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Federal Court finds PMPRB not to have jurisdiction over ratiopharm and Sandoz
On May 27, 2014, Justice O'Reilly of the Federal Court overturned decisions of the Patented Medicine Prices Review Board (PMPRB or the "Board") finding that in both cases, the Board has no jurisdiction to review the prices set by the generic manufacturer.
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Supreme Court of Canada matters
Sanofi-aventis seeks leave to appeal re: section 8 decision. As reported in the April 2014 edition of Rx IP Update, the Federal Court of Appeal released its first decisions addressing quantification of damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations"). The cases related to ramipril. Sanofi-aventis has sought leave to appeal.
Sanofi-Aventis, et al v Apotex Inc, et al, SCC Case No. 35886.
Federal Court decision — 2012 FC 553.
Federal Court of Appeal — 2014 FCA 68.
Health Canada news
On June 4, 2014 the Government of Canada published an amendment to the data protection provision of the Food and Drug Regulations ("Regulations") to streamline and clarify the language in subsections C.08.004.1(2), (6), (7) and (8) of the Regulations.
Regulations Amending the Food and Drug Regulations (Data Protection — Miscellaneous Program).
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court applies 'matching requirement' for listing for a combination product. Prothonotary Milczynski granted Teva's motion dismissing Viiv's application for a prohibition Order regarding a combination product containing abacavir and lamivudine, Viiv's KIVEXA, pursuant to section 6(5)(a) of the Regulations.
Although the patent "contemplates pharmaceutical formulations where one or more classes of therapeutic agents may be combined with abacavir, including classes that do not include lamivudine" the patent explicitly claimed only abacavir, and contained no claim for the combination of abacavir and lamivudine. Citing the Federal Court of Appeal's decision in Gilead Sciences Canada v Minister of Health, 2012 FCA 254 as reported in the April 2013 issue of Rx IP Update, the Prothonotary held that "the medicinal ingredient or formulation approved in the NOC must "match up" and be claimed in the patent sought to be listed." As the patent claimed only one of the active ingredients, it was not eligible for inclusion on the Patent Register. Viiv has appealed.
Viiv Healthcare UlC v Canada (Minister of Health), April 3, 2014
Prothonotary's decision — 2014 FC 328.
Bayer's application for prohibition order re: drospirenone and ethinylestradiol (Bayer's YAZ) dismissed. As reported in the November 2013 edition of Rx IP Update, Justice Hughes granted a prohibition Order regarding approval of Cobalt's proposed generic version of Bayer's YAZ (drospirenone and ethinyl estradiol), until the expiry of one of two patents at issue. One patent claims a pharmaceutical composition comprising drospirenone particles with certain characteristics, including a specified dissolution rate, and ethinyl estradiol. The second patent claims the use of an oral dosage form comprising an estrogen and a gestagen for contraception.
Bayer brought applications regarding Apotex's corresponding product and the same patents. On May 1, 2014, Justice Hughes adopted the reasons given in his previous decision for the second patent and dismissed the application: Bayer Inc v Apotex Inc, 2014 FC 403.
Regarding the first patent, Bayer Inc v Apotex Inc, 2014 FC 436, Justice Hughes found that Apotex's allegations of non-infringement were justified and dismissed the application.
Justice Hughes had already considered many of the issues, including obviousness, in the Cobalt decision, and relied on his reasons for those issues. For new issues, or where "substantially different evidence" was raised, including infringement and listing, Justice Hughes undertook a "fresh examination." Construction was one of the issues requiring more detailed reasons. In this case, Justice Hughes construed the term "drospirenone particles" in all of the claims "not to include a drospirenone solution nor particles of a matrix into which drospirenone has previously been dissolved." He also held that claims for "ethinylestradiol" include a clathrate of ethinylestradiol.
On the issue of infringement, Justice Hughes held that Apotex's product did not infringe as the drospirenone in the product is not provided in an infringing form.
