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US Policy Making Transparency: A Good Example and a Really Bad Example

Knowledge Ecology International - Wed, 16/04/2014 - 18:59

This short note is about giving people the heads up about four upcoming USPTO public meetings relating to copyright policy making: re remixes, digital first sale and calibration of statutory damages. It is a good example of ONE US agency (PTO is within a Task Force) wisely seeking "additional input from the public in order for the Task Force to have a complete and thorough record upon which to make recommendations." But this blog post is also about a really bad example: USTR.

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The Declaration on Patent Protection: Regulatory sovereignty under TRIPS.

ICTSD - Tue, 15/04/2014 - 07:00

The Declaration on Patent Protection: Regulatory sovereignty under TRIPS was drafted under the auspices of the Max Planck Institute for Innovation and Competition in Munich. It is the result of two decades of intensive research and prepared with the support of scholars all over the world. It has been issued in the context of the 20th anniversary of the establishment of the WTO and the adoption of the TRIPS Agreement on 15 April 1994.

The purpose of the Declaration indicates the interpretive scope of the TRIPS norms. Overall, it remains neutral – it is neither directed at states with a specific level of development nor does it aspire to provide recommendations for legal action. It only points out the regulatory discretion that national legislators enjoy when it comes to implementing their own patent systems.

According to the drafters

“Sovereign states should retain the discretion to adopt a patent system that best suits their technological capabilities as well as their social, cultural and economic needs and priorities, with the proviso that the exercise of such discretion must remain within the boundaries of international law. Taking into account the customary principles of interpretation of international law, this Declaration seeks to shed light on these boundaries. The purpose is to clarify the policy space that the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) leaves to national legislators and judicial authorities with regard to the implementation and administration of their patent systems.”

The Declaration deals accordingly with the following aspects of patent law: a) general principles; b) differentiation of fields of technology; c) patentability and disclosure; d) scope of protection; e) exhaustion issues; f) exceptions to the scope of protection; g) compulsory licence; h) government use; i) undisclosed information; j) enforcement; k) goods in transit; and l) criminal measures.

The Declaration on Patent Protection shows that it is possible to design a patent system that reflects both the interest of inventors and right holders as well as the national public interest, without infringing the international obligations of WTO members and taking advantage of the TRIPS Agreement flexibilities.

You can access the document here

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SCCR27: UK proposal on the Proposed WIPO treaty on the protection of broadcasting organizations (the BBC experience)

Knowledge Ecology International - Mon, 14/04/2014 - 12:28

On 8 April 2014, the United Kingdom of Great Britain and Northern Ireland submitted a paper to the 27th session of WIPO's Standing Committee on Copyright and Related Rights (SCCR) on the Proposed WIPO treaty on the protection of broadcasting organizations (SCCR/27/3). In its proposal, the UK endeavors to "shed light on a number of different technologies already being used by broadcasters from around the world" including the deployment of the BBC iPlayer and the BBC Red Button services.

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32 Members of US House of Representatives ask USTR to sanction Canada for not granting patents on drugs

Knowledge Ecology International - Fri, 11/04/2014 - 20:21

The attached letter, dated April 10, 2014 and signed by a bipartisan group of 32 members of the House of Representatives, asks USTR to elevate Canada to the Special 301 "priority watch list," for "violation of their international obligations" for not granting enough patents on "innovative medicines." According to the members of Congress signing the letter, Canada is in violation of its WTO TRIPS obligations.

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On the Table for the next Standing Committee on Copyright and Related Rights (SCCR27) April 28 to May 2

Knowledge Ecology International - Wed, 09/04/2014 - 17:06

What is on the table for the next Standing Committee on Copyright and Related Rights: Twenty-Seventh Session (SCCR/27) April 28 to May 2, 2014 (Geneva, Switzerland)?

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A victory for medicine trial transparency but there is still a long way to go

Trans Atlantic Consumer Dialogue - Fri, 04/04/2014 - 07:16

 

 

 

The European Parliament voted on Wednesday the adoption of the new Clinical Trials Regulation, which has removed the legal framework on commercial confidentiality that previously allowed pharma not to publish its data. With the new Regulation information from trial study reports on the efficacy and safety of new medicines should not be considered commercially confidential.

