The latest available documents of the closed-door meeting addressing recommendations on ways to finance neglected diseases largely afflicting developing countries show progress heading into this afternoon’s session. They reflect efforts to agree on how to take the process forward, including agreement reached last night on putting the issue to regional groups later this year.

The document on progress made on “operative” paragraphs is available here.

The document pulling together all of the “prambular” paragraphs is available here.

For background, see here (IPW, WHO, 24 May 2012), and here (IPW, WHO, 24 May 2012).

Below is the full text on “operative” paragraphs heading into this afternoon’s meeting:

“Text as of 24/5/2012 at 22:26

CALLS UPON Member States*, the private sector, academic institutions and nongovernmental organizations to [increase] investments in health research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases;
* And, where applicable, regional economic integration organizations

REQUESTS regional committees
to discuss at their 2012 meetings the report of the CEWG in the context of the implementation of the GSPA-PHI in order to contribute to concrete proposals and actions. [agreed]

REQUESTS the Director-General
to convene a[n] [intergovernmental] meeting open to Member States** that will take into account the results from national consultations and regional committee discussions,[as compiled in a report by the Director-General,] and will develop proposals, or options on (1) research coordination, (2) financing and (3) monitoring of R&D expenditures* [(4) possible instruments, including a binding global agreement,] to be presented under a substantive item dedicated to the follow up of the CEWG report in the Sixty-sixth World Health Assembly through the 132nd session of the EB.
*as defined in the GSPA-PHI
** And, where applicable, regional economic integration organizations”

By Catherine Saez

The chair of the World Intellectual Property Organization patent committee today circulated informal suggestions on ways forward for this week’s wide-ranging committee agenda.

After more than three days of discussions at the 21-25 May Standing Committee on the Law of Patents (SCP) meeting, delegates have retreated to informal consultations and discussions.

Chair Vittorio Ragonesi of Italy issued informal suggestions on future work this afternoon, saying they were “just some ideas that everybody can use.”

The text of the chair’s suggestions is here [pdf].

Acknowledging strong positions taken by SCP delegates during the week, he recalled the bumpy road of the committee and said future work was a delicate issue. He asked that delegates bear in mind that in October 2010 (IPW, WIPO, 16 October 2010) the agreement on the agenda of the SCP was only reached as a result of an extended process of discussions and represented a delicate balance, which should not be tipped.

Main issues on future work are exceptions and limitations to patent rights, quality of patents, patents and health, and technology transfer. Developing and developed countries have stood firm on their rather different perceptions of the international patent system and its effects.

Members of the World Health Organization tonight will consider a draft decision on how the organisation will address the prevention and control of noncommunicable diseases, such as tobacco use, unhealthy diet, physical inactivity and harmful use of alcohol.

The draft decision text, A65/A/Conf.Paper No. 3 Rev.1, is available here [pdf].

According to sources, a drafting group reached agreement on this document yesterday and it was made available today. Targets (paragraph 3) were not agreed and will be taken up again at a meeting in October, they said.

The annual World Health Assembly is taking place from 21-26 May.

By Catherine Saez

CIOPORA, an international association of plant breeders, held its annual meeting recently with a focus on novelties in plant patents introduced by the America Invents Act, to become effective on 16 March 2013.

According to a press release [pdf] on the outcome of the meeting and an article by two patent experts in the CIOPORA Chronicle, three major areas of plant patenting are related: grace period, priority claim and novelties in procedures.

The one year “grace period”, which allows plant breeders to announce or commercialise their inventions within the year following the plant patent application, has been maintained in the America Invents Act. There had been some expectation that it might be removed.

Plant patent applicants must indicate the priority claim for the earlier plant breeders’ rights application issued by the respective governmental authority when applying for a US plant patent. Once the priority claim is confirmed, the effective date for the US plant patent will be considered to be the earlier plant breeder’s rights application, according to the release.

Third parties can submit information relevant to the patentability of new plant varieties or challenge the plant patent after it has been granted under the new act, CIOPORA said.

CIOPORA is the International Association of Breeders of Vegetatively Reproduced Ornamental and Fruit Varieties.

By Matthew Gibson for Intellectual Property Watch

The information and communications technology (ICT) for development community is meeting in Geneva this week for a series of conferences on the 2003-2005 World Summit on the Information Society. Government stakeholders, civil society, and the private sector will evaluate progress towards meeting the goals set at the last WSIS in Tunis in 2005 and establish new common goals looking beyond 2015.

