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Novartis’s challenge on validity of Indian patent laws was put down by Indian High Court August 7, 2007

Posted by mais in Drugs, India, IP Systems, Litigation, Patent, TRIPS.
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Swiss pharma giant, Novartis, faced another blow in India, when Chennai High Court rejected its writ petition challenging the validity of Indian Patent Laws.

Novartis had sought to declare Section 3 (d) of the Indian Patents Act as substituted by Patents (Amendment) Act (2005) as being “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality).”  The section denies patent protection to the discovery of new form of known substance which does not result in enhancement of the known efficacy of that substance.

Novartis also rasied concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”. The Bench rejected the concerns by saying that the amended section cannot be invalidated solely on ground that there was a mere possibility of misuse of power.

Since Novartis’s 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate and the crystalline forms of imatinib mesylate. The crystalline forms of imatinib mesylate claimed in the application in question does not differ significantly in properties with respect to efficacy. In fact, with respect to efficacy, the current specification of Novartis itself admits that wherever β-crystals are used the imatinib free base or other salts can be used. The various forms of imatinib mesylate can, therefore, very well be considered the “same substance” under section 3(d) of the Patents Act.   view of IP practitioner Swarup Kumar

Novartis unlikely to challenge High court ruling in Indian Supreme Court. Novartis faced first setback  in January last year, when the Indian Patent Office rejected a patent application of its leukaemia drug Gleevec. It had filed appeal against the patent office decision to Intellectual Property Appellate Board and a writ petition in Chennai High Court.


Defending a patent infringement in court – take recourse of Reverse Doctrine of Equivalents July 11, 2007

Posted by mais in IPR Laws, Litigations, Patent, USA.
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Doctrine of Equivalents was set forth by US Supreme Court in 1950 to extent the protection of patent rights to a good patent holders beyond the literal meaning of the claims i.e. literal infringement. US Supreme Court also established Function-Way-Result test with the objective to ensure the fundamental fairness to it to all.

Reverse of the doctrine is also hold good, i.e. if the claim elements did not Function is the same Way to accomplish the same Result then there would not be actual infringement under the doctrine.

Till date, neither US Supreme Court nor Federal Circuit Courts of Appeal had reversed a finding of non-infringement based on reverse doctrine of equivalence.

read more from ipfrontlines authored by Jay Sandvos

Indian Whisky Producers restrained to use “Scotch” June 26, 2007

Posted by mais in GI, India, TRIPS, WTO.
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Scotch Whisky Association of UK has won a legal action in Delhi High Court to refrain Indian whisky manufacturers to use word “Scot” or Scotch”.

The association filed suit against Indian producer “Golden Bottling Ltd” under the Geographical Indications of Goods (Registration and Protection) Act, 1999. India enacted it under WTO-TRIPS Agreement obligations.

GIs are IPRs attributed to the products of a particular place like Darjeeling Tea, Banarsi Saari, Champagne etc.

India 2nd best innovation facilitator places in the World May 17, 2007

Posted by mais in IPM Strategies.
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India emerged as the country with 2nd best conditions for innovation, after the US. UK ranked third and Japan at the fourth.

Japan has emerged as the world’s most innovative nation in terms of business practises, followed by Switzerland, US and Sweden. India has been ranked at 58th position, ahead of China’s 59th position in a ranking of 82 economies, based on their level of innovation during 2002-06. India fared marginally better on a study of innovation enablers (or the ability of a country to facilitate innovation), coming in at No. 50.

The Economic Intelligence Unit, The Economist, survyed 485 senior executives worldwide and analysed data collected between 2002 and 2006. 

A forecast by the agency for 2007-2011 expects China to improve its rank by five positions, while India is expected to move up by two. Hence, India will give away its lead over China as an innovative country in the next five years.

The top four will maintain their positions, according to the forecast, while China will move up five places to 54th and Mexico will climb six places to 39th.

Indian firms and brazilian AIDS patients to be benefit from compulsory licensing May 9, 2007

Posted by mais in Drugs, India, Patent, TRIPS, WTO.
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The Brazilian government’s decision to override the patent rights of Merck’s HIV/AIDS drug Stocrin (efavirenz) and buy reverse engineered generic versions of the drug at low cost has come as a boon for Indian pharmaceutical companies manufacturing generic versions of efavirenz such as Cipla, Ranbaxy, Aurobindo Pharma and Strides Arcolab.

