The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: data protection

Biotech Trends Update — IP Constituencies: Indian Industry Lobbies to Keep IP Out of Free Trade Agreement with EU

An article in yesterday’s Hindu Business Line says the Indian Drug Manufacturers’ Association is lobbying heavily to keep data protection and other innovator-friendly IP provisions out of the free trade agreement being negotiated between India and the EU. But, with Glenmark and Jubilant on the rise, and with even Biocon carrying the R&D water in its deal with Pfizer, demands for IP protection from domestic constituents are bound to be increasingly loud.

Keep an eye on the progress of the free trade talks, continuing with the India-EU summit this week. Apparently, the main gaps are: the percentage of tradable goods that are tariff-free; a sustainable development clause; and the IP issues noted above. We’ll see how hard India pushes to keep IP out of the picture.

Canada’s Data Protection Regulations Upheld Against Court Challenge

Scale_of_justiceJPEGLast Friday* the Federal Court of Canada upheld the constitutional validity of Canada’s Data Protection Regulations, dismissing the applications of the Canadian Generic Pharmaceutical Association and Apotex Inc.

Canada’s data protection regime provides innovative drugs with:

  • a six-year data exclusivity period;
  • an eight-year market exclusivity period; and
  • an additional six-month period of market exclusivity in some cases for pediatric applications.

The Data Protection Regulations were enacted in 2006 to bring Canada into compliance with its TRIPS and NAFTA obligations.  Here’s today’s press release from Rx&D.

*The decision has not yet been posted. The citation will be 2009 FC 725.

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Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel.

Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both.

Two VA Initiatives!  In addition to the electronic medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

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