Only 9 products have got GI status so far

Acquisition of GIs by more and more Indian products is “a concentrated focus to enhance their market value besides assuring Indian exporters of premium price overseas”.

G. Srinivasan
New Delhi, July 20

After five years of the enactment of the Geographic Indications of Goods (Registration and Protection) Act that came into effect from September 2003, only nine products have been accorded the Geographical Indicator (GI) status while another two are due to get the status from the Registrar of GIs in India.

Official sources told Business Line here though innumerable agricultural, natural and manufactured products ranging from basmati rice, Darjeeling tea, Kanchipuram silk saree, Alphonso mango, Nagpur orange, Kolhapuri chappal to Bikaneri bhujia could form GIs, the registration is not compulsory as it only provides legal protection to Indian GIs.

This in turn helps boost exports, besides promoting economic prosperity of the producer of goods in a geographic territory.

India and Pakistan have resolved to jointly register Basmati abroad to ensure that no spurious or fake rice in such appellation gets into their lucrative overseas market, depriving them of the premium price their basmati rice commands.

Ministry initiative
When contacted, the Minister of State for Commerce, Mr Jairam Ramesh, said that though GIs are not compulsory, his own Ministry has taken the initiative to get registrations of GIs from the Chennai-based Registrar of GIs.

He said that he was happy that though numerous products in India got registered, some of the products that are registered by the commodity boards in his Ministry have bagged the GIs.

These include, among others, he said, Darjeeling tea, Kangra tea of Himachal Pradesh, Malabar pepper, Alleppey coir, Telechery pepper, Alleppy green cardamom, Coorg green cardamom, Monsooned Malabar Arabica and EI leather.

He said both Assam orthodox tea and Nilgiris orthodox tea would shortly get the GI status.

Mr Ramesh said that the Commerce Department has applied for GI to Darjeeling tea in Europe six months ago and hopes to get it within a year. He said the acquisition of GIs by more and more Indian products is “a concentrated focus to enhance their market value besides assuring Indian exporters of premium price overseas”.

Registration
Explaining the slower growth in registration of GIs, the sources said that once an application is made to the registrar, a number is allotted and after which the application gets scanned by a consultative group of experts to ascertain the veracity of claims and to check whether it meets the requirements of the Act and Rules.

After a GI is registered any person claiming to be the producer of the registered GI could file an application for registration as an authorised user. The procedure for registration as an authorised user is similar to that for the registration of a GI.

The sources noted that the registered proprietor and authorised users could initiate infringement action if their GI products are sold without their permission and the authorised users could exercise the exclusives right to use the GIs.

A special link between the goods and place of production is evolved resulting in the growth of GIs, the sources said adding that Indian exporters and traders or those dealing with the traditional Indian goods could surmount the problem of fake or counterfeit goods if only they have armed themselves with GIs registration.

http://www.thehindubusinessline.com/2008/07/21/stories/2008072151270300.htm

---

IPRs policy proposes ‘knowledge commons’
Roy Mathew
THIRUVANANTHAPURAM: The Intellectual Property Rights (IPRs) Policy for Kerala, released by Chief Minister V.S. Achuthanandan here on Friday, puts forth the concept of ‘knowledge commons’ and ‘commons licence’ for traditional knowledge.

The policy says that all traditional knowledge, including traditional medicine, must belong to the domain of “knowledge commons” and not to public domain. The system should be introduced through legal arrangements. While community or family custodians will have rights to knowledge that belonged to them, the rest of the traditional knowledge will belong to Kerala State.

No entity registered as a medium or large enterprise may be deemed to have any rights over traditional knowledge. Any community or family custodian of traditional knowledge would have to register as knowledge-practitioner with the Kerala Traditional Knowledge Authority proposed by the policy.

All rights holders of traditional knowledge will be deemed to be holding their rights under a ‘commons licence’. Under this licence, the right holder permits others the use of the knowledge for non-commercial purposes. If any development is made using that knowledge, it will have to be put back into the ‘knowledge commons’ and cannot be patented anywhere. For commercial use by others, an agreement would have to be reached with the rights holder. In the case of rights held by the State, all actual practitioners of knowledge would have automatic rights for commercial use provided that they are not medium or large enterprises.

Mandatory provision
The policy proposes that the State should make it mandatory for all applications from foreigners to the National Biodiversity Authority for making use of traditional knowledge of Kerala to be referred to the State Biodiversity Board.

