Synthon BV v Smithkline Beecham plc, [2005] UKHL 59 [Synthon] Lord Hoffmann stated that enablement
means that the person of skill in the art would have been able to perform the invention which satisfies the requirement of disclosure.
26. Enablement means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure.
According to Lord Hoffmann, the invention that must be enabled is the one disclosed by the prior art, not the one that is claimed.
33. There is also a danger of confusion in a case like Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, in which the subject-matter disclosed in the prior art is not the same as the claimed invention but will, if performed, necessarily infringe. To satisfy the requirement of disclosure, it must be shown that there will necessarily be infringement of the patented invention. But the invention which must be enabled is the one disclosed by the prior art. It makes no sense to inquire as to whether the prior disclosure enables the skilled person to perform the patented invention, since ex hypothesi in such a case the skilled person will not even realise that he is doing so. Thus in Merrell Dow the question of enablement turned on whether the disclosure enabled the skilled man to make terfenadine and feed it to hay-fever sufferers, not on whether it enabled him to make the acid metabolite.
Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 [Sanofi] The Supreme Court of Canada noted that even if there is disclosure, that is not enough to prove anticipation. There must also be enablement. Justice Rothstein accepted that enablement
means that the person skilled in the art would have been able to perform the invention
. However, he left open the question of whether enablement for purposes of sufficiency is identical to enablement for purposes of anticipation.
[26] If the disclosure requirement is satisfied, the second requirement to prove anticipation is enablement
which means that the person skilled in the art would have been able to perform the invention (para. 26). Lord Hoffmann held that the test for enablement for purposes of anticipation was the same as the test for sufficiency under the relevant United Kingdom legislation. (Enablement for the purposes of sufficiency of the patent specification under the Canadian Patent Act, s. 34(1)(b) of the pre-October 1, 1989 Act, now s. 27(3)(b), is not an issue to be decided in this case and my analysis of enablement is solely related to the test for anticipation. The question of whether enablement for purposes of sufficiency is identical in Canada is better left to another day.)
The person skilled in the art is assumed to be willing to make some trial and error experiments to get the invention to work.
[27] Once the subject matter of the invention is disclosed by the prior patent, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work. While trial and error experimentation is permitted at the enablement stage, it is not at the disclosure stage. For purposes of enablement, the question is no longer what the skilled person would think the disclosure of the prior patent meant, but whether he or she would be able to work the invention.
…
[43] The applications judge was of the opinion that the skilled reader following the prior art must be able to arrive at the invention claimed in the impugned patent the first time he or she tries and every time thereafter
(para. 65 (emphasis in original)). However, under the test for enablement as described in these reasons, some trial and error is permitted.
As to how much trial and error or experimentation will be permitted before a prior disclosure will be found not to constitute an enabling disclosure, the Court held that the person skilled in the art must be able to perform or make the invention work without an inventive step
or undue burden
.
[33] What amount of trial and error or experimentation is permitted before a prior disclosure will not constitute enabling disclosure? Certainly, if the applications judge finds that an inventive step was required to get to the invention of the second patent, the specification of the first patent will not have provided enabling disclosure. But even if no inventive step is required, the skilled person must still be able to perform or make the invention of the second patent without undue burden.
The Court provided a list of factors that should normally be considered when assessing enablement. It noted, amongst other things, that routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine.
[37] Drawing from this jurisprudence, I am of the opinion that the following factors should normally be considered. The list is not exhaustive. The factors will apply in accordance with the evidence in each case.
- Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art.
- The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time.
- The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal. If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine.
- Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted.