Tag Archives: University

Post Covid-19 Lockdown: Is Pharma Industry Ready?

Posted on by
Reply

It’s over a month now since national lockdown in India came into force to win the war against Covid-19. Many promises and apprehensions about whether or not Covid-19 will keep ravaging human life, continue surfacing. As it appears today, whatever best happens post May 03, 2020, the Coronavirus outbreak is going to change the way we live and the businesses used to operate, in many respects, till an effective vaccine comes, at the very least. This change also includes the health care, in general, and the pharmaceutical industry, in particular.

It is obvious now that Covid-19 will stalk the planet for a long time to come. On April 22, 2020, the World Health Organization (WHO) also reiterated: ‘Make no mistake, Coronavirus will be with us for a long time.’ This vindicates many apprehensions against an early promise of winning the Covid19 war decisively in 21-days or even by May 03, 2020, or whenever the national lockdown is phased-out in a calibrated manner. Further, W.H.O has also cautioned: “Most countries are still in the early stages of their epidemics. And some that were affected early in the pandemic are now starting to see a resurgence in cases.”

As on April 26, 2020, the recorded Coronavirus cases in India has sharply climbed to 26,496 and 825 deaths, with the Union Health Ministry saying on April 23, 2020: ‘Doubling rate of Covid-19 cases in country is now 10 days.’ Whereas, on the same day, Indian Council of Medical Research (ICMR) also said, ‘for now, it is very difficult to tell when a peak state of COVID-19 pandemic in the country will arrive.’

The life-changing disruptions that Covid19 has caused, and may continue to cause in the near future, has apparently made a significant impact, also on how the healthcare consumers think about the available disease treatment solutions, including buying medicines. Thus, in this article, I shall, focus on this area.

Why winning the Covid-19 war can’t be immediate: 

Covid-19 pandemic brought the drug industry under a sharp focus of the entire world, with an expectation to win the war against this deadly and invisible virus. This solution could be anything – an effective prevention, such as, with a vaccine, or a curing the infection with a drug, or even a mechanism that is able to make the virus less contagious. There are still no scientifically proven and approved drugs or vaccines for Covid-19. Although, many trial and error experiments are in progress, mainly based on anecdotes and gut-feeling, for the respiratory disease caused by Coronavirus.

The good news is, since January 2020, after scientists in China provided the virus’s genetic sequence, over 40 teams of global drug companies and the academia, are working on a vaccine and drugs for Covid-19. As of now, six Coronavirus vaccines are on clinical trial. Last Thursday, human safety trial of Oxford University developed Covid-19 vaccine, with the first two of 800 healthy volunteers, has commenced. Meanwhile, Serum Institute of India (SII) has tied-up with the Oxford University to manufacture the vaccine in India, if the trial succeeds.

Some bad news in this area also came by, such as, ‘remdesivir’ – the well-hyped drug, thought to be one of the best prospects for treating Covid-19, failed to have any effect during the first full trial. However, Gilead – the drug company developing this product has said, ‘the findings were inconclusive because the study was terminated early.’

The bottom-line is, although, first tests for more new vaccines may commence within a few months, the final regulatory approval of these will take much longer - at least 18 months, i.e. not before 2022, according to W.H.O. Meanwhile, some disruptive changes within current health care delivery systems, involving both behavior and transaction practices of key stakeholders, may prompt equally disruptive changes in the Indian health care delivery mechanisms. These changes are likely to have unforeseen impact on several pharma operations, critical for business excellence in the drug industry.

Commonly followed procedures for the Indian healthcare system:

The procedures that most health care consumers currently follow for healthcare in India, require patients to be physically present in most touchpoints of a disease treatment process. These include, doctors, chemist shops, hospitals, diagnostic clinics, among others. During the national lockdown period, redressal of non-Covid-19 related common health issues, has been a great challenge for many people, such as:

  • visiting a doctor
  • going to a hospital outdoor
  • procurement of medicines from retail shops for chronic conditions
  • visiting a diagnostic clinic even for follow-up – previously advised by a doctor

This happened primarily due to the need of compliance of social distancing and mostly out of fear of getting the Covid-19 infection. Fortunately, the available digital platforms to address the pressing common health issues, proved to be of immense help to many.

Pharma business has also been greatly impacted: 

Driven by initial panic buying of regular medicines by the people, for the lockdown period and may be beyond, monthly sales of pharma might show a spurt. But, that is unlikely to be the real picture for a medium to long term. Otherwise, like many other industry sectors, pharma business has also been greatly impacted by the Covid-19 outbreak, across its various domains – right from planned R&D – through manufacturing, sales and marketing – to supply chain.

The early adopters to the new normal will be the outright winners:

For example, meeting a doctor for product detailing following the conventional chain of activities, and simultaneously maintaining strict ‘personal distancing’ or ‘social distancing norms, may not be the same again. The changes required by the pharma companies to make this process effective and productive, may also be disruptive in nature.

No-one can accurately predict toady, how exactly the important business operations can be resumed, ensuring full health-safety for all and with compromising on the effectiveness and productivity of business. Nevertheless, one thing for sure, lockdown during Covid-19 pandemic has brought the possibility and the opportunity of going digital to the fore, for both – the healthcare business and also its consumers, including various other stakeholders. The early adopters to the new normal are expected to be the outright winners.

Green shoots of digitalization within healthcare consumers and providers: 

As digital transformation at health care consumers and providers level, gain a critical mass, the healthcare business would require to be not just digitalized, but also digitally innovative. The situation would demand from them to be much more ‘customer centric’ on digital platforms, as the locked down – homebound health care consumers, complying with ‘social distancing’ norms, get increasingly more digitally empowered.

Bain & Company in its March 20 ‘Brief’, titled ‘How the Coronavirus Will Transform Healthcare in China,’ discussed some of these issues from China perspective, which are already visible there. To illustrate this point in this deliberation from the Indian perspective, let me draw examples from the country’s health care consumers’ standpoint.

Is the traditional health care system slowly undergoing a metamorphosis?

The overall impact of Covid-19 outbreak in India has made visiting general practitioner’s (GP) clinics, pathological labs or even hospital emergency facilities, a tough challenge for many patients. This is primarily out of fear of getting a Coronavirus infection from others during the process, with strict compliance to ‘social distancing’ becoming a top priority for many. Consequently, traditional healthcare related activities in India, is likely to undergo an early metamorphosis.

