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Patents Misused for Minor Pharma Innovations, Goyal Claims

Patents Misused for Minor Pharma Innovations, Goyal Claims

Patents Misused for Minor Pharma Innovations, Goyal Claims

 

Union Minister Piyush Goyal raises significant concerns regarding “evergreening” practices in the pharmaceutical industry, advocating for authentic innovation rather than simple modifications.

Introduction: Standing Against Patent Evergreening

In a firm stance that could have significant implications for the pharmaceutical industry, Union Minister of Commerce and Industry Piyush Goyal has sharply criticized companies’ attempts to secure patent extensions through minor or trivial innovations.
Speaking at a recent public event focused on intellectual property rights (IPR) and innovation, Goyal emphasized that such practices undermine the spirit of genuine innovation and hinder affordable healthcare access, particularly in developing nations.
His comments have rekindled the ongoing debate about the “evergreening” of patents, a controversial practice in which pharmaceutical companies attempt to prolong the life of their patents through marginal modifications to existing drugs.

The Problem: Minor Tweaks, Major Profits

At the heart of Goyal’s criticism is the practice by some drug manufacturers to:
Modify the chemical structure of existing medications slightly.
Alter delivery mechanisms (like extended-release versions).
Adjust the dosage forms or treatment protocols slightly.
Such tweaks are then used to seek new patents, extending exclusivity rights beyond the original 20-year period guaranteed by global patent norms.
Goyal warned that this tactic blocks the entry of cheaper generic medicines, prevents healthy market competition, and artificially inflates healthcare costs for patients, governments, and insurance providers.
“Patents must be granted for truly path-breaking innovations that demonstrate real therapeutic advances,” Goyal said. “We must not allow a few marginal modifications to stifle competition and deny the common man affordable medicines.”

India’s Global Role in the Fight for Affordable Medicines

India, often called the “Pharmacy of the World,” has played a crucial role in providing low-cost generic medicines to millions across Africa, Asia, and Latin America.
Thanks to strong generic industry and judicious patent law interpretations, Indian pharmaceutical firms have been able to manufacture and export vital treatments for:
HIV/AIDS
Tuberculosis
Malaria
Cancer
Goyal stressed that India’s Section 3(d) of the Indian Patents Act, which bars the patenting of incremental innovations unless they significantly enhance therapeutic efficacy, must be upheld and strengthened.
“India has fought long battles at the WTO and other international forums to protect its right to use TRIPS flexibilities for public health. We cannot allow our achievements to be eroded by weak enforcement against patent evergreening,” Goyal added.

Global Pressure and Corporate Pushback

The Minister’s remarks come amid mounting pressure from multinational pharmaceutical companies and some Western governments seeking stronger patent protections in India.
These entities often argue that even minor innovations involve significant R&D investments and deserve intellectual property protection to encourage continued innovation.
However, Goyal pushed back firmly against these arguments, asserting:
Genuine innovation should result in significant clinical benefits.
The safeguarding of public health should take precedence over corporate profits.
It’s important to maintain regulatory and legal oversight in order to filter out trivial patents.
He emphasized the government’s commitment to balancing innovation incentives with societal needs, ensuring India’s IPR policies do not become tools for monopolistic practices.

Need for a Collaborative Innovation Ecosystem

Instead of focusing on incremental gains, Goyal urged the Indian pharmaceutical sector to invest more deeply in original R&D, new drug discovery, and biosimilar development.
He called for collaboration between academia, startups, and major pharma companies to build a stronger innovation pipeline rooted in high-impact research rather than surface-level tweaks.
“India’s future is not only about being the world’s pharmacy but also about becoming a hub for innovative treatments that can transform healthcare globally,” he stated, presenting a vision of cost-effective innovation that aligns with the nation’s development objectives.

Looking Ahead: Strengthening Patent Examination and Public Health Safeguards

Following Goyal’s remarks, experts expect:

The Indian Patent Office is now applying more rigorous scrutiny during the patent examination process.
Heightened scrutiny of secondary patent applications by advocacy groups focused on public interest.
Encouragement of generic competition to improve affordability and accessibility.
India’s stance will also likely influence global discourse, particularly among other developing nations advocating for more balanced and equitable IPR frameworks.

Conclusion: Prioritizing True Innovation and Public Good

Piyush Goyal’s criticism affirms India’s long-standing commitment to affordable healthcare, genuine innovation, and equitable intellectual property practices.
As India strides forward as a pharmaceutical powerhouse and a knowledge economy, policymakers seem determined to ensure that innovation protection does not come at the cost of public welfare.
India seeks to cultivate a pharmaceutical environment that balances innovation and accessibility by opposing evergreening and promoting transformative advancements.

