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IP-Watch interns talk about their Geneva experience in summer 2013. 2:42.

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1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

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9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

The Politicization Of The US Patent System

The Washington Post story, How patent reform’s fraught politics have left USPTO still without a boss (July 30), is a vivid account of how patent reform has divided the US economy, preempting a possible replacement for David Kappos who stepped down 18 months ago. The division is even bigger than portrayed. Universities have lined up en masse to oppose reform, while main street businesses that merely use technology argue for reform. Reminiscent of the partisan divide that has paralyzed US politics, this struggle crosses party lines and extends well beyond the usual inter-industry debates. Framed in terms of combating patent trolls through technical legal fixes, there lurks a broader economic concern – to what extent ordinary retailers, bank, restaurants, local banks, motels, realtors, and travel agents should bear the burden of defending against patents as a cost of doing business.


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    Interpol, Pharma Join Hands Against The Crime Of Fake Pharmaceuticals

    Published on 14 March 2013 @ 8:19 pm

    By , Intellectual Property Watch

    Members of the pharmaceutical industry and Interpol have agreed on a plan to fight “fake” medicines and other pharmaceutical crimes, echoing efforts to address the issue at the World Health Organization in recent years.

    Announced on 12 March, the initiative, which proposes to address “pharmaceutical crime,” including counterfeits, is somewhat reminiscent of the World Health Organization’s task force against counterfeit medicines. That initiative was considered to mingle intellectual property issues with public health and has been supplanted by a new member state mechanism.

    The Interpol Pharmaceutical Crime Programme will focus on the prevention of all types of “pharmaceutical crime,” including branded and generic drug counterfeiting, a press release said, and will also serve to identify and dismantle organised crime networks linked to this activity. Interpol said such products threaten the health of millions of people.

    The three-year programme will cost €4.5 million (approximately US$5.8 million) and will build on the work of Interpol’s Medical Product Counterfeiting and Pharmaceutical Crime unit. A total of 29 pharmaceutical companies are part of the agreement, among which are Abbott, Bayer, Bristol-Myers Squibb, Merck, Novartis, Roche and Sanofi. Interpol is the world’s largest international police organisation, with 190 member countries, and is based in Lyon, France.

    Interpol Secretary General Ronald Noble said in the release, “With no country, no drug, no medical product immune from counterfeiting, a global effort is needed to combat this threat which puts the lives of millions of people at risk every single day,” adding that the initiative is bridging the public and private sectors to help Interpol and its members to tackle the problem.

    [Update:]  India generics companies have raised concerns that the initiative could backfire, as “in the global market place, generics have had to constantly fend off overt and covert efforts to disparage them and label them ‘counterfeit’.” In a story published on 14 March, the Hindu (Business Line) quoted D.G. Shah of the Indian Pharmaceutical Alliance as saying that the Interpol agreement is “a continuation of the efforts by branded companies to use such agencies as Customs and universal postal unions to target generics as counterfeits.” [end update]

    Public Awareness, Capacity Building – and Definitions

    One of the missions of the programme is to raise public awareness of the dangers of fake drugs, in particular in the digital world, the release said. The programme is expected to include training, capacity building and “targeted enforcement actions to build awareness of the issue, as well as to disrupt and dismantle the organized crime networks involved in the various types of pharmaceutical crimes such as counterfeiting, illicit sales or illicit diversions.”

    “In the case of drug counterfeiting, it can mean the difference between life and death for a patient,” Sanofi CEO Christopher Viehbacher said in the release. Interpol illustrated the issue by citing a “counterfeit” cough syrup containing diethylene glycol that caused “eight mass poisonings around the world including in 2006 in Panama where more than 100 people died, many of them children.”

    According to a civil society source, the World Health Organization Bulletin reported on a case of poisoning in Panama in 2006 involving a cough syrup containing diethylene glycol provoking acute renal failure, however it does not appear to have been established that the contamination was the result of drug counterfeiting. Rather, it appeared to have been a case of a wrongly labelled imported ingredient.

    According to the WHO Bulletin, “Epidemiological and laboratory findings implicated a prescription liquid cough syrup, produced by a CSS [Caja del Seguro Social] hospital pharmaceutical manufacturing facility, as the cause of the outbreak in Panama.” “The presence of DEG was finally confirmed in a single lot number of a product that was labelled as glycerin and that was imported to Panama from China via a European broker,” the bulletin said.

    WHO is seen as having competency in determining the quality of medical products, but not in whether there have been intellectual property rights violations. For many, counterfeiting implies IP rights violations. It is not clear whether Interpol and the companies are making this distinction in terms or not.

    Interpol defined pharmaceutical crime as involving “the manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices,” it said. “It encompasses the counterfeiting and falsification of medical products, their packaging and associated documentation, as well as theft, fraud, illicit diversion, smuggling, trafficking, and money laundering.”

