Patently-O considers a new Federal Circuit case in the USA dealing with the scope of s 271(e)(1) – a defence to infringement by working the patent to prepare regulatory data.
It would appear that the defence should now apply in proceedings against imports before the ITC.
Patents Act 1990 (Cth) s 119A (introduced with effect from 25 October 2006 following ACIP’s report) permits such activity where the working:
- is for purposes of having a therapeutic pharmaceutical product included in the Australian Register of Therapeutic Goods;
- or a similar foreign regulatory approval.
Although working for a foreign regulatory approval may take place only in the supplementary protection period (see e.g. ACIP on experimental use p. 44 (pdf)).
See now Alphapharm Pty Ltd v H Lundbeck A/S  FCA 559 at ff.
IP Australia is considering extending this: see paragraphs 9 and 17 of IP Australia’s Consultation Paper on experimental use (pdf) [NOTE: submissions should be in by 8 May 2009. Submissions on the Getting the Balance Right paper (pdf) are also due by then.]