A similar mechanism should be put in place against misappropriation of knowledge by Indian corporates also. The Board will ensure that traditional knowledge and development based on them remained within the realm of ‘knowledge commons.’ Commercial use of biological resources of the State by foreigners will have to be referred to the State Biodiversity Board besides the National Biodiversity Board. The policy lays down that the functions of the Knowledge Authority and the State Biodiversity Board should be supervised by a specialised governmental body called the Supervisory Council on Intellectual Property under the Chairmanship of the Chief Minister.

Policy on patents
The policy also specifies that patents taken out on research output by State government research institutions funded by private or foreign sources should be in the domain of ‘commons.’ In the case of research funded by the government, the government will decide whether the output should be placed under ‘commons.’ When the Union government or other official agencies fund projects, the status of output would be decided in advance on a case by case basis. That will also need the approval of the Supervisory Council.

S.P. Shukla, former Chief Negotiator of India at the Uruguay Round, who received the copy of the policy from the Chief Minister at a formal function, said that the commons concept would ensure that the incentives for research would not lead to proliferation of proprietary rights.
http://www.hindu.com/2008/06/28/stories/2008062856600100.htm

---

To patent or not to patent
One of the main objectives of the patents system-to develop new knowledge for prosperity of mankind-is getting diluted. The system is instead helping monopolisation of new knowledge for exploiting mankind. The need of the hour is to grant patents in a way that serves public interest

B K Keayla
The patent system was introduced in the legal scheme during the 19th century with a view to promoting basic inventions, enabling disclosure of inventions for further research and dissemination of the fruits of new research for the benefit of the public. The broad idea behind the system was to ensure availability of new knowledge for prosperity of mankind.

Patent rights are granted by the patent authority under the national law legislated through an enactment of Parliament. The rights are granted to both nationals and foreigners at par and are enforceable for a specified period of time and within the territorial limits of the country. In order to be patentable, an invention needs to meet certain criteria like novelty, non-obviousness and industrial applicability. That is, the invention should be previously unknown to the public, it should contain sufficient innovativeness to merit protection, and should be useful.

The patents system has acquired a unique position in the industrial economy of each country. It is a system which has to be carefully evolved to ensure that exploitation of the consumer does not take place through creation of absolute monopolies over new products. The interests of the patent holders and consumers have to be balanced to ensure achievement of objectives and smooth working of the patents system.

Scope of patentability
This is a core component of the patents system. The definitions of 'patentable invention' and 'patentable pharmaceutical substance' in particular have to be carefully framed to ensure that only subject matter of basic research are patented. Since the patents system prevents third parties from the acts of making, using, offering for sale, selling, or importing products for these purposes without the owner's consent, it is important to carefully frame the patentability as otherwise the system

will deprive effective competition in new products by other industrial enterprises. This scenario will be against public interest. The public health policy and laws, national drug policy and the patents system are intensely

co-related. This aspect should have been kept in view while implementing the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in amending the Patents Act 1970.

Our former prime minister, the late Indira Gandhi, while speaking at the historic session of the World Health Assembly in Geneva on May 6, 1981 emphatically stated, "My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death." This statement was made not only with regard to India but for the entire world at the World Health Assembly where an important resolution on 'Health for All by 2000 AD' was also unanimously adopted by all countries. Forgetting this resolve, the Uruguay Round of GATT Negotiations, which concluded in December 1993, gave birth to the TRIPS Agreement containing high standards for a universally applicable new patent system to be implemented both by the poor and rich countries alike. Negotiations at the Uruguay Round kept in view only the interests of multinational corporations and not the ailing poor, particularly in developing and under developed countries. The present political regime seems to have totally forgotten the strong statement of their leader about the scope of patentability for pharmaceutical products.

India, being a member of the World Trade Organisation (WTO), was required to amend its Patents Act 1970 to bring its provisions in line with the TRIPS Agreement. The process was completed by amending our Act three times; in 1999, 2002, and 2005. During a debate in Parliament in April 2005 on the final amendments of the Patents Act 1970, several Members of Parliament (MPs) raised issues about 'patentable subject matter for pharmaceutical products' and 'exclusion of patenting of micro-organism'. The Minister for Commerce and Industry realised the importance of the issues raised and assured that they would be referred to a government-constituted Technical Export Group (TEG) for examination. When their report was submitted in December 2006, it was found that the recommendations of the Group were biased and not based on cogent reasons. Some parts of the report were even plagiarised from the submission made before the Group on behalf of the MNCs. So far, no decision has been taken on the report and the critical issues relating to the scope of patentability are still undecided.

