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.
WIPO Patent Law Committee Seeks To Overcome North-South Divide On Priorities 27/07/2015 by Catherine Saez, Intellectual Property Watch 1 Comment The World Intellectual Property Organization patent law committee meets this week with a work programme reflecting strong interests that are not equally shared by member states. Developed countries in the past have focused on ways to share work between patent offices, while developing countries would favour more time being spent on limitations and exceptions to patent rights, in particular in the area of health.
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.
WIPO Program And Budget Committee Works Through Issues 22/07/2015 by Catherine Saez and William New, Intellectual Property Watch 2 Comments The World Intellectual Property Organization Program and Budget Committee (PBC) last week took note of WIPO’s mostly positive 2014 progress report, walked through its proposed program and budget for 2016-2017, and addressed issues of investment, governance, new external offices, and development. Many issues will be carried forward to the next PBC meeting in mid-September, just prior to the annual WIPO General Assembly.
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.
TISA Stocktaking Meeting Reveals There Is Still Ground To Cover 16/07/2015 by Monika Ermert for Intellectual Property Watch Leave a Comment The ambassadors for the Trade in Services Agreement (TISA) have endorsed a deadline of notifying any additional new annexes by 31 July, and submitting completed offers by 15 September. This is the result of the most recent meeting of negotiators of the 25 TISA parties, according to a spokesperson for the Australian Department of Foreign Affairs and Trade. Australia hosted the TISA round from July 6-10 in Geneva.
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.
Learning From Ebola 14/07/2015 by Intellectual Property Watch 1 Comment 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.
New ARIPO Plant Protocol: Conflict Of Farmers’ And Breeders’ Rights? 10/07/2015 by Hillary Muheebwa for Intellectual Property Watch 3 Comments KAMPALA, UGANDA — Member states of African Regional Intellectual Property Organization (ARIPO) have adopted a protocol for the protection of new varieties of plants. The measure is aimed at modernising African agricultural practices, but some say it comes at the expense of age-old traditional farming practices, such as saving and re-using seed.