Bharti-Walmart flagship brand faces Trademark opposition in India:

The management will fight to protect intellectual property of its Great Value label; applications filed in '08

 Wal-Mart Stores Inc., which recently launched several of its global private labels in India, through joint venture Bharti-Walmart Pvt. Ltd, is facing opposition to efforts to register its flagship brand Great Value (GV) here, according to information from the Indian trademark office's website.

"Wal-Mart has registered Great Value in various countries including India and we aggressively protect it as our intellectual property," a Bharti-Walmart spokesperson said in an email statement.

The spokesperson, however, denied knowledge of any opposition.

"Currently, Wal-Mart is not aware of any opposition to our GV brand but, if necessary, we will take necessary steps to protect our intellectual property," the spokesperson added.

Bharti-Walmart, the US retailer's joint venture with Bharti Enterprsies Ltd, had filed in 2008 about a dozen applications to trademark Great Value's logo: 'GV' in a circle emblazoned with 'Great Quality. Low Prices.' The applications were in various categories—baby food, dental wax, dried fruits, jellies and jam, bleaching preparation, soap, cosmetics, hair lotions and others, according to information from the trademark office. Most of those applications are being opposed, according to the trademark office's website.

Bharti-Walmart has already launched several Great Value products including tea, snacks, ketchup, dish-washing bar, toilet cleaner and glass cleaner; it plans to launch more in coming months, according to the company.

It takes about two years for India's Controller General of Patents, Designs and Trademarks to scan and process any application before they are put in the public domain. Any kind of opposition to a trademark application can be made within four months from the day the trademark office makes any application public, trademark lawyers say. Bharti-Walmart's applications were made public late last year and most of its applications are being opposed.

Mint couldn't ascertain the identity of the individuals or companies opposing the Bharti-Walmart applications. Bharti-Walmart had earlier filed dozens of trademark applications seeking to trademark Indian-sounding names including Sankskar, Sabhyata, Cimran, Sur, Sitrali, Pranay, Srishti, Jovaki, Amokhya but the company faced opposition to most of the applications. It now says it will not contest the opposition.

"The application for registration of Astitva and a few other names was filed in August 2008. However, based on consumer feedback and legal opinion we went ahead with the brand name Astitva as our private label brand for Indian ethnic products. Some of the other names that had been filed for registration (except for Astitva) will lapse as we will not be pursuing them further," the Bharti-Walmart spokesperson added.


Source: livemint.com
Publication date: 1/19/2010

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
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Intellectual Property Regime and the Development of Orissa

Due to fast growth of biotechnological research units at different parts of world, coming days will witness more of development of transgenics that can meet the challenges due to climatic changes, environment pollution and enhanced production from unit land. This will definitely boost the growth of Intellectual Property (IP) in the state. Since technologies are now available for transfer of gene across taxa and there is greater scope for genetic manipulation, 21st century will witness trade of gene across boundary. Protection to traditional knowledge associated with agriculture is also required to forestall any attempt by other institutions/countries from acquiring illegal rights on them.

 

Orissa being a gene rich state can derive full advantage from this trade provided suitable measures are taken for conservation and protection of genetic resources. Similar steps need to be taken in case animal, fish, and microbial genetic resources. This can be achieved through systematic survey, collection and publication in appropriate media including the digital ones. Through the genetic manipulation of different crop species and their wild relatives either conventionally or through biotechnological approach, the state can produce wide array of plant varieties/transgenics for commercial exploitation.

 

 

Orissa rich in agro-biodiversity has vast potential for plant variety development. Being the hot spot of rice and many other crops including medicinal plants, cucurbits. brinjal, pulses, the state is rich in genetic resources. Orissa being a state-known for its excellence in art and craft and traditional knowledge can take this opportunity in its favour. Government has already initiated steps for the registration of Kotpad Saree and Baragarh Saree dying technology under this act to protect the interest of producers of these two GI. Similar scope exists in the field of agriculture that needs to be identified and steps need to be taken for their registration at GI Registry Chennai.