Being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, for common illnesses or follow-up consultations, such as:

  • for medical consultation on digital platforms, e.g., Skype, Facetime etc.
  • getting diagnostic tests done at home by requesting through digital apps,
  • sending test reports to doctors digitally,
  • getting doctors prescription through digital mode,
  • ordering medicines through e-pharmacy apps by uploading prescriptions,
  • getting medicines delivered at home after e-payment,
  • repeating the same process whenever required.

An upside of the situation: 

The upside of the situation is, these patients are feeling more digitally empowered and self-reliant to get non-too-serious ailments addressed against all odds. Some of these practices, such as, online consultation with doctors, getting most of the medical tests done at home, buying medicines through e-pharmacies, I reckon, may continue even after calibrated withdrawal of the national lockdown in India.  The net impact of all could trigger a meaningful attitudinal change in patients, especially towards health care delivery processes, in general.

The healthcare industry is ready to log on to this digital mode? 

Many early adopters in the global pharma industry, are going for digitalization within various functional domains of the company, at a varying scale. This has started happening in India, as well. However, as social distancing becomes the new normal in the foreseeable future, how prepared are the pharma companies to adopt themselves with the increasing number of digitally empowered consumers, is still unclear. More importantly, how will the industry meet new demands at various points of transaction and interaction with various critical stakeholders, such as, doctors, in the post Covid-19 eraof social distancing, ensuring health safety of all?

Another requirement that should form the bedrock of the grand integrated corporate strategy of a customer-centric pharma business, necessarily, in the changing times. This is – all decisions in this area must be based on a huge pool of contemporary data, analyzed by sophisticated data analytics and thereafter, the strategic and tactical pathways need to be charted, desirably, through skillful application of Artificial Intelligence (AI), because of evolving complex and multi-dimensional health care needs of the consumers.

Alongside, telemedicine in different new formats – even for GP level consultations, besides, drug procurement through e-payment from approved e-pharmacies by uploading doctor prescriptions, signal a great potential in the years ahead. This appears to be very close to reality, especially, going by the W.H.O prediction for a long-haul Covid-19 battle, where compliance with ‘social distancing,’ is one of the basic requirements of health safety for all.

Conclusion:

‘Month of lockdown impedes virus – a long battle lies ahead’. As the former President of the Unites States twitted on April 25, 2020, ‘If we want life to approach anything like normal anytime soon, we need a comprehensive testing program. It’s not going to be cheap, but it will ultimately pay off many times over in saved lives, saved businesses, and saved jobs.’

In any case the crux of the matter is, Covid-19 is not going to vanish soon, even after scaling down of the lockdown in a calibrated way. Moreover, the fear, if not the panic of a large population in India and around the world, on the possibility of getting infected by Covid-19, will continue – till one does not get vaccinated or acquire ‘herd immunity’ in a different way. Meanwhile, related behavioral changes and habits, of a large number of people, including health care consumers, will continue taking place.

From this perspective, besides the existing ones, once the lockdown-period-converted ‘e-consumers’ of health care get used to the new digital mode of availing healthcare services against e-payments, it could have a snowballing impact on many others. That will help usher in a new paradigm of medical consultation, follow-up interaction, disease diagnosis, drug procurement and all related transactions, through digital platforms.

Having experienced the convenience and user-friendliness of the digital mode, during an extended period of social or physical distancing and other new normal, instead of time-consuming legwork, it seems unlikely that the majority will try to go back to the traditional mode of pre-Covid 19 era. In that situation pharma companies will have no option but to necessarily re-engineer the business operations, bringing disruptive digitalization at the center of any strategy formulation related to mainly patients and doctors, besides others.

Covid-19 prompted lockdown and the post lockdown period, I reckon, is unlikely to be a ‘switch-off’ and ‘switch-on’ type of a situation for anyone or any industry, as threat of getting Coronavirus infected will continue for quite some time. The need of the hour for pharma players in India, therefore, is gaining deep insight, through continuous data capturing and analysis, on each component of the changing market dynamics – prompted by Coronavirus pandemic. The point to ponder, therefore, is pharma industry getting ready for a possible disruptive change in the future environment?

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.

‘The Memory Thief’ Still Eludes Grasp Of Pharma R&D

Posted on by
Reply

Over several decades, in fact, since its very inception, pharma R&D has been playing a crucial role in alleviating diseases of various types – from severe acute infections, to a large variety of non-infectious chronic illnesses, including many dreaded diseases, such as, cancer.

In the battle against diseases, pharma research and development initiatives, both by a large number of academia and also the pharma players, have mostly won, decisively. R&D has been consistently coming out with flying colors, both in finding cures and also in effective disease management, to prolong and improve the quality of life of billions of people, the world over.

However, there is still an important disease area, where pharma R&D has not been successful yet. Without any prior warning, this disease stealthily affects the human brain and completely erases the entire lifetime memory of the person, gradually but surely, over a relatively short period of time. This disease is known as Alzheimer’s, following the name of Dr.  Dr. Alois Alzheimer, who first detected it in 1906. Due to its devastating impact on human memory, some, very appropriately, term the Alzheimer’s disease – ‘The memory thief’.

I discussed this subject in one of my previous articles titled, “It Took 90 Years To Accept The Dreaded Disease Discovered In A Mental Asylum”, published in this Blog on December 01, 2014.

A recent alarm for a future epidemic:

A January 6, 2016 paper titled, “Sounding the alarm on a future epidemic: Alzheimer’s disease”, published by the well reputed public research university in the United States, ‘The University of California, Los Angeles (UCLA), made the following noteworthy observation:

“If the aging trend illustrates the success of public health strategies, it also raises the specter of a major public health crisis – a sharp rise in the number of people living with Alzheimer’s disease.”

Causing havoc in many lives and families:

‘Alzheimer’s Disease Education and Referral (ADEAR) Center’ of the United States, currently ranked Alzheimer’s disease as the sixth leading cause of death in the United States, but recent estimates indicate that the disorder may rank third, just behind heart disease and cancer, as a cause of death for older people.

According to Mayo Clinic, the frightful disease – Alzheimer’s, is progressive in nature. At the onset, the afflicted persons may exhibit just mild confusion and some difficulty in remembering.

Tragically, in around five years or a little after, Alzheimer’s would erase the entire lifetime memory of most of the affected persons, when they may even forget the important people in their lives and undergo dramatic personality changes.

The dreaded disease – Alzheimer’s, still without any effective medication in place, has been causing havocs in many lives and families since long, involving many great international personalities too. It is one of those ailments, where the disease process mostly commences almost a decade before the visible appearance of above clinical symptoms.

Worldwide Projections of Alzheimer’s Disease Prevalence:  

The above UCLA report highlights the worldwide projections of Alzheimer’s disease prevalence from 2005 to 2050, which includes both the early and late stage patients.

