In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

  • All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
  • Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
  • One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.
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Federal Circuit decision in AMP v. USPTO results in three-way split in reasoning; 2-1 decision finds isolated DNA patentable

It has been estimated that 1 out of every 8 women in the United States will develop invasive breast cancer during her lifetime. Although a diagnostic test exists to identify mutations on the BRCA1 and BRCA2 human genes, two genes associated with breast and ovarian cancer, many women are not afforded the opportunity to have testing done because Myriad Genetics holds exclusive rights over these genes. Continue Reading

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WIPO General Assembly: Expectations loom over decisions on treaties for actors, reading disabled persons and genetic resources

The WIPO General Assembly meets from Monday, 26 September 2011 to Wednesday, 5 October 2011 and will take place at the International Conference Center Geneva (CICG), 17 rue de Varembé, 1211, Geneva.

The tentative schedule for 49th session of the WIPO General Assembly can be found here: http://www.wipo.int/edocs/mdocs/govbody/en/a_49/a_49_1_prov_2.pdf.

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Medicines Patent Pool agreement with Gilead contains flexibilities including termination provisions and severability of licenses

On 12 July 2011, the Medicines Patent Pool (MPP) and Gilead announced an agreement for Gilead to license patents for tenofovir (TDF), emtricitabine (FTC), elvitegravir (EVG), cobisistat (COBI) and a four drug combination of these drugs. KEI’s initial comments on the agreement are available here. Continue Reading

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Decision for WIPO GA 49: Matters Concerning the IGC on IP and genetic resources, traditional knowledge and folklore

After ten years of deliberations, the 19th session (18-22 July 2011) of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC/GRTKF) submitted a Decision for approval to the WIPO General Assembly (26 September-5 October 2011) that could pave the way for the General Assembly in 2012 to convene a Diplomatic Conference on an international legal instrument(s) for the protection of genetic resources, traditional knowledge and traditional cultural expressions (TCEs).

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Of WIPO, diplomatic conferences and international legally binding instruments

The 19th session of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore is meeting this week in Geneva (18-22 July 2011) to make a a decision on a possible international legal instrument (or instruments) to protect genetic resources, traditional knowledge and folklore. At the discussions of future work on 19 July 2011, the United States (Albert Tramposch, USPTO) asked the WIPO Legal Counsel (Edward Kwakwa) the following question.

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Like-Minded Group requests convening of WIPO Diplomatic Conference on genetic resources, traditional knowledge and folklore

From 27 June to 30 June 2011, representatives from the like minded group of countries including Algeria, Angola, Bangladesh, Colombia, Egypt, India, Indonesia, Malaysia, Myanmar, Namibia, Pakistan, Peru, South Africa, Tanzania, Thailand, and Zimbabwe met in Bali, Indonesia to discuss the protection of genetic resources, traditional knowledge and folklore. This group submitted a joint recommendation to the WIPO secretariat (WIPO/GRTKF/IC/19/8) requesting the following:

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2nd meeting of WHO Consultative Working Group on R&D Financing (CEWG): Summary of proceeedings by Chair (John Arne Røttingen)

On 8 July 2011, the WHO Consultative Expert Working Group on R&D Financing and Coordination (CEWG) held an open session to brief the public on their preliminary assessments and recommendations.

To access the slide presentation presented by the Chair (John Arne Røttingen, Norway) and Vice-Chair (Claudia Inês Chamas, Brazil), please click on the following link: http://www.who.int/phi/news/Open_Session_July_v3.pdf

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