Category Development

Medicines Patent Pool At 5 Years: Promises Kept, Changes Ahead – An Interview With Greg Perry

The Medicines Patent Pool in Geneva is celebrating five years of existence this month. MPP Executive Director Greg Perry sat down with Intellectual Property Watch Catherine Saez to describe progress made since its inception, the success of its licensing agreement model, and plans for the future, including a possible extension to other diseases such as tuberculosis and hepatitis C.

Decision Time On Biologics Exclusivity: Eight Years Is No Compromise

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.

India IPR Policy Update: Final Draft Circulated

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

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.

EU Commissioner Signals Support For LDC Request To Waive IP Rights Enforcement On Pharma

European Trade Commissioner Cecilia Malmström said in a recent speech that providing she has the backing of the College of Commissioners, the Council and the European Parliament, she would like to answer positively to the request by least developed countries (LDCs) to extend a particular exemption to enforce intellectual property rights on medical products as long as they remain an LDC.

Learning From Ebola

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.