According to this report, the number of people afflicted by this total memory-erasing disease, would grow from 35.26 million in 2015 to as high as 106.23 million populations in 2050, as follows:

Year Alzheimer’s disease prevalence (in Millions)
2005 25.73
2010 30.12
2015 35.26
2020 41.27
2025 56.55
2040 77.49
2050 106.23 
Similar situation in India: 

The situation in India seems to be no different, though we are living today in the midst of the hype of ‘Demographic Dividend’.

According to the March 2012 report of ‘The Population Reference Bureau’ of Washington DC of the United States, India’s population with ages 60 and older, who are more prone to Alzheimer’s disease, is projected to increase dramatically over the next four decades, from 8 percent in 2010 to 19 percent in 2050. By mid-century, this age group is expected to encompass 323 million people, a number greater than the total US population in 2012.

Currently available treatment:

At present, there are no treatments available that can stop or slow down the progression of Alzheimer’s disease in the brain of the affected persons.

As I wrote earlier, very often the onset of this disease starts decades before the visible manifestation of even preliminary symptoms. Thus, there is a critical need for early medical interventions to arrest the disease progression.

Again, quoting Mayo Clinic, current Alzheimer’s disease medications and management strategies may at best temporarily improve symptoms. These symptomatic treatments can sometimes, help Alzheimer’s patients maximize cognitive and other related functions to the extent possible, and thereby maintain independence for a little while longer.

Primary reasons:

Many earlier research had postulated that plaques and tangles are primarily responsible for the permanent damage and destruction of nerve cells.

While the plaques are abnormal clusters of beta-amyloid protein fragments between nerve cells, tangles are twisted fibers made primarily of a protein called “tau” that accumulates in the brain cells, damaging and killing them.

The appearance of these two in the brain structure makes the affected persons suffer from almost irreversible memory loss, altered thinking pattern and associated behavioral changes, which are usually serious in nature.

However, I shall discuss below about a very recent research that is focusing on a different and novel target.

Key hurdles in Alzheimer’s drug development:

Despite all these, almost at a regular interval, we have been getting to know about various new studies on Alzheimer’s disease, mostly from academic and scientific institutions. It clearly vindicates, at least, the global academia and also some pharma players, are working hard to get an effective key to unlock the pathway of Alzheimer’s disease process.

The hurdles in developing a suitable drug for effective treatment of Alzheimer’s disease are many. A paper titled, “Researching Alzheimer’s Medicines: Setbacks and Stepping Stones Summer 2015”, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) – a trade association of leading biopharmaceutical researchers and biotechnology companies of the United States, cited the following three major reasons as examples:

  • Scientists still do not understand the underlying causes and mechanisms of the disease. It remains unknown whether many of the defining molecular characteristics of the disease are causes, effects, or signs of progression. This scientific knowledge gap makes the identification and selection of viable targets for new medicines difficult. 
  • Current preclinical models of Alzheimer’s disease are limited in the extent to which they can be extrapolated or translated to the human condition. Better models are needed to facilitate preclinical testing of drug candidates and better predict the effects of the drug in humans. 
  • The absence of validated, non-invasive biomarkers to identify disease presence and progression means the diagnosis is delayed until an individual becomes symptomatic. This makes it particularly challenging to evaluate, enroll, retain, and follow up with patients in clinical studies. It also makes it challenging to assess the effects of the drug candidate. Ultimately, this leads to long and very expensive clinical trials. 

The PhRMA publication also states that “researchers believe that no single medicine will be able to defeat Alzheimer’s; rather, several medicines will probably be needed to combat the disease. Thus, researchers need not one, but an array of options to prevent or treat Alzheimer’s disease.”

High rate of R&D failure, with flickers of success:

The above PhRMA publication also indicates, between 1998 and 2014, 123 medicines in clinical development have been halted and have not received regulatory approval.

In this rather gloomy R&D scenario, there are also some flickers of success in this pursuit.

In a recent study, the scientists at the University of Southampton announced that their findings added weight to evidence that inflammation in the brain is what drives the disease. A drug, used to block the production of these microglia cells in the brains of mice, had a positive effect. The study, therefore, concluded that blocking the production of new immune cells in the brain could reduce memory problems seen in Alzheimer’s disease. This finding is expected to pave the way for a new line of treatment for Alzheimer’s disease.

Currently, most drugs used for the treatment of dementia targeted amyloid plaques in the brain, which are considered as a key characteristic of people with the Alzheimer’s disease. According to an article published in Forbes on March 20, 2015, several amyloid-clearing drugs have failed to show statistically significant benefits in large clinical trials. Notable among those are Bapineuzumab – developed by Elan Pharmaceuticals, Pfizer and Johnson & Johnson failed in 2009; Solanezumab of Eli Lilly failed in 2012; and so did Gantenerumab of Roche in 2014.

The latest study, as quoted above, published in the journal ‘Brain’, on January 8, 2016 suggests that targeting inflammation in the brain, caused by a build-up of immune cells called microglia, could halt progression of the disease.

Another flicker of hope is, another drug being developed by Biogen Idec for the treatment of Alzheimer’s disease appeared to slow down the inexorable cognitive decline of patients’, though in a small and a preliminary study.

Lack of research funding is a critical impediment:

Be that as it may, many experts believe that not enough is still being done in Alzheimer’s research, especially in the area of funding.

In an article titled, “Alzheimer’s disease: are we close to finding a cure?” published by ‘Medical News Today (MNT)’ on August 20, 2014, quoted the Alzheimer’s Society, as follows:

“Dementia is the biggest health and social care challenge of our generation, but research into the condition has been hugely underfunded. This lack of funding has hampered progress and also restricted the number of scientists and clinicians working in the dementia field.”

As an illustration, MNT mentioned that in the United States Alzheimer’s research received US$504 million in funding from the National Institutes of Health (NIH) in 2014, while cancer received more than US$5 billion. Breast cancer alone received more funding than Alzheimer’s at US$674 million. 

Quoting an expert in this field the report highlighted, “Other diseases have demonstrated that sustained investment in research can improve lives, reduce death rates and ultimately produce effective treatments and preventions. We have the tools and the talent to achieve breakthroughs in Alzheimer’s disease, but we need the resources to make this a reality.”

Conclusion:

From the published research reports, it appears that the quest to decipher the complicated Alzheimer’s disease process continues, at least by the academic and scientific institutions, with equal zest. 

