Archive for November 21st, 2012

Parmaceutical Patents Review

Wednesday, November 21st, 2012

Last month, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.

Now the Panel have published a Background and Issues Paper.

The Panel’s initial impressions of key issues include:

  • a number of concerns have been raised about the length and breadth of protection provided by the extension of term provisions, that is, the duration of the extension and the types of pharmaceutical patents eligible.
  • Are the recent amendments to increase the thresholds for the grant of an Australia patent appropriate in the context of pharmaceuticals? If not, why not and what further changes are necessary?
  • Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
  • Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
  • Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
  • Are follow-on patents being used to inappropriately extend protection for pharmaceuticals? If so, how? And, if they are, is this sound policy and what changes, if any, are needed?
  • should the period of data exclusivity be extended in line with the patent term
  • patent certificates: a generic company must provide a certificate stating that it believes that it is not marketing, and does not propose to market, the therapeutic goods in a way that would infringe a valid patent, or that the generic company has given the patent owner notice of the application
  • the mess arising from copyright in product information documents

Be warned: submissions are due by 21 January 2013, hearings are proposed for February 2013, a draft report in March 2013 and the final report in April 2013.

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