News Archives - 2004

 

 

December  News

 

 
 

Sami Labs gets US award

Ministry planning pre-negotiation of patented drug prices

Intellect Inc chips in $1.6 b for AP semiconductor unit

Local production to be must for MNC drug patent-holders

Left warns against `hasty passage' of amended Patents Act

Overseas patents may need NOC

Developments in IP Regime

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Sami Labs gets US award

Our Bureau (BL)

BANGALORE: The Bangalore-based pharmaceutical company Sami Labs Ltd, along with its associate company Sabinsa Corporation, USA, has been awarded the Thomas Alva Edison Patent Award for the year 2004 at the Liberty Science Centre in New Jersey.

The award has been instituted by the Research and Development Council of New Jersey, USA, for the best patent of the year.

The award was given for its invention, which involves developing ForsLean, a drug made out of the extract from the roots of the Coleus Forskohlii plant. ForsLean is a product that naturally and safely promotes lean body mass by increasing the body's thermogenic response to food, which improves the absorption of nutrients and their incorporation into lean body mass. It also helps to regulate metabolism for long-term weight loss and treats mood disorders in overweight individuals without any adverse side effects.

ForsLean was also voted as the "Best New Product" of the year 2001 by the industry association "Nutracon" in the US.

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Ministry planning pre-negotiation of patented drug prices

Nithya Subramanian (BL)

New Delhi , Nov. 14

EVEN as the Government gears up to put in place a product patent regime by introducing the Patent (Amendment) Bill, concerns about astronomical prices for patented drugs have cropped up. And the Ministry of Chemicals and Fertilisers is keen that adequate safeguards are in place to prevent arbitrary pricing.

Highly-placed officials in the Ministry said that one of the options being considered is to go in for pre-negotiation of prices for patented drugs. Currently, about 74 bulk drugs are under price control. "However, once the patent regime comes into effect, we must take steps to ensure that the patent-holder does not price the drugs very high. We want to ensure that these drugs are affordable and therefore one of the options being considered is pre-negotiation of prices," they said.

An appropriate authority may be appointed to look into the pricing issue.

This concern also gains significance because the Group of Ministers (GoM) looking into the Patents Bill has decided to scrutinise the 4,000-odd applications filed in the Mail Box facility.

The Indian pharmaceutical industry has been maintaining that less than 250 new drugs have been invented since 1995 and several applications aim at patenting pre-1995 molecules. Hence, patents for these molecules should not be granted, it said. But with the GoM deciding otherwise, several pharmaceutical companies would have to withdraw generic versions of the drugs.

"The GoM felt that companies are well aware of the change in Government policies and if generic companies have filed applications in the Mail Box, they have done so knowing fully what the consequences could be," said officials.

The Indian pharma industry has stated that drugs worth over Rs 3,000 crore would have to be withdrawn and this could lead to a price hike.

On the other contentious issue of compulsory licensing of drugs that are protected by patents especially during a national emergency, the GoM has decided to follow the Paris Convention Treaty on Intellectual Property Rights.

Under this, a cooling off period of three years is prescribed for the patent holder to launch the product. If the patent holder fails to do so, the Government can give the drug to another manufacturer under the compulsory licensing clause.

While the Chemicals and Fertilisers Ministry preferred the TRIPs agreement under which there is no cooling off period and compulsory licenses can be issued to manufacturers during an emergency, the Commerce Ministry was in favour of abiding by the Paris Convention Treaty.

"In the case of a national emergency, the law provides for Governments to procure drugs directly for distribution through hospitals. This could be done by allowing parallel imports and offering some duty concessions," they added.

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Intellect Inc chips in $1.6 b for AP semiconductor unit


OUR CORPORATE BUREAU (FE)
, November 16, 2004


HYDERABAD. NOV 15: Korea-based Intellect Inc, a semiconductor/chip fabrication company, has decided to set up a plant in Hyderabad with an estimated investment of around $1.6 billion in two phases. This could be the largest-ever investment proposal by any company in the Indian hardware sector so far.

This was disclosed by Andhra Pradesh chief minister YS Rajasekhara Reddy at the Microsoft campus inauguration ceremony here on Monday. The location would be the Hardware Park near Hyderabad.

The government is in the final stage of negotiations with the Korean company and expects that the ground-breaking ceremony will take place soon, Dr Reddy said. “We try to promote both software and hardware and the new hardware project will pave way for AP’s focus on promoting hardware too in a big way,” Dr Reddy added.

