Category Health & IP

Civil Society And TRIPS Flexibilities Series – Translations Now Available

Patients around the world, in developing and developed countries, are encountering barriers to access to affordable medical products, in part due to patents and resulting high prices. This is occurring despite longstanding protections built into international trade rules to allow smaller economies to act on behalf of their people and make such medical products available regardless of patents. These protections are often referred to as flexibilities in the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The prevailing view is that knowledge, understanding and use of them remains limited among policymakers and many potential beneficiaries, even as patent-strong nations and their industries work to narrow the reach and ability to use these flexibilities. In the face of this, global civil society in recent years have increasingly begun work to change the direction of this trend, with the ultimate goal of helping people everywhere - but particularly poor populations - obtain drugs they need that exist but are out of their reach. Now, the series of Intellectual Property Watch stories on this subject sponsored by Make Medicines Affordable have been translated into five languages.

A Look At Honduras’ Appeal In WTO Ruling On Tobacco Plain Packaging

In an appeal of a recent World Trade Organization dispute panel ruling, Honduras detailed a list of alternate interpretations of the decision to uphold Australia’s tobacco plain packaging measures. Honduras called on the WTO Appellate Body to “reverse the Panel’s findings and conclusions,” claiming that the ruling was “not the result of an objective assessment of the matter.”

Negotiations On UN Tuberculosis Declaration Still Open, Reports Say

Negotiations for a United Nations declaration on ending tuberculosis had drawn to a close earlier this week, with the United States seeming to succeed on a hardline position to keep mention of intellectual property rights and affordability of medicines out of the text. But nongovernmental reports say the draft has not been accepted by all members and that negotiations will have to be reopened.

UN Political Declaration On TB Finalised: No Commitment To TRIPS Flexibilities

Members of the United Nations concluded negotiations on the draft of the Political Declaration on the Fight Against Tuberculosis on 20 July. After weeks of heated negotiations over the inclusion of references to TRIPS flexibilities in the operative paragraphs, with the Group of 77 pushing for inclusion and the United States against it, the final text of the political declaration reflects the deadlock of these positions. Due to the inability of member states to reach agreement, the final text does not include substantive reference to TRIPS flexibilities.

If no countries object, this final draft of the Political Declaration on TB will be adopted by the General Assembly at the High-Level Meeting on Tuberculosis, which will take place on 26 September at the United Nations in New York, and will serve as the authoritative agreement from which action plans will be drawn. According to sources, countries have until tonight in New York to decide whether to object, and G77 nations are considering their options.

Balance Achieved In Future Work For WIPO Patent Law Committee, Delegates Say

The last World Intellectual Property Organization committee before the summer break ended on a happy note this week. After some time spent tweaking the future work of the WIPO committee on the law of patents, delegates appeared satisfied with the balance achieved. The week saw plans for conferences, numerous new proposals and calls for reports, on subjects such as research exceptions, patents and medicines access, compulsory licensing, technology transfer, and patent quality.

Monopolies: State And Corporate Interests Surrounding Access To Medicines

Amongst the many issues faced by developing countries to ensure access to medicines, cost is a primary one. Proposals to tackle it include limiting the price and regulating competitive conditions. Monopolies created by patents are seen by many as an impediment to accessing basic healthcare. Meanwhile, countries have realised that imposing stringent criteria for granting patents and taking a long duration to process them could be detrimental to them as much as resisting the regime.

Excessive Pricing And Sham Patent Litigation: The Pfizer And AbbVie Decisions

Frederick Abbott writes: Competition law is a critical tool in seeking to maintain some semblance of reasonable pricing in the pharmaceutical market. It is particularly important as legislators around the world appear extremely hesitant to address pharmaceutical pricing in meaningful ways, regrettably influenced by well-funded lobbying.

Two recent competition law decisions discussed below illustrate the importance of and challenges to regulating the pharmaceutical sector. In the first, the UK Competition Appeal Tribunal (CAT) partially upheld and partially reversed and remanded (pending briefing) a decision by the Competition and Markets Authority (CMA) fining Pfizer and Flynn close to £90 million for abuse of dominant position in the excessive pricing of an anti-epilepsy drug. The CAT decision is problematic because it creates unnecessary and unwarranted hurdles to findings of excessive pricing in the UK. In the second decision, the US Federal Trade Commission succeeds in proving that AbbVie engaged in abuse of monopoly power by engaging in sham patent litigation against two generic producers in order to delay market entry of competitive products. The Federal District Court found that AbbVie’s patent lawyers by “clear and convincing” evidence had knowingly pursued patent infringement claims without chance of success for no other purpose than to delay market entry.