SCP22: Australian response to GRULAC proposal to revise 1979 WIPO Model Law for Developing Countries on Inventions
On 29 July 2015, Australia provided the following response to the proposal by the Group of Latin American and Caribbean Countries (GRULAC) to revise the 1979 WIPO Model Law for Developing Countries on Inventions.Australian Delegation Proposal
The Secretariat prepare a study on:
1) experiences of how developing countries and least developed countries (LDCs) have implemented the patent model law; or
2) to determine the unmet need for a patent model law.
Knowledge Ecology International (KEI) delivered the following intervention on 29 July 2015 during WIPO discussions on the proposal by the Group of Latin American and Caribbean Countries (GRULAC) to revise the 1979 WIPO Model Law for Developing Countries on Inventions.KEI statement on GRULAC proposal (SCP/22/5)
WIPO Standing Committee on the Law of Patents (SCP)
29 July 2015
Proposal: Engage Member States in the Revision of the 1979 WIPO Model Law for Developing Countries on Inventions
India delivered this lengthy, nuanced intervention on inventive step on 28 July 2015 citing the US Supreme Court observations on a person skilled in the art (PSIA), the KSR Int'l Co. v. Teleflex, Inc. decision on obviousness as applied to patent claims, the IPAB Roche decision (in relation to inventive step) and jurisprudence from the House of Lords on inventive step.
India’s Intervention on a study on inventive step (SCP/22/3) at SCP/22
On Monday afternoon, 27 July 2015, Brazil on behalf of the Group of Latin American and Caribbean Countries (GRULAC) delivered the following opening statement which,inter alia, called for a
Attached is a letter from eleven of the 28 House Democrats that supported the Trade Promotion Authority (TPA) Fast Track legislation, on the topic of intellectual property rights and medicine. The letter, which is moderate and cautious in substance, but overall helpful given where negotiations stand, closes by telling Ambassador Froman that "As members who support trade done right, we strongly believe that TPP must not inhibit access to lifesaving medicines."
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).