Tag Archives: Pharmaceuticals

India as a global pharmaceutical outsourcing hub: Some key advantages and the areas of improvement.

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All over the world, pharmaceutical research and development pipelines are gradually getting dried up. Lesser and lesser blockbuster drugs are now coming up from the ‘mind to the market’. Currently the average annual turnover of over 90% of patented drugs is around US $150 million each. At the same time regulatory requirements to obtain the marketing approval are becoming more and more stringent, spiralling the R&D costs of the innovator companies very significantly.
The name of the game:

In today’s perspective of the global pharmaceutical industry, ‘competitive efficiency’ in speed of implementation of various projects and optimizing costs of operations, can be easily considered as the ‘name of the game’.
Such competitive efficiency is as much essential for a relatively quick turnaround from ‘the mind to market’ of New Chemical Entities (NCEs) or New Molecular Entities (NMEs), to reducing manufacturing costs through various outsourcing opportunities and/or innovative application of technology and spreading geographical marketing operational network.

Towards this direction, ‘Business Process Outsourcing’ in R&D, manufacturing, clinical trials etc. is now gradually emerging as one of the most critical ways to achieve this important objective. It is expected that gradually outsourcing of specialized manufacturing like, biopharmaceutical and sterile manufacturing and specialized processes like, improvements in catalyst activity, will be gaining grounds.

India is emerging as a potential outsourcing hub:

India is fast emerging as a key player in the outsourcing business of the global companies, with its high quality facilities, world class services at a very competitive cost, in various areas of pharmaceutical business operations. India is not only a vibrant democracy, it has now a good Intellectual Property Rights (IPR) system in place and offers very significant cost advantages both in contract research and contract manufacturing space, as compared to many other countries.

Many Indian pharmaceutical companies are scaling up their capacities and investing in establishing more number of world class facilities. Currently India has over 100 pharmaceutical plants approved by the US foods and drugs administration. Incidentally this number is the largest outside the USA.

The key advantages:

India with its total pharmaceutical market size of around US $ 14 billion offers both value and cost arbitrage, which are as follows:

1. Familiarity with the regulatory environment and requirements of the developed markets

2. Extensive global operations in the generics business

3. World class facilities

4. Lower employee wages

5. Large number of young workforce

6. High capacity of skilled labour (350,000 engineers/year)

7. High quality of engineers, process chemists

8. Low communication barriers due to high levels of English

9. Speed of operation

10. Cost effective IT infrastructure, facilitating all key business processes

Contract research investment strategies of the global companies in India:

Most common investment strategy in the collaborative arrangement is risk-sharing outsourcing co-development of a NCE/NME. For example, Johnson & Johnson (J&J) signed an outsourcing agreement with Advenus Therapeutics of India in November 2008 with a contract value of US $ 247 million including milestone and royalty payments in the areas of inflammation and metabolic diseases. In this contract Advinus will be responsible for development upto ‘the proof of concept’ (Phase II a) and then J&J will take over till commercialization of the molecule.

Areas of improvements:

1. Biotech contract research as a whole

2. Economies of scale in manufacturing products like, recombinant proteins, small interfering Ribonucleic Acid (siRNAs), vaccines, antibodies etc.

3. Fully integrated service offerings in contract research and contract manufacturing

4. In genomics and proteomics research

5. Pre-clinical research

In all these important areas our neighbouring country China seems to score over India

Conclusion:

Availability of world class contract research and manufacturing facilities and the ability of the domestic pharmaceutical industry to deliver the agreed deliverables in a cost-efficient manner with desired operational speed, make India a potential contract research and manufacturing hub of the world.

India can expect to compete effectively in these areas with any other countries, including China, provided the improvement areas, as indicated above, are addressed with equal speed of action and with a missionary zeal.

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.

Collaborative commercialization of inexpensive smaller incremental innovation in Chemistry will play an important role in bringing affordable new drugs or new drug delivery systems

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It started in the 17th century:

Alchemy, a medieval chemical science and speculative philosophy aiming to achieve the transmutation of the base metals into gold, searching for a universal cure for disease and indefinitely prolonging life, not considered a science by many, gradually became the basis for the development of chemistry into the 17th century. However, perceivable impact of chemistry on humanity, through its smaller incremental innovation, started being felt only in the second half of the 19th century.

Chemistry – an interface between the physical world and humanity:

Experts in this field often opine that the current form of human civilization has been made possible, to a great extent, through significant advancement of such innovation in chemistry and its role in modern technology. Chemistry is indeed an interface between the physical world on the one hand and the humanity on the other.

Getting a perspective of resource and time requirements for such initiatives:

Is there any similarity between development of pharmaceutical chemistry and IT software?

