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When Patents, Patients and Prices Collide

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Supreme Court Clears Natco to Launch Low-Cost Version of Roche’s Spinal Drug in India: A Judgment That Redefines Access and Innovation in India’s Pharma Landscape.

The Supreme Court of India has just recently refused to interfere with the Delhi High Court’s order allowing Natco Pharma to manufacture and market a generic version of Roche’s spinal muscular atrophy (SMA) drug, Risdiplam (Evrysdi). This landmark development doesn’t just mark a legal win for generics — it revives the deep, ongoing debate between patent protection and public access to life-saving medicines.

A Ruling That Speaks the Language of Access:

On October 17–18, 2025, Roche’s plea seeking an injunction against Natco was dismissed by the Supreme Court, which found no reason to interfere with the Delhi High Court’s earlier decision.

The Delhi court had refused to grant Roche interim relief, noting credible grounds to challenge the patent’s validity and the public-interest urgency of allowing cheaper treatment for SMA — a devastating genetic disorder that affects infants and children.

The court’s reluctance to grant an interim injunction places patient affordability front and center — and that changes the dynamics of pharma patent battles in India.

The Price Gap That Altered the Equation:

Roche’s Evrysdi reportedly costs several lakh rupees per bottle in India, putting it beyond the reach of most families. Natco’s generic version, as reported, could be priced over 90% cheaper — transforming what was once an impossible dream into a realistic treatment option.

This price gap didn’t just influence public sentiment; it played a significant role in shaping the courts’ stance. Judges openly recognized that blocking a low-cost version could effectively deny treatment to children with SMA — a life-and-death consequence.

Why the Supreme Court’s Refusal Matters:

The Supreme Court’s decision not to grant Roche an interim injunction reinforces a growing Indian legal trend: interim injunctions in pharma patent cases are no longer automatic.

Courts now weigh:

  • Patent strength and the credibility of validity challenges,
  • Irreparable harm to the innovator, and
  • Public interest, especially access to life-saving drugs.

This signals that the right to enforce a patent is conditional upon the broader social consequences of that enforcement.

Balancing Innovation and Access:

This case captures the perennial dilemma:

  • Innovators argue that strong patent enforcement is essential for recouping high R&D investments and incentivizing new drug development.
  • Public health advocates argue that patents cannot become instruments of exclusion in countries where millions live below the affordability line.

When prices put essential medicines out of reach, the courtroom becomes a public-health tool — not just a commercial arena.

The Natco–Roche case has forced policymakers, the judiciary, and especially the multinational pharmaceutical companies to re-examine that delicate balance.

Wider Ripples Across the Pharma Ecosystem:

This decision could shape the future of pharmaceutical litigation and policy in India in at least three ways:

  1. Fewer automatic injunctions:
    Courts are likely to scrutinize the public-health impact before granting injunctions for high-priced patented drugs.
  2. Pricing pressure on innovators:
    Multinationals may increasingly adopt tiered pricing, voluntary licensing, or expanded patient-assistance programs to avoid reputational and legal setbacks.
  3. Inspiration beyond India:
    India’s judicial balancing act could influence other developing countries grappling with rare-disease affordability and IP rights.

What It Means for Stakeholders:

  • For patients and caregivers: A crucial breakthrough — real hope for families fighting SMA who could never afford imported treatment.
  • For Indian pharma: A signal that robust patent challenges and ethical pricing can reshape access debates.
  • For global innovators: A call to re-engage with India through more collaborative models — not courtroom showdowns.

Access and innovation need not be enemies. The challenge is rewriting the incentives so they can be allies.

Conclusion:

A Broader Reflection:

This judgment underscores a truth India’s policymakers have long recognized — that patent law is not just about ownership, but about obligation. Society grants exclusivity to foster innovation, but that exclusivity loses legitimacy when it bars life-saving treatment for those who need it most.

While this verdict helps address immediate patient needs, the long-term path must include transparent pricing frameworks, stronger patent examination, and public–private partnerships to make rare-disease drugs sustainably accessible.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Sources and References:

  • Supreme Court of India order (October 2025)
  • Delhi High Court proceedings in Roche vs. Natco (2024–2025)
  • Reporting: Moneycontrol, The Economic Times, LiveMint, SwissInfo, Knowledge Ecology International

 

When Patents Meet Patients: Why India Revoked Novartis’ Vymada Patent

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India’s bold move against Novartis’ blockbuster heart drug patent highlights the country’s uncompromising balance between innovation incentives and affordable access to medicines.

The Verdict That Stirred the Industry:

On September 12, 2025, the Indian Patent Office revoked Novartis’ patent on Vymada (internationally known as Entresto - a combination of sacubitril and valsartan). The decision came after post-grant opposition from domestic firms, who argued that the patent lacked novelty, inventive step, and failed to meet India’s unique anti-evergreening provisions.

The Deputy Controller of Patents and Designs, D. Usha Rao, concluded that Novartis had not shown a clear therapeutic advantage for the claimed “supramolecular complex” formulation over existing drugs. Without robust clinical or technical evidence, the patent could not stand.

