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Mint
28-05-2025
- Business
- Mint
India puts big pharma concessions on table as US trade deal nears finish line
New Delhi: As the trade deal negotiations between India and the US move towards finalisation, the pharmaceutical sector is at the heart of a significant give-and-take between the two countries. According to two people familiar with the matter, India's proposals include supply of low-cost complex generic medicines at sharply reduced costs, patent reforms to allow earlier entry of generics in the US, increased US-based manufacturing by Indian pharma firms of active pharmaceutical ingredients (APIs) and fixed dosage forms (FDFs), and tariff exemptions for life-saving and critical medicines imported into India from the US. An API is the main component of a drug (think paracetamol), while an FDF is a combination of two or more APIs in a single drug, such as a tablet that contains both paracetamol and ibuprofen. India's offer comes in the backdrop of the US administration's stated desire to sharply reduce local drug prices, and gains significance considering every second prescription in the US has a generic drug made by an Indian company. Amid the US push to bring pharmaceuticals under its reciprocal tariff regime, India has proposed to supply complex generic medicines at 20-25% of current branded prices for the first three years after patent expiry. An additional 10-15% cost reduction will follow over the following seven years, the people cited above said on the condition of anonymity. Also read | Mint Explainer: Why Indian pharma is spooked by Trump's latest drug policy 'Along with the pricing commitment, India has proposed allowing final stages of drug processing—including semi-finished and finished dosage forms—to be done in the US under the Trump administration's 'Make in America' push," said the first person cited above. 'In return, India has sought targeted incentives for its pharma firms willing to set up API and formulation facilities in the US." Other countries are reluctant to invest in US-based manufacturing of low-cost generics unless the products are high-value or there's a supply gap. 'India has effectively mastered this space," this person said. The second person said that in patent reform, Indian negotiators have suggested an end to 'evergreening" by US pharma companies and a reduction in patent exclusivity from India's end—steps they claim would significantly lower drug costs. Patent 'evergreening" is the alleged practice of filing for new patents on secondary features of a pharmaceutical as earlier patents expire, thereby extending effective patent exclusivity past the original 20-year term. Currently, Indian patent law—under Section 3(d) of the Patents Act—already places restrictions on evergreening, but India has now proposed tightening these provisions further while also reducing the duration or scope of exclusivity granted to new drug patents, to speed up the availability of generics. Read this | Trump's planned drug price cuts trigger decline in share prices: Will Indian pharma be impacted? 'India has also proposed tariff exemptions for life-saving and critical drugs with thin margins, and called for greater transparency and public access to US export-import data," the second person said. To be sure, a high-level Indian delegation led by chief negotiator Rajesh Agarwal, additional secretary, ministry of commerce, returned from Washington on Sunday night after what officials described as a positive round of talks. As reported by Mint on 16 May, the first tranche of the bilateral trade agreement (BTA) is expected to be finalised before 8 July—the date that marks the end of the 90-day pause on US President Donald Trump's reciprocal tariffs. Queries sent to the commerce ministry and industry association Pharmexcil remained unanswered till press time. A US Embassy spokesperson said, 'We do not comment on ongoing bilateral negotiations." Expert views India's offer comes amid efforts by US President Donald Trump to rein in drug prices. On 21 May, Trump signed an executive order to cut prescription drug prices by up to 80% under the 'Most Favored Nation' rule, pegging US drug prices to the lowest globally. 'While this may benefit US patients, it could trigger global price realignment and pressure countries like India to raise prices by tightening patent laws through trade deals," said Ajay Srivastava, co-founder of a trade think tank Global Trade Research Initiative (GTRI). 'India has long resisted foreign pressure to amend its patent laws, but the India–UK FTA marked a shift, including provisions that go beyond TRIPS. This could lead to further concessions in EU and US talks, risking delayed generics and costlier medicines in the Global South," Srivastava said. Also read | India to boost production of combat medicines, pharma dept told to prepare list of drugs TRIPS refers to the agreement on Trade-Related Aspects of Intellectual Property Rights, a WTO pact that sets minimum standards for protecting intellectual property, including patents, trademarks, and copyrights, across member countries. 'India must defend its patent regime, which ensures affordable access, prevents monopolistic extensions, and safeguards public health. The world depends on India's generics. Preserving this model is both a national and global imperative," Srivastava added. Biswajit Dhar, economist and trade expert from Delhi-based think tank, Council for Social Development said that with President Trump coming down heavily on American companies for selling high-priced medicines, his move to encourage imports of cheap generic products has created an opportunity for the Indian companies to expand their presence in the US. 'Indian companies must make the most of this opportunity," said Dhar. 'They must utilise the PLI scheme fully to increase production of pharmaceutical products. Alongside, Indian companies must ensure that their products fully meet the stringent quality requirements of the US FDA." Daara Patel, secretary general at the Indian Drugs Manufacturers' Association (IDMS) said the US may not immediately need generic plants, but it is looking for API units. 'The cost is very high to set up a unit in the US; they also want to save money," said Patel. 'There is a wrong notion that they have an insurance scheme. Insurance also has limitations. They want goods at affordable prices from India or our support to produce in the US itself." Generics powerhouse India is a key supplier of generic drugs to the US, with $10.52 billion worth exports making their way to the US in FY25, as per Pharmexcil. Indian firms supply nearly 47% of the generics used in the US, underlining their crucial role in the American healthcare system. Commerce ministry data shows the segment has grown steadily, with exports rising from $7.08 billion in FY22 to $7.55 billion in FY23, then sharply to $8.73 billion in FY24, and further to $10.52 billion in FY25. And read | Online pharmacies, chemists at odds over home delivery of medicines as Centre mulls stopping the practice The US pharmaceutical market was valued at $634.3 billion in 2024. India's $10 billion contribution in generics helps the US save around $216 billion annually by potentially replacing expensive patented drugs, according to the Indian Brand Equity Foundation (IBEF), a commerce ministry body. That means a huge $624-billion market opportunity is still available for India to step into. If the US decides to stop evergreening of patents, many patented drugs will fall into generics. If $400 billion translates from patent to generic from the $634 billion, this will add to the generic drug segment.
