules by February 9, 2024. To share your suggestions and comments with us, please reach out directly to your K&S Partners contact by February 3, 2024.