Why It Matters:

The revocation was more than a legal blow to Novartis; it was a reaffirmation of India’s stance on pharmaceutical patents:

  • Section 3(d) of the Indian Patents Act continues to be the line of defense against evergreening. Incremental modifications must show substantial enhancement of efficacy to deserve protection.
  • Affordability and access remain cornerstones of Indian policy. By clearing the way for generics, the decision is expected to slash prices for a critical heart-failure treatment.
  • Innovation incentives for multinational drugmakers are under renewed scrutiny. While India welcomes innovation, it demands stronger proof of novelty and efficacy before granting or upholding patents.

A Familiar Pattern:

This is not the first time India has stood firm against a global pharmaceutical giant. In 2013, the Supreme Court’s Glivec ruling denied Novartis a patent extension for its cancer drug, setting a powerful precedent against evergreening. The Vymada case extends that tradition: India’s patent office is willing to revoke rights even after grant, if challenges hold merit.

Implications for Stakeholders:

For Global Pharma

  • Signals that India remains a tough jurisdiction for secondary patents.
  • Requires more robust data, comparative studies, and technical evidence to prove novelty or efficacy.
  • Increases the risk of post-grant challenges, adding uncertainty to long-term exclusivity.

For Indian Generics

  • Creates a clear pathway for companies like Natco, Torrent, MSN, and Eris to launch affordable alternatives.
  • Strengthens India’s role as the pharmacy of the world, delivering low-cost medicines without breaching TRIPS.

For Patients

  • Offers a life-saving affordability boost, especially for millions of Indian patients battling heart disease.
  • Reinforces India’s reputation for prioritizing public health over monopoly pricing.

The Bigger Picture:

India’s approach sits at a crossroads of law, economics, and ethics. While critics argue that strict provisions reduce incentives for pharmaceutical innovation, defenders point out that without access, innovation is meaningless for patients in low- and middle-income countries.

Globally, the Vymada revocation will likely be studied as a case in point — showing how India balances TRIPS compliance with its domestic public-health priorities.

Conclusion:

The revocation of Novartis’ Vymada patent is not an isolated event. It’s a reaffirmation of India’s unique intellectual property environment, where patents must prove their worth beyond doubt, and patients’ right to affordable medicines remains paramount.

Hence, the ‘Key Takeaways’ are as follows:

  • Patent Revoked: India’s Patent Office cancelled Novartis’ Vymada (Entresto) patent on grounds of lack of novelty, inventive step, and evergreening concerns.
  • Section 3(d) in Action: The ruling reinforces India’s strict bar on incremental patents unless they show substantial therapeutic advantage.
  • Generics Open the Door: Indian firms like Natco, Torrent, MSN, and Eris can now launch low-cost alternatives, making treatment more affordable.
  • Global Signal: The case highlights India’s unique IP stance — balancing innovation with access to essential medicines.

As the dust settles, this case will likely serve as a landmark reference in future IP disputes, shaping both corporate strategies and policy discussions. For India, it underlines a central philosophy: when patents meet patients, public health comes first.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

India’s Push for Affordable Mental Health Meds: Triumphs and Challenges in 2025

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In June 2025, a small clinic in rural Ghana celebrated a milestone: it provided affordable antidepressants to 500 patients, thanks to India’s generic sertraline, costing just $2 a month per person. This was unimaginable a decade ago, when branded versions cost $30 – far beyond reach for most. As the world grapples with a mental health crisis, with 1 in 8 people facing disorders like depression or anxiety, India’s role as the “pharmacy of the world” is saving lives. Its affordable generic medications are a beacon of hope for millions in low-income countries. Yet, while India has made remarkable strides, significant hurdles remain.

Since long, I have been deliberating on this growing concern in this Blog. For example, on January 17, 2017, I wrote: ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India’. However, in today’s article, let’s explore what India has achieved, what’s left to do, and why this matters to us all.

India’s Game-Changing Achievements:

India’s ability to deliver mental health medications at a fraction of global prices is nothing short of revolutionary. Supplying 40% of the world’s generic antidepressants and antipsychotics, companies like Cipla and Sun Pharma make drugs like fluoxetine (Prozac’s generic) and risperidone accessible to millions. For example, a month’s supply of fluoxetine costs under $1 in India, compared to $15-$20 in the US or Europe. This affordability transforms lives, like that of Priya, a fictional but representative single mother in rural India, who manages her depression with generic escitalopram for $3 a month, allowing her to work and support her family.

The backbone of this success:

The backbone of this success is India’s 1970 Patents Act, which blocks “evergreening” – minor drug tweaks by big pharma to extend patents and keep prices high. This policy ensures generics hit markets fast, benefiting not just India but countries like Nigeria and Bangladesh. In 2022, during UK-India free trade agreement talks, leaked drafts suggested “data exclusivity” clauses that could delay generics for years. Health policy researcher Kavya Shah, reportedly warned, “Such rules could choke access to mental health drugs.” India’s firm rejection of these clauses in the 2023 FTA ensured that drugs like quetiapine, used for bipolar disorder, remained affordable globally. Another report highlighted – Dr. Kanica Rakhra, an Asia Global Fellow, calls this “a masterstroke for health equity,” cementing India’s role as a global health champion.

India’s recent efforts go beyond generics: 

The 2025 Mental Health Mission, launched with a $300 million budget, has boosted production of psychotropic drugs and trained 10,000 community health workers to identify and treat mental health issues early. Public awareness campaigns, like nationwide ads featuring relatable stories of recovery, are chipping away at stigma. Partnerships with the World Health Organization have also scaled up access to drugs like aripiprazole for schizophrenia, reaching patients in Nepal and South Africa. These steps show India’s commitment to leading the global mental health conversation.

The Challenges India Still Faces:

Despite these triumphs, India’s work is far from done. Domestically, the country’s mental health infrastructure is strained. A 2025 Indian Council of Medical Research study reveals only one psychiatrist for every 130,000 people, leaving millions without specialized care. Over-the-counter sales of psychotropic drugs, often misused due to lax regulation, fuel risks like dependency. For instance, in urban India, easy access to unprescribed benzodiazepines has led to rising misuse cases, a problem the government is yet to tackle effectively.

Globally, trade pressures loom large. The EU’s 2024 imposition of a 15% tariff on Indian pharmaceuticals has raised costs for African nations reliant on India’s generics, making drugs like sertraline less affordable. Ongoing EU-India FTA talks in 2025 still carry risks of stricter intellectual property rules that could limit generic production. Developing new mental health drugs is another hurdle. With global investment in psychotropic medications lagging – only 10 new drugs approved since 2015, per WHO – India’s R&D sector needs more funding to innovate.

Access gaps persist even within India. Rural areas, where 70% of the population lives, often lack pharmacies stocking mental health meds. Take Raj, a fictional farmer in Uttar Pradesh, who travels 50 kilometers to find generic citalopram for his anxiety, only to face stockouts. Scaling up distribution and enforcing stricter regulations on drug sales are critical steps India has yet to fully implement.

Conclusion:

India’s leadership in delivering affordable mental health medications in 2025 is a global triumph, transforming lives from rural Ghana to urban India with generics like sertraline and risperidone. Yet, challenges like strained infrastructure, trade tariffs, and innovation gaps demand action. By strengthening domestic systems and resisting restrictive trade policies, India can solidify its role as a health equity pioneer. Join the movement – share these stories, advocate for access, and use #MentalHealthForAll to amplify India’s promise of hope for a healthier world.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

No Compromise: India Protects Patents Act in High-Stakes UK Trade Pact

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India, the “pharmacy of the world,” has long been a lifeline for millions, churning out affordable generic medicines that make healthcare accessible across the Global South. With over $25 billion generic drug industry exporting half its production, India’s commitment to low-cost medicine is a global game-changer. Yet, this role has often pitted it against pharmaceutical giants and developed nations pushing for tighter intellectual property (IP) rules. The India-UK Free Trade Agreement (FTA), finalized on July 24, 2025, showcases India’s firm stand in safeguarding its generic drug industry while navigating complex trade dynamics. By rejecting patent evergreening and data exclusivity—tactics Big Pharma uses to prolong monopolies—India has struck a bold balance between public health and international trade. This article dives into how India’s resolute stance, as highlighted in a July 29, 2025, Economic Times report, reflects its dedication to affordable healthcare while addressing foreign pressures and trade opportunities.

The Stakes: Evergreening and Data Exclusivity:

Evergreening is a clever ploy: pharmaceutical companies tweak existing drugs—think new dosages or slight formula changes—and secure fresh patents to extend their market control beyond the standard 20 years. These tweaks rarely add meaningful therapeutic value but delay cheaper generics, keeping prices sky-high. Data exclusivity, meanwhile, blocks generic makers from using original clinical trial data for regulatory approval, forcing them to run costly, redundant trials. This stalls generic drug launches, hitting hardest in poorer nations where every dollar counts.

The Economic Times noted on July 29, 2025, that “the India-UK free trade agreement (FTA) does not mandate patent term extensions or data exclusivity, which are two common tools of evergreening of patents, the commerce and industry ministry said Monday, adding that this would protect the interests of the domestic generic drugs industry.” This clarity from the ministry signals India’s triumph in shielding its generic sector from provisions that could favor multinational giants like AstraZeneca or GSK, ensuring medicines remain within reach for millions.

Facing Down Foreign Pressure:

The UK, a hub for pharmaceutical innovation, pushed hard for data exclusivity during FTA talks, echoing demands made by the European Free Trade Association (EFTA) in 2024. These “TRIPS-plus” provisions, which go beyond the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, prioritize innovator companies but threaten India’s ability to supply affordable generics to its 1.4 billion people and countless others globally. An expert quoted in The Economic Times emphasized that “data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO,” giving India solid ground to push back.

India’s resistance isn’t just about principle—it’s about lives. The country’s generic industry has slashed costs dramatically, like when compulsory licensing in 2012 dropped Bayer’s cancer drug Nexavar from $5,500 to $175 a month. By rejecting data exclusivity and preserving Section 3(d) of the Indian Patent Act, which bars patents for minor drug tweaks unless they significantly improve efficacy, India ensures generics hit the market faster. The commerce ministry’s statement that “India’s patent law provisions on patentability criteria under Section 3(d) remain fully protected” is a clear signal: India won’t bend to foreign advocacy at the expense of public health.

