Tag Archives: Patent

Path-breaking medicines are just not enough… a comprehensive healthcare reform in India is long overdue

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The Prime Minister of India, Dr. Manmohan Singh reiterated the following in his speech at the 30th Convocation of PGIMER, Chandigarh on November 3, 2009:

”As in economics, so as in medicine too, it is easy to get lost in high level research and forget the ground realities. A common perception among the public is that institutions running with public money end up as ivory towers. It is widely felt that the poor and under-privileged sections of our population do not have adequate access to the health care system. The system needs structural reforms to improve the quality of delivery of services at the grass-root level. It has to be more sensitive to the needs of our women and children. We must also recognize that a hospital centered curative approach to health care has proved to be excessively costly even in the advanced rich developed countries. The debate on health sector reforms is going on in US is indicative of what I have mentioned just now. A more balanced approach would be to lay due emphasis on preventive health care”.

Some key research findings on ‘Public Health’:

Interesting research studies on public health highlight two very interesting points:

- Health of an individual is as much an integral function of the related socio-economic factors as it is

influenced by the person’s life style and genomic configurations.
- Socio-economic disparities including the educational status lead to huge disparity in the space of healthcare.

WHO ranking of the ‘World’s Health Systems’:

The WHO ranking of the ‘World’s health Systems’ was last produced in 2000. This report is no longer produced by the WHO due to huge complexity of the task.

In this interesting report, the number one pharmaceutical market of the world and the global pioneer in pharmaceutical R&D, the USA features in no. 37, Japan in no. 10, UK in no.18 and France tops the list with no.1 ranking. Among emerging BRIC countries, India stands at no. 112, Russia in no.130 and China in no. 144.

In a relative yardstick, although India scored over the remaining BRIC countries in year 2000, one should keep in mind that China has already undertaken a major healthcare reform in the last year. Early this year, we all have seen how President Obama introduced a new healthcare reform for the USA, despite all odds. India’s major reform in its healthcare space is, therefore, long overdue.

Details of WHO ‘World’s Health Systems’ ranking of the countries are available at the following link:

http://www.photius.com/rankings/healthranks.html

No need to reinvent the wheel:

When we look at the history of development of the developed countries of the world, we observe that all of them had invested and are continuously investing to improve the social framework of the country where education and health get the top priority. Continuous reform measures in these two key areas of any nation have proved to be the key drivers of economic growth. This is a work in continuous progress. Recent healthcare reforms both in China and the USA will vindicate this argument. In India we, therefore, do not require to reinvent the wheel, any more.

It has been observed that reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, the minority population with adequate access to knowledge, social and monetary power will always have necessary resources available to address their concern towards healthcare, appropriately.

Path breaking medicines are just not enough:

Regular flow of newer and path breaking medicines in India to cure and effectively treat many diseases, have not been able to eliminate either trivial or dreaded diseases, alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, polio, hepatitis and measles, our children still suffer from such diseases.

Reducing socio-economic inequalities is equally important:

All these continue to happen in India, over so many decades, because of socio-economic considerations, as well. Thus, together with comprehensive healthcare reform measures, time bound simultaneous efforts to reduce the socio-economic inequalities will be essential to achieve desirable outcome for the progress of the nation.

Proper focus on education is critical for a desirable health outcome:

Education is of key importance to make any healthcare reform measure to work effectively. Very recently we have witnessed some major reform measures in the area of ‘primary education’ in India. The right to primary education has now been made a fundamental right of every citizen of the country, through a constitutional amendment.

As focus on education is very important to realize the economic potential of any nation, so is equally relevant in the healthcare space of the country. India will not be able to realize its dream to be one of the economic superpowers of the world without a sharp focus and significant resource allocation in these two critical areas – Health and Education, simultaneously.

Progress in the healthcare space of India:

It sounds quite unfair, when one comments that nothing has been achieved in the area of healthcare in India, as is usually done by vested interests with a condescending attitude in various guises. Since independence, India has made progress, may not be highly significant though, with various government sponsored and private healthcare related initiatives, as follows:

- Various key disease awareness/prevention programs across the country, for both communicable and non-communicable diseases.
- Eradication of smallpox
- Excellent progress in polio eradication program
- Country wide primary vaccination program
- Sharp decline in the incidence of tuberculosis
- Significant decrease in mortality rates, due to water-borne diseases.
- Good success to bring malaria under control.
- The mortality rate per thousand of population has come down from 27.4 to 14.8 percent.
- Life expectancy at birth has gone up to 63 years of age.
- Containment of HIV-AIDS
- India has been recognized as the largest producers and global suppliers of generic drugs of all categories and types.
- India has established itself as a global outsourcing hub for Contract Research and Contract Manufacturing Services (CRAMS).
- The country has now been globally recognized as one of the fastest growing emerging markets for the pharmaceuticals

New healthcare initiatives in India:

There are various hurdles though to address the healthcare issues of the country effectively, but these are not definitely insurmountable. National Rural health Mission is indeed an admirable scheme announced by the Government. Similar initiative to provide health insurance program for below the poverty line (BPL) population of the country, is also commendable. However, effectiveness of all such schemes will warrant effective leadership at all levels of their implementation.

