Author Archives: Tapan Ray

CRAMS opportunities – India is strongly poised, a time to leverage

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Cost containment pressures due to various factors have prompted the global pharmaceutical companies to contract out various research related and manufacturing activities, over a period of time, from Europe and North America to low cost destinations like India and China. Such activities started gaining momentum before the turn of the new millennium and have now emerged as huge business opportunities to many domestic Indian pharmaceutical companies. This lucrative business opportunity of ‘Contract Research and manufacturing Services’ is now popularly known in its abbreviated form CRAMS.

Many global pharmaceutical companies have already engaged themselves in the CRAMS space with India and some of them have commenced the pilot programs and are seriously contemplating to offshore a significant part of their research related and manufacturing operations in India.

The Market Size:

Global market for CRAMS was around U.S. $ 55.47 billion in 2007 and is expected to be of U.S $ 76 billion by 2010 with a CAGR of 10%.

Contract research market alone was U.S $16.58 billion with a CAGR of 13.8% and contract manufacturing at U.S $38.89 billion accounted for around 70% of the total global pharmaceutical CRAMS market, according to a study done by Piribo, a Business Intelligence Organization.

According to ASSOCHAM, CRAMS market in India was valued at U.S $532.10 million in 2005, of which contract manufacturing accounted for 84% of the total market and the remaining 16% came from contract research excluding clinical trials, with a growth of over 40% over the previous year.

According to Frost & Sullivan, contract research market in India is estimated to be around U.S $ 1 billion by end 2010.

Preparation started much earlier – unknowingly:

In 1970 when product patent law was abolished to encourage domestic Indian companies to manufacture and market low cost modern medicines in the country, the skill sets to make the best use of this opportunity started developing at a faster pace. Brilliant chemists of India got encouragement to hone their reverse engineering and efficient manufacturing process development skills, which are of immense importance to manufacture low cost medicines in the country. Availability of skilled and high quality technical talent pool at much lower costs together with capital efficiency of the local entrepreneurs further helped the country to acquire cutting edge expertise in the CRAMS space.

CRAMS – not just a bed of roses:

Days of struggle:

CRAMS business cannot be developed overnight. It needs months, if not years of negotiation and fulfilling all technical, financial and regulatory requirements of the innovator companies to commence business.

Days of continuity:

Since financial costs are high and regulatory requirements are stringent to switch over to new outsourcing arrangements, there are very good chances that once CRAMS business is commenced, the partnership with innovator companies will continue for a long time, unless any breach in the supply agreement takes place.

Days of nightmares:

All offshore supply contracts need to be successfully executed within the given timeframe. If not, relationship with the innovator companies may get strained. At the same time, if the innovator company fails to take delivery of the custom made material from the CRAMS partner, costly inventory at the manufacturing location will pile up and consequently precious working capital will get blocked, adversely impacting the manufacturing capacity utilization.

Operating margin:

In CRAMS business operating margins are usually quite good. For patented products margins are generally higher than the products which have gone off patent. The volume of business in CRAMS usually picks up over a period of time.

Contract Research:

While developing a New Chemical Entity (NCE), the research based pharmaceutical companies need smaller quantities of variety of intermediates and active pharmaceutical ingredients (APIs). As the NCE gradually passes through various advancing stages of clinical developmental processes, quantity requirements of such material also increases.

Contract Research outfits develop and deliver such smaller quantities of specific chemicals and intermediates to the innovator companies through custom chemical synthesis (CCS), which usually attracts relatively higher margin .

Although in India early and late stages contract research services are doing well, the segments like medicinal chemistry and bioinformatics with high business potential have not been adequately tapped, as yet.

Key areas of outsourcing in future are expected to be:

• Genomics
• Screening technology platforms
• Therapeutics

Contract Manufacturing:

Contract Manufacturing market for pharmaceuticals spans across mainly USA, Europe and Asia. The market is segmented into solid, liquid and injectable dosage forms. Although sold dosage form covers almost 50% of the total market, injectable forms are registering the fastest growth and the liquid dosage forms being the laggard.

Contract manufacturing in India involves both patented and off-patent APIs and formulations manufactured with world class standards conforming to international regulatory norms like the US-FDA, MHRA- UK, TGA – Australia and EMEA.

India, with more than 100 US FDA-approved manufacturing facilities, is one of the most preferred locations for outsourcing manufacturing services by the global pharmaceutical companies.

Companies like, Divi’s Labs, Jubilant Organosys, Dishman, Piramals, Shasun, Cadila healthcare, Aurobindo are gradually establishing themselves as strong CRAMS players having large global pharmaceutical companies like, GlaxoSmithKline, Merck, Wyeth, Eli Lilyy, Astra Zeneca, Pfizer as their major clients.

