Decision Time On Biologics Exclusivity: Eight Years Is No Compromise 27/07/2015 by Intellectual Property Watch 14 Comments 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.
Intellectual Property Law Under The Prism Of The Right To Culture 24/07/2015 by Jos̩phine De Ruyck for Intellectual Property Watch Leave a Comment STRASBOURG, FRANCE РAlthough the right to science and culture has been enshrined in several international treaties, their exact implications in the intellectual property field have remained vague.
India IPR Policy Update: Final Draft Circulated 23/07/2015 by William New, Intellectual Property Watch 3 Comments The final draft of India’s national intellectual property policy has been circulated for inter-ministerial consultation and will be sent to the Cabinet for approval after receiving comments, the Ministry of Commerce and Industry said this week. Meanwhile, today public health groups in India announced that revocation of a Roche pharmaceutical patent has been upheld under Indian law.
Coalition Asks WIPO To Follow Proposed Guidelines To Better Defend IP Rights 22/07/2015 by Catherine Saez, Intellectual Property Watch Leave a Comment An international coalition of intellectual property rights defenders wrote a letter to World Intellectual Property Organization Director General Francis Gurry yesterday providing suggested international guidelines to protect IP rights.
UK Proposes To Allow Designers To Mark Their Products With A Web Link 22/07/2015 by Intellectual Property Watch Leave a Comment The United Kingdom government is calling for evidence on a proposal to provide designers with an option to mark their products with a web link instead of stamping the product or attaching a label with registered design numbers to provide public notice of registered design rights.
Investor-State Cases Could Have Cost Cash-Strapped Argentina $80B, Paper Says 21/07/2015 by Catherine Saez, Intellectual Property Watch 1 Comment A new developing country policy brief warns against use of the investor-state dispute settlement mechanism, arguing that it has a low capacity to adapt to exceptional circumstances that can afflict developing countries.
Is The European Unitary Patent System On Its Way To A Tepid Start? 17/07/2015 by Monika Ermert for Intellectual Property Watch Leave a Comment For nearly two decades, the European Union has pondered the completion of a unitary patent system (UP) and a Unitary Patent Court (UPC). But even after the European Court of Justice has ruled the UP/UPC agreement to be constitutional, users, including some big ones, remain cautious.
UNCTAD Official: Need For Policy Coherence In Local Pharmaceutical Production 17/07/2015 by Ani Mamikon for Intellectual Property Watch and Rishi Dhir for Intellectual Property Watch Leave a Comment Despite progress in recent years to boost local pharmaceutical production in developing countries, policy coherence across the countries is lacking, according to an official at the United Nations Conference on Trade and Development (UNCTAD).
Defendants, Non-Profits, Defensive Aggregators And Hedge Funds: Common And Less Common Uses Of Inter Partes Review 16/07/2015 by Intellectual Property Watch Leave a Comment 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.
A Geneva Look At Jurisdiction, Dispute Resolution And The Internet 15/07/2015 by Eimear Murphy for Intellectual Property Watch 1 Comment A conference on jurisdiction and dispute resolution in the age of the internet raised topical issues of concern to internet-based public policy, such as the notion of how jurisdiction and internet governance is a question of power, and an update on the International Law Association guidelines project. In addition, a debate arose as to the state of the patent system.