Tag Archives: IPR

Unlike China, IPR issues in India are being hijacked by the issue of ‘Access to Affordable Modern Medicines’.

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‘Incremental innovation’, related to the pharmaceutical industry, has become a point of raging debate in India. Over a period of time ‘not really a breakthrough’ but ‘incremental inventive steps’ to discover New Chemical Entities (NCE), which would offer significant benefits to the patients, are being considered as of critical importance by the stakeholders of the pharmaceutical industry, the world over. Such types of innovations are being termed as ‘incremental innovation’ , with underlying implied meaning of ‘frivolous’ nature of the innovation, to some section of people.

Most innovations in the pharmaceutical industry have always been ‘incremental’ in nature:

We have been observing such ‘incremental innovation’ from ‘Penicillin era‘ with different derivatives of penicillins, right through to ‘Quinolone era’ with ciprofloxacin, ofloxacin, sparfloxacin etc to ‘H2 receptor antagonists’ with cimetidine, ranitidine, roxatidine to ‘proton pump inhibitors’ with omeprazole, esomeprazole, rabeprazole etc.

We see such important ‘incremental innovation’ with many successful drugs across various disease areas. How many different varieties of ‘statins’, ‘betablockers’, ‘ace inhitors’ etc we have been prescribed by the medical profession over so many years with amazing results? This trend continues to offer better and better treatment options to the patients through the medical profession, across the world.

Unfortunately ‘incremental innovation’ has become a contentious issue in India. Section 3d of the Indian Patents Act 2005 has become a key barrier to continue with this process of innovation, in search of better and better medicines. ‘Breakthrough innovations’, which are very important though, are not as frequent in the pharmaceuticals industry, just as in many other industries, including Information technology (IT). ‘Incremental innovations’ are, therefore, the bedrock to improve the types of medications to treat various disease conditions.

A quick comparison with China:

As reported by the Department of Commerce of the U.S Government, domestic consumption of medicines both in India and China is around 70% of the domestic productions of the respective countries. These medicines are available at a very reasonable price to the local populations.

Fuelled by strong domestic demand, coupled with exports to other countries, the pharmaceutical industry in both India and China are showing impressive growth, China being ahead of India in both pace of growth, as well as in terms of market size.

Why some key IPR issues, like ‘incremental innovation’, are facing stiff opposition in India when it is not so in China?

Intellectual Property Regime (IPR) is now in place in both the countries. However, criteria of ‘patentability’, as mentioned above, still remain a contentious issue in India. The issue of ‘access to affordable modern medicines’ is being unnecessarily dragged into the discussion of IPR related issues, where resolution of each of these two issues warrants totally different types of approaches.

The issue of ‘access’ and ‘affordability’ of medicines must be addressed with all earnestness by all concerned, but surely, I repeat, with a different kind and sets of measures. Mixing IPR issues with the issue of ‘access to affordable modern medicines’ sends a wrong message, which would mean that IPR is the cause of this problem in India or in other words, IPR has aggravated this problem since January 1, 2005, the day the new Patents Act came into force in India. This definitely is not the reality in our country.

As I have been saying repeatedly, why then from 1972 to 2005, when pharmaceutical products patents were not being granted, the access to affordable modern medicines were denied to 650 million population of India? The solution to this problem, in my view, lies in effectively addressing the issue of healthcare infrastructure, healthcare delivery and healthcare financing (health insurance for all strata of society) with an integrated approach and in tandem through Public Private Partnership (PPP) initiatives.

Is this issue cropping up because of intense pressure and public opinion created by over 20,000 small to medium scale producers of generic drugs, who have grown within the industry in a much protected environment created by the Government of India and had thrived in business by introducing copycat versions of innovators drugs for over three decades, during the old paradigm?

Large Indian companies are by and large in favour of IPR:

The large Indian Pharmaceutical Companies like Piramal Healthcare support the new IPR regime, envisaging the benefits that it will bring to the country in general and the domestic pharmaceutical industry in particular, in medium to longer term. These benefits will not only come from the fruits of their R&D initiatives, but also through various emerging opportunities of business collaboration in areas of their respective strengths, with the Multi National Corporations (MNCs) across the globe.

The Indian pharmaceutical industry, which had registered a double digit CAGR growth rate over the past decade, is poised to record a turnover of U.S$ 20 billion by 2015, as reported by Mckinsey & Co. Even at that time patented products are expected to contribute just about 10% of the total market and balance 90% of the market will continue to be dominated by low cost branded generic drugs.