Competition:

In the CRAMS space the key competitor to India is undoubtedly China driven by its economies of scale. Overall manufacturing costs in China, be it labour or power, are much less than India. This has already made China a formidable competitor to India in majority of the bulk drugs and intermediates. Even, many domestic Indian pharmaceutical companies now source their raw materials from China.

Pharmaceutical manufacturers in China, over a period of time, have become quite proficient in filing Drug Master Files (DMF) and Abbreviated New Drug Applications (ANDAs). Together with significant cost advantage, China has started making huge progress to capture a sizable share of CRAMS business from the developed markets of the world. Along with China, countries like South Korea and Taiwan are also making considerable progress in this field.

To combat with this threat some Indian pharmaceutical companies have started setting up their businesses in China, collaborating and even acquiring stakes in the Chinese pharmaceutical companies. This process is expected to accelerate further in future.

Conclusion:

CRAMS business in India is expected to grow at a rapid pace and offer relatively high operating margins to the Indian pharmaceutical companies. As a result, companies of various scales of operations with interest in CRAMS business, have started initiating all possible measures to prove themselves as the best option for offshore activities of the global players. All these companies are trying to leverage the wide diversity of the country, rich English speaking talent pool and strong manufacturing base in pharmaceuticals created over last four decades. Thus it appears that capturing at least 10% of the global CRAMS market by 2015 may not be a big deal for India.

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.

How to have a robust product patent enforcement mechanism, without getting involved into expensive litigations, frequently?

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On August 28, 2009, the Supreme Court of India dismissed the special leave petition filed by Roche challenging the order of the division bench of the Delhi High Court. Earlier the division bench had refused to grant an interim relief on Roche’s allegation that Cipla’s generic version of the anti-cancer therapy ‘erlotinib’ has infringed upon the patent granted to ‘Tarceva’. The Supreme Court, at the same time, issued an order to the Delhi High Court to hasten the trial of Tarceva patent infringement case, which is pending with the honourable court for some time.One of the main grounds for not granting an interim relief in favour of Roche by the Delhi High Court was of ‘public interest’, as the generic version of the Tarceva equivalent being sold by Cipla costs almost a third of that of the originator.Thereafter, when the case came before the Division Bench of the Delhi High Court, the appellate bench upheld the earlier judgement of the court on the subject, with some other additional observations. One of which was on the challenge by Cipla regarding the validity of Tarceva patent.

After the August 28 order of the Supreme Court, it is expected that the patent infringement dispute of the case will be now be expeditiously resolved.

However, despite the above developments, the answer to the key question, ‘how to effectively enforce product patents in India, without getting involved into expensive and protracted litigation’, still remains as illusive.

How to find an answer to the root question?

Although astute legal experts will keep expressing their legal interpretations on such cases for all time to come and similar disputes will not cease to come up even after the pending cases are resolved, the key question about the effective enforcement mechanism of product patents in India, still keeps haunting. The moot question is:

‘How to effectively protect the product patents in India avoiding time consuming and expensive litigations by all concerned’?

Possible scenario:

It is quite likely that soon, we may witness the following scenario, as a routine:

1. Product patent is granted to the innovator, in India.

2. The product is marketed in India.

3. Marketing approval is granted to generic equivalents of the patented molecule, soon after the launch of the patented product.

4. Generic company launches the product with significant price differential.

5. The originator files a suit for patent infringement and seeks an interim relief from the court.

6. The generic company files a countersuit on the product patent.

7. The honorable court decides not to grant an interim relief against marketing of the cheaper generic equivalent, on the ground of ‘Public Interest’ among other key reasons.

8. The generic Company continues to sell the product.

9. Patent infringement case continues in the court of law.

10. The originator Company has no other option available, but to operate without a robust patent protection mechanism in the country and keep incurring expensive litigation related expenses, for years.

11. The next step, which may follow, we have not witnessed, as yet, in India.

12. However, if more number of generic equivalents is launched by more number of generic players, the litigation costs of the originator to protect the product patent will indeed be very exhorbitant.

What then could be the role of the government in such a scenario?

It is indeed a robust argument that all patent related disputes after the grant of a product patent (beyond post grant opposition) and product launch should be resolved by a court of law. But, will it encourage an innovator to grow its business in India with the patented products, meeting the unmet needs of many patients and contributing to the growth of the industry?

Why then should the country have a product patent law?

