The World Intellectual Property Organization's (WIPO) Twenty-Second session of the Standing Committee on the Law of Patents (SCP) is taking place from 27 July 2015 to 31 July 2015 in Geneva, Switzerland. The prior session of the Committee (November 2014) ended in deadlock. Ultimately, patents and health proved to be the deciding factor.
On Wednesday, July 22, 2015, the Senate Veterans Committee held a mark-up to consider several bills. During the mark-up, Senator Sanders offered an amendment, attached below, that would create a compulsory license mechanism in the Department of Veterans Affairs, for patents on medical inventions. (See amendment text below). The motivation for the amendment was a crisis in the VA involving access to drugs for the hepatitis C virus (HCV).
On the topic of the TPP and copyright, KEI has sent a letter to Maria Pallante, the Register of Copyrights, Shira Perlmutter, Chief Policy Officer and Director for International Affairs for USPTO, and Nancy Weiss, Senior Advisor to the Chief Technology Officer, Office of Science and Technology Policy (OSTP), Executive Office of the President.
KEI asked these agencies to address certain issues in the TPP intellectual property chapter that relate to access to copyright issues, with a focus on orphan works, and uses by governments.
Attached are two documents from Mylan regarding their concerns about the TPP. The first is an April 13, 2015 10 page letter from Heather Bresch, the CEO of Mylan, to USTR head Michael Froman. (Copy here). The second is a table of inconsistencies between the TPP and US law (Copy here).
On Thursday, 23 July 2015, at 11AM Eastern Time (Washington, DC), KEI will host a seminar on drug pricing featuring Dr. Ruth Lopert, the Deputy Director of Pharmaceutical Policy and Strategy at the Center for Pharmaceutical Management, at Management Sciences for Health (MSH).
EU Trade Commissioner Backs LDC Request for TRIPS Exemption for Pharmaceuticals Until Graduation from LDC Status
In a comprehensive, 2000 word speech to the European Parliament's International Trade Committee (INTA) on Modernising Trade Policy - Effectiveness and Responsibility, European Trade Commissioner, Cecilia Malmström, cast a wide net in her speech covering in her words, 1) the "benefits of trade for all: our economy in general, consumers, entrepreneurs, SMEs and the poorest countries", 2) "trade policy's commitment to our values in the world, supporting our foreign policy, promoting the respect of human rights, soci
Based on intervention made for TACD at TTIP stakeholders plenary July 15th in Brussels
With a clear lack of balance in its approach the EU position in the TTIP negotiations asks for more copyright protections for the renumeration of broadcasters and rights holders but makes no mention of the needs of public interest exceptions for libraries or people with disabiities.
“On copyright, in the EU flagged the following priorities as areas of offensive interest in the TTIP negotiations: 1) remuneration rights for broadcasting and communication to the public (public performance) for performers and producers in phonograms, 2) a full right of communication to the public (public performance) for authors in bars, restaurants and shops and 3) a resale right for creators of original works of art (Source:EU Position Paper on Intellectual Property, March 2015).” http://keionline.org/node/2281
Sorely missing from this one-sided rights-holder perspective is support for the Marrakesh Treaty for Visually Impaired Persons that permits the cross-border sharing of materials formatted for blind persons around the world. Surprisingly, this copyright and human rights treaty has still not been rartified by the European Union. TTIP could be an opportunity for both the US and the EU to assure swift ratification and implementation of the Marrakesh Treaty.
While the EU is energetically supporting in TTIP and at WIPO a very questionable new layer of copyright protection for broadcasters and their transmissions on the internet (not the content!), it is opposing internationally at WIPO and ignoring in TTIP any progress toward providing copyright flexibilities for the public interest role libraries carry out for preservation and dessemination of science, culture and education.
This monochrome EU copyright strategy for TTIP reflects a total lack of equilibrium between IPR protection and the right to culture of consumers and citizens as a whole.
From presentation by TACD at TTIP stakeholders event on July 15th, 2015
At TACD we are afraid that while some proposals on the table are positive, others could chill future reform or lock us in old business models of biomedical innovation that could work against the common good, affordable medicines and transparency.