 

The Regulation also requires, among other things, that

 

  • all drug trials in Europe are registered on the publicly accessible EU clinical trials register

  • a summary of the results — “understandable to a lay person” — from these trials is published on the register within a year of the trial’s end

  • Clinical Study Reports are be made publicly available, and that

  • a new, publicly accessible EU clinical trials register is set up and run by the European Medicines Agency (EMA).

 

This new EU transparency policy goes significantly beyond the FDA´s policy in the US (similar to the initial European Commission proposal for the Regulation) that only requires a summary of the trial to be publicly available. The most important improvement is that it mandates the publishing Clinical Study Reports (CSRs), which are comprehensive documents presenting clinical trial results in a detailed and structured manner, that“should not be considered commercially confidential once a marketing authorisation has been granted, the decision making process on the application for a marketing authorisation has been completed, or an application for marketing authorisation has been withdrawn”(Recital 20a).

 

This victory for transparency is only partial. It only applies to new medicines starting in 2016 and a number of large and dangerous loopholes remain. As well, Big Pharma has announced that they will try to influence the implementation of the Regulation to restrict the new pro-transparency rules. The European pharma industry association, EFPIA, has said that “[It] is critical that the Commission and EMA interpret the Clinical Trial Regulation in a manner that respects patient privacy, the integrity of regulatory decision-making, and incentives for companies to make long-term investments in biomedical research.

 

 

Some of Regulation´s loopholes are the following:

 

- It fails to mandate that investigators (clinicians) and not the industrial sponsors report all serious adverse reactions to health authorities, whether they are “expected” or “unexpected”, meaning that safety data can still be withheld.

 

-It allows for “low intensity trials”, either post-authorization or “off-label”, and “non-commercial” trials to have much lower reporting requirements.

 

-It fails to require comparative clinical trials so that the new medicine would be compared with the reference (“gold standard”) treatment, as opposed to only a placebo, in order to determine whether it has a therapeutic advantage over existing treatments.

-It does not mandate the public registration of all individual trial patient data.

 

 

The transparency camp will have to be vigilant throughout the long implementation process of the Clinical Trial Directive to assure a positive, pro-public health interpretation of the legislation. The Pharma industry will continue lobbying the EU institutions and the EMA heavily in the opposite direction.

 

 

Unfortunately, other threats to clinical trial transparency are looming. In the coming months the European Parliament will be considering the Trade Secret Directive that could have a devastating impact on transparency by re-affirming commercial confidentiality as a legal imperative. We must also be conscious of the negotiations of the EU-US Free Trade Agreement, TTIP, that is also discussing new transatlantic rules proposed in Big Pharma that would roll back any gains made in the present regulation.

 

 

The new Clinical Trial Regulation has been a partial but significant victory for civil society, socially committed medical professionals and the independent scientific community. This coalition must stay organized if we wish to move forward an ambitious agenda for medical science based on evidence and public health needs.

Text of Clinical Trial Regulation: http://register.consilium.europa.eu/doc/srv?l=EN&t=PDF&gc=true&sc=false&f=ST%2017866%202013%20INIT:

 

 

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KEI comment on ViiV license to Medicines Patent Pool for HIV drug dolutegravir (DTG)

Knowledge Ecology International - Wed, 02/04/2014 - 13:16

On April 1, 2014, ViiV, a consortium of Pfizer and GSK, and the Medicines Patent Pool (MPP), announced two new licensing agreements that expand generic competition for dolutegravir (DTG), and integrase inhibitor used for the treatment of adult and pediatric HIV infection. (MPP press release here.) Dolutegravir is a new drug, approved for marketing by the US FDA on August 12, 2013.

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Leaked EU analysis of TTIP IPR negotiations

Knowledge Ecology International - Fri, 28/03/2014 - 15:27

Below is a two page excerpt from a March 20, 2014 EU analysis of the TransAtlantic Trade and Investment Partnership (TTIP) negotiations on intellectual property rights, including geographical indications. The memo summarizes in a sentence or two the negotiations in eight types of intellectual property, patents, copyrights, designs, pharmaceutical regulatory test data, plant varieties, trademarks, trade secrets, geographical indications (GIs), as well as negotiations on enforcement, voluntary best practices, and cooperation on third country and multilateral IPR negotiations.

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KEI Comments regarding USTR Public Interest Trade Advisory Committee

Knowledge Ecology International - Tue, 25/03/2014 - 20:34

Comments of KEI, regarding USTR Request For Comments From The Public On The Creation Of The Public Interest Trade Advisory Committee And Request For Nominees To That Committee.

