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Court of Appeal permits Janssen to amend its plea, dissolves STELARA injunction and orders new trial
The Federal Court of Appeal ("FCA") has ordered a new trial in the STELARA litigation. As reported in the January 20, 2014 issue of IP Update — Canada, earlier this year Justice Hughes of 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 (2014 FC 55). Following a second trial, Justice Hughes granted AbbVie an injunction (2014 FC 489, reported in the June 2014 edition of Rx IP Update).
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Children's Hospital of Eastern Ontario (CHEO) seeks declaration of invalidity and non-infringement of Long QT syndrome gene patents
By Statement of Claim issued November 3, 2014 ("Claim"), the Children's Hospital of Eastern Ontario ("CHEO") seeks a declaration of invalidity and non-infringement of five Canadian patents relating to nucleotide and amino acid sequences of genes and proteins implicated in Long QT syndrome ("Long QT"), an inherited cardiac disorder. The patents at issue are owned by one or more of the defendants University of Utah Research Foundation, Genzyme Genetics, and Yale University.
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Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) receives royal assent
The Food and Drugs Act ("Act") has been amended: on November 6, 2014, Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), received royal assent, and many of the provisions are now in force. As reported in the July 2014 issue of Rx IP Update, the Bill was initially introduced in December 2013, and was amended in the House of Commons before passing through the Senate without any further amendments.
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Supreme Court of Canada matters
Supreme Court grants sanofi-aventis leave to appeal re: section 8 decision. As reported in the June 2014 edition of RX IP Update, sanofi-aventis sought leave to appeal one of the first decisions from the Federal Court of Appeal which addressed quantification of damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") relating to ramipril. On October 30, 2014, sanofi-aventis was granted leave.
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.
Apotex discontinues Supreme Court appeal regarding PLAVIX patent. As previously reported on November 3, 2014, Apotex discontinued its appeal to the Supreme Court of Canada regarding the validity of sanofi-aventis' patent claiming clopidogrel bisulfate (PLAVIX); as a result, the hearing scheduled for November 4, 2014 has been cancelled: Press Release.
Had the appeal proceeded, the Supreme Court of Canada was expected to provide guidance on Canada's "promise" doctrine of utility and the test for sound prediction of utility. See the January 2014 special edition of Rx IP Update for background regarding the Federal Court of Appeal's decision: 2013 FCA 186, rev'g 2011 FC 1486.
Eli Lilly files memorial in NAFTA challenge
As previously reported in Rx IP Update, most recently in the August 2014 issue, Eli Lilly filed a Notice of Arbitration pursuant to the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada, asserting that the Canadian judiciary's application of the promise doctrine to Eli Lilly's STRATTERA (atomoxetine) and ZYPREXA (olanzapine) patents contravenes Canada's obligations under NAFTA and the Patent Cooperation Treaty (PCT). On September 29, 2014, Eli Lilly filed its memorial.
Health Canada news
Health Canada imposes import ban on products from three further sites in India. Health Canada reported on October 27, 2014 that it took action to restrict the import of health products from three Micro Labs facilities in India (Bangalore, Goa and Hosur) because of data integrity concerns identified in recent inspections by international partners.
Information Update.
Health Canada releases FAQs regarding Review of Drug Brand Names. As reported in the August 2014 issue of Rx IP Update, Health Canada released a Guidance Document for the Review of Drug Brand Names. The Guidance Document aims to provide market authorization holders direction on the process to be followed and information to be submitted to Health Canada for its assessment of the acceptability of a proposed drug brand name. On October 22, 2014, Health Canada posted answers to frequently asked questions regarding the Guidance Document.
Frequently asked questions.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court of Appeal upholds prohibition Orders re: celecoxib, rejects Mylan and Apotex's promise arguments. As reported in the March 2014 and May 2014 issues of Rx IP Update, Justice Harrington allowed applications for Orders of prohibition regarding the patent that claims celecoxib (Pfizer's CELEBREX) and uses of celecoxib, against Mylan and Apotex. Both Mylan and Apotex appealed. On October 30, 2014, the Federal Court of Appeal dismissed the appeals.