The conferences will focus on rural development, ICT infrastructure, cyber security, multilingualism, environmental sustainability, and healthcare and innovation. More than 1,500 representatives from 150 countries are expected to attend the event, which comprises of approximately 140 sessions, according to organisers.

The week is co-organised by the UN International Telecommunication Union (ITU), UN Educational, Scientific and Cultural Organisation, (UNESCO), UN Conference on Trade and Development (UNCTAD), and the UN Development Programme (UNDP).

More information on this week is here.

The Drugs for Neglected Diseases initiative (DNDi) has released a policy brief in support of the proposed convention on research and development for neglected diseases to be considered at the upcoming World Health Assembly.

DNDi, a Geneva-based non-profit drug R&D organisation developing new treatments for neglected diseases, is generally seen as non-partisan on public health issues.

The policy brief is entitled: ‘Transforming Individual Successes into Sustainable Change to Ensure Health Innovation for Neglected Patients: Why an Essential Health R&D Convention Is Needed‘ [pdf].

The brief was issued in response to the recently released report of the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). The CEWG report is agenda item 13.14 of the WHA, which will be held from 21-26 May (IPW, WHO, 2 May 2012).

“Based on our own experience,” DNDi said in a release, “the brief outlines the factors that we deem essential, in the long term, for enhancing R&D to respond to the needs of neglected patients in developing countries: open innovation and pro-access IP management, sustainable financing mechanisms, coordination of R&D with commitment from endemic countries, and innovative regulatory pathways.”

Switzerland has postponed signature of the Anti-Counterfeiting Trade Agreement (ACTA) until it has more information from several ongoing processes in Europe, the government said yesterday.

It said in a press release that the questions raised about the agreement in recent months have led it to reconsider, as it takes citizens’ fundamental liberties and legal rights seriously.

This was the message in the response of the Swiss Federal Council to a letter from the Commission on Foreign Affairs of the Parliament. According to an informal translation, it said that Switzerland renounces its signature and will re-examine the question when new elements are available on which to base its decision. These elements could include the procedures in the five European Union member states that have postponed the ACTA signature, the conclusion of the conformity examination requested by European Commission of the European Court of Justice, or the ongoing ratification procedures at the EU level, it said.

The original (in French) press release is here.

By Matthew Gibson for Intellectual Property Watch

With the launch of a new report concerning research and development for diseases predominately afflicting developing countries, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) today convened a panel of public health specialists to discuss the findings.

The report, entitled “Assembling the Pharmaceutical R&D Puzzle for Needs in the Developing World,” was released earlier today. The report aims to identify and close the gaps in the R&D process through emphasis on integration, providing incentives for innovation, and an effort to de-link research costs from the final price of medicines.

Information about the event, including the report, is here.

The IFPMA-commissioned report was authored by Meir Perez Pugatch, managing director of the Pugatch Consilium, a consulting group. “Our study … concludes that increasing R&D is best achieved with a combination of mechanisms,” Pugatch said in a release. “In other words, there is no ‘one size fits all’ approach.”

IFPMA Director General Eduardo Pisani said in the release that the report contributes to the policymaking process through “an evidence-based approach.” He said industry regularly adapts its R&D process, but that “some gaps remain.” Solutions should be found through R&D that “builds on existing models,” he said.

Pugatch and his colleague, Rachel Chu were joined on the panel by Pascale Boulet of Drugs for Neglected Diseases initiative and Thiru Balasubramaniam of Knowledge Ecology International. Both speakers stressed the importance of de-linkage and integration regarding the R&D process and addressed the role of the World Health Organization in achieving these ends. Chris Gray, a representative of Pfizer, presented the private sector viewpoint and highlighted the work that pharmaceutical firms undertake to align with the goals presented by the other speakers with regard to keeping medicine costs low and streamline the R&D process.

Matthew Gibson is an intern at Intellectual Property Watch. He is a student at Colgate University (US).

By Matthew Gibson for Intellectual Property Watch

The heads of the World Intellectual Property Organization and the European Patent Office today signed a three-year agreement to mutually improve the procedural framework of the Patent Cooperation Treaty (PCT).

The agreement calls for annual work plans of cooperation on “areas of mutual interest surrounding the PCT,” according to a joint press release. These work plans include “fully electronic exchanges of PCT documents and an enhanced digital exchange of patent information products.” The agreement text was not available at press time.

