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USPTO publishes new estimates of "IP-Intensive" industries, spin results

Knowledge Ecology International - Mon, 26/09/2016 - 19:48

USPTO has just published its new estimates of "IP-intensive" jobs for the US economy. The report is titled: Intellectual Property and the U.S. Economy: 2016 Update, and is available as a PDF file here. USPTO press release here:

I took a quick look at the report, and below are some initial bullet points:

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Differences between the march-in, royalty free right, and government use options

Knowledge Ecology International - Thu, 22/09/2016 - 20:50

I wanted to post a brief note about three separate mechanism to overcome patent monopolies in current US law. All are useful, in the right context, and all have some limits.

1. The Bayh-Dole March-In rights under 35 U.S.C. 203, as defined by 35 U.S.C. 201(f).

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National Association of Manufacturers told USTR the EU position on LDC extension made a mockery of international trading system

Knowledge Ecology International - Wed, 21/09/2016 - 20:36

On September 10, 2015, the National Association of Manufacturers (NAM), wrote to USTR expressing alarm at the European Union support of an indefinite extension of a WTO waiver of obligations to grant patents on pharmaceuticals for UN defined least developed countries (LDCs). In 2015, there were 954 million persons living in LDCs, with a per capita income of $964, according to the World Bank. The EU had aligned itself with health advocates trying to protect the bottom billion access to life saving medicines.

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500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies

Knowledge Ecology International - Mon, 19/09/2016 - 21:02

Knowledge Ecology International recently obtained extensive email correspondence between officials at the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Football League (NFL), which shed light on accusations of NFL attempts to control the NIH research agenda related to repeat concussion injuries in football players.

The records, which we received through FOIA, are available here:

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NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs

Knowledge Ecology International - Fri, 16/09/2016 - 19:26

The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.

The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.

The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way.

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Summary of Report of United Nations Secretary-General's High-Level Panel on Access to Medicines

Knowledge Ecology International - Wed, 14/09/2016 - 16:35

On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]

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KEI Statement on United Nations Secretary-General's High-Level Panel on Access to Medicines Report

Knowledge Ecology International - Wed, 14/09/2016 - 13:51

On September 14, 2016, the United Nations Secretary-General's High-Level Panel on Access to Medicines issued its long-awaited report, which addressed the policy incoherencies between intellectual property, trade, human rights, innovation, and public health.

The report is available here: http://www.unsgaccessmeds.org/final-report/

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Cancer Moonshot Blue Ribbon Panel Does Not Address Pricing, Alternative Funding Models

Knowledge Ecology International - Thu, 08/09/2016 - 17:54

On September 7, 2016, the National Cancer Advisory Board Blue Ribbon Panel issued a draft report with recommendations directed to the Cancer Moonshot Task Force.

The draft included 10 interesting and useful recommendations (see A - J) related to cancer research, but none to address the pricing or affordability of products.

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German Court Issues Compulsory License on HIV Drug Patent

Knowledge Ecology International - Thu, 08/09/2016 - 16:29

A German patent court has ordered a compulsory license under Section 24 of the Patent Act, allowing Merck (US) to continue to market the HIV drug raltegravir (marketed as Isentress).

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Commentary on Hillary Clinton's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs

Knowledge Ecology International - Tue, 06/09/2016 - 20:28

Democratic presidential nominee Hillary Clinton has published a factsheet presenting, "Hillary's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs."

Today via Twitter, KEI Director James Love offered a six point commentary on Secretary Clinton's proposal to address drug price hikes:

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KEI Briefing Note 2016:2: 2015-2016 Pharmaceutical Transparency Legislation

Knowledge Ecology International - Tue, 06/09/2016 - 15:37

The attached briefing note analyzes transparency legislation that has been proposed in 14 states in 2015 and 2016. The bills would require various degrees of transparency for research and development (R&D) and marketing costs, as well as for drug prices and price changes.

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Bloomberg: CVS Will Exclude Xtandi From Formulary in 2017

Knowledge Ecology International - Tue, 02/08/2016 - 20:07

Bloomberg reported on August 2, 2016, that CVS Health announced that it plans to exclude 35 drugs from its formulary beginning in 2017, including Xtandi, bringing the total number of excluded drugs to 131.

