WTO and Intellectual Property Rights
Introduction Intellectual property (IP)
IP is the work of the intellect or the mind to create products that have commercial uses—products like drugs, literature, paintings and so on. It is protected in the same way as physical property with property rights based on trademarks, patents and so on. Holders of the patents and so on are entitled to the commercial proceeds exclusively for a specified time period.
Types of Intellectual Property Rights
• A patent is granted for a new, useful, and non-obvious invention, and it gives the patent holder an exclusive right to commercially exploit the invention for a certain period of time.
• Copyright is given for creative and artistic works, such as books, movies, music, paintings, photographs, and software, and give the copyright holder an exclusive right to control reproduction or adaptation of such works for a certain period of time.
• A trademark is a distinctive sign that is used to distinguish the products or services of different businesses.
• An industrial design right protects the form of appearance, style or design of an industrial object (e.g., spare parts, furniture, or textiles).
The need for agreement on IP arises from the fact that its creation takes substantial investment and should be incentivized. The commercial proceeds from trade in intellectual property are growing in worth.
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement on TRIPS lays down legal standards for the member countries to protect intellectual property by way of copyright rights, geographical indications, industrial designs, integrated circuit layout designs, patents, monopolies for the developers of new plant varieties, trademarks and so on. It regulates dispute resolution procedures and enforcement procedures. However, the brunt of TRIPS is for patents.
TRIPS and Patents
A patent is an exclusionary right. It grants the right to exclude others from making use of the patented inventions for a given period. In return for the patent, the inventor offers the knowledge with commercial use to be put in public domain after the expiry of the patent. A patent is an incentive to innovate and invent. It sustains research and development (R and D).
Product and Process Patents
Under WTO, patents can be granted for the process or product. Product patents provide for absolute protection of the product, exhausting all the processes that may lead to similar products, whereas process patents provide protection with regard to a specific process or method of manufacture. Protection for process patents would not prevent the manufacture of patented products by a process of reverse engineering, where a different process or method from that which has been invented (and patented) is used. Before TRIPS, national legislation permitted only process patent protection, which allowed manufacturers in some countries like India to make generic versions of patented medicines. The aim was to make drugs and foods available at a cheaper price. But TRIPS does not allow it as it is a disincentive to innovation. The TRIPS agreement:
• Allows both process and product patents.
• Only product patents must be awarded to food, pharmaceuticals and chemicals.
• Product patents are valid for 20 years.
Developing countries that had apprehensions about product patents agreed to it because they benefited under other agreements, for example, services and so on. The guiding principle is single undertaking—all or none. They agreed also because they received concessional terms under TRIPS—a grace period of 10 years to adopt product patents in the fields of food, pharmaceutical and chemical. In line with WTO’s TRIPS, India changed its patent laws. Some additional safeguards were incorporated as given below. Patents (Amendment) Act 2005 provides for:
• The availability of pre-grant and post-grant challenges.
• Incremental innovation involving small scale improvements do not qualify for new patents.
• The introduction of a provision for enabling grant of compulsory license and parallel imports to meet public health crises as provided for in TRIPS.
Prior to 1970, 85 per cent of medicines available in India were produced and distributed by multinational corporations (MNCs), and the prices of drugs in the country were among the highest in the world. The 1970 Patents Act of India provided for process patents for pharmaceuticals and agrochemical products. This enabled the growth of a strong local generic drug industry, which produces the same drugs as the MNCs at relatively low prices. When Indian manufacturers of generic drugs such as Cipla, Ranbaxy and others began manufacturing and selling drugs at much lower prices, it served a public health cause. The demand for these drugs grew in countries that could not afford to buy these drugs from MNCs.
