Decision Time On Biologics Exclusivity: Eight Years Is No Compromise

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Burcu Kilic and Courtney Pine write: As the Trans-Pacific Partnership (TPP) negotiations approach their endgame, biologics exclusivity is still considered “one of the most difficult outstanding issues in the negotiation.”[2] Pharmaceutical companies seek longer data and marketing exclusivities to further delay market entry of cost-saving biosimilar drugs. Data exclusivity prevents follow-on pharmaceutical developers from relying on originators’ test data submitted for marketing approval while seeking such approval for its own product. The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires some protection against unfair competition for this sort of data, but it does not require countries to adopt rules conveying exclusive rights over it in the same way as it does regarding patents.[3] Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).[4] The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law, The Patient Protection and Affordable Care Act. A robust debate over what would be an appropriate exclusivity period, if any, was overshadowed by other controversial aspects of the bill commonly referred to as Obamacare.

Defendants, Non-Profits, Defensive Aggregators And Hedge Funds: Common And Less Common Uses Of Inter Partes Review

Richard Hung,
Photo ©John Swanda 2013

Inter partes review (“IPR”) proceedings were originally intended to allow defendants in patent infringement lawsuits to invalidate questionable patents cheaply and quickly. But these proceedings increasingly are being used by parties that are not defendants in active litigation matters at all, write Rich Hung and Alex Hadduck.

Learning From Ebola

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In 1976, Yambuku village school headmaster Mabalo Lokela felt sick when he returned from a trip to northern Zaire near the Central African Republic border. He had a high fever, diarrhea, and bleeding. Because he was initially believed to have malaria, Lokela was given quinine, but his symptoms got worse and he soon died. Shortly afterwards, those who had been in contact with Lokela also died. … Almost four decades later, there is still no cure for Ebola, despite the fact that drug development on average takes about a third of this time frame, write William Fisher and Quentin Palfrey.

3D Printing And Public Policy

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John Hornick writes: Although legal principles apply to 3D printing the same as they apply to any other technology, 3D printing has the unique potential to upset the legal status quo. It is the potential scale of 3D printing that may have profound effects on the law. 3D printing cuts across many areas of law, most types of technology, and almost all types of products. Eventually, anyone may be able to make almost anything. No one else will know they made it or be able to control it, which I call 3D printing away from control.

Copyright And The Public Interest: Not Necessarily Competing Forces

Neil Turkewitz

Copyright protection advances the public interest, and good public policy must properly consider “the role of intellectual property as a tool for economic emancipation, a catalyst for cultural diversity, and a powerful protector of individual dignity and fundamental human rights,” argues RIAA’s Neil Turkewitz.

US Political Trademarks And Campaign Branding 2016

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As prospective presidential candidates prepare to plunge voters in the United States into campaign purgatory, it is time for pundits to examine how candidates are branding their political campaigns and crafting their messages to appeal to the electoral audience. With the presidential race beginning to heat up, which candidate will seize the message that resonates most with American voters? And what will that message be?

ICANN Is Not The Internet Content Police

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ICANN’s Allen Grogan writes: Allow me to say this clearly and succinctly – ICANN is not a global regulator of Internet content, nor should the 2013 Registry Accreditation Agreement (RAA) be interpreted in such a way as to put us in that role. Our mission is to coordinate, at the overall level, the global Internet’s systems of unique identifiers, and in particular, to ensure the stable and secure operation of the Internet’s unique identifiers. ICANN was never granted, nor was it ever intended that ICANN be granted, the authority to act as a regulator of Internet content.

African Civil Society: Disillusionment, Mistrust In Bonn

PanAfrican Climate Justice Alliance

We, the African civil society organisations participating in the Bonn Climate Change Conference, are gravely concerned about the progress of negotiations and wish to express our utmost disillusionment on the mistrust reigning the corridors of the new World Conference Centre here in Bonn.

Firm Performance In Countries With & Without Open Copyright Exceptions

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Mike Palmedo writes: This post presents preliminary data showing that firms in industries sensitive to copyright can succeed in countries other than the US when copyright limitations include fair use. It is an early product of an interdisciplinary project at American University, in which legal researchers are working with economics professor Walter Park to study how country’s copyright exceptions effect economic outcomes. The project has been undertaken as part of American University’s larger role coordinating the Global Network on Copyright User Rights. The research supports and expands on other recent research attempting to measure the value of fair use abroad.

Statement: Blumenthal Offers Amendment On Trade Transparency

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Senators Blumenthal, Brown, Baldwin, and Udall introduced today a trade negotiation transparency bill that would require that all formal U.S. proposals for trade agreement restrictions on domestic regulations be posted on a website. This is a common sense policy that should be broadly supported. The bill would require policies similar to the transparency policies currently followed by the European Union and by intergovernmental organizations that set similar minimum regulatory standards. But it would be a major change in the current process for trade negotiations followed by the U.S. Trade Representative, which are infamously secretive, write Sean Flynn and David Levine.