 

This will enhance the export potential of agricultural goods services and provide protection against misuse of GI by unscrupulous traders/unauthorized users. Literary creations, musical works, dramatic works, sculptural works, motion pictures, computer software, gene sequences etc. can be protected under copyright Act. Wealth can be generated from their protection and exploitation in the trade and commerce.

 

Enforcement of Protection of Plant Varieties and Farmers Right Act-2001 and initiation of registration of plant varieties since February 2007 provides scope of not only registering the extant plant varieties of the state developed by public/private R & D, units but also registration of farmers' variety developed by the farming community. Any community/group of farmers, farmer's society, claiming to be the breeder and successor of breeder of any farmer's variety can register their variety (ies) and derive full commercial benefit from their trade. Funds are being provided from the national gene fund for rewarding gene saviours and for conservation of threatened genetic resources. State government should initiate appropriate steps in this regard so as to take full advantages of different provisions of the PPV and FR Act. Geographical indications (Registration and Protection) Act, 1999 provides protection (Gl) to geographical indications of the country.

 

Besides the act has also made provision to recognize and reward farmers/farming communities who have played the role of saviour of the genetic resources of any crop/species through their age old effort in conserving, maintaining the traditional varieties, land races and agro-biodiversity of crops.  Steps to boost such kind of activity and protection to both existing and new creations and exploiting them in commerce will definitely help to improve the economic condition of individuals agencies associated with such activity. This will facilitate flow of knowledge in the society and conservation of creations which are either in unsafe state or in a state of erosion. Wide scope also exists in the state for boosting design trade particularly in agro industry sector.

 

The said discussions are only a few of many points available for development of agriculture in the state through generation, protection and commercialization of knowledge associated with agriculture and allied sector. Hope state can take full advantage of globalization process and IP regime to make it prosperous and developed in a highly competitive world. Design of agricultural machinery, equipments, and containers of different agricultural product can be protected under Indian design Act 2000 and can be commercially exploited for the growth and development of this sector. Agricultural Industries, food processing plants, traditional healers of disease can protect their IP even through Trade mark or Trade secret.

 

Industries/Institutions providing services and goods can protect their goodwill in business through registration of trademark or through appropriate confidentiality agreement in case of protection intended through trade secret. There is very good news for Orissa peoples that recently by cooperation with various stakeholders in the School of Biotechnology, KIIT University a business incubation centre is established. I am also cooperating with centre as an Intellectual Property Law advisor. Now peoples are coming with different IP issues and getting proper solutions that is providing further motivation to the IP creators.

 

 

References:

1. Gupta, Anil, K.; and Vikas Chandak (2005) competitive strategies for agricultural technology development and export through value addition: the International property right prospective.

2. Mashalkahr, R.A. (2005). Intellectual Property Rights and the third world. Current Science 81(8): 955 965.

3. Baburam Singh, www.orissa.gov.in/e-magazine/Orissareview/2009/Jan

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
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Whether RTI should be applicable to CJI?

Whether Right To Information is applicable to Chief Justice of India is a substantial question of law and will be finally decided by the Supreme Court. The High Court itself had granted a certificate of appeal to the Supreme Court as substantial questions of law being involved in the case. A Full Court of the Supreme Court will take the final decision on whether or not to prefer an appeal.

As we know that Certain issues dealt with by the Supreme Court collegiums on appointment of judges, personal opinions given by judges, and response to complaints against judges could not be revealed. Covering the said matters under RTI will hamper the independence of judiciary which is right now one of the basic structures of the constitution. We should not forget that there are various constitutional obligations where strict confidentiality is must for proper governance.

During the appointment of Supreme Court and High Court judges' members of the collegiums gives their free and frank opinion. If these opinions will be disclosed to public then no judge will provide free and frank opinion that will further effect the appointment of good judges.

There are also certain matters with respect to not only Judiciary but also President and the Prime Ministers office dealing with various sensitive issues day in and day out and there was a constitutional mandate and fiduciary principle that these must be kept confidential. So the independence of the judiciary should not be compromised by exposing every aspect of the work of the courts to the public.

