Friday, June 8, 2012

Certification Not Required to Establish Start Date for Section 8 Compensable Period

Apotex Inc v. Merck & Co., Inc. / lovastatin (NOC) 2012 FC 620 Snider J on remand from 2011 FCA 364 (blogged here)

Section 8(1)(a) of the NOC Regulations provides that the presumptive start date for the compensable period under s 8 is “the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations.” In this case, there was no evidence that the Minister had certified a date. Snider J held that despite the absence of a certification, the appropriate start date was the date on which, on the facts, Apotex would have received its NOC:

[15] Merck is correct that there is no Ministerial “certification” of May 25, 1996 as contemplated by s. 8(1)(a). However, I am satisfied that, but for the Regulations, Apotex would have received its NOC for Apo-lovastatin no later than May 25, 1996.

Thus certification by the Minister is not a prerequisite to recovery of s 8 damages; the main consideration is when the generic would have received its NOC, but for the Regulations. In this case it was uncontroversial that the “patent hold date” was May 25, 1996 [14]. This conclusion is somewhat difficult to reconcile with the text of the Regulations, as even the discretion provided for in s 8(1)(a)(ii) refers to “the certified date.” However, the evident purpose of the Regulations is to permit recovery from the patent hold date, and it is reasonable to interpret the certification date as being a matter of evidence rather than substance. The 1998 amendments to the Regulations remedied many drafting problems in the notoriously obscure 1993 version, but it not surprising that more drafting issues will arise as s 8 cases are fully litigated.

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