The Indian government accepted TRIPS and product patents because the Indian pharma industry is going global and TRIPS helps R and D to capture the global pharma market. It attracts MNC investment as well. TRIPS is a part of the larger WTO package. There was a fear that the prices of medicines would spiral due to product patents as it can lead to monopoly pricing. But on balance, it was felt that since 97 per cent of all drugs in India were off-patent, prices would be protected. Add to that the fact that the government could control the prices of essential medicines, and the fear of price rise was seen to be largely unfounded. Drug Price Control Order (DPCO) gives the government the power to regulate prices and make them affordable. The other criticism is that patents being given for 20 years will stunt technological development in India. However, this opinion is being debated. On the positive side, the act, it:
• modernizes the law, • helps Indian pharma companies to grow into MNCs,
• enables Indian companies to take up contract research,
• allows FDI to flow in with all the technological benefits,
• safeguards provisions to help meet public health concerns,
• allows generic manufacturers to continue in India for product patented drugs by paying a reasonable fee, and
• includes built-in safeguards.
(Generic medicines are unbranded drugs. They have the same active chemical content as the patented drug. They can be granted to drugs for which either there is a process patent or the product patent has expired.)
TRIPS and Public Health Safeguards
While the TRIPS provisions are good in the long term for the development of new medicines, they may go against availability of affordable medicines when there is a public health emergency. Therefore, there are two safeguards in TRIPS law that are incorporated into Indian law as well:
• Compulsory licensing
• Parallel imports
Compulsory licensing means that the government of the country facing public health crisis can ask for the production and sale of the drugs in the country at concessional prices based on a compulsory license that is issued. If the patent holder is ready, it gets the license; If not, it allows the government to temporarily override a patent and give license to another company. This allows generic copies of a patented product to be produced domestically, and compensation is paid to the patent holder. Generic copies of patented drugs are much cheaper than branded drugs, thereby ensuring an adequate, affordable stock of the essential drugs. This works without the consent of the patent owner. When the pharma company that holds the patent for the drug is unwilling to price it affordably, parallel imports are the recourse available. Parallel importation is the importation of drugs from another country because the country that has a health emergency does not have the manufacturing capacity. India’s first ever compulsory license was granted by the Intellectual Property Appellate Board (IPAB) in 2012 to Natco Pharma for the production of the generic version of Bayer’s Nexavar, an anti-cancer agent used in the treatment of liver and kidney cancer. Health experts and NGOs welcomed the order as it was pro-health and pro-patient. It was the only case when compulsory licensing was invoked. The US did not like this and so India was placed on the Priority Watch List in the US Trade Representative’s (USTR) Special 301 Review. Special 301 is a section in the US trade law that seeks to penalise the countries whose IP laws go against US interests.
Incremental Innovations
Section 3(d) of the Indian Patents Act disallows evergreening of patents unless it differs significantly in properties with regard to therapeutic efficacy. In 2013, the Supreme Court in a landmark ruling rejected the Swiss drug maker Novartis’ plea for a patent for its anti-cancer drug Glivec, a beta crystalline of a known molecule called imatinib mesylate, saying it lacked novelty and failed to meet the country’s patenting standards. It upholds India’s policy stance that incremental innovations lacking ‘enhanced therapeutic efficacy’ as assessed by the patenting authorities will not qualify for patents. Novartis enjoyed the patent for Glivec for 20 years and later, without adequate value addition, applied for a new patent for the same drug with mere incremental innovation.
Voluntary Licensing
Gilead Sciences entered into licensing agreements with seven Indian generic manufacturers for its Sovaldi (anti-Hepatitis-C drug). This license allows Indian companies to manufacture and sell the drug in any of the 91 voluntary-licence (VL) countries at their own price but at a 7 per cent royalty rate on sales. The manufacture of the active pharmaceutical ingredients (APIs) is in India. The criticism is that the license restricts export to only some countries and excludes many important middle-income countries. However, the consensus opinion is that Gilead’s licenses are an important victory for public health.