Generic equivalent of a patented product will always cost significantly less than an innovator’s patented product for which there will perpetually be an important issue of ‘Public Interest’. This issue will not be very easy to ignore either. However, if the government also feels that way, it will be interesting to fathom, why then did the country opt for a product patent regime, enacting product patent laws in 2005 with a promise for effective enforcement of product patents in the country?

Conclusion:

In my view, as I expressed in my previous articles as well, if the government wants to enforce the product patents granted in India, without burdening the companies with expensive litigation costs, the only way will be to work out a robust system of ‘Patent Linkage’ within the country.

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.

Increasing socio-economic inequality within the healthcare delivery systems of India

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Increasing inequality between the wide diversity of population of ‘haves’ and ‘have-nots’ in the socio-economic and cultural set up of India, clearly gets reflected in the healthcare delivery system of the country. Many research studies on this subject have established a clear relationship between healthcare services and socio-economic inequality. Several lakh of Indians still perish in the country because of this reason.
Economic growth needs to be inclusive – better said than done:
Initiation of financial reform measures since 1990 and the process of globalization during this period have spurred the economic growth of the country, the rate of which comes just next to China in the global scale of comparison for the same. However, many people strongly believe that this reform process has not been as inclusive as it should have been. Otherwise why will the country continue to witness worrisome instances of abject poverty within a large section of the society with an abnormally high rate of mortality?

Healthcare sector in India – huge socio-economic inequality:

According to the Investment Commission of India, the healthcare sector of the country has experienced rapid growth of around 12% since last 4 years and is expected to be of U.S. $ 280 billion industry by 2022.

However, due to socio-economic inequality, this growth has not been evenly distributed. As a result, 65% of the population of India still do not have access to modern medicines and a vast majority of the population experience poor healthcare facilities. Around 10 lakh women and children die in India either due to poor access to healthcare services or they cannot afford the healthcare expenses.

Centers of excellence – but not for all:

In the healthcare sector, despite having many centers of excellence of global standards, which are also attracting ‘medical tourists‘ from across the world, healthcare needs of a large number of population of the country are not being addressed adequately. About 700 million of population have no access to specialists’ care even today. The Government of India alone will not be able to address this problem of gigantic proportion without workable and time-bound Public Private Partnership (PPP) initiatives with an investment of over U.S $ 20 billion at least for next five years. For example, in terms of availability of hospital beds per 1000 population, India stands at 0.7 against 3.96 of world average.

“Fortune at the bottom of the pyramid” – anybody follows in India?

Professor C. K. Prahalad’s famous dictum, “Fortune at the bottom of the pyramid” has not been realised yet by many within the global healthcare industry, perhaps with the solitary exception of Andrew Witty, the young CEO of GlaxoSmithKline.

As per data available from the Government publications, the bottom of the pyramid where a large proportion of the Indian population is located, reflects a huge socio-economic inequality even in the healthcare sector as follows:

• Overall spending on healthcare in India is around 6% of GDP (Public and Private sectors put together). However the public expenditure is only 0.9% of the total spending.

• In rural areas per capita expenditure on healthcare is seven times lower than urban areas.

• In rural areas the ratio of hospital beds to population is fifteen times lower than the urban areas.

• In rural areas the ratio of doctors to population is almost six times lower than the urban areas.

• The rate of Infant Mortality in the 20% of the poorest population is 2.5 times higher than the richest 20% of the population in rural areas.

• Despite more health issues an individual from the poorest quintile of the population is six times less likely to access hospitalization than a person from the richest quintile in rural areas.

• From the poorest quintile of the population, the child delivery of a mother is over six times less likely to be attended by a medically trained person than during child delivery of a mother from the richest quintile of the population in rural areas.

• On an average 78% healthcare expenditure in India comes as ‘out of pocket payments’ by the people, whereas only 18% of the same is borne by the state followed by 4% by medical insurance.

• Towards public healthcare spending, only five other countries in the world (Pakistan, Burundi, Myanmar, Cambodia and Sudan) are worse off than India.

• Only 38% of all Public Health Centres (PHCs) have essential manpower and only 31% have the essential supplies with only 3% of PHCs having 80% of all critical inputs.

As a result of inadequate and unequal spending on the healthcare infrastructure, healthcare systems, healthcare financing and healthcare delivery, both by the public and private sectors in the rural areas, such inequalities towards access and affordability of the healthcare services,especially in rural India where over 70% of the country’s population reside, have now assumed an alarming proportion .

Access to healthcare is fundamental in many countries of the world:

Most of the developed countries of the world extend comprehensive healthcare access to its citizens. Even our close neighbour Thailand and Fidel Castro’s land, Cuba along with many other developing countries of the world extend basic healthcare facilities to all their citizens.

