Author: Guest

A New Contesting Narrative? WIPO Report Downplays Patent Barriers to Vaccine Access

By HU Yuanqiong  – Advocates of access to medicines movement would not feel unfamiliar with the issue of patent evergreening on chemical medicines while monopoly could get prolonged through applying for multiple patents on small changes of the same medicine. The similar tricks have also been practiced on other medical products, such as vaccines. As a traditional public health intervention, vaccines have been costing more money in recent years when a couple of newer generation of products are exhausting governments’ budgets largely due to their monopoly situations. Recent researches have suggested that patent thicket and evergreening, among others, have played an instrumental role. However, the newly launched report by World Intellectual Property Organization (WIPO) Global Challenges division (herein the WIPO report) has concluded with several contestable remarks and downplayed the role of patent in hindering vaccine competition. Firstly, the WIPO report has either overstated or overlooked the role of patent in the context of vaccine access and innovation. On one hand, it states that the control derived from patent ‘can help ensure vaccine quality and safety’ [Page 19 of the WIPO report]. It seems peculiar to read such overstatement, because it is commonly known that it is rather good manufacture practice standards and government regulations that can ensure quality and safety of any medical products including vaccines. Patent, on another hand, is governed by different legal framework and criteria. On...

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Drug Price Gouging: Int’l Union of Operating Engineers Stationary Engineers Local 39 Health & Welfare Trust Fund et al v. Celgene

[by Zhao Zhao] On June 14th, 2017, the International Union of Operating Engineers Stationary Engineers Local 39 Health and Welfare Trust Fund, The Detectives’ Endowment Association, Inc., and David Mitchell (“Plaintiffs”) filed a class action antitrust complaint against Celgene Corporation (“Celgene”) over Celgene’s alleged exclusion of competition from the market for two drugs: thalidomide and lenalidomide. Celgene sells them under the brands Thalomid and Revlimid for treating leprosy and multiple myeloma. According to the Complaint, Celgene has exploited its monopoly power by raising prices. In 2014, for example, the price of Thalomid was between $212 and $357 per capsule, in contrast to its price of only about $6 per capsule when it was initially approved to enter the market. Celgene set the price of Revlimid to nearly $500 per capsule in 2014. Since 2006, Celgene has profited more than $38.9 billion from the sale of these two drugs. In order to prevent generic competition, Celgene allegedly engaged in a series of unlawful tactics to block the market entry of generic versions of Thalomid and Revlimid. Celgene’s anticompetitive conduct includes fraudulently obtaining patents on procedures to ensure the safe use of the two drugs, and engaging in sham litigation against competitors whenever they obtain samples of Thalomid or Revlimid for generic bioequivalence testing...

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Copyright Amendment (Disability Measures and Other Access) Bill Passes in Australia

Delia Browne, University of Auckland The Copyright Amendment (Disability Access and Other Measures) Bill 2017 (the Bill) was passed on Thursday 15 June 2017 and will become law sometime in late December this year (six months from Royal Assent) See here for a copy of the Bill. See here for a copy of the Explanatory Memorandum (EM).​ The new law includes a number of reforms that have been sought by the education sector for years.  These include  ​a simplified, streamlined educational statutory licences; the introduction of a new exception to enable the use of copyright materials in online assessments and digital exams; and the introduction of a new fair dealing exception for people with disabilities (Including organisations assisting people with disabilities).  Streamlined statutory licence The new provisions implement the practical agreement between the education sector (schools, TAFEs, universities) and collecting societies (Copyright Agency and Screenrights):​​ There will be one licence scheme to replace the existing VA and VB licences. There will no longer be an express limit on the amount of a work that can be copied/communicated. The only limitation will be that the amount copied/communicated “does not unreasonably prejudice the legitimate interests of the owner of copyright”. The prescriptive rules in the existing statutory licences – ie rules regarding marking, anniversary copying, limits on the amount of a work that can be made available online, surveys/record keeping, methods of determining remuneration etc – will be removed. There will be flexibility for schools to reach agreements...

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Against the Privatization of Argentina’s Photographic Memory

[Luisa Guzmán] Last week Fundación Via Libre released a statement urging Argentinian lawmakers to drop a bill proposing a Copyright term extension for photographs, and asking them to open a public debate with the purpose of improving the general conditions for the circulation of cultural goods. To date, over 50 cultural, artistic, and digital rights organizations have signed the statement. Currently, in Argentina, photographs pass to the public domain 20 years after publication. However, the proposal aims to increase the term of Copyright protection to life of the author plus 70 years, with retroactive effects over the photographs that have already entered into the public domain under existing legislation. In the statement, the signatory organizations recognized the importance of protecting cultural workers, and the lack of legal protection that these workers have to face everyday, especially in terms of social security and fair contracts. Nonetheless, they pointed out that the main beneficiaries of the term extension would be the publishing companies and the media that own the rights. Thus, the proposed bill does not solve the core problems faced by photographers, nor does it result in actual benefits for them. Conversely, the extension of the Copyright monopoly will harm the access to culture and the preservation of the Argentinian historical memory. According to the statement, if the bill is approved, thousand of photographs must be erased from the Internet...