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Vivendi-SFR lobbyist nominated to WIPO

Knowledge Ecology International - Tue, 02/08/2016 - 17:18

Vivendi-SFR lobbyist nominated to WIPO by Hervé Le Crosnier

On July 14, 2016, the former Vivendi-SFR lobbyist Sylvie Forbin was named Deputy Director General of the WIPO “Culture and Creative Industries Sector” (the World Intellectual Property Organization is a United Nations agency). Incidentally the new name of the Sector, “Copyright and Creative Industries,” is revealing of her future professional activities.

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Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs

Knowledge Ecology International - Mon, 25/07/2016 - 20:13

The Associated Press recently released a chart from the Centers for Medicare and Medicaid Services' Office of the Actuary that outlines spending for the top 20 costliest drugs to Medicare in 2015 after reaching Medicare's catastrophic spending threshold: http://www.nytimes.com/aponline/2016/07/25/us/ap-us-medicare-pricey-drugs-glance.html.

UPDATE: The AP also released another story, on July 24, 2016, outlining the overall program costs of catastrophic spending and explaining various spending increases: http://www.nytimes.com/aponline/2016/07/24/us/politics/ap-us-medicare-pricey-drugs.html.

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Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiatives

Knowledge Ecology International - Wed, 20/07/2016 - 18:39

20 July 2016
For Immediate Release

Contacts
Knowledge Ecology International: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670
Public Citizen: Peter Maybarduk, pmaybarduk@citizen.org, +1 (202) 588-7755

Public Health, Human Rights, and Faith Organizations Question State Department Pressure Against Global Access to Medicines Initiatives

Evidence shows pattern of interference in national and international efforts to improve access to affordable medicines, according to Doctors Without Borders (MSF USA), Knowledge Ecology International, Public Citizen, Oxfam, and other leading public interest groups.

Washington, DC — More than 50 public interest organizations and experts asked Secretary of State John Kerry today to explain evidence that the State Department recently pressured the United Nations and the governments of Colombia and India against taking action to improve access to affordable medicines, citing U.S. business interests and implying that relations with Washington would suffer.

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Francis Gurry appoints Sylvie Forbin, lobbyist for Vivendi, as new head of copyright at WIPO

Knowledge Ecology International - Wed, 13/07/2016 - 22:41

Francis Gurry has appointed the new Deputy Director General for the Copyright and Creative Industry Sector. She is Sylvie Forbin, a national of France, and most recently Senior Vice President for Public and European Affairs, for Vivendi. Here is the WIPO announcement: as PDF.

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SCP24:WIPO patent committee adopts robust work program on patents and health, limitations and exceptions and quality of patents

Knowledge Ecology International - Thu, 07/07/2016 - 11:05

On 30 June 2016, the 24th session of the WIPO Standing Committee on the Law of Patents (SCP) agreed to an ambitious work program on patents and health, exceptions and limitations to patent rights, quality of patents, transfer of technology and confidentiality of communications between clients and their patent advisors.

On patents and health, the Committee agreed to the following:

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WIPO Marrakesh Treaty for the blind to come into force September 30, 2016, following ratification by Canada

Knowledge Ecology International - Tue, 05/07/2016 - 15:44

On June 30, 2016, the WIPO Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled received its 20th ratification, from Canada, and this will bring the Treaty into force September 30, 2016. The WIPO announcement was here. WIPO Director General Francis Gurry made a statement about the Marrakesh Treaty's imminent entry into force in the video below:

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Human Rights Council adopts watershed resolution on Access to Medicines

Knowledge Ecology International - Fri, 01/07/2016 - 07:00

*(The author thanks Mirza Alas and Alexandre Gajardo for their notes of the 2nd round of informal consultations held on 22 June 2016 and Sophia Simon for transcribing the statements delegations made during the plenary discussions held on 1 July 2016.)

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SCP 24 - A fruitful discussion?

Knowledge Ecology International - Thu, 30/06/2016 - 07:00

30 June 2016

By Sophia Simon

The World Intellectual Property Organization’s (WIPO) Standing Committee on the Law of Patents (SCP) plays a significant role as the United Nation’s only dedicated, multilateral forum for the discussion on patents. The WIPO SCP convened for its 24th session in Geneva from 27 June 2016 to 30 June 2016.

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