 

 

 

 

 

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Lupin Soars on USFDA Nod for Billion-Dollar Drug

Lupin Soars on USFDA Nod for Billion-Dollar Drug

Lupin Soars on USFDA Nod for Billion-Dollar Drug

 

 

Exclusive 180-day window fuels stock jump after Tolvaptan approval for kidney disease treatment.

Shares of the Mumbai-based pharmaceutical giant, Lupin Limited, experienced a significant surge, climbing nearly 3% on Thursday, April 24th. This positive market reaction followed the announcement that the company had secured a crucial approval from The USFDA granted approval for Lupin’s New Drug Application concerning Tolvaptan tablets, available in strengths of 15mg, 30mg, 45mg, 60mg, and 90mg.

Exclusive Opportunity in a Lucrative Market

This regulatory clearance is particularly significant for Lupin as it marks their position as the first generic manufacturer to receive approval for this specific drug. This “first-to-file” status grants Lupin a valuable 180-day period of exclusive marketing rights for generic Tolvaptan in the United States. Industry analysts anticipate that Lupin will effectively be the sole generic supplier of this medication for a substantial portion of the financial year 2026, providing a considerable competitive advantage.

Substantial Revenue Projections

Financial experts have already begun to assess the potential financial impact of this approval on Lupin’s performance. Preliminary projections indicate that Lupin may earn $150 million to $200 million this fiscal year from the launch of generic Tolvaptan. This influx of revenue is poised to significantly bolster the company’s financial results.

Strategic Manufacturing and Swift Market Entry

Lupin has announced that its Tolvaptan tablets will be produced at their state-of-the-art pharmaceutical facility in Nagpur, India. The company has also indicated its intention to expedite the launch of the product in the US market, aiming to capitalize on the 180-day exclusivity period as quickly as possible.

Bioequivalence to a Key Branded Drug

The approved Tolvaptan tablet developed by Lupin is a bioequivalent version of Jynarque tablets, which are marketed by Otsuka Pharmaceutical Company. Bioequivalence signifies that Lupin’s generic version is designed to have the same therapeutic effect as the original branded drug, ensuring patients have access to a comparable treatment option.

Addressing a Critical Medical Need

Tolvaptan is indicated for use in adult patients who are at risk of experiencing a rapid decline in kidney function due to autosomal dominant polycystic kidney disease (ADPKD). The development of many kidney cysts is a hallmark of ADPKD, a hereditary condition that can ultimately result in renal failure. Tolvaptan plays a crucial role in slowing down this progression, offering a vital treatment option for affected individuals.

A Significant Market Opportunity

In the US, there is a sizable market for tolvaptan. According to data from December 31, 2024, the estimated annual sales of Tolvaptan in the US reached an impressive $1.467 billion. This figure underscores the significant commercial potential that Lupin can now tap into with its generic version.

Boosting Earnings and Offsetting Losses

Analysts predict that the introduction of generic Tolvaptan (Tolvaptan) could contribute over 25% to Lupin’s overall earnings in the current fiscal year. Additionally, in the fiscal year 2026, it is anticipated to be the main factor driving the drugmaker’s financial success. This new product launch is also strategically important as it will help to counterbalance any potential revenue decline anticipated from the generic version of Mirabegron (gMirabegron) in FY26.

Revised Financial Outlook

Following this significant USFDA approval, financial institutions are revising their forecasts for Lupin. Axis Capital, for instance, has adjusted its Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) and Profit After Tax (PAT) estimates for Lupin in FY26 upwards by 8% and 10%, respectively. These revisions directly reflect the anticipated positive impact of the tolvaptan launch on the company’s profitability.

Market Reaction and Investor Confidence

The positive market response was evident in the nearly 3% gain in Lupin’s share price on the day of the announcement. The stock reached an intraday high of ₹2149.5 apiece, demonstrating strong investor confidence in the company’s prospects following this regulatory success. Even after some fluctuation, the stock continued to trade significantly higher, indicating sustained positive sentiment.

Final Thoughts

Lupin’s recent USFDA approval for its generic Tolvaptan tablets marks a significant milestone for the company. Securing the first-to-file status and the accompanying 180-day exclusivity period positions Lupin for substantial revenue generation in a nearly $1.5 billion market. Analysts foresee this launch as a major catalyst for the company’s earnings growth in the coming fiscal years, effectively offsetting anticipated losses from other generic products. The market’s positive reaction, with a notable surge in Lupin’s share price, underscores the significance of this regulatory achievement and its potential to drive the company’s future financial performance. This strategic win not only strengthens Lupin’s presence in the US generic market but also highlights its capabilities in navigating the complex regulatory landscape and bringing crucial medications to patients.