On Friday, Brazilian President Luiz Inacio Lula da Silva announced invoking the compulsory licensing provision for pharmaceuticals under the World Trade Organisation’s (WTO) agreement on intellectual property – the TRIPS (Trade-Related Aspects of Intellectual Property Rights) – to buy copycat versions of efavirenz from laboratories certified by the World Health Organisation.

With over 200,000 registered cases, Brazil has the most AIDS patients in Latin America. Of them, only 75,000 patients are currently treated with efavirenz.

Welcoming the Brazilian government’s move, Amar Lulla, joint managing director of Cipla, said it was heartening to note that Brazil has invoked the compulsory licensing provision to treat its HIV/AIDS patients with affordable generic drugs.

“The compulsory licensing provision of the TRIPS help countries to protect the rights of its citizens. We welcome the Brazilian move,” he said.

Lulla confirmed that the Brazilian government was negotiating with Cipla for the supply of these medicines.

US pushes bill to promote competitive presence of generic drug manft. March 7, 2007

Posted by mais in Drugs, USA.
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The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market.

The bill brought by Senator Patrick Leahy, (D-Vt.), and supported by Senators Herb Kohl (D-Wisc.), Chuck Grassley (R-Iowa), Russ Feingold (D-Wisc.), and Charles Schumer (D-NY).

The bill aims to end the trend of anti-competitive agreements between brand name pharmaceutical companies and generic companies to delay entry of affordable generics into the market.

Today, the law can’t stop the original patent holder from launching an “authorized generic” through a subsidiary or a third party. Sales of an authorized generic during the exclusivity period can cut the generic maker’s profits by 59 percent, according to research by Merrill Lynch analyst Greg Gilbert.

On the other hand Branded drug companies are lobbying with Bush administration to impose a new fees for the drug application filed by generic drug companies

Is infringment of patent in abroad liable to claim damages in the country…. ? March 7, 2007

Posted by mais in Litigations, Patent, software.
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This is the question .. going to be decided by US SC in july 2007, while hearing Microsoft Corp. v. AT&T Corp., 05-1056 case.

In a long-running case between Microsoft and AT&T, AT&T had been able to secure favorable judgments from lower federal courts.

In this case, Microsoft has accepted the infringement of an AT&T patent in US but disputed the infringement of the patent in overseas markets.

The patent is related to technology that converts speech into computer code, so the speech can be transmitted electronically. It accused Microsoft Corp. of infringing the patent by including similar capabilities in its Windows software.

AT&T has cited the provision of US patent law, which restricts the export or infringed products from country. It says by incorporating the infringed technology in windows and selling it overseas Microsoft has violated the said provision and hence liable for the damages.

Microsoft, has pleaded that it is exporting only the “master copy” of the software and said feature has been added by computer  manufacturers in the foreign markets.

AT&T  protested the idea of “master version” of the software and argued that Microsoft has collected the royalty on the infringing software sold in the overseas markets, hence it is liable for the damages for the infringement in  overseas markets.

US Supreme Court is expected to deliver its judgment on the issues in july 2007.

The secret to successful use of technology in a corporate setting January 31, 2007

Posted by mais in IPM Strategies, Patent.
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The secret to successful use of technology in a corporate setting

By Ernest Svenson on Legal Tech

It’s sad how much money is wasted on technology. If you need transportation and you buy a car then you aren’t wasting money. But if the car doesn’t run properly so that you don’t use it then you have a problem. Corporations buy lots of technology. Amazingly, most of that money is wasted because they don’t know how to use technology properly.

What’s the secret to using technology well in a corporate world? I don’t really care, because I gave up on the corporate world. But, if I ever went back to that world, then it would have to be a company that understands this principle.

IP Due Diligence – put simply (with the 6 T’s) January 8, 2007

Posted by mais in Patent.
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Duncan Bucknell  talks about the  ‘6T’ framework for analysing IP issues.  This article uses the same framework to show you how to simply structure an IP due diligence. 

Just to remind you, here are the 6 T’s:

1 ­- Type of IP

2 – Time (until expiry)

3 – Territories (in which IP is held/registered)

4 – Terminated (ie the status of the IP)

5 – Technical Scope of the monopoly

6 – True monopoly? (validity)

more here

Steady Flow Of Patent Application In India December 7, 2006

Posted by mais in India, Patent.
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An Indian Law firm Lex Orbis analyzies the trend in patent application in India.

The revival of the Indian economy and globalization of markets have thrown open new opportunities in the field of foreign investments and a strong patent regime is a key driver for foreign investment in India, particularly when other competing countries in South East Asia, including China offer better investment climate. As technological innovation is facilitated by healthy IPR protection, the onus is on the policy for correct balance between industrial development goals and protection of national interest.