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
Blog: http://tabrezahmad.technolexindia.com http://iplexindia.blogspot.com
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Law Faculty AMU Aligarh, Organizing National Seminar on Changing Dimensions of Intellectual Property Rights in Present Economics Perspective

Subject: National Seminar on Changing Dimensions of Intellectual Property Rights    in Present Economics Perspective [Feb.6-7, 2010] 

Since the topic is very thematic and timely, I hope you will be interested in the deliberation of this seminar. I hope you will contribute a paper on the theme of seminar and participate. Your participation will go a long way to make the seminar not only successful but a memorable one. 

INSTITUTIONAL OVERVIEW 

The Aligarh Muslim University, Aligarh is one of the most reputed and prestigious academic institutions in the globe. Situated in western Uttar Pradesh, it is at a distance of 130 km southeast of Delhi on the Delhi-Howrah rail route and the Grand Trunk Road. The longitude and latitude of Aligarh city are 79˚ 40' E and 27˚ 30' N respectively. The Aligarh Muslim University, a premier Central University with several faculties and maintained institutions, was established in 1920 by an Act of Parliament. It draws students from all corners of the country as well as from foreign countries, especially Africa, West Asia and Southeast Asia. It is well acclaimed for its rich heritage, culture, best traditions, secular credentials and ethos of Indian civilization. 

The faculty of Law, A.M.U is one of the oldest and well reputed faculties in India which was established in 1891 and has produced innumerable legal icons serving the nation. Popularly it is known as mother faculty because many well known law faculties in India are headed by its illustrious ex- students. The students of this faculty are rendering excellent services, both in bar as well as benches through out the nation. The faculty of Law has already introduced many new specialized subjects like Cyber Laws. Intellectual Property Rights, Human Rights, Women and laws, Environmental Laws and Clinical Legal education etc. 

The Faculty of Law, A.M.U has been successfully pursuing higher academic excellence. The faculty of law Journal entitled Aligarh Law Journal is being regularly issued with numerous researches oriented articles of the eminent personalities. Monographs and text books publication is a regular feature of the faculty. Appreciating the performance of the faculty of law, Dr. Ambedkar Chair of Legal Studies and Research has been given to it which is performing excellently. One Journal Quest for Justice and various books are being regularly published by this chair also. The faculty of law has a unique distinction in arranging large number of extra mural lectures, debates, quiz, Moot Court competitions, mock trials etc. More over at the national level, the students of the faculty have been regularly participating in various competitions, thus bringing laurels to the faculty. At the level of pedagogy, the method has lost its primacy; the emphasis today is more upon interactive learning through discussions, seminars, presentations, tutorial work etc. apart from study through case laws method.

AIMS & OBJECTIVES

A spurt of interest about Intellectual Property Rights (IPR) has been visible in the country for the almost last 15 years. The recent interest started with a curiosity and an element of apprehension but now graduated to a need based compulsion and desire to introspect into the changing dimension of IPR in present economic perspective. The newly industrialized countries (NICS) gave enough vent to this concern and aimed at not only to set new rules on IPR but also to ensure that they are enforced equitably. The mandate of Trade Related aspects of Intellectual property Agreement (TRIPS) including Trade in Counterfeiting Goods (TCG) in Punta Del EST Declaration in unmistakable term enunciates to reduce the distortion and impediments to international trade by taking into account effective and adequate protection of IPR. It was also enjoined that the 'the measures and procedures for  enforcement of IPR should not become barriers to World Trade Organization (WTO) and promulgation of TRIPS Agreement however have become more susceptible to infringement without adequate return to the creators of the knowledge. The Stakes of developer of technology in new economic perspective have become very high and hence the need to protect knowledge from unlawful use has become expedient to ensure globalization research and development (R&D) to ensure recovery and profit in globalized melt down economy. The globalization, multi- lateral trade and new economic order are continuously reducing the geographical barriers rendering the global trade very complex.  

THRUST AND THEMES 

It is under this background, changing dimension of IPR in present economic perspective become important parameters influencing trade environment and development. The IP rights in such scenario require serious engagement in view of rapidly changing technology, product life cycle and trade competitiveness. This second generation reform of Indian IP Laws poised scholars to recommend changes in the context of globalized challenges and opportunities.