Indian Pharmaceutical Industry has potential to emerge as an international force to reckon with. But will it..?

Within knowledge based industries, after meteoric success of the Information Technology (IT), Indian pharmaceutical industry armed with its fast growing biotech sector, has all the potential to be a major global force to reckon with. It just needs to foster the culture of innovation. One will feel happy to note that the Department of Pharmaceuticals (DoP) of the Government of India has started taking, at least, some initiatives towards this direction.

The key issues of ‘patentability‘ together with lack of a strong regulatory framework for effective patent enforcement and data protection are becoming barriers to development of international collaboration in the space of pharmaceutical research and development in India.

Why is China different?

From the beginning of 90’s China initiated its reform processes in the IPR area, which may not be perfect though, as yet. However, since 1998 with stricter regulations on pharmaceutical manufacturing and introducing Drug Management Law, China to a great extent regulated entry of ‘fringe players’ in the pharmaceutical business. It enacted TRIPS compliant patent laws in 2002, extending pharmaceutical product patent for 20 years and regulatory data protection (RDP) for 6 years.

Currently China is focusing more on biotech drugs and has wheezed past India in terms of success in this important sector of the healthcare industry, though they have still miles to go to catch up with the developed world in this space. With the creation of innovative environment within the country, China is fast getting international recognition and collaboration, in genomic and stem cell research and technology.

In the pharmaceutical sector also China has brought in significant regulatory reforms since 2001. Because of its stronger IPR regime than India and other important regulatory reform measures that the country has been undertaking, China is racing past India to become one of the largest markets of the global pharmaceutical industry. In this process, China is attracting far more foreign direct investments (FDI) than India, almost in all verticals of the pharmaceutical industry, from R&D, clinical trials to contract research and manufacturing.

Where India scores over China:

Quality of co-operation and relationship between global pharmaceutical companies and the domestic Chinese pharmaceutical industry is believed to be not as good as what is prevailing in the Indian pharmaceutical industry. There are many reasons for such difference, language being the key reason. In China, English is still not a very popular language, in sharp contrast to India. This limits effective human interaction with the foreigners in China. In the area of, especially, pharmaceutical chemistry, Indian scientists are considered to have a clear edge over their Chinese counterparts.

Chinese policy makers are gradually trying to shed off their protectionist’s attitude in the globalization process.

Steps taken by China to encourage innovation are far more encouraging than what is being done in India. Global pharmaceutical companies are finding China more attractive than India to expand their business. As the saying goes, ‘proof of pudding is in its eating’, predominantly because of this reason, FDI for the pharmaceutical sector is coming more in China than in India.

Instead of creating drivers, is India creating barriers to innovation?

It is indeed unfortunate that the Indian law differentiates innovation based on its types and denies grant of patent for ‘incremental innovation’, which is the bedrock of progress for the pharmaceutical industry. For this reason section 3d of Indian Patent Acts 2005 does not consider the ‘salts, esters, polymorphs and other derivatives of known substances unless it can be shown that they differ significantly in properties with regard to efficacy’, patentable.

Strong propaganda campaign unleashed by the vested interests alleging rampant violation of section 3d by the Indian Patent Office (IPO) is another case in point. Interestingly the aggrieved parties decided to fight this issue through media, avoiding the legal route for redressal of their grievances. They on record cited a hilarious reason for the same that no lawyer in India is coming forward to fight their cases, at the behest of the MNCs.

The way forward:

To encourage innovation within a TRIPS compliant IPR regime, as one sees in China,
stereotyping innovations as ‘breakthrough’ or ‘incremental’ will dampen the spirit of innovative culture within the country. Inventive steps in an innovative process of a pharmaceutical product are directed to satisfy some important needs of the patients. As I said before, most innovations, which are an integral part of the progress of this industry, have been ‘incremental’ in nature. Thus ignoring ‘incremental innovation’ in India could be counterproductive, in more than one way.

Investments required towards R&D that a ‘breakthrough type’ innovation would warrant are very high. Indian pharmaceutical industry will have a serious limitation in that direction. The path of ‘incremental innovation’ ably backed by a strong IPR enforcement process, would, I reckon, be the best way forward for the Indian players to compete effectively with global innovator companies, leave aside their Chinese counterparts.

Any innovation, which has gone through inventive steps, even if it is ‘incremental’ in nature, should not be considered ‘frivolous’. It demeans the very process of innovation.