Per capita public expenditure towards healthcare is inadequate:

Per capita public expenditure towards healthcare in India is much lower than China and well below other emerging countries like, Brazil, Russia, China, Korea, Turkey and Mexico.

Although spending on healthcare by the government gradually increased in the 80’s overall spending as a percentage of GDP has remained quite the same or marginally decreased over last several years. However, during this period private sector healthcare spend was about 1.5 times of that of the government.

It appears, the government of India is gradually changing its role from the ‘healthcare provider’ to the ‘healthcare enabler’.

High ‘out of pocket’ expenditure towards healthcare in India:

According to a study conducted by the World Bank, per capita healthcare spending in India is around Rs. 32,000 per year and as follows:

- 75 per cent by private household (out of pocket) expenditure
- 15.2 per cent by the state governments
- 5.2 per cent by the central government
- 3.3 percent medical insurance
- 1.3 percent local government and foreign donation

Out of this expenditure, besides small proportion of non-service costs, 58.7 percent is spent towards primary healthcare and 38.8% on secondary and tertiary inpatient care.

Role of the government:

In India the national health policy falls short of specific and well defined measures.

Health being a state subject in India, poor coordination between the center and the state governments and failure to align healthcare services with broader socio-economic developmental measures, throw a great challenge in bringing adequate reform measures in this critical area of the country.

Healthcare reform measures in India are governed by the five-year plans of the country. Although the National Health Policy, 1983 promised healthcare services to all by the year 2000, it fell far short of its promise.

Underutilization of funds:

It is indeed unfortunate that at the end of most of the financial years, almost as a routine, the government authorities surrender their unutilized or underutilized budgetary allocation towards healthcare. This stems mainly from inequitable budgetary allocation to the states and lack of good governance at the public sector healthcare delivery systems.

Encourage deep penetration of ‘Health Insurance’ in India:

As I indicated above, due to unusually high (75 per cent) ‘out of pocket expenses’ towards healthcare services in India, a large majority of its population do not have access to such quality, high cost private healthcare services, when public healthcare machineries fail to deliver.

In this situation an appropriate healthcare financing model, if carefully worked out under ‘public – private partnership initiatives’, is expected to address these pressing healthcare access and affordability issues effectively, especially when it comes to the private high cost and high quality healthcare providers.

Although the opportunity is very significant, due to absence of any robust model of health insurance, just above 3 percent of the Indian population is covered by the organized health insurance in India. Effective penetration of innovative health insurance scheme, looking at the needs of all strata of Indian society will be able to address the critical healthcare financing issue of the country. However, such schemes should be able to address domestic and hospitalization costs of ailments, broadly in line with the health insurance model working in the USA.

The Government of India at the same time will require bringing in some financial reform measures for the health insurance sector to enable the health insurance companies to increase penetration of affordable health insurance schemes across the length and the breadth of the country.

A recent report on healthcare in India:

A recent report published by McKinsey Quarterly, titled ‘A Healthier Future for India’, recommends, subsidizing health care and insurance for the country’s poor people would be necessary to improve the healthcare system. To make the healthcare system of India work satisfactorily, the report also recommends, public-private partnership for better insurance coverage, widespread health education and better disease prevention.

Conclusion:

In my view, the country should adopt a ten pronged approach towards a new healthcare reform process:

1. The government should assume the role of provider of preventive and primary healthcare across the nation to ensure access to healthcare to almost the entire population of the nation.

2. At the same time, the government should play the role of enabler to create public-private partnership (PPP) projects for secondary and tertiary healthcare services at the state and district levels.

3. The issue of affordability of medicine can best be addressed by putting in place a robust model of healthcare financing for all sections of the population of the country. Through PPP a strong and highly competitive health insurance infrastructure needs to be created through innovative fiscal incentives.

4. These insurance companies will be empowered to negotiate all fees payable by the patients for getting their ailments treated including doctors/hospital fees and the cost of medicines, with the concerned persons/companies, with a key objective to ensure access to affordable high quality healthcare to all.

5. Create an independent regulatory body for healthcare services to regulate and monitor the operations of both public and private healthcare providers/institutions, including the health insurance sector.

