Quarterly Case Summaries - April 1 to June 30, 2009

Ken Crofoot and Jerry Topolski for the Plaintiff, Apotex Inc. (“Apotex”)
Brian Daley and Julie Jauron for the Defendants, Pfizer Canada Inc. et al. (“Pfizer”)

This was a motion for summary judgment in an action by Apotex to recover damages pursuant to Section 8 of the PM(NOC) Regulations. Apotex alleged that Pfizer’s application for an order of prohibition had delayed Apotex’ Notice of Compliance for its drug Apo-fluconazole. Pfizer was the owner of Canadian Patent No. 1,181,076 (“‘076 Patent”), which claimed a process for making fluconazole, a compound used to treat fungal infections.

There was no dispute about the following facts:

March 20, 1992 – Nu-Pharm filed an ANDS for the “acetate process” to fabricate fluconazole in bulk. They then served an NOA on Pfizer alleging the acetate process did not infringe the ‘076 Patent;
August 16, 1994 – Nu-Pharm, without amending its ANDS or filing a new ANDS served an NOA on Pfizer alleging the “cyclic sulphate process” to make fluconazole did not infringe;
September 12, 1994 – Apotex submitted an ANDS cross-referencing NU-Pharm’s ANDS, which at the time only related to the acetate process.
May 1, 1995 – Nu-Pharm serves another NOA on Pfizer alleging the “olefin process” to make fluconazole would not infringe.
June 28, 1995 – Apotex served an NOA on Pfizer alleged its fluconazole tablets would not infringe the ‘076 Patent on the basis they would be made using the olefin process;
August 10, 1995 – Pfizer started prohibition proceedings in response to Ni-Pharm’s NOA claiming the olefin process and Apotex’s NOA claiming the olefin process;
June 27, 1996 – Nu-Pharm sent a letter to the Minister for process maps for alternative process for making the drug, including the olefin process. The Minister did not review the letter and no further correspondence was sent to the Minister by either Apotex or Nu-Pharm;
August 18, 1997 – the Court issued prohibition orders in relation to Nu-Pharm’s acetate and cyclic sulphate process and Apotex’s cyclic sulphate process based on the finding that the allegations of non-infringement by these processes were unjustified;
January 30, 1998 – the Court dismissed Pfizer prohibition proceedings in relation to Apotex in respect of the olefin process. Apotex claims Pfizer is liable for damages from August 10, 1995 (commencement of prohibition proceedings) to January 30, 1998 (the date of dismissal of the proceeding). However, the Minister did not issue an NOC to Apotex on the basis that there was no information in Nu-Pharm’s ANDS, or therefore no information in Apotex’s ANDS which cross-referenced the Nu-Pharm ANDS;
March 16, 1998 – Apotex starts an application (Nu-Pharm and Pfizer were not parties) to compel the Minister to issue an NOC to Apotex. Apotex relied upon Nu-Pharm’s letter of June 27, 1996 as a filing of the olefin process. The Minister took the position that any change in the process required a “Supplemental New Drug Submission” or a “Notifiable Change”;
June 1998 – Apotex, Nu-Pharm and the Minister enter into an agreement whereby the Minister would issue an NOC after Nu-Pharm and Apotex submit a notifiable change and supporting documents. Apotex’s application to compel was discontinued;
June 29, 1998 – Nu-Pharm filed a Notifiable Change Submission with the Minister, though the Minister found this to be deficient;
October 9, 1998 – Nu-Pharm sent the requested additional information to the Minister. Apotex submitted its Notifiable Change Submission the same day based on its cross-reference to the Nu-Pharm ANDS.

The issue on the summary judgment motion was whether Pfizer’s prohibition application caused any damages allegedly suffered by Apotex. Apotex argued that it would have received a NOC for the olefin process much earlier if Pfizer had not commenced prohibition proceedings in relation to the olefin process. The Court concluded it could grant judgment on a summary judgment where the only genuine issue is a question of law, or where there is a genuine issue but the Court can on the whole of the evidence find the facts necessary to decide the questions of fact and law. On this latter point, the Court concluded it was not appropriate to grant summary judgment where, inter alia, there are issues of credibility or there is a serious question of fact or law which turns on the drawing of inferences.

It was undisputed in the evidence that the Minister’s position regarding the Nu-Pharm letter of June 27, 1996 was unrelated to any action by Pfizer. Nonetheless, Apotex took the position that the dispute with the Minister would have taken place much earlier if Pfizer had not commenced prohibition proceedings. In this respect, the Court concluded there was a genuine issue for trial requiring an assessment of credibility.

In addition, the dispute between the parties is based on differing interpretations of Section 8 of the PM(NOC) Regulations. The Court found that there was strong support in the case-law for the proposition that, where a question of law in relation to section 8 is raised in relation to the facts, summary judgment is not appropriate. Thus, the Court held that summary judgment was not appropriate in this case.

The Court dismissed the motion by Pfizer for summary judgment with costs in the cause.

By Michael Crinson, Dimock Stratton LLP