There are few proposals, some of which have been under discussion before TTIP, that are win-win propositions within EU-US cooperation, like the joint technical inspections of third-party installations or the sharing of data on pharmaceuticals. We support common- sensical cooperation on these kinds of issues that could save time and money.
At the same time we are concerned that new trade rules could trump some important public health and affordable access guarantees.
We sincereley hope that pricing and reimbursement procedures being considered in TTIP are not adopted by the negotiators. These measures would force Governments to have to give cumbersome justifications for choosing a less expensive medical product. EU member states should not have to jump through torturous hoops or have short time deadlines to decide on drug procurement pricing or purchases. See: http://www.beuc.eu/publications/drug-pricing-and-reimbursement-decisions-have-no-place-ttip/html
The elements that constrain governments from choosing the best and most affordable medicine for procurement, that are present in other free trade agreements, such as the EU-Korea FTA, should not be in TTIP. Governments should not be under pressure to buy medicines without proof that they work (often important information is precisely hidden as commercially sensitive).
TACD is also worried that new trade secret and commercial confidentiality rules included in TTIP could limit clinical trial transparency and inhibit or chill future open innovation models for affordable, accessible and effective medicines. As well, extending commercial confidentiality through trade secret rules could hurt the sharing of scientific data in open innovation, limit transparency of biomedical R and D investments and block key life-saving information on the safety and efficacy of medical products.
Another important cross-cutting issue in TTIP that could also impact access to medicines is investor protection or ISDS(investor-state dispute scheme). ISDS allows investors to challenge sovreign decisions by Governments and, whether these challenges are successful or not, could chill future legisaltion for affordable and innovative medicines in the EU and US. This specially affects the patentability of new medicines, trademarks, transparency and other public health issues. For example, ISDS has permitted a 500 million dollar case brought by Lilly against Canada because Canadian courts rejected a number of patents for their products. It is concerning that tobaco companies are using ISDS against public health laws on plain packaging of cigarrettes.
TACD is also against any proposals in TTIP that would mean the prolongation of patent monopolies over biomedical products such as the proposal to extend patent protection for biological drugs which would mean significant delays in the access to affordable generic mediciines.
While EU-US could produce many consumer-friendly results, we are concerned that EU-US regulatory cooperation institutionalized in TTIP that would consider new legislation on both sides of the Atlantic could mean that phamaceutical policy will be subject to even greater industry lobbying and that any new legislation could be greatly slowed and influenced. The proposed Regulatory Cooperation Council could have the secondary effects of regulatory chill and even greater lobby power in favour of corporate capture of policy given the disfavourable relationship of forces between industrial interests and the public health interest of consumers and citizens.
With pharmaceuticals on the table during this week’s TTIP negotiations, we expect negotiators to consider that most of these decisions should be an exclusive competence of national governments and have no place in an EU-US trade deal, especially if these measures could mean more problems for the affordability, efficacy and safety of our medicines.
For more detail and information please see: http://test.tacd.org/wp-content/uploads/2014/01/TACD-IP-15-13-IPR-in-the-Transatlantic-Trade-and-Investment-Partnership.pdf http://www.beuc.eu/publications/beuc-x-2015-064_ipa_ttip_health_beuc_position.pdf and http://tacd.org/wp-content/uploads/2013/09/TACD-IP-Resolution-on-access-to-medicines.pdf
On 20 March 2015, the European Union published a position paper on intellectual property outlining its priorities for the Transatlantic Trade and Investment Partnership (TTIP). At the time of publication of this position paper, the EU noted that "the U.S. has not yet formally identified the areas of interest that it could consider as priorities."
Notes from presentation by TACD at TTIP stakeholders event on July 15th, 2015
IS TTIP THE PILL FOR ALL OUR ILLS? Maybe for a few but not for most of them. At TACD we are afraid some proposals on the table could chill future reform or lock us in old business models of biomedical innovation that could work against the common good, affodable medicines and transparency.
