Tag Archives: Patent

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

Posted on by
Reply

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.

 

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

Posted on by
Reply

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.

Curbing Patent Evergreening: Advancing Innovation and Health Equity for a Vikshit Bharat

Posted on by
Reply

As published in The Economic Times of April 27, 2025:  India’s Commerce and industry minister - “Piyush Goyal stated that India frequently receives requests to extend pharmaceutical patents for minor modifications. He criticized this practice, known as ‘evergreening,’ for prioritizing corporate profits over global healthcare access.’

Against the above backdrop, I reckon, as India strides toward the goal of becoming a ‘Vikshit Bharat by 2047’, we must dismantle the hidden structural barriers that undermine self-reliance, stifle true innovation, and deny affordable healthcare to our people. One such barrier- largely invisible to the public yet devastating in its impact- is the global pharmaceutical industry’s misuse of patent evergreening.

This practice – where companies file successive, often trivial, secondary patents to extend monopolies on old drugs—chokes competition, delays biosimilars, and imposes crippling costs on patients and health systems. It is not innovation; it is legal manipulation.

India, through its bold and visionary Section 3(d) of the Patents Act, has stood almost alone in resisting this exploitation. But as pressures continues to mount from powerful trade lobbies and multinational corporations, India’s resolve is being tested.

Evergreening: Innovation’s Parasite?

The concept of evergreening is deceptively simple but deeply corrosive. When the primary patent on a blockbuster drug nears expiry, companies file dozens—or even hundreds – of minor patent claims on formulations, delivery methods, or metabolites. These “secondary patents” are designed not to protect new inventions, but to delay affordable alternatives.

Consider Humira, a biologic drug that should have gone off-patent in 2016. Through aggressive evergreening, its U.S. monopoly was extended until 2023, amassing over $240 billion in revenue—while millions of patients waited for cheaper biosimilars.

This is not an isolated case. Imatinib, Rituximab, Enbrel, and many more biologics have seen similar fates in Western markets. These tactics have turned the global patent system into a tool for rent-seeking, rather than discovery.

If allowed unchecked, this model will undermine India’s biosimilar leadership, strain our healthcare budgets, and compromise our ambition to be a Vishwa Guru in inclusive, ethical innovation.

Section 3(d): Bharat’s Intellectual Firewall:

India’s response—crafted in the 2005 Patents Act and embodied in Section 3(d)—rejects trivial innovations from being patented. It is not anti-IP; it is pro-science, pro-accountability, and pro-Bharat.

This legal firewall has enabled Indian companies to launch biosimilars for some of the world’s most expensive biologics—at a fraction of global prices. It is why cancer patients in India don’t pay $100,000 a year for treatment. It is why generic drug diplomacy became India’s soft power during COVID-19.

Weakening Section 3(d), under global trade pressure or lobbying, would open the floodgates to evergreening in India—replacing our public health logic with corporate greed.

Vikshit Bharat Demands Patent Integrity in true sense:

To achieve the Vikshit Bharat vision, India must be both an innovation hub and a justice champion. This requires moral clarity and policy courage on the patent front.

  1. Make evergreening unprofitable: Reform examination practices, increase patent office scrutiny, and use AI to flag secondary patent abuse. No drug should get 20 more years of monopoly for marginal tweaks.
  2. Preserve Section 3(d) as a global model: Far from being “TRIPS non-compliant,” Section 3(d) should be exported to other nations. India can lead a coalition of countries in the Global South to challenge evergreening through WTO forums.
  3. Empower biosimilar innovation as strategic sector: Just as India leads in generic vaccines; we must become the world’s biosimilar leader. This is not just a market opportunity – it is a sovereignty imperative.
  4. Expose evergreening through transparency: Let public databases track all secondary patents filed, so regulators, researchers, and citizens can hold bad actors accountable.

The Moral Choice for Vikshit Bharat:

Evergreening is not merely a legal trick—it is a moral failing, where life-saving treatments are hoarded for profit. If Bharat is to be vikshit (developed) in the truest sense, then access to medicines cannot be a privilege—it must be a right.

By resisting evergreening, India is not rejecting innovation—it is defending its soul. It is declaring that patents are a means to progress, not tools of profiteering.

Let the world know: a Vikshit Bharat will not inherit broken systems—it will lead with better ones. And in doing so, it will set a new global gold standard for innovation with integrity.

Reclaiming Patent Integrity for Vikshit Bharat: Making Innovation Work for All:

As India marches toward Vikshit Bharat 2047, the vision of a developed, self-reliant nation hinges not just on economic growth, but on systems that are fair, future-ready, and aligned with national interest. Nowhere is this truer than in healthcare and pharmaceuticals—sectors critical to both public welfare and strategic sovereignty.

India has already earned global recognition as the “Pharmacy of the World” by supplying affordable generics and vaccines to over 200 countries. Yet, to fully realize the Vikshit Bharat vision, we must go further: from low-cost manufacturing to innovation leadership. This requires building an ecosystem where patent law rewards true invention without compromising access—a system that puts Janta (the people) and Jan Arogya (public health) at the center.

A Broken Global Model and India’s Course Correction:

The traditional model of pharmaceutical innovation is under stress. While patents were designed to incentivize breakthrough research, the global biopharma industry is increasingly plagued by “evergreening”—the strategic use of secondary patents to extend monopolies on blockbuster drugs long after their primary patents expire.

Section (3d) of the Indian Patents Act is not just a legal provision. It is a civilizational ethos: that science must serve society. That the gains of innovation should be shared, not hoarded. That Bharat’s development must include the last mile, the last person.

Patent Integrity Alongside Leadership in Ethical Regulation Are Pillars of Vikshit Bharat:

For India to become a global innovation hub under Vikshit Bharat, we must lead not only in discovery but in ethical regulation. There are three strategic imperatives:

  1. Safeguard India’s patent standards: Attempts to dilute Section 3(d) through trade pressure or lobbying must be firmly resisted. Weakening this clause would not attract innovation—it would enable exploitation. A Vikshit Bharat sets the rules, not follows them.
  2. Modernize our patent ecosystem: While the spirit of our law is sound, enforcement is uneven. Nearly 70% of drug patents granted in India are secondary in nature. We must invest in capacity-building at the Indian Patent Office, deploy AI-based scrutiny tools, and uphold transparency and scientific rigor in patent examination.
  1. Champion biosimilar access as global public good: With rising non-communicable diseases and biologics dominating pipelines, affordable biosimilars are critical to Jan Arogya. India has the scientific talent and manufacturing prowess to lead this space. But unless we protect our regulatory autonomy, we risk becoming dependent again—this time not for vaccines, but for cancer and autoimmune therapies.

