Interlocutory Decision; s.6(7) of the PM(NOC) Regulations; 2009 FC 226; amlodipine; March 4, 2009
The Court upheld the decision of the Prothonotary refusing further production of ANDS documents. The first patent at issue related to the besylate salt of the product and Apotex' allegation was that its product would not contain that particular salt, nor would the salt be used in the manufacturing process. The second patent related to an enantiomer of amlodipine and Apotex' allegation was that it was not infringing as it was using the racemate.
Prior to the motion, Apotex had voluntarily disclosed large portions of its ANDS. The Prothonotary found these portions to be sufficient.
The Court held that the issue to be determined by the judge is whether the process Apotex states it will use would infringe, not whether some other process would infringe. Thus, as the process documents Apotex states it is using have been disclosed, it cannot be said that the further documents requested are relevant.
The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc226/2009fc226.html