PATENTS |
Practice |
Syntex (U.S.A.) L.L.C. v. Canada (Minister of Health)
A-654-01
2002 FCA 289, Rothstein J.A.
8/7/02
6 pp.
Appeal from Motions Judge's decision striking out application for judicial review on grounds did not disclose any possibility of success, abuse of process--In February 2001, respondent Apotex sent notice of allegation (NOA) under Patented Medicines (Notice of Compliance) Regulations for apoketorolac solution for ophthalmic application--Appellants say that after expiration of 45 days provided by Regulations to apply for order of prohibition, came to their attention that NOA originally served on them deceptive, misleading, preventing them from realizing Apotex's product infringed their patent, otherwise would have filed application for order of prohibition within required time--In June 2001, appellants brought application for judicial review to prohibit Minister from issuing notice of compliance (NOC) to Apotex, saying deceptive or misleading NOA tantamount to no notice at all, that Regulations never engaged, that Minister had no jurisdiction to issue NOC to Apotex--Motions Judge dismissed application on basis so clearly improper as to be bereft of any possibility of success--Appeal dismissed--Issue whether deceptive or misleading NOA tantamount to no NOA at all--Regulations engaged by service of NOA on patentee, even if NOA deceptive or misleading--Once NOA served on patentee, latter must decide whether or not to seek prohibition--If decides not to within prescribed time, cannot later resurrect its rights under Regulations by bringing application for judicial review--Minister not required to assess whether NOA might deceive or mislead patentee--If NOA satisfying formal requirements of Regulations, s. 5 has been served, Regulations engaged and up to patentee to take steps to protect its rights--Once NOA has been served, all proceedings must be under and within Regulations and in accordance with time limits provided in Regulations-- Whether notice deceptive or misleading or otherwise deficient in substance to be determined by Court in prohibition proceedings commenced by patentee--Ample discretion in motions judge under Regulations, s. 8(5) to take into account deceptive, ambiguous or uninformative nature of NOA that force patentee to apply unnecessarily for order of prohibition --Generic producer filing deceptive or misleading NOA risking serious consequences--If patentee does not apply for order or prohibition under Regulations because of deceptive or misleading NOA, patentee may seek punitive damages or solicitor-client costs in patent infringement action--As result, generic producer should be discouraged from serving deceptive or misleading NOA--Even though Minister recently issued NOA for Apotex's drug, not necessary to decide mootness issue--Patented Medicines (Notice of Compliance) Regulations, SOR/93-379, ss. 5 (as am. by SOR/98-166, s. 4; 99-379, s. 2), 8(5) (as am. by SOR/98-166, s. 8).