A Message to Stakeholders: Innovation Must Serve Bharat:

To global pharmaceutical companies, Indian regulators, and policymakers: this is not a call to reject IP, but to restore its legitimacy. Secondary patents, when used as tools for revenue preservation rather than discovery, undermine public trust, delay life-saving access, and divert resources from genuine innovation.

The world is watching. As India negotiates trade agreements, leads the Global South, and shapes digital and health diplomacy, our stance on patent fairness will define not just our domestic health outcomes, but our moral authority on the world stage.

Conclusion: Building a Bharat That Heals and Leads:

A Vikshit Bharat is not just an economic powerhouse—it is a nation where healthcare is affordable, innovation is inclusive, and laws reflect both wisdom and will. By defending the integrity of our patent regime and leading global reform on evergreening, India can prove that development does not mean adopting broken models—it means offering better ones.

Let India show the world that Atmanirbharta in healthcare is not just about making in India—it is about thinking for India, and leading for the 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.

Big Pharma Fails Avoiding Drug Price ‘Control’? Even In The US? Why?

Posted on by
Reply

It ultimately happened – even in the United States, as the US President signed a bill on August 16, 2022 that aims to reduce healthcare costs, alongside fighting climate change, besides raising taxes on the rich. This new law was enacted, despite powerful lobbying and the vehement opposition of big pharma associations and that too in their home turf.

According to the Fierce Pharma report of the same day, since the current US President moved into the White House in 2020, the drug industry left no stone unturned battling to preserve pricing status-quo. It further added, the ‘pharmaceutical industry, including, PhRMA, its allies, and the nation’s largest pharmaceutical firms’ have spent more than $205 million in multi-media ads opposing ‘Medicare price negotiations’ and lobbying against efforts to lower drug prices for consumers.’

No wonder, when the bill was just introduced to the US lawmakers, big pharma’s disappointment on the bill was palpable. This gets well-captured in what the AbbVie CEO pointed out at that time. He said, ‘the legislation would force manufacturers to accept the government’s proposed price or face a harsh tax on their revenues from a given product.’ He also said: “So, it’s not a negotiation,” as stated in the bill. He further opined in his conference call: “We should just call it what it is. It’s price controls,’ which is what the lawmakers are ‘basically putting in place, if the language stays the same,’ the AbbVie chief added.

Capturing this new development in the United States, at least, in the recent past - Fierce Pharma in its August 08, 2022, issue commented: “The seemingly unstoppable pharma lobbying force has lost its charm. With the passage of a new bill, the U.S. Senate is opening the door to major drug pricing reform, leaving the drug industry licking its wounds.”

In the Eldorado of the global drug industry, this is indeed an unprecedented initiative to significantly reduce costs of many important drugs and reduce patients’ out of pocket expenses. Consequently, it has created so much of hullabaloo, across the world, for various reasons. In this article, I shall track this emerging scenario along with the message that it sends across the globe, and its possible impact on new drug innovation to meet unmet needs of patients. In India, one such area could be revisiting the price negotiation proposal for patented drugs, a government initiative that failed to take off earlier.

Would lowering prices stifle new drug innovation?

The apprehension, I reckon, that big pharma will continue to play with - price control will stifle new product innovation – adversely impacting patient interest. Notably, to many industry experts, this argument doesn’t just lack robustness, seems more a conjecture rather than the outcome of any peer- reviewed research study findings. On ewthe contrary, several highly credible and independent studies prove otherwise. Thus, let me put hereunder:

  • One – what big pharma directly and through their powerful industry associations or some financially sponsored studies are saying
  • And – what the top experts concluded from their independent analysis in this regard, as published in the globally acclaimed journals.

I leave it to my readers to evaluate the credibility of each to form their views.

Drug industry arguments supported by recent studies:

The findings of a study conducted recently, with the financial support of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), Amgen, Pfizer, Alexion, AbbVie, Genentech, and Bristol Myers Squibb, were released by PhRMA on November 23, 2021. The study was conducted by Vital Transformation. The key findings of this study highlighted: ‘Every 10% drop in the price of medicines in price-controlled EU markets was associated with a:

  • 14% decrease in total VC funding (10% early stage and 17% late stage)
  • 7% decrease in biotech patents
  • 9% decrease in biotech start-up funding relative to the US
  • An 8% increase in the delay of access to medicines.

It concluded: ‘Drug pricing controls implemented in the US would likely have an even greater impact on Biopharma KPIs given its global leadership in investment and innovation.’

Independent expert studies, published in highly reputed journals:

Around the same time as the above report, an independent study published in the Harvard Business Review (HBR) on October 01, 2021, found exactly the opposite. It categorically stated: ‘The U.S. can lower drug prices without sacrificing innovation.’

The paper summed up: ‘With Congress considering legislation to allow Medicare to use its bargaining power to negotiate lower drug prices, large pharmaceutical companies are once again waging a campaign that contends that doing so would seriously harm the development of breakthrough drugs. This is not true. Smaller companies now account for the lion’s share of such breakthroughs. The key to supporting drug innovation is to increase NIH funding of the efforts that give rise to these new companies, cut the costs, and accelerate the speed of clinical trials, and reform patent law.’

Drug pricing in the Indian context:

Prices of, especially, new drugs and the overall cost of healthcare are two major concerns – more in the developing countries like India. Responding to this need drug price control for pre-defined essential medicines are already in place in the country. More recent studies further vindicate the relevance of such regulation from the perspective of affordability of drugs for the poorer section of the society, and where out of pocket expenses are very high.

Let me quote one such paper, published on June 04, 2022, which received no outside financial support from this study, where the researchers concluded: ‘With induced demand and an inadequate competitive environment, the pharmaceutical industry fails to reduce prices. Supply-chain trade margins are very high. Hence, government intervention through price control of essential and life-saving drugs is a necessity in India.’

In this context, another question that is being raised – are there other alternatives to expand access to high-priced life-saving drugs at an affordable cost to all those who need those most? The most common alternative that floats, encourage more competition for those drugs as soon as they go off patent. Let me examine what’s big pharma players are doing in that area.

Does Big Pharma encourage increasing competition to reduce drug prices?

Another way to reduce the price of an expensive product is encouraging competition to enable market forces bring down the price. An interesting article on breaking the rule of drug pricing by pharma companies was published in the Forbes magazine on June 29, 2022. I also wrote on June 10, 2013: ‘To scale-up access to health care, especially for the marginalized population of any country, greater access to affordable generic drugs will always remain fundamental, besides improving healthcare infrastructure and its delivery mechanism.’

Thus, there should be a robust mechanism, across the world, to facilitate quick entry of cheaper generic equivalents immediately after patent expiry of the original molecule. Increasing attempts of blocking entry of generics surreptitiously by vested interests, leaves no other alternative, but price control. This is imperative, ‘as without the availability of newer generics, unmet medical needs of the most vulnerable section of the society cannot be met effectively by any country, as I wrote there.