These scientists remain committed to finding out the ‘magic bullet’, which would be able to effectively address the crippling disease. As a result, the research has also moved from discovery of effective amyloid-clearing drugs to search for new molecules that targets inflammation in the brain, caused by a build-up of immune cells called microglia. 

Undeniably, the challenges ahead are still too many.

Nevertheless, enough confidence is also building up to halt the epidemic of Alzheimer’s by overcoming those hurdles, the world over. Experts are hoping that both a cure and also successful preventive measures for the disease, are not too far anymore.

Though some Global Pharma majors invested significantly to discover effective drugs for Alzheimer’s disease, overall research funding in this area is still far from adequate, according to the Alzheimer’s Society. 

For various reasons, not many pharma players today seem to believe that it would be financially prudent for them to make significant investments in developing new molecules for the treatment of Alzheimer’s – the disease that robs memory of millions of people, completely, and without any prior warning whatsoever.

‘The Memory Thief’ continues to prowl, undeterred, still eluding otherwise brilliant Pharma R&D, across 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.

 

Has Prime Minister Modi Conceded Ground To America On Patents Over Patients?

Posted on by
Reply

Unprecedented high profile engagement of the Indian Prime Minister with various interested groups during his recent visit to the United States under equally unprecedented media glare, has invited overwhelmingly more kudos than brickbats, from across the world.

However, in the context of upholding patients’ health interest in India, a lurking fear did creep in, immediately after his visit to the United States. This was related to whether or not demonstrably tough minded Prime Minister Modi has yielded to enormous pressure created by all powerful American drug lobby against the current Intellectual Property (IP) regime in India.

The backdrop:

This apprehension started bothering many as the Prime Minister appeared to have moved away from a much-reiterated stand of India that any IP related issue would be discussed only in a multi-lateral forum.

That India’s Patents Act is TRIP’s compliant, has been categorically endorsed by a vast majority of international and national experts, including, a key intellectual belonging to Prime Minister Modi’s ‘Think -Tank’ – Arvind Panagariya, Professor of Economics at Columbia University, USA.

Subsequent to my blog post of February 5, 2014, an article dated March 4, 2014 titled “India Must Call The US’ Bluff On Patents” penned by Panagariya stated as follows:

“Critics of the Indian patent law chastise it for flouting its international obligations under the TRIPS Agreement. When confronted with these critics, my (Arvind Panagariya) response has been to advise them:

  • To urge the US to challenge India in the WTO dispute settlement body and test whether they are indeed right.
  • Nine years have elapsed since the Indian law came into force; and, while bitterly complaining about its flaws, the USTR has not dared challenge it in the WTO. Nor would it do so now. Why?
  • There is, at best, a minuscule chance that the USTR will win the case.
  • Against this, it must weigh the near certainty of losing the case and the cost associated with such a loss.
  • Once the Indian law officially passes muster with the WTO, the USTR and pharmaceutical lobbies will no longer be able to maintain the fiction that India violates its WTO obligations.
  • Even more importantly, it will open the floodgates to the adoption of the flexibility provisions of the Indian law by other countries.
  • Activists may begin to demand similar flexibilities even within the US laws.

On possible actions against India under the ‘Special 301’ provision of the US trade law, Professor Arvind Panagariya argues:

“Ironically, this provision itself was ruled inconsistent with the WTO rules in 1999 and the US is forbidden from taking any action under it in violation of its WTO obligations. This would mean that it couldn’t link the elimination of tariff preferences on imports from India to TRIPS violation by the latter. The withdrawal of preferences would, therefore, constitute an unprovoked unilateral action, placing India on firm footing for its retaliatory action.”

Examples of some global and local views:

On this score, a large number of business experts from all over the world have expressed their views, recently. Some examples are as follows:

  • The former Chairman of Microsoft India reportedly advised the new ‘Modi Regime’ as follows:

“While the new government must work hard to make India more business friendly, it must not cave in to pressure on other vital matters. For instance, on intellectual property protection, there is enormous pressure from global pharmaceutical companies for India to provide stronger patent protection and end compulsory licensing. These are difficult constraints for a country where 800 million people earn less than US$ 2 per day.”

  • Maruti Suzuki, India’s largest car manufacturer, aircraft maker Boeing, global pharma major Abbott and technology leader Honeywell have reportedly just not supported India’s IP regime, but have strongly voiced that IPR regime of India is “very strong” and at par with international standards.
  • The Chairman of the Indian pharma major – Wockhardt also echoes the above sentiment by articulating, “I think Indian government should stay firm on the Patents Act, which we have agreed.”
  • Other domestic pharma trade bodies and stakeholder groups in India expect similar action from the ‘Modi Government’.

Who are against Indian IP regime?

By and large, American pharma sector and their well-paid lobbyists representing drug multinationals are the strongest critics of Indian Patents Act 2005. They allege that Indian IP law discriminate against US companies and violates global norms, severely affecting their investments in India.

Recent stand of India on unilateral US measures:

Just to recapitulate, on April 30, 2014, the United States in its report on annual review of the global state of IPR protection and enforcement, named ‘Special 301 report’, classified India as a ‘priority watch list country’.

On this report, India responded by saying that the ‘Special 301’ process is nothing but unilateral measures taken by the US under their Trade Act 1974, to create pressure on countries to increase IPR protection beyond the TRIPS agreement.

The Government of India has always maintained that its IPR regime is fully compliant with all international laws.

The Indo-US working group on IP:

The Indo-US high-level working group on IP would be constituted as part of the Trade Policy Forum (TPF). The US-India TPF is the principal trade dialogue body between the countries. It has five focus groups: Agriculture, Investment, Innovation and Creativity, Services, and Tariff and Non-Tariff Barriers.

The recent joint statement issued after talks between Prime Minister Narendra Modi and US President Barack Obama states:

“Agreeing on the need to foster innovation in a manner that promotes economic growth and job creation, the leaders committed to establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the TPF.”

This part of the Indo-US joint statement on IPR created almost a furore not just in India, but in other parts of the world too, interpreting that Prime Minister Modi has conceded ground to America on patents over patients.

IP experts’ expressed concerns even in the US:

Commenting on this specific move by the Obama Administration to push India on issues related to IP, even the independent American healthcare experts expressed grave concern.

Professor Brook K. Baker from the Northeastern University School of Law has reportedly said:

“This working group will give the US a dedicated forum to continue to pressure India to adopt TRIPS-plus IP measures, including repeal of Section 3(d) of the India Patents Act, adoption of data exclusivity/monopolies, patent term extensions, and restrictions on the use of compulsory licenses”.

