Feb 092016
 

palmedoAs readers of this blog are well aware, one of the most controversial issues in the Trans Pacific Partnership was the length of data exclusivity for biologic drugs. The U.S. sought a twelve year period (which would be consistent with current U.S. law) during which competitors would be unable to enter the market to compete with innovator firms unless they duplicated safety and efficacy data to obtain regulatory approval. Other countries sought lesser terms, arguing that long periods of data exclusivity raised the price of biologic medicines by blocking generic competition. Continue reading »

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Feb 022016
 

butler150pxThe Trans-Pacific Partnership (“TPP”) is a massive new trade agreement recently negotiated between the US and a host of countries including Australia, Japan, Canada, Mexico, Singapore, and Chile. The TPP’s IP Chapter (PDF) includes a series of provisions that address rightsholder abuse. While the agreement’s acknowledgment of abuse is salutary, and the protections it affords to users are real, these provisions rely largely on the discretion of judicial or administrative authorities, making the agreement’s protections for users less certain than protection for rightsholders. Continue reading »

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Jan 252016
 

USTR SealOfficials from the U.S. Trade Representative’s office have been signaling to businesses unhappy with the deal finalized last year that they may win extra concessions from TPP partner countries through the implementation process.

Politico reports that U.S. Trade Representative Michael Froman “is sending the message that he’s listening to calls from business groups and some members of Congress to address their complaints with TPP through the way it is implemented, as well as other avenues. Continue reading »

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Jan 122016
 
Image: EFF (CC-BY)

Img: EFF (CC-BY)

A group of 1,525 civil society groups have signed onto a letter sponsored by the Citizen’s Trade Campaign urging Members of Congress to “to oppose the Trans-Pacific Partnership (TPP), a binding pact that poses significant threats to American jobs and wages, the environment, food safety and public health, and that falls far short of establishing the high standards the United States should require in a 21st Century trade agreement.” The full letter is available here.  The section describing the intellectual property chapter’s threats to public health are below: Continue reading »

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Dec 222015
 

rimmer[Cross posted from Medium] Published by the Australian Government on the 20th March 2014, the independent “Pharmaceutical Patents Review Report” recommends to shorten and reduce patent term extensions, to address the problems of evergreening and data protection, and to reverse Australia’s passive approach to the negotiation of intellectual property and international trade. The report emphasizes the need for Australia to protect its public health interests in the negotiation of the “Trans-Pacific Partnership.”

This week, the secrecy surrounding an independent Australian report on patent law and pharmaceutical drugs has been lifted, and the work has been published to great acclaim. Continue reading »

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Dec 202015
 
Photo by Caelie Frampton (CC-BY-SA-NC)

Photo by Caelie Frampton (CC-BY-SA-NC)

[Gisela Pérez de Acha and Pepe Flores, Digital Rights LAC, Link (CC-BY)] On November 6 2015, the Mexican Ministry of Economy made public the Spanish version of the Trans Pacific Partnership (TPP), allowing a wider view about the effects that the chapter regarding intellectual property will have on Mexican legislation and how human rights on the digital environment will be affected. One thing is sure: Mexico has a lot more to lose that it has to win with the made agreements.

TPP’s final draft has confirmed what was previewed on the leaks made by WikiLeaks: the agreement will promote negative changes on copyrights, access to culture or intermediary liability. This implies that local legislation must align to TPP’s dispositions, which in turn will bring significant impact on rights. In Mexico’s case, the consequences  on the matter of intellectual property will be devastating, promoting a scheme based on restrictions and sanctions out of proportion. Continue reading »

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Dec 142015
 

gleesonAnnex 26-A: Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices

Dr Deborah Gleeson | December 12, 2015 | Full Text (PDF)
School of Psychology and Public Health, La Trobe University

Introduction and Background: The intent of Annex 26-A of the Trans Pacific Partnership Agreement (TPP) is to discipline national pricing and reimbursement schemes for pharmaceutical products and medical devices.

While the language of the Annex is framed around principles of transparency and fairness, the objectives of the pharmaceutical and medical device industries clearly go much further than this. The ultimate objective of the industry is expanded market access at monopoly prices dictated by industry: the target is mechanisms that impact on both market access and prices. The Annex was intended to achieve this objective through greater disclosure of information, greater industry participation, and ultimately more leverage for the industry in decision making regarding pricing, reimbursement and other decisions that impact on market share, such as the range of therapeutic indications for which a product is subsidised. Continue reading »

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Dec 112015
 

sean at podiumStatement of Sean Flynn, Program on Information Justice and Intellectual Property

Standing Committee on Copyright and Related Rights: Thirty-First Session December 7-11, 2015 (Geneva, Switzerland)

Thank you for recognizing me on the issue of promoting limitations and exceptions for educational purposes, potentially within the discussions underway on the needs of libraries.  Continue reading »

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Dec 092015
 

effbig[Maira Sutton, EFF, Link (CC-BY)] The Internet is a diverse ecosystem of private and public stakeholders. By excluding a large sector of communities—like security researchers, artists, libraries, and user rights groups—trade negotiators skewed the priorities of the Trans-Pacific Partnership (TPP) towards major tech companies and copyright industries that have a strong interest in maintaining and expanding their monopolies of digital services and content. Negotiated in secret for several years with overwhelming influence from powerful multinational corporate interests, it’s no wonder that its provisions do little to nothing to protect our rights online or our autonomy over our own devices. For example, everything in the TPP that increases corporate rights and interests is binding, whereas every provision that is meant to protect the public interest is non-binding and is susceptible to get bulldozed by efforts to protect corporations. Continue reading »

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Nov 252015
 

jbandThis article is part of an IP-Watch and Infojustice.org series analyzing the Trans Pacific Partnership intellectual property provisions by leading experts around the world.  The series will publish weekly through the first quarter of 2016.

During the negotiation of the Trans-Pacific Partnership Agreement, many concerns were voiced about how TPP would mandate adoption of U.S. style statutory damages. Under the U.S. Copyright Act, a court can award damages of up to $30,000 per work infringed, which can be ratcheted up to $150,000 per work infringed in cases of willful infringement. Scholars have found that statutory damages in the U.S. have discouraged investment in innovative technologies while incentivizing the emergence of copyright trolls.

So how bad is the statutory damages provision in the final TPP agreement? Continue reading »

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Nov 242015
 

software-freedom-law-center-logo[Software Freedom Law Center, Link (CC-BY-SA)] The first official public release of the text of the Trans-Pacific Partnership Trade Agreement (known universally as the TPP) on November 5, 2015 generated much heated speculation. The ideal of “open agreements, openly arrived at” remains regrettably unattainable in international affairs. “Fast track” trade negotiating authority in the US means that parties excluded from the negotiating process have a short time in which to mobilize for or against the treaty as a whole in light of their specific concerns. The premium on speed of response to a very lengthy and complex legal document—and the presence of intense public attention—guarantees that hasty judgment and occasional self-promotion will always outrun professional analysis; this is one of the inherent defects of secret legislation. Continue reading »

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Nov 232015
 

Annemarie-BridyThis article is part of an IP-Watch and Infojustice.org series analyzing the Trans Pacific Partnership intellectual property provisions by leading experts around the world.  The series will publish weekly through the first quarter of 2016.

Section J of the TPP’s IP chapter, on ISP safe harbors, looks a lot like Section 512 of the DMCA, but the two frameworks differ in some important respects that could negatively impact the global environment for user speech online. This post offers a comparison of Section J and Section 512 with a focus on the rights of users and the status of user expression in the TPP’s intermediary safe harbor provisions. Continue reading »

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