Attempts to game the system to minimize competition continue unabated:

Even after my article, this red flag is being raised for quite some time. It will be evident from another Harvard Business Review article titled, ‘How Pharma Companies Game the System to Keep Drugs Expensive,’ published in the on April 06, 2017. Acknowledging: ‘Drug development is risky and expensive, thanks to the long testing and approval process,’ the author concluded from their study – ‘But, increasingly, makers of branded drugs are using a variety of tactics to extend their exclusive rights,’ enabling them to maintain high drug prices for much longer time.

More recently, the above Forbes article of June 10, 2022 also highlighted, ‘even the most generous patent protections come to an end and companies must face the potential for generic competition. That’s when major drug manufacturers shift tactics from influencing policy to crushing the competition.’ There are several legal and semi-legal approaches that big pharma players adapt to game the system and maintain pricing monopoly. Let’s recap it with just three of these examples:

- ‘Patent Thicket: Delaying entry of lower price off-patent molecule through a Patent Thicket. This involves creation of ‘a dense web of overlapping intellectual property rights that a generic pharma company must hack its way through in order to actually commercialize new technology of a drug molecule,’ even after the original patent expires. For example, AbbVie’s Humira, the world’s best-selling drug for a long time. I also discussed this issue in my blog over three years ago – on April 22, 2019.

- ‘Pay-for-delay deals’:  I discussed this issue in this blog on June 19, 2013. Moreover, the above Forbes article of June 29, 2022, also underscored this tactic. It explained that this is a deal in which drug companies agree not to compete for a set amount of time to maintain high prices of their brand-name drugs. The article, published in Bloomberg Law on February 20, 2020, captures it nicely.

- Authorized generics: As many would know, law permits six months of exclusivity to the first generic version of an off-patent new molecule coming into the market. Interestingly, just before patent expiry of an innovative drug, several drug makers roll out their own generics to stifle competition. Although, they keep different names for the generic versions, but pricing remains almost similar. Such a practice obliviously delays the entry of cheaper generics, at least by six months.

In this scenario, the new drug prices continue racing north. Something was to be surely done – for patients’ sake, as many believe, at least, where it all started – the US.

New drug prices are highest in 2022:

As reported by Reuters on August 16, 2022:

  • Eight of 13 drugs launched in 2022 priced over $200,000 per year
  • Median annual price for new U.S. drugs this year is $257,000
  • Some drugmakers disclose less information on pricing

Despite this, as reported on August 15, 2022: ‘The main U.S. drug lobby has said it will push back against the legislation, which includes policies that drug makers have opposed for decades.’

Conclusion:

The significance of the above development in the US healthcare scenario, was aptly summed-up by the US House Speaker, as she said: “If you are sitting at your kitchen table and wonder how you’re going to pay the bills – your health care bills, your prescription drug bills – this bill is for you.” For the first time in the US – the champion of champions of free-drug pricing market, will negotiate the drug price with their manufacturers to become patient -centric.

The reverberations of this difficult decision, especially on new drug prices, are expected to prompt the need for price negotiation or price control, primarily for expanding access to new drugs for a larger number of patients. This deserves to be a focus area for the Government, including India. Moreover, the August 18, 2022, media report also suggests that the top court of India may now encourage the Government to investigate, report and take remedial action on drug industry malpractices.

Finally, it’s worth noting that over a decade ago, international media widely reported -  ‘India considering price controls for patented drugs.’ Its objective was to address the aggressive new drug pricing trend in the country. Accordingly, the price negotiation proposal for patented drugs was notified by the Department of Pharmaceuticals (DoP) in 2007. The constituted Committee submitted a report, as well, on February 21, 2013. But it did not take off as on date. Many apprehend, this is due to intensive and ongoing lobbying by big pharma, just as what happened in the US. Nevertheless, the question that surfaces – will the above new drug law in the largest pharma market in the world encourage the DoP to revisit price negotiation for patented drugs - to make modern drugs affordable to a larger patient population in India – now?

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.

To Allay Customers’ New Apprehensions Pharma Needs A New Conversation

Posted on by
Reply

Since the beginning of 2020, witnessing the rapid spread of Covid pandemic with very high global fatality rate – virtually the entire global populations – directly or indirectly, have been looking up to the health care industry for help. This, of course, includes the drug industry – with high expectations of people on deliverables, blended with palpable apprehensions on what’s happening around.

Amid the wave after wave attack of Covid-19, many have realized that there will neither be any quick-fix or immediate solution to tame the virus. As India goes through the Covid 2.0 catastrophe, while waiting for Covid 3.0, a similar situation prevails in the country – with a sense of lurking fear for future uncertainties, slowly but steadily creeping in.

Thus, an unprecedented public expectation for speedy disentanglement of Covid-19 disruptions, confer a huge responsibility to all health care providers and entities, such as, the drug industry, which will be my key focus in this article. Just as any extraordinary situation calls for extraordinary initiatives, this national tragedy also demands from pharma professionals to start a new and proactive conversation, driven by ‘out of-box’ thinking.

I shall explore in this article, in which areas pharma needs to roll out a new conversation to meet with new expectations of its stakeholders, formed during the Covid Pandemic. This engagement needs to go beyond drugs and vaccines, spanning across key contemporary developments that are bothering pharma customers. The aim should be to help customers visualize a brighter horizon based on scientific reasons, in not-too-distant future, such as:

  • How several pharma companies are taking novel initiatives, as a part of their corporate objectives to save lives and livelihoods, faster.
  • How pharma players are thinking ‘out of the box’ to allay Covid related public apprehensions and neutralizing gross misinformation on Covid cure – based on scientific reasons, often selectively deploying their staff members.

In this regard, let me start with a recent advice of a top pharma veteran of global repute, especially on political and public expectations of ‘the endpoint’ for successful prevention and effective treatment of Covid-19 infections.

When focus is on ‘the end point – the price point’, it needs pharma’s attention:

Former CEO of Novartis Joe Jimenez – Ex-Novartis CEO and CEO & Cofounder of Aditum Bio, advised the same in an interview with Reuters Events, published on April 06, 2021. Although this was against the backdrop of the United States, the same is applicable to India, as well.

There, Jimenez said: “And I think the political focus in the United States is too often on the end point, the price point, which definitely needs attention, but not enough on the whole pipeline. And that absolutely needs attention and can bring down the price point at the end of the day.”

“It’s the pharmaceutical industry’s responsibility to show how their drug can lower total costs through the system, whether it’s reducing hospitalization or whether it is reducing other health care costs and comorbidities that lead to ever increasing budgets. If the industry focuses on that, I think I think that’s going to result in better launch success in the next few years,” he added.

