Wednesday, February 27, 2013

Imatinib Procedural Posture

Novartis Pharmaceuticals Canada Inc v Apotex Inc / imatinib (NOC) 2013 FC 142, Snider J
Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J
            GLEEVEC / imatinib mesylate / 2,093,203

There is a lot of meat in Snider J’s decision relating to relating to Novartis’ GLEEVEC (imatinib mesylate). I started writing a general overview, and realized that even that was too much for one post, so I will start by dealing with the NOC proceeding and the somewhat unusual procedural posture.

Apotex and Teva both wished to sell a generic version of GLEEVEC, but in their initial ANDS, submitted in 2007 and 2010, respectively, they indicated that they would wait until the expiry of the ‘203 patent, which is listed against GLEEVEC on the Patent Register. In 2011 both changed their minds and submitted revised Form Vs purporting to amend their election to allege invalidity. At about the same time, each brought an action against Novartis seeking a declaration under s 60(1) that the ‘203 patent was invalid. All four proceedings were eventually consolidated, though Snider J gave separate reasons for judgment in respect of the declaratory action (2013 FC 141) and the NOC proceeding (2013 FC 142).

In lengthy reasons in 2013 FC 141, Snider J dismissed the declaratory action, holding the key claims not to be invalid. That conclusion was also determinative in the NOC proceedings, because “it follows that the allegations of invalidity contained in the NOAs cannot be justified,” [NOC 7]. A separate question in the NOC proceedings was whether the NOC Regulations permit the amendment of a Form V to change an election [NOC 28], as Apotex and Teva had done in 2011. I would infer that it was because Apotex and Teva had doubts as to whether they would prevail on this point in an NOC proceeding that they chose to adopt the unusual course of seeking a declaration of invalidity in addition to serving an NOA (though there is nothing in Snider J's decisions that states this, even implicitly). In the end, Snider J declined to answer that question, on the basis that it is not determinative in light of her conclusion the substantive question, and because it is a question of law on which she would be owed no deference on appeal “[b]y wading into this legal question – which has become purely academic – I would not be assisting either the parties before me or the Court of Appeal” [31]. Her NOC decision was therefore primarily devoted to setting out the factual background of the proceedings. 


  1. may have started NOC proceedings for s.8 purposes...

  2. Good point. That plus the concern with the amendment to Form V would explain why they proceeded with both.

  3. I live in Ottawa and my son has CML...he has been on Gleevec for 2 years now and in remission..... My pharmacist called yesterday when I requested a renewal of his prescription earlier in the day, and said they could not order a generic drug if imatinib made by Teva which costs $800/month instead of $3700...... everything I see online states that Teva and Apotex lost their challenge in court in Feb this year..... I am confused! Please advise.

  4. Sorry... my prior entry should have stated that the pharmacist said he could now order the generice version of the drug.... sorry about the typo!