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Federal Court of Appeal acknowledges NIA defence in assessment of damages for patent infringement
As previously reported, in a case relating to lovastatin (Merck’s MEVACOR), the Federal Court of Appeal held that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement. However, the Court of Appeal held that such a defence was not available to Apotex on the facts of the case, upholding the lower Court’s award of damages to Merck (previously reported here).
Federal Court of Appeal permits listing of a formulation patent naming a single medicinal ingredient against a fixed-dose combination product
As previously reported, on July 17, 2015, the Court of Appeal held that a patent with a claim for a formulation naming one medicinal ingredient was eligible for listing on the patent register against a fixed-dose combination product (TRIFEXIS, containing spinosad and milbemycin oxime): Eli Lilly v Minister of Health, 2015 FCA 166.
Court of Appeal upholds the invalidity of AstraZeneca’s patent for esomeprazole (NEXIUM), comments on utility
In reasons released July 6, 2015, the Federal Court of Appeal dismissed AstraZeneca’s appeal from a decision of the Federal Court invalidating AstraZeneca’s patent for esomeprazole (NEXIUM): AstraZeneca v Apotex, 2015 FCA 158.
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Update on Biologics
We previously reported on some decisions of Health Canada and the Federal Court regarding biologics. Since that time, proceedings relating to biologics continue to unfold:
- The patent litigation between AbbVie and Janssen Inc. regarding Janssen’s antibody drug STELARA (ustekinumab) has settled, after the Court of Appeal ordered a re-trial of the decision holding AbbVie’s patent valid and infringed.
- Infliximab (Celltrion’s REMSIMA and INFLECTRA and Janssen’s REMICADE) is the subject of two court proceedings:
- Hospira Healthcare Corporation is seeking a declaration of invalidity and non-infringement of Patent No 2,261,630, listed against Janssen’s REMICADE (Court File No. T-396-13). The trial is scheduled for September 2016.
- Hospira received a Notice of Compliance (NOC) for INFLECTRA on June 4, 2015, with the same drug identification number as Celltrion’s INFLECTRA product (for which an NOC issued on January 15, 2014). Janssen applied for a judicial review of the Minister’s decision, asserting that an NOC should not have issued to Hospira as it failed to address Patent No 2,261,630 (Court File No. T-1516-14), which was not addressed by Celltrion as it was added to the Patent Register after Celltrion filed its submission. The Court issued an Order on consent quashing Hospira’s NOC, which both the Minister of Health and Hospira have appealed (consolidated Court of Appeal File Nos. A-172-15 and A-143-15). The consolidated appeal will be heard at the same time as the appeal of Pfizer Canada Inc v Canada (Attorney General) (2014 FC 1243), previously reported. The issue on appeal is whether an administrative drug submission, in which a manufacturer is licensed to sell a drug identical to a marketed drug (also referred to as a cross-referenced submission), triggers the requirement to address patents under the Patented Medicines (Notice of Compliance) Regulations.
- There will be a fall hearing (October 26, 2015) of Amgen’s application for prohibition Order regarding Apotex’s version of the granulocyte colony-stimulating factor filgrastim (Amgen’s NEUPOGEN) (Court File No. T-2072-12).
- sanofi-aventis has applied for a prohibition Order regarding Eli Lilly’s insulin glargine solution (BASAGLAR; sanofi-aventis’s LANTUS) (Court File No. T-2247-14).
- Amgen has applied for a prohibition Order regarding Samsung Bioepis’s version of the recombinant antibody etanercept (Amgen’s ENBREL) (Court File No. T-1283-15).
Health Canada news
Therapeutic Products Directorate Statistical Report (2014/2015) for the PM (NOC) Regulations and Data Protection. On July 8, 2015, the Therapeutic Products Directorate released its report providing a statistical overview of Health Canada's administration of the Patented Medicines (Notice of Compliance) Regulations and data protection under the Food and Drug Regulations for the 2014/2015 fiscal year. The statistics include: number of patent lists added/rejected; judicial review applications regarding patent eligibility and requirement to address; outcomes of prohibition applications; and the number of submissions on IP hold.