Urban poor also face the harsh reality of healthcare affordability issue:

Survey results indicate the following facts so far as urban poor are concerned:

• Healthcare facilities though skewed towards urban India, the healthcare cost, lack of culturally appropriate services; social prejudices etc prevent access to healthcare even to the urban poor.

• Infant and under-five mortality rates in the urban slums for the poorest 40% are as high as is prevalent in the rural areas.

• Because of mainly poverty, poor hygienic and almost non-existent sanitation conditions, urban slums have now become the breeding ground for diseases like cholera, malaria, hepatitis, tuberculosis, HIV – AIDS and a large variety of infectious disease.

All these conditions coupled with almost total lack of health education in slums further aggravate the healthcare situation.

Has the National Health Policy delivered?

It is widely believed that Infant and Maternal Mortality rates of a country are the most important indicators of the health of any society. For the year 2000 The National Health Policy of India had set a target to bring down the Maternal Mortality Rate to below 200 per 1 lakh live births. However, even today around 407 mothers die every year due to pregnancy related complications. So far as infant mortality is concerned the figure remain as high as 22 lakh every year.

A very sad state of public healthcare delivery system gets reflected through these very basic numbers, despite various government initiatives and mushrooming private and corporate investments towards healthcare. The privileged class of the society, as a result, is getting better and better private healthcare services and the under-privileged class is denied of, in many cases, even the very basic healthcare facilities. All these bring out to the open the social and economic inequality in our civil society even for the very basic healthcare needs of its citizens.

Growth of Private Healthcare initiatives is welcome, but are they maintaining an urban-rural balance?

Urban centric private healthcare sector in India is growing at a faster pace. However, overwhelming dominance of this sector in absence of robust PPPs will further increase the urban bias with focus on higher profit margin being more important than offering primary and secondary healthcare services to a large number of the deprived population with lesser profit margin. Following published facts may help understand the prevailing situation:

• The increasing cost of healthcare paid predominantly through ‘out of pocket’ is making healthcare unaffordable to a large number of the population.

• The number of people who are unable to seek healthcare services due to affordability issue is growing, despite rapid economic growth of the country.

• The number of people who cannot afford to basic healthcare services has doubled compared to just a decade ago.

• One in three people who need hospitalization and paying ‘out of pocket’ are forced to borrow money or sell assets to cover healthcare expenses.

• Because of ‘out of pocket’ spending on healthcare, over 20 million Indians are pushed below the poverty line every year.

• A World Bank report acknowledges the facts that doctors recommend unnecessary investigations and over-prescribe drugs in private healthcare sector.

• The same report acknowledges the relationship between the quality and cost of healthcare services in the private healthcare system with high priced services being excellent but unaffordable to many.

Conclusion:

All these facts will further establish the prevalent socio-economic inequality within the healthcare delivery systems of India. Rapidly growing urban centric private healthcare initiatives are welcome but these are now just catering to the privileged few, keeping the pressing healthcare issues of India unanswered. Only well planned time-bound PPP initiatives, in my view, are capable to address the humongous healthcare issues of India.

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.

Envisaging ‘five emerging key strategic changes’ in the Indian Pharmaceutical Industry

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In India, the domestic pharmaceutical market has clocked a CAGR of around 13% to 14% since the last five years. Currently, the market is dominated by the drugs for mass ailments. However, such trend has already started showing a shift towards ailments related to the life-style of patients. This emerging trend is expected to fast accelerate in future.All such factors put together, driven by the following key drivers for growth backed by strong logistics support and hopefully improving healthcare delivery system are expected to contribute significantly towards faster growth of the Indian pharmaceutical industry, as we move on.Key growth drivers:

The growth drivers may primarily be divided into two categories:

- Local and
- Global

Local:

• Rapidly growing more prosperous middle class population of the country.

• High quality, cost effective, domestic generic drug manufacturers who will have increasing penetration in both local and emerging markets.

• Rising per capita income of the population and in-efficiency of the public healthcare system will encourage private healthcare systems of various types and scales to flourish.

• Expected emergence of a robust healthcare financing/insurance model for all strata of society.

• Fast growth in Medical Tourism.

• Evolving combo-business model of global pharmaceutical companies with both patented and generic drugs boosting local outsourcing opportunities.

Global:

Global pharmaceutical industry is going through a rapid process of transformation. Cost containment pressures due to various factors are further accelerating this process. Some of the critical effects of this transformation process like Contract Research and Manufacturing Services (CRAMS) will drive growth of many Indian domestic pharmaceutical players.