A Global Health Lifeline:

India’s firm stand resonates far beyond its borders. Developing nations rely on its generics to combat diseases like tuberculosis and HIV. Médecins Sans Frontières (MSF) has flagged data exclusivity as a threat to drugs like delamanid, critical for multi-drug-resistant tuberculosis. In 2022, leaked FTA drafts raised red flags among activists, hinting at provisions that could curb pre-grant patent oppositions or weaken anti-evergreening measures. MSF’s Leena Menghaney warned, “India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations.” The final agreement’s rejection of these provisions proves India listened, cementing its role as a global health champion.

But the fight isn’t one-sided. The UK and other developed nations argue that stronger IP protections fuel innovation, enabling the development of new drugs. Without patents or data exclusivity, they claim, companies might hesitate to invest billions in research. India, however, counters that innovation shouldn’t come at the cost of access. The TRIPS agreement already balances these interests, and India’s generics don’t stop innovation—they democratize its benefits.

Trade Wins Without Compromise:

The FTA isn’t just about medicine; it’s a masterclass in balancing priorities. India secured zero-duty access for over 95% of its agricultural exports to the UK, boosting farmers and traders, while granting duty concessions on British niche products like cranberries and durians, which don’t compete with Indian crops. This give-and-take shows India’s knack for negotiating trade gains without sacrificing its generic industry.

Still, there’s a shadow of concern. Some experts worry the FTA’s focus on voluntary licensing—where generic makers negotiate with patent holders—could weaken compulsory licensing, a TRIPS tool allowing governments to authorize generic production in emergencies. The agreement’s nod to “adequate remuneration” for patent holders raises questions about potential hurdles. While the government insists compulsory licensing rights are untouched, full transparency in the IP chapter’s terms would ease these concerns.

Conclusion:

A Purposeful Advance – Guiding Progress with Balance:

India’s firm stand in the UK FTA is a compelling narrative of principle meeting pragmatism. By blocking evergreening and data exclusivity, India protects not just its citizens but millions worldwide who depend on its generics. Yet, the tension between trade and health equity looms large. Can India keep fending off Big Pharma’s influence while forging global partnerships? The UK FTA suggests it can, blending trade wins with a fierce defense of affordable healthcare.

This isn’t just a policy win—it’s a moral statement. ‘India’s vigilance is critical to keeping medicines accessible’. In a world where healthcare is often a luxury, India’s fight to make it a right is both a challenge to global powers and an inspiration. As more FTAs loom, India’s ability to hold this line will shape not just its future but the health of nations worldwide.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Robust Patents, Not Tweaked Monopolies: India’s Practical Route to Affordable Medicines

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In April 2025, the United States Trade Representative (USTR) released its annual Special 301 Report, once again placing India on its “Priority Watch List” for intellectual property (IP) concerns. The report highlights persistent issues, particularly in the pharmaceutical sector, citing challenges such as potential patent revocations, discretionary application of patentability criteria under the Indian Patents Act, and prolonged patent grant processes.

While the USTR acknowledges India’s efforts to modernize its patent system—such as the finalization of the Patents (Amendment) Rules, 2024, aimed at reducing burdens on patent applicants—it maintains that significant concerns remain. These include high customs duties on IP-intensive products and inadequate IP enforcement mechanisms.

India, however, defends its stance, emphasizing that its IP regime is fully compliant with the World Trade Organization’s TRIPS Agreement and is designed to balance innovation incentives with public health needs. The country asserts that its legal provisions, particularly Section 3(d) of the Patents Act, are crucial in preventing “evergreening” – a practice where pharmaceutical companies make minor modifications to existing drugs to extend patent monopolies without significant therapeutic benefits.

Balancing Innovation and Access:

India’s approach to pharmaceutical patents is rooted in its commitment to public health. The Patents Act, 1970, particularly Section 3(d), prevents the patenting of new forms of known substances unless they result in enhanced efficacy. This provision aims to curb “evergreening,” where minor modifications are used to extend patent monopolies without significant therapeutic benefits.

India’s patent regime also includes mechanisms like pre-grant opposition, allowing stakeholders to challenge patent applications, ensuring that only genuine innovations receive protection.

Some Recent Case Studies: Upholding the Balance:

1. Johnson & Johnson’s Bedaquiline Patent Rejection (2023):
The Indian Patent Office rejected J&J’s attempt to extend its patent on bedaquiline, a critical tuberculosis drug, citing lack of enhanced efficacy. This decision paved the way for generic versions, improving access for patients.

2. Novartis’ Entresto Application Denied (2022):
Novartis’ patent application for the heart failure drug Entresto was denied due to lack of inventive step, preventing potential market monopolization.

3. Roche’s Trastuzumab (Herceptin) Patent Lapse:
Facing legal challenges, Roche allowed its patent on the breast cancer drug Herceptin to lapse in India, enabling the production of affordable biosimilars by Indian companies.