Although the two organisations had worked together previously, this agreement marks the first of its kind relating to the PCT, they said. The agreement aims to increase the use of the PCT framework among patent applicants, and targets efficiency and patent quality.

“This agreement ushers in a new epoch in the already long-standing relationship between the EPO and WIPO,” EPO President Benoît Battistelli said after their meeting in Munich.

WIPO General Director Francis Gurry noted that the cooperation “reflects a shared vision of the PCT as the core work-sharing platform of the international patent system.”

The EPO conducts some 70,000 patent searches related to patent applications filed under the PCT, they said. This amounts to about 40 percent of the total, originating both from Europe and elsewhere. The PCT, administered by WIPO, allows the filing of a patent application in some 140 countries simultaneously.

Matthew Gibson is an intern with Intellectual Property Watch.

By Monika Ermert for Intellectual Property Watch

Eben Moglen, a professor of law and history at Columbia University, made a haunting appeal to participants of the 6th re:publica conference that opened in Berlin this morning: Do not to fail in completing the fight for freedom of thought.

Social networks like Facebook, search engines like Google, or online shopping malls like Amazon are “consuming” the users. Governments, large and small, are eager to re-use the profiling, predicting and persecuting activities and passing laws to store these data indefinitely, Moglen said.

“They own our search box, we are reported everywhere and every time,” and with mobile devices always on it is “confession 24/7”.

“The Stasi gets some bargain this time, because Zuckerberg does its work for it,” Moglen said, and added Facebook is a data warehouse containing the thinking and behaviour of a billion people. Moglen also had nothing nice to say about Apple genius Steve Jobs whose death he said was a good day, as Jobs was a “moral monster” who disliked sharing.

Moglen said there is an ever-urgent need for free (un-surveilled) media, free software and free, not network operator controlled networks. Without such freedoms, freedom of thought will be lost permanently, he said. Moglen’s appeal got thundering applause at the re:publica, which has developed into the largest alternative internet-related conference in Europe with 4,000 registered participants, 200 hours of talks and panels 350 speakers from 30 countries.

Copyright, innovation, open government, the role of blogs and bloggers, reforms in journalism, e-health will be discussed in 14 different tracks. Neelie Kroes, EU Commissioner for the Digital Agenda will give her keynote on internet freedoms on 11 May. Moglen asked participants today to implore the commissioner to consider freeing content from academia for “non-surveilled” free reading.

By Catherine Saez

The European Commission Directorate General for Internal Market and Services has awarded a contract to three lobbying groups promoting geographical indications to conduct a study on GIs.

According to a press release [pdf], Brussels-based Insight Consulting, a group giving advice on the protection and the promotion of GIs, Geneva-based Organization for an International Geographical Indications Network, and Swiss-based REDD, which promotes “quality labels” and provides advice on product valorisation, received the award as a consortium. The object of the contract is a study on non-agricultural geographical indications and will provide an “analysis of existing legal frameworks in force in the 27 EU Member States,” as well as in Iceland, Norway and Liechtenstein and Switzerland.

The consortium, which said the results of the study should be available “before the end of the year,” is hoping that it “will assist the European Commission in identifying an appropriate strategy to address the key issue of GIs for non-agricultural products.”

By Monika Ermert for Intellectual Property Watch

Opponents and proponents of the Anti-Counterfeiting Trade Agreement (ACTA) in the European Parliament have positioned themselves in meetings of several committees preparing opinions.

As the head of the Liberal Party Group (ALDE) joined Greens and Socialists & Democrats in rejecting the agreement negotiated behind closed doors between the European Union, United States, Japan and seven more countries since 2007, some observers declared ACTA was dead.

Legal Affairs Committee (JURI) rapporteur Marielle Gallo and several representatives of her party group, the conservative European Peoples, on the other hand pointed to the merits of better intellectual property enforcement and asked for the potential to “repair” some of the shortcomings and make an attempt to renegotiate.

Representatives of the European Commission reacted by warning that Europe would be left behind while the other ACTA partners go ahead, and the Commission especially attacked this week’s critical statement by the European Data Protection Supervisor (EDPS) as unbalanced and highly “selective”. The EDPS on 24 April questioned ACTA because of its vagueness and potential negative effect on fundamental rights.