Raising various public sensitive and emotive issues on product patents and combining it with issues of ‘access’ and ‘affordability’ of modern medicines, some powerful lobby of vested interests may seriously retard the progress of India. The Government of India should recognize that it will very adversely affect the country in its pursuit of excellence in the field of research and development, in medium to longer term.

Such emotive misconceptions are compelling the policy makers to divert their attention from the root cause, which I have enumerated above, of the issue of ‘access to affordable modern medicines’ to the vast majority of Indian population.

In my earlier article, I suggested a public private partnership (PPP) model to address these critical healthcare issues. Examples of such PPP are already there in India in states like Tamil Nadu, Andhra Pradesh and Karnataka.

Astute policy makers of the Government of India, I am sure, will soon realize that encouraging, rewarding and protecting patents through a robust TRIPS compliant IPR framework would enable India to place itself ahead of China, as the choicest destination for 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.

Innovation, IPR and Indian Pharmaceutical Industry – a growth formula is brewing.

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Innovate or perish:Many of us expect that ‘tomorrow’ will be a ‘mega today’ and prefer to run our business more or less the same way, as what we are doing today. At the same time the global market keeps us sending, in very small measures though, but definite and continuous signals of change. As we move on, we realize that ‘tomorrow’ will not be a ‘mega today’, just as ‘today’ is not a ‘mega yesterday’. To meet such challenge of change squarely and realistically, we need to embrace a culture of ‘continuous innovation’.Therefore, the name of the game, while competing within the globalised economy is “continuous innovation”. An innovation, as we know, is more than a novel idea. It is, in fact, the process of translating the novel idea into reality.

Like other industries, the pharmaceutical industry in India will also have to innovate with cutting edge ideas, convert them to innovative and implementable business models, which in turn would help these companies to remain competitive in the market place. The innovation, which I am talking about, extends beyond Intellectual Property Rights (IPR).

While innovation is an absolute must to remain and grow the business, having patented products and marketing these brands effectively are desirable and not a ‘must do’ in the pharmaceutical industry of India.

Many would like to ‘stick to knitting’ and innovate:

Indian Pharmaceutical Industry is now an internationally acclaimed player in process development, contract research, manufacturing and domestic marketing skills. The Government of India created this environment for the industry through amendments of the Indian Patents Act 1970.

During post product patent regime in India, there is no dire need for the entire domestic industry to shift its focus from world class process development skills to new molecule development skill. On the contrary, the strengths acquired by the domestic industry in such skill sets should be further honed, to utilize benefits from opportunities that arise out of basic R&D processes. Some of these are collaborative activities with the multinational companies (MNCs) to create a win-win situation in areas like, contract research, clinical development, contract manufacturing and domestic marketing of in-licensed products.

The domestic pharmaceutical industry should therefore adopt strategies like manufacturing off patent products, like recent collaboration between Aurobindo Pharma and Pfizer, Jubilant Organosys with French company Guerbet, for distribution of its nuclear medicine products in Europe. ‘Financial Express’ dated March 13, 2009 reported “Eli Lily seeks partner for Indian TB initiatives.

Such opportunities will keep on coming, may be more frequently and more in number, especially when global innovator companies take more interest in the generic pharmaceutical business, like, Novartis, Daiichi Sankyo, GlaxoSmithKline, Sanofi Aventis etc.

To grab such opportunities, the strategy of ‘stick to the knitting’ with continuous innovation is expected to help the domestic pharmaceutical companies immensely.

IPR regime – emerging opportunities:

Discovery Research:

While above approach will help many small and medium sector enterprises, many large pharmaceutical companies and research boutiques in India are investing significantly to discover New Molecular Entities (NMEs). It has been reported that by 2011, at least two Indian pharmaceutical companies are planning to launch their NMEs.

Biotech Research:

Research in the field of Biotechnology is rapidly evolving, especially in the areas of diagnostics, vaccines, cellular and molecular biology. It is heartening to note that for doing stem cell research National Institute of Health, USA, identified Reliance Life Sciences in Mumbai and the National Institute of Biological sciences in Bangalore to receive state funding from the USA. Both these two organizations entered into contracts to supply embryonic stem cells to the US based researchers. Moreover, in the field of ‘Biometrics’ raw clinical data are now being transmitted to the specialists in India for their scientific evaluation.