Giving more details, the state’s joint director (promotion), IT and communications department C K Veeresh said that the Korean company, promoted by June Min, former vice-chairman of Daewoo Corporation and former senior MD of the LG group, has already set up four similar fabrication plants in China and Taiwan.

To be set up as India Semiconductor Manuf-acturing Company (ISMC), the Korean company has proposed to invest $600 million in phase I and another $1 billion in phase II.

“We are in the final stages of negotiations with the Korean company and hope the construction work will begin in 2005,” Mr Veeresh said. Commercial production, if it goes as per schedule, will begin by end of 2006 or early 2007, he added.

The project will be developed in joint collaboration by Intellect with the world’s leading hardware firms, chip manufacturers and telecom majors and financial institutions for technical and financial collaboration, Mr Veeresh added.

Coming up in an area of 50 acres near the proposed international airport at Shamshabad in Hyderabad, and expected to provide a direct employment of 10,000 people, the company will manufacture chips for SIM cards, micro processors and other applications, including telecom. Based on the firming up of ancillary units around the fab, the total employment will go up further, he said.

Unlike other fabs, this project will be a unique one, the technology and chips have value for over 10 years and are expected to have mass consumption at all levels, he added.

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Local production to be must for MNC drug patent-holders


KG NARENDRANATH
Posted online: Thursday, November 18, 2004 at 0000 hours IST


NEW DELHI, NOV 17: In what could be a major setback to pharma MNCs, the government has decided that patent-holders would have to manufacture the product in India or forgo monopoly rights. Import and marketing would not be deemed as ‘working’ of a patent on Indian territory.

According to official sources, the Patent Amendment Bill to be introduced in the winter session of Parliament would make it clear that if the patentee failed to ‘work’ the patent on Indian territory, the compulsory licence facility could be invoked to bypass the patent, sources said.

Currently, the Patent Act is vague on what constitutes ‘working of a patent’ in India, allowing MNCs and domestic pharma companies to interpret the term variously. But the amendment clearly provides for issuance of compulsory licence on the grounds of ‘non-working’ of the patent.

Pharma MNC bodies like the US-based PhRMA had made several representations to the government, saying that the law must clearly provide that ‘import tantamounts to working of the patent’.

Local drug companies, on the other hand, argue that the extant law does not squarely exclude imports as a means to operate a patent. MNCs could, therefore, take advantage of the ambiguity on transfer pricing norms and escape the price control based on landed cost of imports, say domestic companies.

As per the Patent Act, “Patents are granted to encourage invention and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable, without undue delay.”

It is further clarified that patents are not granted “merely to enable patantees to enjoy a monopoly for the importation of the patented article.” It is silent as to whether local manufacture would be compulsory for the patent-holder.

Pharma MNCs like GSK, Pfizer and Abbott have already shown an inclination to close down their production units in the country and resort to contract manufacturing.

In this light, the new laws do not augur well for multinationals.

 

 

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Left warns against `hasty passage' of amended Patents Act

By Our Special Correspondent (The Hindu)

NEW DELHI, NOV. 25. The Left parties have cautioned the Government against "hasty passage" of amendments to the Indian Patents Act to make it Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant.

"We are strongly of the opinion that any hasty passage of the Bill (amendments 2003), without any informed discussion, will not be in the larger interests of the country. We give below a list of amendments that, we feel, need to be incorporated in the existing Indian Patents Act and the draft Bill 2003. These we believe are the minimum that need to be done to safeguard national interests," the parties said in a three-page note submitted to the Government on Wednesday.

The broad areas of concern of these parties include patentable subject matter; differentiating inventions; compulsory licensing; export by a licensee; transitional agreement and mailbox; royalty payment; and pre-grant opposition.

The Left parties said the Government must make full use of the "flexibilities" available in the TRIPS agreement and recounted the experience of many countries since the agreement came into force in 1995. They cited the instance of how an Indian pharmaceutical company was offering drugs for HIV-AIDS particularly in Africa at vastly reduced prices whereas global companies were selling them at 20-50 times their actual cost by seeking shelter under laws mandated by the agreement.

`Reserve term'

On patentable subject matter, the parties said that the term "invention" should be reserved for a `new' product or process involving an inventive step and capable of industrial application. All three criteria of `novelty,' `inventive step' and the quality of being "capable of industrial application" must be insisted upon especially to limit the number of applications and discourage frivolous claims.