As the ACTA debate is raging through the various committees, the lead rapporteur, David Martin, has postponed the vote of the International Trade Committee to 20 June, shifting the plenary vote to early July, swiftly followed by the Legal Committee, which also postponed its vote on its own opinion and send more questions to the Commission on ACTA’s framework. Some ACTA opponents quickly warned against manoeuvring through the delays.

The United States Department of State has announced its approval of 12 anti-crime projects around the world aimed at intellectual property protection.

The US$2.6 million in total funds for the current fiscal year “will enable U.S. law enforcement agencies and diplomatic missions to collaborate on the delivery of IPR protection criminal enforcement training and technical assistance programs for foreign law enforcement partners,” the State Department said.

The projects include: three regional workshops in Africa that include a special focus on counterfeit medicines; training of judges and others in the Association of Southeast Asian Nations (ASEAN); training seminars to get Brazil off the US Trade Representative’s “notorious markets” list; training of Chilean judges and Colombian police; workshops with IP officials from India, China and ASEAN; training for Mexican “enforcement partners on following the money trail, digital evidence in online piracy cases, and border and customs enforcement”; and seminars/training for judges and prosecutors in the Philippines, Thailand, and Turkey.

According to State, the Bureau of International Narcotics and Law Enforcement Affairs and the Bureau of Economic and Business Affairs selected the projects “after considering input from the U.S. Intellectual Property Enforcement Coordinator, other federal agencies, our overseas missions, Congress, and industry representatives.” No mention was made of public interest groups.

The full press release is available here.

A recent book comes in time for the international policy debates coming to a head over access to medicines, intellectual property rights and public health in developing countries.

Intellectual Property, Pharmaceuticals and Public Health: Access to Drugs in Developing Countries contains chapters by a wide range of scholars and experts looking at national strategies for pharmaceutical development and the protection of public health in the context of globalisation of trade and production, and harmonisation of IP laws.

Chapters provide a reference on key issues and developments in Bangladesh, Brazil, Canada, China, Colombia, Mexico, Morocco, South Africa, and Thailand that form the core of global policy debates in recent years. The book is considered to offer “much-needed” empirical evidence on issues surrounding changing regulatory frameworks and research and development structures.

Available here from Edward Elgar, the book was edited by Kenneth Shadlen of the London School of Economics and Political Science; Samira Guennif of the Université Paris 13; Alenka Guzmán of the Autonomous Metropolitan University-Iztapalapa, Mexico; and N. Lalitha of the Gujarat Institute of Development Research, India.

A copy of a key judgment by the High Court of Kenya last week that found a national anti-counterfeiting law was overly broad and might interfere with access to generic medicines is now available on Intellectual Property Watch.

The text of the decision is here [pdf].

A joint statement in support of the judgment has now been issued by leading public health advocacy groups Médecins Sans Frontières (MSF, Doctors without Borders), Health Action International, and the Kenya Ethical and Legal Issues Network on HIV and AIDS (KELIN). The statement is here.

A local legal analysis is offered here.

The decision, issued on 20 April, was written about here (IPW, Public Health, 21 April 2012).

By Rachel Marusak Hermann for Intellectual Property Watch

The 2012 Global INET Forum is uniting some of the architects and builders behind the internet with the industry leaders and policymakers who are shaping it today in an event taking place in Geneva from 22-24 April.

Organised by the Internet Society, the conference theme, “Meeting at the Crossroads: Imagining the Future of the Internet,” covers some of the major issues facing the internet and its development. Topics include balancing governance and freedom, defining intellectual property rights and encouraging innovation, developing structures and policies to support billions of new users, and managing privacy issues.

The complete agenda is available here.

A speaker roster stacked with key internet actors include Jimmy Wales, founder of Wikipedia, Mitchell Baker, leader of the Mozilla Project, and Dr. Leonard Kleinrock, developer of ARPANET, the predecessor to the internet. Other keynote speakers include Francis Gurry, director general of the World Intellectual Property Organization; Hamadoun Touré, secretary general of the International Telecommunication Union; Vint Cerf, vice president and chief internet evangelist of Google; and Lynn St. Amour, president and CEO of the Internet Society.

Additionally, marking its 20th anniversary, the Internet Society will open its Internet Hall of Fame by inducting its inaugural class of honourees at the Awards Gala on 23 April.

The High Court of Kenya yesterday ruled that the country’s 2008 Anti-Counterfeit Act was too broad and could interfere with the flow of legal generic medicines to patients, leading the UNAIDS organisation to issue a statement praising the decision. It also said intellectual property rights should not be put before life and health, according to reports.