Now a days, one finds a striking similarity between small incremental innovation in IT software and the same in pharmaceutical chemistry. Both are creative and belong to the knowledge economy. Scientists in both the communities try to generate innovative ideas, which can lead to their effective commercialization.

Resource requirements for these two are strikingly different:

However, the nature of the commercialization process of these two sciences, though seemingly similar in terms of innovativeness, is indeed quite different. In the software community, two people can implement an idea with minimal resource requirement and could end up with a profitable commercialized product, without much difficulty. In contrast, two chemists may come up with a brilliant idea, which in many cases, may require significant investment of resources much before to even think to get the initial product commercialized. Subsequent steps of scaling up will be a separate issue altogether, with more resource commitment.

The process of commercialization of smaller incremental innovation in pharmaceutical chemistry is much longer:

As we all know, the process of commercialization of incremental innovation in chemistry takes a much longer time scale, as these are not usually spare time projects, unlike computer softwares. The cost involved in testing out and implementing a new idea in chemistry is very high and may not even be possible without any robust institutional backing.

Target inexpensive smaller incremental innovation in pharmaceutical chemistry:

Some illustrative examples of such smaller incremental innovation in chemistry are as follows:

1. Development of pharmaceutical co-crystals

2. Merger of chemistry of traditional and modern medicines for synergy in both efficacy and safety

3. Chemical technology switch: taking technology of one field and transferring it to a different field to get a new drug substance

4. Application of polymorphic chemistry in drug discovery.

The process has begun:

International experience:

The chemistry department of Oxford University, U.K, which is incidentally the biggest chemistry department of the western world, has made significant advances in commercializing incremental innovation in chemistry. Among many, they created and commercialized the following three entities through such incremental innovation:

• Medisense

• Oxford Molecular

• Oxford Assymetry

The Indian experience:

Despite all challenges, in India, as well, the commercialization process of smaller incremental innovation in chemistry has already begun. The Chemistry Department of the University of Delhi has developed 11 patentable technologies for improved drug delivery system using nano-particles. One of such technologies was development of ‘smart’ hydrogel nano-particles for encapsulating water-soluble drugs. This technology was sold to Dabur Research Foundation in 1999.

Another nano-particle drug delivery technology in opthalmogy area was also commercialized by transferring it to Chandigarh based Panacea Biotech Ltd.

Conclusion:

This process is expected to gain momentum in our country too, contributing significantly to the progress of the healthcare sector of the nation. “Commercializing smaller incremental innovation in Pharmaceutical Chemistry”, I reckon, will play a key role in providing affordable modern medicines to a vast majority of the population, as India transforms itself into a knowledge superpower.

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 top 10 environment polluters of the world should now transform themselves into the top 10 saviours of the world from the disaster of Climate Change

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Global awareness dawned early:

After World War the second, various types of atmospheric pollution started drawing increasing public attention in the western world, both in the USA and Europe.

In Europe, the incidence of London’s ‘Great Smog’ in 1952 initiated the process of bringing in ‘The Clean Air Act’ in 1956. This Act is believed to be one of the first legislations on environment in the world. Similarly in the USA in 1969 ‘The National Environment Policy Act’ was passed by the US Congress.

As we know, globally environmental pollution takes place mainly through carbon emission related to various developmental activities like construction, manufacturing, mining, motor vehicles, aircrafts; combustion equipment etc. All such emissions are gradually assuming alarming proportions.

Though CO2 is absolutely essential for photosynthesis of plant life, its raised level through the above developmental activities, very often adversely impacts the protective ozone layer of the earth triggering the process of climate change.

Sustained increase in atmospheric CO2 has also been shown to critically affect the sea water by increasing its acidity level, which in turn could endanger the marine ecosystem.

The key question:

Therefore, the moot question now is how to balance various developmental activities related to social and economic progress of nations with the preservation of global natural ecosystems.

Top 10 environment polluters of the world:

As per recent reports the top 10 environment polluters of the world are as follows:

1. China: Emits maximum CO2 of 6,018 million tonne. However, in terms of per capita emission, with 4.5 tonne China ranks 44 in the world, Australia being at the top of the list with 20.58 tonne followed by USA, Canada and Saudi Arabia. China has now pledged to cut its carbon intensity goal by 40-45 per cent by 2020.

It is important to note that against the suggestion of Denmark, the BASIC countries (Brazil, South Africa, India and China) have refused to set a target of reduction of the global carbon emission by half, by 2050. BASIC countries emphasized that the developed nations should first work out an implementable model for emission cut before setting up any target.

2. United States: Emits 5,903 million tonnes of CO2 with a plan to cut the emission by 17 per cent from 2005 level by 2020. Per capita emission of CO2 of the USA, which ranks no.2 in the world, is 19.78 tonne.