Global Pressures vs. Domestic Realities:

Despite international pressure, India’s IP policies prioritize access to affordable medicines. The country’s stance is not anti-innovation but seeks to prevent monopolistic practices that hinder public health.

India’s role as a major supplier of generic medicines globally underscores the importance of its balanced IP approach. Diluting these safeguards could adversely affect access to essential medicines worldwide.

The Way Forward:

To strengthen its position, India should:

  • Enhance R&D Investment: Boost funding for pharmaceutical research, particularly in neglected diseases.
  • Streamline Patent Processes: Implement measures to reduce patent grant delays while maintaining rigorous examination standards.
  • Maintain Legal Safeguards: Preserve provisions like Section 3(d) to prevent patent evergreening. It ensures that only real therapeutic advances get patents, preserving access to affordable medicines while still rewarding meaningful R&D.
  • Engage Internationally: Continue constructive dialogues with global partners to address IP concerns without compromising public health priorities.

Conclusion:

Let me reemphasize here that Section 3(d) does not prohibit incremental innovation – it simply filters out superficial tweaks that offer no therapeutic benefit and are aimed primarily at extending monopolies and delaying broader patient access to medicines.

Thus, in my view, India’s pharmaceutical IP regime exemplifies a pragmatic approach that balances the protection of genuine innovations with the imperative of public health. By resisting patent abuses and ensuring access to affordable medicines, India sets a precedent for equitable healthcare globally.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Will ‘Patent Thicket’ Delay Biosimilar Drug Entry in India?

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Do pharma and biotech investors encourage companies indulging in ‘patent thicket?’ This question recently grabbed media headlines. On April 02, 2019, one such report brought out: AbbVie investors are calling for the Chair-CEO power split, flagging the CEO’s USD 4 million bonus payout, fueled by the company’s Humira ‘patent thicket’ strategy related aggressive price hikes. It prolonged the brand’s market monopoly, blocking entries of its cheaper biosimilar equivalents.

I have discussed some related issues in this blog, previously. As the issue is gaining relevance also in the Indian context, this article will deliberate the ill-effects of ‘patent thicket’ on patient health-interest. The sole beneficiaries for the creation of this self-serving labyrinth are the manufacturers of high-priced patented drugs, as reported above. Before I proceed further, let me recapitulate what exactly is a ‘patent thicket.’

‘Patent Thicket’:

The dictionary definition of patent thicket is: ‘A group of patents in a field of technology which collectively impede a party from commercializing its own patents or products in that field.’In the current context, it means a dense web of overlapping patent rights that restrict a generic or a biosimilar drug maker from commercializing its cheaper equivalents post expiry of the original patent.

This scenario has been well-captured by the above media report, which states: “AbbVie leadership has also been accused of creating a ‘patent thicket’ in its battle to stave off biosimilar competitors to Humira.” Boehringer Ingelheim is among the few still fighting AbbVie’s ‘patent thicket’ hoping to launch its Humira biosimilar - Cyltezo, even after receiving US-FDA approval on August 29, 2017. ‘Top biosimilar makers, including Novartis’ Sandoz unit and Mylan, have settled their own Humira patent fights with deals that put off launches until 2023,’ the report indicated.

In its favor: AbbVie says, Cyltezo infringes about 70 patents the company currently holds for Humira. Whereas, ‘Boehringer’s lawyers say AbbVie’s copious patents overlapped in an attempt to exclude competitors from the market.’ Notably, in March this year, New York’s UFCW Local 1500 Welfare Fund, reportedly, also accused AbbVie of using overlapping patents to exclude biosimilars.

‘Patent thicket’ – a way of ‘evergreening’ beyond 20 years patent term:

Much concern is being raised about various ploys of especially by the drug MNC and their lobby groups – directly or under a façade, to delay entry of cheaper generic drugs for greater patient access. Mostly the following two ways are followed for patent ‘evergreening’ beyond the term of 20 years:

  • ‘Incremental innovation’ of the existing patented drugs through molecular manipulation, with its clinical performance and safety profile remaining similar to the original one. As the cost benefits of such drugs are not shared with patients, cannibalizing the sales of the older molecular version with the newer one highlighting its newness, the sales revenue can be protected. With this approach, coupled with marketing muscle power with deep-pocket the impact of generic entry of the older version can almost be made redundant. For example: Omeprazole was first marketed in 1989 by AstraZeneca, under the brand name Losec (later changed to Prilosec at the behest of the US-FDA). When Prilosec’s US patent expired in April 2001, AstraZeneca introduced esomeprazole (Nexium) as a patented replacement drug. Both are nearly identical in their clinical efficacy and safety.
  • ‘Patent thicket’ is yet another tool for ‘evergreening’, delaying launch of similar drugs, or resorting to ‘pay for delay’ sort of deals. As another recent report reiterates, AbbVie’s ‘patent thicket’ for Humira, has deterred other potential challengers, such as Amgen, Samsung Bioepis and most recently Mylan, each of which struck settlements with AbbVie to delay their biosimilar challenges in the United States.

