In recent years, there has been much discussion regarding
patents for blockbuster drugs being invalidated in Canada for
lacking utility. In Canada, the invention claimed in the patent
must be useful. However, the utility does not have to be
demonstrated at the time of filing. Patentees are permitted to rely
on a sound prediction of utility.
In deciding an invalidity challenge involving the utility of the
patent, Canadian Courts first construe the "promise of
utility" from the patent. The Courts then consider whether
that promise has been demonstrated as of the filing date of the
patent, or whether the patentee must rely on a sound prediction of
utility in fulfilling the promise. If the promised utility is
demonstrated as of filing, the inutility challenge fails. The
Courts generally accept that proof of that utility need not be in
However, if the patentee needs to rely on the sound prediction
of utility, the Court moves on to a further test: 1) identify the
factual basis for the prediction; 2) determine whether there is a
sound line of reasoning from the prediction to the promise of
utility; and 3) decide whether the factual basis and the line of
reasoning are properly disclosed in the patent specification.
Without disclosure of the factual basis and sound line of
reasoning, the inventor is seen to be giving nothing to the public
in exchange for the monopoly.
The idea of sound prediction was originally incorporated into
Canadian law as a patent-friendly policy, as it allowed protection
of useful inventions without the need to make and test every
compound covered by a patent. However, in practice, the lower
courts have used this doctrine to invalidate many pharmaceutical
patents. The current heightened standard for utility has no
statutory basis and contravenes Canada's treaty obligations and
The construction of the "promise" is often the key to
the utility discussion, as it will determine the level of utility
the patentee will have to meet in order to maintain the
patent's validity. Where there is no explicit promise provided
in the specification, the courts have agreed that only a "mere
scintilla" of utility is required.
In many past pharmaceutical cases where the Court has construed
an explicit promise from the patent, the threshold of utility
required will generally only be satisfied if the patent contains
longer term proof of utility within the patent. The promise in some
of these earlier cases has been held to be, for example, treatment
of a chronic disease in humans; long term treatment of a disease in
humans; all of the stated advantages in the patent; and a reduction
in side effects. With these types of promises, even clinical data
in the patent was often held not to be sufficient to help meet the
sound prediction test.
More recently, the Courts have started to recognize that the
"promise" is different from the objects, advantages and
mere statements of a practical purpose, which are also found in a
patent. Furthermore, the Court has allowed different claims to have
different promises. In particular, compound claims, process claims,
use claims, and claims to medicaments containing compounds all have
been held to have different promises when considering inutility
allegations. Finally, there may be recognition from the Court that
the disclosure element of this test can be met by taking into
account the common general knowledge of the person skilled in the
art. The Supreme Court will be hearing a case focused on this issue
in November 2014. That decision will be anxiously awaited by
patentees and challengers alike.
Thus, in the meantime, it appears that the pendulum may be
swinging back towards centre when it comes to patentees trying to
uphold their patents in Canada. While the "promise"
doctrine and the enhanced disclosure requirements (which the courts
have now suggested may not be so stringent) are still unique to
Canada, an invalidity challenge based on inutility may not be the
"crushing hammer" that it used to be. Patents covering
drugs are being upheld in the face of such challenges, when the
"promise" is construed reasonably, and the patentee has
made appropriate disclosures.
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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