The two day national seminar on Changing Dimensions of IPR in Present Economic Prospective therefore, is timely and thematic for deliberation on the following thrust areas for meaningful deliberation and recommendation of strategies for IP management and legislative reforms. 

                                    I.        Impact of WTO and IPR Realization.

                                 II.        Enforcement of TRIPS Agreement.

                               III.        Patent Laws, Indian Innovations and Licensing Policies.

                              IV.        Challenges of Copyright and cyberspace.

                                 V.        Traditional knowledge and management in Plant variety, Geographical Indication on food and Biodiversity and Its impact.

                              VI.        Emergence of Designs and Trade mark laws.

                            VII.        Trade secret and Competitive law in liberalized economy.

Participation and Registration

The Seminar is aimed at capacity building in IPR teaching and research at academic and technical Institutions, government organization, research and development sector, non-governmental organization and professionals. The National Seminar aims to bring together the scholar of IPR law and policies from academics, enforcement and implementation agencies and industrial organization. The Seminar endeavors to provide a platform to share the diversity of knowledge of multi stakeholders in IPR development and research. The primary objectives of the Seminar is establishment of synergy, inter-disciplinary approaches and unified strategy to look at Changing Dimensions of IPR in Present Economic Perspectives. The registration fee will be as follows:

1. Private/Public Sector Organization    Rs. 1000

2. Research and Development laboratory and Academic Institutions and Non-Governmental Organization        Rs. 500

3. Research Scholars and Students          Rs. 300

 

Registration fees are to be paid at the venue and Registration desks.

 

 

 

Registration Form 

National Seminar

                                                                            On        

Changing Dimensions of Intellectual Property Rights in Present Economic Perspective

[February 6 -7, 2010]

 
Name                                                                      …………………………………………… 

Organization                                                            ………………………………………… 

Address                                                                   ………………………………………… 

Email                                                                      ………………………………………… 

Phone/fax                                                               ………………………………………… 

Payment Details                                                      ………………………………………..

 

Date                                                                                                                        Download the original attachment

Signature

 

Please mail the registration form to:

Professor (Dr.) Iqbal Ali Khan                                                        Dr. Zafar Mahfooz Nomani

Convener &Chairman                                                                  Organizing Secretary

Department of Law                                                                     Department of Law                                                                    

Aligarh Muslim University,                                                           Aligarh Muslim University    

Aligarh-202002(U.P.)                                                                  Aligarh-202002(U.P)  

Mobile: +91-9927008430                                                            Mobile: +91-9897211417

 

 

For Further Details contact the following Professors:

 

Professor (Dr.) Iqbal Ali Khan

Convener & Chairman

Department of Law

 Aligarh Muslim University, Aligarh-202002(U.P.)

Mobile: +91-9927008430

E-mail :<iakhan_1402@yahoo.co.in >

OR

Zafar Mahfooz Nomani

Associate Professor of Law

Organizing Secretary

Department of Law

Aligarh Muslim University, Aligarh-202002(U.P.)

Mobile: +91-9897211417

E-mail :< zafarnomani@rediffmail.com>

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
Blog: http://tabrezahmad.technolexindia.com http://iplexindia.blogspot.com
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Nanotechnology and Intellectual Property

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. There are multiple questions arising. How do we legally classify these new technologies? Who controls – and benefits from – fundamental innovations that are the foundation for future innovation? The nanotech applications are expanding the limits of science and medicine; they are stretching the boundaries of intellectual property law. As with other waves of innovation, nanotechnology will catalyze change in social, scientific, and legal arenas. Shifts in the way intellectual property (IP) is defined and administered are already becoming visible as a result of nanotechnology trends.

 

As the Biomedical nanotechnologies are unique because they cover innovations emerging from a previously inaccessible environment – the nanoscale. The watershed development which made the nanoscale accessible and catalyzed the nanotechnology field was the 1981 invention of the scanning tunneling microscope (STM), which earned its inventors the Nobel Prize for Physics in 1986 and the praise of the Nobel committee, which noted the invention opened up "entirely new fields...for the study of the structure of matter." The STM was the first of a new generation of tools empowering scientists and

Engineers to pursue possibilities at the nanoscale.

