As TPP Ministers Meet, NGOs Make Urgent Push For Public Interest

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Trade ministers negotiating the Trans-Pacific Partnership (TPP) agreement meet this week in Maui, Hawaii to try to finish the deal. Along with them are numerous public interest groups strenuously lobbying to steer the deal away from single-minded corporate interest.

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.

WIPO Patent Law Committee Seeks To Overcome North-South Divide On Priorities

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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

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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.

France Spearheads Push For Plain Packaging Of Tobacco Products

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The country that made smoking cool is now taking steps to make it uncool. France this week organised what it defined as “the first international ministerial meeting” on plain packaging for tobacco products, gathering countries that support the public health measure aimed at discouraging tobacco use.

Treaty On ‘Medicines Crime’ Not Best Response To Counterfeit/Substandard Medicines, Paper Says

A recent paper by public health experts argues that a treaty on ‘medicines crime’ to combat counterfeit and substandard medicines may not be the best step forward. Rather, it proposes to form an international agreement to “ensure that all proven effective and necessary medicines are affordable, available, and of assured quality,” if the goal is to protect the interests of people and public health.

Investor-State Cases Could Have Cost Cash-Strapped Argentina $80B, Paper Says

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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.

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

Cecilia Malmström  EU Trade Commissioner

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.

Aid Agencies Hail Agreement On Access To Early Infant HIV Diagnostic Technologies

Community Health Workers Working with HIV-infected Mothers, photo credit USAID

An agreement entered into by a range of international organisations and others announced this week is expected to lower the price of early infant HIV diagnostic technologies by 35 percent, according to the parties.

WHO Negotiations To Continue On Non-State Actors

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Third World Network reports: New Delhi, 20 July (K M Gopakumar) – Member States of the World Health Organization have decided to continue the negotiations on a Framework of Engagement with Non-State Actors (FENSA) as several key issues remain unresolved.