Expecting the need for ‘New Strategic Changes’ of radically different in nature:

The impact of many of these evolutionary changes is being felt in India already. However, some more radically different types of changes, which the industry has not experienced, as yet, are expected to be felt as the country moves on to satisfy the desired healthcare needs of its population while fully encashing the future growth opportunities of the Indian pharmaceutical industry.

Five ‘New Strategic Changes’ envisaged:

Five new key strategic changes, in my view, will be as follows:

1. As the country will move towards an integrated and robust healthcare financing system:

• Doctors will no longer remain the sole decision makers for the drugs that they will prescribe to the patients and the way they will treat the common diseases. Healthcare providers/ medical insurance companies will start playing a key role in these areas by providing to the doctors well thought out treatment guidelines.

• For a significant proportion of the products that the pharmaceutical companies will sell, tough price negotiation with the healthcare providers/ medical insurance companies will be inevitable.

• Health Technology Assessment (HTA) or outcome based pricing will play an important role in pricing a healthcare product.

2. An integrated approach towards disease prevention will emerge as equally important as treatment of diseases.

3. A shift from just product marketing to marketing of a bundle of value added comprehensive disease management processes along with the product, will be the order of the day

4. Patents will be granted on truly innovative medicines and incremental innovation to be protected within the patent life of the original product only or separately for a much lesser period.

5. Over the counter medicines, especially originated from natural products for common and less serious illness, will curve out a larger share as the appropriate regulations will be put in place.

Conclusion:

With the above changes in the ball game of the Indian pharmaceutical industry, it may not be easy for the local players to adapt to such changes sooner and compete with the global players on equal footing. Those Indian Pharmaceutical companies who are already global players on their own rights, will be well versed with the nuances of this new game, within the country. These domestic companies, in my view, will offer a tough competition to the global players, especially, in the generic space.

However, so far as other domestic players are concerned, the new environment could prove to be a real tough time for them, further accelerating the process of consolidation within the Indian pharmaceutical industry. So the ‘writing on the wall’ appears to be ‘prepare now’ or ‘perish’.

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.

Recent Bayer Case Judgment: Patent Linkage: Encouraging Innovation in India

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Delhi High Court turned down the request of Bayer Corporation in August 18, 2009 to link patent status of its kidney cancer drug Nexavar (sorefenib tosylate) with the marketing approval of the generic equivalent of the same patented molecule manufactured by Cipla, during the patent life of Nexavar in India.Bayer received an Indian patent for Nexavar in March 2008, which is one of the potential blockbuster drugs of Bayer Corporation and is expected to clock an annual global sales turnover of around U.S $1 billion soon.In this particular case, Bayer argued that an approval for its generic equivalent from Cipla would infringe on their patent.

The interim and the final judgment of the Delhi High Court:

Honorable Delhi High Court granted an interim injunction in response to the petition filed by Bayer Corporation and refrained the Drug Controller General of India (DCGI) from granting marketing approval of the generic version of sorefenib tosylate of Cipla, until the final order is passed by the Court.

In its final judgment, the Delhi High Court ruled that Bayer should not have brought this case to the honorable court as the drug regulation is not linked to patent rights in India.

Further, the court could not, “conclude that unpatented drugs are spurious drugs” and said, “this court is constrained to observe that the present litigation was what may be categorized as speculative foray, and attempt to ‘tweak” public policies through court mandated regimes.”

Besides, the honorable Court has asked the Bayer Corporation to pay Rs 6.75 lakh to the Government and Cipla as legal costs.

Will this High Court ruling encourage more such incidence in India?

Some experts feel that the Delhi High Court ruling may encourage generic pharmaceutical companies to launch generic versions of patented drugs in India despite the risk of paying damages, if patent infringement is proved in a court of law.

Keeping all these in view, let us now discuss the relevance of Patent Linkage in India.

What really is a patent linkage?

The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India.

It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.

However, the generic companies argue that the role of the DCGI is restricted to regulating safety and efficacy of the drugs, whereas ascertaining patent status of products fall within the ambit of Indian Patent Offices. Thus these two cannot be linked.

The argument in favour of a robust Patent Linkage system:

1. WTO TRIPS Article 28.1a says that the member countries agree to ensure exclusive rights to patent holder for a specific time period. In case of India, like most other countries, this time period is for 20 years.

2. During this period the member countries agree to prevent third parties from making, using, offering for sale the patented product without the owner’s consent.

3. In India there is no known strong deterrent for patent infringement. In absence of which, the opportunity to make significant commercial gain through patent infringement, on the pretext of extending benefits to patients could indeed be, many a times, difficult to resist.

