Indian Railway released a book, titled ‘India Junction – A Window to the Nation’. The book has been brought out by Public Relations Directorate, Railway Board. The book has been edited by Ms Seema Sharma.
Read,Write & Revise.Minimum reading & maximum learning
18 May 2014
Why is there no Indian equivalent of Microsoft or Google?
Why is there no Indian equivalent of Microsoft or Google?
Why don’t Indian software services companies develop products? Companies like TCS, Infosys and Wipro may be very profitable, but why is there no Indian equivalent of Microsoft, Google or Oracle? Such questions have dogged the Indian software services industry for many years (Krishnan and Prabhu, 2003).
What services do these Indian companies offer? One service is developing new software systems for clients, starting from a set of requirements and a choice of platform: a programming language, an operating system and a database system. However, most of their business (perhaps 70-80 per cent) comes from upgrading and supporting large operational software systems, removing software bugs as they appear and adding features to meet new requirements. A major function of software services companies is to reduce the inherent risk of developing and maintaining software systems for its clients.
There are excellent reasons for software services companies to do R&D:
First, large software systems are extremely complex and hard to manage with just manual programming effort. A variety of software tools can be used to automate functions.
However, the platforms on which software systems run can differ in numerous major or minor ways and the analysis tools must be available for use on any required platform. Such tools are not available in the market and developing new tools can take years. R&D has been used in some software companies in India to find ways of producing such tools automatically and making them available in time for use in time-bound projects. The goal is always to speed up software construction, reduce cost and remove defects.
Second, with many software service companies offering what may seem to be similar services, a company has a major advantage if it can offer a unique differentiator. The main distinction between companies is often just the skills and experience of their staff; these can be augmented by a wide set of software tools. Use of such tools results in both improving the quality of the final software and reducing the development time
Finally, corporate Information Officers (CIOs) of clients provide computing services to other divisions in the company; their focus is on improving quality and reliability, and reducing cost. They deal with problems as they arise and rarely have time to look beyond this; IT outsourcing has been a boon to them.
Service companies, by contrast, can use their own R&D to identify future trends. This can give them the means of solving anticipated problems before these impact a client’s business, perhaps also adding new capabilities to increase competitiveness.
Important as these R&D directions are, they are far removed from what a software product company does. Software services companies differ from software product companies in everything from size, marketing, sales and customer support to R&D and strategy.
Services and products are not usually offered within one company. It would no more suit TCS or Wipro to masquerade as a product company than it would Microsoft to pose as a services company; Hewlett Packard is a rare exception. What are often referred to as ‘products’ from Indian companies are in fact branded offerings for financial services, like TCS’s BaNCS and Infosys’s Finacle: almost-ready software systems that can be configured and customised to a client’s requirements in a fraction of the time it would take to develop, say, a full banking or insurance system.
As a rule, software products have been developed by small, agile companies. The idea behind PowerPoint originated with a small company called Forethought; Word and Excel were created by Microsoft in the early 1980s when it was a small company. Product development is typically funded by venture capital companies, which filter out 90 per cent of new products that will fail to survive the risky route to market success and guide the remaining 10 per cent to an eventual IPO and sale.
Though services companies and product companies belong to different business species, R&D can provide a link from one to the other. Tools developed by a services company must be robust and effective if they are to be used by project teams.
Such tools will inevitably have a much wider market (not just among other service companies) if they are spun off and managed in an independent company. Done with care, this need not deprive the creating company of its advantages and can help to realize the full value of the innovation in the tools.
That is a route no Indian services company has yet ventured to take.
Why don’t Indian software services companies develop products? Companies like TCS, Infosys and Wipro may be very profitable, but why is there no Indian equivalent of Microsoft, Google or Oracle? Such questions have dogged the Indian software services industry for many years (Krishnan and Prabhu, 2003).
What services do these Indian companies offer? One service is developing new software systems for clients, starting from a set of requirements and a choice of platform: a programming language, an operating system and a database system. However, most of their business (perhaps 70-80 per cent) comes from upgrading and supporting large operational software systems, removing software bugs as they appear and adding features to meet new requirements. A major function of software services companies is to reduce the inherent risk of developing and maintaining software systems for its clients.
There are excellent reasons for software services companies to do R&D:
First, large software systems are extremely complex and hard to manage with just manual programming effort. A variety of software tools can be used to automate functions.