However, there is another endpoint – of equal importance, especially in the Covid-19 prevention and the treatment process.

The other end point is equally important, as there may be an extended need for Covid vaccines: 

Wider access to Covid drugs and vaccines is another political and general public’s ‘end point’ of expectations, besides price. As I wrote in my previous article, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products.

Thereafter, on May 05, 2021, the United States also issued a statement supporting the IP waiver for Covid-19 vaccines at the WTO, in its ‘service of ending this pandemic.’ As reported on May 13, 2021, even China now backs the drugs and vaccine IP waiver at the WTO.

Patent waiver for Covid drugs and vaccines make sense for the coming years, especially, in view of the reports that ‘Pfizer, Regeneron CEOs see extended need for COVID-19 vaccines, treatments as pandemic enters the next phase.’ Adding that the data stressed a “need” for re-vaccinations, the Pfizer CEO said, while protection remains high for those six months, it does “go down by time.” Thus, the need for Covid vaccine may continue to remain as important as of date, to prevent the pandemic over, at least, a couple of years, if not beyond.

That apart, some interesting developments followed soon – coincidentally or otherwise.

Meanwhile, some pharma companies responded with laudable initiatives: 

Presumably, for wider availability and affordability of Covid drugs and vaccines, several pharma players alone or in association with governments, took some laudable initiatives. A few examples are, as follows:

  • On May 10, 2021, BioNTech, which has partnered with Pfizer to produce its COVID-19 vaccine, said it plans to set up a new manufacturing site in Singapore, with a capacity to produce several hundred million doses of mRNA-based vaccine.
  • As reported on the same day, as above, Eli Lilly promised to supply India with thousands of tablets of baricitinib for hospitalized COVID-19 patients. It also pledged to sign a royalty-free, non-exclusive voluntary licensing agreements with Cipla, Lupin and Sun Pharma—to expand baricitinib’s availability in the country. Notably, in this month itself, the DCGI has authorized baricitinib plus remdesivir combo for emergency use of ‘hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).’ Baricitinib has also faced a shortage of during the Covid 2.0 surge.
  • As per reports of May 12, 2021: ‘The US is looking at joint production of Johnson and Johnson’s Covid vaccine in India and ways to help manufacturers like Serum Institute of India (SII) to boost production,’

Pharma’s new role to allay public apprehensions in many Covid related areas:

In this complex scenario, various public apprehensions on Covid vaccines and drugs, need to be explained with scientific evidence – in a common man’s language. These include frequent changes in the dosage interval between two doses of some vaccines, whereas for other vaccines there isn’t any change in this area. Or why in India even within a group of fully vaccinated individuals, wearing masks or maintaining social distancing norms are necessary, when these requirements have been relaxed for fully vaccinated people in the United States. Or, when reports like: ‘Covid Cases Double In World’s Most-Vaccinated Nation, Raising Concerns,’ add fuel to the fire of public apprehensions in this regard.

Drug companies, especially those who are engaged in the global battle against Covid-19 – in their research lab, product development process, including clinical trials, can play an additional stellar role in this area, too. With ‘out of the box ideas’ for Covid related public engagement, they can scientifically respond to all public apprehensions with scientific reasons, in a simple language, on what is happening around most people, nowadays. Selective deployment of their own staff members can also make the initiative more meaningful.

This conversation may also include, science-based response to some bizarre claims of ‘Covid cure’ – from religious leaders having significant followers, and even by Union Ministers, without hurting their feelings or sentiments. These ‘advices’ were widely circulated by the mainstream global and local media, including the Wall Street Journal.

For example, one such report said: The president of a century-old religious organization declared that “consuming cow urine and cow dung will stop the effect of infectious coronavirus.” The swami added that a “person who chants ‘om namah shivay’ and applies cow dung” on his body “will be saved.” However, it was also reported that ‘Indian doctors warn against cow dung as Covid cure.’ Similar advice in different forms, even by elected politicians, keeps misguiding many unsuspected members of the public.

Conclusion:

A series of Covid related contemporary needs and apprehensions, besides the traditional ones are surfacing. These are to be mitigated, on an ongoing basis. Pharma players – individually and collectively, instead of being always reactive, may wish to volunteer to proactively address these issues to help people move in the right direction.

As Covid appears to be a medium to long-haul battle – unlike most other pandemics, pharma companies need to think ‘out of the box’ to create innovative – new – and proactive conversation models in this space. In turn, the initiatives will help them win long-term trust and loyalty of customers – that will always remain as invaluable assets, fueling sustainable growth in business.

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.

 

Impact of Covid Vaccines’ Possible IP Waiver In India

Posted on by
Reply

Just when Covid 2.0 rages in India with almost 4,000 people died in just 24 hours, scientists warn that Covid 3.0, and further waves are now ‘inevitable, reported Reuters on May 06, 2021. With hospitals running short of beds and oxygen during the onslaught of Covid 2.0, the World Health Organization (WHO) highlighted, ‘India accounted for nearly half the coronavirus cases reported worldwide last week, and a quarter of the deaths.’

The report revealed some more heartrending details: ‘Many people have died in ambulances and car parks waiting for a bed or oxygen, while morgues and crematoriums struggle to deal with a seemingly unstoppable flow of bodies.’

No visible overall improvements with ‘here and now decisions’ or maybe the lack of it, of the National Covid Management Team, is perceptible, just yet. It’s also a matter of further concern that unlike what happened during Covid 1.0, the second wave of the virus, reportedly, ‘started hitting even young adults hard – leaving countless children to fend for themselves.’

Ironically, alongside a rapid surge in infections, India witnesses a sharp decline in Covid vaccination numbers though more people are eligible. The key reasons being supply chain related problems, despite India being one of the largest vaccine producers, globally. In my last article  published in this blog, I broached on finding a possible exit to this covid 2.0 maze in India. However, this article will explore some unprecedented developments of the last week in this area. To give a perspective, let me start by exploring whether the people responsible for Covid Governance in India, grossly misjudged the situation, claiming the ‘endgame’ of Covid-19, too soon.

‘India announced its triumph over Covid-19 early’:

A third Covid-19 wave is inevitable, but the timing could not be predicted, said India’s principal scientific advisor on May 05, 2021. Intriguingly, less than two months back, the national Government announced its triumph over Covid-19. On March 08, 2021, as Covid vaccination process for senior citizens and people above 45 years with comorbidities had just commenced, the Union Health Minister claimed, ‘India is in the endgame of the novel coronavirus pandemic.’ Just about a couple of months later, it sounded akin to a note of hubris for many, which prevailed, by and large, across the nation.

