FC Invalidates Four of the GLEEVEC Patent Claims for Inutility Due to Lack of Sound Prediction

FC Invalidates Four of the GLEEVEC Patent Claims for Inutility Due to Lack of Sound Prediction

Teva Canada Limited v.
Novartis AG
, 2013 FC 141

Novartis is the owner of
Canadian Patent No. 2,093,203 (the '203 Patent) covering imatinib, the active
ingredient in GLEEVEC.

Apotex and Teva
commenced impeachment actions against Novartis under s. 60(1) of the Patent
. Novartis in return sought an injunction against Apotex and delivery up
of its bulk imatinib stocks.

The Court held that
claims 1, 2, 3 and 4 are invalid on grounds of inutility due to lack of sound

The Court declined
Novartis’ claim for an injunction and delivery up of Apotex’s bulk imatinib.


Claim Construction –
Meaning of “Can Be Used”

The skilled person would read the phrase “the compounds . .
. can be used” in the '203 Patent to mean that the compounds have the
potential, demonstrated or predicted through reasonable inferences, to be used
as “tumour‑inhibiting active ingredients”.

The issue is whether the use of the word “can” when
referring to the therapeutic use of the compounds means that the compounds are
guaranteed to treat the described medical conditions?

To establish a purposive meaning for the phrase “can be
used”, it is necessary to examine the context and subject matter of the '203
Patent. In the context of the '203 Patent and the world of cancer research, the
word “can” does not convey a meaning of certainty; rather it should be equated
to the term “potential”. The Court agreed that the use of “can” in this context
implies more than pure speculation or lucky guess. It also accepted that the
phrase “can be used” means more than “might be used”; a potential for use is
certainly a higher threshold than “might”. In other words, there must be
substance to the link between the claimed use and cancer treatment.



Claims 1-4
were held to be invalid, void and of no force and effect on grounds of
inutility due to lack of sound prediction.

The Court rejected the Plaintiffs’ assertion that every
claim must have the same utility. The Court held that there is no overarching
promise that applies to all the claims of the '203 Patent.


The promised utility of the compound claims is that they
selectively inhibit certain enzymes.

The promised utility of the use claims is the potential to
treat the identified diseases.

The Court went on to conduct an assessment of actual and
predicted utility based on a detailed analysis of the evidence.


Sufficiency of the

The '203 Patent does not fail to meet the disclosure
requirement of s. 27(3) of the Patent Act.


        Nature of
the Invention

There is a strong link
among all of the claims which leads to the conclusion that there is a single
inventive concept. Alternatively, there are two inventions: one including the
Group 1 compounds and the second including the Group 2 compounds.

The '203 Patent breaks
down the claims into four categories: claims are to the compounds,
pharmaceutical compositions comprising the compounds, the process to make the
compounds, or the use of the compounds. The question is whether there is a
“single general inventive concept” which forms the foundation of the '203
Patent or whether this separation of the claims into categories results in four

It is not correct to say
that there can be only one invention for any given patent.

The essence of the '203 Patent is the invention of a class
of compounds. The nature of the invention is reflected throughout the
specification, beginning with the title of the '203 Patent “Pyrimidine
Derivatives and Processes for the Preparation Thereof”. This is the first and most
important invention of the '203 Patent. The '203 Patent is a complex patent,
including many compounds and four types of claims; however, the essential link
is the invention of a class of compounds, each one of which can selectively
inhibit certain enzymes. Although some of the claims are for the use of the compounds, the
overall inventive concept of the patent was the finding that certain compounds,
as claimed, could selectively inhibit certain enzymes. The potential uses are inherent in the properties of the
novel compounds.

It may be more in keeping with the nature of the invention
disclosed by the '203 Patent to treat the '203 Patent as being two inventions:
one for each of Group 1 and Group 2 compounds.

        Can the Person of Ordinary Skill in the Art Produce the
Invention Using Only the Instructions 
Contained in the Disclosure?

A lack of data cannot in and of itself result in a finding
of insufficiency. Rather, one must ask whether the omission of the data from
the patent prevents the person of ordinary skill in the art from using the
invention as contemplated by the inventor. In this case the answer is no.

Furthermore, there is no requirement in s. 27(3) that “best
mode” must be disclosed in inventions that are not machines.

In addition, some trial and error may be permitted. The
identification of a solubility problem and the application of what is a routine
modification in the testing protocol is a matter of simple trial and error on
the part of the person of ordinary skill in the art  – and not, as argued
by the Plaintiffs, a “research project”. This means that lack of disclosure of
the minor problem of poor solubility of one of the compounds was not critical
to the understanding or practice of the invention.


Apotex’s Infringement

A part of Apotex’s inventory of imatinib is potentially
infringing; however, the Court declined to order the inventory to be delivered

Apotex acknowledged that it has in its possession certain
volumes of bulk imatinib. Novartis did not seek damages with respect to this
allegedly infringing material; however, it sought an injunction and delivery up
of any infringing material.

The Court held that all but [Redacted] kg of bulk
imatinib is exempt under s. 55.2(1) and (6) of the Patent Act from a
finding of infringement.

However, problems arise with respect to approximately
[Redacted] kg (the Inventory Bulk Imatinib) that remains in Apotex’s
inventory. For the following three reasons, the Court refused to order the
Inventory Bulk imatinib to be delivered up: 1) there was uncontested evidence that all of the
Inventory Bulk imatinib exceeds the manufacturer’s expiry date and, absent
retesting by the vendor, could not be used for commercial purposes; 2) even if the material is not retested, Apotex may be able to
use the remaining lots of bulk imatinib for “further experimental and
processing evaluation” within the research and development laboratory or has
the option of “sending them back to the vendor for a processing or a credit”;
and 3), the chairman of Apotex gave an undertaking  during his testimony
that the Inventory Bulk imatinib will never be used commercially.