Anti-Counterfeiting Trade Agreement (ACTA)
MNCs of the advanced world did not accept the Indian patent laws that refused to allow evergreening and also invoked compulsory licensing provisions. They made an ACTA in 2011—a multinational treaty for the purpose of establishing international standards for intellectual property rights enforcement. The agreement was signed in 2011 between EU, Australia, Canada, Japan, South Korea, United States and some more like-minded countries. Supporters described the agreement as a response to the increase in global trade of counterfeit goods and pirated copyright-protected works. ACTA had its own definition of counterfeit for whatever did not agree with its notion. ACTA described its IPRs protection as TRIPS Plus. If any nation did not follow it, the ACTA countries would confiscate the medicines. For example, Indian generics being sent to other developing countries could be confiscated at airports and ports of ACTA members. It is anti-WTO and was watered down in course of time.
Sui Generis System
The TRIPS agreement provides sui generis option regarding patent laws. Sui generis means generating by itself or of itself. It is a choice given to members in place of TRIPS norms. That is, they can protect inventions either on the basis of TRIPS rules for patents or any other indigenous system (sui generis) that has traditionally been in vogue in the country.
Geographical Indications (GI)
There are some goods
that owe their properties to the region in which they originated and are nurtured. The climate, soil and the native
efforts of the region account for their fame, utility and qualities. Some Indian examples
are—basmati Rice, Darjeeling tea, Kanchipuram silk saree, alphonso mango, Nagpur orange,
Kolhapuri chappal, Bikaneri bhujia, Agra petha,
Mysore silk, Nilgiri tea, Coorg coffee, Mysore sandal products, Malabar
pepper and others. They can apply for
and obtain GI.
GI means any indications that identify
the goods as originating in the territory of a country or a region or locality
in that territory. It is used to identify agricultural, natural or manufactured
goods. The manufactured goods should be produced or processed or prepared
in that territory. It should have a
special quality or reputation or other characteristics. There are many benefits when a product or
process is given a GI:
• It confers legal protection to Geographical Indications in India.
• It prevents unauthorised use of a registered Geographical Indication by others.
• There is greater accountability.
• It provides legal protection to Indian Geographical Indications which, in turn, boost exports.
• It protects the consumers.
• It promotes economic prosperity of producers of goods produced in a geographical territory.
There are rules as to who can apply for a GI. Any association of persons, producers, organisation or authority established by or under the law can apply, but the applicant must represent the interest of the producers. It is generally not granted to an individual but is given to a product for a specific period of time (10 years in India). It can be renewed from time to time for a further period of 10 years each. GI is different from a trademark. A trademark is a sign that is used in the course of trade to distinguish goods or services of one enterprise from those of other enterprises. Basmati rice has a GI but there are many companies that produce it with under different trademarks. In 1999, the Parliament passed the Geographical Indications of Goods (Registration and Protection) Act, 1999. This act seeks to provide for the registration and protection of geographical indications relating to goods in India. The act is administered by the Controller General of Patents, Designs and Trademarks, who is the Registrar of Geographical Indications. The Geographical Indications Registry is located at Chennai. The act came into force in 2003. This is a sui generis legislation intended to give better protection to GIs of India. In 2004–05, Darjeeling tea became the first GI-tagged product in India. Since then, about 330 products were registered as GIs by 2019, including 14 foreign GIs, according to the Cell for IPR Promotions and Management (CIPAM), which is an arm of the Department of Industrial Policy and Promotion (DIPP). Some examples are Kancheepuram silk and Darjeeling tea. Various different states enjoy the