Original news and analysis on international IP policy
After weeks of uncertainty among civil society organisations as to whether or not the United Nations political declaration on noncommunicable diseases (NCDs) would uphold language on intellectual property flexibilities for affordable access to medicines, the document was finalised today with even stronger language affirming the use of these flexibilities.
The negotiated deal over the language of the United Nations political declaration on tuberculosis, a landmark in the fight against TB, has been maintained by member states and was finalised on 14 September, marking the end of intense negotiations over language on intellectual property flexibilities in the document.
[Updated] The European Patent Office (EPO) on 13 September ruled in favour of pharmaceutical company Gilead and maintained the company's patent on hepatitis C drug sofosbuvir. The patent, however, is maintained in an amended form. Civil society involved in the case expressed dismay over the outcome and its potential effect on European drug prices.
Marcela Fogaça Vieira and Pedro Villardi write: The Brazilian Supreme Court (STF) has mysteriously cancelled the judgment of the most important case regarding intellectual property and health ever to be decided by the court. On 28 June, the date of the judgment was set for 6 September. The cancellation occurred on the eve of the judgment, something very rare in the practice of the Court. The lack of decision on the case only benefits the transnational companies awarded with hundreds of undue monopolies. Just a few days before, the President of the STF - Judge Carmem Lucia - had a meeting with Interfarma, the association of multinational pharmaceutical companies in Brazil.
The European Patent Office is expected to hold oral proceedings later this week on a challenge filed against a Gilead patent on hepatitis C treatment. Invalidation of the patent would open the way to competition and lower prices, according to civil society groups which initiated the challenge. But according to an EPO source, the company is seeking at most an amendment to the patent.
Negotiators' agreed draft text for a United Nations political declaration on ending tuberculosis worldwide has been posted for all member states to see, and negotiators hope, not comment on. Under a UN procedure, the text has been placed "under silence" until 10:00am New York time on 14 September. If no one breaks the silence, the text is considered agreed and will advance to the High-Level Meeting on tuberculosis on 26 September as part of the annual UN General Assembly.
Historically, the US has been the primary demandeur of maximalist IP norms in FTAs. Pharmaceutical IP is market-driven, and this is no different for biologic drugs, which dominate the list of bestselling drugs worldwide, making them important economic commodities. Developing country governments must take note of the US pushing for biologics exclusivity through NAFTA as this signifies an effort to change norms worldwide.
A new study by researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Brigham & Women’s Hospital reveals that generic drug companies have been successful about 50% of the time when challenging patents covering FDA-approved pharmaceutical products via a new, administrative review procedure of patent validity created by Congress called “inter partes review.”
Thousands of students have urged a major research university in the United States to drop a patent claim in India related to an important cancer medicine, with the aim of making affordable versions available.
A newly agreed draft text of the United Nations political declaration on tuberculosis was released to governments today, affirming the use of flexibilities in international trade rules on intellectual property, but excluding actionable language on those rules.