The number of patent filing rate in India had tremendously grown in recent years and it has been growing 30% annually since 2002-03. The accession to PTC and the amendment of the Patent Act and Rules are the contributory factors. But the Indian Patent office infrastructure is still undergoing a change. The IT infrastructure is improving and the government realizing the advantages is planning a 1,300 crore-modernization plan. Currently India is ranked 12th in the world in patent filing. It has been reported that the numbers of applications have increased 400 percent over the past 15 years. Nearly 800 companies submitted international applications to the WIPO in 2004, which is more than a double of what has been filed in 2000. An increased patent filing was witnessed in the year 2005-2006 due to the changes brought about in the Patent Act where the product patent was introduced for the first time in pharmaceutical sector.

Currently, the patent office expects the growth to be maintained at 30% this year also. Delhi office has recorded the largest number of application around the country and majority of the application continues to be from foreign countries and is from the chemicals and pharmaceutical segment, which account for half of the applications filed followed by Information Technology and Electronics.

WIPO Report on Worldwide Patenting October 19, 2006

Posted by mais in Patent.
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A report released by the World Intellectual Property Organization (WIPO) on Monday, October 16, 2006, shows that the patent system is an integral part of increasing global economic activity, with the increase in patent filings closely mirroring economic growth around the world. The WIPO Patent Report 2006 shows that companies are increasingly using the intellectual property (IP) system to protect their investments in new markets. The report reveals that a total of 5.4 million patents were in force worldwide in 2004, the last year for which complete statistics are available.

The WIPO Patent Report (2006 Edition) presents an overview of worldwide patenting activity based on statistics up to the end of 2004. It provides analyses of different aspects of the patent system, cross-country comparisons and special sections on technical features of the patent system such as the Patent Cooperation Treaty and the European Patent Convention.

Patent statistics are useful indicators of inventive activity and of technology flows. Research into the use and interpretation of such statistics is an on-going activity at WIPO. In this first edition, the WIPO Patent Report includes indicators to measure patenting intensity across countries. Three indicators (population, GDP and R&D expenditure) are used to weight patent filings according to country size and economic activity.

Growth in patent activity. Patent filings have grown at an average annual rate of 4.75% over the past ten years, to a total of nearly 1.6 million in 2004. The growth rate is comparable to the overall increase in economic activity as measured by world GDP growth. Patents granted worldwide have also increased at a similar rate, to more than 600,000 in 2004. At the end of 2004, there were more than 5.4 million patents in force worldwide.

Increasing internationalization. Patenting activity has expanded across more countries in recent years. This can be seen in the growth rate of patent filings by non-residents (7.4% average annual increase since 1995) and in the increase in patent filings in countries such as Brazil, China, India, the Republic of Korea and Mexico. That said, the use of the patent system remains highly concentrated with five patent offices (United States of America, Japan, European Patent Office, Republic of Korea and China) accounting for 75% of all patent applications and 74% of all patents granted.

Increased use of the Patent Cooperation Treaty (PCT). The WIPO-administered PCT has become a major route for international patent filing. The number of PCT international applications grew at an average annual rate of 16.8% from 1990 to 2005 and reached 135,000 in 2005. PCT national phase entries account for 47% of all non-resident patent filings

Patent_report_200621 The report notes a boom in patent filings in northeast Asia over the past 20 years, most notably with the emergence of China and the Republic of Korea as major industrial economies. For several decades Japan has been the largest patent office in the world with more than 400,000 patent applications filed by residents and non-residents in 2004. In only 20 years, China has become the 4th largest patent office in the world (by number of patent applications filed) and patent filings by Chinese residents grew more than five-fold between 1995 and 2004 to reach 65,786. Today, the Republic of Korea is the 3rd largest patent office in the world and is also experiencing very high growth rates with a three-fold increase in patent filings by residents between 1994 and 2004.

EU Law Blog: Compulsory licenses of pharmaceutical patents for export October 4, 2006

Posted by mais in Patent.
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EU Law Blog: Compulsory licenses of pharmaceutical patents for export
Compulsory licenses of pharmaceutical patents for export
The Community has adopted and published a regulation – Regulation 816/2006 – on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with health problems.

This regulation sets up, within the EC, the system that had been foreseen in paragraph 6 of the Decision of the General Council of the WTO of August 30th, 2003 implementing the Doha Declaration on the TRIPS Agreement and public health. It enters into force at the end of June 2006.

