[Ip-health] (no subject)

Sat Nov 4 13:56:03 2006

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This morning the Supreme Court released its decision in AstraZeneca Canada =
Inc. v. Canada (Minister of Health), 2006 SCC 49, (November 3, 2006) http:/=
/scc.lexum.umontreal.ca/en/2006/2006scc49/2006scc49.html . It allowed the a=
ppeal by generic manufacturer and applied its earlier ruling in Bristol-Mye=
rs <http://scc.lexum.umontreal.ca/en/2005/2005scc26/2005scc26.html>  Squibb=
 Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533; 2005 SCC 26 (May 19=
, 2005) http://scc.lexum.umontreal.ca/en/2005/2005scc26/2005scc26.html (als=
o known as the Biolyse case).

In this case, Astrazeneca held a patent for a drug that it was no longer pr=
oducing and marketing. When the patent expired it obtained two new patents =
with respect to the product, but did not incorporate this new technology in=
to any of its products. When the generic manufacturer, Apotex, sought to pr=
oduce the drug on which the patent had expired, the Notice of Compliance th=
at Apotex obtained was challenged by Astrazeneca because its two new patent=
s were ignored. Astrazeneca lost at the first phase, won on appeal and lost=
 in the Supreme Court.

In assessing the broader statutory purpose of the NOC Regulations (Canada=
=E2=80=99s equivalent of the Hatch-Waxman Act and the Orange Book) Mr. Just=
ice Binnie wrote

 =E2=80=9CGiven the evident (and entirely understandable) commercial strate=
gy of the innovative drug companies to evergreen their products by adding b=
ells and whistles to a pioneering product even after the original patent fo=
r that pioneering product has expired, the decision of the Federal Court of=
 Appeal would reward evergreening even if the generic manufacturer (and thu=
s the public) does not thereby derive any benefit from the subsequently lis=
ted patents.  In my view, s. 5(1) of the NOC Regulations requires a patent-=
specific analysis, i.e. the generic manufacturer is only required to addres=
s the cluster of patents listed against submissions relevant to the NOC tha=
t gave rise to the comparator drug, in this case the 1989 version of Losec =
20.=E2=80=9D

Regards

Paul Jones   =E9=92=9F =E4=BF=9D =E7=A6=84   =D0=9F=D0=BE=D0=BB  =D0=94=D0=
=B6=D0=BE=D1=83=D0=BD=D1=81
Barrister , Solicitor & Trade-mark Agent

Jones & Co.
365 Bay Street, 2nd Floor

Toronto, Ontario

Canada M5H 2V1

Phone : 416.703.5716
Fax : 416.703.6180
Cell : 416.670.6889
E-mail :  <mailto:pjones@jonesco-law.ca> pjones@jonesco-law.ca

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