However, the platforms on which software systems run can differ in numerous major or minor ways and the analysis tools must be available for use on any required platform. Such tools are not available in the market and developing new tools can take years. R&D has been used in some software companies in India to find ways of producing such tools automatically and making them available in time for use in time-bound projects. The goal is always to speed up software construction, reduce cost and remove defects.
Second, with many software service companies offering what may seem to be similar services, a company has a major advantage if it can offer a unique differentiator. The main distinction between companies is often just the skills and experience of their staff; these can be augmented by a wide set of software tools. Use of such tools results in both improving the quality of the final software and reducing the development time
Finally, corporate Information Officers (CIOs) of clients provide computing services to other divisions in the company; their focus is on improving quality and reliability, and reducing cost. They deal with problems as they arise and rarely have time to look beyond this; IT outsourcing has been a boon to them.
Service companies, by contrast, can use their own R&D to identify future trends. This can give them the means of solving anticipated problems before these impact a client’s business, perhaps also adding new capabilities to increase competitiveness.
Important as these R&D directions are, they are far removed from what a software product company does. Software services companies differ from software product companies in everything from size, marketing, sales and customer support to R&D and strategy.
Services and products are not usually offered within one company. It would no more suit TCS or Wipro to masquerade as a product company than it would Microsoft to pose as a services company; Hewlett Packard is a rare exception. What are often referred to as ‘products’ from Indian companies are in fact branded offerings for financial services, like TCS’s BaNCS and Infosys’s Finacle: almost-ready software systems that can be configured and customised to a client’s requirements in a fraction of the time it would take to develop, say, a full banking or insurance system.
As a rule, software products have been developed by small, agile companies. The idea behind PowerPoint originated with a small company called Forethought; Word and Excel were created by Microsoft in the early 1980s when it was a small company. Product development is typically funded by venture capital companies, which filter out 90 per cent of new products that will fail to survive the risky route to market success and guide the remaining 10 per cent to an eventual IPO and sale.
Though services companies and product companies belong to different business species, R&D can provide a link from one to the other. Tools developed by a services company must be robust and effective if they are to be used by project teams.
Such tools will inevitably have a much wider market (not just among other service companies) if they are spun off and managed in an independent company. Done with care, this need not deprive the creating company of its advantages and can help to realize the full value of the innovation in the tools.
That is a route no Indian services company has yet ventured to take.
16th Lok Sabha will be richest, have most MPs with criminal charges
16th Lok Sabha will be richest, have most MPs with criminal charges
This Lok Sabha will have the highest proportion of MPs with criminal cases against them and will also be the richest, since 2004, when declaring criminal cases became legally mandatory in India.
Over a third, or 34% of new MPs face criminal charges, data from the Association for Democratic Reforms' (ADR) analysis of election affidavits filed before the Election Commission of India (ECI) shows, as against 30% in 2009 and 24% in 2004, that was the first Lok Sabha election for which the filing of election affidavits became compulsory following a PIL filed by ADR.
Among the major parties, the Rashtriya Janata Dal (RJD), with all of its four MPs facing criminal charges, led, followed the Shiv Sena (15 of 18 MPs) and the Nationalist Congress Party (4 of 5 MPs). Over a third of the Bharatiya Janata Party's (BJP) new MPs face criminal charges and over a fifth face serious criminal charges. For the Congress, the proportion is lower at 18% and 7% respectively.
Across parties, candidates facing criminal procedures were more than twice as likely to win as compared to candidates with a clean record, ADR data shows. Maharashtra, Uttar Pradesh and Bihar have the highest proportion of candidates facing criminal procedures.
With 82% of its members worth over Rs. 1 crore each, this will also be the richest known Lok Sabha, compared to 2009 (58%) and 2004 (30%). Crorepati candidates are ten times more likely to win than a candidate worth less than Rs. 1 crore.
The three Andhra Pradesh parties — the TDP, TRS and YSRCP — have the richest MPs, with the average assets of each of their MPs being over Rs. 50 crore. India's richest MP — Jayadev Galla of Guntur — is worth Rs. 683 crore and is also from the TDP, while the three next richest MPs are also from Andhra Pradesh. The average Congress MP is worth over Rs. 16 crore, BJP candidates over Rs. 11 crore and the CPI(M) has the poorest candidates, with average assets of Rs. 79 lakh. India's poorest MP is Uma Saren of the Trinamool Congress.