Professor Baker further said:

“The US, in particular, will work to eliminate local working requirements that India is seeking to use to promote its own technological development…. The fact that this working group will have ‘decision-making’ powers is particularly problematic as it places the US fox in the Indian chicken coop.”

“FDI and innovation are also always rhetorically tied to strong IPRs despite inclusive evidence that typically shows that most low and middle-income countries do not benefit economically from IP maximization, since they are net importers of IP goods. It is also because the path to technological development is ordinarily through copying and incremental innovation – development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements,” Baker elaborated.

Jamie Love, Director, Knowledge Ecology International, an NGO working on knowledge governance also reportedly said:

“It is very clearly going to be used to pressure India to expand liberal grants of drug patents in India, and to block or restrain the use of compulsory licenses on drug patents.”

Has India conceded to American bullying?

On this backdrop, during Indian Prime Minister’s interaction with the President of the United States and his aids, it was reportedly decided to set up a high-level working group on IP, as a part of the TPF, to sort out contentious issues which have been hampering investments. This was interpreted by many experts that India has conceded to American bullying, as it apparently deviated from its earlier firm stand that the country would discuss IP issues only in multilateral forum such as the World Trade Organization (WTO).

No change in India’s position on patents:

Taking note of this humongous misunderstanding, on October 4, 2014, the Union Ministry of Commerce in an official clarification reiterated that during Prime Minister Modi’s visit to America:

  • There has been no change in India’s stated position on Intellectual Property Rights (IPR).
  • India has reaffirmed that the IPR legal regime in India is fully TRIPS-compliant.
  • A bilateral Innovation and Creativity Focus Group already exists in the Trade Policy Forum (TPF) since 2010. Any IP related issues have to be discussed by the United States only in the TPF. This group consults each other no less than twice a year on improving intellectual property rights protection and enforcement, enhancing awareness of intellectual property rights, fostering innovation and creativity, and increasing collaboration between American and Indian innovators.
  • The Indo-US joint statement issued now merely reiterates whatever has existed in the earlier Trade Policy Forum. IPR issues are critical for both the countries and India has been repeatedly raising the issue of copyright piracy and misappropriation of traditional knowledge with the US.
  • The US agreeing to discuss IPR issues through the bilateral mechanism of the Trade Policy forum is in fact a re-affirmation of India’s stand that issues need bilateral discussion and not unilateral action. The statement on the IPR issue will only strengthen the bilateral institutional mechanism.

Conclusion:

Most part of the above statement is indeed quite consistent to what happened even immediately before the Modi regime.

In September 2013, the Commerce Secretary and India’s Chief trade Negotiator, Rajeev Kher, while terming the decision by the US Trade Representative for not labeling India with its worst offender tag in IP as a ‘very sensible decision’, strongly defended India’s right to overrule patents in special cases to provide access to affordable innovative medicines to its 1.2 billion people.

Moreover, many recent judicial verdicts have vindicated that a strong and balanced patent regime of the country not just secures the bonafide rights of the patentee, but at the same time ensures genuine needs of the public and in case of pharma of the ailing patients.

The Indian Supreme Court judgment on Glivec of Novartis in the recent past, have re-established, beyond an iota of doubt, that to secure and enforce patents rights of genuine inventions, other than evergreening, India provides a very transparent IP framework.

Taking all these into consideration, it seems unlikely to me that Prime Minister Modi, who is a self-confessed nationalist and holds India’s interest first, would in any way compromise with the country’s TRIPS compliant patent regime, sacrificing millions of Indian patients’ health interest at the altar of American business needs.

The above official clarification by the Union Ministry of Commerce is expected to tame the fire of this raging debate to a great extent. However, the grave concern expressed in the following lines by the independent healthcare experts, such as Professor Baker, on the high-level IP working group, cannot just be wished away:

“The fact that this working group will have ‘decision-making’ powers is particularly problematic as it places the US fox in the Indian chicken coop.”

That said, from your government Mr. Prime Minister “Yeh Dil Maange Much More”.

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.

 

Drug, Patent and Hype: Quo Vadis Pharma Innovation?

Posted on by
Reply

A recent research report reveals, though the pharmaceutical companies in the United States since mid 2000 have spent over US$ 50 billion every year to discover new drugs, they have very rarely been able to invent something, which can be called significant improvement over already existing ones.

As per available reports, from the year 2000  to 2010, the US-FDA, on an average, approved just 24 new drugs per year. This number is a sharp decline from the same of 1990, when on an average 31 new drugs were approved per year.

These studies throw open some important questions to ponder:

  • What is then the real issue with pharma innovation? 
  • Is it declining quality or quantity (number)?
  • What impacts the patients more?

Quantity vs quality of innovation:

A recent paper explored whether declining numbers of New Molecular Entities (NMEs), approved in the United States (US) each year, is the best measure of pharmaceutical “innovation.”

Thus, studying in detail the NME approvals in the US during 1987 to 2011, the authors proposed the following three distinct subcategories of NMEs:

  • First-in-class
  • Advance-in-class
  • Addition-to-class

This classification was aimed at providing more nuanced and informative insights into underlying trends.

The paper established that trends in NME approvals were largely driven by ‘Addition-to-class’, or “Me too,” drug approvals. However, the good news is that ‘First-in-class’ approvals remained fairly steady over the study period.

Thus I reckon, there should be much greater focus with higher resource deployments for  more of ‘First-in-class’ drugs research and development.

To achieve this objective with requisite wherewithal, there will be a need to drastically cut down massive R&D expenditures on “Me-too” types of so called ‘innovative’ drugs. Such drugs, carrying exorbitant price tags,  creating a financial burden to the payers, could perhaps help increasing the number of innovations, but certainly not the quality of innovations to meet important unmet needs of patients in a cost effective manner.

Some facts: 

In 2010, the healthcare journal Prescire rated 97 new drugs or new indications. Only 4 of these provided any therapeutic advantage over the available existing drugs. Interestingly, 19 others (1 in 5) were approved despite having more harms than benefits.

According to another analysis, “About 1 in 6 new products had more harms than benefits, while more than half of all new products provided no advantages over existing options.”

Further, a different article published in Nature Reviews indicated, “doctors were more likely to rate drugs more than a decade old as transformative.”

Decline in the quality of innovation:

In this context, Dr Mark Olfson of Columbia University and statistician Steven Marcus of the University of Pennsylvania have reportedly established as follows:

“By the 1980s new drugs were less than four times better; by the 1990s, twice as good, and by the 2000s just 36 percent better than a placebo. Since older drugs were much superior to placebo and newer ones only slightly so, that means older drugs were generally more effective than newer ones.”

