jump to navigation

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.
add a comment

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.

Advertisements

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

Posted by mais in GI, India, TRIPS, WTO.
add a comment

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.

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

Posted by mais in Drugs, India, Patent, TRIPS, WTO.
add a comment

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.

State of Innovation in Global Pharma Industry March 22, 2006

Posted by mais in Innovation, TRIPS.
add a comment

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.
add a comment

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

WTO upholds cheaper drugs waiver December 14, 2005

Posted by mais in TRIPS.
add a comment

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.

‘Landmark’

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. “

US again threatns to suspend patent rights on health hazard grounds.. November 11, 2005

Posted by mais in Drugs, TRIPS, USA.
add a comment

Apprehension about offering the stringent Product Patent protection to Pharma inventions during the TRIPs negotiations are turning the to be true.

Even in developed world, companies holding the key patented medicine were reluctant to offer the medicines to the needy people at the time of community health crises and in order to avoid any catastrophy might govts like US has literally threat to them suspend/ revoke their patent rights over the life saving medicine.

Perhaps, most of developing countries are not strong enough to compel any such patent holder to make available the life saving drugs to the public on reasonable prices.

We have to ensure that natural human lives are always placed above the profit making motives of legal entities.

IPBiz: Washington Post on Tamiflu: U.S. bullies IP owners: “Monday, November 07, 2005
Washington Post on Tamiflu: U.S. bullies IP owners
But the U.S. isn’t a model of respect for intellectual property, either. Panicked by its own lateness, the Bush administration has bullied Roche into opening a new production operation in the United States; if Roche had refused, the administration was ready to break the patent. Sen. Chuck Schumer has gone further, denouncing Roche for elevating profits above health and demanding that the firm license its technology to other drugmakers or face legislation compelling it to do so. Coming on top of similar bullying four years ago of Bayer, the maker of an anti-anthrax drug, this browbeating sends a clear signal: If you make a drug that turns out to be really important, don’t expect patent laws to protect you.

The WTO angle and TRIPS November 22, 2004

Posted by mais in IP Systems, Patent, TRIPS, WTO.
Tags: , ,
add a comment

The WTO angle and TRIPS: “The WTO angle and TRIPS

By Lawrence B. Ebert

Of the Ballmer quote: ‘Someday, for all countries that are entering the [World Trade Organization], somebody will come and look for money owing to the rights for that intellectual property.’

Section 5, Article 27, paragraph 1 of TRIPS recites:

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

Paragraphs 2 and 3 don’t say anything about business method or software patents.

[http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm#5]

David Berlind writes: Given the significant overlap between the members of the WTO and the European Union [EU], I’m having a tough time imagining how, if Europe can’t uphold patents on software, the WTO can. One poster observed that the EU could take the position that business methods/software are not a ‘field of technology’ or perhaps even ‘inventions.’ Further, if the USA did even try to get WTO to force a change in the EPC, the EU would counter-attack with TRIPS complaints about various aspects of the US patent system which currently favour US-based inventors. –> Mutually assured standoff.

Berlind also wrote of the WTO remark: ‘the easiest way to get rid of a potential customer forever is to sue them. Especially when that customer is a government. Governments usually have pretty big budgets.’

Within the US, patent holders have sued customers. Go back to the days of the Selden patent on the automobile. One of the advertising slogans for licensed cars was ‘Don’t buy a lawsuit.’ Henry Ford said that this tactic by the Selden patent holder (ALM) launched Ford’s business. In the pharma business today, many claims on drugs are written such that patients, doctors, and pharmacists could be sued for use of competitor’s infringing drugs. For example, this could have happened with omeprazole. But, of course, it didn’t. In the area of copyright, there have been some exemplary suits brought by the RIAA against consumer-infringers, but this is tricky business.

A different website gives a different example.
http://www.linuxworld.com.au/index.php/id;1874419189;fp;4;fpid;1

–>Up to now, not many users have faced such threats. When asked for an example of a user actually getting sued over intellectual property rights, Microsoft spokesmen go back four years.

In 2000, Allan Konrad, a computer scientist, sued three dozen corporations, including General Motors, Ford Motor, The Boeing Co., Daimler Chrysler, United Air Lines and Eastman Kodak. Konrad held three patents and ownership to the mechanism of Web-based delivery of information. He went after corporations serving Web information from back-end databases.

‘Microsoft worked to get IBM, Sun and AOL, whose products were also implicated, to step in collectively on behalf of our customers. We hired one law firm to defend them, paid the cost of that. The outcome was very positive, the infringement claims were thrown out,’ said David Kaefer, director of business development at Microsoft.

full window
full window

No Progress on Bio/TK Disclosure for Patents September 30, 2004

Posted by mais in EU, India, IP Systems, Patent, TRIPS, WTO.
Tags: , , ,
add a comment

I/P Updates: TRIPS: No Progress on Bio/TK Disclosure for Patents – News and Information for Intellectual Property Practitioners: “TRIPS: No Progress on Bio/TK Disclosure for Patents
According to an article in BRIDGES Trade BioRes, Vol. 4 No. 17 23 September, 2004
, the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) considered a proposal by Brazil, India, Pakistan, Peru, Thailand, and Venezuela on September 21, 2004 suggesting a checklist of issues to be covered in negotiations on biodiversity, traditional knowledge and folklore. The proposal elaborates on possible disclosure requirements in patent applications relating to the source and country of origin of a biological resource and/or traditional knowledge used in an invention.

The US and Japan again voiced their opposition to using the checklist. No substantive progress was made and the meeting closed after one day rather than the scheduled two. The next TRIPS Council is reportedly scheduled for December 1-2.
posted at 1:58 PM ”

full window