Acknowledging the same, on May 04, 2021, even Uday Kotak, MD&CEO Kotak Mahindra Bank and President CII commented, ‘India announced triumph over Covid-19 early’. He further urged: “We have to do whatever it takes to save lives first, even as we battle for livelihoods. And if our healthcare capacity is currently going through its challenges, we must be ready to curtail non-essential economic activities.” The latest editorial from ‘The Lancet’ also highlighted the same.

India’s Covid 2.0 – “A self-inflicted national catastrophe” – The Lancet 

Yes. The editorial of the latest – May 08, 2021 issue of The Lancet, also reiterated so. It emphasized, ignoring warnings about the risks of super spreader events, the government allowed congregations of millions of people from across India in religious festivals, along with huge political rallies with utter disregard to Covid appropriate behavior. ‘The message that COVID-19 was essentially over also slowed the start of India’s COVID-19 vaccination campaign, which has vaccinated less than 2% of the population.’ India’s national vaccination plan soon fell apart with the government abruptly expanded vaccination to all 18 years, draining supplies, ‘and creating mass confusion and a market for vaccine doses in which states and hospital systems competed.’

The IHME estimates a staggering 1 million deaths from COVID-19 in India by Aug 01, 2021. ‘If that outcome were to happen, Modi’s Government would be responsible for presiding over a self-inflicted national catastrophe. India squandered its early successes in controlling COVID-19. Until April, the government’s COVID-19 task force had not met in months,’ The Lancet editorial revealed.

Besides, India also misjudged the complexities involved in procurement, distribution and for speedy inoculation of affordable Covid vaccines, at least, to its entire adult population. But, before delving into that area, let me highlight an interesting mismatch.

India’s vaccine shortage when Pfizer logs a record vaccine turnover during pandemic:

Two contrasting scenario surfaces – as the world is reeling under unprecedented disruptions caused by successive waves of Covid-19. Witnessing India’s unparalleled healthcare tragedy in Covid 2.0, the W.H.O director general said: “The situation in India is beyond heartbreaking.” Outlining the reason for the same a separate report commented: A ‘complete collapse’ of preventive health: How India’s 2nd COVID wave exploded.

Concomitantly, one reads news items, which bring out, ‘Pfizer eyes $26B in COVID-19 vaccine sales for the year, with $3.5B already in the bag.’ Notably, most vaccine companies received huge public funding much before Covid vaccines were rolled out. For example, ‘The New York Times’ article of July 22, 2020 came with a headline: ‘Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End.’

The Scientific American also reported on November 18, 2020, ‘For Billion-Dollar COVID Vaccines, Basic Government-Funded Science Laid the Groundwork.’ It added: ‘Much of the pioneering work on mRNA vaccines was done with government money, though drugmakers could walk away with big profits.’ That’s exactly, I reckon, is the reality today.

Similarly, Moderna’s COVID-19 vaccine generated $1.73 billion in revenue during the first quarter, as compared to $3.5 billion of Pfizer’s Covid vaccine in the same quarter. Moderna now predicts its vaccine will generate $19.2 billion by year’s end. Interestingly, through its COVID-19 vaccine partnership with the U.S. government, Moderna also received nearly $1 billion in research aid. The Company is now joining a list of other vaccine players to take a supply order from the federal government.

By the same token, Serum Institute of India (SII) – the contract manufacturer of Covishield, developed and owned by Oxford University and AstraZeneca has also received initial advance funding from the governments, prior to its manufacturing.

Was India’s ‘Vaccine Maitri’ a pragmatic step?

Today, India is one such country facing the brunt of Covid vaccine shortage alongside arriving at an affordable price per dose of the same – a part of which is due to ‘unrealistic’ planning, as many experts believe.

For example, on January 20, the Indian government launched Vaccine Maitri – an ambitious program to export the two Indian-made shots – Covishield and Covaxin – to the world. On that exact date, India counted 14,112 fresh cases of Covid-19. Going by a report of May 01, 2021: ‘According to the government’s own submission before the Parliament, more shots were sent out of the country than administered to Indians as of mid-March.’ Many, therefore, wonder, whether this was a pragmatic decision that helped save lives of Indians during Covid pandemic.

An unprecedented development on vaccine IP waiver:

This is regarding IP waivers for Covid vaccines. In my last article, I wrote about it, stating, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products. It was also widely reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

However, on May 05, 2021, a statement of the U.S. Trade Representative said, ‘as the extraordinary circumstances of the pandemic call for extraordinary measures, in its service of ending this pandemic the US also supports the IP waiver for Covid-19 vaccines, although the US administration supports IP protections generally. As expected, Big Pharma lobby groups, including PhRMA, reportedly, have strongly criticized the move.

Let me hasten to add, there is, at least, one exception in this area. Months ago, on October 8, 2020, Moderna said, ‘it won’t enforce its vaccine patents against other companies during the pandemic.’ Without specifying any names, the Company revealed, ‘other Covid-19 vaccines in development might already be using Moderna-patented technology.

The WTO process is expected to begin now, but how long will it take?

As the Reuters report dated May 06, 2021 indicated – with the U.S. backing a proposed waiver of Covid-19 vaccine IP rights, the next stop is for the World Trade Organization to hammer out a deal – a process that could take months. “At a minimum, it’s going to be a month or two,” said a former Trump White House trade official who previously worked at the U.S. trade mission to the WTO in Geneva. The waiver, if happens, could also be significantly narrower in scope and shorter in duration than the one initially proposed by India and South Africa.

The relevance of IP waiver:

Currently, only drug companies which own patents or their authorized manufacturers like SII can produce Covid vaccines. A global decision on patent waiver may encourage the patentees to share the formula and manufacturing technology, instead of reverse engineering, as is done for off-patent small molecules and some biotech drugs.  All companies with requisite resources may legally manufacture Covid vaccines, in that situation, leading to cheaper, and significantly more quantity of generic versions of Covid vaccines. This may help overcoming vaccine shortages, making the vaccines affordable, as well.

Some counter arguments and response:

As I wrote in my last article, the following three critical questions may arise in that scenario:

  • Will IP waiver help solve the immediate issues of vaccine shortages?
  • Can Covid vaccines be reverse engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • If yes, how long can it take?

The answer to the first question is – it may not help resolve the immediate crisis. But, for a medium to long term solution, there will be an emphatic yes, as Covid-19 fight is expected to be a long-haul one, as experts caution about subsequent waves of rapidly mutating new Coronavirus.

Moreover, Pfizer – BioNTech vaccine took less than a year from ‘mind to market,’ with support from all concerned. This is evident from Pfizer’s Press Release for the launch of Covid vaccine in the United States last year, on December 11, 2020. Thus, an efficient reverse engineering may also take that much time to respond to medium and long-term issues with Covid vaccines, especially in India.

