Biovail v. Rhoxalpharma, 2006 FC
784
Biovail commenced a notice of application seeking to prohibit
the Minister of Health from issuing a Notice of Compliance (“NOC”)
to Sandoz for its bupropion hydrochloride sustained release
formulation. Biovail claimed the Sandoz formulation infringed
patent nos. 2,142,320 (the “‘320 Patent”) and 2,168,364 (the
“‘364 Patent”) listed against WELLBUTRIN SR. In reasons released
June 21, 2006, Justice O’Reilly dismissed the application on
the basis that Sandoz did not infringe either patent. He found
that Sandoz did not infringe the ‘320 Patent because hydroxypropyl
methylcellulose was an essential element of the patent and was
not present in the Sandoz formulation. He also found Sandoz
did not infringe the ‘364 Patent because Sandoz’s tablet did
not use any of four stabilizing agents claimed in the patent.
He rejected Biovail’s argument that the Sandoz product used
hydrochloric acid (“HCl”) as a stabilizer and in any event found
HCl to be outside the claims of the ‘364 Patent. Sandoz was
represented by Ed Hore and Kevin Zive.
AstraZeneca v. Apotex, 2006 SCC
49
In unanimous reasons released November 3, 2006, the Supreme
Court of Canada overturned the Federal Court of Appeal, and
restored the lower court’s decision that the Minister of Health
was correct to issue a Notice of Compliance to Apotex for its
omeprazole magnesium capsules. The issue turned on the correct
interpretation of the words “another drug” in subsection 5(1)
of the Patented Medicines (Notice of Compliance) Regulations
(“Regulations”). That provision says that a generic must address
patents when it "compares ...or makes reference to, another
drug...and that other drug has been marketed in Canada." AstraZeneca
had listed new patents for its omeprazole capsules (LOSEC) after
it had pulled its capsules off the market. AstraZeneca claimed
Apotex was required to address these newly listed patents because
the words “another drug” included a drug that was once marketed
in Canada but no longer is. Apotex claimed “another drug” referred
to the drug as it was when it was marketed in Canada, which
was when the comparison was made, and excludes patents listed
afterwards. The Supreme Court of Canada agreed with Apotex’s
interpretation, noting that as the intent of the Regulations
was to offset the benefit derived by generic drug manufacturers
from the “early working exception” (s. 55.2 of the Patent Act),
it would be unfair to require them to address patents which
they could not have benefited from. Ed Hore and Kevin Zive represented
the intervener, Canadian Generic Pharmaceutical Association.
CGPA v. Canada (ongoing)
On November 14, 2006, the Canadian Generic Pharmaceutical
Association (CGPA) launched a constitutional challenge to the
October 2006 amendments to the Food and Drug Regulations passed
by the federal government. The amendments call for eight years
of data protection after a “brand” drug manufacturer receives
a Notice of Compliance (NOC) during which no generic drug company
can receive an NOC for the same drug. The new amendments also
restrict a generic company’s ability to file a new drug submission
comparing its drug to a brand drug until six years has passed
since the issuance of the brand’s NOC. Under the previous legislation,
the term of data protection was five years and there was no
ban on filing drug submissions during that time. CGPA argues
the legislation is ultra vires because the statute under which
the regulations are passed only authorizes regulations “deemed
necessary” for the implementation of Canada’s international
obligations under NAFTA and TRIPS. CGPA argues the Federal Court
of Appeal explicitly stated that Canada was in compliance with
its treaty obligations under the existing rules. CGPA also argues
the regulations are ultra vires the federal government since
protection of intellectual property is exclusively provincial
jurisdiction under s. 92(13) of the Constitution Act (Property
and Civil Rights in the Province). The Attorney General of Canada's motion to strike was denied (2007 FC 154 aff'd 2007 FCA 375). For more information see
the article
“Legal challenges hit data protection law amendments”
published February 5, 2007 in Law Times (Vol. 18 No. 5). Ed
Hore is representing CGPA.