European patents and software October 4, 2006

Posted by mais in Patent, software.
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European patents and software

Things are getting curioser and curioser in the long drawn out debate on whether computer software is patentable or not. The Commission had proposed back in 2000 that computer software patents could be invalidated. Then in 2002 the Commission proposed that software should be patentable (see proposal COM (2002) 92 final Also here). The the European Parliament rejected that proposal (see generally, legislative history).

Now, the Commission in response to a parliamentary question (P-1625/06 by Adam Gierek) seems to indicate that

…the draft Community patent Regulation confirms in its Article 28.1(a) that patents granted for a subject matter (such as computer programs), which is excluded from patentability pursuant to Article 52 EPC, may be invalidated in a relevant court proceeding.

So it seems like the Commission is reverting to its position in 2000 and abandon the position it took when the EP rejected the software patent proposal.

WHO is Right? GphA or PhRMA You Decide– August 14, 2006

Posted by mais in Patent.
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A recent independent study released by GPhA, challengded the findings of PhRMA study.
The study, “An Assessment of Authorized Generics: Consumer Effects and Policy Issues,” conducted by Dr. Aidan Hollis and Dr. Bryan A. Liang Reveals that Authorized Generics are Bad for Consumers, Lead to Higher Pharmaceutical Prices, leads to the dimnishing the Competition in the market and in long term would lead to reduced access to cheaper drugs to the consumers.

The PhRMA study concluded that:

the prices consumers pay will be virtually unchanged by the presence or absence of AGs noting that much of PhRMA’s alleged “discount” of prices associated with AGs is accounted for by higher brand name drug prices;

allowing authorized generic entry during the 180-day exclusivity period harms the incentives generic firms have to challenge invalid patents or develop products; and,

Authorized generics will lead generic firms to be less aggressive in competing against brand name firms and the ultimate losers will be consumers.

Glaxo’s patent on AIDS drug opposed by INP+ in India April 25, 2006

Posted by mais in Drugs, Patent.
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Glaxo's patent on AIDS drug opposed by INP+ in India
The World Trade Review: "Intellectual Property Rights (TRIPs), 16-30 April 2006

Mumbai: People living with HIV/AIDS are taking on drug major GlaxoSmithKline's efforts to patent its AIDS-medicine Combivir in India.

The Manipur Network of Positive People (MNP+), under the aegis of the Indian Network of People Living with HIV/AIDS (INP+) has filed a pre-grant opposition to GSK's patent application at the Indian Patent office in Kolkata. The pre-grant opposition has been filed for the patient organisations by Lawyers' Collective.

Combivir is the backbone of AIDS therapy and is used in the first-line of treatment, Mr Loon Gangte, a HIV-positive person with INP+, told Business Line. GSK's patent application is being opposed on technical and health grounds, he said.

Combivir is a fixed-dose combination of two existing AIDS drugs – zidovudine and lamivudine, technically that is not a new invention, Mr Gangte said. GSK officials were not available for comment.

A pre-grant opposition allows people to oppose patent applications filed by a company. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. Only recently, the Patent Office in Chennai had rejected Novartis' patent on cancer drug Glivec.

Generic or copycat versions of Combivir are available in India from drug-makers such as Cipla, Ranbaxy, Aurobindo, Emcure and Strides. They are priced at about Rs 1,100 per patient, per month. These drug-makers supply to patients to other developing countries too, he said. GSK's Combivir is not available in the local market, said Ms Priti Radhakrishnan of Lawyers' Collective.

But international aid organisation Medecins Sans Frontieres (MSF) purchases it at about $237 per patient per year compared to the cheapest generic at $182, said Ms Leena Menghaney with Campaign for Access to Essential Medicines and MSF.

Generic competition has brought down the price on Combivir-clones. If GSK gets a patent, it becomes a monopoly and could control the price, Mr Gangte said.

Though the present product-patent regime in India may allow Combivir-clones to sell provided they pay a royalty to GSK, there is a risk of a price increase. There is no clarity in the law on the royalty to be paid. Either way a price increase is on the cards, he said.

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Overview of Chinese Patent Litigation System April 24, 2006

Posted by mais in IP Systems, Litigation.
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An informative overview of Chinese Patent Litigation System "Patent Litigation in Chinese Courts" by J. Benjamin Bai, Helen Cheng and Peter Wang from JONES DAY appired on Mondaq.com A must read….

