Hughes J. Holds the Relevant Date for Assessing Sufficiency of a Canadian Patent Is the Date of Publication

Hughes J. Holds the Relevant Date for Assessing Sufficiency of a Canadian Patent Is the Date of Publication

Novartis Pharmaceuticals Canada Inc. v. Teva
Canada Limited
, 2013 FC
283

Novartis brought two applications under the provisions of the PM(NOC)
Regulations to restrain the Minister of Health from issuing a Notice of
Compliance to Teva in respect of zoledronic acid IV infusion until the expiry
of Canadian patents 1,338,895 and 1,338,937. Novartis brought these
applications in response to Teva’s Notice of Allegation challenging the
validity of the two patents.

Teva’s allegations with respect to invalidity, on the basis of inutility
and lack of sufficiency of the ‘895 patent, claim 14, are justified. Therefore,
the application is dismissed with respect to that patent.

Teva’s allegations with respect to invalidity of the ‘937 patent are not
justified; therefore, the application is allowed in respect of that patent.

 

CONSTRUCTION

The ‘895 Patent

The only claim at issue is claim 14, which claims a class of some 1.2
million compounds all sharing a selection of molecules at the R1 and R2
positions placed on a biphosphonic backbone; zoledronate is but one of such
compounds.

The ‘937 Patent

The '937 patent contains only two claims, both of which are at issue.
Claim 1 claims a single compound – zoledronate. Claim 2 is a mixture of
zoledronate and pharmaceutical excipients.

 

OBVIOUSNESS

Neither claim 14 of the '895 patent, nor claims 1 and 2 of the '937
patent, are invalid for obviousness. Teva’s allegations in this respect are not
justified.

Step 1(b): Relevant Common General Knowledge

Given that both patents at issue are “old” Act patents, the common
general knowledge must be ascertained as of the “date of the invention”. In
turn, such an inquiry must begin with “what is the invention”.

“Inventive Concept” of Claim 14 of
the '895 Patent

The inventive concept of claim 14 is a family of (about 1.2 million
members) novel compounds having biological activity as calcium complex formers
and bone resorption inhibitors.

“Inventive Concept” of Claims 1 and
2 of the '937 Patent

In the present case, the '937 patent contains only two claims directed
to one compound only, zoledronate. In effect, it is a “divisional” in that
claims to any other compound have been removed.

Unlike the '895 patent, the '937 patent, because it claims only one
compound, zoledronate, is, on a case-by-case basis, distinguishable from that
considered by the Supreme Court in Teva. The inventive concept of the
'937 patent is that zoledronate is a useful inhibitor of bone resorption in
rats and that, as such, is suitable for use as a medicament in the treatment of
diseases in humans associated with impairment of calcium metabolism.

Date of the Invention – ‘895 Patent

The inventors made and tested two compounds, only one of which falls
within the parameters of claim 14 (and is not zoledronate) before the filing of
the priority German application on August 1, 1986. There is no support for
leaping from one or two compounds to a class of 1.2 million compounds.

Therefore, the “date of invention” can be no earlier than the date of
the draft of the priority application, June 23, 1986, wherein a “class” was
articulated.

Date of the Invention – ‘937 Patent

The inventors made and tested zoledronate in rats in July 1987, which is
after the filing of the priority application, but before the filing of the
Canadian application. The date of invention of the inventive concept of the
'937 patent is July 1987.

The date of the invention is not the priority filing date of the '937
patent, which is the filing date of the Swiss application, November 21, 1986,
since there is no evidence that the inventors had made or tested zoledronate as
of that date; nor is there any evidence that they could have, as of the
priority date, soundly predicted that zoledronate would be the compound of
choice.

Common General Knowledge at the Time of the
Invention

The common general knowledge or state of the art must be considered as
of two different dates; for the '895 patent, it is June 23, 1986; whereas, for
the '937 patent, it is July 1987.

Even given a broad number of choices for atoms or molecules or compounds
that could be attached to the carbon backbone of a bisphosphonate, there is
still too much uncertainty as to whether any particular combination will be
useful.

Therefore, it would not be “more or less self evident” that the class of
compounds claimed in claim 14 of the '895 patent or zoledronate as claimed in
the '937 patent ought to work as of their respective dates of invention. It was
not “self evident” that what is claimed in either patent ought to work.

 

UTILITY

Claim 14 of the ‘895 Patent

Teva’s allegations as to lack of utility of claim 14 of the ‘895 patent
are justified.

The question of utility must be considered not with respect to a few
specific compounds, but to the class of 1.2 million compounds embraced by claim
14. The Court held that the inventors named in the '859 patent did not, as of the
Canadian filing date, establish that the class of 1.2 million compounds
embraced by claim 14 had utility. Further, there is nothing in the description
of the '859 patent that would establish a basis for sound prediction that all
members of that class would have utility. In brief, the state of the art was at
the empirical stage where compounds would have to be assessed individually.

Claims 1 and 2 of the ‘937 Patent

Teva’s allegations as to lack of utility in respect of claims 1 and 2 of
the '937 patent are not justified.

The claims of the '937 patent are directed to one compound only,
zoledronate. The inventors made and tested that compound before the Canadian
application was filed and found it to be useful for the stated purpose namely,
a pronounced regulatory action on the calcium metabolism of warm-blooded
animals.

 

SUFFICIENCY

Teva’s allegations as to insufficiency of the '895 patent, claim 14, are
justified.

Teva’s allegations as to insufficiency of the '937 patent are not
justified.

Relevant Date

The most appropriate date for consideration of sufficiency of a Canadian
patent is the date of publication. That is the date that the public is seized
with the application. In the case of an “old” Act patent, this would be the day
that the patent was issued and granted. In the case of a “new” Act patent, it
would be the date of publication.

Teva asserts that the date for determination is the date of filing the
application in Canada. Novartis asserts that it is the date of publication
which, in this case, is the dates upon which the patents were issued and
granted.

For the same reasons as discussed with respect to utility, the '895
patent, claim 14, is insufficient, even at the date that the patent was issued
and granted.

The matter is different with respect to the '937 patent, claims 1 and 2.
The patent was issued and granted with only two claims – both specific to
zoledronate. For the same reasons as previously set out, this patent is
distinguishable from that considered by the Supreme Court in Teva on the
basis that the claims were specific to zoledronate, only. However, when the
application was filed in Canada, the application contained claims to many
compounds, including genus claims and claims to specific compounds; including,
but not restricted to, zoledronate. If sufficiency were to be considered as of
the date of filing the application, the application would be found to be no
different than that considered by the Supreme Court in Teva, and thus
invalid for lack of sufficient disclosure.

When the '937 patent – an “old” Act patent – was issued and granted, the
patent claims were restricted to zoledronate, and thus the patent is
distinguishable from that considered by the Supreme Court of Canada in Teva.
Accordingly, the Court held that Teva’s allegations as to insufficiency of the
'937 patent are not justified.