Apotex also alleged that the patent was not eligible for listing as YAZ contains drospirenone and a molecular inclusion complex formed between ethinylestradiol and B-cyclodextrin. Apotex argued that the ethinylestradiol and B-cyclodextrin complex was not claimed in the patent. Justice Hughes dismissed Bayer's assertion that Apotex should have raised this issue in a motion before the hearing. He held that, unlike allegations made under subsections 5(1) and 5(2), Apotex bears the burden of proving this allegation. Based on the evidence of Apotex's expert and Apotex's Abbreviated New Drug Submission, Justice Hughes found that "a clathrate of ethinylestradiol is not distinguished as such from the simpler term ethinylestradiol and that ethinylestradiol includes the clathrate," and the patent was thus not improperly listed.
Apotex had also alleged that the claims of the patent were anticipated by Bayer's clinical studies. Justice Hughes held that there had been disclosure — although there was no evidence that any person connected with the studies was ever provided with the ingredients of the tablets or analyzed the tablet to determine the ingredients, there was a "theoretical" possibility that a tablet could have been kept and analyzed. However, he found that the studies were experimental use and thus the disclosure was not anticipatory.
Alcon successful in obtaining prohibition Order re: VIGAMOX. Alcon brought an application for a prohibition Order regarding moxifloxacin ophthalmic solution (Alcon's VIGAMOX) in response to Cobalt's assertions of invalidity and non-infringement of three patents. Justice Phelan allowed the application for one of the patents. Cobalt had admitted infringement of the patent, but had alleged lack of utility and obviousness. Justice Phelan dismissed the application for the two other patents on the basis of obviousness and non-infringement, respectively.
Alcon Canada Inc v Cobalt Pharmaceuticals, May 14, 2014
Federal Court decision — 2014 FC 462.
Federal Court bifurcates determination of start date for section 8 proceeding. Pfizer brought a motion for bifurcation of a section 8 proceeding regarding atorvastatin (Pfizer's LIPITOR). Although the parties agreed on the liability period end date they differed on start date: Pfizer asserted a start date resulting in a three month liability period, whereas Apotex asserted a three-year liability period. Pfizer moved to bifurcate the determination of the start date from the remainder of the issues. Prothonotary Aalto considered several factors, including the complexity of the issues, whether there would be a saving of cost and time and whether bifurcation could facilitate settlement of the remaining issues, and ordered bifurcation, holding that bifurcation of the start date issue would "lead to saving of cost, time and judicial resources."
Apotex Inc v Pfizer Canada Inc, February 20 2014
Federal Court decision — 2014 FC 159.
Other decisions
Abbvie obtains injunction regarding Janssen's STELARA (ustekinumab). As reported in the January 20, 2014 issue of IP Update — Canada, the Federal Court concluded that Janssen Inc (Janssen)'s antibody drug STELARA (ustekinumab) infringed Abbvie's patent for the use of an antibody with certain characteristics for the treatment of psoriasis, and that the patent was valid. The decision dealt only with infringement and invalidity — issues relating to remedy were deferred.
Motion for stay
Janssen has appealed the infringement and invalidity decision, and also brought a motion to stay or suspend the remedies portion of the trial. The Court of Appeal dismissed the motion (2014 FCA 112), holding that Janssen had not established irreparable harm.
Injunction
The trial regarding Abbvie's entitlement to an injunction was heard the week of May 12, 2014, and Justice Hughes of the Federal Court (the same Judge who heard the previous trial) granted the injunction on May 22, 2014 (2014 FC 489). Janssen is enjoined from "making, using, selling, offering for sale, or promoting the use" of STELARA in Canada for the treatment of psoriasis until Abbvie's patent expires. Justice Hughes did not prohibit Janssen from, among other things, providing STELARA to existing and new patients (provided the new patient's physician has determined the treatment is necessary), nor from communicating information it is "required by law" to disseminate, responding to enquiries about STELARA, and complying with requests made by Health Canada.
Justice Hughes stated that he was required to balance Abbvie's rights to the exclusive use of the invention with Janssen's "commercial desire" to sell STELARA and with the public's medical need to have access to STELARA. Abbvie's HUMIRA (adalimumab) competes with STELARA, but does not fall within the scope of Abbvie's patent. Justice Hughes held there was no evidence that an injunction would cause "serious or irreparable harm to Janssen." He also considered the public's interest, both patients for whom "there is no alternative treatment" and the "the needs of the larger community."