protection. Some such products are Nagpur orange, Kangra painting, Moradabad metal craft, Firozabad glass, Kannauj perfume, Kanpur saddlery, Saharanpur woodcraft, Dharmavaram handloom pattu sarees and paavadas, Warli painting, Kolhapur jaggery, Thewa art work and the three Manipur-based knit works Moirang phee, Wangkhei phee and Shaphee lanphee. Tirupati laddu is given as prasadam to devotees after having the darshan in the temple. It received Geographical Indication tag, which entitles that only Tirumala Tirupati Devasthanams can make and sell it. Bird’s Eye chilli, Mizo chilli has been given GI. The Hyderabad haleem is one among the few Indian dishes that got a GI status. So is the famous traditional craft of Rajasthan, blue pottery made in Jaipur. Also, Pattachitra is a form of art that originated in Odisha. It is a pictorial narrative painted on a cloth-based scroll. Generally, the scrolls depict the tales of Hindu gods and goddesses. Famous Banganapalle mangoes of Andhra Pradesh and Tulapanji rice of West Bengal are among the seven commodities that have been granted Geographical Indications in 2017– 18. Others who got the GI tag recently are Pochampally Ikat of Telangana, Gobindobhog Rice rice of West Bengal, Durgi stone carvings and Etikoppaka toys of Andhra Pradesh and Chakhesang shawl of Nagaland. In 2016–17, as many as 33 items got GI registration. Karnataka tops the national list, followed by Tamil Nadu, Andhra Pradesh and Kerala. Joynagarer moa is a seasonal Bengali sweetmeat delicacy made of puffed rice and palm jaggery that that got a Geographical Indication tag. Sangli chi halad (Sangli’s turmeric) from Maharashtra and Erode turmeric got the GI in 2018. In 2019, Palani Panchamirtham panchamirtham from Palani Town in Dindigul district of Tamil Nadu, Tawlhlohpuan and Mizo Puanchei from the state of Mizoram and Tirur betel leaf from Kerala were given GI. Palani prasadam was the second temple prasadam after Tirupati laddu that got the GI. Tawlhlohpuan, a compactly woven fabric from Mizoram, is known for warp yarns, warping, weaving and intricate designs that are made by hand. Mizo Puanchei is a colourful Mizo shawl considered essential by most women from the state and a common costume in Mizo festive dances and official ceremonies. Some applications are pending. Following are some examples: Himachal Pradesh’s Kangra Arts Promotion Society sought GI, saying the art form was in vogue in the foothills of the western Himalayas and that pigments used in Kangra paintings are derived from organic and inorganic sources. The central theme of Kangra paintings is love, and the recurring themes are the six seasons or music or Krishna–Radha or Shiva–Parvati. Manipur government’s department of commerce sought GI for Moirang phee, Wangkhei phee and Shaphee lanphee, which are shawls/fabric with unique needle work, to be worn as a special recognition of honour. Kolhapur jaggery seeks unique recognition for its white and golden chemical-free product with no added colour, chemicals, additives and flavours. Its application said the jaggery had natural sweetener and contained glucose, vitamins, calcium and minerals.
French champagne and cognac, the USA’s Napa Valley, the UK’s Scotch whisky and Mexican tequila are among foreign products that have acquired GI tags in India.
Rasgolla
There has been a long debate between West Bengal and Odisha over where the sweet originated. In 2017, West Bengal was granted the tag for Rasagolla Bangla, which led people to erroneously believe that the GI Registry recognized Bengal as its exclusive place of origin, which is factually incorrect.
West Bengal got GI for its Version of the Sweet
Odisha received the geographical indication (GI) tag for its
local version of the Rasagolla in 2019,
the Odisha Rasagola. The GI tag for
Bengal and Odisha Rasagolas recognise two distinct versions of the sweet. The Odisha Small Industries
Corporation Ltd has been awarded the GI where the sweet originated is a moot point. Both West
Bengal and Odisha are claiming the sweet as
their own, but both the states have their own versions and dates of its
origin, and the GI tags have officially
accepted both the versions. Bengalis
claim that the Rasagolla was invented in the 19th century by Nobin Chandra Das in Kolkata, while Odias believe that the
tradition of Niladri Bije, where Rasagola is
offered, started in the 12th century.