4. Media reports that the National Pharmaceutical Pricing Authority (NPPA) has raised huge demand in crores of rupees for overcharging the common man, flouting the drug pricing norms, by some of these large companies involved in patent infringement litigations, vindicates the point of their basic overall intention of significant commercial gain over extending pricing benefits to the common man.

Who is responsible to ensure the sanctity of the product patent system in India?

1. The prevailing situation warrants a strong regulatory system, which could prohibit marketing approval of generic equivalents of patented molecules during their patent period.

2. The question that is often raised in this context is who exactly be held responsible for implementation of such a system in our country? While addressing this question one should realize that it is the Government in its entirety and not just the Patent offices or any particular ministry or ministries of the Governments is bound by the WTO TRIPS Agreement. Therefore, it is justifiably the responsibility of all Government departments/ministries to ensure that TRIPS obligations of the Government on proper enforcement of patent are properly met.

3. The process of granting marketing approval for patented molecules, in general, rests on the Ministry of Health (MoH) of WTO member states. Thus for WTO member states to meet TRIPS obligations effective communication between the MoH and the Patent offices of the country is absolutely essential. Such a system will help prevent approval of generic versions of patented molecules before expiration of the product patents.

4. Establishing this communication process will ensure that one department/ministry of the Government (say DCGI) does not impair the efforts of another Government department/ministry (say IPOs) to provide effective intellectual property protection as articulated in Article 28.1 of the WTO TRIPS Agreement.

5. This system will ensure that Health Regulatory Authorities do not, even unintentionally, undermine the commitment of the Government to conform to the TRIPS Agreement.

Will India be the unique country if such a system of “Patent Linkage” is put in place?

The answer is obviously ‘no’. The system of Patent Linkage exists around the world.

Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be effectively implemented soon to encourage innovation in India.

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.

The Government of India accepts the Mashelkar Committee Report on ‘Incremental Innovation’ – what does it really mean?

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‘The Mashelkar Committee’ re-submitted its report in March 2009, which primarily deals with incremental innovation related to Pharmaceuticals Research.The conclusion of the report on the incremental innovation reads as follows:“It would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a ‘statutory exclusion of a field of technology”.

Government accepts the Mashelkar committee Report:

It has now been reported that the Government has accepted this revised report, last week. With this the questions raised in the raging debate, whether incremental innovation is TRIPS compliant or not have possibly been answered well, beyond any further doubt.

The acceptance of this report by the Government further vindicates the point that all patentable innovations are not “eureka type” or “path breaking”. Innovation is rather a continuous process and more so in pharmaceuticals. Such type of innovation in the pharmaceutical industry is quite similar to what one observes in the IT industry, where incremental innovation based on existing knowledge is more a norm than an exception. With incremental innovation not just efficacy of a product, but many other important unmet needs of the patients like safety, convenience and ease of administration of the drugs can be successfully met.

Thus innovations whether “path breaking” or “incremental” in nature, need to be encouraged and will deserve patent protection, if they are novel, have followed inventive steps and are industrially applicable or useful.

R&D based Indian Pharmaceutical industry gains considerably:

Many Indian Pharmaceutical Companies have already started working on the ‘incremental innovation’ model. Appropriate amendment of section 3(d) of the Indian Patents Act 2005 will thus help all concerned – the patients, the industry and other stakeholders, as long as the prices of such medicines do not become unaffordable to majority of the population for various reasons. In any case, the Government has the law available within the patents Act to deal with any such situation, if arises at all.

Does section 3(d) warrant an amendment now?

Mashelkar committee categorically observes the following:

1. “It would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a statutory exclusion of a field of technology”, as stated above.

2. “Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity. Therefore, ‘incremental innovations’ involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged.”

Thus, taking these recommendations together will the DIPP now finally conclude that Section 3(d) of the Patent Acts 2005 is not TRIPS compliant and recommend necessary amendments, accordingly to satisfy the needs of the Research based pharmaceutical industry?

Wait a minute – wait a minute:

The report also suggests:

1. “The Technical Experts Group (TEG) was not mandated to examine the TRIPS compatibility of Section 3(d ) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues.”

Will this comment make the Government conclude that Section 3(d) is TRIPS compliant, which includes ‘incremental innovation’ in general, however, with the rider of ‘properties related to significant improvement in efficacy’?

2. “Every effort must be made to provide drugs at affordable prices to the people of India”.

What will these efforts mean and how will these be implemented by the Government?

3. The TEG also recommends, “every effort must be made to prevent the practice of ‘ever greening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has the full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ‘evergreening’, rather than to introduce an arguable concept in the light of the foregoing discussion (paras 5.6 – 5.8 and paras 5.12 – 5.29) above of ‘statutory exclusion’ of incremental innovations from the scope of patentability.”

