The India Controller General Controller General of Patents, Designs & Trade Marks has just (March 12, 2012) issued an order granting a compulsory license to patents on the cancer drug sorafenib/Nexavar, in the matter of NATCO Vs. BAYER. A copy of the decision is attached below.
This intervention was delivered by India at today’s WTO Council for TRIPS during discussions of agenda item “N” on IP Enforcement Trends. The statement raises India’s concerns with plurilateral agreements like ACTA and TPPA and their potential impacts on public health, international exhaustion, border measures and digital goods and internet freedom.
IIPA Special 301 complaints regarding unauthorized copying of textbooks and other educational materials
USTR asked to use trade pressure to curtail unauthorized copying of educational materials
KEI’s comments on WIPO’s Development Agenda Project on Open Collaborative Development Models
Written comments of Knowledge Ecology International (KEI) regarding the World Intellectual Property Organization’s Taxonomy Analytical Study for the Project on Open Collaborative Projects and IP-Based Models (CDIP/8/INF/7)
21 February 2012
USPTO Holds Public Hearing on Genetic Diagnostic Testing
On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, permitting stakeholders to present their views relating to DNA patents, exclusive licensing, patient health and genetic testing, particularly as they relate to secondary or confirmatory genetic diagnostic testing. Notes from the hearing and speaker statements are included below. KEI’s oral statement can be found here.
Who USTR clears to see secret text for IPR negotiations? (Such as TPPA)
In a meeting with USTR on February 15, 2012, KEI, MSF, Oxfam and Public Citizen pressed USTR to release the negotiating text for the intellectual property rights chapter in the TPPA trade agreement negotiation. USTR said the negotiation had “unprecedented” transparency, but maintained the text needed to be secret from the general public. USTR also claimed than no one on its many advisory boards, who are cleared to see the negotiating text, were lobbyists.
What we don’t know, and why, about incentives to stimulate biomedical R&D
This is an essay about strategic ignorance, as regards evidence relevant to policies that cost consumers and taxpayers billions of dollars.
The United States government grants 20 year patents on pharmaceutical drugs, and it also provides a growing number of other non-patent incentives and subsidies to stimulate R&D investments in new medicines. Are these incentives and subsidies necessary or cost effective? How would anyone know?
Here are some of the incentives we offer:
- Up to five year extensions of patents on pharmaceutical drugs.
Sorafenib (Nexavar)
On February 14, 2012, KEI filed an affidavit in an India compulsory licensing case involving Bayer patents on cancer drug Sorafenib (Nexavar). The price for Nexavar in India is $47 per 200 milligram tablet. At a daily dose of 4 tablets, this comes to $5,637 per month, or more than $68 thousand per year. The per capita income in India was $1,330 in 2010.
Initial FDA approval
Date of FDA NDA application 21-923: Signed July 6, 2005. Received by FDA on July 8, 2005.
Date on FDA approval: December 20, 2005.
Continue ReadingNGO views on the Africa IP Summit
Sangeeta Shashikant from TWN recently collected and published several NGO statements on the Africa IP Summit, in the TWO Info Service on Intellectual Property Issues (Feb12/03), which included a link also to a letter to WIPO signed by more than 100 NGOs. Continue Reading
KEI and Essential Inventions comments to Special 301 Committee