While even in earlier years, newer patented drugs on an average used to be 4.5 times more effective, as compared to placebo.

The winds of change?

As a result, under the new ‘Affordable Care Act’ of President Obama, “comparative effectiveness research” by an independent research institute could well conclude that older drugs or even cheaper generic equivalents are better than the high priced patented ones, which create fortunes for the innovator pharmaceutical companies at the cost of patients and payers.    

The above initiate in ‘Obamacare’, if and when fructifies, will indeed hit the ‘Me-too’ type of drug innovators, especially in the United States, very hard. Nevertheless, is a music to the ear for the private health insurance companies and the patients at large.

A ray of hope?

‘Comparative drug effectiveness analysis’, as stated above, could eventually lead to replacement of newer high priced ‘me-too’ patented drugs by older relatively low priced generic equivalents, at least, for reimbursements.

This will, no doubt, lead to huge profit erosion of the big pharmaceutical players. Hence, extensive lobbying by industry groups in top gear, against this ‘patient-centric’ proposal, is currently on, .

As the new federal healthcare law will find its roots in America, despite strong opposition  from the powerful and influential pharma lobby groups, a ray of hope is now  faintly seen in otherwise blatantly exploitative and rather cruel drug pricing environment.

Where hype is the key driver:

Despite enormous hype, being created and spearheaded by the Big pharma, on the ‘essentiality’ of most stringent Intellectual Property Rights (IPR) regime in a country with patent laws blatantly in favor of commercial considerations, to enjoy a monopolistic marketing climate with pricing freedom, breakthrough pharma innovations are now indeed rather difficult to come by, as we shall deliberate below.

Reasons for decline:

Many experts believe that the following reasons, among many others, have attributed to the decline in the quality of pharmaceutical R&D output:

  • Most important drug discoveries for mankind have already been made or in other words, the low hanging fruits of pharma R&D have already been plucked. Now not so easy and rather difficult drug targets are remaining.
  • In the last decade, most of pharma R&D efforts were reportedly concentrated mainly in four major disease areas: central nervous system, cancer, cardiovascular and infectious diseases.
  • There is a need now to focus more on poorly understood and more complex therapeutic areas such as, autoimmune diseases or complex diseases related  immune system of the body, to meet greater unmet needs of patients.
  • Clinical trial volunteers are now more difficult to recruit and treat.
  • More stringent regulatory requirements for clinical trials with studies using much larger number of patients, making the clinical drug development process very expensive.

Could it be worse for Big Pharma?

The evolving situation, though very early in the day now, has the potential to turn much worse for the big pharma and good for the patients, if some key changes take place.

Many industry analysts, across the world, feel that ‘liberal’ patent laws are responsible for acceptance of minor advances over the existing products as patentable with 20 years of market exclusivity.

Thereafter, another ‘liberal’ minded drug regulatory framework allows the pharma players to market such ‘not-so-innovative patented medicines’ aggressively, enabling them to amass astronomical profits in no time at the cost of patients’ interests and payors’ financial burden , as happened in the United States and many other countries recently.

To avoid such trivial innovations the law and policy makers in the industrialized countries may well ponder as follows:

1. Align the country’s ‘Patents Act’ with similar to what Indian law makers had formulated in 2005 to avoid minor and ‘evergreening’ types of patents under section 3(d) of the Act.

2. The clinical research data must establish that the new drugs offer significantly more tangible benefits to the patients than the existing ones.

Denial of patentability for ‘me-too’ innovations and their subsequent regulatory approvals would significantly reduce the drug treatment cost with virtually no adverse impacts on patients, across the world.

If such measures are taken by the developed countries of the world and also the emerging markets, the Big Pharma would be compelled to change their respective business models, making ailing patients of varying financial status, color and creed central to their respective strategic ideation processes.

Otherwise, it is highly unlikely that anything will change for the patients from what we are all experiencing today, at least in the near to medium term.

A possible pathway:

Highly conflicting interests of Big pharma and the patients, should get resolved sooner than later and that again for the interest of both. 

Thus, to find a meaningful and generally acceptable solution to this issue, there is a dire need for a much wider global debate. The deliberations, at the same time, should include possibilities of finding ways to avoid huge wasteful expenditures on pharmaceutical R&D for developing new products that offer no significant benefits to the patients over the existing ones. On the contrary, such products burden them with exorbitant incremental drug treatment costs, 

The motions of the debate could well be in the following lines:

1.  ‘Should United States amend its patent laws by categorically stating that a mere “discovery” of a “new form” of a “known substance” that does not have properties resulting in significant improvement in clinical efficacy, will not be patentable?

2. Shouldn’t the clinical research data must always establish that the new drugs offer significantly more tangible benefits to the patients than already available cheaper equivalents?

The positive outcome of this global debate, if fructifies, will indeed be considered as a paradigm shift in the new world order for all, hopefully.

Unfathomable reluctance: 

Despite all these developments, a recent report indicated that the heads of seventeen industry associations of the United States wrote a letter to President Obama complaining, among others, India’s patents regime. This includes the most powerful, yet equally controversial, pharmaceutical lobby group of America.

The letter alleged that the recent policy decisions in India undermine internationally recognized Intellectual Property (IP) standards, which are “jeopardizing domestic jobs” in America and are unacceptable to them.

Though the details of issues were not highlighted in the letter, One concern it specifically expressed that the defeat of Novartis on the Glivec case that challenged Section 3(d) of the Patents Act of India has raised the bar on what can be considered a true innovation for the grant of patent in India.

Though this judgment of the apex court of India was widely acclaimed even globally, American Trade Association Lobby Groups seem to project exactly the opposite, reportedly, driven solely by profit motives of their members and shorn of patients’ interests

Interestingly, an article published in The New England Journal of Medicine, July 17, 2013 also states as follows:

“A patent law that treats incremental innovation and significant innovation in the same way, encourages companies to prioritize less important research over more important research.”

A diametrically opposite viewpoint:

Another school of thought leaders opine, ‘me too’ innovations will continue to remain alive and well. This will happen, even if such new products are starved of oxygen by ‘the tightening purse strings of the eventual customers’. These innovations are sustained by the stronger imperative to avoid clinical failures and to play relatively safe in the space of expensive R&D investments.

They feel that pharma players will continue to focus on to leaner drug discovery and development models to have healthier late-stage product pipelines of such types.  In tandem, by cutting costs even more aggressively, as we witness today, they will find space to keep the level of risk optimal for delivering real innovation, when the time comes.