Will the Government (mis)interpret it as a vindication of Section 3(d), which does does not mean “statutory exclusion of incremental innovations from the scope of patentability” but has just made necessary provision within this section “to prevent the practice of ‘ever greening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product”, as recommended by the Mashelkar Committee?

Conclusion:

In the re-submitted report of the Mashelkar committee, the TEG has made quite a few very profound comments, recommendations and suggestions, the implications of all of which are important to all the stakeholders in various different ways. Will the acceptance of this report, as a whole, by the Government and subsequent attempt by the authorities for its implementation both in the letter and spirit, will amount to “chasing a rainbow”, as it were?

Only time will us, how this “satisfy all” zig-saw-puzzle gets solved in future.

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.

‘Prevention is better than cure’: Such a healthcare policy focus could effectively reduce the disease burden in India

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First National Health Policy was passed by the Parliament of India in 1983 and was last updated in 2002. How much of the policy intent has seen the light of the day is anybody’s guess.
Healthcare issues are not being effectively addressed:
Even after six decades of independence only one in three Indians has access to basic sanitation facility like toilets, exposing a large number of population to various types of ailments. World Health Organization (WHO) reports that around 9 lakh Indians die every year breathing polluted air and drinking contaminated water. Maternal mortality rate is the highest in India. Almost half of the children in our country are grossly underweight and this phenomenon is growing at a rate which is nearly double the rate of even Sub-Saharan Africa. One third of the world’s tuberculosis patients live in India. It is indeed an irony that even today India belongs to one of those four countries of the world where polio has not been successfully eradicated, as yet.

Increasing incidences of chronic ailments are exerting further pressure on the disease burden:

Along with diseases originating due to poor hygienic conditions and life style, new challenges are coming up with rapid emergence of non-infectious chronic diseases like, diabetic, cardiovascular and psychosomatic disorders.

Chronic diseases could soon become the most critical issue in the Indian healthcare system, if these are not prevented and successfully managed. It has been reported that population suffering from, for example, diabetes could generate health care costs which are almost double of those without this ailment.

All these factors together are leading to an abnormally high disease burden in the country where very unfortunately over 65% of the population are not having access to modern medicines, either due to lack of infrastructural facilities or the people just cannot afford the basic costs of healthcare.

Most of the diseases are preventable:

Many of these chronic ailments ascribe to common preventable risk factors. Poor hygienic conditions, unhealthy nutrition, lack of proper physical activity, alcohol and tobacco abuse are the major risk factors for these diseases. An integrated approach towards disease prevention, though challenging for the nation, is the need of the hour. It is a pity that our healthcare systems do not support this process. India as a whole carries an abysmally poor track record for a well thought out and structured healthcare promotion and disease prevention policies and strategies.

Indian healthcare system is highly skewed towards disease treatment rather than disease prevention:

Current healthcare systems of India, which offer access to modern medicines just to 35% of the population, are aimed mostly towards responding to urgent needs of patients.

Relieving symptoms of the disease with an expectation of curing the ailment are the basic pattern of healthcare in our country, wherever it is available and in whatever scales and proportion. Preventive health care is quite different from the above approach.

Australia has shown a way:

Australian National Health and Hospitals Reforms Commission report titled, “A healthier future for all Australians”, published in July 2009 recommends the establishment of an independent National Health Promotion and Prevention Agency, with a significant budget for creating a robust evidence base to find out what exactly works in prevention of a disease. Like for example , the report highlights “comparison of the relative efficacy of a medical intervention (gastric bypass), a pharmaceutical intervention (an anti-obesity drug), an allied health intervention (an exercise and diet program) and a population health intervention ( a community walking program) in reducing obesity.”

The report clearly articulates that just collecting evidence on prevention will not be enough; disease prevention should be put on the same footing as the treatment of the disease.

Are we listening?

The way forward in India:

As many diseases are preventable, every interaction with a healthcare professional should include advice and follow-up on the preventive measures. When with an integrated and systematic approach, patients will be provided with information and practices to reduce health risks, it is quite likely that they will then try to maintain a healthy and hygienic life style with regular exercise, drinking safe water, eating healthy food which they can afford, practicing safe sex, avoiding tobacco and alcohol abuse.

Such integrated and systematic preventive healthcare measures can significantly help reducing the disease burden of individuals and families, besides improving vastly the quality of life. To promote prevention in healthcare, the very basic requirement is the change in mindset of both the policy makers and the civil society. A collaborative or partnership approach involving all concerned to create mass awareness is absolutely essential to ensure commitment of the common man towards such an important healthcare initiative.