 

Now due media hype about nanotechnology, not only the scientific community but the public at large has heard about the huge impact that nanoparticles and their capabilities may have on our lives in the ongoing 21st century. How will the government resolve these issues and review patents that do not easily fit into the existing system? Any one of these issues would challenge a field of scientific endeavor; combined, they present the nanotechnology field with a complex legal landscape that will require skill and collaboration to navigate.

 

Along with a new generation of tools came a new generation of IP problems. As the Nanotechnology provides biomedical scientists, access to the nanoscale environment and its unique surface properties and other distinctive characteristics which opens the door to a world of transformative treatment possibilities. Because Nanotechnology applications did not conform to the existing classifications of IP. From an IP perspective, some aspects of biomedical nanotechnology fall easily into one of the four categories. Diagnostic equipment, for example, classifies as machinery and there are few complications with applying IP laws to this category because, in this instance, size does not matter. Materials built on a nanoscale are not treated any differently from their larger counterparts. But most of nanotechnology is not nearly as easy to classify, since many of the emerging technologies often draw upon innovations across multiple disciplines. The key difference with nanotech is the multidisciplinary nature of it. The closest example is biotech, which is a much focused technology.

 

Nanotechnology is the first technology wave highlighting a shift in IP patterns that favors universities. In the past, private companies drove the trends in IP protection, simply because they dominated the patent landscape. Universities, by contrast, have differing aims from the private sector, where protection of the individual company's interests comes first and patents may be closely held. As a result, certain lessons on how IP leads to commercialization learned from past waves, such as biotechnology, may not be applicable in this new IP landscape. University patents often emerge from basic science and, without proper oversight, can become overly broad "building block" patents, which protect fundamental concepts

upon which all subsequent advances are based. One of the unique characteristics of nanotechnology IP, as differentiated from biotech and other previous waves of innovation, is that a number of "building block" patents have issued from the outset, thereby creating a different dynamic in the IP landscape. "Indeed, many of the most basic ideas in nanotechnology are already patented or may well end up being patented. These building block patents can be very lucrative because the fundamental technologies they claim may become prerequisites for many downstream innovations, and thus can generate substantial licensing revenues for the university that holds them.

 

The complexity of nanotechnology patents means that there are potentially more players in the field than might appear at first glance. A basic nanotechnology patent may have implications for semiconductor

design, biotechnology, materials science, telecommunications, and textiles, even though the patent is held by a firm that works in one of these industries. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well.

 

At the same time, nanotechnology patents tend to be concentrated in a relatively small number of hands. Although there are some holders who hold nanotechnology patents, out of that IBM and MIT, hold one-half of all nanotechnology patents thus far issued. Given the potential financial rewards of bringing new technology to market, other industries, including biotech, have seen high-profile legal battles over patents. Yet the question of how the technology from these fundamental upstream patents is made available to the broader research and development community will be critical to their rapid application. Ultimately, universities are likely to be motivated by the benefits of licensing, creating a relatively free flow of building block patents to broader downstream users. Certainly, large patent-holding pharmaceutical companies are increasingly interested in obtaining licenses for nanotechnology IP.

 

A quick look at some recent developments in the field highlights just how complex the science behind nanotechnology is – a complexity that may lead to new IP territory. But this is more than just an intellectual legal exercise. Failing to find a good path around and through these complexities could stifle the development of nanotechnology- based therapeutics and diagnostics and limit the ultimate benefit for patients.

Source: http://www.nanowerk.com

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
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Saudi Economy is Affected Due to Weak IPR Regime

 

Third symposium on the laws of the intellectual property rights opened Tuesday at the Jeddah Chamber of Commerce and Industry .The two-day symposium under the title: "Litigation and Compensation In Intellectual Property Rights, organized on 6^th and 7^th January 2010 by Saudi Law Training Center (SLTD) discussed the issues pertaining to intellectual property rights including: patent, trademarks, copy rights, the settlement of cases and other issues. "The intellectual property rights, with its two divisions of arts and industry, is an integral part of human life in science, culture, food, medicine, engineering, electronics, furniture, perfumes, clothes and others.