6. Levy a ‘healthcare cess’ to all, for effective implementation of this new healthcare reform process.

7. Effectively manage the corpus thus generated to achieve the healthcare objectives of the nation through the healthcare services regulatory authority.

8. Make this regulatory authority accountable for ensuring access to affordable high quality healthcare services to the entire population of the country.

9. Make operations of such public healthcare services transparent to the civil society and cost-neutral to the government, through innovative pricing model based on economic status of an individual.

10. Allow independent private healthcare providers to make reasonable profit out of the investments made by them

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.

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

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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.

India and China…Practical relevance of ‘Priority Watch List (PWL)’ status in ‘Special 301 Reports’ of America…and the REAL ‘Game Changers’

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Many stakeholders around the world believe that Intellectual Property Rights (IPR) environment in China is far better than what we have in India. Interestingly “2010 Special 301 Report” of the United States of America dated April 30, 2010, paints a totally different picture.

The priority watch list (PWL)’ countries:

The Office of The United States Trade Representative, in the Press Release of ’2010 Special 301 report’, mentioned the names of PWL countries as follows:
“Trading partners on the Priority Watch List (PWL) do not provide an adequate level of IPR protection or enforcement, or market access for persons relying on intellectual property protection. China, Russia, Algeria, Argentina, Canada, Chile, India, Indonesia, Pakistan, Thailand, and Venezuela are on the Priority Watch List. These countries will be the subject of particularly intense engagement through bilateral discussion during the coming year”.

It is, therefore, quite clear that so far as IPR environment is concerned both China and India feature in the PWL of America. This totally breaks the perceived myth, as is being very often made out to be by many, that China is a better implementer of IPR than India.
Reasons for featuring in the ‘Priority Watch List’ (PWL):
“2010 Special 301 Report” makes the following comments for China and India being in the PWL of the USA:

China:
1. China will remain on the Priority Watch List in 2010 and will remain subject to Section 306 monitoring. China’s enforcement of IPR and implementation of its TRIPS Agreement obligations remain top priorities for the United States…the overall level of IPR theft in China remains unacceptable.
2. The United States is heartened by many positive steps the Chinese government took in 2009 with respect to these issues, including the largest software piracy prosecution in Chinese history, and an increase in the numbers of civil IP cases in the courts.
3. The United States is also deeply troubled by the development of policies that may unfairly disadvantage U.S. rights holders by promoting “indigenous innovation” including through, among other things, preferential government procurement and other measures that could severely restrict market access for foreign technology and products.
4. China’s IPR enforcement regime remains largely ineffective and non-deterrent.
5. The U.S. copyright industries report severe losses due to piracy in China.
6. Counterfeiting remains pervasive in many retail and wholesale markets.
7. China maintains market access barriers, such as import restrictions and restrictions on wholesale and retail distribution, which can discourage and delay the introduction into China’s market of a number of legitimate foreign products that rely on IPR.
8. China’s market access barriers create additional incentives to infringe products.
9. China adopts policies that unfairly advantage domestic or “indigenous” innovation over foreign innovation and technologies.
10. Draft Regulations for the Administration of the Formulation and Revision of Patent-Involving National Standards, released for public comment in November 2009 by the Standardization Administration of China (SAC), raise concerns regarding their expansive scope, the feasibility of certain patent disclosure requirements, and the possible use of compulsory licensing for essential patents included in national standards.
11. With respect to patents, on October 1, 2009, the Third Amendment to China’s Patent Law, passed in December 2008, went into effect. While many provisions of the Patent Law were clarified and improved, rights holders have raised a number of concerns about the new law and implementing regulations, including the effect of disclosure of origin requirements on patent validity, inventor remuneration, and the scope of and procedures related to compulsory licensing, among other matters. The United States will closely follow the implementation of these measures in 2010.
12. The United States encourages China to provide an effective system to expeditiously address patent issues in connection with applications to market pharmaceutical products.
13. The United States continues to have concerns about the extent to which China provides effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products.
14. Generally, IPR enforcement at the local level is hampered by poor coordination among Chinese government ministries and agencies, local protectionism and corruption, high thresholds for initiating investigations and prosecuting criminal cases, lack of training, and inadequate and non-transparent processes. As in the past, the United States will continue to review the policies and enforcement situation in China at the sub-national levels of government.