State of Innovation in Global Pharma Industry March 22, 2006

Posted by mais in Innovation, TRIPS.
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An article appierd in Forbs Magzine, the state of innovation in Global Pharma Industry as ……….But right now, big drug companies are suffering from an innovation drought. Aitken says that there were only 30 new medicines launched in key markets in 2005, well off the peak of the 1990s. A more encouraging sign: There are 2,300 experimental drugs being tested in humans. In the late stages of human testing, IMS counts 96 cancer drugs, 51 heart treatments, 37 antivirals and 28 potential medicines for arthritis or pain. However, more and more drugs are being developed by biotech–though Aitken argues that this is less of a problem than people think."

TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies January 11, 2006

Posted by mais in Drugs, TRIPS.
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TRIPS & Convention on Biological Diversity (CBD) Alaince worries Western Pharma/ Biotech Companies

Tuesday, January 10, 2006
By Stephanie Weinberg

U.S. biotech firms representing a variety of industries are working to ward off efforts by India, Brazil and other developing countries that want to amend World Trade Organization rules to require patent holders to disclose the origin of their patents and share benefits when those patents are based on genetic plant material or traditional knowledge from developing countries. Failure to meet these new rules would result in the loss of patents if these changes to WTO rules were approved.

The firms expect to create an education campaign this spring to build opposition among other WTO members to demands from India and Brazil, and argue that developing countries could actually be disadvantaged by such rules. In addition, the group hopes to find allies within India’s biotech industry, which also could be disadvantaged by the new requirements, they said. This could include Indian companies making patented health care and personal grooming products based on ayurveda, or Hindu traditional medicine.

The U.S. biotech firms have been brought together under the recently formed American BioIndustry Alliance, which includes pharmaceutical companies Merck, Pfizer, Bristol Myers-Squibb and Eli Lilly, as well as General Electric and Procter & Gamble. The membership of companies not strictly in pharmaceuticals shows the issue is important to firms beyond the drug industry, industry sources said. Procter & Gamble, for example, is chiefly interested in how new WTO rules requiring benefits sharing and disclosure of origin could adversely affect its skin care products, an industry source said.

The goal of the group is to prevent such requirements from being incorporated into the WTO Agreement on Trade-Related Aspects on Intellectual Property Rights, as demanded chiefly by Brazil, India and Peru. At the December 13-18 WTO ministerial in Hong Kong, those countries successfully negotiated language into the final ministerial text that calls for the WTO director general to intensify his consultations on all outstanding implementation issues, including the relationship between TRIPS and the Convention on Biological Diversity, which covers the use of biological materials.

Paragraph 39 also calls for the WTO General Council to review progress and “take any appropriate action” no later than July 31, 2006 on the implementation issues. Implementation refers to issues during the Uruguay Round that developing countries argue were not effectively implemented, but the only two issues specifically highlighted in paragraph 39 are the traditional knowledge and genetic material issue, and the European Union’s demands for protections for foods with geographic names or indications such as Parma ham. Some fear the EU may ultimately support talks on negotiating new rules on the use of traditional knowledge and genetic material if this also allows the GIs issue to move.

U.S. firms would have preferred to see language calling for open-ended consultations rather than a date indicating some decision could be made by this summer, sources said. However, one industry source said open-ended language was too much to expect given the push by Brazil and India for an endorsement of talks on amending WTO rules to be included in the ministerial text. At the same time, the source acknowledged it would be better to have more than six months to consult with other WTO members and potential allies in India as a way to counter the current demands from India, Brazil and Peru.

The July 31 date corresponds to deadlines for members to submit comprehensive draft schedules of commitments in agriculture and industrial market access, although this depends on members meeting a separate deadline agreed in Hong Kong to establish specific negotiating terms or modalities in those areas by April 30. Still, it is conceivable that Brazil and India could use the deadline on these schedules as leverage to win concessions on the TRIPS issue.

However, U.S. industry sources indicated they are hopeful of softening the position of India, which in Hong Kong indicated to the U.S. that its position was based on domestic political reasons, and that its biotechnology and pharmaceutical industry had not raised its voice on the issue, sources said. The ruling party in India shares power with several minority parties, including the Communists, who support introducing WTO requirements for benefits sharing and origin disclosure.

As a result, industry sources said it could be possible to get India to lower its demands if industry groups in that country announced their opposition to rules that would threaten to invalidate a patent if a patent holder failed to share benefits or disclose the origin of related traditional knowledge or genetic material. These sources indicated U.S. groups would reach out to potential supporters in India in the hopes of changing the dynamics there.