This Lok Sabha will have the highest proportion of MPs with criminal cases against them and will also be the richest, since 2004, when declaring criminal cases became legally mandatory in India.
Over a third, or 34% of new MPs face criminal charges, data from the Association for Democratic Reforms' (ADR) analysis of election affidavits filed before the Election Commission of India (ECI) shows, as against 30% in 2009 and 24% in 2004, that was the first Lok Sabha election for which the filing of election affidavits became compulsory following a PIL filed by ADR.
Among the major parties, the Rashtriya Janata Dal (RJD), with all of its four MPs facing criminal charges, led, followed the Shiv Sena (15 of 18 MPs) and the Nationalist Congress Party (4 of 5 MPs). Over a third of the Bharatiya Janata Party's (BJP) new MPs face criminal charges and over a fifth face serious criminal charges. For the Congress, the proportion is lower at 18% and 7% respectively.
Across parties, candidates facing criminal procedures were more than twice as likely to win as compared to candidates with a clean record, ADR data shows. Maharashtra, Uttar Pradesh and Bihar have the highest proportion of candidates facing criminal procedures.
With 82% of its members worth over Rs. 1 crore each, this will also be the richest known Lok Sabha, compared to 2009 (58%) and 2004 (30%). Crorepati candidates are ten times more likely to win than a candidate worth less than Rs. 1 crore.
The three Andhra Pradesh parties — the TDP, TRS and YSRCP — have the richest MPs, with the average assets of each of their MPs being over Rs. 50 crore. India's richest MP — Jayadev Galla of Guntur — is worth Rs. 683 crore and is also from the TDP, while the three next richest MPs are also from Andhra Pradesh. The average Congress MP is worth over Rs. 16 crore, BJP candidates over Rs. 11 crore and the CPI(M) has the poorest candidates, with average assets of Rs. 79 lakh. India's poorest MP is Uma Saren of the Trinamool Congress.
12 May 2014
Supreme Court allows Tamil Nadu to raise Mullaperiyar height
Supreme Court allows Tamil Nadu to raise Mullaperiyar height
The Supreme Court has given permission to Tamil Nadu to raise the height of a 116-year-old Mullaperiyar Dam from 136 feet to 142 feet quashing the objections raised by Kerala which opposed the move citing safety concerns of the dam and nearby areas.
The decision marks second consecutive defeat for Kerala as on February 27, 2006 the court permitted Tamil Nadu to raise the dam height and carry out necessary repairs setting aside Kerala’s objections on safety. A month after the judgment, Kerala passed a law — Kerala Irrigation and Water Conservation (Amendment) Act 2006 fixing the full reservoir level of dam at 136 feet.
Tamil Nadu challenged the constitutional validity of this law that has now been declared null and void by the apex court. The court was fully satisfied that the dam was safe after an Expert Committee submitted its report assuring safety of dam from all aspects — hydrological, structural and seismic safety. Besides, it observed no change in circumstances since its earlier order of 2006. However, the court’s judgment would facilitate TN to divert more water for its agricultural purposes.
The Supreme Court has given permission to Tamil Nadu to raise the height of a 116-year-old Mullaperiyar Dam from 136 feet to 142 feet quashing the objections raised by Kerala which opposed the move citing safety concerns of the dam and nearby areas.
The decision marks second consecutive defeat for Kerala as on February 27, 2006 the court permitted Tamil Nadu to raise the dam height and carry out necessary repairs setting aside Kerala’s objections on safety. A month after the judgment, Kerala passed a law — Kerala Irrigation and Water Conservation (Amendment) Act 2006 fixing the full reservoir level of dam at 136 feet.
Tamil Nadu challenged the constitutional validity of this law that has now been declared null and void by the apex court. The court was fully satisfied that the dam was safe after an Expert Committee submitted its report assuring safety of dam from all aspects — hydrological, structural and seismic safety. Besides, it observed no change in circumstances since its earlier order of 2006. However, the court’s judgment would facilitate TN to divert more water for its agricultural purposes.
4 Indian companies among Forbes ‘Global 2000’
4 Indian companies among Forbes ‘Global 2000’
In the latest released Forbes ‘Global 2000’ list, Mukesh Ambani-led Reliance Industries leads the set of 54 Indian companies in the annual list of the world’s 2000 largest and most powerful public companies. The top three positions of the list is occupied by the Chinese companies.