The Mylan and Apotex appeals were heard together, and the Court of Appeal issued one set of reasons.
The Court made the following general statements regarding the promise doctrine:
The promise doctrine will hold an inventor to an elevated standard only where a clear and unambiguous promise has been made. Where the validity of a patent is challenged on the basis of an alleged unfulfilled promise, the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person as excluding this promise....
The Court held that the patent contained no explicit promise of treatment in humans, no promise of reduced side effects, and no "overarching" promise of colorectal cancer prevention. On the latter point, one claim was directed to the use of celecoxib for the prevention of colorectal cancer. The issue was whether, as a matter of law, any given promise must be construed as overarching to the invention and all of the patent's claims. While the Court accepted that some promises may impose utility requirements across each of the claims, the promise of colorectal prevention was properly severed pursuant to s. 58 of the Patent Act which provides for severance of valid from invalid claims.
The Court also upheld Justice Harrington's dismissal of Mylan and Apotex's arguments regarding abuse of process, stare decisis and comity.
Federal Court decisions — 2014 FC 38 (Mylan); 2014 FC 314 (Apotex).
Federal Court of Appeal — 2014 FCA 250.
Other decisions
U.K. Supreme Court upholds ruling on illegality defence regarding infringement by Apotex in Canada. Apotex sought to recover damages from Servier on an undertaking given to obtain a 2006 interim injunction relating to perindopril erbumine (Servier's COVERSYL), following the Court's finding that the U.K. patent at issue was invalid: [2007] EWHC 1538, aff'd [2008] EWCA Civ 445. Justice Arnold, applying the illegality defence, found that Apotex was disentitled from recovering its lost profits, as Apotex would have infringed a Canadian patent by manufacturing the active ingredient in Canada: [2011] EWHC 730.
As reported in the June 2012 issue of Rx IP Update, prior to the hearing of Apotex's appeal, Apotex accepted that what the Canadian court would have ordered Apotex to pay for infringement in manufacturing and exporting for sale in the U.K. absent the injunction should be deducted from its damages. The question that remained was whether Servier was liable for Apotex's remaining lost profits. The Court of Appeal allowed Apotex's appeal, noting that — particularly in view of Apotex's concession — the illegality defence does not defeat Apotex's claim. The concession placed Apotex in the position it would have been had there been no interlocutory injunctions in the U.K. without offending comity with Canada: [2012] EWCA Civ. 593.
On October 29, 2014, the U.K. Supreme Court dismissed Servier's appeal: [2014] UKSC 55. Lord Sumption (Lords Neuberger and Lord Clarke agreeing) held that the illegality defence is not engaged by the fact that Apotex's lost profits would have been made by selling product manufactured in breach of the Canadian patent. "Turpitude" for the purpose of the defence means criminal and quasi-criminal acts. Here, only the patentee's interest is affected, and the patentee's interest will be "sufficiently vindicated" by damages for infringement in Canada, which will be deducted from Apotex's recovery in the U.K.
"There is no public policy which could justify in addition the forfeiture of Apotex's
rights."
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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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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Respondents:
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Pharmaceutical Partners of Canada Inc ("PPC") and Minister of Health
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Respondent Patentee:
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Millennium Pharmaceuticals, Inc
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Date Commenced:
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September 25, 2014
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Court File No.:
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T-2002-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,203,936. PPC alleges non-infringement (certain claims only) and invalidity.
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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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Respondents:
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Pharmaceutical Partners of Canada Inc and Minister of Health
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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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September 25, 2014
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Court File No.:
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T-2003-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,435,146. PPC alleges non-infringement and invalidity.
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Medicine:
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cinacalcet hydrochloride (SENSIPAR)
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Applicant:
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Amgen Canada Inc
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Respondents:
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Mylan Pharmaceuticals ULC, The Minister of Health, and NPS Pharmaceuticals, Inc
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Date Commenced:
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October 3, 2014
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Court File No.:
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T-2056-14
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,202,879. Mylan alleges non-infringement and invalidity.
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To check the status of Federal Court cases, please click here.
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