India:
1. India will remain on the Priority Watch List in 2010.
2. India continues to make gradual progress on efforts to improve its legislative, administrative, and enforcement infrastructure for IPR.
3. India has made incremental improvements on enforcement, and its IP offices continued to pursue promising modernization efforts.
4. Among other steps, the United States is encouraged by the Indian government’s consideration of possible trademark law amendments that would facilitate India’s accession to the Madrid Protocol.
5. The United States encourages the continuation of efforts to reduce patent application backlogs and streamline patent opposition proceedings.
6. Some industries report improved engagement and commitment from enforcement officials on key enforcement challenges such as optical disc and book piracy.
7. However, concerns remain over India’s inadequate legal framework and ineffective enforcement.
8. Piracy and counterfeiting, including the counterfeiting of medicines, remains widespread and India’s enforcement regime remains ineffective at addressing this problem.
9. The United States continues to urge India to improve its IPR regime by providing stronger protection for patents.
10. One concern in this regard is a provision in India’s Patent Law that prohibits patents on certain chemical forms absent a showing of increased efficacy. While the full import of this provision remains unclear, it appears to limit the patentability of potentially beneficial innovations, such as temperature-stable forms of a drug or new means of drug delivery.
11. The United States also encourages India to provide protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.
12. The United States encourages India to improve its criminal enforcement regime by providing for expeditious judicial disposition of IPR infringement cases as well as deterrent sentences, and to change the perception that IPR offenses are low priority crimes.
13. The United States urges India to strengthen its IPR regime and will continue to work with India on these issues in the coming year.

Responses and reactions in India:
‘Special 301 Reports’ have always been received with skepticism both by the Government of India and the domestic media. Even in the past, PWL status has hardly bothered either India or China to bring in a radical change in the IPR environment of the respective countries, as desired by the USA.

A recent article on the ‘Special 301 Report 2010’ that appeared in ‘Business Standard’, Sunday, May 2, 2010 comments as follows:

“India, in fact, continues to be on the ‘priority watch list’ of the USTR’s ‘Special 301’ report, despite a detailed submission of the intellectual property rights (IPR) compliance measures initiated by it in 2009”.

Many stakeholders in India feel and have also articulated that despite the country taking important steps to improve implementation of IPR within the country, the position of India in ‘Special 301 Reports’ has not changed much since last so many years. India, therefore, envisages no harsh measures by the US Government as a result of being continuously in the PWL of the ‘Special 301 Reports’.

Why then China attracts more Foreign Direct Investments (FDI) than India in the Pharmaceutical space?

In my view, this has got not much to do with the IPR environment in these two countries. The key ‘Game Changers’ for China, I reckon, are as follows:

1. Larger market size due to greater access to medicines:
Access to medicine in China covers 85% of their 1.2 billion population, against 35% of 1.1 billion population of India.

2. Larger market size due to better affordability of medicine:

Around 85% of the population in China is covered through various medicine price reimbursement schemes. Whereas in India around 78% of such expenditure is ‘out of pocket’ expenses. Conversely, not more than 22% of the population is currently covered by drug price reimbursement schemes in India.

3. Strong signals to the Government that ‘innovative companies’ are contributing to the ‘Economic Progress’ of the country:

In such a booming pharmaceutical market scenario, it is essential for the business to keep the government engaged to help create a more ‘innovative pharmaceutical business’ friendly environment, where even a slight improvement in the prevailing IPR conditions will give a significant boost to their business performance.

IMS forecasts that by 2013 China is going to be the third largest pharmaceutical market in the world with an estimated turnover of US $66.7 billion against 13 ranking of India in the same league table, with an estimated turnover of US $15.5 billion.

Similar trend was observed in the immediate past, as well. As reported by IMS MAT September 2009, China registered a turnover of US $24 billion with 27.1% growth against US $7.7 billion with 12.9% growth of India, during the same period. IMS, based on their research data forecasts that during 2008-13 period, China will contribute 36% of the growth of the Asia Pacific Region, against 12% of India.

Under this situation, it appears quite prudent for the ‘innovative pharmaceutical companies’ to send signals to the Chinese Government that they are contributing to the ‘Economic Progress’ of the nation by making significant direct investments, obviously with an expectation to get more business friendly environment in that country.

Recent ‘Healthcare Reform’ in China has further improved its market attractiveness.

Thus the business attractiveness of China as a pharmaceutical market scores much higher than India, fetching more FDIs for them, prevailing IPR environment and PWL status in the ‘Special 301 Reports’ for the country not withstanding.

Conclusion:

Overall IPR environment in India, many experts strongly believe, does not seem to be much different from China, if not a shade better. While interacting with Chinese experts recently in that part of the world, I understand, ‘Data Protection’ is just ‘on paper’ in China, causing a huge issue for the innovator companies in that country. Similar situation prevails so far as the effectiveness of patent enforcement mechanism is concerned, where innovator companies are fighting and required to fight such infringement cases in the provincial level and in so many provinces of the country, posing a huge challenge to the patent holders.