The Forbes ‘Global 2000′ is a comprehensive list of the world’s largest, most powerful public companies, as measured by revenues, profits, assets and market value.
Some notable points from Forbes ‘Global 2000’:
World’s top three biggest public companies and five of the top 10 are from China.
564 companies enlisted are from the US which marks its dominance as the country with the most Global 2000 companies.
Japan follows the US with 225 companies in total.
India is home to 54 of the world’s biggest companies.
Reliance Industries, with a market value of $ 50.9 billion and $ 72.8 billion in sales, ranked 135.
State Bank of India ranked 155 with a $ 23.6 billion market value.
Some other Indian companies making it to the list are: Oil and Natural Gas ranked 176, ICICI Bank (304), Tata Motors (332), Indian Oil (416), HDFC Bank (422), Coal India (428), Larsen & Toubro (500), Tata Consultancy Services (543), Bharti Airtel (625), Axis Bank (630), Infosys (727), Bank of Baroda (801), Mahindra & Mahindra (803), ITC (830), Wipro (849), Bharat Heavy Electricals (873), GAIL India (955), Tata Steel (983), Power Grid of India (1011), Bharat Petroleum (1045), HCL Technologies (1153), Hindustan Petroleum (1211), Adani Enterprises (1233), Kotak Mahindra Bank (1255), Sun Pharma Industries (1294), Steel Authority of India (1329), Bajaj Auto (1499), Hero Motocorp (1912), Jindal Steel & Power (1955), Grasim Industries (1981) and JSW Steel (1990).
In the latest released Forbes ‘Global 2000’ list, Mukesh Ambani-led Reliance Industries leads the set of 54 Indian companies in the annual list of the world’s 2000 largest and most powerful public companies. The top three positions of the list is occupied by the Chinese companies.
The Forbes ‘Global 2000′ is a comprehensive list of the world’s largest, most powerful public companies, as measured by revenues, profits, assets and market value.
Some notable points from Forbes ‘Global 2000’:
World’s top three biggest public companies and five of the top 10 are from China.
564 companies enlisted are from the US which marks its dominance as the country with the most Global 2000 companies.
Japan follows the US with 225 companies in total.
India is home to 54 of the world’s biggest companies.
Reliance Industries, with a market value of $ 50.9 billion and $ 72.8 billion in sales, ranked 135.
State Bank of India ranked 155 with a $ 23.6 billion market value.
Some other Indian companies making it to the list are: Oil and Natural Gas ranked 176, ICICI Bank (304), Tata Motors (332), Indian Oil (416), HDFC Bank (422), Coal India (428), Larsen & Toubro (500), Tata Consultancy Services (543), Bharti Airtel (625), Axis Bank (630), Infosys (727), Bank of Baroda (801), Mahindra & Mahindra (803), ITC (830), Wipro (849), Bharat Heavy Electricals (873), GAIL India (955), Tata Steel (983), Power Grid of India (1011), Bharat Petroleum (1045), HCL Technologies (1153), Hindustan Petroleum (1211), Adani Enterprises (1233), Kotak Mahindra Bank (1255), Sun Pharma Industries (1294), Steel Authority of India (1329), Bajaj Auto (1499), Hero Motocorp (1912), Jindal Steel & Power (1955), Grasim Industries (1981) and JSW Steel (1990).
CANWFZ Treaty signed to recognize Central Asia as Nuke-Free Zone
CANWFZ Treaty signed to recognize Central Asia as Nuke-Free Zone
Five recognized nuclear weapon states- China, France, Russia, UK and USA inked the Protocol to the Central Asian Nuclear-Weapon-Free-Zone (CANWFZ) Treaty in New York, marking a major positive development in the global non-proliferation efforts. The treaty was signed on the sidelines of the Nuclear Non-Proliferation Treaty (NPT) Preparatory Committee Meeting at the United Nations.
CANWFZ Treaty
The CANWFZ Treaty was inked on September 8, 2006 in Semipalatinsk by the five Central Asian nations – Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan. It came into force on March 21, 2009. As chair of the CANWFZ Treaty, Kazakhstan has steered the negotiations with the five nuclear states on behalf of its Central Asian neighbors.