    The use of the denomination of counterfeit medicines in unsafe, falsely labelled or spurious medicines has been fought over by some developing countries and civil society as mixing a trademark issue with the issue of quality, accessibility, and affordability of medicines, and even the sale of legitimate generic versions of medicines. Under global trade rules, counterfeit would refer to a trademark violation, purposely labelled as a brand-name product by someone other than the trademark owner.

    But the new programme announcement said that generics can also suffer the same fate as brand names. “Both brand-name and generic pharmaceuticals are susceptible to counterfeiting, putting patient lives at risk,” said Haruo Naito, president and CEO of Eisai. In recent years, a number of brand-name pharmaceutical companies have invested in generic manufacture.

    Meanwhile, developing countries have repeatedly asked for help in addressing the problem of counterfeit and substandard medicines.

    “Putting an end to counterfeiting requires broad, coordinated action on a global scale,” said John Lechleiter, chairman, president, and chief executive officer of Eli Lilly. “This new initiative between the pharmaceutical industry and Interpol is aimed at helping ensure that patients can trust in the safety and efficacy of the medicines they rely on.”

    International Federation of Pharmaceutical Manufacturers & Associations Director for Public Affairs & Global Health Policy, Mario Ottiglio, told Intellectual Property Watch that “IFPMA supports this partnership between Interpol and our industry to combat counterfeit medicines, which is a crime against patients. It complements anti-counterfeiting efforts, such as awareness-raising, that we and our companies have led for several years and will contribute to protecting patients.”

    WHO Supportive of Strict Public Health Target, No IP

    A WHO source told Intellectual Property Watch that the WHO is supportive of actions that minimise the risks to patients and consumers from substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.

    The issue of poor quality medicines has been addressed at the WHO for a number of years. In 2006, the WHO launched, in conjunction with Interpol, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). But IMPACT’s location within the WHO was criticised by developing countries and civil society as putting a focus on counterfeiting, which they said is an intellectual property rights issue rather than a health issue (IPW, WHO, 3 March 2011).

    In 2010, the World Health Assembly (WHA) convened a working group to examine WHO’s role in ensuring the availability of safe and affordable medicines, its role in the prevention of SSFFC medical products, and its relationship with IMPACT, according to the WHO. In 2012, the WHA adopted a resolution to create a new member state mechanism on SSFFC medical products. The first meeting of the member state mechanism took place from 19-21 November 2012 in Buenos Aires, Argentina.

    But final agreement on the mechanism was not reached in Buenos Aires, and another meeting is expected to be held before the upcoming WHA from 20-28 May (IPW, WHO, 28 January 2013).

    “Interpol will work with all those involved in fighting fake medicines including the WHO and have enjoyed success with them in the past. We intend to continue to work with them in the future,” an Interpol source told Intellectual Property Watch.

    The WHO, the source said, is entirely focused upon the detrimental effect upon public health posed by these products as opposed to the enforcement and protection of intellectual property rights, which is a responsibility of other agencies.

    According to a WHO spokesperson, the Interpol initiative is completely separate from the new member state mechanism. Meanwhile, IMPACT still exists, and IMPACT’s secretariat is now held by the Italian National Medicines Regulatory Authority, the spokesperson said.

    It is estimated that up to 50 percent of medicines supplied through websites which conceal their physical address are supplied illegally or are falsified, according to the WHO.

    According to Christopher Paun, a scholar at the University of Bremmen, Germany, “this public-private partnership at Interpol is another sign of how Interpol’s role in fighting counterfeit medicines has increased over the last years, while the role of the WHO has declined.” Paun recently completed his Ph.D. on this subject.

    This is the result of the deadlock at the WHO concerning the IMPACT taskforce, he told Intellectual Property Watch, adding that “the pharmaceutical companies are only willing to support a global PPP [public-private partnership] if they think it is worthwhile. While there is deadlock at the WHO, Interpol has shown tangible results, e.g. with the Interpol-led operation Pangea.”

    The Pangea operation is coordinated by Interpol and brings together customs, health regulators, national police and the private sector from countries around the world, according to Interpol.

    Civil Society Concerns About Confusion

    According to Sangeeta Shashikant of the non-profit Third World Network, “In defining medical products with compromised quality, safety and efficacy, WHO is moving away from using the word ‘counterfeit’ which actually refers to a specific type of trademark infringement.”

    “The Interpol initiative, rather than assisting in bringing more clarity to the issue, continues to create confusion as to what specifically is being targeted by using the term ‘counterfeit’,” she said. “It is also unclear if the initiative is targeting all forms of poor quality and unsafe medical products or medical products from unlicensed manufacturers or if it includes unsafe medical products from licensed manufacturers.”

    “Further, the approach taken by Interpol is rather concerning as it focuses on law enforcement without addressing the critical lack of functioning drug regulatory authorities in most of the developing world and access to affordable medical products,” she told Intellectual Property Watch. “Without addressing these fundamental issues, the problem of medical products with compromised QSE [quality, safety and efficacy] cannot be addressed effectively. Also concerning is the involvement of the private sector in criminal law administration.

     

    Catherine Saez may be reached at info@ip-watch.ch.

     


    Leave a Reply

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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