Important areas for action:

• Effective use of persuasive communication tools to establish that preventive health care can help avoiding expensive disease burden and improve quality of life

• Mass awareness and demonstration program to help creating a positive attitude and required skill sets in disease prevention activities within the community

• Motivate healthcare professionals to make prevention an integral part of every interaction with the patients

• Medical insurance and healthcare policies to offer adequate incentives for preventive healthcare through innovative means

What the government of India is doing towards preventive healthcare:

The Planning Commission of India reports as follows:

• Health education for primary and secondary prevention of Non Communicable Diseases (NCDs) through mobilization of community action

• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs

• Research support for: Multi-sectoral population-based interventions to reduce risk factors

• Explanation of the role of nutrition and lifestyle-related factors

• The development of cost effective interventions at each level of care.

All these are very appreciable statements of intent. However, how much of these intents are getting translated into reality will be very difficult fathom by the common mortals.

Conclusions:

Most of the serious types of ailments of a vast majority of the population of India can be prevented and the disease related complications can be effectively avoided, if we all have a will to do that. Can we take a leaf out of the formation of “National Health Promotion and Prevention Agency” in Australia?

Healthcare costs of the nation and utilization of its scarce resource can be successfully optimized by properly focusing on disease prevention related activities. In my view, effective measures towards preventive healthcare can quite efficiently address many pressing healthcare issues of the nation.

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.

An image makeover is in progress in the global pharmaceutical industry.

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At the beginning of 2009, Andrew Witty, the young head honcho of Glaxo SmithKline (GSK) initiated a one CEO tirade to recognize the global poor as a stakeholder of the global pharmaceutical industry. The industry that has been much maligned over a period of time, despite its yeoman contribution to the mankind, for aiming its drug discovery and delivery more often at the rich patients and not at the sick poor of mostly the developing and underdeveloped nations of the world.
Walking the talk:
Witty perhaps wondered and questioned why the poor population must share disproportionately the disease burden of the world. As the saying goes, ‘the proof of the pudding is in the eating’. Witty walked the talk and announced:

1. GSK medicines will be available in the least developed countries (LDC) of the world at 25% of their price in the United Kingdom (U.K).

2. 20% of profits from these medicines will be re-invested for various projects in those countries.

3. GSK will put 800 potential drug patents in a ‘patent pool’ to find cures of neglected, mainly, tropical diseases.

4. Scientists will be able to share the Research Center of GSK located at Tres Cantos in Spain for this purpose.

Will other global pharmaceutical players join in?

Andrew Witty, it appears, nurtures a very keen and very real desire to change the public image of the global pharmaceutical industry through transformation of its decade long culture and setting some of these path breaking examples, which only bravehearts can follow. However, many still feel, “Improving the greedy and uncaring image of the pharmaceutical industry is indeed a tough call.”

It has been reported in the media, during his announcement for the ‘patent pool’, the GSK CEO, in fact threw a challenge to other global pharmaceutical players to join him. What resulted thereafter was a bit of an anti-climax though with a very lukewarm response from others and Andrew with a sense of perhaps despair commented, “It has caught them a bit by surprise because we didn’t go around talking to people at the time, and they’ve had to come up this curve from zero.”

The Guardian in a very recent article on Andrew Witty, quoted him in the same context of extending access to modern medicines to the poor of LDCs, “he’s encouraging Indian companies to knock off its on-patent meds for sale in poor countries, as long as they make quality products and asks GSK for a license, which it will give royalty-free.”

In the same article, The Gurdian wrote, “He’s calling on every foreign company that makes profits in Uganda to cut its prices there”. “I don’t just mean drug companies,” Witty told the newspaper -”everybody.”

It does not cost much:

The GSK CEO admits that he is not losing much on his price cuts in the least developed countries. Uganda market of GSK is very small with turnover of about £9 million a year. The total profit from the LDCs is less than £5 million. “Those sorts of sums are like the 1p coins people don’t trouble to pick up off the pavement for a company with revenue of £24bn and a stock market valuation of £60bn,” he commented.

Conclusion:

Despite not too many encouraging responses being forthcoming from others, it is indeed admirable that a top global pharma company head honcho is setting such tough goals for himself in particular and the industry in general. The question that flows from here, even reading all these:

Are you kidding Andrew Witty? Do you really mean all these? Or it is another smart global pharma CEO hankering for just cheap publicity?

Seeing you Andrew Witty, though long ago, in flesh and blood, my heart says, you are possibly not made of that stuff to befool the world on this pressing issue of the world, being at your wit’s end.

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.