Central-Asian parties to the CANWFZ treaty aim to make the region a nuclear-weapon free zone. For the zone to be recognized internationally, it also requires to get the so-called negative guarantees from the five nuclear weapon countries, meaning legally-binding assurances not to use nuclear weapons against the parties of the treaty and not to use the threat of the use of nuclear weapons against them. The Protocol signed on May 6, 2014 in New York provides all these guarantees. The Protocol awaits ratification by the parliaments of the signing states enter into effect.
Five recognized nuclear weapon states- China, France, Russia, UK and USA inked the Protocol to the Central Asian Nuclear-Weapon-Free-Zone (CANWFZ) Treaty in New York, marking a major positive development in the global non-proliferation efforts. The treaty was signed on the sidelines of the Nuclear Non-Proliferation Treaty (NPT) Preparatory Committee Meeting at the United Nations.
CANWFZ Treaty
The CANWFZ Treaty was inked on September 8, 2006 in Semipalatinsk by the five Central Asian nations – Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan. It came into force on March 21, 2009. As chair of the CANWFZ Treaty, Kazakhstan has steered the negotiations with the five nuclear states on behalf of its Central Asian neighbors.
Central-Asian parties to the CANWFZ treaty aim to make the region a nuclear-weapon free zone. For the zone to be recognized internationally, it also requires to get the so-called negative guarantees from the five nuclear weapon countries, meaning legally-binding assurances not to use nuclear weapons against the parties of the treaty and not to use the threat of the use of nuclear weapons against them. The Protocol signed on May 6, 2014 in New York provides all these guarantees. The Protocol awaits ratification by the parliaments of the signing states enter into effect.
Defending India’s patent law
Defending India’s patent law
No one can attack India’s well-founded Intellectual Property regime as being weak merely because a drug that is claimed to be an invention fails the test of law
India and its intellectual property (IP) laws have been the subject of sharp criticism recently. Now, there is talk of the government invoking emergency provisions with regard to Dasatinib, a cancer drug. The decibel level may go up several notches.
Let us look at our law. The sovereignty of a country includes its power to make laws. Any person who pursues commercial interests in another country must submit himself/herself to the laws of the country. No one can attack our regime as being weak only because his/her invention did not stand up to the test of our legislation. Nor can India be accused of robbing Peter to pay Paul. It sounds romantic, but it is still robbery.
The Novartis case and the Nexavar case of compulsory licence (CL) are what have impelled this attack. Innovation and invention have speeded up in myriad ways in the last few decades and our country had committed itself to the obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights. Therefore, it was necessary for India to revisit its patent law; in 2005, the Indian Patents Act was amended, Section 3(d) being one of the amendments. It was the basis of the Novartis case.
TRIPS recognises that members have the right to use/adopt measures to protect public health so long as they are consistent with TRIPS. A recent study notes: “Policy makers in developing and developed countries need to base their implementation of intellectual policy rules on these pro-public health and pro-access principles.” The Doha Declaration is an affirmation of the right to use the flexibilities in TRIPS, especially by developing and less developed countries, regarding access to medicine. The language of the Doha Declaration emphasises the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health.
“The TRIPS agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems affecting access to and rational use of medicines in India but the provisions within the country’s patent laws, if more extensively and properly applied, should help rather than hinder such access. India’s laws and experiences could provide a useful example for low-income and middle-income countries worldwide.”
About patentability, not price
In Novartis, the Supreme Court said that while harmonising the patent law in the country with the provisions of the TRIPS Agreement, India had attempted to balance its obligations under the international treaty and its commitment to protect and promote the public health considerations of people in the country and elsewhere. The ‘thorn in the flesh’ Section 3(d) had been challenged by Novartis before the Madras High Court earlier. But the court upheld its constitutionality and rejected the attack on the grounds of vagueness and arbitrariness. Novartis did not file an appeal against that judgment. Novartis claimed a patent for Gleevec, a cancer drug which was refused. Novartis then appealed to the Supreme Court.
The intellectual property of the inventor lies in the invention which is claimed to be novel, inventive and patentable. The patent is a creature of law by which the state bars public access to that invention for a fixed period. The economic reward from the invention is earned during this time after which it goes to the public domain. Section 3(d) is a test of patentability. With reference to Gleevec, it is enough to know that 3(d) inter alia says that in the absence of evidence of enhancement of known efficacy, the mere discovery of a new form of a new substance is not an invention deserving the grant of patent. Imatinib Mesylate was the known substance and Novartis claimed a patent for its (the substance) beta-crystalline form.