Time of India
22-05-2025
- Business
- Time of India
Morality can't determine patent decision without tech proof: HC
1 2 3 4 Kolkata: Without considering any independent scientific or technical evidence, morality could not be the basis for denying a patent, the Calcutta High Court held as it asked the Controller of Patents, Designs and Trademarks to reconsider the patent application of an invention by ITC Limited. "The interaction of patent laws and ethics is an uncomfortable relationship and has always produced difficulties. In such circumstances, Section 3(b) (of the Patents Act, 1970) ought not to be interpreted to deal with all subjective concerns of morality, public order or health, regardless of any scientific or technical evidence or any cogent reasoning," Justice Ravi Krishan Kapur said. On Aug 21, 2024, the application for a patent of an invention, titled 'A heater assembly to generate aerosol', filed by the company, was rejected by the controller on the grounds that the invention caused serious prejudice to human life, health, public order and morality. The company's counsel contended the finding that the invention was contrary to "public order and morality" was cryptic and completely bereft of reasons. "With the increasing demand for handheld aerosol-generative devices, which are able to deliver aerosol for user inhalation, the invention was designed to provide a uniform heat distribution system throughout the aerosol-forming substrate present with an aerosol-generating article," the company submitted in court. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like [Click Here] - 2025 Top Trending Search - Local network access Esseps Learn More Undo T he counsel for the controller submitted that the order was adequately reasoned and was in conformity with The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage, and Advertisement) Act, 2019. But the judge noted that the Act dealt with the sales, manufacture, import and export and not with the grant or non-grant of a patent for an invention. Justice Kapur noted in the judgment on May 20: "The controller has fundamentally erred in his understanding of the invention. Though the invention works on substrates (solid or in liquid form) which may or may not contain tobacco compounds, it is not predicated or limited to the substrate at all. The impugned order erroneously proceeds on the basis that the invention shall exclusively be only used with substrates comprising active tobacco compounds and thus cause prejudice to human life and health. " He further held that the controller misjudged not only the role of the patents office but also misinterpreted the subject invention. The matter was remanded back to the controller to take a decision afresh after giving a hearing to all the parties within three months. "The preconceived and subjective notion that all tobacco products cause serious prejudice to human life and health without any reliance on scientific or technical evidence or any other supporting facts is unsustainable," the judge observed.
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Business Standard
20-05-2025
- Business
- Business Standard
Newgen shares soar 25% thus far in May; zoom 67% from April low. Here's why
On May 12, Newgen said Newgen Software Technologies Company, a wholly owned subsidiary of the company incorporated in Saudi Arabia, has executed agreements worth of $1.632 million with a customer Mumbai Newgen Software Technologies share price today Shares of Newgen Software Technologies (Newgen), a leading provider of an AI-first unified digital transformation platform, moved higher by 7 per cent to ₹1,232.90 on the BSE in Tuesday's intraday trade. By comparison, the BSE Sensex was down 0.25 per cent at 81,856 at 10:23 AM. Thus far in the month of May 2025, Newgen shares have appreciated 25 per cent. Moreover, it has zoomed 67 per cent from its previous month low of ₹740.05, touched on April 7, 2025. The stock had hit a 52-week high of ₹1,795.50 on January 15, 2025. What's driving the rally in Newgen share price? Shares of Newgen Software have been on investor radar amid a slew of news flow. On May 16, Newgen Software said that the Indian patent office has granted a patent to the company for inventing the 'System and Method for Data Compression'. Newgen's patent will have a term of 20 years, starting April 26, 2017, in accordance with the provisions of the Patents Act, 1970. Newgen said the invention addresses efficient data compression for large volumes of data files where the majority of content is similar, with a smaller amount of varying data, especially in scenarios where traditional compression techniques may not be optimal. That apart, on May 12, Newgen informed the stock exchanges that Newgen Software Technologies Company, a wholly-owned subsidiary of Newgen Software Technologies, incorporated in Saudi Arabia, has executed agreements with a customer. The aggregate value of these agreements was $1.632 million. ALSO READ | Why did NLC India share price rally 9% on May 20? Key details here Newgen said the agreements govern the provision of delivery of software licence and related services which Newgen is delivering to its customer as part of the agreed scope of work including Annual Technical Support (ATS). Newgen March 2025 financial results In the fourth quarter of financial year 2024-25 (Q4FY25), Newgen reported a 2.9-per cent year-on-year (Y-o-Y) growth in its consolidated profit after tax at ₹108.3 crore. Further, revenue from operations grew 14.6 per cent Y-o-Y at ₹ 429.90 crore, driven by strong growth in APAC and US region. The quarter specifically witnessed strong growth and deal wins in the US region. Looking