 

As per the speakers in the symposium "he excessive number of organizations allowed to rule on issues concerning intellectual property rights in the Kingdom has weakened the application of laws and regulations concerning it" and the aggression against the intellectual property rights cost the Saudi economy billions of riyals every year . Local and foreign experts have participated in the symposium being organized by the SLTC in collaboration with the Ministry of Culture and Information. The center has signed agreements and MOUs with a number of universities and law centers in various parts of the world in order to exchange expertise and trainees.

 

The bodies concerned with issues relating to intellectual property rights in Saudi Arabia included the Ministries of Culture and Information, Commerce and Industry, Rural and Municipal Affairs, the Department of Customs, King Abdul Aziz City for Science and Technology and the Court of Grievances. There are more than 100,000 cases of intellectual property rights now being investigated by all these bodies. This has prolonged the litigation period and made it difficult to follow up the cases. The ministry had established a committee on copyrights under the chairmanship of the undersecretary of the ministry; the committee is composed of experts in law, Islamic Shariah and information and is charged with protecting the material and moral rights of authors and writers.

Source: http://www.arabnews.com

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
Website: www.site.technolexindia.com
Blog: http://iplexindia.blogspot.com
Profile: http://www.google.com/profiles/tabrezahmad7.
Blogs: http://www.blogger.com/profile/15337756250055596327
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India's Product Patent Protection Regime and Access of Medicine to the Poor.

The year 2005 marks the end of the transition period for many developing countries with competent pharmaceutical sectors that previously competed in supplying generic versions of patented drugs to least-developed countries (LDCs), thereby inducing price competition and enhancing access to medicines.

India's product patent regime for drugs, which is now five years old, has entered into a phase in which there are distinct changes in the kind of patents sought as well as patent challenges.  It shows that the vigour of compulsory licensing as a price-leveraging instrument is incumbent mainly on its economic feasibility. India, without a doubt, recognizes that there is perhaps no industry that relies as heavily on patents as the pharmaceutical industry. And now that the Patents (Amendment) Act, 2005 provides for the Trade Related Aspects of Intellectual Property Rights (TRIPS) regime, it is indeed very important to understand the impact it will have on the $4.5 billion Indian Pharmaceutical Industry representing 1.6% of the global market, and, also considering the fact that patent is a critical issue that impinges upon the life of every common man.

 

According to the World Health Organization, about 10 million people—most of them in low- and middle-income countries—die needlessly every year because they do not have access to existing medicines and vaccines. Countless others suffer from neglected tropical diseases, such as sleeping sickness, lymphatic filariasis, and blinding trachoma, for which there are still too few safe or effective medicines. Drug companies have traditionally been reluctant to develop drugs for neglected diseases because the patients are too poor to pay for them, so there is no financial incentive for drug development.

 

The prices of drugs in India are in fact much lower than the prices in other countries like Pakistan, U.K. and U.S.A., where product patents are in force. Ranitidine is sold by Glaxo in India at Rs. 7.20. The same product is sold by the same company in Pakistan at Rs. 65 and in the U.S.A. at Rs. 545. Similarly, the anti-viral drug Aciclovir costs Rs. 33.75 in India while the same drug is sold in Pakistan at Rs. 363.

Under the Patents (Amendment) Act, 2005 patents are now granted both for products and processes for all the inventions in all fields of technology. The other implications for the pharmaceutical sector under this new patent system are: Under Article 34 the onus of proving on the legal complaint that process used by another enterprise is totally different than the patented process would lie with the defendant and he will have to prove that he is not guilty of infringement. (in the 1970 Act, the responsibility was with the patent holder).