The Supreme Court asked: “Now, when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?” If an invention fails the 3(d) test, it means there was no inventive step. There was no intellectual property in the alleged invention, and nothing that could be stolen. Our lawmakers meant to check any attempt at repetitive patenting or extension of the patent term on spurious grounds, and blocked attempts to keep an invention “evergreen.” If those who attack the Indian patent regime claim that a minor tweaking of chemicals is a giant step forward for an invention, then our legislators begged to differ. The Supreme Court said that it was not ruling that all incremental innovations were non-patentable and that every case would be examined. Our law says that new forms of known substances which do not have enhanced efficacy are in effect advances without real innovation. Therefore, Section 3(d) is actually a catalyst for genuine inventions.
The Supreme Court said that Novartis had attempted to get a patent for a drug which would otherwise not be permissible under our law. Filtering doubtful patents is the strength of our law and not its weakness. The Novartis judgment was not about price but about patentability.
Let us look at the compulsory licence (CL) case, i.e. Bayer vs. NATCO. The mechanism of CL is essentially about balancing patent rights with access to medicine. The words “social and economic welfare,” “public health,” “national emergency” and “public health problems/crises” used in the Act are all pointers to the CL provisions being centred around access to medicine.
A CL is granted subject to three conditions; one of them is about price. The reasonable requirement of the public with regard to the invention should be satisfied. The price at which it is made available should be reasonably affordable. It should be worked in India. A CL may be granted if the answer is a “no” to any of the three conditions. The interpretation of the word “working” by the Controller-General was criticised. It is incorrectly projected that the CL was granted on this score alone. Bayer failed in the other two tests. As far as working is concerned, the question is this: should the inventor manufacture the invention locally or is it sufficient to import it? The Controller held that “working” meant local manufacture to a reasonable extent. The Intellectual Property Appellate Board (IPAB) said that “working” could in some cases mean local manufacture entirely, while in others, only importation, and that it would depend on the facts and evidence of each case. “Working” is not defined in the Act. This issue will be settled by the superior courts on review. The power of review by the superior courts is sufficient to show that our law provides for safeguards.
Compulsory licence
Even in the U.S., it is believed that CL would be a beneficial addition to its patent system, would not significantly impact the incentives for innovations, and that, “a compulsory licensing provision would ensure that the American public is adequately supplied with a product. If the patentee is unable to produce enough supply to meet the demand for the product, another producer should be able to license the product to meet the demand.” This is precisely what our law says!
In all these years, there has been only one instance of the grant of compulsory licence. In fact it was refused recently for Dasatinib, the drug that is now in the news. And Section 3(d) has been invoked by our patent office only rarely. If Gleevec was refused a patent, it is only because it failed the test of Indian law. Refusal is not an act of robbery, for it means there was no invention and hence no property in the first place. There is really no case made out for there being a weakness in Indian law. The pharmaceutical industry’s anxiety behind the clamour against Indian law cannot be on account of any inherent weakness in our law, but only because other countries will follow it.
No one can attack India’s well-founded Intellectual Property regime as being weak merely because a drug that is claimed to be an invention fails the test of law
India and its intellectual property (IP) laws have been the subject of sharp criticism recently. Now, there is talk of the government invoking emergency provisions with regard to Dasatinib, a cancer drug. The decibel level may go up several notches.
Let us look at our law. The sovereignty of a country includes its power to make laws. Any person who pursues commercial interests in another country must submit himself/herself to the laws of the country. No one can attack our regime as being weak only because his/her invention did not stand up to the test of our legislation. Nor can India be accused of robbing Peter to pay Paul. It sounds romantic, but it is still robbery.
The Novartis case and the Nexavar case of compulsory licence (CL) are what have impelled this attack. Innovation and invention have speeded up in myriad ways in the last few decades and our country had committed itself to the obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights. Therefore, it was necessary for India to revisit its patent law; in 2005, the Indian Patents Act was amended, Section 3(d) being one of the amendments. It was the basis of the Novartis case.
TRIPS recognises that members have the right to use/adopt measures to protect public health so long as they are consistent with TRIPS. A recent study notes: “Policy makers in developing and developed countries need to base their implementation of intellectual policy rules on these pro-public health and pro-access principles.” The Doha Declaration is an affirmation of the right to use the flexibilities in TRIPS, especially by developing and less developed countries, regarding access to medicine. The language of the Doha Declaration emphasises the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health.
