2,370,565 / calcipotriol & betamethasone / DOVOBET
In Teva v Leo Pharma the FCA affirmed the decision of Locke J (blogged here) granting an order of prohibition. Yesterday's post discussed the FCA holding regarding sufficiency. Teva also raised an interesting technical argument regarding sound prediction.
The test for sound prediction set out in AZT, 2002 SCC 77, requires a sound line of reasoning from which the desired result can be inferred from the factual basis . In Bell Helicopter 2013 FCA 219 , the FCA held that the elements of the sound prediction doctrine, including the line of reasoning, need not be explicitly disclosed in the specification if they would be self-evident to the skilled person . Teva argued that the line of reasoning which supports a sound prediction must nonetheless be the actual line of reasoning followed by the inventors of the invention at hand [15.1]. Teva referred to this, appropriately, as a “subjective” approach . This is in contrast to an objective approach, under which it would suffice if a sound line of reasoning would be apparent to the notional skilled person, whether or not the inventors did not have that particular line of reasoning in mind.
The FCA rejected this argument, treating it essentially as a factual matter. It is undisputed that a skilled person would have to have a sound line of reasoning, and it is open to the court of first instance to infer, as a matter of fact, that the inventors shared that line of reasoning, even if the inventors were not personally called to testify . Gauthier JA pointed out that such an inference must be permissible if the inventor had died before trial, and if it is permissible in that case, it must be generally permissible, as being simply a matter of how the patentee has chosen to prove a fact -.
While that response was sufficient to dispose of the issue, it leaves open the technical question of whether the correct test for a sound line of reasoning is indeed subjective, or objective. Given the FCA’s point regarding how the facts may be proven, this will not often make any difference, but I’m not sure it will always be moot. Gauthier JA noted that
 From the perspective of a person skilled in the art, I see no difference in this case between an express sentence [stating the inventor’s line of reasoning] and conveying the same logic through technical information disclosed in the specification read as a whole. In both instances, the inventor conveys his or her logic to the person to whom the patent is addressed, thereby fulfilling its part of the patent bargain if this line of reasoning is held to be reasonable and sound at the relevant times. In short, in both instances, the person to whom the patent is addressed, namely, the person skilled in the art, understands the sound line of reasoning of the inventors premised on what is said in the patent.
In my view, this is a compelling argument for the objective approach. The patent bargain is an objective one; it is what the inventor actually gave the world, not what she might have thought she was giving the world. If an inventor truly believes that she was making full and sufficient disclosure, but in fact she was not, the patent will be invalid notwithstanding her subjective intent. The converse should also hold; if the inventor in fact make a disclosure that was sufficient for a skilled person, and thereby gave the invention to the world, that fulfils the bargain, even if the inventor subjectively did not understand her own invention.