They said the Indian Patent Act allows patenting of "micro-organisms" and "non-biological and microbiological processes." Patenting of these inventions are under mandated review by the World Trade Organisation since 1999 and in the absence of any decision, patenting of these should not have been provided for. All life forms and research tolls for biotechnology should be excluded from the scope of patentability.

Compulsory licensing

Compulsory licensing, they said, was an instrument available in the TRIPS agreement to safeguard the legitimate interest of consumers by limiting the possibilities of monopolies being created in different sectors. "Unfortunately the Indian Act has not made full use" of such provisions unlike Brazil and China which have passed legislations allowing compulsory licensing in cases where the patentee does not respond within stipulated time the offer of reasonable commercial terms and conditions to the patent holder.

Similarly, the TRIPS agreement allows export by manufacturers who produce through a compulsory licence, and suggested that the same be incorporated in the amendment so that the Indian pharmaceutical companies could export drugs to developing countries at relatively lower prices to the mutual benefit of both.

The agreement also provided for receipt of patent applications through a mailbox between January 1995 and December 2004, which are to be examined after January 1. On being granted, the patent would remain effective for 20 years from the date of application. The parties said that in cases where production had been started by any enterprise during the transition period, it should be allowed to continue production on payment of a nominal royalty instead of being accused of violating the patent. The quantum of royalty payment should be explicitly stipulated if compulsory licensing was issued.

There was no justification in removing the existing pre-grant opposition from the Act in the proposed amendment Bill. They said countries such as Australia, Japan, Canada and the United Kingdom provide for pre-grant opposition in their laws.

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Overseas patents may need NOC


KG NARENDRANATH (FE)
November 26, 2004 at 0038 hours IST


NEW DELHI, NOV 25: Indians wanting to file for overseas patents will have to obtain a no-objection certificate (NOC) from the Centre, according to the re-drafted Patent Bill 2004.

The Bill is going to be introduced in the winter session of Parliament. The government is awaiting the report of the Left parties, which have raised many objections to the Bill.

The government plans to introduce the mandatory NOC for filing patents in foreign countries as a safeguard against patenting of technologies that have dual purpose, one of which could be hazardous. Senior government officials told FE the NOC would not become a hurdle in the way of filing of international patents by Indian companies, institutions or individuals. “The NOC application shall be disposed of in 90 days,” an official said.

The government also proposes to introduce patenting of software embedded with hardware in the re-drafted Patent (Amendment) Bill. The Bill, as originally drafted by the previous government, did not have this provision. The Bill seeks to amend the Patent Act 1970 for a third time primarily to meet the Trips (trade related intellectual property rights) obligation of introducing product patents in pharma, agrochem and food sectors. However, it does not tinker with the ‘patentability’ criterion.

Neither does it propose any changes in the compulsory licensing (CL) provision. CL is a facility available to national governments under Trips to side-step patents and license the patented article to a third party under certain defined circumstances such as national emergency, extreme urgency and for public non-commercial use.

Sources said the Prime Minister’s office (PMO) had taken a ‘blanket decision’ not to tinker with any provision in the Act that conformed to the views of the joint parliamentary committee (JPC) which dealt with the relevant issues in detail prior to the second amendment in 2002. “The JPC had discussed these issues for nearly two years in 40 sessions. There is no reason for an overarching decision upon the JPC’s now,” the official said.

A patentable invention is one that is new, involves an inventive step and is capable of industrial application. Sections of the domestic drug industry wanted the Act to explain these terms and restrict patents to new chemical entities.

Significantly, the government has also decided to retain the provision for pre-grant objection in the Act, which the original Bill proposed to dispense with. Pre-grant objection would be, however, allowed only on one ground, i.e., patentability.

Again, sections of the Indian drug industry wanted the objection to be allowed on a host of other grounds also. “Patentability is a comprehensive term that covers all possible objections to a patent. Why should there be more grounds?,” government sources said. They added that the Bill will also provide for post-grant objection.

At present, the patent controller’s decision can be challenged only in a court of law. The proposal is to introduce a two-tier post-grant opposition, one consisting of appeals to the controller himself and later to the Appellate Board, and another the route of appealing to a civil court.

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Developments in IP Regime
OUR CORPORATE BUREAU (FE)
October 26, 2004.

