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Federal Court of Appeal reverses inutility and obviousness findings re: PLAVIX patent
On July 24, 2013, the Federal Court of Appeal overturned Justice Boivin's decision which had invalidated the patent that claims clopidrogel bisulfate (sanofi-aventis's PLAVIX) on the basis of lack of utility and obviousness. The Court returned the issues of remedies to the Trial Judge.
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Patented Medicine Prices Review Board news
Notice of Hearing. As reported in the May 2013 issue of RxIP Update, on April 30, 2013, Justice Zinn of the Federal Court set aside a decision of the Board wherein it ordered Teva to pay the government $2,801,285 for having sold COPAXONE Syringes (glatiramer acetate) at an "excessive price" between 2004 and 2010, and returned the matter for redetermination. On July 5, 2013 the Board issued a Notice of Hearing in the redetermination of the matter. The matter is to be heard on October 9 and 10, 2013.
New NEWSletter released. The PMPRB has released its July 2013 NEWSletter.
Eli Lilly serves second Notice of Intent to submit claim to arbitration under NAFTA: STRATTERA and ZYPREXA
As reported in the January 2013 issue of RxIP Update, on November 7, 2012 Eli Lilly served the Government of Canada with a Notice of Intent to Submit a Claim to Arbitration under NAFTA Chapter 11. The claim in the first Notice of Intent related to Eli Lilly's STRATTERA (atomoxetine). On June 13, 2013, Eli Lilly filed a second Notice of Intent seeking arbitration pursuant to NAFTA Chapter 11. The claim in the second Notice of Intent relates to Eli Lilly's STRATERRA and ZYPREXA (olanzapine).
Notice of Intent.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court dismisses prohibition proceeding re: Apotex's valganciclovir. On July 12, 2013, the Federal Court dismissed Hoffmann-La Roche ("Roche")'s application for an Order prohibiting the Minister of Health from issuing an NOC to Apotex for its generic version of Roche's VALCYTE (valganciclovir). The patent claims valganciclovir. Justice Kane held that Apotex's allegations of anticipation and obviousness were justified, but that the allegation of claims broader was not justified. Justice Kane further held that Apotex's allegation with respect to non-infringement of claim 4 (valganciclovir in crystalline form) was justified. There was no dispute that Apotex would have infringed all valid claims other than claim 4.
Hoffmann-La Roche Limited v Apotex Inc, July 12, 2013
Federal Court decision — 2013 FC 718.
Other decisions
Apotex ordered to pay more than $119 million in damages to Merck for infringement of lovastatin patent. In 2010, the Court found that Apotex had infringed Merck's product-by-process patent for lovastatin, the patent was valid, and that Merck was entitled to damages rather than to an accounting of profits (Merck & Co Inc v Apotex Inc: 2010 FC 1265, aff'd 2011 FCA 363). At the subsequent trial to determine the quantum of damages, Apotex argued that Merck's damages should be under $10 million. On July 16, 2013, Justice Snider awarded Merck over $119 million in damages made up of:
- approximately $63M as lost profits to Merck Canada on lovastatin (MEVACOR) sales it would have made but for Apotex's infringement;
- approximately $51M as lost profits to Merck US on sales of lovastatin it would have sold to Merck Canada but for Apotex's infringement;
- a reasonable royalty for post-expiry domestic sales of Apo-Lovastatin that was made before patent expiry (sales that Merck would not have made); and
- a reasonable royalty for infringing export sales (sales that Merck would not have made).
The reasonable royalty was an amount in the mid-range of the difference between Apotex's costs to use the infringing process and their costs to use the non-infringing alternative.
Apotex's main argument was that Merck was entitled only to nominal damages (a reasonable royalty) in view of the availability of a non-infringing alternative (NIA), i.e. Merck could not claim lost profits for lost sales because such losses were not caused by use of the infringing process. Justice Snider rejected Apotex's argument, confirming that under Canadian law, the existence of a NIA alternative is not relevant to an assessment of damages.
While accepting that the Patent Act does not preclude recovery of "springboard" damages, Justice Snider rejected Merck's claim for such damages, finding that Apotex had insufficient notice of the issue and the evidence was in any event inadequate.
The award of pre-judgment interest (1997 Bank Rate plus 1%) will significantly increase the amount payable, as Apotex had entered the market in 1997. Apotex has appealed.
Merck & Co Inc v Apotex Inc, July 16, 2013
Federal Court decision — 2013 FC 751.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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desmopressin acetate (DDAVP MELT)
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Applicant:
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Ferring Inc and Ferring B.V.
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Respondents:
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Mylan Pharmaceuticals ULC and The Minister of Health
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Date Commenced:
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June 17, 2013
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Court File No.:
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T-1071-13
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,484,724. Mylan alleges invalidity and non-infringement.
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Other proceedings
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Drug:
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latanoprost ophthalmic solution (XALATAN, APO-LATANOPROST)
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Plaintiff:
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Apotex Inc
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Defendant:
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Pfizer Canada Inc
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Date Commenced:
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June 14, 2013
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Court File No.:
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T-1064-13
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Comment:
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Action for damages pursuant to section 8 of the PM(NOC) Regulations in relation to the alleged delay in issuance of an NOC for Apo-Latanoprost by reason of the Defendant's institution of proceedings under the PM(NOC) Regulations (T-124-08).
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Drug:
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norgestimate and ethinyl estradiol (TRI-CYCLEN, APO-NORGESTIMATE)
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Plaintiff:
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Apotex Inc
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Defendant:
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Janssen Inc
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Date Commenced:
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June 14, 2013
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Court File No.:
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T-1065-13
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Comment:
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Action for damages pursuant to section 8 of the PM(NOC) Regulations in relation to the alleged delay in issuance of an NOC for Apo-Norgestimate by reason of the Defendant's institution of proceedings under the PM(NOC) Regulations (T-1833-11).
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Drug:
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valganciclovir hydrochloride (VALCYTE, APO-VALGANCICLOVIR)
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Plaintiff:
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Apotex Inc
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Defendant:
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Hoffmann-La Roche Limited
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Date Commenced:
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July 3, 2013
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Court File No.:
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T-1179-13
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Comment:
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Action for damages pursuant to section 8 of the PM(NOC) Regulations in relation to the alleged delay in issuance of an NOC for Apo-Valganciclovir by reason of the Defendant's institution of proceedings under the PM(NOC) Regulations (T-1247-11).
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