Cobalt Pharmaceuticals Inc.
Registration:
3
of
16
(2010-03-17
to
2010-06-18)
Legislative Proposal, Bill or Resolution
- Industry Canada regarding export provisions of the Patent Act.
- Industry Canada with respect to the Patent Act as it pertains to pharmaceuticals.
- Modernization of the Food and Drug Act (formerly Bill C-51) with respect to the development and implementation of a Progressive Licensing Framework for pharmaceuticals.
Policies or Program
- Health Canada regarding the need for appropriate, dedicated resources for the Therapeutic Products Directorate to meet performance targets for the review of generic drug submissions.
- Health Canada, Industry Canada, and International Trade Canada regarding effective measures to combat counterfeit drugs in Canada and around the world.
- Science and Technology Strategy regarding the need for a balanced Intellectual Property (IP) regime and the important role competition plays in encouraging innovation.
- The development and implementation of an approval pathway for Subsequent Entry Biologics (SEBs).
Regulation
- Amendments to the Patented Medicines (Notice of Compliance) Regulations with regard to section 8 of the regulations, the inclusion of a mechanism that would prevent a brand company from suing a generic company twice on the same patent and an administrative change to explicitly allow a generic company to amend a Notice of Allegation.