[Ip-health] Canada: Supreme Court rules against drug patent "evergreening" (CMAJ, 5 Dec 2006)

Tue Dec 5 03:44:38 2006

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The Supreme Court of Canada decision referred to in the article below is
available online at:
http://scc.lexum.umontreal.ca/en/2006/2006scc49/2006scc49.html.

The unfortunate new regulations extending the period of data exclusivity ar=
e
online at:
http://canadagazette.gc.ca/partII/2006/20061018/html/sor241-e.html

***************

CANADIAN MEDICAL ASSOCIATION JOURNAL

CMAJ =95 December 5, 2006; 175 (12). doi:10.1503/cmaj.061513.

http://www.cmaj.ca/cgi/content/full/175/12/1508?etoc

NEWS

Supreme Court rules against drug patent "evergreening"

Wayne Kondro

CMAJ

It has become almost axiomatic in the pharmaceutical world that litigation
has replaced innovation as the primary mode of operation, says the head of
the Canadian Generic Pharmaceutical Association.

The Supreme Court of Canada tossed another salvo into that litiginous world
Oct. 3 by ruling that the controversial practice of evergreening =97 which
allowed brand-name pharmaceutical firms to obtain an automatic 2-year
extension on the term of patent protection by filing new patents of an
altogether marginal nature, such as the shape, dosing range or colour of a
pill, and then claiming infringement on its original patent =97 should not
have been allowed under Health Canada's old drug regulatory regime.

This latest decision overturned a lower-court ruling to quash Apotex Inc.'s
notice of compliance to market a knock-off of the AstraZeneca proton-pump
inhibitor, omeprazole, which was sold in Canada from 1989 to 1996. The drug
was removed from the market and its patent expired in 1999 but AstraZeneca
used the regulatory system to successfully trigger a series of successive
24-month "stays" to prevent Health Canada approval of a lower-cost generic
equivalent.

In his October decision, Mr. Justice Ian Binnie wrote that "Given the
evident (and entirely understandable) commercial strategy of the innovative
drug companies to evergreen their products by adding bells and whistles to =
a
pioneering product even after the original patent for that pioneering
product has expired, the decision of the Federal Court of Appeal would
reward evergreening even if the generic manufacturer (and thus the public)
does not thereby derive any benefit from the subsequently listed patents."

Given that the government of Canada moved a month before the ruling with ne=
w
regulations to limit evergreening to instances in which there is proof of
actual infringement of the original patent, the decision was somewhat of a
pyrrhic victory for the generic industry.

Nevertheless, Canadian Generic Pharmaceutical Association president Jim Keo=
n
was "very pleased. We've felt all along that these evergreening practices
were problematic and costly for consumers."

Keon also argued consumers will bear the financial brunt of the Oct. 5
amendments to the Food and Drug Regulations to extend data protection on
brand-name drugs from 5 to 8.5 years (including 6 months pediatric
exclusivity), as well as eliminate the ability of generic firms to make
damage claims for profits made by a brand-name company while it's using
evergreening to delay competition.

If a generic product is now held off the market because of a protracted
legal dispute, its maker can now only seek redress for its own lost profits=
,
Keon lamented. "Any disincentive is now gone. If I were the CEO of a brand
name company, I'd be telling my legal people, let's see how many patents we
can get, how many various aspects we can patent and then list every one of
those and litigate to the maximum. If successful, fantastic. We get the
extra profits. If the court later on finds against us, we'll pay a small
fine for that because there's no other downside."

Canada's Research-Based Pharmaceutical Companies (Rx&D) spokesman Francois
Lessard says they have no comment to make on the decision other than that i=
t
"is commercial in nature and applies to a single product. The association
doesn't have a commercial mandate."

__________________________________
Richard Elliott
Deputy Director

Canadian HIV/AIDS Legal Network

+1 416 595-1666 ext. 229

 <http://www.aidslaw.ca> www.aidslaw.ca

Directeur adjoint

R=E9seau juridique canadien VIH/sida

+1 416 595-1666 (poste 229)

 <http://www.aidslaw.ca> www.aidslaw.ca