Update to Post-NOC Changes: Quality Guidance document. On July 20, 2015, Health Canada published an update to its guidance document entitled Post-Notice of Compliance (NOC) Changes – Quality Guidance, originally published in September 2009, regarding the conditions for the categorization of any post authorization change and recommendations for supporting documentation.
Health Canada releases Notice regarding updates to drug establishment licence applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients. As reported previously, the Food and Drug Regulations were amended to extend establishment licensing and good manufacturing practice (GMP) requirements to active ingredients used in pharmaceutical drugs for human use. The amended Regulations came into force on November 8, 2013, but are being implemented over a three-year period. Moving towards full implementation, on July 31, 2015, Health Canada released the following information for active pharmaceutical ingredient (API) and finished dosage form importers:
- Updated Table A and instructions for new and amending drug establishment licence applications related to importing drugs, including APIs; and
- Updated information about the GMP evidence required by Health Canada to demonstrate GMP compliance of API foreign buildings.
Notice
Competition Bureau and Pfizer agree re: acquisition of Hospira
In his review of the proposal of Pfizer to acquire Hospira, the Commissioner of Competition concluded that the transaction is likely to result in a substantial lessening of competition and/or prevention of competition in Canada for the supply of four products (methotrexate sodium tablets, injectable cytarabine, injectable epirubicin hydrochloride and injectable voriconazole). On August 13, 2015, the Competition Bureau reached an agreement with Pfizer, pursuant to which Pfizer will sell its Canadian assets related to its three products and to Hospira’s pipeline injectable voriconazole product. The Commissioner of Competition has sole discretion to approve one or more buyers for these products to ensure effective competition in Canada.
Announcement; Competition Bureau statement regarding Pfizer’s acquisition of Hospira; Consent Agreement
Eli Lilly’s application for prohibition order against Apotex for tadalafil granted.
On July 20, 2015, Justice Gleason granted Eli Lilly’s application for a prohibition Order for tadalafil (Lilly's CIALIS) regarding Patent No. 2,226,784. First, the Court held that Apotex’s allegation based on same-invention and obviousness double patenting in view of an earlier patent, Patent No. 2,181,377, was not justified. The Court followed the prior decision, Eli Lilly Canada v Mylan Pharmaceuticals, 2015 FC 17 (appeal pending), regarding construction of the respective patents. Justice Gleason declined to make a firm determination as to the correct date (as between the priority date for the 784 or 377 patents) for assessing obviousness-type double patenting, as she would have reached the same result based on either date. Second, the Court rejected Apotex’s insufficiency argument that the patent fails to provide guidance on how to produce hydrate forms of the claimed compounds. The Court found, “there is adequate disclosure in the 784 Patent to enable the production of solvates of tadalafil and 3-methyl tadalafil and that, from there, the skilled person, relying on his or her common general knowledge, would be able to create and if necessary modify reaction conditions so as to favour hydrate formation.” Finally, the Court rejected Apotex’s argument that Eli Lilly lacks standing to bring the application as it failed to show a proper chain of title. Apotex has appealed.
Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875
Federal Court stays issuance of NOC for Horizon’s RAVICTI pending judicial review of Minister’s decision denying data protection
Hyperion Therapeutics, now merged with Horizon Pharma, has a pending new drug submission with Health Canada for its glycerol phenylbutyrate product, RAVICTI. The Office of Patented Medicines and Liaison (OPML) advised Hyperion that RAVICTI was eligible for data protection, subject to a final review upon NOC issuance. While Hyperion’s new drug submission (NDS) was pending, an NOC issued to a third party (Medunik) for sodium phenylbutyrate (PHEBURANE). As a result of this NOC, the OPML refused to grant RAVICTI data protection, advising Hyperion that its product was either an “ester variation” of PHEBURANE or was a “second minor variation” of phenylbutyric acid, which was approved in PHEBURANE as a sodium salt.