This type of business model, the experts feel is based on the belief that it is far better to acquire a product with very little innovation ensuring that it can hardly fail to be approved by the regulator. Thereafter, the concerned players may figure out ways of how payors will actually pay for it, rather than focusing primarily on acquiring a genuinely innovative ‘First-in-class’ product and then discover it has ‘feet of clay’.

For example, AstraZeneca reportedly invested a little over US$1 billion in two such products in one month: another LABA combination from Pearl Therapeutics and a prescription ‘Fish Oil’ capsule from Omthera Pharmaceuticals.

Conclusion:

Be that as it may, a large number of experts do opine, especially in the light of the above letter of the American Trade Associations that the verdict of the Honorable Supreme Court of India on the Glivec case, though does not serve the business interests of pharma MNCs, definitely signals the triumph of justice over ruthless patient exploitations. It also vindicates that this particular rule of law, as enacted by the Indian Parliament, is indeed for the best interest of the patients of India at large.

This verdict could well be construed as a huge lesson to learn and implement by other like minded countries, across the world.

Having a glimpse at the pharmaceutical innovations, which are often laced by crafty hypes created by expensive PR Agencies of the pharma lobby groups, the global thought leaders do tend to believe, rather strongly, that Section 3(d) of the Patents Act of India would encourage more ‘First-in-class’ innovations, in the long run, benefiting all.

Such a provision, if implemented by many countries, could also help saving significant wasteful expenditures towards ‘Me-too’ type pharma R&D, favorably impacting billions of lives, across the world.

That said, the question keeps haunting – ‘Sans Hype, Quo Vadis Pharma 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.

 

 

 

Transparency in Drug Trial Data: Thwarted by Lobbyists or Embroiled in Controversy?

Posted on by
Reply

Based on a leaked letter from overseas pharma industry bodies, a leading international daily in late July 2013 reported:

“Big pharma mobilizing patients in battle over drugs trials data.”

Some experts consider it as a poignant, if not a bizarre moment in the history of drugs development, keeping patients’ interest in mind. However, the concerned trade bodies could well term it as a business savvy strategy to maintain sanctity of ‘Data Exclusivity’ in real sense.

That said, it is important for the stakeholders to figure out where exactly does this strategy stand between the larger issue of patients’ drug safety and efficacy concerns and the commercial interest of the innovator companies to grow  their business.

Lack of transparency in drug trials data and consequences:

Outside pharmaceutical marketing, some of the biggest scandals in the drug industry have been alleged hiding of data related to negative findings in drug Clinical Trials (CTs) by the innovator companies.

Many stakeholders have already expressed their uneasiness on this wide spread allegation that research based pharmaceutical companies publish just a fraction of their CT data and keep much of the drug safety related information to themselves. Not too distant withdrawals of blockbuster drugs like Vioxx (Merck) and Avandia (GSK) will vindicate this point.

Examples of global withdrawals of drugs, including blockbuster ones, available from various publications, are as follows. 

Brand

Company

Indication

Year of Ban/Withdrawal

Reason

Vioxx

Merck

Anti Inflammatory

2004

Increase cardiovascular risk

Bextra

Pfizer

Anti Inflammatory

2005

Heart attack and stroke

Prexige

Novartis

Anti Inflammatory

2007

Hepatotoxicity

Mylotarg

Wyeth

Acute Myelogenous Leukemia

2010

Increased patient death/No added benefit over conventional cancer therapies

Avandia

GSK

Diabetes

2010

Increased cardiovascular risk

Reductil

Abbott

Exogenous Obesity

2010

Increased cardiovascular risk

Paradex

Eli Lilly

Analgesic, Antitussive and Local Anaesthetic

2010

Fatal overdoses and heart arrhythmias

Xigris

Eli Lilly

Anti-Thrombotic, Anti-Inflammatory, and Profibrinolytic

2011

Questionable efficacy for the treatment of sepsis

A recent example:

A recent report indicates that Japan (Tokyo) based Jikei University School of Medicine plans to withdraw a paper on the hypertension drug Diovan of Novartis from the prestigious British Medical Journal (BMJ) due to “data manipulation,” suggesting the drug could help treating other ailments.

The report also indicates that an investigative panel formed by the university to look into the allegations of ‘rigged data’ for Diovan concluded that the results were cooked.

The decision of the Japanese University to withdraw this paper is expected to hurt the reputation of Novartis Pharma AG and at the same time raise ethical concerns about the company’s behavior concerning its best-selling hypertension drug, the report says.

Drug regulators contemplating remedial measures:

Now being cognizant about this practice, some drug regulators in the developed world have exhibited their keenness to disband such practices. These ‘gatekeepers’ of drug efficacy and safety are now contemplating to get the entire published CT data reanalyzed by the independent experts to have a tight leash on selective claims by the concerned pharma companies.

A review reportedly estimates that only half of all CTs were published in full and that positive results are twice as likely to be published than negative ones.

Recently the European Medicines Agency (EMA) has published a draft report for public consideration on greater openness of CT data. As stated above, this proposal allows independent experts to conduct a detail analysis on the safety and effectiveness of new drugs.

Mobilizing patients to thwart transparency?

Interestingly, as stated in the beginning, it has recently been reported that to thwart the above move of the drug regulator in favor of patients’ interest:

“The pharmaceutical industry has mobilized an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.”

The same report highlights that two large overseas trade associations had worked out a grand strategy, which is initially targeted at Europe. This is for the obvious reason that the EMA wants to publish all of the clinical study reports that drug companies have filed, and where negotiations around the CT directive could force drug companies to publish all CT results in a public database.

Embroiled in controversy:

It has also been reported simultaneously, “Some who oppose full disclosure of data fear that publishing the information could reveal trade secrets, put patient privacy at risk, and be distorted by scientists’ own conflicts of interest.”

Pharmaceutical trade associations in the west strongly argue in favor of the need of innovator companies to keep most of CT data proprietary for competitive reasons. They reiterate that companies would never invest so much of time and money for new drug development, if someone could easily copy the innovative work during the patent life of the product.

However, the report also states, “While many of these concerns are valid, critics say they can be addressed, and that openness is far more important for patients’ drug safety reasons.“

Addressing the concerns:

To address the above concerns the EMA has reportedly separated clinical data into three categories:

  • Commercially confidential information.
  • Open-access data that doesn’t contain patients’ personal information.
  • Controlled-access data that will only be granted after the requester has fulfilled a number of requirements, including signing of a data-sharing agreement.

However experts do also reiterate, “Risks regarding data privacy and irresponsible use cannot be totally eliminated, and it will be a challenge to accommodate diverse expectations across the scientific and medical community. However, the opportunity to benefit the health of individuals and the public must outweigh these concerns.”