Submitted to Regulations.gov on March 25, 2014, under docket number USTR-2014-0005.

Intellectual property issues are an important element of US trade agreements, and according to a recent study by Open Secrets, the most intensively lobbied issue, by far.

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17 March 2014: The African Group highlights the hidden costs of implementing the Design Law Formalities Treaty

Knowledge Ecology International - Sat, 22/03/2014 - 19:35

On 17 March 2014, the African Group delivered the following opening statement at the Thirty-First Session of the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) highlighting the need for an inclusion of an article on technical assistance (with legally binding effect) in the proposed design law treaty. The African Group noted,

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17 March 2014: European Union urges WIPO SCT to finalize work on a Design Law Formalities Treaty

Knowledge Ecology International - Sat, 22/03/2014 - 18:29

On 17 March 2014, the European Union and its Member States issued the following clarion call to the Thirty-First Session of the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) urging the committee to "make a clear and unambiguous recommendation to convene a diplomatic conference to the upcoming Extraordinary General Assembly" for a Design Law Formalities Treaty.

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Geographical indications, country names and the domain name system: Czech Rep, Germany, Hungary, Italy, Moldova and Switzerland

Knowledge Ecology International - Thu, 20/03/2014 - 10:59

On 18 March 2014, the delegations of the Czech Republic, Germany, Hungary, Italy, Republic of Moldova and Switzerland submitted the following proposal (SCT/31/8 Rev.) on the Protection of Geographical Indications and Country Names in the Domain Name System for consideration by the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT).

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International technology transfer: Current implementation and future course of action

ICTSD - Mon, 17/03/2014 - 21:06

Improving technology transfer flows and arrangements directed towards developing countries and LDCs has emerged as an important priority in a number of international forums such as the WTO, WIPO and beyond. It has also been a shared interest in the research agendas of ICTSD and the Centre for Global Development (CGD).

In this context, this expert meeting will discuss the draft of a new CGD paper entitled: ‘Europe Beyond Aid: Evaluating Europe’s contribution to the transfer of technology and knowledge to developing nations’ developed in cooperation with Walter Park (American University) and Owen Barder (CGD) who will present the paper at the dialogue. Beyond Europe, the meeting will also examine the status of current technology transfer discussions at both WTO and WIPO.

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Discussion on Orphan Works and Mass Digitization at US Copyright Office, March 10-11, 2014

Knowledge Ecology International - Mon, 17/03/2014 - 17:46

The US Copyright Office held a two day roundtable event on the topic, "Orphan Works and Mass Digitization." The two days were split into ten sessions, with extensive panels convened for each roundtable discussion. The meetings were held in the Montpelier Room at the Madison building of the Library of Congress, with the exception of the afternoon panels on the second day, which was held downstairs in the hearing room of the Copyright Office.

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Multilateral IP negotiations: Between rhetoric and reality

ICTSD - Mon, 17/03/2014 - 10:42

Multilateral intellectual property (IP) negotiations face multiple challenges in an increasingly complex global innovation landscape. From climate change to biodiversity and access to medicines, IP has become a cross-cutting issue with important public policy implications. Regional/bilateral trade agreements and plurilateral initiatives have also become a key feature of this global landscape.

In this context, what are the present realities and future challenges facing these negotiations? How can traditional differences be bridged to reach consensual outcomes? How to ensure coherence across the variety of international forums where IP issues are raised? These are some of the questions to be addressed in this dialogue which will bring together capital-based officials to interact with Geneva based IP negotiators, who will provide a practical perspective on how IP negotiations are conducted at forums such as the WTO and WIPO.

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First Geneva Dialogue on Traditional Knowledge

ICTSD - Mon, 17/03/2014 - 10:34

The International Centre for Trade and Sustainable Development (ICTSD), the Australian Centre for Intellectual Property in Agriculture (ACIPA) and the Institute for Sustainable Development and International Relations (IDDRI) are holding the First Geneva Dialogue on Traditional Knowledge on Friday, March 21, 2014 (9h30 - 18h00).

The objective of this dialogue is to provide an informal space to debate key issues relevant for the effective development and implementation of an international regime for the protection of TK, with a primary focus on the ongoing process at the IGC.