 

 

 

 

 

 

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Sun Pharma Shares surge 5% as U.S. court clears Launch of key Autoimmune Drug

Sun Pharma Shares surge 5% as U.S. court clears Launch of key Autoimmune Drug

The legal victory in the U.S. opens new revenue avenues for Sun Pharmaceutical as restrictions on launching its autoimmune drug are lifted, boosting investor confidence and stock performance.

Introduction
In a significant development for India’s largest pharmaceutical company, Sun Pharmaceutical Industries Ltd., shares surged by 5% after a U.S. court lifted legal restrictions that had previously barred the company from launching a key autoimmune drug in the American market. The stock rallied in early trading hours, closing firmly on investor optimism surrounding the potential revenue windfall from this greenlight.
This legal breakthrough marks a critical turning point in Sun Pharma’s global expansion strategy, especially in the high-stakes immunology segment, where fierce competition and massive market potential exist.

Background: The Legal Dispute
The case revolved around Sun Pharma’s plans to launch its generic version of a blockbuster autoimmune drug that had been under patent litigation in the United States. The originator company, a major U.S.-based pharmaceutical giant, had secured an injunction preventing Sun from releasing its version until the expiration of certain patent claims.
However, the District Court U.S. for the District of Delaware ruled in favour of Sun Pharma, stating that the company did not infringe on the remaining valid patents and could proceed with its launch. Industry observers welcomed the decision as a positive step for competition and affordability in the immunology drug segment.

Market Reaction and Investor Sentiment
The Bombay Stock Exchange (BSE) witnessed a sharp spike in Sun Pharma shares, which jumped nearly 5% intraday, hitting a fresh 52-week high. The trade volume on the National Stock Exchange (NSE) doubled compared to the daily average, indicating strong institutional interest.
Brokerage firms were quick to revise their short-term outlook for the stock. Analysts at ICICI Securities upgraded the stock to “Buy” with a revised target price, citing the court ruling as a “game-changing” event that could lead to increased market share and higher margins in the U.S. generics segment.
Retail investors also joined the rally, reflecting growing confidence in the pharmaceutical sector’s long-term prospects amidst an improving regulatory and legal environment in the U.S.

Strategic Importance of the Autoimmune Drug
The drug at the center of the controversy is used to treat autoimmune disorders like psoriasis, rheumatoid arthritis, and Crohn’s disease. These conditions affect millions of Americans and represent one of the fastest-growing therapeutic markets, with annual global sales exceeding $50 billion.
With the court’s decision in its favour, Sun Pharma is now well-positioned to capture a significant share of the lucrative market by offering a cost-effective generic alternative to patients and healthcare systems.
The company had already completed clinical trials and secured U.S. FDA approval but was waiting on the resolution of the patent litigation to proceed with the launch. With the legal obstacle removed, the company is expected to roll out the drug within the next few quarters.

Company’s Response
In an official statement, Sun Pharma said:
“We welcome the U.S. District Court’s decision and are committed to bringing affordable and effective treatment options to patients worldwide. This development reinforces our efforts to deliver on our global innovation and access strategy.”
The company also reaffirmed its focus on speciality drugs and complex generics, a segment it has heavily invested in over the past few years through acquisitions and internal R&D.

Broader Industry Implications
This ruling could set a precedent for other Indian pharmaceutical companies involved in litigation with multinational drug makers. It showcases that Indian firms can hold their ground in complex intellectual property battles, mainly when supported by rigorous clinical data and regulatory compliance.
Moreover, the decision is seen as a win for U.S. consumers and insurance providers, who now have access to cheaper alternatives in the high-cost autoimmune therapy space.
Healthcare policy advocates in the U.S. have long criticized the prolonged monopoly of originator drugs due to aggressive patent extensions, and this decision is likely to be seen as a corrective measure that promotes fair competition.

Challenges and the Road Ahead
Despite this win, Sun Pharma will face stiff competition from other generic manufacturers eyeing the U.S. immunology market. Pricing pressures, supply chain logistics, and ongoing regulatory scrutiny in the U.S. remain potential challenges.
However, the outlook remains positive given Sun Pharma’s strong product pipeline, global presence, and now a major legal victory. The company’s ability to monetize this opportunity swiftly and scale distribution will determine the extent of its success in the post-litigation phase.

 

 

 

 

 

 

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