On January 15, Health Canada approved Celltrion's REMSIMA and INFLECTRA (NOC now in the name of Hospira),
each containing the monoclonal antibody, infliximab. They were
filed as subsequent entry biologics to Janssen's
REMICADE and did not receive approval for all of
On March 14, the Federal Court of Appeal reversed in part the
first two decisions quantifying section 8 damages, employing
different hypothetical models from that of the trial judge. The
cases relate to ramipril (sanofi-aventis'
ALTACE, Apo-Ramipril and
Teva-Ramipril). The Supreme Court subsequently
granted sanofi-aventis leave to appeal the Apotex
On May 27, the Federal Court decided that ratiopharm (selling an
authorized generic version of VENTOLIN HFA) and
Sandoz, a subsidiary of the patentee Novartis, are not
"patentees" and are therefore not subject to the
Board's pricing jurisdiction. The PMPRB has appealed.
On September 18, the Federal Court upheld a Prothonotary's
finding that a patent explicitly claiming 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 will
be amending the Patented Medicines (Notice of Compliance)
On September 23, the Competition Bureau released a white paper
providing the Bureau's preliminary views on how the
Competition Act may apply to both entry-date settlements
(limited to generic entry prior to patent expiry) and
On September 26, the text of CETA (the Comprehensive Economic and
Trade Agreement between Canada and Europe) 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
7. Health Canada imposes import ban on products from sites in
India; Apotex sues
On September 30, Health Canada commenced action to stop the import of health products
from Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research
Private Limited (ARPL), and IPCA Laboratories (the Department in
India), noting "serious doubts about the quality and safety of
finished products and APIs produced at these sites." Apotex
brought applications challenging this decision (T-2223-14) and Health Canada's decision
refusing a NOC for Apo-Rasagiline stemming from
this import ban (T-2411-14).
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 of Canada regarding the validity of sanofi-aventis'
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.
October 30, the Federal Court of Appeal provided further
clarity regarding the "promise" doctrine, upholding
prohibition Orders regarding celecoxib (Pfizer's
On November 3, the Children's Hospital of Eastern Ontario
("CHEO") 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 ("Long QT"), an inherited
11. Vanessa's Law: Health Canada has heightened powers to
address adverse drug reporting
On November 6, the Protecting Canadians from Unsafe Drugs Act
(Vanessa's Law) received royal assent. The Act
strengthens oversight of drugs, devices and drug-device
combinations post-approval, and provides Health Canada with new
powers to compel and disclose information, order changes to labels
and packages and recall products that present serious or imminent
risk of injury to health.
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 Queen has appealed.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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