Some laudable responses:

Amidst mega attempts to thwart the move of EMA towards CT data transparency surreptitiously, there are some refreshingly good examples in this area, quite rare though, as follows:

  • As revealed by media, GlaxoSmithKline (GSK) has recently announced that it would share detailed data from all global clinical trials conducted since 2007, which was later extended to all products since 2000. This means sharing more than 1,000 CTs involving more than 90 drugs. More recently, to further increase transparency in how it reports drug-study results, GSK reportedly has decided to disclose more individual patient data from its CTs. GSK has also announced that qualified researchers can request access to findings on individual patients whose identities are concealed and confidentiality protected.The company would double the number of studies to 400 available by end 2013 to researchers seeking data of approved medicines and of therapies that have been terminated from development.
  • Recently Canada reportedly announced the launch of Canadian Government’s new public database of Health Canada-authorized drug CTs. It is believed that providing access to a central database of clinical trials is an initial step that will help fill an existing information gap as the government works to further increase transparency around CTs.
  • The well-known British Medical Journal (BMJ) in one of its editorials has already announced, “BMJ will require authors to commit to supplying anonymised patient level data on reasonable request from 2013.”

All these are indeed laudable initiatives in terms of ensuring long term drug safety and efficacy for the patients.

Conclusion:

It is quite refreshing to note that a new paradigm is emerging in the arena of CT data transparency, for long-term health interest of patients, despite strong resistance from powerful pharmaceutical trade bodies, as reported in the international media. This paradigm shift is apparently being spearheaded by Europe and Canada among the countries, the global pharma major GSK and the medical Journal BMJ.

A doubt still keeps lingering on whether or not independent expert panels will indeed be given access to relevant CT data for meaningful impartial reviews of new drugs, as the issue, in all probability, would increasingly be made to get embroiled in further controversy.

Moreover, if the innovator companies’ often repeated public stand – “patients’ interest for drug efficacy and safety is supreme” is taken in its face value, the veiled attempt of thwarting transparency of CT Data, with an utterly bizarre strategy, by the lobbyists of the same ‘patient caring’ constituent, can indeed be construed as a poignant moment, now frozen in time, in the history of drug development for mankind.

Be that as it may, to resolve this problem meaningfully and decisively, I reckon, a middle path needs to be carefully charted out between reported thwarting moves by pharma lobbyists and the embroiled controversy on the burning issue.

Thus, the final critical point to ponder:

Would the commerce-driven and cost-intensive pharma innovation also not be in jeopardy, affecting patients’ interest too, if the genuine concerns of the innovator companies over ‘CT Data Protection’ are totally wished away? 

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.

 

George Washington University Law School’s “The India Project” – Arguments and Counter Arguments

Posted on by
Reply

Recently we witnessed yet another huge controversy on the ‘IP Summit’ organized by the George Washington University Law School (GWULS), USA. It was alleged that this summit supported by law firms, some pharmaceutical companies and others, was intended to influence the participating sitting judges on the pharmaceutical patent related cases currently being fought in various courts in India.

The Arguments:

However, the GWULS reiterated that this summit is intended to help India to build capacity in the IP law of the country. GWULS states the following in its magazine of winter 2009:

“From New Delhi to Bangalore, GW Law is building bridges of understanding between the United States and Indian legal communities through its fast-growing India Project, a collaborative enterprise fostering broad-based relationships and heightened international dialogue on issues of mutual concern”.

During their recent visit to India, in an announcement to the media GWULS explained the following:

“We have contributed to education by heightening the dialogue and understanding between India and the U.S. on IP law. We have done so in a collaborative way, as we have much to learn from our Indian counterparts. For example, the new Indian patent law, enacted in 2005, involves a range of issues that require clarification, and the project has resulted in a two-way discussion of real importance to the future of IP protection in India and across the world. Is the new law in compliance with Indian constitutional standards? How does it compare with U.S. law in addressing issues that arise during the processing of a patent application? (With regard to this question we recently held educational sessions with patent examiners at various Indian patent offices). Is it consistent with international standards? These are just some of the issues that attract the attention of people associated with GW’s India Project.”

The Counter Arguments:

The other group strongly counter argues highlighting that Indian judiciary and lawmakers have a long history of dealing with the patent laws since 1911. Although in between from 1970 to 2004, the situation slightly changed with the abolition of ‘Pharmaceutical Product Patent’, the re-introduction of the same effective January 1, 2005, does not call for an ‘un-called for’ indirect intervention in the judicial process of the country by law schools located beyond the shores of India.

This group feels that GWULS indirectly casts aspersions on the legal standard of the country and the competence of Indian judiciary, which needs to be protested, unequivocally. Moreover, the group argues, “even if IP awareness had to be taken to the people once again after the 2005 amendment, why did GWULS mount such a major campaign here?”

So far the Patent Law is concerned; this group accepts that our Patent Attorneys and particularly those lawyers who will argue the cases in front of the judges must possess impeccable knowledge in the nuances of patent law with all its nitty- gritty. Thus lawyers rather than judges should regularly update their knowledge on the details of patent related issues.

Laws are by and large country specific, with an exception probably of international law. After hearing the arguments of respective lawyers, this group feels that the judge will interpret the law of the land and give his/her judgment accordingly, as happens in any other comparable sphere of law. Just as for laws related to ‘terrorist’ act, India will not require its judges to be trained by other countries, this group reiterates, the same argument holds good for patent law, as well.

The Times of India (March 29, 2010), a leading daily of the country, reported the following in a news item titled, “’Vested interests behind discussion on patents”:

“Several civil society groups have come together to question the commerce and industry ministry’s alleged complicity in allowing meetings and interactions undermining India’s legal position on intellectual property (IP). These interactions are being organized annually with Indian judges and policy makers by the George Washington University Law School (GW Law), under its India Project, with funding from multinational pharmaceutical companies, industry associations and corporate law firms”.

Conclusion:

Be that as it may, the arguments from either side do not seem to be unbiased without any vested interests and are not convincing enough. In a globalized economy, from such comments it appears that the one group is feeling that Indian legal system is inefficient, if not incompetent, to deal with its patent related cases involving global pharmaceutical companies. On the other side, the local voice seems to be afraid of a ‘foreign hand’ intruding into the judicial space of India, which in my view is stretching the imagination far too much.

Overall, Indian Judiciary has a long tradition of keeping the institution robust enough and free from any external influences, whatsoever, notwithstanding GWULS coming to India almost every year, since around 2005.

By Tapan 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.