Category Development

South Africa Draft Copyright Amendment Bill Published For Public Comment

The publication for public comment of the much-anticipated South African draft Copyright Amendment Bill has cautiously been welcomed by some stakeholders, who believe that parts of the draft are unworkable.

Nairobi WTO Ministerial Conference Preparation On Track, Says Ambassador

“Membership is comfortable with the level of preparedness and what we have done as a country” to host the December trade ministerial, the Kenyan trade minister told press at the World Trade Organization today.

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.

UNCTAD Official: Need For Policy Coherence In Local Pharmaceutical Production

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).

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.

WIPO Committee Tackles Program, Budget Issues

The World Intellectual Property Organization Program and Budget Committee (PBC) is meeting this week with a full agenda of issues relating to planning for the next biennium as well as management matters.

New ARIPO Plant Protocol: Conflict Of Farmers’ And Breeders’ Rights?

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.