Original news and analysis on international IP policy
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.
Last week, Chilean Health Minister Emilio Santelices, appointed by President Piñera - who took office this year - rejected an attempt from company Gilead and a Big Pharma-related association of international drug makers in Chile to put down the resolution 399/2018 declaring public health justifications for the issuing of compulsory licences for sofosbuvir to treat a hepatitis C epidemic in Chile, that was issued by the previous government of Michele Bachelet, writes Luis Villarroel.
Health ministers from the World Health Organization Africa region last week endorsed a roadmap for access for the years 2019-2023 concerning areas such as fair pricing, intellectual property management, and supply chain management. The previous day, they pledged to implement key strategies to end cholera outbreaks in the African region by 2030.
With negotiations over the final language of a United Nations high level declaration on ending tuberculosis still ongoing, the stakes are high as different TB stakeholders await the outcome. The language in question could either raise or reduce barriers to affordable access to life-saving TB drugs, according to civil society groups.
The governments of Cuba and Indonesia today chose not to appeal a June ruling at the World Trade Organization that upheld Australia's law requiring tobacco products sold in the country to be packaged without logos or other trademarked designs. That leaves Honduras and the Dominican Republic alone in their appeals of the decision.
The newly established Dutch Pharmaceutical Accountability Foundation has announced its first action to address unreasonably high medicines prices in the Netherlands. The Foundation will request the Netherlands Authority for Consumers and Markets to look into the price hike for the medicine chenodeoxycholic acid (CDCA) by the company Leadiant Biosciences Ltd (formerly Sigma-Tau). CDCA is used for the treatment of children and adults with cerebrotendinous xanthomatosis (CTX), a rare genetic metabolic disease that affects around 60 people in the Netherlands.
NEW YORK – Negotiators for a United Nations declaration on tuberculosis, meeting intensively in New York this week, may have reached agreement today on a key sticking point related to intellectual property, innovation and access to new medicines, according to sources. An agreement, if accepted by other delegations, could allow the text to proceed to the high-profile High-Level Meeting scheduled to take place at the UN General Assembly next month.