In Teva Canada Ltd v Pfizer Canada Inc,
the Supreme Court of Canada (the "SCC") held Pfizer's
Canadian Patent No. 2,163,446 (the '446 Patent) to be
"void" for not disclosing that sildenafil, the active
ingredient in ViagraTM, was the compound that had been
demonstrated to work in patients. (Please click here for further details.) The SCC has now
revised and clarified the wording of its decision. However, the
immediate effect of the revised decision on the marketplace has not
changed because generic sildenafil still has marketing
authorization and is available for sale in Canada.
The holding by the SCC that the '446 Patent was
"void" was unusual in that the appeal had originated as an application brought by Pfizer
under the Patented Medicines (Notice of Compliance) Regulations
(the "PM(NOC) Regulations"). Teva (then Novopharm)
had asserted to the regulator, Health Canada, that the '446
Patent was invalid and therefore should not prevent Teva from
getting authorization (aka a Notice of Compliance "NOC")
to market sildenafil for the use covered by the '446 Patent.
Pfizer then initiated the application to request an order
prohibiting the Minister of Health from issuing the marketing
authorization to Teva until the expiry of the '446 Patent.
An application brought under the PM(NOC) Regulations is
not the same as a full patent infringement or validity
(impeachment) action. Applications are summary in nature and not
determinative of the validity of a patent. Instead, a court
determines whether or not the applicant (typically a brand name
pharmaceutical company) has established, on a balance of
probabilities, that allegations of invalidity put forward by the
party seeking marketing authorization (typically a generic drug
company) are not justified. If the court finds that these
allegations are not justified, Health Canada is prohibited from
giving the generic company its NOC until the patent expires. On the
other hand, if the court finds allegations of invalidity put
forward by the generic company are justified, it receives its NOC
and can sell a generic version of the drug.
Irrespective of the litigation under the PM(NOC)
Regulations, a patent impeachment action can still be brought
separately. For example, another generic company, Apotex, has
brought such an action seeking to invalidate the '446
Why the SCC Order Changed
Subsequent to the SCC decision, (as reported
here) Pfizer brought a motion requesting an order amending the
judgment of the SCC or alternatively, an order directing that a
motion for a re-hearing on the issue of remedy be made.
The SCC released a decision on the motion on June 4, 2013,
granting it in part. The order granted amends the original reasons
of the SCC to insert a passage indicating that the appeal
originated as an application brought by Pfizer under the
PM(NOC) Regulations. Portions of the reasons suggesting
that the patent is "invalid" or "void" have now
been replaced with language indicating that Teva established its
allegation that the patent is not valid and that Pfizer's
application for an order of prohibition is dismissed. Similar
amendments were also made to the formal order.
These amendments indicate that the SCC did not
invalidate Pfizer's '446 Patent in this case. In the
separate Apotex impeachment action, the Federal Court of Appeal has yet to consider a lower court decision declaring the '446 Patent to be
invalid and void. In the decision, the lower court had suggested
that the SCC's determination that the '446 Patent did not
meet the disclosure requirements was binding on it and would
invalidate the patent regardless of whether the SCC went on to
grant Pfizer's motion. A ruling that a patent is invalid in an
impeachment action affects the patent itself and not just the
parties involved in the case. Therefore, if all avenues of appeal
uphold the lower court decision in the Apotex case, the '446
Patent (which will expire on May 13, 2014) will no longer stand in
the way of parties seeking authorization to market generic
sildenafil. If an appeal overturns the lower court decision, then
Pfizer and Apotex may continue on with the lawsuit toward a final
determination of validity.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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