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19 January 2015
Appeal Court issues first Section 8 quantification decisions
Federal Court finds PMPRB has no jurisdiction over ratiopharm and Sandoz
Heightened matching requirement for patent listing
Competition Bureau releases white paper on patent litigation settlements
CETA: Text released, patent term restoration coming to Canada
Appeal court orders retrial of STELARA infringement case
Utility: Apotex discontinues PLAVIX appeal on eve of hearing
Children's hospital challenges validity of gene patents
Health Canada found negligent in handling of Apo-Trazodone
This update examines the key developments in Canadian pharmaceutical IP and regulatory law in 2014.
On March 14 the Federal Court of Appeal reversed in part the first two decisions quantifying Section 8 damages, employing different hypothetical models from the trial judge. The cases relate to ramipril (Sanofi-Aventis's ALTACE, Apo-Ramipril and Teva-Ramipril). The Supreme Court subsequently granted Sanofi-Aventis leave to appeal the Apotex decision.
On May 27 the Federal Court decided that ratiopharm (selling an authorised generic version of VENTOLIN HFA) and Sandoz, a subsidiary of the patentee Novartis, are not 'patentees' and are therefore not subject to the Patented Medicine Prices Review Board's (PMPRB) pricing jurisdiction. The PMPRB has appealed.
On September 18 the Federal Court upheld a prothonotary's finding that a patent that explicitly claimed one medicinal ingredient was not eligible for listing on the Patent Register against the fixed-dose combination products KIVEXA and TRIZIVIR. Viiv has appealed. Industry Canada has stated that it intends to amend the Patented Medicines (Notice of Compliance) Regulations.
On September 23 the Competition Bureau released a white paper providing its preliminary views on how the Competition Act may apply to both entry-date settlements (limited to generic entry before patent expiry) and 'pay-for-delay' agreements (for further details please see "Competition considerations in IP settlement agreements").
On September 26 the text of the Comprehensive Economic and Trade Agreement between Canada and Europe (CETA) was released and includes patent term restoration and an innovator right of appeal under the Patented Medicines (Notice of Compliance) Regulations. The agreement must still be ratified and domestic laws amended (for further details please see "Text of CETA released").
On October 28 the Federal Court of Appeal granted Janssen's appeal of a pre-trial Order denying its request to plead further prior art references, consequently set aside the lower court's decision declaring Abbvie's patent valid and infringed by Janssen's antibody drug STELARA (ustekinumab), and remitted the matter back for a new trial before a new judge. The injunction was also set aside. The new trial has been scheduled for January 2016. Abbvie has sought leave to appeal from the Supreme Court.
On November 3 Apotex discontinued its appeal to the Supreme Court regarding the validity of Sanofi-Aventis's patent claiming clopidogrel bisulfate (PLAVIX). Had the appeal proceeded, the Supreme Court was expected to provide guidance on Canada's 'promise' doctrine of utility and the test for sound prediction of utility.
Separately, on October 30 the Federal Court of Appeal provided further clarity regarding the 'promise' doctrine, upholding prohibition orders regarding celecoxib (Pfizer's CELEBREX). Apotex and Mylan have sought leave to appeal from the Supreme Court.
On November 3 the Children's Hospital of Eastern Ontario brought a claim seeking 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, an inherited cardiac disorder.
On November 18 the Federal Court found the minister of health liable to pay damages to Apotex for misfeasance in public office and negligence for its failure to abide by a settlement agreement relating to use of a foreign reference product, which delayed the approval of Apotex's generic trazodone product. The crown has appealed.
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514), fax (+1 416 591 1690) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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