Goes against patients’ health interest:

On May 09, 2018, the Biosimilars Council reported, just as generic medicines saved Americans USD 1.67 trillion in the last decade, biosimilars are poised to do the same – ‘if they aren’t thwarted by delaying tactics instituted by some pharmaceutical companies.’ Echoing similar concern, the outgoing US-FDA Commissioner Scott Gottlieb also, reportedly said, ‘some drugmakers are using unacceptable tactics such as litigation and rebate schemes to stall the entry of cheaper copies.’

‘Of the nine biosimilars the FDA has approved to date, only three have made it into the hands of patients – an alarmingly small number. Patients can’t access the six others due to barriers thrown in their way by pharmaceutical companies that want to protect their monopolies and keep prices high,’ highlights the Biosimilars Council report. Net sufferer of this self-serving ‘patent thicket’ strategy of pharma and biotech players to extend product patents beyond 20 years, are those patients who need these drugs the most – to save their lives.

Despite law, patent ‘evergreening’ still not uncommon in India:

With section (3d) on the Indian Patents Act 2005 in place, the country is expected to protect itself from patent ‘evergreening’ through ‘incremental innovation.’ This section articulates:“For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

On this ground, Indian Patent Office (IPO) rejected Novartis’ drug Glivec (imatinib mesylate) patent application, which was ultimately upheld by the Supreme Court in 2013. Nevertheless, a study report of April 30, 2018 emphasized: ‘Though the law with regard to anti-evergreening, upheld and clarified by Indian courts, remains on the books, its application by the IPO has been far from satisfactory.’

The esteemed author of the report, after analyzing about 2,300 drug patents, granted between 2009 and 2016 concluded that evergreening practices may be rampant in India. The report pointed out, ‘the IPO could be operating with an error rate as high as 72 percent for secondary patents, despite provisions to keep them in check.’

Are these IPO’s mistakes, or due to external pressure?

As the paper, published in the January 2016 edition of the Journal of Intellectual Property Rights (JIPR) said,‘The multi-national pharma companies (MNCs) and the US-India Business Council (USIBC) have suggested in their report for elimination of Section 3 (d) so that drug patents can be granted in India for incremental improvement and modification. As per US 301 report, India is listed among countries with inadequate IP regime.’ Keeping all these aspects into consideration, the article expressed some key concerns pertaining to the impact of Section 3 (d) with special emphasis on its interpretation. Does it mean any possibility of wilting under such extraneous and high impact pressure?

A fresh pressure from drug MNC on the DCGI:

Since long drug MNCs have been attempting to delay the entry of even those generics, which are fully compliant with the Indian Patent Law 2005. One such effort was their demand for ‘patent linkage’ with the marketing approval of new generic drugs. However, it could not pass through legal scrutiny – first by the Delhi High Court in the Bayer Cipla case in 2010, and then by the Supreme Court – on the same case. The Court, reportedly, ‘noted the Indian patent system was distinct from the drug regulatory system with no linkage between them and so Bayer can’t prevent DCGI from granting marketing approval to generic versions of patented drugs.’

According to another recent media report of April 04, 2019, in a fresh endeavor ‘to delay launch of low priced generic medicine, multinational drug makers have asked the government to create a registry providing information about all drug applications pending manufacturing and marketing approval. The proposal, which is still pending with the Department of Pharmaceuticals (DoP), if accepted, could involve the generic players into expensive and time-consuming litigations, delaying early market entry of the cheaper generic or biosimilar equivalents.

To date, the health ministry has opposed the proposal, as it will be “unfair to local drug manufacturers to disclose their product strategy” and also has “the potential to substantially increase health care costs for the public.” The government further argued, “such information about product applications filed for approval are not disclosed anywhere in the world.”

India encourages new drug innovation, but not at any cost:

Despite shrill and disparaging comments of MNC lobbyists and the strong vested interests, that India’s Patent Law 2005, doesn’t encourage innovation, many independent international experts do praise the same for the following reasons:

  • Does encourage new drug innovation
  • Does extend product exclusivity for twenty years
  • Strikes a right balance with patients’ health interest
  • Indian judicial system deals with patient infringements and disputes, just as any other developed countries
  • Even 14 years after the enactment of patent laws, just one compulsory license has been granted, which is much less than other countries, including the United States.

What India doesn’t legally allow is, unfettered profit making through ‘evergreening of drug patents’ – at the cost of millions of patients-lives. Nonetheless, powered by deep pockets, the pharma and biotech players are unlikely to cease from this practice, anytime soon. Only patient-awareness, and stringent counter-legal measures can contain this unfair game of drug monopoly practices – in the name of ‘encouraging innovation’.

Conclusion:

The article titled, ‘Over patented, overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices’ revealed:“Top grossing drugs have on average 125 patent applications, which are filed with a strategic intent to extend the commercial monopolies far beyond the intended twenty years of protection.” It also quoted American President Donald Trump as saying, “Our patent system will reward innovation, but it will not be used as a shield to protect unfair monopolies.”