“A vast majority of people in Kenya rely on quality generic drugs for their daily survival. Through this important ruling, the High Court of Kenya has upheld a fundamental element of the right to health,” UNAIDS Executive Director Michel Sidibé said in a release. “This decision will set an important precedent for ensuring access to life-saving drugs around the world.”

High Court Judge Mumbi Ngugi ruled that the act is “vague and could undermine access to affordable generic medicines since the Act had failed to clearly distinguish between counterfeit and generic medicines,” according to UNAIDS.

The court called on Kenya’s Parliament to review the Act and “remove ambiguities that could result in arbitrary seizures of generic medicines under the pretext of fighting counterfeit drugs,” UNAIDS said.

The judgment also said that intellectual property rights should not override the right to life and health, it said.

The publication AllAfrica reported that the case dealt with the confusion between quality control efforts and intellectual property rights. That issue is also under debate at the World Health Organization.

Sidibé said it is possible to have both generic drugs and strong anti-counterfeit laws.

By Monika Ermert for Intellectual Property Watch

The US National Telecommunications and Information Administration (NTIA) on Monday re-issued a request for proposals to manage the sensitive IANA contract. IANA, the Internet Assigned Numbers Authority function, includes the management of the central root zone of the internet domain name system, the allocation of internet protocol addresses to the Regional Internet Registries and other core parts of the internet infrastructure.

The re-issuing became necessary after the NTIA (which is part of the US Commerce Department) declared failure in its original call for tenders in March, just before a meeting of the Internet Corporation for Assigned Names and Numbers (ICANN), which has performed the function since 1998 and was said by many to be the sole bidder. NTIA’s announcement that it had “received no proposals that met the requirements requested by the global community” was seen as a slap in the face of ICANN. The nonprofit private organisation on 12 January opened a first window for applications for new top level domains (TLDs), an activity watched with some suspicion by many trademark owners as well as governments.

The re-issuing of the IANA contract request for proposals now comes at a rather unlucky moment for ICANN, which had to stop the TLD application procedure only some hours before the deadline last Thursday because of software problems and had to concede that parts of data from some applicants had been visible to other applicants. A new CEO at ICANN expected to come on board soon will have his hands full.

The re-issued contract is here.

By Monika Ermert for Intellectual Property Watch

The rapporteur of the lead European Parliament committee on the Anti-Counterfeiting Trade Agreement, David Martin, today published his draft recommendation on the controversial agreement. If the International Trade Committee agrees on the draft, the plenary will be asked to state that it “declines to consent to conclusion of the agreement.”

The rejection would be forwarded not only to the European Council and the Commission, but also to governments and parliaments of all ACTA negotiating partners.

Martin, who had announced the rejection proposal last week, wrote in the explanatory statement that while the problems ACTA seeks to address are real, the unintended consequences with regard to individual criminalisation, the role of internet service providers, and the possible interruption of the transit of generic medicines are too grave.

“Given the vagueness of certain aspects of the text and the uncertainty over its interpretation, the European Parliament cannot guarantee adequate protection for citizens’ rights in the future under ACTA,” said Martin’s verdict. Yet he also asks the European Commission to “come forward with new proposals for protecting IP.”

The draft recommendation is here.

A recently published book by Harvard Law School Professor John Palfrey offers a thoughtful and useful handbook for executives or just about anyone else to better understand and use intellectual property, in ways that encourage sharing and openness.

In “Intellectual Property Strategy”, published by MIT Press, Palfrey uses a patient educator’s tone in walking the reader through the steps to assessing IP and making it work in often surprising ways.

With plenty of clear, real-life examples making points along the way, Palfrey opens up new thinking on topics such as treating IP as a core asset class; benefiting from the IP of others – legally; creating freedom of action through IP; and establishing a flexible IP strategy.

An example of the common sense style is the message that, “Sharing can be good for a brand. It is also good to be known as a fair player in the marketplace – honestly licensing to and from others for the benefit not just of the organizations involved but your customers too.”

Another example: “The idea behind open innovation is simple: the creators of new ideas don’t have to be within your organization in order to be helpful.”

The book is not only published in print, but also in an experimental format with a series of companion case studies and related material, to be read in a purely digital format. This allows a “deeper dive” in at points throughout the book online.

More about the book is here.