There are few minor proposals, some of which have been under discussion before TTIP, that are a win-win in EU-US cooperation, like the joint technical inspections of third-party installations that could save time and money. We support common- sensical cooperation on these kinds of issues.
At the same time we are concerned that new trade rules could trump public health and affordable access guarantees.
We are concerned about:
- Pricing and reimbursement decision procedures that are forced on Governments in order to justify choosing a less expensive product. Governments should not have to jump through torturous hoops or have short time deadlines to decide on drug procurement pricing or purchases.
- Trade secret and commercial confidentiality rules that limit clinical trial transparency and inhibit or chill present and future open innovation models for affordable, accessible and effective medicines. Extending commercial confidentiality can hurt the sharing of scientific data in open innovation, limit transparency of R and D investments or pricing and block key life-saving information on the safety and efficacy of medical products.
- Investor protection or ISDS can challenge sovreign decisions by Governments and can chill future legisaltion for affordable and innovative medicines in the EU and US. This specially affects the patentability of new medicines or other public health issues (500 million case by Lilly against Canada or possible Plain packaging case against Ireland or UK).
- EU-US Regulatory Cooperation that considers new legislation could constitute great concerns that phamaceutical policy will be subject to even greater industry lobbying and that new legislation could be greatly slowed and influenced. The proposed TransAtlantic Regulatory Cooperation Council could have the dangerous secundary effects of regulatory chill and even greater lobby frenzy in favour of corporate capture with a disfavourable relationship of forces between industrial interests and the public health interest of consumers and citizens.
National governments should maintain full autonomy to make drug pricing and reimbursement decisions in the public interest. The elements that constrain governments from choosing the best and affordable medicine for procurement, that are present in other FTAs, such as EU-Korea, should not be in TTIP. Otherwise, national governments can be under excessive pressure to purchase large quantities of medicines purchased in the absence of convincing evidence that they work (often with important information precisely hidden as commercially sensitive).
With pharmaceuticals on the table during this week’s TTIP negotiations, we expect negotiators to consider that most of these decisions should be an exclusive competence of national governments and have no place in an EU-US trade deal if it could mean more problems for the affordability, efficacy and safety of our medicines.
10th TTIP Stakeholder Event, Round 10
SESSION 2 Issues related to intellectual property including Geographical Indications and public health
15 July 2015
Knowledge Ecology International
A Positive Agenda for TTIP
My presentation today will address creating a positive agenda for TTIP focusing on the following six themes
1. Cooperation in funding R&D as a public good
2. Promoting the transparency of drug development costs, revenues, and prices
3. Standards for putting government funded research data and articles into free public archives
Attached below is a letter KEI sent to Emily Bleimund, Senior Policy Advisor for International Trade for the Department of Health and Human Services (HHS), and several other U.S. trade officials. The letter addresses three issues in the TPP text:
- There is a need for exceptions to exclusive rights in pharmaceutical and biologic drug test data.
- WTO standards for compulsory licenses should not be modified as part of a secret negotiation, or constrained by a 3-step test.
Standing Committee on the Law of Patents (SCP) - GRULAC proposal - Revision of 1979 WIPO Model Law for Developing Countries
The World Intellectual Property Organization's (WIPO) Twenty-Second session of the Standing Committee on the Law of Patents (SCP) will be convened from 27 July 2015 to 31 July 2015 in Geneva, Switzerland. For consideration of the Committee, the Group of Latin American and Caribbean Countries (GRULAC) have submitted a proposal entitled, Revision of 1979 WIPO Model Law for Developing Countries on Inventions (SCP/22/5).
July 2015: WTO reports on EU competition policy and copyright law - WTO Trade Policy Review - European Union
On 6 July 2015 and 8 July 2015, the World Trade Organization (WTO) conducted a trade policy review of the European Union. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). As noted by the WTO secretariat, the "basis for the review is a report by the WTO Secretariat and a report by the Government of the European Union" (Source: Trade Policy Review - European Union, July 2015).
Campaigners hope that a year after signing, the member states blocking its ratification will back down
By Mari Eccles • 25 June 2015
Few would argue about the worthiness of the Marrakesh Treaty.