This is the broad framework, which will guide the pharmaceutical industry of India in the WTO regime; Patents will be granted irrespective of the fact whether the drugs were produced locally or imported from another country; though the grant of the patent excludes unauthorized use, sale or manufacture of the patented item, yet there are clauses which provide manufacturing or other such rights of the patented item to a person other than the patent holder under Article 31; The patent term will be twenty years from the date of the application under Article 33 of the TRIPS agreement (compared to the seven years under the 1970 Act), which is applicable to all the member countries and thus rules out all the differences in the protection terms prevailed in different countries; It shows that Indian firms view the market potential (in terms of market size and profits involved in such supply, especially if they have to make specific technological investments to produce the drug) of the mechanism much more severely than before, and may be less inclined to engage in such production if their commercial expectations are grossly unmet. The analysis assesses implications of emerging strategies of firms in the Indian pharmaceutical sector for access to medicines both domestically and internationally, and highlights the challenges involved.

The pre-1995 inventions are not eligible for product patenting in India. All product patent applications received during 1995-2005 were categorised as "mailbox" applications and scrutinised after India changed laws to permit product patents in medicines from January 1, 2005. Now all the pending "mailbox" applications (received until 2005)  by the Indian Patent office have already been cleared and there are specialised groups in place to analyse sector-specific applications. Right now, patent office is looking at the 2005-06 applications, which are better than the earlier ones. India received approximately 11,000 applications in the mailbox during the 1995-2005 period.  A good number of these were challenged as they did not merit patent protection. The backlog is almost over. The new patent applications are of better quality and hence will face less pre-grant oppositions.

 

In last five years, there have been over 470 pre-grant oppositions and 200 post-grant oppositions. The second phase of India's patent regime will be marked by less pre-grant oppositions and more post-grant oppositions. There has, meanwhile, been an improvement in the quality of patent examination due to the specialised systems that are in place now. The next phase of the patent regime is also likely to see better enforcement, according to the head of medical affairs, Asia Pacific Region of US drug major Merck & Co Naveen Rao. "The industry has more clarity on patent laws and the country will gradually move towards a better system", he said. Over 80 per cent of India's patent applications are from foreign firms. Of the 6,000 plus applications that reached patent offices in 2008-09, only 17 per cent were Indian filings.

Irrespective of the competition, because of the socio-welfare implication of the pharmaceutical prices, all over the world other than in the US, the prices of medicines are subject to government regulations. In France and Italy, the manufacturer's price must be approved for a product to be reimbursed by the social insurance programme. In the absence of such health security schemes and with the very low purchasing power of the people in India, the Government of India has brought certain essential drugs under the price control. The price control along with the amendment of patent laws in early 70s resulted in a declining impact on prices. Based on India's own experience and on a selective comparison of prices of a few drugs in countries where product patents is in force, intellectuals forewarn that the stronger protection would result in increase in the prices of the drugs and thus medicines will be inaccessible to common people.

One of the major advantages of the universal system is that, it would facilitate access to new medical products. While the welfare loss due to the possible price increase in the post WTO regime is highlighted in most of the studies, the welfare loss due to the non-introduction of new-patented drugs in India due to the weak protection regime is not discussed adequately. In this context, one of the advantages of the product patents is that the stronger patents will provide access to the latest inventions in drugs, which the developed world will not shy away from introducing in India. It is observed that, though Pakistan also has process patent regime, some of the new drugs that were introduced in Pakistan by the MNCs were not introduced in India at all even though these MNCs were present in the country. This is because the MNCs feared about the competition from the counterfeit products in India, whereas in Pakistan MNCs are stronger than the domestic firms.

 

But it also argued that since the new patent regime would either raise the prices of new drugs to the international level or make the Indian population wait until the patent expires and drugs become cheaper, they in any case will be consuming old drugs, and the purpose of getting quicker access to new drugs will be defeated. So actually prices would increase without much welfare gains in terms of access to new drugs.

 

It is also possible that higher prices charged by the MNCs may not really affect the consumers because; the research activities undertaken by the MNCs are totally different and not pertain to the Least Developed Country (LDC) market. Only 13 of 1373 new molecules developed during the last 30 years target diseases of tropical countries like India. Hence it can be said that the percentage of population affected by the price rise would be very less.

 

For instance, the UK multinational Glaxo was faced with several local competitors on the first day when its subsidiary marketed its proprietary drug Ranitidine in India, because the competitors enabled by the weaker patent regime were ready with the indigenous version of Ranitidine.