Coming back to ‘patent thicket’ and the same classic case, another report of March 20, 2019 indicated, a new class action lawsuit filed by New York’s largest grocery union has accused AbbVie of violating antitrust and consumer protection laws, which AbbVie has defended by saying that its patent strategy for Humira has protected the investments that are necessary to “advance healthcare.”

Pharma and biotech companies’ maintaining patent monopolies far beyond twenty years has significant consequences on India’s healthcare system. Only patent lawyers and experts can possibly answer whether or not the Indian Patent Law 2005 can effectively deal with the practice of ‘evergreening’ with patent thicket. Intriguingly, taking a cue from recent developments, it seems many pharma and biotech investors too, deem ‘patent thicket’ rather distracting for longer-term undiluted focus on new product development, and sustainable investors’ return.

That apart, the question also comes, whether just as ‘antitrust and consumer protection laws’ in the US, the Competition Law of India will be able to do contain such unfair practices? Otherwise, with MNC lobbyists’ renewed activities in this area, ‘patent thicket’, especially for expensive biologic drugs, will delay market-entry of their cheaper biosimilar versions in India, as well, just as what is happening in the developed nations.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

High Innovation-Cost Makes Cancer Drugs Dear: A Fragile Argument?

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Cancer is a major cause of high morbidity and mortality in India, just many other countries, according to a report of the World Health Organization (W.H.O). While deaths from cancer worldwide are projected to continue to rise to over 1.31 million in 2030, the Indian Council of Medical Research (ICMR) estimates that India is likely to have over 1.73 million new cases of cancer and over 8,80,000 deaths due to the disease by 2020 with cancers of breast, lung and cervix topping the list.

 Cancer treatment is beyond the reach of many:

Despite cancer being one of the top five leading causes of death in the country, with a major impact on society, its treatment is still beyond the reach of many. There are, of course, a number of critical issues that need to be addressed in containing the havoc that this dreaded disease causes in many families –  spanning across its entire chain, from preventive measures to early diagnosis and right up to its effective treatment. However, in this article, I shall focus only on the concern related to affordable treatment with appropriate cancer with medicines.

To illustrate this point, I shall quote first from the address of the Chief Minister of Maharashtra during inauguration of Aditya Birla Memorial Hospital Cancer Care Center on November 26, 2016. He said: “Cancer is the dreadful disease of all the time and for Maharashtra it is a big challenge as we are infamously at number two position in cancer cases in the country as after Uttar Pradesh, most cases are found here.” Incidentally, UP is one of the poorest state of India.

Underscoring that the biggest challenge before the technology is to bring down the cost of the cancer treatment and make it affordable and accessible for all, the Chief Minister (CM) further observed, “although, technological innovation has increased in last one decade, the accessibility and affordability still remain a challenge and I think, we need to work on this aspect.”

A new cancer drug launch vindicates the CM’s point:

The Maharashtra CM’s above statement is vindicated by a national media report of September 13, 2017. It said, Merck & Co of the United States have launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India, around a year after its marketing approval in the country. Keytruda is expected to be 30 percent cheaper, compared to its global prices, costing Rs 3,75,000 – 4,50,000 to patients for each 21-day dose in India.

The point to take note of, despite being 30 percent cheaper, how many Indian patients will be able to afford this drug for every 3 weeks therapy? Doesn’t it, therefore, endorse the CM’s above submission? Well, some may argue that this exorbitant drug price is directly linked to high costs for its innovation and clinical development. Let me examine this myth now under the backdrop of credible research studies.

Cancer drugs are least affordable in India – An international study:

On June 6, 2016, by a Press Release, American Society of Clinical Oncology (ASCO) revealed the results of one of the largest analyses of differences in cancer drug prices between countries worldwide. The researchers calculated monthly drug doses for 15 generic and eight patented cancer drugs used to treat a wide range of cancer types and stages. Retail drug prices in Australia, China, India, South Africa, United Kingdom, Israel, and the United States were obtained predominantly from government websites. The study shows that cancer drug prices are the highest in the United States, and the lowest in India and South Africa.

However, adjusting the prices against ‘GDPcapPPP’ – a measure of national wealth that takes into consideration the cost of living, cancer drugs appeared to be least affordable in India and China. The researchers obtained the ‘GDPcapPPP’ data for each country from the International Monetary Fund and used it to estimate the affordability of drugs.

Why are cancer drug prices so high and not affordable to many?

The most common argument of the research based pharma companies is that the cost of research and development to bring an innovative new drug goes in billions of dollars.

The same question was raised in a series of interviews at the J.P. Morgan Healthcare Conference, published by the CNBC with a title “CEOs: What’s missing in the drug pricing debate” on January 11, 2016, where three Global CEOs expressed that the public is getting overly simple arguments in the debate about drug pricing. All three of them reportedly cited three different reasons altogether, as follows:

  • Eli Lilly CEO said, “Some of the noise you hear about drug pricing neglects the fact that we often must pay deep discounts in a market-based environment where we’re competing in many cases against other alternative therapies, including those low-cost generics.”
  • Pfizer CEO took a different approach by saying, “if you look at the market, about a decade ago, 54 percent of the pharmaceutical market was genericized; today 90 percent is genericized.”
  • However, as reported by CNBC, Novartis CEO Joseph Jimenez, focusing on innovation and in context on cancer drugs, argued “innovation has to continue to be rewarded or we’re just not going to be able to see the kind of breakthroughs that we have seen in cancer research, specifically regarding the uses and benefits of the cancer-fighting drug Gleevec. We continued to show that the drug was valuable in other indications in cancer and so we needed to be reared for that innovation and we’re pricing according to that.”