So far as PWL status in ‘Special 301 Reports’ is concerned, it seems to have almost lost its relevance, as both India and China become stronger economies with increasing global dependence on them, consistently registering double digit or near double digit GDP growth.

In china, the pharmaceutical market attractiveness, its size and growth are driven by two key factors as mentioned above, viz, huge domestic market access/ penetration and better affordability of medicines through various effective medicine price re-imbursement schemes, across the country. The recent ‘Healthcare Reform’ of the country has added further momentum to this progress.

So long as India does not take robust policy measures, followed by their effective implementation to address, much ignored, the access and affordability issues of medicines for the common man, the country will continue to be a laggard, compared to China in the race of market leadership within the global pharmaceutical industry.

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.

My thoughts on the world IPR day, April 24

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Ushering in the Product Patent Regime in India, effective January 1, 2005, heralds the dawn of a new era… an era that is expected to add speed to the wheels of progress of the nation. The new paradigm vindicates the importance of encouraging, protecting and rewarding innovation to meet the unmet needs of the population. At the same time this change instills new hope in our mind that India will now compete with the bests in the world, more innovatively and effectively, to curve out a significant share of the global economy.

Criticism continues, unfortunately though…

However, it is quite unfortunate that the pharmaceutical product patents that protect today’s innovations and drive research and development to create tomorrow’s life-saving treatments, are under criticism from some quarters. India chose to follow an alternative to Product Patent regime for many years. In 1970, the Government of India amended its IP laws with a clear objective in mind to reduce the prices of medicines to improve their access to the ailing population of the country.

A panacea:

As a result, some drugs were made cheaper. However, the moot question that we need to address now: was it a panacea? While looking back, it does not really appear so. On the contrary, the situation remained as gloomy thereafter, so far as the access to medicines is concerned. After almost four decades of continuation with the above policy, around 65% of Indian population still does not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China.

Children still go without routine vaccinations, though the Government has made the primary vaccination programs free in our country, for all. Even in a situation like this, where affordability is no issue, only about 44% of infants (12 – 23 months) are fully vaccinated against six major childhood diseases – tuberculosis, diphtheria, pertussis, tetanus, polio and measles. Moreover, as we know, despite distribution of cheaper generic HIV AIDS drugs by the Government and others mostly free for years, only 5% cent of India’s AIDS patients were receiving any drugs by the end of 2006.

The above two important examples prove the point very clearly that addressing the issue of price alone will not help our country to solve the issue of poor access to medicines to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare delivery system, healthcare financing and rapid development of healthcare infrastructure of the country by the Government or through Public Private Partnership (PPP), will help address this pressing issue.

 

Paving way for innovation…issues of affordability and access need to be addressed differently :

Indian Patents Act 2005 has paved the way for innovation and hi-tech research and development within the country. Contrary to adverse forecasts from some quarters, prices of medicines have not gone up.

However, while medicines play a relatively small role in rising overall healthcare spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to required medicines. Thus a good affordable insurance coverage (both Government and Private) available to all Indians belonging to various socio-economic strata, together with the above measures, will help address the key issues of both access and affordability of medicines to all, in a holistic way.

IPR regime…is it more robust in China?

India is continuously compared with China in various parameters both within and outside the country. It is known to all that China is now attracting more Foreign Direct Investments (FDIs), be it Pharmaceutical R&D or Clinical developments of the new drugs. The moot question is why?

India restricts incremental innovation with section 3(d) of the Patents Act, but China has no such restrictive provisions. India does not protect regulatory data of the innovators, but China does. India does not have any patent linkage system with the marketing approval of the generic versions of the patented molecules, but China has put in place such system in their country.

With all these has India been able to improve affordability and access to medicines better than China or as even much as China? No, unfortunately, it has not. In China about 85% of the population has access to medicines, in India the equivalent figure will read as just 35%. Why then are such restrictions in the Patents Act of India? Have the drug prices gone up disproportionately in India post 2005? No… Not really. Unfortunately, the share of voice of the generic industry on these issues being much shriller, the voice of the innovator companies, be it Indian or global, is getting lost in the din, on all these important issues.

Conclusion:

The attack on patents is not a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above. Health of our nation will depend on how well these key issues are being addressed by the policy and decision makers. Our country cannot afford to ignore the fact that intellectual property is one of the keys to prosperity of a great nation like India and it should be encouraged, protected and rewarded under a robust patents act of the country for inclusive growth.

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.