It has been reported that in the developing countries of the world malaria afflicts about 300-500 million population and kills 1-3 million of them. Malaria also allows some fatal genetic illnesses, like sickle cell anaemia to thrive in the gene pool. Hence a vaccine developed for this disease through Indian biotech initiatives, would indeed be a great boon for the developing countries of the world.

Industry – Academia Collaboration:

In the Western countries, close collaboration exists between the industry and academic institutes in the field of Pharmaceutical Research. Such type of collaboration has now started developing in India too, where Council of Scientific and Industrial Research (CSIR) is playing major role.

An effective collaboration between the pharmaceutical industry and the academia will ensure productive use of research talents where both the parties will draw benefits. The research done by the CSIR, Indian Institute of Technology (IITs), Indian Institute of Science and various universities is expected to throw open new avenues of collaboration and partnership between industry and Academia.

Benefits of Technology Transfer and increased Foreign Direct Investment (FDI):

The new product patent regime is also expected to facilitate flow of technology and foreign direct investment in India with adequate patent enforcement mechanism being put in place. Inadequate patent and regulatory data protection are considered by the developed nations as the key barriers, which restrict the flow of both technology and foreign investments.

In these areas, India mainly competes with China and Brazil, besides other emerging markets. Degree of patent and regulatory data protection in each of these countries will eventually decide who will emerge as a winner in these fields.

The issue of ‘Access to New Innovative Patented Drugs’:

Innovative pharmaceutical products patented in India will facilitate access to the latest modern medicines to Indian population. Such medicines will help to meet the unmet needs of the ailing population. Many multinational companies like, Merck, GlaxoSmithKline (GSK) have already announced a differential pricing mechanism for such medicines in the developing countries.

Moreover, to improve access of such medicines to the common man, the Government of India should have robust plan to purchase these medicines, at a negotiated price, for supply to Government Healthcare Units

Improving ‘Access to affordable modern medicines’ – a challenge to the nation

There are three key elements to improve access to affordable medicines to a vast majority (650 million) of Indian population:

1. Healthcare infrastructure and delivery
2. Healthcare financing
3. Procurement price of these medicines at the Government Healthcare units

Price of patented products will not have any impact on existing medicines available in the market. However, the reality is, price regulation in some form will continue to play a key role in India. The long overdue new Drug Policy of India is now expected to come only after the new Government takes charge, post General Election of the country. The new policy is expected to articulate the details on this important subject both for patented and generic medicines, in India.

A determined and focused approach of the Government on the above three elements would effectively address the key healthcare issues of India.

Small Scale Enterprises in India – expecting large scale consolidation:

In India over 70% of the small-scale units, within the pharmaceutical industry, currently operate as contract manufacturers, either for the domestic or multinational companies. These small scale units with their low operating cost ,make the contract sourcing model an attractive proposition. Many of these small scale enterprises, are mostly catering to the export business in non-regulated markets.

The demand for high quality standard by the drug regulatory authorities of various countries is fast increasing. It is, therefore, essential for these units to make significant investments to qualify for such stringent quality requirements. Some units would be able to invest enough to meet such regulatory standards. However, the cost of production for those units, which will invest towards facility up gradation is expected to increase significantly, leading to fierce cut throat competition. In a situation like this, we can expect to witness a large scale consolidation process within the industry.

Intense competition from China – cannot be ignored:

Globalisation of the markets could lead to significant dumping of products in different countries. Such a situation may adversely affect the cash flow of business, making the domestic industry highly vulnerable. Currently, Indian manufacturers are facing intense competition from China, in Pharmaceutical Intermediates (PI) and Active Pharmaceutical Ingredient (API) segments. This is mainly because China has a much better economies of scale in manufacturing, which gives them a pricing edge over their Indian counterparts.

PI and he API manufacturers in the small scale enterprise segments of India have already been very adversely impacted, leading to closure of many units in various states like, Andhra Pradesh, Karnataka and Gujarat.

Conclusion:

The issue of a robust world class patent regime in India has sparked off an intense debate with a heavy dose of acrimony. The key areas of concern of various stakeholders are as follows:

1. General public: inadequate access of affordable modern medicine to the common man
2. Domestic generic industry: overall industry growth and to some extent its survival
3. The Government of India: combination of 1&2

After many years of tough resistance mainly from the domestic generic pharmaceutical industry, in January 1, 2005, India re-entered into the pharmaceutical product patent regime. In this article, I have tried to give a snapshot of this new regime, for a quick reading.

