In a recent decision in Apotex Inc. v. Merck & Co., Inc., 2010 FC 1264, the Federal Court denied Apotex damages resulting from the delay it experienced in bringing its generic version of the drug lovastatin to market as a result of Merck’s prohibition application. This is an important decision which resolves an action commenced nearly 10 years ago and will provide other pharmaceutical companies involved in similarly long-lasting litigation with insight into the scope of section 8 in the 1993 version of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations).
Both current and past versions of section 8 of the NOC Regulations purport to permit a company whose product has been kept off of the market due to a prohibition application to recover damages from the applicant for any loss resulting from the delay. Although Apotex’s statement of claim was filed in 2001, subsequent to significant amendments in 1998, the Court determined that the 1993 version of the NOC Regulations would apply. Section 8 was amended again in 2006 and 2010 and, as a result, will remain ripe for further litigation as to its interpretation. In any future disputes, it will be useful to note the preference demonstrated by the Court in this case for textual interpretations of the NOC Regulations’ technical provisions.
This case was heard contemporaneously with another case which we have discussed here
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