Such a scenario, however, is unlikely with Brazil, which is seen as more interested in advocating fundamental changes to TRIPS, sources said.

The alliance will argue to developing countries that creating a mandatory patent disclosure obligation would make it less likely that industry would invest in bio-prospecting in developing countries, which would add to uncertainty in the bio-industry and make it less likely that genetic resource inventions would become commercially viable. This would go against the interest of countries rich in traditional knowledge and genetic material, since these countries would not get to share in any benefits unless products appear on the market.

Determining where genetic material comes from can also be complicated, and is another reason why linking patents to disclosure or benefit sharing would be a bad idea, the alliance argues. For example, questions could be raised about the origin of bio-materials found in the Brooklyn Botanical Garden. Another possible complication could occur if a company disclosed that the country of origin for its material was India, but it turned out the same material could be found in, for example, China. This could lead to conflicts over how benefits should be shared among various countries.

U.S. firms and the U.S. government have advocated a contractual system for sharing benefits, and have urged members to reject a linkage between patents and benefit sharing, these sources said.

Finally, the alliance argues the goals that would need to be captured in an international regime on access and benefit sharing related to genetic resource inventions go beyond the expertise of the WTO TRIPS Council. It argues the better forum for an agreement would be under the Convention on Biological Diversity, which the U.S. has not ratified. There is also no dispute settlement mechanism under the CBD.

Stephanie Weinberg
Trade Policy Advisor
Oxfam America

Evaluation of EU Rules on Databases December 15, 2005

Posted by mais in EU.
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Interesting development on database protection tracked by BLOG@IP::JUR


‘[…] The European Commission has published an evaluation of the protection EU law gives to databases. EU law protects databases by copyright if they are sufficiently creative. Other databases, especially those that are compilations of information or commonplace data, such as telephone directories, music charts or football match listings, may benefit from a new form of protection introduced by the 1996 Database Directive. This protection is known as the ‘sui generis’ database right, i.e. a specific property right for databases that is unrelated to other forms of protection such as copyright. The evaluation focuses on whether the introduction of this right led to an increase in the European database industry’s rate of growth and in database production. It also looks at whether the scope of the right targets those areas where Europe needs to encourage innovation. Stakeholders are invited to comment on the evaluation by 12 March 2006. […]’

The evaluation paper is available EXTERNAL LINKhere. Policy options discussed therein are:

* Option 1: Repeal the whole Directive;
* Option 2: Withdraw the ‘sui generis’ right;
* Option 3: Amend the ‘sui generis’ provisions; and
* Option 4: Maintaining the status quo.

‘[…] Before deciding on its future policy approach with respect to the ‘sui generis’ protection for ‘non-original’ databases, the Commission services deem it appropriate to further consult stakeholders on the four policy options outlined above. Stakeholder consultation should also provide further evidence on the economic impact of ‘sui generis’ protection in stimulating the production of European databases. Stakeholders are invited to submit their observations by 12 March 2006.'”

WTO upholds cheaper drugs waiver December 14, 2005

Posted by mais in TRIPS.
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It is a great win for humanity as well as opportunities for pharma companies from developing countries like India, in Generic Market producing Life Saving Drugs.

The agreement will extend a 2003 temporary rule
World Trade Organization (WTO) members have agreed to uphold a rule that allows poor countries to import cheaper copies of patented medicines.

Its general council has agreed to make permanent a 2003 waiver that allows poorer nations to import generic drugs to treat serious diseases such as Aids.

The measure would become permanent by 1 December 2007, the WTO said. The current waiver remains until then.

WTO boss Pascal Lamy said the agreement showed the body’s humanitarian concern.


US Trade Representative Rob Portman added that America was fully behind the move.

‘This is a landmark achievement that we hope will help developing countries devastated by HIV/Aids and other public health crises,’ he said.

The European Union (EU) has also backed the change.

‘The EU has worked hard for this outcome and welcomes that others have moved to make this possible,’ said EU Trade Commissioner Peter Mandelson.

And for the UK, Trade Secretary Alan Johnson said ‘this announcement should be an important step in making drugs available in poor countries.

‘The lack of access to essential medicines in developing countries is one of the biggest health issues – and one of the gravest injustices – in the world.’

Under the rule, poorer nations will be allowed to import the generic drugs for humanitarian reasons and not for commercial purposes.

Some of the larger developing countries, like India, hope that they will be able to sell antiretroviral Aids drugs to Africa under the deal. “