Subsequent Covid-19 waves could be triggered by unpredictable compliance to Covid appropriate behavior of people. W.H.O has also warned: “When personal protective measures are being relaxed, when there are mass gatherings, when there are more contagious variants and the vaccination coverage is still low this can create a perfect storm in any country,”

Conclusion:

‘The pandemic is not a competition between companies and will not end without more-equal distribution of coronavirus vaccines,’ wrote Nature on March 30, 2021. It suggested: ‘It’s time to consider a patent reprieve for COVID vaccines.’

The world needs around 11 billion doses of Coronavirus vaccines to immunize 70% of the global population – assuming two doses per person. Interestingly, around 6 billion doses are meant for high- and upper-middle-income countries, against advance orders. Poorer nations, accounting for 80% of the global population, so far, have access to less than one-third of the available vaccines. ‘Unless manufacturing and supply can be distributed more evenly, researchers forecast that it will be at least another two years before a significant proportion of people in the lowest-income countries are vaccinated’, the paper concluded.

In this situation, I reckon, a temporary IP waiver would help in accelerating the end of the pandemic. It may not help immediately, but certainly in the foreseeable future, as discussed above. It may also call for an efficient and well thought out ‘Hub and Spoke’ distribution model. Simultaneously, of course, similar systems for raw and ancillary materials for vaccine production need to put in place to avoid intermittent shortages. 

As reported on May 08, 2021, India registered a record 4,187 Covid death with 4.01 Lakh new cases, in 24 hours. Capturing the depth of the Indian crisis, ‘India Today’ is coming out with a cover page article in its May 17 issue, with the headline – ‘Covid 2.0 – The Failed State.’ Another article terms India as the ‘Flailing state in Covid storm.’

As I reasoned above, if this unprecedented step of IP waiver for Covid vaccines is finally taken by the WTO, it will significantly help India – along with the world – may not be immediately, but certainly in the foreseeable future. Only adverse impact that the decision could possibly make, is curbing Big Pharma’s unprecedented profit on Covid vaccines, and that too, during a deadly global pandemic.

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.

 

Covid Prompts Pharma To Move Away From Competition Driven Business Model

Posted on by
Reply

As deliberated in my just previous article in this blog, Covid has been a watershed in several areas of pharma business. One such key area is its competition driven strategic business model. It aims to deliver significant value for a longer time than the competition, protected by a patent thicket driven TINA factor – and only for those who can afford such patented drugs. It didn’t matter, if a vast majority of patients are denied access to these medicines, with a dangerous pricing trend acting as an insurmountable barrier. Flying solo has been the motto of most players in this ball game, to delight the stock markets.

Interestingly, Covid pandemic seems to be changing this model. Pharma industry, by and large, is now trying to demonstrate its core value for the society – moving away from displaying competition driven one-upmanship. In this article, I shall deliberate on this area.

Covid poses both – a humongous challenge and a great opportunity:

As the article, published in the MIT Sloan Management Review on April 16, 2020 highlights: ‘The COVID-19 pandemic may well prove to be the biggest challenge for humankind since World War II.’ The same holds good for the pharma industry, as well. The drug companies are now expected by all, to play a pivotal role in the fight against the pandemic ‘that is bringing health care systems to their knees and sending shock waves through economies across the globe.’

This is generally because, pharma industry possesses wherewithal to develop effective drugs and vaccines to combat this health crisis – if not alone, but certainly collectively. It also offers a great opportunity for pharma to ‘walk the talk,’ by demonstrating upfront that meeting all patients’ unmet needs lie at the core of the pharma business. As I quoted a global CEO in one of my articles articulating, this crisis also comes as ‘a Shot at Redemption in Pharma Industry.’

Thus, if the industry reacts quickly and responsibly, it may have the chance to also redeem a reputation that’s been tarnished for years. Some of these instances are, illegal marketing practices, corruption scandals, and obscene pricing of vital drugs, the MIT Sloan article underscored. Flying solo in this situation may not be just enough, if not foolhardy.

Flying solo in this situation may not be enough:

Taking this initiative won’t be a piece of cake, either, if pharma companies prefer to do it alone during this unprecedented health crisis.  The drug players will need to be willing and able to successfully collaborate with other players in the race to develop treatments and vaccines. Otherwise, their legitimacy will be fundamentally questioned, especially when the entire world is running against time.

The rationale of two top drug companies entering into collaborative arrangements is obvious – the realization that pooling of all resources together is the best way of delivering effective Covid related solutions to the society at the shortest possible time. The good news is, pharma has already taken the first step in this direction, even when some of them are competitors, in several areas – moving away from their competition driven business models, as of now.

Once strange bedfellows – now partners:

The article published in the Bloomberg Law on June 05, 2020 very aptly observed: ‘The race to address the pandemic has brought together strange bedfellows as big-name companies’ partner with their rivals.’ The Scientist also wrote on July 13, 2020: ‘The urgent need for tests and therapeutics has brought companies together and pushed researchers to work at breakneck speeds.’

One can find this happening on the  ground now, as some major pharma and biotech companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share resources and expertise to try to accelerate the development of effective therapies and vaccines for COVID-19. Besides, Roche Holding AG and Gilead Sciences Inc. have teamed up on trials for a drug combination to treat Covid-19.

There are several instances of such collaboration also in the Covid vaccine area. For example, GlaxoSmithKline plc struck a deal with Sanofi to produce 1 billion doses of a coronavirus vaccine booster. Besides, Pfizer from the US and BioNTech from Germany are joining hands to co-develop and distribute a potential Coronavirus vaccine, aimed at preventing COVID-19 infection.

It’s a reality today that Covid-19 has brought not just the strange bedfellows within pharma and biotech companies together. Academia and governments have also moved on to the same collaborative platforms, to save people from a deadly and super contagious infection, in the shortest possible time. We have witnessed this

in India, as well. For example, the Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited have also announced a collaboration to develop vaccines to protect against SARS-CoV-2 or COVID-19.

The rationale and some possible issues: 

Each of these players is bringing some expertise and intellectual property to the table. “As they work together, they’re going to create more, so you have the ‘yours,’ the ‘mine,’ and the ‘ours’ of collaboration,” as the Bloomberg Law points out. That said, any collaboration of such nature and scale will have its own share of legal issues, such as, patents, trademarks, trade secrets, revenue sharing models, and more.

The collaborators, in pursuit of saving mankind from Covid-19, are expected to find enough alternatives to resolve these glitches for a win-win outcome – not just for now, but much beyond – with the dawn of a new collaborative model. The rapid general acceptance of this collaborative model by more and more drug companies to meet unmet medical needs in many other areas – much faster, in all probability, will delight the health care consumers and also be appropriately rewarded.