The dialogue will thus bring together a multi-stakeholder group of country delegates, experts, academics and indigenous people representatives to discuss the current direction of the IGC negotiations on TK. The morning sessions will provide opportunities to discuss the IGC draft text on TK, its relationship to the CBD Nagoya Protocol, and the treatment of customary law and its role in securing effective TK protection. The contribution of proposals included in the recent IGC draft text on GRs to the prevention of TK misappropriation will also be examined. The afternoon sessions will address key issues in the draft TK text, as well as cross-cutting issues in the draft GRs text, such as: i) scope; ii) economic rights/beneficiaries; iii) shared TK and iv) limitations and exceptions.

If you wish to attend, please register in advance with Ms. Anna Jedrusik (Tel: +4122-9178855, email: ipprogramme@ictsd.ch). Places are limited.

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Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules

Knowledge Ecology International - Fri, 14/03/2014 - 10:07

Informed sources have revealed that Mark Dybul, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, is the brains behind an initiative to create global framework for the tiered pricing or in the Global Fund's own words, "Equitable Access to Essential Medicines and Vaccines: Developing a Framework for Success", enforced by the rules of the World Trade Organization. KEI has obtained this internal concept note prepared by the Global Fund which we understand is a work in progress.

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WIPO Ctte Nominates Gurry for Second Term

ICTSD - Thu, 13/03/2014 - 09:33

Francis Gurry is set to serve another six years as the head of the UN’s intellectual property body, after a selection committee nominated him for a second term last week. The recommendation is expected to be formally approved during May’s meeting of the World Intellectual Property Organization (WIPO) General Assembly.

Gurry’s first term as WIPO Director-General, which began in 2008, saw the adoption of two major treaties: the Marrakesh Treaty on copyright exceptions for the visually impaired and the Beijing Treaty on Audiovisual Performances. (See Bridges Weekly, 4 July 2013 and 27 June 2012, respectively)

This year’s Director-General race featured four candidates competing for the top slot, some of whom indicated that their candidature was motivated by a perception that WIPO was in need of strengthening as an institution. Traditionally when an incumbent UN agency chief is seeking re-election, they are endorsed by consensus, without any challengers.

Along with Gurry, who was nominated by Australia, the other candidates included Deputy Director-General Geoffrey Onyeama of Nigeria, Estonian Ambassador Jüri Seilenthal, and Panamanian Ambassador Alfredo Suescum.

Under WIPO procedures, a final nominee is chosen by the organisation’s Coordination Committee, which votes by secret ballot to whittle down the list of candidates. The committee serves as WIPO’s executive body, and is made up of 83 member states. The outcome is then sent to the full WIPO membership for final approval or rejection.

Last Thursday, in the first round of voting, Gurry received 46 votes, followed by Onyeama with 20, Suescum with 10, and Seilenthal with 7. The top three candidates were slated to advance to the second round. However, Onyeama and Suescum withdrew their candidacies later in the day, leaving Gurry as the consensus nominee.

In his acceptance speech, Gurry thanked the committee for its confidence in him. “The world of intellectual property is a challenging one, but one with great opportunities,” he said.

“I think that our task in the future is to manage those tensions that inevitably occur around intellectual property, innovation, and creativity in order to maximise the opportunities for all member states,” he added.

After approval in May, Gurry will begin his second term in October.

ICTSD reporting.

Categories: Front page

What's in a name? Geographical indications stir the pot at WIPO trademark committee

Knowledge Ecology International - Wed, 12/03/2014 - 12:12

Protection for geographical indications is an issue that divides the generally united front that Australia, Canada, the European Union, Japan, Switzerland, New Zealand and the United States maintain at WIPO and WTO negotiations on setting rules for the enforcement of patents, copyright, trademarks and industrial designs. In a 12 March 2014 piece, Europe wants its Parmesan back, seeks name change, the Associated Press reported that,

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KEI's comments on Special 301, March 7, 2014

Knowledge Ecology International - Fri, 07/03/2014 - 22:02
KEI’s Additional Comments Special 301

March 7, 2014

James Love, Knowledge Ecology International

Docket # USTR-2013-0040

These comments supplement KEI’s February 7, 2014 written submission (Also available here: http://www.keionline.org/ustr/special301, and http://keionline.org/node/1927), and our February 24, 2014 oral testimony, and provide also comment or reply to the written or oral submissions by others.

1. India is an important source of affordable medicines.

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