Need to define patentability
In the absence of a proper definition of patentable invention, it is observed that patent authorities in India are granting patents on trivial and even unusual patents. (See Box: Patent Parody) So who is responsible for granting such patents? It would be improper to blame the Patent Authorities alone for grant of such patents. The real blame lies with the broad-based provision on patentability stipulated in the amended Patents Act 1970.

The crucial issue is whether the patent system is meant for researchers/scientists or trading enterprises like shopkeepers, dhabas, vendors, etc. The government must get its act together and refer the matter of 'scope of patentability' covering definition of patentable invention, patentable pharmaceutical substance and even patenting of micro-organism to the concerned Parliamentary Committee so that time is not lost in amending our Patents Act. Patentability should be for a real basic invention and not for trivial subject matter. Flooding of patents on trivial matters will only create a crisis and raise costs as in USA.

The problem does not end with the need to modify the 'scope of patentability'. In a recent statement made by a government official, it was observed that the government was thinking of granting patents for encouraging incremental innovations. The statement in question reads as follows: "It may not be prudent to award patents only for a new molecule discovery, something which requires billion of dollars worth of R&D investment. No Indian company can afford it. So we are looking for ways to award patents for discovery of a new form of a known substance which results in the enhancement of the known efficacy of that substance."

With regard to the above statement, it may be emphasised that certain technological innovations to pharmaceutical patented products may qualify for patentability under the patents system. Technological innovations, when they satisfy the prescribed criteria, can and should be protected only through process patents. The other possibility is that if there is significant technical advance over the invention claimed in the first patent, it is possible to grant a dependent patent. Section 91 of the Patents Act 1970 provides for licensing of related patents based on conditions stated therein. These available possibilities are sufficient and could be suitably availed by the industry. The government should not succumb to pressure from multinational corporations to further liberalise the scope of patentability.

It is a fact that the US is also extremely worried about the patent frequency in that country. "No patent examiner has enough time in their life to examine all innovations completely," states John Doll, the US Commissioner for Patents. Even the American Supreme Court has raised the bar for what subject matter deserves to be given a patent. A serious debate is on in the US as to how grant of patents could be contained. Even an important IPR Commission established by UK has suggested containing of patents by the developing countries. The WHO Commission on IPR and Innovations has also made a similar recommendation. These aspects must not be ignored by our government. And before considering further flexibility for patenting of incremental innovation, there should be adequate public debate.

The government must consider in-depth and determine means for containing the scope of patentability. TRIPS review under Article 71 of that Agreement is also over due. There are also a a number of Doha Ministerial Declaration (November 2001) issues pending for decision. Government should also make all efforts with the WTO to have decisions on these long pending issues expedited. This will serve public interest and also strengthen competitive environment and role of domestic enterprises.

(The author is the Convener of the National Working Group on Patent Laws. He can be contacted at wgkeayla@del6.vsnl.net.in)
http://www.expresspharmaonline.com/20080715/management04.shtml

---

USFDA plans to set up offices in India
20 Jul, 2008, 1059 hrs IST, PTI

NEW DELHI: With a view to make inspection of drug production in a more efficient manner, American health regulator US Food and Drug Administration is looking to set up offices in different parts of India.
According to sources, the US Food and Drug Administration (USFDA) has submitted a proposal to the government for setting up offices in three cities Mumbai, Delhi and Hyderabad and at the same time it is interested in working in collaboration with its Indian counterpart Drug Controller General of India

"Presently, USFDA is waiting for the Health Ministry's response," a source added. Confirming the developments, Indian Pharmaceutical Alliance (IPA) General Secretory DG Shah said the USFDA officials had discussions with the the industry associations.

In February, the officials had come to India for a follow up visits after their trip to the country in September last year. The delegation also met senior Health Ministry officials, including health secretary and discussed the plan to establish three offices in the country. The delegation has initiated these activities in China also.

The American regulator has expressed desire to work in close cooperation with the drug regulator DCGI and both are planning to made joint inspections in the country, the sources added. Currently, USFDA inspects facilities in India on periodic basis and comes with prior notices to ensure that these units comply with the good manufacturing practices.

Eco-friendly tattoo removals

Lasers are used routinely in plastic surgery to remove tattoos and other skin blemishes. But surgeons have to be careful that the radiation doesn't heat the skin above 70°C, the threshold above which cell damage causes scarring.

To prevent this, they usually spray the skin with a cold, volatile liquid such as tetrafluoroethane which reduces the temperature of the skin to around 3 ??C as it evaporates. Precooling can increase the amount of heating the skin can safely accept by a factor of two, allowing the surgery to proceed more quickly.

Tetrafluoroethane is currently the liquid of choice because it does not damage the ozone layer, but recent work has shown that the chemical is a greenhouse gas many times more potent than carbon dioxide.

