Canada: "Frozen Register" Concept Renders Janssen's Disclaimer Irrelevant

Janssen-Ortho Inc. v. Apotex Inc. , 2009 FC 650

This was a motion brought by Apotex pursuant to section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) to dismiss Janssen's prohibition application on the basis that it was "redundant, scandalous, frivolous, or vexatious or otherwise an abuse of process". The motion raised a unique issue which appears not to have been decided in any prior proceeding under the Regulations. In particular, the issue was whether a generic manufacturer was required to respond to claims in a patent which changed as a result of a disclaimer filed by the innovator subsequent to service of the generic's notice of allegation (NOA) and prior to the commencement of an application to prohibit the issuance of a notice of compliance (NOC). Or, in the words of the prothonotary hearing the motion, "using a football analogy, does the field goal count if the goalposts are moved after the ball is in the air?"

For background, Janssen filed Canadian patent application no. 2,095,523 (the '523 patent) for a "Pharmaceutical composition comprising a tramadol material and acetaminophen" on September 3, 1992. Well after the '523 patent issued on June 22, 2004, Apotex filed its abbreviated new drug submission (ANDS) on February 1, 2008 and delivered a NOA in respect of the '523 Patent on March 11, 2008. The NOA addressed the claim set of the '523 patent as it then existed, alleging invalidity of the claims on the basis of anticipation and over-breadth. Janssen, on April 22, 2008, filed a disclaimer in respect of the '523 patent, disclaiming all 13 of the original claims, and replacing them with a narrower set of 13 new claims. Three days later, Janssen commenced the application at issue in response to Apotex's NOA.

Although it has been held that a motion under s. 6(5)(b) of the Regulations is an "extraordinary remedy that should only be granted in limited circumstances", the prothonotary sided with Apotex and concluded that "this is one of the extraordinary cases where the application should be struck".

Relying on the "frozen register" concept, it was noted that a generic manufacturer, such as Apotex, when filing a submission for a NOC, was only required to address those patents on the register in respect of the innovative drug as of the filing date of the submission. In the result, "the rights of the respective parties crystallized upon the receipt by Janssen of the Apotex NOA." This principle is grounded in fairness.

If a generic wishes to attack the validity of the claims as reformulated by the disclaimer, it cannot revise its Notice of [Allegation] since proceedings, as in this case, have already been commenced. Apotex cannot raise new grounds for invalidity nor allege non-infringement since the proceedings in this Court were initiated immediately after the filing of the Disclaimer thus, in effect, locking in the Notice of Allegation.

The only proper way to approach the matter is to do so in the way that the Privy Council did in BVD namely fix a date prior to the disclaimer for the purpose of construing the claims.

Unfortunately for Janssen, instead of opposing any of Apotex's allegations as contained in its NOA, Janssen incorrectly declared in the notice of application that Apotex was required to "address the claims of the '523 Patent as they now stand and as they are deemed in law to have stood from the date of issue". But, by not opposing any of Apotex's allegations of infringement and invalidity, the application amounted to a waste of judicial resources since it was bereft of any chance of success. As stated by the prothonotary, "Janssen [was] not entitled to have filed a patent that is overbroad and after being found out, seek to retroactively bootstrap its position by disclaiming the claims and thereby obtain an advantage that it otherwise would not have". Accordingly, the application was dismissed with costs throughout to Apotex.

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