Justice Hughes declined to stay the injunction, citing the lack of evidence of harm to Janssen and the ability of existing and new patients to receive the drug under the terms of the injunction. Janssen has appealed.
The remaining issue of quantum of damages is scheduled to be heard in September 2015.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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pemetrexed disodium (MULTI-TARGETED ANTIFOLATE)
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Applicant:
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Eli Lilly Canada Inc
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Respondent:
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Taro Pharmaceuticals Inc and the Minister of Health
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Respondent/Patentee:
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Eli Lilly and Company
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Date Commenced:
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April 22, 2014
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Court File No.:
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T-950-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,400,155. Taro alleges non-infringement and invalidity.
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Medicine:
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oxycodone hydrochloride (OxyNEO)
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Applicant:
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Purdue Pharma Canada
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Respondent:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentees:
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Gruenenthal GmbH, Purdue Pharma LP, and Euro-Celtique SA
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Date Commenced:
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April 24, 2014
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Court File No.:
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T-1009-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,557,845; 2,595,954 and 2,661,573. Teva alleges non-infringement and invalidity.
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Medicine:
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methylphenidate hydrochloride (BIPHENTIN)
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Applicant:
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Purdue Pharma
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Respondent:
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Pharmascience Inc and the Minister of Health
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Respondent/Patentee:
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Euro-Celtique SA
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Date Commenced:
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May 2, 2014
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Court File No.:
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T-1086-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,355,644 and 2,355,854. Pharmascience alleges non-infringement and invalidity.
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Medicine:
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moxifloxacin hydrochloride (AVELOX I.V.)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondent:
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Pharmaceutical Partners of Canada Ltd, Pharmaceutical Partners of Canada Inc and the Minister of Health
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Date Commenced:
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May 2, 2014
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Court File No.:
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T-1092-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114; 2,192,418 and 2,378,424. Pharmaceutical Partners acknowledges it is not seeking to receive an Notice of Compliance until expiry of the 114 patent and alleges non-infringement (114 and 418 patents) and Gillette Defence (418 patent).
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Medicine:
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bortezomib mannitol boronic ester (VELCADE)
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Applicant:
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Janssen Inc
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Respondent:
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Accord Healthcare Inc and the Minister of Health
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Respondent Licensee and Sub-Licensor:
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Millennium Pharmaceuticals, Inc.
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Respondent Patentee:
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United States of America represented by the Secretary, Department of Health and Human Services
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Date Commenced:
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May 8, 2014
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Court File No.:
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T-1144-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. Accord Healthcare alleges non-infringement and invalidity.
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Medicine:
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varenicline tartrate (CHAMPIX)
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Applicant:
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Pfizer Canada Inc and Pfizer Products Inc.
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Respondent:
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Apotex Inc and the Minister of Health
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Date Commenced:
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May 9, 2014
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Court File No.:
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T-1163-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,447,405. Apotex alleges non-infringement and invalidity.
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Medicine:
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moxifloxacin hydrochloride (AVELOX)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondent:
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Phamascience Inc and the Minister of Health
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Date Commenced:
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May 16, 2014
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Court File No.:
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T-1211-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114 and 2,192,418. Pharmascience alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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valacyclovir hydrochloride (VALTREX, Novo-Valacyclovir, Teva-Valacyclovir)
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Plaintiff:
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GlaxoSmithKline Inc., The Wellcome Foundation Limited, Glaxo Group Limited, GlaxoSmithKline Intellectual Property (No. 2) Limited, GlaxoSmithKline Trading Services Limited, GlaxoSmithKline Export Limited, GlaxoSmithKline LLC and Glaxo Wellcome S.A.
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Defendant:
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Teva Canada Limited
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Date Commenced:
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May 8, 2014
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Court File No.:
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T-1147-14
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Comment:
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Patent infringement action regarding Patent No. 1,340,083.
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To check the status of Federal Court cases, please click here.
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