Leveraging the collaborative business model beyond pandemic:

E that as it may, it still remains an open question to many, whether such collaborative model will be leveraged for an accelerated rate of drug, vaccine and diagnostics development beyond the pandemic.

The good news is, as The Scientist article reported, some pharma players are seriously pondering how to continue working in this new way – with the same sense of urgency and purpose, for other disease areas too. They believe, the lessons being learned with the collaborative models, may help expedite development of therapeutics in other serious conditions, such as, Alzheimer’s, intractable cancers and autoimmune diseases.

If and when it happens as a predominant business model, suffering patients and the society, in general, would lap it up and the innovators would be suitably rewarded. However, the paper also says, there are still some drug companies who prefer to continue working in a more insular fashion, as was happening in the old normal. But, experts also feel, that should not cause any worry, as long as majority prefers to continue following the collaborative models, in the new normal, as well.

Pharma would make a good profit from collaborative business models too:

For those who say that drug companies won’t make good profit from Covid drugs and vaccines, Pfizer CEO has an answer. Albert Bourla, Pfizer’s CEO, reportedly, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. This article highlights, at $19.50 per dose, the 1.3 billion doses of Pfizer BioNTech Covid vaccine that the Pfizer plans to make by the end of next year, could translate to nearly $13 billion in sales, after the company splits its revenue with its partner BioNTech. It is roughly the same as Pfizer’s all-time best-selling drug Lipitor sold in its best year.

Adding to it, another article on the same issue, published by Fierce Pharma on August 13, 2020, further reinforced the above expectation. It wrote, the longtime Evercore ISI pharma analyst haspredicted the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. It assumed frontrunner Moderna would supply about 40 percent of the market, Novavax would take 20 percent and the other vaccine developers would split the rest. “One could look at the field under this base scenario and conclude it is reasonably valued in total,” the analyst concluded.

Nonetheless, there could still be several points that remained unanswered in this analysis. But the bottom line is, the collaborative model is not just profitable, it starts generating profit earlier and faster – virtually eliminating the cost of possible delays when a company flies solo.

Conclusion:

With a seemingly flattening curve, the Covid pandemic still continues, alarmingly. As of October 25, 2020 morning, India recorded a staggering figure of 7,864,811 of Coronavirus cases with 118,567 deaths.

With this backdrop, COVID-19 has provided the pharma industry a new opportunity to demonstrate its true value to the society – not the self-serving ones. It’s now clear that no one can rule out, there won’t be a similar unprecedented health catastrophe in the future too. It may come in various different forms, or may even be from a rapid and complex mutation of the same lethal virus.

Moreover, such crisis may not come and go in just a few months – may even linger for a long time. In any case, these may again be equally disruptive – or even more disruptive to lives, livelihoods and the economic growth engine. In such a scenario, putting the brightest scientific brains of the world together will be critical, and adding top speed to the process being the essence to come out of the crisis with least possible damages.

Covid pandemic has also demonstrated that the competition-based model of the drug could be a serious retarding force in that endeavor. What will matter, is a well-structured collaborative model that can create a win-win situation – both for patients and the business. I reckon, it’s about time to move into this model to find most effective drugs and treatment solutions for many other unmet needs related to a host of intractable diseases, much sooner.

There could, of course, be some business issues with this model. But those can be resolved amicably for an all-weather greater success in business, along with protecting the society – for all. From this overall perspective, it appears, Covid pandemic now sends a strong signal to pharma companies to move away from predominantly competition driven business models, expanding more into collaborative ones.

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.

 

Setting A Cost Of Time That Patients May Gain From A New Therapy

Posted on by
Reply

Since quite some, an intense ongoing debate about setting a cost of time, often by a few months, that patients could possibly gain from a new therapy for complex diseases. The answer still remains elusive.  Meanwhile, newer therapies for treating cancer, such as, Kymriah, priced at US$ 475,000, alongside several rare diseases, hit the market with jaw-dropping prices. The latest being - Zolgensma of Novartis, carrying a price tag of US$ 2.12 million – the most expensive treatment ever. This trend assumes greater significance as Bio – claimed as the world’s largest trade association representing biotechnology companies, and related organizations, across the United States and in more than 30 other nations, also makes some interesting points in this area.

This article will dwell on the relevance of this important issue, both in today’s and also in the future perspective. It will try to explore, why pharma and biotech companies are not keen to use a ‘transparent multi-factorial life-value calculator’, especially for prolonging life or curing an incurable disease, with a high-priced novel therapy.

Emotional ads to justify the trend, against tough practical questions: 

A part of a sleek looking advertisement from Bio, depicting the power of new therapies to prolong life, carries a headline – ‘Time. The Currency of Life,” followed by three emotive lines and two equally emotive questions: “Another decade with a spouse. A few more years with your best friend. A rich, fuller life rather than one cut short. How do we place value on these?” It then asks: “What is more precious? What is more priceless?”

Turning this emotive question on its head to a rational one, an article published in the Stat News on February 25, 2016 questioned: “How much is an extra month of life worth?” It asked the drug makers to calculate the same. The same article also quoted a Yale University economist and practicing radiologist asking: “It’s all well and good to just say life is priceless, but the reality is we are paying for it.”

Emotive ads try to justify funding towards innovation for such drugs:

The same advertisement, as above, while trying to indirectly justify such exorbitant drug costs, used yet another emotive note in its playbook. It emphasized: “By continuing to fund the innovation pipeline that has served us so well, we will be able to reduce the costs associated with modern-day health care.”

Such claims are being scientifically challenged – head on, by many important studies. To illustrate this point, I shall quote the following two, both were published in the JAMA Network. The first one in the JAMA Otolaryngology-Head & Neck Surgery and the next one in JAMA Oncology.

The first article is the ‘John Conley Lecture’, carrying a title, ‘Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity,’ appeared on December 2014. On innovative drugs of such genre, the paper concluded: “The use of expensive therapies with marginal benefits for their approved indications and for unproven indications is contributing to the rising cost of cancer care. We believe that expensive therapies are stifling progress, by:

  • Encouraging enormous expenditures of time, money, and resources on marginal therapeutic indications and
  • Promoting a me-too mentality that is stifling innovation and creativity.

The second article is an ‘original investigation, titled ‘Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated with New Cancer Medicines.’ It also underscored: ‘Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.’

Here again, the emotional appeal is being made by creating a ‘perfect World’ scenario. Whereas, scientific analysis of the innovative and high-priced drugs, reveals the reality for other stakeholders to take note of. Different pharma trade associations, although being a part of the same orchestrated effort, try differently to take the eyes off the humongous prices of new life-saving drugs. But many continue to believe that new cancer drug prices have long gone beyond control.