Basmati Rice
It is a variety of aromatic rice with short and long grains that is cultivated
in India and Pakistan. Basmati rice is
globally known for its aroma and many unique cooking and taste properties owing to the agro-climatic
conditions and farmers’ efforts in the geographical areas of origin. In 2008, the Agricultural and
Processed Food Products Export Development
Authority (APEDA) applied for GI tag of Basmati rice. The Geographical
Indication Registry approved the tag for the states of Punjab, Haryana,
Himachal Pradesh, Delhi, Uttarakhand and parts of western Uttar Pradesh and
Jammu and Kashmir. Madhya Pradesh filed
an application for a GI tag on basmati rice for its thirteen districts. The place of origin for of the basmati rice
is the Indo-Gangetic plains. Madhya Pradesh was
unable to establish that it is a part of Indo-Gangetic plains and
therefore the application was rejected
by the Registry. In 2019, Delhi High Court struck down the decision of the
central government which restricted the
basmati rice production to only seven states in the IndoGangetic plains.
Kadaknath Chicken
Madhya Pradesh and Chhattisgarh contested for the Geographical Indication (GI) tag for Kadaknath, a black-feathered chicken known for its high protein and very low fat and cholesterol levels. It is in high demand and is local to Jhabua and Dhar districts of western
Madhya Pradesh. MP’s claim over the breed was recognised, while Chattisgarh lost. It is the only animal to have a GI Tag in India.
APEDA
APEDA is a non-trading statutory body created under the Agricultural and Processed Food Products Export Development Authority Act, 1985 (APEDA Act), which provides for the development and promotion of export of certain agricultural and processed food products from India, including basmati rice. The APEDA Act was amended in 2008 to confer it powers to protect intellectual property in special products such as basmati rice. As such, APEDA is qualified to be an applicant under the GI Act.
Government Measures to Promote GIs
The government has undertaken several steps for the promotion of Indian products registered as GIs, such as:
• Participation in trade fairs and other events to promote and create awareness on GIs and increase the sale of GI products.
• Promotion of GIs through social media.
• Involving state governments and union territory administration and other relevant organizations for the facilitation of GI producers.
• In order to spread awareness for registration of GI-authorised users, awareness programmes are conducted for concerned stakeholders at various places in the country.
• Engagement with Textiles Committee under the Ministry of Textiles for marketing of commercially viable GIs.
• The online system of filing GI applications is operational since 2015. However, the examination of the application is done offline.
The Cell for IPR Promotion and Management (CIPAM) has taken up the initiative to promote Geographical Indications to supplement the incomes of our farmers, weavers, artisans and craftsmen. It is a professional body under the aegis of the Department for Promotion of Industry and Internal Trade (DPIIT), which ensures focused action on issues related to IPRs. CIPAM assists in simplifying and streamlining of the IP processes, apart from undertaking steps for furthering IPR awareness, commercialization and enforcement.
IPR Policy 2016
National Intellectual Property Rights (IPR) Policy lays down an institutional mechanism for implementation, monitoring and review. It aims to incorporate and adapt global best practices to the Indian scenario and bring together the strengths of the government, research and development organizations, educational institutions, corporate entities including MSMEs, start-ups and other stakeholders in the creation of an innovation-conducive environment, which stimulates creativity and innovation across sectors, and also facilitates a stable, transparent and service-oriented IPR administration in the country. The National Intellectual Property Rights (IPR) Policy endeavours for a ‘Creative India; Innovative India.
Objectives
The Policy lays down the following seven objectives:
• IPR Awareness: Outreach and Promotion—To create public awareness about the economic, social and cultural benefits of IPRs among all sections of society.
• Generation of IPRs—To stimulate the generation of IPRs.
• Legal and Legislative Framework—To have strong and effective IPR laws, which balances the interests of rights owners with larger public interest.
• Administration and Management—To modernize and strengthen service-oriented IPR administration.
• Commercialization of IPRs—Get value for IPRs through commercialization.
• Enforcement and Adjudication—To strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements.
• Human Capital Development—To strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs.
