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.
Overall impression of product design key for establishing design piracy
In December, the Delhi High Court made a significant ruling regarding design piracy, in the Havells India Limited v Polycab India Limited case.
Advancing towards Net-Zero Emissions through Strategies in the Net Zero Pathway
Havells India Limited (Havells) filed a suit seeking a permanent injunction against Polycab India Limited (Polycab) for infringing their three registered fan model designs, namely ENTICER (2016), BIANCA ART (2021) and BIANCA ART-SANGANER (2022). The allegedly infringing fan designs of Polycab were ELANZA and ELGANZ PLUS.
Havells argued that ELANZA closely matched the design of Havell’s ENTICER, while ELEGANZ PLUS infringed upon the BIANCA ART and BIANCA ART-SANGANER designs. Earlier, in June 2023, the Court had granted an interim injunction in favour of Havells restraining Polycab from using all three allegedly infringed registered designs. Polycab had moved an application to vacate the injunction order.
Upon examining each design of the suit Design, the Court observed that Polycab’s ELANZA was strikingly similar to Havells’ 2016 design ENTICER, noting “hardly any difference” between them. The Court also agreed with Havells’ contention that Polycab consciously imitated the ENTICER design and also used the same colour names as used by Havells. The Court accordingly maintained the interim injunction previously granted.
As regards Havells’ 2022 suit Design BIANCA ART-SANGANER, the Court concluded that the novelty and originality of this Suit Design was certified as residing only in the surface pattern. The Court held that the surface patterns of Polycab’s ELEGANZ PLUS range were sufficiently different from the 2022 suit Design. Hence it did not infringe the 2022 suit Design. The Court agreed with Polycab’s argument that Havells could not have clubbed the 2021 and 2022 suit Designs to argue infringement against ELEGANZ PLUS as both design registrations were for different design features.
The Court accordingly dismissed Havells’ plea vis-à-vis the 2021 BIANCA design given insufficient specific evidence and held that no piracy case was established.
Referring to the Calcutta High Court order in Castrol India Ltd v. Tide Water Oil Co. (I) Ltd, the Court held that “the copy must be a fraudulent or obvious imitation”. The Court further held that under Section 22(1)(a) of the Designs Act (Act), piracy matters ought to be analysed from the visual aspect of design. Further, the Court highlighted that, while opposing an injunction, the defendant, in this case, Polycab, ought to raise a credible challenge to the validity of the plaintiff’s designs.
In conclusion, the Court upheld the interim order against Polycab’s ELANZA series for design infringement but lifted the same against its ELEGANZ PLUS series. This decision highlights the crucial role of the overall visual impression in determining design piracy, actual end product design and submitting substantial evidence during infringement proceedings.
India gov’t publishes Draft GI of Goods Amendment Rules, 2023
India’s Ministry of Commerce and Industry published the draft rules to amend the Geographical Indications (GIs) of Goods (Registration and Protection) Rules, 2002 in the Gazette and on its website on October 17, 2023, and October 27, 2023, respectively.
“The ministry intends to amend the table in the first schedule of the existing Rules, 2002, which lays down the fees structure as per Rule 10(1).
Navigating the Metaverse: Design Protection’s Exciting New Frontier
The metaverse is more than just a digital space; it’s an expansive universe. Every month, 400 million users dive in, their digital avatars exploring 3D worlds, powered by virtual and augmented realities. They attend concerts, purchase goods, play sports, build homes and live lives here. As Mark Zuckerberg once said: “[The] Metaverse isn’t a thing a company builds. It’s the next chapter of the internet overall.”
Seeing the obvious trajectory of these trillion-dollar spaces, industries like gaming, retail, arts, healthcare, and blockchain are participating in this emerging ecosystem. From Nike to Gucci, brands are designing clothes and accessories for the metaverse. Even J.P. Morgan and Samsung have set up shop.
Court assesses lung cancer drug patent infringement by the company.
In Chugai Seiyaku Kabushiki Kaisha and Hoffmann-La Roche AG v Frensenius Kabi Oncology Limited and Fresensius Kabi India Private Limited, the plaintiff, Chugair Seiyaku Kabushiki Kaisha (CSKK) sought a permanent injunction against Fresenius Kabi Oncology Limited (FKOL) and Fresensius Kabi India Private Limited for infringing its Indian patent protecting Alectinib, an oral drug used to treat a certain type of non-small-cell lung cancer.
CSKK and its exclusive licencee, Hoffmann-La Roche, contended that, in May 2021, FKOL imported Alectinib and exported Alectinib hydrochloride. CSKK further contended that an independent online investigation revealed various online listings of FKOL for a generic version of Alectinib on the Pharma Compass and Chemical Book websites.
Filing the SoW by September 30 is crucial for patentees & licensees
In the intricate landscape of patent law, the filing of statements of working (SoW) of patents aka working
statements stands out as a unique requirement in India, necessitating patentees and licensees to annually report
the commercial utilization of their patented inventions.
This obligation stems from Section 83 of the Indian Patents Act, 1970, which lays out the general principles of working of patents encouraging full-scale commercial use of patented inventions in India.
Delhi High Court to address conflicting views on Divisional applications
The Delhi High Court referred its order of July 2023 in Syngenta Limited v Controller Of Patents And Designs to a two-judge bench (Division Bench or DB) to review the issue of filing divisional patent applications in India.
Decoding the Biological Diversity (Amendment) Act, 2023
Indian biodiversity holds vast potential, significantly influencing sectors like agriculture, forestry, fisheries, and biopharmaceuticals, among many others.
The article, published in the Biospectrum Magazine, undertakes a meticulous dissection of the recent amendments under the Biological Diversity Amendment Act, (BDA Act) and covers BDA Act’s pivotal amendments, sectoral implications and its strategic role in steering India towards its $300 billion bio-economy target by 2030.
Decoding the Amendments to the Biological Diversity Act (2023)
On 3 August 2023, India introduced significant changes to its Biological Diversity Act (BDA) 2002 through the Biological Diversity (Amendment) Act 2023 (the amended Act).
Originating from the United Nations Convention on Biological Diversity signed in Rio de Janeiro, the BDA aims to ensure the conservation and sustainable use of India’s biological resources. It also establishes a framework for fair and equitable sharing of benefits derived from the use of these resources. Over the years, both local and international organisations have grappled with complexities and obligations laid down by the BDA. The recent amendments, therefore, aim to provide clarity, particularly benefiting Indian enterprises.