Digests

AB Hassle v. Apotex

T-1747-00

2001 FCT 530, Blais J.

25/5/01

40 pp.

Motion to set aside Prothonotary's order dismissing application as frivolous, vexatious, abuse of process; dismissing motion for order requiring affiants to re-attend to answer questions on cross-examination--By letter dated August 1, 2000 Apotex providing notice of allegation stating no claim for medicine itself and no claim for use of medicine in patents infringed by its making, constructing, using, selling of Apo-Omeprazole tablets--Submitting patents covering pharmaceutical compositions comprising core, inert subcoating, outer enteric coating, but its tablets not having subcoating between core, enteric coating; thus not within scope of, not infringing patents--In response, applicants commenced application to prohibit Minister from issuing notice of compliance to Apotex in respect to omeprazole and/or omeprazole magnesium tablets in three dosages until after expiration of patents, and for declaration Apotex' August 1, 2000 letter not constituting notice of allegation--Apotex brought motion to dismiss--Prothonotary finding Patented Medicines (Notice of Compliance) Regulations not requiring Apotex to identify which drug subject of allegation; matter not res judicata since proceedings commenced in 1998 withdrawn on consent without being tried on merits--Applicants maintaining reaction of enteric outer layer with substances in core layer resulting in intervening or third layer--Prothonotary concluding two-step procedure not infringing three-step procedure as would not end up with centre layer deployed before outer layer added--Granted motion to dismiss--Application allowed--(1) Whether beyond doubt applicants could not possibly succeed on issue of whether notice of allegation complying with Regulations on basis (a) notice of allegation must identify drug or (b) notice of allegation abuse of process--(a) Regulations not requiring drug, active ingredient be identified in notice of allegation--No conceivable consequence relevant to this application turning on identity of active ingredient--Allegation of non-infringement, reasons why Apotex' product will not infringe patents applies to both omeprazole, omeprazole salts--(b) Applicants submitting notice of allegation abuse of process since Apotex made same allegations in respect of patents in 1998--Prothonotary correctly holding matter not res judicata, abuse of process--(2) Whether beyond doubt applicants could not possibly succeed on following issues relating to whether Apotex' allegation of non-infringement justified--(a) Whether allegation justified on basis specified in notice of allegation--Applicants alleging issue of spontaneous generation of subcoat requiring determination at hearing--Apotex not attempting to rely on issues not set forth in notice of allegation as applicants raising issue--Questionable whether issue of subcoating could raise serious question as to whether Apotex' allegation of non-infringement justified--But this issue, and (b) issue of whether applicants' pending motion for disclosure precluding motion for summary dismissal relating to construction of patent--(c) With respect to construction of patent (i) whether patent construction argued by Apotex detailed in notice of allegation--Applicants submitting Prothonotary decided issues of construction not in notice of allegation--Submitting Apotex advanced patent construction not in its detailed statement--Prothonotary stating Apotex alleged enteric covering will partially react on contact with core to precipitate intervening neutral layer between core and enteric layer--Although new matters cannot be considered in notice of allegation, Apotex not adding new matter since still stating two-step procedure, and would not be any subcoating layer between cores, enteric layers--(ii) If so, should question of construction be left for hearing on merits--Construction of patent always engaged by assertion of non-infringement--Furthermore, applicants had opportunity to file expert evidence as to construction of patents--Prothonotary not erring in making determination about patent construction on motion for summary dismissal--(iii) If not, does construction require consideration of expert evidence--Prothonotary concluded expert evidence as to meaning of `coating, disposing, covering' not needed--Applicants submitting where dispute among experts matter should properly be left for trial--Trial Judge, with help of experts, better able to determine real meaning of `coating, disposing, covering' for pharmaceutical purposes--Prothonotary erred in making own decision without advice of experts--(iv) If so, what is proper construction--Applicants submitting claims of patents not limiting manner in which subcoating formed--Question as to proper construction of patents should be left to Trial Judge hearing case on merits--(v) If claims construed as process-dependent composition claims, does presumption of infringement apply--Apotex arguing applicants must do more than raise mere speculative possibility of infringement, and must establish that, if notice of compliance granted, infringement will occur--Prothonotary went too far and questions whether construction argued by Apotex, and whether Apotex' tablets will avoid infringement of patents as construed should be left for determination by judge hearing case on merits--Affiants ordered to reattend to answer certain questions--Applicants allowed extension of 30 days to bring motion before Court--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.