John Stuart Nelson Medical Director at the Beckman Laser Institute of the University of California, Irvine, US, says that laser surgeons can ease their eco consciences by switching to a carbon-dioxide spray that does the job just as well, while reducing the impact on the environment.

His idea is to store liquid CO2 under pressure and spray it onto the skin undergoing laser treatment. This produces a fine mist of solid CO2 particles ??? dry ice ??? that cool the skin before sublimating into gas.

Read the full green skin cooling patent application.
http://www.newscientist.com/blog/invention/

---

Bajaj sets sights on Royal Enfield for patent infringement
Siddharth Vinayak Patankar
Tuesday, July 15, 2008 (New Delhi)

Eicher group company Royal Enfield might find itself caught in a courtroom drama in the near future, as its new bike is being questioned by Bajaj Auto over possible patent infringement.

Yes, you guessed it right – it is twin spark plugs yet again – leading to another patent war brewing in the beleaguered two wheeler space.

Bajaj Auto has said it will take a closer look at the new Thunderbird TwinSpark. Bajaj holds a patent on twin spark technology and the bike maker has already dragged TVS Motor to court over a similar battle over the TVS Flame a few months ago.

"This engine has been under development for 6 years. It means a Means a lot to us. The future of Royal Enfield depends on it," said Siddhartha Lal, MD & CEO, Eicher Motors.

That is the importance that Royal Enfield places on its UCE or Unit Construction Engine on the new Thunderbird TwinSpark.
RE says that its engine does not infringe on Bajaj's patent since that patent is just for bikes between 75 and 250 cc while the displacement on the new Thunderbird is 350 cc.

The company also feels that since TVS flame is a 125 cc bike the same rules don't apply in this case.

The TVS - Bajaj battle over the twin spark plug technology is still far from over with rulings pending in the High Courts of Chennai, Mumbai for both the patent and defamation suits respectively.

While the Royal Enfield management is adamant that their bike is not contentious any legal issues could not have come at a worse time.

The company plans to use this engine technology on its entire lineup as other bikes like the Electra and Bullet also go under the scalpel and is also rolling out a capacity expansion to facilitate this at its Chennai plant.
http://www.ndtvprofit.com/2008/07/15001109/Bajaj-sets-sights-on-Royal-Enf.html

---

Drugs patents 'killing millions of poor'
Sunday July 20 2008 14:58 IST

LONDON: Drugs companies should be given incentives to serve the health needs of the global poor as international rules on intellectual property are contributing to millions of avoidable deaths, a leading political philosopher has told a major meeting of European pharmacologists.

Thomas Pogge, professor of philosophy and international affairs at Yale University in the United States, told an audience that included senior figures from the pharmaceutical industry Thursday that intellectual property rights rules "contribute to the fact that millions of poor people avoidably die each year from a lack of effective medicines".

Pogge said people were dying from a lack of locally-available drugs; a lack of access due to the high prices of patented medicines; and a lack of research into diseases concentrated among the poor - a state of affairs he said was "morally unacceptable".
He said huge mortality and morbidity rates could be dramatically lowered by reforming the way the development of new medical treatments are funded.

Pogges's comments, made to the Federation of European Pharmacological Societies (EPHAR) 2008 Congress at the University of Manchester, come as the prickly issue of intellectual property rights emerges as a hot negotiating topic at world trade talks in Geneva.

A group of more than 100 developing countries led by India want indigenous knowledge and traditions to be taken into account when pharmaceutical and other patents are granted, so that poor people are not forced to pay high prices of medicines that are derived from existing local knowledge.

Pogge said the creation of a Health Impact Fund (HIF), the details of which are being worked by an international interdisciplinary team, could help make the existing intellectual property regime "human-rights compliant".

Proposed as a global agency underwritten by governments, the HIF would reward the patentee of any new medicine during its first decade or so, with annual payments proportional to the medicine's demonstrated global health impact.
Registering a medicine with the Fund would be voluntary and require a concession affecting its price. Pogge says this would give innovators the opportunity to forego "monopoly rents in favour of an alternative path that would provide ample rewards for the development of new high-impact medicines without excluding the poor from their use".

"The main responsibility for change lies with politicians and citizens. But pharmaceutical companies are also citizens, and they play a significant role in the political process of most societies. They lobby a lot. And here I do see fault. They lobby for holding the line on a status quo that is simply morally unacceptable," he said.

http://www.newindpress.com/NewsItems.asp?ID=IE320080720043650&Page=3&Title=Health&Topic=-162