Despite tough competition from China and increased possibility of consolidation within small scale pharmaceutical units, overall emerging scenario in India is indeed encouraging. Imbibing innovation culture and with the opportunities available in the new IPR regime, Indian pharmaceutical industry, I believe, will be able to catapult itself to newer heights of global success.

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.

R&D and Protection of IPR related to Pharma sector, are now the responsibilities of the Department of Pharmaceuticals (DoP) – a quick look at the initiatives taken by the department.

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On July 2, 2008, the Cabinet Secretariat of the Government of India notified creation of a new department to be known as the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilisers with an objective to have a sharper focus on the Pharmaceuticals Industry of India. In that notification besides other important areas, Research and Development (R&D) and protection of Intellectual Property Rights (IPR) related to the Pharmaceutical sector, were brought under the newly created department.In this discussion let us try to have a look at the progress in both the R&D and IPRareas, separately.After creation of the new department, the Minister of Chemicals and Fertilisers Shri Ram Vilas Paswan, announced a proposed allocation of Rs. 10,000 crores (around US$ 2 billion), together with necessary regulatory reforms, towards annual Pharmaceutical R&D funding by the DoP.

The Government expects that such initiatives will help bringing in transformation of the Indian Pharmaceutical Industry from brilliant and highly successful ‘imitators’ to world class ‘innovators’ of path breaking medicines. Discovery of such medicines in India is also expected to help the Government significantly, to improve access to affordable innovative modern medicines to the common man of the country. All these are no doubt, very laudable initiatives by the DoP, with a very capable, effective and a ‘can do’ leader at its helm.

The DoP plans to bring in significant changes in the clinical trial facilities available within the country. Currently even very basic clinical trials on ‘dogs’ cannot be undertaken because of protests from the activists related to ‘prevention of cruelty on animals’. Such reform measures, I am sure, will be sincerely welcomed by many.

It is interesting to note that the DoP is also planning to extend Regulatory Data Protection (RDP) to innovators. It has been reported that the invaluable data generated by the innovators towards development of the New Molecular Entity (NME) will, in near future, be protected from ‘piracy’ during 20 year patent life of the product. However, the DoP cautions that attempt to ‘evergreen patent’ through data protection, beyond the patent life of a product will not be permitted.

The argument of the innovators on this issue is that Product Patent and Clinical Data are two different types of intellectual properties and should not be considered as one and the same. While patent protection is extended for discovery of the molecule, data protection is for the immense and expensive clinical data that the innovators share with the Government for regulatory approval of the patented molecule, within the country. The argument that such valuable data generated by the innovators is an intellectual property (IP), lies in the premise that if the innovator would not have been required to part with the data with the regulatory authorities, such data would have been regarded as a ‘trade secret’, which is an IP. Therefore, the innovators argue that for sharing this IP with the Government, specific period of data protection to be extended to them, which should be unrelated to the life of the patent.

Thus far, we see that DoP has taken some very important and admirable initiatives to encourage R&D within the country. However, while looking at another important area of its responsibility i.e. protection of IPR within the Pharmaceutical sector, nothing has been announced by the department, as yet.

Encouraging R&D without effective protection of IPR, points towards an incomplete agenda to effectively address pharmaceutical product innovation related issues by the department. I sincerely hope that the DoP will soon announce its policy initiatives towards IPR protection to further encourage the innovators, both within and outside the country.

The DoP has taken some significant steps to address various important issues of the pharmaceutical industry under its terms of reference, within a very short period. I look forward to knowing from the DoP the detail initiatives in each of its nine functions and responsibilities, as announced in the notification of the cabinet secretariat on July 2, 2008.

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.

We need to encourage the new product patent regime

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Ushering in the Product Patent Regime in India heralds the dawn of a new era. The era that vindicates not only the need to encourage, protect and reward innovation for the rapid progress of our nation but also to compete effectively, in the knowledge economy with the best in the world to establish India as a leading country with a significant share of the global economy.However, it is quite unfortunate that the 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.

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 of medicines is concerned. After almost 4 decades of continuation with the above policy, around 65% of Indian population still do not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China (Source: International Policy Network, November 2004).

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% 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 of medicine to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare 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.

Indian Patent 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 health care spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to their 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 for all, in a holistic way.

The attack on patents is not really a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above, which are healthcare system, healthcare financing and healthcare infrastructure. 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 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 Patent Act of the country for inclusive growth.

By Tapan Ray

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