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Update on IP Watch’s FOIA Case Seeking Release of USTR Documents from the TPP Negotiations

Brianna van Kan, Ben Picozzi, and Rebecca Wexler Yale Media Freedom and Information Access Clinic On April 3, 2015, Intellectual Property Watch (IP-Watch) completed its written arguments to the federal district court in Manhattan in a case that could compel the United States Trade Representative (USTR) to release basic information regarding USTR’s negotiations over the proposed Trans-Pacific Partnership (TPP) trade agreement. In particular, IP-Watch’s lawsuit and summary judgment motion asks U.S. District Judge Edgardo Ramos to order USTR to release documents that relate to the intellectual property provisions of the TPP—including USTR’s final negotiating positions, the portions of the draft agreement that the U.S. has proposed or adopted, and communications between USTR and the industry representatives who sit on Industry Trade Advisory Committees (ITACs). Both IP-Watch and USTR have filed opposing summary judgment motions and are now waiting for Judge Ramos to rule on the case. If IP-Watch prevails in its motion for summary judgment, the public will have much greater opportunity to scrutinize the TPP. Until now, only members of the ITACs have enjoyed meaningful access to the negotiation process, because only they have the ability to actually review the draft language of the agreement and comment directly to the USTR, which negotiates on behalf of the United States. However, the ITACs may not accurately represent all of the stakeholder communities who have interests in the outcome. The...

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India Posts Model Bilateral Investment Treaty Text for Review

Leena Menghaney India, like South Africa, is concerned about the Bilateral Investment Treaties (BITs) it has signed in the past. India has put out a draft its New Model text for BITs negotiations, Now posted online: https://mygov.in/sites/default/files/master_image/Model%20Text%20for%20the%20Indian%20Bilateral%20Investment%20Treaty.pdf The last date for submission of comments is 10th April....

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Online Retransmission Consent and DMCA Liability Protections

Seth Johnson At the following link you will find the FCC’s NPRM for establishing a “retransmission consent” regime online for a specific class of online services called Multichannel Video Programming Distributors. It addresses all services that make multiple linear video programming streams available online on a subscription basis: > https://www.federalregister.gov/articles/2015/01/15/2014-30777/promoting-innovation-and-competition-in-the-provision-of-multichannel-video-programming-distribution It would establish the first formal exception to the broad protections against copyright infringement liability provided to online service providers under the DMCA’s Notice and Takedown procedures — and it is being proposed by the FCC, not by Congress. In addition, I was informed in an email exchange a week before this NPRM was initiated that the US sees retransmission consent as a basis for the national implementation that would be required for the Broadcaster’s Treaty, a treaty proposing to establish a new international layer of rights for broadcasters online that is not yet formalized or ratified, but which has been regularly resurrected despite ongoing opposition and concern voiced by many organizations. With the national implementation already in place, treaty negotiators could readily ratify and implement the Broadcaster’s Treaty without the domestic public and legislative debate that it warrants. The FCC makes no mention in this NPRM of this relationship between establishing retransmission consent online under domestic law and the Broadcaster’s Treaty. Here’s my submission, submitted on the final day of the Reply Comments period (They were extended to...

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Chilean Constitutional Court to decide on the constitutionality of the patent linkage bill

The following message was sent to infojustice from an observer in Chile who wishes to remain unidentified… On March 5, the Chilean Constitutional Court (CC) decided to review the constitutionality of the patent linkage bill currently being discussed in the Chilean Congress. This bill would set forth a non-merit based preliminary injunction only eligible for pharmaceutical patent holders. According to the Chilean general rules on preliminary injunctions, they should only be granted by a court based on the merits of the case (substantial likelihood of success on the merits of the case and faces a substantial threat of irreparable damage or injury if the injunction is not granted). A group of 11 senator filed a constitutional action with the CC arguing that this special set of rules would be only the for benefit of a specific group (pharmaceutical patent holders) without a reasonable justification for creating this special regime and by doing so infringing the equal treatment clause, among other arguments, like due process of law and right to health. This case may have an effect on the Chilean position vis-à-vis the Trans-Pacific Partnership (TPP), since the Chilean Government would not be in a position to commit to implement a patent linkage system if its constitutionality is questioned by this group of senators and being reviewed by the CC. If you want to follow the case see: http://www.tribunalconstitucional.cl/wp/expedientes?rol=2411  ...

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