“The TRIPS agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems affecting access to and rational use of medicines in India but the provisions within the country’s patent laws, if more extensively and properly applied, should help rather than hinder such access. India’s laws and experiences could provide a useful example for low-income and middle-income countries worldwide.”
About patentability, not price
In Novartis, the Supreme Court said that while harmonising the patent law in the country with the provisions of the TRIPS Agreement, India had attempted to balance its obligations under the international treaty and its commitment to protect and promote the public health considerations of people in the country and elsewhere. The ‘thorn in the flesh’ Section 3(d) had been challenged by Novartis before the Madras High Court earlier. But the court upheld its constitutionality and rejected the attack on the grounds of vagueness and arbitrariness. Novartis did not file an appeal against that judgment. Novartis claimed a patent for Gleevec, a cancer drug which was refused. Novartis then appealed to the Supreme Court.
The intellectual property of the inventor lies in the invention which is claimed to be novel, inventive and patentable. The patent is a creature of law by which the state bars public access to that invention for a fixed period. The economic reward from the invention is earned during this time after which it goes to the public domain. Section 3(d) is a test of patentability. With reference to Gleevec, it is enough to know that 3(d) inter alia says that in the absence of evidence of enhancement of known efficacy, the mere discovery of a new form of a new substance is not an invention deserving the grant of patent. Imatinib Mesylate was the known substance and Novartis claimed a patent for its (the substance) beta-crystalline form.
The Supreme Court asked: “Now, when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?” If an invention fails the 3(d) test, it means there was no inventive step. There was no intellectual property in the alleged invention, and nothing that could be stolen. Our lawmakers meant to check any attempt at repetitive patenting or extension of the patent term on spurious grounds, and blocked attempts to keep an invention “evergreen.” If those who attack the Indian patent regime claim that a minor tweaking of chemicals is a giant step forward for an invention, then our legislators begged to differ. The Supreme Court said that it was not ruling that all incremental innovations were non-patentable and that every case would be examined. Our law says that new forms of known substances which do not have enhanced efficacy are in effect advances without real innovation. Therefore, Section 3(d) is actually a catalyst for genuine inventions.
The Supreme Court said that Novartis had attempted to get a patent for a drug which would otherwise not be permissible under our law. Filtering doubtful patents is the strength of our law and not its weakness. The Novartis judgment was not about price but about patentability.
Let us look at the compulsory licence (CL) case, i.e. Bayer vs. NATCO. The mechanism of CL is essentially about balancing patent rights with access to medicine. The words “social and economic welfare,” “public health,” “national emergency” and “public health problems/crises” used in the Act are all pointers to the CL provisions being centred around access to medicine.
A CL is granted subject to three conditions; one of them is about price. The reasonable requirement of the public with regard to the invention should be satisfied. The price at which it is made available should be reasonably affordable. It should be worked in India. A CL may be granted if the answer is a “no” to any of the three conditions. The interpretation of the word “working” by the Controller-General was criticised. It is incorrectly projected that the CL was granted on this score alone. Bayer failed in the other two tests. As far as working is concerned, the question is this: should the inventor manufacture the invention locally or is it sufficient to import it? The Controller held that “working” meant local manufacture to a reasonable extent. The Intellectual Property Appellate Board (IPAB) said that “working” could in some cases mean local manufacture entirely, while in others, only importation, and that it would depend on the facts and evidence of each case. “Working” is not defined in the Act. This issue will be settled by the superior courts on review. The power of review by the superior courts is sufficient to show that our law provides for safeguards.
Compulsory licence
Even in the U.S., it is believed that CL would be a beneficial addition to its patent system, would not significantly impact the incentives for innovations, and that, “a compulsory licensing provision would ensure that the American public is adequately supplied with a product. If the patentee is unable to produce enough supply to meet the demand for the product, another producer should be able to license the product to meet the demand.” This is precisely what our law says!
In all these years, there has been only one instance of the grant of compulsory licence. In fact it was refused recently for Dasatinib, the drug that is now in the news. And Section 3(d) has been invoked by our patent office only rarely. If Gleevec was refused a patent, it is only because it failed the test of Indian law. Refusal is not an act of robbery, for it means there was no invention and hence no property in the first place. There is really no case made out for there being a weakness in Indian law. The pharmaceutical industry’s anxiety behind the clamour against Indian law cannot be on account of any inherent weakness in our law, but only because other countries will follow it.
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