3. Russia: Emits 1,704 million tonnes of carbon dioxide and agreed to cut emission by 25 percent, by 2020, if others also do the same.

4. India: Emits 1,293 million tonne of carbon dioxide with per capita emission of 1.16 tonne and agreed to cut emission by 20 to 25 per cent from 2005 level by 2020.

5. Japan: Emits 1,247 million tonne of carbon. It is important to note that last year in Japan CO2 emission came down by 6.2 per cent and the country agreed to reduce its CO2 emission by 2020 from its 1990 level by 25 per cent, if similar steps are taken by other developed nations of the world.

6. Germany: Emits 858 million tonne of carbon dioxide.

7. Canada: Emits 614 million tonne of carbon dioxide with per capita emission of 18.81 tonne. The country agreed to reduce its emissions by 2020 from 2006 level by 20 per cent.

8. U.K: Emits 586 million tonnes of carbon dioxide with a declining emission level. As compared to 1990 level, EU has agreed to a 20 percent cut in emission by 2020.

9. South Korea: Emits 514 million tonnes of carbon dioxide and agreed to reduce its emissions 4 per cent below 2005 levels by 2020.

10. Iran: Emits 471 million tonnes of carbon dioxide. The country is worst hit by environmental pollution with marine ecology of the Caspian Sea is in great danger.

Conclusion:

Besides recent Copenhagen Accord more practical and effective steps must be taken by the global community, especially by these top 10 environmental polluters, to ensure quick and more substantial reduction in CO2 emission to arrest the climate change. This is obviously not expected to happen, as said earlier, at the cost of development and economic progress of any nation. The issue of climate change can primarily be addressed with initiation of various energy efficient measures to produce clean energy with increased sense of urgency.

Greater use of existing technologies like solar and wind power, electric and hybrid cars together with integrated robust projects to preserve natural ecosystems could save the humanity from the disastrous consequences of global climate change.

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 global meet on climate change in Copenhagen: what were achieved and what were not.

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Long before the commencement of Copenhagen climate change meet, many from all over the world started talking passionately about the “dangerous climate change”, which as we know deals with the issue of increase of global temperature of 2 degrees Celsius (2C) from the preindustrial level.

This issue was discussed at length in Copenhagen and an accord was ultimately announced on December 18, 2009 followed by a plenary session on December 19, 2009.

What does it say?

The Accord is a 12-paragraph document of statement of intents and non-binding pledges to address the “dangerous climate change” issues.

Towards this direction the Intergovernmental Panel on Climate Change (IPCC) at Copenhagen recommended even to the developed countries of the world to reduce carbon emission from their respective 1990 level by not less than 25% by 2020, from when the global carbon emission is expected to start declining.

USA and China were the key partners of IPCC with a strong supporting role played by Brazil, South Africa and India to have an accord that suits the emerging large developing economies of the world. The accord though recommends to the developed countries, barring the US, to ensure their carbon emission cuts, but not under the Kyoto Protocol. Most influential 26 countries of the world agreed with this accord and other 192 countries, though appeared to be unhappy in the plenary session, accepted the same with their ‘silence’, which perhaps means indirect consent.

The key points of the accord:

The main points of the Copenhagen Accord are as follows:

• Cooperation by all in containing emissions within 2 degrees Celsius above preindustrial levels.

• To reduce carbon emission, the developing nations will report in every two years on their non-binding voluntary actions. This report will be subject to international consultations and analysis.

• US $ 10 billion each year will be financed by the developed countries for a three-year program to pay for the projects taken up by the poorer nations to develop clean energy and effectively address drought and other climate-change impacts.

• A goal of mobilizing US $ 100 billion per year by 2020 was also set for achieving the same objectives.

Is this accord a triumph of USA or China or the BASIC countries?

This accord is seen by some as a triumph of the USA to influence the ultimate outcome of the Copenhagen climate change summit. US President Barack Obama, in fact, brought back the negotiation from the brink of collapse, at the last minute, through hectic negotiation with the heads of states of Brazil, South Africa, India and China (BASIC countries).

What will the success of the summit depend upon?

The success of this accord will depend on whether the USA will be able to live up to its promises to reduce carbon emissions in their own country and help other countries to address the same by raising billions of dollars.

BASIC countries, especially China, emerged stronger:

The process of this accord also witnessed China coming stronger leveraging their clout in a multilateral forum of the African continent, which is very rich in various valuable natural resources. However, many other less powerful nations, as said earlier, felt left out in this deal brokered mainly by the US initiative and interest.

Thus even after reaching the accord, at the plenary session on the last Saturday, a large number of speakers from the developing nations sharply criticized the deal alleging it as a pact meant only for the rich and BASIC countries.

Lack of a clear roadmap:

Be that as it may, without a clear road map for research and development of low-carbon technologies and no binding collective carbon emission target, achieving 2C by 2020 still remains a pipe dream.