Indian Patent office (IPO) asks for details of ‘working of patents’ in India – does it herald the beginning of a new chapter in the IPR regime of the country or it could trigger another raging debate

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A Public Notice dated 24/12/2009 issued by the Controller General of Patents, Design & Trade Marks, directing all Patentees and Licensees to furnish information in Form No.27 on ‘Working of Patents’ as prescribed under Section 146 of the Patents Act (as amended) read with Rule 131 of the Patents Rule 2003 ( as amended). The notice also draws attention to penalty provisions in the Patent Act, in case of non-submission of the aforesaid information.The Last date for filing the information is March 31, 2010. Only history will tell us about the possible future impact of this notification.Why is this information needed by the IPO?

Indian Patent Law specifies a provision for submission of information in Form 27 regarding the details of ‘working of a patent’ granted in India, which is a statutory requirement.

The information sought by the IPO in Form 27 can be summarized as follows:

A. For not ‘working of patent’: the reasons for not working and steps being taken for ‘working of the invention’ to be provided by the patentee.

B. In case of establishing ‘working of a patent’, the following yearly information needs to be provided:

1. The quantity and value of the invention worked; which includes both local manufacturing and importation.
2. The details to be provided if any licenses and/or sub-licenses have been granted for the products during the year.
3. A statement as to whether the public requirements have been met partly/adequately to the fullest extent at a reasonable price.

NB:

• A fine of up to (USD $25,000 may be levied for not submitting or refusing to submit the required information by the IPO.
• Providing false information is a punishable offence attracting imprisonment of up to 6 months and/or a fine.

What would amount to ‘Local Working of Patent’ in India?

Obviously, the question will arise what then would constitute ‘working of patent’ in the country. It is generally believed that ‘commercial exploitation’ of patented products in India will mean local ‘working of patent’ in the country.

This is still a controversial issue as some experts claim that ‘local working of patent’ can be established only through local manufacturing and thus importation of such products will not be considered as ‘local working of patent’ in India.

However, other groups of experts opine, as a signatory of article 21 (1) of TRIPS, India is under clear obligation to accept importation of a locally patented product as ‘local working of patent’.

How affordable is affordable?

Besides, ‘local working of patent’ issue, section 84.1 of the patent Act 2005 under ‘Compulsory licenses’ says:

“At any time after the expiration of three years from the date of the (grant) of a patent, any person interested may make an application to the controller for grant of compulsory license on patent on any of the following grounds, namely:

a. that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
b. that the patented invention is not available to the public at a reasonably affordable price, or
c. that the patented invention is not worked in the territory of India.”

The question, therefore, will arise, who will determine whether a patented product is available to the public at a reasonably affordable price or not? Moreover, what will be the measure, formula or yard to stick to decide reasonably affordable price? The next question could be – reasonably affordable price for whom … for the rich minority… or for around 300 million middle class population of the country… or for another 713 million lower middle class or poorer section of the society?

How ‘affordable’ then will be considered as ‘affordable’ in such cases?

Conclusion:

Whatever may be the case, it would be interesting to know, how the Indian patent Office (IPO) would deal with these details. In any case, such information will not remain a secret. ‘The Right to Information Act’ will help ferret all these details out in the open.

Thus, when the ‘moment of truth’ comes, one will be quite curious to note how the proponents of ‘compulsory licensing (CL)’ would try to push their envelope hard enough on this score to establish their view points… And on the other hand how would the innovator companies establish that the price is indeed a function of the value that the product would offer… and in that process would gear themselves up with relevant and credible, possibly ‘Health Technology Assessment (HTA)’ details to establish the price premium of patented products in India to meet the ‘unmet needs of the ailing patients.’

Striking a right balance in this matter by the IPO between rewarding fruits of expensive, risky and time consuming innovation, on the one hand, and help improving access to affordable modern medicines to a vast majority of the population of the country, on the other, will indeed be a daunting task.

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.

Regulatory Data Protection and Indian Interest

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Of late, I read and hear raging debates, especially through media, on the relevance of Regulatory Data Protection (RDP) or Data Exclusivity in India. This issue is being considered by many as a fight between the commercial interests of multinational and the domestic Indian companies. In this fight the provision for RDP is being highlighted as something, which is against our national interest.

In this scenario, I shall try to argue that in our country, on the contrary, a provision for a robust RDP mechanism, which will protect clinical trial data of ANY innovator both against disclosure and unfair commercial use, is in the best interest of India, at least, for the following four important reasons:

1. RDP to benefit even small to medium size domestic Indian pharmaceutical companies:

Small to medium size pharmaceutical companies in India, who do not have adequate wherewithal to get engaged in drug discovery research, will also be benefitted from RDP. They will be able to obtain data exclusivity for a specific period on the new clinical data that they will be generating for new fixed dose combinations (FDC), new medical uses and new formulations of medicines. This will help them create more resources to invest in R&D to meet the unmet needs of the patients.