Horizon brought a motion to stay the issuance of its NOC (planned for June 27, 2015) pending the resolution of the judicial review of the Minister’s decision. On June 12, 2015, the Federal Court found that Horizon met the tripartite test for an injunction (serious issue, irreparable harm, and balance of convenience). The irreparable harm, a non-compensable loss, stemmed from Horizon’s position that it would withdraw its NDS if RAVICTI was not subject to data protection. If Horizon were to withdraw its NDS, patients would be left without a treatment option, which tipped the balance of convenience in Horizon’s favour. The Court therefore enjoined the Minister of Health from granting an NOC for RAVICTI until completion of the judicial review application, either by judgment or discontinuance. Horizon’s judicial review application is set down to be heard December 8, 2015.
Horizon Pharma plc v Canada (Minister of Health), 2015 FC 744
Judicial review of Apotex’s Access to Information Act request pertaining to Apo-Pantoprazole allowed in part
On April 28, 2015 (public reasons released June 24, 2015), Justice O’Keefe of the Federal Court allowed in part an application for judicial review regarding the Minister of Health’s decision to refuse to disclose information to Apotex under the Access to Information Act, specifically, records related to the processing of an abbreviated new drug submission and issuance of a NOC for Apo-Pantoprazole. Apotex has a pending claim against the Minister alleging it has suffered damages due to Health Canada’s refusal or delay in approving drug submissions with respect to six drugs, including Apo-Pantoprazole.
The Minister refused to disclose eight pages of documents on the basis of solicitor-client privilege. Justice O’Keefe held that solicitor-client privilege should be analyzed “in a continuum of communication and documents should not be examined in isolation” and found that all except for one part of the records under judicial review were subject to solicitor-client privilege and that the Minister reasonably exercised her discretion in refusing to waive privilege. As a result, the application was allowed, but only in part.
Canada (Office of the Information Commissioner) v Canada (Health), 2015 FC 789
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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dasatinib (SPRYCEL)
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Applicants:
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Bristol-Myers Squibb Canada and Bristol-Myers Squibb Holdings Ireland
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Respondents:
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Apotex Inc and The Minister of Health
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Date Commenced:
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July 2, 2015
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Court File No.:
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T-1100-15
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,366,932 and 2,519,898. Apotex alleges non-infringement and invalidity.
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Medicine:
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timolol maleate (DUOTRAV PQ)
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Applicants:
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Alcon Canada Inc and Alcon Research, Ltd
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Respondents:
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Apotex Inc and The Minister of Health
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Date Commenced:
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July 2, 2015
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Court File No.:
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T-1101-15
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,716,994 and 2,717,679. Apotex alleges non-infringement and invalidity.
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Medicine:
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etanercept (ENBREL)
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Applicants:
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Amgen Canada Inc and Immunex Corporation
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Respondents:
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Samsung Bioepis Co Ltd and the Minister of Health
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Date Commenced:
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July 31, 2015
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Court File No.:
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T-1283-15
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Comment:
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Application for Order of Prohibition until expiry of Patents Nos. 2,476,934 and 2,366,785. Samsung alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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esomeprazole (NEXIUM)
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Plaintiff:
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Pharmascience Inc
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Respondent:
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AstraZeneca Canada Inc
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Date Commenced:
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July 17, 2015
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Court File No.:
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T-1200-15
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Comment:
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Action for s. 8 damages.
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Medicine:
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ledipasvir/sofosbuvir (HARVONI)
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Plaintiffs:
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AbbVie Inc, AbbVie Corporation and AbbVie Ireland Unlimited Company
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Defendant:
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Gilead Sciences, Inc, Gilead Sciences Canada, Inc Gilead Sciences Ireland Unlimited Company, Gilead Pharmasset LLC and Gilead Sciences Limited
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Date Commenced:
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August 11, 2015
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Court File No.:
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T-1330-15
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Comment:
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Infringement action regarding Patent No. 2,811,250.
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Medicine:
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ledipasvir/sofosbuvir (HARVONI)
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Plaintiff:
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Gilead Sciences Canada, Inc
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Defendant:
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AbbVie Ireland Unlimited Company
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Date Commenced:
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August 11, 2015
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Court File No.:
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T-1332-15
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Comment:
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Action seeking declaration of invalidity of Patent No. 2,811,250.
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