DPIIT is the nodal department to for the coordination, guidance and oversight of the implementation and future development of IPRs in India. The policy recognizes that India has a well-established TRIPS-compliant legislative, administrative and judicial framework to safeguard IPRs, which meets its international obligations while utilizing the flexibilities provided in the international regime to address its developmental concerns. It reiterates India’s commitment to the Doha Development Agenda and the TRIPS agreement. While IPRs are becoming increasingly important in the global arena, there is a need to increase awareness on IPRs in India, be it regarding IPRs owned by oneself or respect for others’ IPRs. The importance of IPRs as a marketable financial asset and economic tool also needs to be recognized. For this, domestic IP filings, as well as commercialization of patents granted, need to increase. Innovation and sub-optimal spending on R and D too are issues to be addressed.
PPVFR Act
The Protection of Plant Variety and Farmers Right Act, 2001 (PPVFR Act) was made to:
• Set up an effective system for the protection of plant varieties.
• Protect the rights of farmers and plant breeders.
• Encourage the development and cultivation of new varieties of plants.
The act was enacted to grant intellectual property rights to plant breeders, researchers and farmers who have developed any new or extant plant varieties. The rights granted under this Act are heritable and assignable and only the registration of a plant variety confers the right. Farmers are entitled to save, use, sow, re-sow, exchange or sell their farm produce, including seeds of a registered variety in an unbranded manner. Farmers’ varieties are eligible for registration. The period of protection for field crops is 15 years and for trees and vines 18 years. The rights granted under this act are an exclusive right to produce, sell, market, distribute, import and export the variety. Civil and criminal remedies are provided for enforcement of breeders’ rights. There are provisions relating to benefit- sharing and compulsory licencing, in case a registered variety is not made available to the public at a reasonable price. Compensation is also provided for villages or rural communities if any a registered variety has been developed using any variety in whose evolution such a village or the local community has contributed significantly.
PepsiCo
The US snack and beverage giant PepsiCo sued a handful of farmers in Gujarat for cultivating a variety of potato that the multinational claims as its own. The American major uses the particular tuber in question for making Lay’s brand of chips. PepsiCo has taken the farmers to court for infringing on its intellectual property right (IPR) by cultivating FL 2027, one of the two potato varieties registered by the company. Registration confers an exclusive right on the breeder to produce, sell, market, distribute, import and export the said variety. Indian law gives an upper hand to the farmers as per the PPVFRA, which overrides other provisions to guarantee the right of farmers to use seeds. It says that ‘notwithstanding anything contained in this act,’ a farmer is entitled ‘to save, use, sow, re-sow, exchange, share or sell his farm produce, including seed of a variety protected under this act in the same manner as he was entitled before the coming into force of this act, provided that the farmer shall not be entitled to sell branded seed of a variety protected under this act.’ The Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV and FRA), a sui generis system, was enacted to meet the World Trade Organization’s (WTO) demand for legislation to protect breeders’ interests. India’s law is unique because it seeks to protect the rights of breeders as well as farmers. There is a special chapter that safeguards farmers’ access to seeds too, and it is the only legislation globally guaranteeing farmers’ rights. Other countries subscribe to an instrument called the Union for the Protection of Plant Varieties (UPOV), an international agreement with several versions, that offers limited rights to farmers.
World Intellectual Property Organization (WIPO)
The World Intellectual Property Organization (WIPO) is one
of the 15 specialized agencies of the
United Nations (UN). WIPO was created in 1967 ‘to encourage creative activity,
to promote the protection of intellectual
property throughout the world’. WIPO
currently has 191 member states, administers 26 international treaties like
Patent Cooperation Treaty, the Madrid
system for trademarks and the Hague system for industrial designs among others.
It is headquartered in Geneva,
Switzerland.The WTO and WIPO have a cooperation
agreement. The difference between
WTO and WIPO is that
1. WTO has a wider mandate for regulating global trade.
2. WTO is not a UN-specialized agency and is neither a part of the UN system.
3. All WTO members have to compulsorily accept the TRIPS rules,
Comments
Post a Comment