2. RDP on traditional medicines to benefit Indian Pharmaceutical companies:

Rich reservoir of Indian traditional medicines, commonly categorized under Ayurvedic, Unani and Siddha, are being used by a large majority of Indian populations over centuries. Such medicines are not protected by product patents, as such.

Further clinical development of these traditional medicines for greater efficacy and safety profile or newer usage, even if the ultimate product is not patentable, will help the common man immensely with affordable medicines.

The new clinical data generated by the researcher for such initiatives will be protected through RDP for a specific time period both against disclosure and unfair commercial use to make such efforts commercially viable and attractive.

RDP in this way can help the researcher to invest in the R&D of traditional plant based or similar medicines, which are not protected by any product patent. This in turn will help many domestic Indian pharmaceutical companies to get engaged in less cost intensive R&D with a robust economic model, built around RDP or data exclusivity.

3. RDP to boost outsourcing of clinical trials to India:

As per CII, clinical trials market in India is currently growing at 30-35%. McKinsey estimated that EU and US based pharmaceutical companies will spend US$ 1.5 billion per year on clinical trials in India by 2010. Currently China with 5 year regulatory data protection in place is having significant edge over India in this area.

Many CROs have started making investments in India to create world class clinical trial facilities to encash this opportunity. Such investments, both domestic as well as in form of FDI, are expected to further increase, if an effective RDP mechanism is created within the country.

4. RDP to help Competition from China:

Despite some significant inherent weaknesses of China, as compared to India, in terms of a preferred global pharmaceutical business destination, China is fast outpacing India in R&D related activities. More number of global R&D based pharmaceutical companies has started investing quite significantly in China. One of the key reasons for such development is that China provides product patent, patent linkage and RDP, whereas India provides only product patent.

R&D based global pharmaceutical and biotech companies who want a robust IPR regime in the countries where they will invest more, therefore, prefer China to India in terms of FDI.

A robust RDP mechanism in India would help bridging this gap considerably.

Conclusion:

There is a widespread apprehension in some quarters in India that RDP will delay the entry of cheaper generic drugs in the country. This apprehension seems to be unfounded.

Unlike product patent, RDP will not provide any market exclusivity even within the specified period of RDP. Any generic manufacturer can generate its own regulatory data and obtain marketing approval from the Drug Controller General of India (DCGI) to market a non patent related product in the country, just as in any developed market of the world. Thus RDP will not delay any generic entry into the market.

My final argument, if the provision for RDP or Data Exclusivity will delay the entry of cheaper generic medicines into India, why the same is not happening in the developed markets of the world like, USA, EU, Japan and even in China, despite having a robust provision for RDP or Data Exclusivity firmly in place in each of these countries?

Thus in my view, the provision for RDP in India is undoubtedly in the best interest of our 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

Indian Patent offices (IPOs) have started showing improvement in their functioning; still lot of grounds to cover.

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Indian Patent offices are located, with four clearly specified jurisdictions, at New Delhi, Mumbai, Kolkata and Chennai.

Since last few years enough efforts have been made towards overall capacity building initiatives, training of personnel and digitalizing the huge databank of these offices, with wide scale application of information technology (IT). As a result the patent offices are now having almost a centralized database to provide online services to the users in various areas of their operations. Users are now having the facilities of not only online patent search, but also for online patent applications.

More extensive IT applications are required to achieve greater system efficiency and transparency:

However, to bring in more efficiency and transparency in the system, there is a need to introduce appropriate IT applications in all the transactional interfaces between the patent office personnel and the patent applicants.

Still there are lots of grounds to cover:

Following are the key areas which should be taken care of by the Controller General of Patents, Design and Trade marks (CGPDTM) to make the IPOs more efficient, transparent and effective:

1. The Patent Manual, which provides essential guidelines to the patent examiners to bring in uniformity in the patent application examination process, is long overdue.

2. Many patent applicants feel that there is a need to include the International Non-proprietary Names (INN) in the title of pharmaceutical patent applications by the IPO.

3. Inadequate bandwidth makes the IT system slow, reducing its operational efficiency.

4. Electronic-filing of patent applications has been introduced, but there is no facility of paying the fees online by credit card. This facility should be introduced to make it more convenient for applicants to file patent applications online, adding more speed to the process.

5. Electronic prosecution of patent applications should be introduced to make the patent prosecution virtually paperless and more efficient.

6. Despite new technological measures most patent officers and also the public in general are still following the traditional method of filing the patent applications due to the ease and authenticity of filing records. To encourage applicants to file applications electronically, incentives such as reduced fees may be offered to those who file their applications electronically.

7. The IPOs should digitize all the physical files lying with them, so that file histories of each application are available online.