Signed by the EU in June 2014, it focuses on copyright exceptions to allow greater distribution of books in formats accessible to visually impaired citizens.
The treaty has cross-spectrum support: a debate calling for ratification at the European Parliament on 24 June was sponsored by members from the left, right and centre, while the President of the European Blind Union, Wolfgang Angermann, calls greater access to such material “a human rights issue”.
Why then, has the treaty not been ratified?
Blocking in Council
Although few publicly oppose the Marrakesh Treaty, seven EU states – three of which have been confirmed as Germany, Italy and the UK – have formed a minority block in the Council and rejected a compromise proposal drawn up under the Latvian Presidency on the conclusion of the treaty.
Four other member states are thought to have sided with them, with EU sources hinting that the Czech Republic and Hungary may be among them.
Sources say that while these member states may not oppose the substance, they are worried about the EU claiming more and more exclusive competence when it comes to international treaties, fearing that this could lead to a ‘slippery slope’.
Campaigner David Hammerstein of the Transatlantic Consumer Dialogue, who moderated the event in Parliament, said their argument over EU competence has been refuted by legal experts.
He said: “It is a very sad commentary about the state of EU affairs if legally baseless competence excuses are used to punish blind persons. The blocking of the treaty is not at all about competence issues: it is about the politically blind incompetence and insensitivity of a few big member state bureaucrats.”
He believes the key to unblocking the dossier in Council is to gain the support of one big member state, such as Germany, whose influence could have a domino effect.
There is also momentum coming from MEP Julia Reda’s copyright report, which advocates swift ratification and which will be voted on in July’s plenary in the European Parliament.
Role of the Commission
The European Commission is also working behind the scenes to get things moving, with representatives from the cabinets of Commissioners Andrus Ansip and Günther Oettinger expressing confidence that ratification could go ahead under the Luxembourg Presidency, although EU sources believe it is too early to say whether the treaty will be prioritised in the coming months.
Speaking privately to Europolitics, disability campaigners say they fear the treaty could be swept aside as focus turns to the more attention-grabbing elements of the digital single market strategy, such as geo-blocking.
While the Commission is working on compromises it hopes will appeal to the remaining seven member states in an attempt to “unblock” the dossier in Council, it seems reluctant to go to the EU Court of Justice, a representative citing this as a last resort.
Campaigners also see this option as time-consuming, unlikely to conclude before 2017, but having waited one year since signing by the EU (and two years for some member states), this route – likely to conclude in the result they want – is becoming more attractive.
The SCCR failed to adopt these recommendations. The dipcom in 2017 recommendations in Item 6 was too strong, and the exceptions recommendations for items 7 and 8 were too weak.Also Attached as pdf
Proposed Recommendations SCCR/30
Proposed Recommendation Agenda Item 6:
Attached is the document the chair distributed as the summary of the week long SCCR 30 meeting.
Today on the last day of the SCCR 30, under Agenda Item 9 “Other Matters” Congo-Brazzaville asked for the floor to propose that the WIPO Copyright and Related Right Committee start working on the Resale Right, a fundamental right for authors of graphic and plastic arts. This economical rights consists of a small percentage of the resale price that art market professionals pay to artists at each resale of their works be it in auction or in a gallery.
This was presented in the morning in the debate on education copyright exceptions.
Thank you, Mr. Chair.
KEI would like to comment on the proposals submitted by the African Group in relation to limitation on remedies for infringement contained in paragraph 22 on page 18 of the document. SCCR/26/4 PROV. DATE: APRIL 15, 2013
titled “Access to Educational Materials: Limitation on remedies for infringement.”
SCCR30: United States- Preservation - Copyright limitations and exceptions for libraries and archives
On Thursday, 2 July 2015, the United States of America presented the following intervention on preservation in the context of copyright limitations and exceptions for libraries and archives. The following statement was captured by the WIPO streamtext.UNITED STATES: Thank you, Mr. Chairman. The United States is pleased to participate in the discussion of preservation, a very important topic for libraries and archives.