The more recent case of adapting the technology developed elsewhere to local conditions enabled by the process patent regime is the case of Viagra introduced by Pfizer. A patent for this drug was granted by the US patent office to Pfizer in 1993. The company spent about 13 years and several millions of dollars to develop the drug. Apparently what took Pfizer 13 years and millions of dollars in R&D to perfect, the Indian firms have managed to do in weeks, for a fraction of costs. Of the 30 raw materials used in this drug, 26 are available locally. Utilising the information that was available on the Internet, US patent records and industry literature some of the Indian firms started their work on the indigenous version of Viagra, which was available in the market within weeks of Pfizer formally launching the product. Absence of stronger protection in the chemical and pharmaceutical sector in developing countries like India is cited as one of the reasons that holds back foreign investment especially from countries like the US, Japan and Germany . However, with the change in scenario, domestic companies, which had invested in biotechnology, were finding the lack of protection as a problem to commercialise their innovations, because in DNA recombinant technologies, novelty is the product. The process of discovery is complicated, but once the product is obtained, its propagation can be achieved in many ways.

 

There has been an apprehension that in the wake of globalisation the focus of research in the LDCs could change and the major R&D firms may be more involved in drug discovery that addresses the global diseases and neglect the research that is more relevant for the LDCs. In this context Amit Sen Gupta, of the National Working Group on Patent Laws, adds: I think for me it is frightening that ten or twelve people today are deciding what are the kind of drugs that need to be researched because clearly those drugs are being researched not because of the health needs but based on how much profits they can bring in. That is why you have research money going into drugs for baldness or Viagra but the last drug for tuberculosis was 30 years back. When you deny people cars or washing machines they don't die, when you deny people drugs they die and they die in millions.

 

The strength of the Indian pharmaceutical industry is in reverse engineering. Such units by utilising the provisions under compulsory licensing and exceptions to exclusive rights under the TRIPS agreement should aim at producing the generic version of the patented product and those that are nearing patent expiry. Such firms should also be engaged in research leading to new drug delivery mechanisms and in identifying new uses of existing drugs. In this context, it is also essential to protect the innovations that have been introduced by the technology spillovers. In order to develop domestic innovations, developing countries require utility models or petty patents. These petty patents can be available for a shorter period of time for process innovations made over an existing product. The TRIPS agreement leaves members to introduce such legislation, as there are no specific rules on this subject. Such patents will encourage the small firms.

 

It is true that the impending WTO regime has stimulated the R&D investment in India. Some of the big units have started strengthening their R&D and have also filed number of applications for patents. One of the concerns regarding product patents is the access to patented products. Some of the provisions within the TRIPS agreement mentioned in the above paragraphs clearly indicate that price controls could be imposed on the patented products. However, exemptions from price controls has been suggested by the government for the products that are produced domestically using the domestic R&D and resources and are patented in India. Such exemptions will keep the prices high and make access to the drugs difficult.

Comprehensive solutions are thus needed to increase both access to existing medicines and research on neglected diseases. These solutions must involve strengthening health-care systems increasing financial flows for the most pressing public health crises, and better matching our research and development efforts to the needs of the poor.

 

As far as India's pharmaceutical industry is concerned, the path currently is being followed by international standards for patent protection moves inevitably toward a clash between public health and intellectual property. Despite the Doha Declarations affirmation of public health as the paramount concern, it is not clear how such an objective would be achieved, because generic substitution is so instrumental in the effort to improve drug accessibility. Stringent intellectual property protection for pharmaceuticals would only retard public health initiatives in the coming years. So only by keeping in mind the true objective of drug  innovation of saving lives and achieving a better understanding of the modern world health situation can we hope to effectively ensure the safety and well-being of the people of India and the world's population as a whole in the ongoing century.

 

Sources: http://www.business-standard.com/

 Sudpkata Sarkar http://www.legalserviceindia.com

http://www.ncbi.nlm.nih.gov

--
Dr.Tabrez Ahmad,
Associate Professor of Law,
KIIT University, Bhubaneswar, India,
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