8. The Patent offices should have designated centres to provide assistance to applicants for filing or prosecuting applications.

9. Clear guidelines to be issued for conducting pre-grant and post grant opposition proceedings. Presently they are being handled in an arbitrary manner.

10. In order to introduce an efficient system of patent prosecution, it is recommended that the IPOs adjust patent term to compensate patentees for any delay in the grant of the patent that reduces the term of the patent, when such delay is caused solely by the IPOs.

11. Decision making and its communication to all concerned to be made faster at the IPOs. A system to be instituted for issuing the operative part of the decision first, followed by details of the decision taken. These should be advertised immediately in the technical journal to close proceedings at the earliest. Delays are leading to increase in the waiting period for the grant of patents, even if the proceedings have been concluded (opposition or otherwise) attracting serial and frivolous pre-grant oppositions. Such delays are also preventing the patent applicants to get their grants. As a result they are unable to initiate infringement proceedings against infringers quickly, defeating the very purpose of the patent system.

12. The timeline for an application, which will be taken up for examination, needs to be clearly defined. Currently, there is no time-line defined for taking up the applications for examination.

Conclusion:

All concerned will feel happy, if the DIPP in general and the CGPDTM in particular take note of these suggestions and formalize a process within the IPOs to address these important issues.

Growing discontentment of the past, in several areas of operation within the IPOs, is now being effectively addressed. However, the system still warrants more capacity building to enable the IPOs provide world class services to the patent applicants. This process needs to be expedited to further enhance the credibility of the new IPR regime 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.

Open Source Drug Discovery (OSDD) initiative for the tropical diseases by CSIR and cancer by GlaxoSmithKline deserves a big applaud and support from all concerned.

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As the name suggest the ‘Open Source Drug Discovery (OSDD)’ is an open source code model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). In this model all data generated related to the discovery research will be available in the open for collaborative research inputs. The licensing arrangement of OSDD where both invention and copyrights will be involved, are quite different from any ‘Open Source’ license for a software development.

In OSDD, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source.

The Objectives of OSDD:

The key objective of OSDD is to encourage drug discovery initiatives, especially for the neglected diseases of the world to make these drugs affordable to the marginalized people, especially of the developing world.

International initiative:

In June 2008, GlaxoSmithKline (GSK) announced in Philadelphia, “It was donating an important slice of its research on cancer cells to the cancer research community to boost the collaborative battle against this disease.”

With this announcement genomic profiling data for over 300 sets of cancer cell lines was released by GSK to the National Cancer Institute’s bioinformatics grid. It has been reported that around 1000 researchers actively contribute to this grid from across the industry, research institutes, academia and NGOs.

Many believe that the OSDD initiative will gain momentum to encourage many more academic institutions, researchers and even smaller companies to add speed to the drug discovery process and at the same time make the NCEs/NMEs coming through such process much less expensive and affordable to a large section of the society.

On an average it takes about 8 to 10 years to bring an NCE/NME to market with a cost of around U.S$ 1.7 billion.

OSDD in India:

In India, Dr. Samir Brahmachari, the Director General of the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement. CSIR believes that for a developing country like India, OSDD will help the common man to meet his unmet medical needs in the areas of neglected tropical diseases.

OSDD in India is a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world, together.

To fund the OSDD initiative of the CSIR the Government of India has allocated around U.S $40 million and an equivalent amount of funding would be raised from international agencies and philanthropists.

It has been reported that current priority of CSIR in its OSDD program is the tuberculosis disease area.

Why tuberculosis?

The published reports indicate, in every 1.5 minutes one person in India dies of tuberculosis and about 33 percent of the global population is infected primarily with Mycobacterium tuberculosis. The world is still quite far from having an effective vaccine or drug, which can offer long term protection against this dreaded disease.

Partnerships of Industry with belief in Open Source systems and models with CSIR in its OSDD project for tuberculosis, could help finding out a suitable answer to this long standing problem, sooner than later.

Success of OSDD initiative of CSIR:

Late November 2009, I received a communication from the CSIR informing that their OSDD project, since its launch in September 2009, has crossed 2000 registered users. The pace of increase in the number of registered users indeed reflects the confidence this initiative has generated among the interested researchers, the world over.

OSDD community of CSIR has several credits to be proud of including open peer review, open funding review, large number of real time data on open lab notebook.

CSIR has also indicated that the next big leap planned by them is to completely re-annotate the MTb genome for which OSDD has launched ‘Connect to Decode’ 2010 (http://crdd.osdd.net). They initially expected about 150 participants to join, but within a week, they got about 450 participants. That is really the strength of collaboration on OSDD!

Congratulations CSIR and its leader Dr. Samir Brahmachari.

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.