Rx IP Update — August 2012 | Smart & Biggar/Fetherstonhaugh

Sandoz's allegations of non-infringement successful regarding fenofibrate formulation patents

On July 5, 2012, the Federal Court dismissed two applications by Fournier Pharma ("Fournier") for Orders of prohibition relating to its LIPIDIL EZ (fenofibrate) and Patents Nos. 2,372,576 and 2,487,054. In both applications, Justice Zinn held that Fournier had not established that Sandoz's allegations of non-infringement were not justified.

Supreme Court of Canada news

Apotex denied leave to appeal decision affirming patent infringement by Apotex regarding lovastatin. On July 12, 2012, the Supreme Court denied Apotex leave to appeal from the Court of Appeal decision affirming the Trial Judge's finding of infringement of certain batches of lovastatin (Merck's MEVACOR) by Apotex and Apotex Fermentation (reported in the January 2011 issue of Rx IP Update).

Apotex Inc v Merck & Co Inc, July 12, 2012 (SCC Case No. 34676).
Federal Court of Appeal decision — 2011 FCA 363.
Federal Court decision — 2010 FC 1265.

Sanofi-aventis and Schering denied leave to appeal decision affirming Trial Judge's dismissal of ramipril infringement claims. On July 12, 2012, the Supreme Court denied sanofi-aventis and Schering leave to appeal from the Court of Appeal decision (reported in the November 2011 issue of Rx IP Update) affirming the Trial Judge's declaration that the relevant claims of a patent covering ramipril (sanofi-aventis's ALTACE) are invalid for lack of sound prediction and, in the alternative, as obvious.

Sanofi-aventis Canada Inc v Apotex Inc, January 3, 2012 (SCC Case No. 34600).
Federal Court of Appeal decision — 2011 FCA 300.
Federal Court decision — 2009 FC 676.

Patented Medicine Prices Review Board news

New NEWSletter released. The PMPRB has released its July 2012 NEWSletter.

NEWSletter.

Health Canada news

Launch of Phase II of the Summary Basis of Decision project. On June 29, 2012, the Health Products and Food Branch of Health Canada announced the launch of Phase II of the Summary Basis of Decision ("SBD") project. The SBD communicates the scientific rationale for Health Canada's decision to authorize a product for sale. The SBD has been made publicly available since the implementation of the first phase in 2005. In Phase II, the format of the SBD will change, as will the scope of SBD-eligible products. Health Canada will now also publish a Post-Authorization Activity Table for drugs and a Post-Licensing Activity Table for medical devices, which will provide information beyond the product's original authorization.

Notice.
Background for SBD project.
Frequently Asked Questions.
Reader's Guide to the Phase II Summary Basis of Decision – Drugs.
Reader's Guide to the Phase II Summary Basis of Decision – Medical Devices.

2011 statistical report for Patented Medicines (Notice of Compliance) Regulations and data protection released. The Therapeutic Products Directorate has released its 2011 statistical report relating to the administration of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") and data protection. The report provides statistics relating to the maintenance of the Patent Register (including the number of patent lists filed by first persons, the number of patent lists accepted and rejected, and related litigation) and statistics relating to the number of notices of allegation served, prohibition applications initiated, and outcomes of the applications. The report also provides statistics on products added to the Register of Innovative Drugs by product type.

Therapeutic Products Directorate Statistical Report 2011.

Recent Court decisions

Court of Appeal affirms that no cause of action exists for "contributory infringement." On December 13, 2010, Prothonotary Milczynski issued decisions refusing to grant Nycomed leave to amend its counterclaim to allege that Apotex and Novopharm should be found liable for contributory infringement of Nycomed's patent covering pantoprazole. On a de novo review, Justice Simpson of the Federal Court affirmed that decision on December 9, 2011. On June 25, 2012, the Federal Court of Appeal dismissed Nycomed's appeal and specifically endorsed Justice Simpson's reasoning that the decision of the Supreme Court in Monsanto Canada Inc v Schmeiser, 2004 SCC 34, is not indicative of an intention to depart from the existing precedents and to recognize "contributory infringement" as a cause of action under Canadian law.

Nycomed Canada Inc v Teva Canada Ltd and Apotex Inc, June 25, 2012.
Federal Court of Appeal decision — 2012 FCA 195.
Federal Court decision — 2011 FC 1441.
Prothonotary's decisions — Court Files Nos. T-368-08 and T-1786-08.

Patent not eligible for listing against Novartis's TOBI PODHALER submission. On June 29, 2012, the Federal Court dismissed Novartis's application for a judicial review of the Minister of Health's decision that a patent was not eligible for listing on the Patent Register against its new drug submission for TOBI PODHALER, which contains tobramycin, an aminoglycoside antibiotic, intended for oral inhalation with the help of the Podhaler inhalation device. The patent includes (i) claims for the use of a bioactive agent in the manufacture of a medicament for pulmonary delivery, comprising a plurality of perforated microstructures and administered by an inhalation device, (ii) claims for a perforated microstructure powder comprising a bioactive agent, and (iii) claims for an inhalation system for pulmonary administration of a bioactive agent to the patient. The Minister held that the patent was ineligible for listing as the patent does not "explicitly mention" tobramycin, although tobramycin is encompassed by the patent claims. With respect to eligibility of formulation claims under section 4(2)(b) of the Regulations, Justice Martineau noted that the case law has established that "a rather high threshold of specificity" is required for listing. He indicated that it is necessary to explicitly specify the particular medicinal ingredient in the claims. With respect to eligibility of dosage form claims under section 4(2)(c) of the Regulations, Justice Martineau held that the patent is ineligible for listing because the claimed delivery system can be used in association with a broad range of medicinal ingredients. Justice Martineau therefore concluded that the Minister correctly construed the relevant claims, correctly interpreted the Regulations and reached a reasonable conclusion that the patent did not contain claims for the approved medicinal ingredient tobramycin.

Novartis Pharmaceuticals Canada Inc v Canada (Attorney General), June 29, 2012.
Federal Court decision — 2012 FC 836.

Ontario Superior Court refuses to strike Apotex's section 8 claim. Apotex is pursuing a claim against Eli Lilly for, inter alia, damages pursuant to section 8 of the Regulations, damages or an accounting of profits pursuant to sections 7 and 53.2 of the Trademarks Act, disgorgement of revenues or profits from the sale of STRATTERA (atomoxetine) and damages or an accounting of profits as may be otherwise available in law, all based on an allegation of delay in marketing its generic version of atomoxetine by the steps that Eli Lilly took under the Regulations. Justice MacDonald refused to strike all but Apotex's claim for "damages or an accounting of profits as may be otherwise available in law" while severing portions of Eli Lilly's motion dealing with Apotex's claims pursuant to the Statute of Monopolies (and related constitutional issues) to be dealt with by a separate hearing. Notably, Justice MacDonald indicated that Apotex's claim against Eli Lilly pursuant to section 7(a) of the Trademarks Act for making a "false or misleading statement tending to discredit the business, wares or services of a competitor" has a "reasonable prospect of success" on the basis that Eli Lilly listed a patent on the patent register that was subsequently determined to be invalid and thus void ab initio.

Apotex Inc v Eli Lilly and Company, July 25, 2012.
Ontario Superior Court decision — 2012 ONSC 3808.