Is drug innovation as expensive and time intensive as claimed to be?

An article titled, “The high cost of drugs is the price we pay for innovation”, published by the World Economic Forum (WEF) on March 28, 2017 reported, “15 spenders in the pharmaceutical industry are investing about US$3 billion in R&D, on average, for each successful new medicine.”

The November 18, 2014 report on the ‘Cost of Developing a New Drug,’ prepared by the Tufts Center for the Study of Drug Development also announced: “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is: US$ 2,558 million.”

Not everybody agrees:

Interestingly, Professor of Medicine of Harvard University – Jerry Avorn questioned the very basis of this study in the article published in the New England Journal of Medicine (NEJM) on May 14, 2015. It’s not just NEJM even the erstwhile Global CEO of GSK – Sir Andrew Witty had questioned such high numbers attributed to R&D cost, around 5 years ago, in 2013. At that time Reuters reported his comments on the subject, as follows:

“The pharmaceutical industry should be able to charge less for new drugs in future by passing on efficiencies in research and development to its customers. It’s not unrealistic to expect that new innovation ought to be priced at or below, in some cases, the prices that have pre-existed them. We haven’t seen that in recent eras of the (pharmaceutical) industry, but it is completely normal in other industries.” Quoting the study of Deloitte and Thomson Reuters on R&D productivity among the world’s 12 top drugmakers that said the average cost of developing a new medicine, including failures, was then US$ 1.1 billion, Witty remarked, “US$ 1 billion price-tag was one of the great myths of the industry.”

A decade after Sir Andrew’s comment, his view was virtually corroborated by yet another research study, published this month. The study reemphasized: “The Tufts analysis lacks transparency and is difficult to judge on its merits. It cannot be properly analyzed without knowing the specific drug products investigated, yet this has been deemed proprietary information and is governed by confidentiality agreements.” I shall discuss this report briefly, in just a bit.

The latest study busts the myth:

The latest study on the subject, titled “Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval”, has been published in the ‘JAMA Internal Medicine’ on September 11, 2017. It busts the myth that ‘high innovation-cost makes cancer drugs dear,’ providing a transparent estimate of R&D spending on cancer drugs. Interestingly, the analysis included the cost of failures, as well, while working out the total R&D costs of a company.

The report started by saying: “A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is US$ 2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication.”

The study concludes: “Prior estimates for the cost to develop one new drug span from US$ 320.0 million to US$ 2.7 billion. We analyzed R&D spending for pharmaceutical companies that successfully pursued their first drug approval and estimate that it costs US$ 648.0 million to bring a drug to market. In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than R&D spending—a sum not seen in other sectors of the economy. Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.” The researchers also established that ‘the median time to develop a drug was 7.3 years (range, 5.8-15.2 years).’

“Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation”:

NPR – a multimedia news organization and radio program producer reported: In an invited commentary that accompanies the JAMA Internal Medicine analysis, Merrill Goozner, editor emeritus of the magazine Modern Healthcare, noted that “the industry consistently generates the highest profit margins among all U.S. industries.” Goozner argues that the enormous value of patent protection for drugs far outweighs the inherent riskiness of pharmaceutical research and development, and agrees with the study authors when he writes: “Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation,” NPR wrote.

Conclusion:

So, the moot question that surfaces: Is Pharma innovation as expensive and time consuming as claimed to be? If not, it further strengthens the credibility barrier to Big Pharma’s relentless pro-innovation messaging. Is the core intent, then, stretching the product monopoly status as long as possible – with jaw dropping pricing, unrelated to cost of innovation?

Further, incidents such as, shielding patent of a best-selling drug from low priced generic competition, by transferring its patents on to a native American tribe, probably, unveil the core intent of unabated pro-innovation messaging of major global pharma companies. In this particular case, being one among those companies which are seeking to market cheaper generic versions of this blockbuster eye drug, Mylan reportedly has decided to vigorously oppose such delaying tactic of Allergan before the Patent Trial and Appeal Board.

As a cumulative impact of similar developments, lawmakers in the United States are reportedly framing new laws to address the issue of high drug prices. For example, “California’s Senate Bill 17 would require health insurers to disclose the costs of certain drugs and force pharmaceutical manufacturers to detail price hikes to an agency for posting on a government website. The proposal would also make drugmakers liable to pay a civil penalty if they don’t follow its provisions.”

The myth of ‘high innovation-cost makes cancer drugs dear’ will go bust with such revelations, regardless of the blitzkrieg of self-serving pro-innovation fragile messaging.  Alongside, shouldn’t the Indian Policy makers take appropriate measures to rein in cancer drug prices, being free from any apprehension of jeopardizing innovation?

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.