90 percent Biopharma companies do not earn a profit – A bizarre claim?

As is well-known, besides justifying high drug prices by highlighting ‘high R&D cost,’ drug manufacturers often say, as the Bio ad campaign makes an eyebrow raising claim – “Of the approximately 1,200 Biopharma companies in the United States, more than 90 percent do not earn a profit.”

Citing the example of the US market where drug prices are very high, it justifies, the general focus on list prices of the drugs is misplaced. This is because, the ‘manufacturers provide billions of dollars in rebates and discounts on their innovative therapies annually, to federal, state and private payors, in addition to offering direct assistance through patient assistance programs.’ It further added, these discounts vary but can result into a significant total of as much as 50 percent or greater depending on the program.

Experts have challenged even this claim that the list prices do matter, even in the US, for many, including uninsured population and those with co-payment arrangement, which are not based on the discounted prices. Leaving aside America, what happens in those countries, such as India, where out-of-pocket expenses on health care are considered the highest in the world?

With new cancer drug prices going beyond control, the price of postponing death is growing:

That the new cancer drug prices have long gone beyond control, isn’t a new realization. A research paper, published in the Journal of Clinical Oncology on May 06, 2013, also noted emphatically: ‘Allowing the producer-dominated market to set drug prices has spiraled the cost of cancer drugs out of control.’  So did another 2015 study, published in the Journal of Economic Perspective.

According to various studies, such as the one published in the JAMA Otolaryngology-Head & Neck Surgery, as quoted above, also found after studying over 70 of such new drugs that the median improvement in survival was around 2.1months. Some other reports indicated this number to be around 3.5 months on an average.

Interestingly, the 2015 study, published in the Journal of Economic Perspective found that ‘the price of postponing death is growing. In 2013, one extra year of life for cancer patients costs US$ 207,000, on average, nearly quadruple what it did in 1995.

Is it quality of life over the quantity of life, or vice versa?

The above findings may lead one to the critical question – what type of treatment choice would create the most desirable net impact on individual cancer patients? This evaluation should include all the three parameters – the extent of prolongation of the ‘Length of Life (LoL)’, the ‘Quality of Life (QoL)’ the patients experience during this period – and the additional drug cost that needs to be incurred.

It should ideally be up to patients whether they will choose quality over quantity of life or vice versa. To facilitate this process, an informed briefing by the doctor on the most likely scenario, vis-à-vis other available treatment alternatives, is expected to help individual cancer patient exercise the best affordable individual option.

This point was scientifically addressed in a research article - ‘Quality of life versus length of life considerations in cancer patients: A systematic literature review,’ published in the Journal of Psycho-Oncology on May 15, 2019. The study noted, ‘Patients with cancer face difficult decisions regarding treatment and also the possibility of trading the Quality of Life (QoL) for Length of Life (LoL).’ Little information is available on patients’ preferences in this regard, including ‘the personal costs they are prepared to exchange to extend their life.’

Another related question that also remains equally elusive, is the relationship between the cost of a medication and the amount of quality-time that it offers to patients. Quantifiable assessment of such nature could bring more transparency in drug pricing, especially for those that help treat life-threatening ailments, such as cancer.

Similar questions are raised on pricey therapy for rare diseases:

The cost of drugs for rare diseases is threatening the health care system – articulated an article, published in the Harvard Business Review (HBR) on April 07, 2017. The paper stated, in December 2016, US-FDA announced the market approval of nusinersen (sold as “Spinraza”), an effective Spinal Muscular Atrophy (SMA) treatment licensed to Biogen by Ionis Pharmaceuticals. SMA is considered the most common genetic cause of infant mortality.

As the author penned, “Patients and providers greeted the approval with near ecstasy, but the celebration was bittersweet. Five days after the FDA approved, the drug, Biogen announced each dose would cost US$ 125,000. Given that patients need six doses in the first year and three per year after that, it means the drug costs US$ 750,000 per patient in the first year and US$ 375,000 annually thereafter.”

A desperate father’s reaction for the price – and the economics behind it:

The HBR article captured the reaction of the father of an infant on this price, who is desperate to save the baby – in the following words – “Then there’s Will’s heartbreaking reaction, which I’m sure echoes the sentiments of many touched by SMA. – “The Biogen announcement of the cost of nusinersen floored me in every way possible,” he says. “Words cannot describe the sickening feeling I get when I think about it.” If this could be a father’s reaction in America, one can well imagine what happens in a similar situation to people in the developing world.

At that time, Zolgensma of Novartis, wearing a price tag of US$ 2.12 million for treatment of the same disease, was also shaping up for market launch. On this drug, the author of this HBR article who also happened to be a professor, vice chair of research, and chief of the Division of Neuromuscular Medicine at the University of Utah School of Medicine, wrote: “A very promising gene therapy for SMA is on the horizon, which would require only one dose and potentially render nusinersen obsolete. Did such mercenary economics influence Biogen’s pricing decision? We may never know; drug companies are not required to justify their prices.” On the contrary, as many believe, the concerned global CEOs, reportedly, get a hefty financial reward, for the same.

Conclusion:

It is not difficult to understand either, that some drugs, especially for rare diseases, will be used for treating a smaller number of patients. Hence, the optimal economies of scale in manufacturing can’t be attained. At the same time, the cost of R&D of the therapy needs to be recouped along with a reasonable profit, for investment towards future drugs. This is in addition to market exclusivity the drug will enjoy through patent thicket.

Nevertheless, despite the existence of several methods of a human life value calculation, such as in the insurance industry the use of a transparent and drug industry specific, multi-factorial live-value calculator is still not in vogue. As the drug industry often highlights, the ‘value of human life is priceless’ – regardless of the costs of drugs. In this situation, many industry experts, academics and patient groups advocate that the ongoing uncontrolled pricing mechanism for such medicines should be brought under a leash. This could come in the form of a tough price negotiation’ before the drug marketing approval, as was promised by the Government, or putting in place a stringent price regulatory system.

Be that as it may, the bottom line is to understand and find an answer to: ‘Why Does Medicine Cost So Much?’ This issue was analyzed by the Time Magazine in its April 09, 2019 edition. Quoting Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, it emphasized: It all starts with the manufacturers. There are essentially no regulations governing how new drugs are priced – drug companies select a price what they “believe the market will bear.” Blockbuster first-in-class treatments, therefore, command a stratospheric price, like what happened with Gilead’s hepatitis medication – Sovaldi, way back in 2013. It was priced at US$ 1,000 a pill, or US $84,000 for the full course of treatment. From this perspective, although, setting a cost of time that patients may gain from a new therapy has a moral and ethical relevance – but actually, it doesn’t seem to be business-friendly in the drug industry.

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.