ahead, the management sees strong momentum building across its business and is energized by the growth prospects ahead. Newgen continues to accelerate its AI-first strategy with significant investments in AI-driven products and solutions. This year, the company has launched groundbreaking AI agents – Lumyn, Harper, and Marvin – which have already demonstrated their potential through several promising and viable use cases. The management anticipates further growth and innovation in AI-led journeys as the company build upon these successes. ALSO READ | About Newgen Software Technologies Newgen is the leading provider of an AI-first unified digital transformation platform with native process automation, content services, customer engagement, and AI/ML capabilities. Globally, successful enterprises rely on Newgen's industry-recognised low-code application platform to develop and deploy complex, content-driven, and customer-engaging business applications on the cloud. From onboarding to service requests, lending to underwriting, and for many more use cases across industries, Newgen unlocks simple with speed and agility.
Business Upturn
16-05-2025
- Business
- Business Upturn
Newgen Software granted Indian patent for System and Method for Data Compression
By Aman Shukla Published on May 16, 2025, 16:28 IST Newgen Software, a provider of digital transformation solutions, has received an Indian patent for a 'System and Method for Data Compression.' The patent term is 20 years starting from April 26, 2017, as per the Patents Act, 1970. The patented invention targets efficient compression of large volumes of data files where most content is similar but contains small differences. This approach is designed for cases where traditional compression methods are less effective. The system aims to reduce storage requirements and enhance the speed and efficiency of data processing. This method is particularly applicable to industries managing high volumes of structured documents, forms, and system-generated reports, helping them reduce storage costs and improve data handling performance. Newgen's system identifies data files with similar structures and divides them into static and dynamic regions. It then applies video compression techniques by treating the files as sequential frames. This results in a single compressed video file along with metadata for accurate storage and retrieval. The granted patent strengthens Newgen's capabilities in building specialized applications that support digital transformation efforts across various organizations. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Time of India
03-05-2025
- Business
- Time of India
Patent officers association moves SC for probe into Intellectual Property data leak
Supreme Court NEW DELHI: Alleging that private multinational firm, Kaizen Institute , was granted unauthorized access to the Intellectual Property Office's (IPO) internal data servers, All India Patent Officers Association has moved Supreme Court seeking CBI probe into it saying that any leakage of sensitive IP data could have devastating economic and strategic consequences for the country. The association of class one officers said that a probe was needed to find out the responsible persons who paved the way for the private firm to access data servers. "The association is gravely alarmed at the potential ramifications of such unauthorized access, particularly the risk of premature disclosure or exploitation of unpublished patent applications. These applications often involve cutting-edge innovations and trade secrets, some of which are of strategic significance in sectors such as pharmaceuticals, energy, and defense. The threat is exacerbated by the fact that Kaizen Institute operates in over 60 countries and services a broad spectrum of industries including pharrna, healthcare, oil and gas, chemicals, automobiles, engineering, FMCG, and textiles-domains where industrial espionage and exploitation of proprietary technologies are rampant. Leakage of sensitive IP data into such an ecosystem could have devastating economic and strategic consequences for India," the petition said. Seeking court's intervention to order probe in the case, the association said while facilitating access to Kaizen Institute, the Controller General of Patents, Designs and Trade Marks(CGPDTM), Prof Unnat P. Pandit, simultaneously denied access to the same or similar information to senior officials in the Department for Promotion of Industry and Internal Trade (DPIIT), including the Joint Secretary. Relying on documents received through the Right to Information Act, publicly available reports, and email communication, the association said, "The cumulative reading of these communications reveals that Kaizen Institute was permitted to interact with and influence the functioning of statutory offices without any traceable administrative order, notification, or fonnal authorization issued either by DPIIT or the CGPDTM." "Such unauthorized access has not only compromised the sanctity of the examination process but also suggests possible violations of the Patents Act, , and acts punishable under the Prevention of Corruption Act, and the Indian Penal Code. The petitioner has reason to believe that this access was facilitated by various individuals, including public servants occupying positions of trust, who misused their official authority to grant such privileges without oversight. This raises serious allegations of corruption, abuse of position, and conspiracy to enable the exploitation of unpublished and sensitive patent data by unauthorized entities, potentially for unlawful financial and strategic gains," the petition said.