Conclusion:

After the Copenhagen Accord, Brazil, South Africa, India and China (BASIC), the four large emerging economies of the world, were immensely successful to display their joint muscle power to the world as a whole, clearly emerging as a major combined force to reckon with, especially by the developed nations of the world lead by the USA.

However, many will strongly feel that interests of smaller and poorer nations of the world were sacrificed in this first global agreement of the century on climate change at Copenhagen.

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

IPR, Biodiversity and India

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The issue of conservation of the biological resources of a country, whether these are local crops or useful plant varieties, available in remote areas of the country, has become a subject of debate in the paradigm of Intellectual Property Rights (IPR). The use of local knowledge and the traditional use of these biological resources are interwoven in the cultural milieu of a region.

Two major international agreements:

Following two major international agreements deal with this issue:

1. The Convention of Biological Diversity (CBD)

2. Trade Related Intellectual Property Rights (TRIPS)

It is worth mentioning that countries like, India, Mexico, Philippines, Peru etc, are coming up with the local country-specific legislation to effectively deal with this issue.

Experts’ Views:

Many experts suggest that IPR may be judiciously used to effectively protect the biological resources. Such use of IPR may range from preventing misappropriation to significant increase in utilization of various resources and investments towards their conservation.

However, others express quite a different view, voicing that the IPR system may work against conservation of biological resources by ‘undermining the knowledge system, culture and social structure.’

Recently there was a suggestion that each country should take some well articulated legal steps to conserve its precious biological resources. It must ensure that only those steps, which are compatible with the concept of ownership and the value system of the local population, are to be taken into account during IPR system of negotiation, related to such biological resources. These experts argue that an IPR system must support appropriate conservation through effective management of biodiversity.

There is yet another totally different school of thought leaders, who nurture a very strong view, which is as follows:

“The history of IPRs shows that the monopolistic hold of governments, corporations and some individuals over biological resources and related knowledge is continuously increasing. A substantial amount of this monopolisation is built upon, and through the appropriation of, the resources conserved and knowledge generated by indigenous and local communities.”

Some IPR related ‘scandals’ in this area:

Activities like the following, which are treated as IPR related scandals keep sending shock waves to many:

1. A Patent was granted vide the US Patent No. 5,401,504, to the healing properties of the ancient Indian herbal remedies turmeric ,which is a traditional knowledge to the Indians, since many centuries.

2. A Patent was granted vide the US Patent No. 5,663,484 to varieties of Basmati rice grown traditionally in both North India and Pakistan.

3. A Patent was granted vide the US Patent No. 5,397,696 to human cell line (human genetic material) of a Hagahai tribesman from Papua New Guinea.

These are just illustrative examples and not exhaustive.

Steps taken by some developing countries:

Alarmed by all these developments, some of the developing countries of the world are seriously contemplating the following:

1. Preventing indigenous traditional knowledge from being “pirated” with IPR claims driven solely by commercial interests.

2. Restricting access to biological resources with appropriate regulatory measures.

Measures taken by India:

A. Legal measures have now been taken by India to address this issue:

1. New plant varieties can now be protected in India under the New Plant Variety and Farmers Rights Protection Actin 2001 and cannot be protected through patents.

2. Protection of ‘Geographical Indications (GI)’, which identify goods as originating in the territory of a member or a region or a locality in that territory, where a given quality reputation or other characteristics of the goods is attributable to their geographical origin.

4. For registration of GI, all applicants will require applying in writing to the Registrar for the registration of such indications.

B. Following GIs cannot be registered in India :

• Use of which would be likely to deceive or cause confusion or contrary to any law.

• Comprising or containing scandalous or obscene matter or any matter likely to hurt religion susceptibility of any class or section of citizens of India.

• Which would otherwise be disentitled to protection in a court.

• Which are determined to be in generic names and are not or ceased to be protected in their country of origin or which have fallen into disuse in that country.

• Which, although literally true as to the territory, region or locality in which the goods originate, but falsely represent to the persons that the goods originate in another territory, region or locality.

C. Punishment for falsifying a Geographical Indication:

A sentence of imprisonment for a term between six months to three years and a fine between fifty thousand rupees and two lakh rupees is provided in the Act. The court may reduce the punishment under special circumstances.

D. Term of GI protection:

The registration of a GI shall be for a period of ten years but may be renewed from time to time for an unlimited period by payment of the renewal fees.

Conclusion:

Detailed studies regarding the involvement of community in conservation and protection of biodiversity along with their drivers and barriers will be of immense use. One-dimensional view of innovation, based only on profit motive, in the space of biodiversity and food security, especially for the developing countries, like India, calls for more enlightened debate within the civil society.

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

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