Sunil Jose

http://ipmusings.blogspot.com/

Bill C-9: Canada's initiative to implement WTO Decision of 30 August 2003

Canada's Bill C-9 (An act to amend the Patent and the Food and Drugs Act) will be the first international attempt to implement WTO General Council Decision of 30 August 2003.

 

The Bill received royal assent on May 2004 and will come into force later this year. The amendment will allow the issuance of compulsory licenses to Canadian firms authorizing them to manufacture in Canada specific patented pharmaceutical products for export to certain developing and least-developed countries.

 

The amendment adds schedules to Patent Act identifying the pharmaceutical products and importing countries that are eligible under the new system.

 

Patent Provisions: India will soon become a 'TRIPS compliant' nation.

 

The third amendment to Indian Patent Act 1970 (The Patents (Amendment) Bill, 2003) will be introduced before the Parliament during Winter Session. The Bill once cleared by the Parliament will make India a 'TRIPS compliant nation' as on 1 January 2005 as far as patent provisions are concerned.

 

In respect of Patent Law, the TRIPS Agreement provides specific time frame to the WTO members to bring their patent legislations in line with their obligations under the Agreement.

 

While mailbox facility (Article 70.8) and Exclusive Marketing Rights (Article 70.9) were required to be introduced from first of January 1995, developing countries has time till January 1, 2005 to introduce product patent provisions (Article 65.4) All other obligations under TRIPS should have been complied with by January 1, 2000.

 

In respect of obligations effective from January 1, 1995, India has amended the Patents Act, 1970 through the Patents (Amendment) Act, 1999 effective retrospectively from January 01, 1995.

 

In respect of obligations from January 01, 2000 India has further amended the Patents Act through the Patents (Amendment) Act, 2002 passed by Parliament in May, 2002 and made effective from May 20, 2003.

 

The third amendment bill will introduce product patent protection in all fields of technology as envisaged in Article 27.1

 

University of California, Berkeley and Samoan leaders agreed on sharing benefits from utilisation of Prostratin genes.

 

On Sept 30, 2004 the University of California, Berkeley (UC Berkeley) announced the signing of an agreement with the Samoan Government to isolate the gene for a potential anti-AIDS drug (Prostratin) from the indigenous mamala tree and to share any royalties from the drugs' sale with the Samoan people. Though Prostratin is a promising Anti –AIDS drug, its supply is limited since it has to be extracted from the bark and stem wood of the mamala trees that naturally produce it.

 

According to the University web site the agreement supports Samoa's assertion of national sovereignty over the gene sequence of Prostratin.

 

The Agreement gives UC Berkeley and Samoa equal share in any commercial proceeds from the genes. The Samoa's 50 percent will be allocated to the government, to villages and to the families of the healers who first taught ethnobotanist Dr. Paul Alan Cox how to use the plant. Agreement also provides for the negotiation for the distribution of the drug in developing nations at a minimal profit.

 

Back in Nov 13, 2001 AIDS ReSearch Alliance of America (ARA) - a Californian based Non Profit Research Organization, which had an exclusive license from US National Cancer Institute to develop Prostratin agreed to return 20% of any commercial profit arising from Prostratin to Samoan people for helping ARA to discover this anti-HIV compound. (NCI had patent for Prostratin for its anti-HIV properties)

 

Under the terms of the agreement commercial proceeds from prostratin would go to the Samoan government, the village where the compound was found and each of the families of the healers who helped discover it.

 

Zambia invokes Article 31.b of TRIPS Agreement; declares AIDS a National Emergency.

 

Zambia has declared HIV/AIDS a national emergency from August 2004 to July 2009. The declaration will enable local firms to obtain licenses to start manufacturing cheaper generic AIDS drugs.

 

Article 31 of the TRIPS Agreement permits member governments to authorise any party to use an invention without the consent of the patent holder of that invention. This practice commonly known as 'Compulsory Licensing' is subject to certain conditions specified in Article 31. Prior Negotiation with the patent holder by the party seeking CL is one among such conditions. However the Member government may do away with prior negotiation in case of a 'National Emergency'.

 

 

 

 

San Marino accedes PCT

 

San Marino, the third smallest state in Europe and an enclave in Central Italy became the 124th Contracting State of the Patent Cooperation Treaty (PCT). It deposited its Instrument of Accession at WIPO on September 14, 2004. The treaty will enter into force for San Marino on December 14, 2004 (Article 63.2 of PCT).

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