Novelty

Outline
  • Novelty: To be patentable, an invention must be new: section 2 of the Patent Act.
  • Two-step approach: An invention is anticipated, or not new, if there is an enabling prior disclosure. The approach for assessing anticipation separates prior disclosure and enablement into two steps: Sanofi. There is anticipation if:
    1. prior disclosure has occurred; and
    2. that disclosure would have enabled a person skilled in the art to the work the invention.
  • Prior disclosure
    • Prior disclosure means that the prior art must disclose subject-matter which, if performed, would necessarily result in infringement: Sanofi.
    • Anticipation must be found in a single disclosure; it is not enough to pick bits and pieces from a variety of disclosures to meld them together: Beloit.
    • No trial and error: At the disclosure stage, the person skilled in the art is looking at the disclosure to try to understand what the author of the prior patent or other disclosure meant. There is no room for trial and error or experimentation by the skilled person. He or she is simply reading or looking at the prior art for the purposes of understanding it: Sanofi.
  • Enablement
    • Enabling means that a person skilled in the art would have been able to perform the invention: Sanofi.
    • 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: Synthon.
    • Some trial and error: At the enablement stage, while some trial and error by the person skilled in the art is allowed, there cannot be inventive steps or undue burden: Sanofi. There is no anticipation if the person skilled in the art would not have been able to perform the invention.
  • Claim by claim: Novelty is assessed on a claim-by-claim basis. In the case of an independent claim that is invalid due to a lack of novelty, the dependent claims may nevertheless be novel and valid: Zero Spill.

Legislation

Section 2 of the Patent Act

An invention must be new, otherwise it is not an invention within the meaning of the Patent Act. This is sometimes referred to as the novelty requirement.

invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter; [Emphasis added.]

Subsection 28.2(1) of the Patent Act

The claimed subject-matter must not have been disclosed:

  • and made available to the public:
  • in a Canadian patent application, filed by another applicant:

Subject-matter of claim must not be previously disclosed

28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the pending application) must not have been disclosed

(a) before the one-year period immediately preceding the filing date or, if the claim date is before that period, before the claim date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;

(b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;

(c) in an application for a patent that is filed in Canada by a person other than the applicant, and has a filing date that is before the claim date; or

(d) in an application (the co-pending application) for a patent that is filed in Canada by a person other than the applicant and has a filing date that is on or after the claim date if

(i) the co-pending application is filed by

(A) a person who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for Canada an application for a patent disclosing the subject-matter defined by the claim, or

(B) a person who is entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party and who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for any other country that by treaty, convention or law affords similar protection to citizens of Canada an application for a patent disclosing the subject-matter defined by the claim,

(ii) the filing date of the previously regularly filed application is before the claim date of the pending application,

(iii) the filing date of the co-pending application is within twelve months after the filing date of the previously regularly filed application, and

(iv) the applicant has, in respect of the co-pending application, made a request for priority on the basis of the previously regularly filed application.

Subsection 27(5) of the Patent Act

In the case of claims reciting alternatives, each alternative is treated as a separate claim under section 28.2.

Separate claims

(5) For greater certainty, if a claim defines the subject-matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3, 56 and 78.3.

Two-Step Approach

Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 [Sanofi]

The Supreme Court of Canada, in Sanofi, adopted a two-step approach for anticipation. Anticipation requires both disclosure and enablement.

[28] … Explicitly separating disclosure and enablement is a refinement of the approach set out in Beloit. It explains the process a person skilled in the art would follow if the original patent anticipated the invention of the subsequent patent. I would adopt this approach.

[49] As indicated above, in the context of anticipation, the two-step approach, disclosure and enablement, is a refinement of the approach set out in Beloit and should be adopted.

Prior Disclosure

Beloit Canada Ltd v Valmet OY (1986), 64 NR 287, 8 CPR (3d) 289 (FCA) [Beloit]

Anticipation must be found in a single disclosure; it is not enough to pick bits and pieces from a variety of disclosures to meld them together.

[30] … anticipation must be found in a specific patent or other published document; it is not enough to pick bits and pieces from a variety of prior publications and to meld them together so as to come up with the claimed invention. One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention. Where, as here, the invention consists of a combination of several known elements, any publication which does not teach the combination of all the elements claimed cannot possibly be anticipatory.

Synthon BV v Smithkline Beecham plc, [2005] UKHL 59 [Synthon]

In Synthon, Lord Hoffmann endorsed the concept of disclosure as explained in the judgment of General Tire. According to General Tire, in the context of a prior publication by another inventor, a claimed invention is anticipated if the prior publication discloses the same invention. But it may not be immediately discernable that the same invention was disclosed. However, if carrying out the directions disclosed in the prior publication would inevitably result in something being made or done which would constitute an infringement of the patentee’s claim, that circumstance demonstrates that the patentee’s claim has in fact been anticipated.

Lord Hoffmann reaffirmed that anticipation requires prior disclosure of subject-matter which, when performed, must necessarily infringe the patented invention.

22. … [T]he matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent.

24. Although it is sometimes said that there are two forms of anticipatory disclosure: a disclosure of the patented invention itself and a disclosure of an invention which, if performed, would necessarily infringe the patented invention … they are both aspects of a single principle, namely that anticipation requires prior disclosure of subject-matter which, when performed, must necessarily infringe the patented invention.

32. Likewise, the role of the person skilled in the art is different in relation to disclosure and enablement. In the case of disclosure, when the matter relied upon as prior art consists (as in this case) of a written description, the skilled person is taken to be trying to understand what the author of the description meant. His common general knowledge forms the background to an exercise in construction of the kind recently discussed by this House in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9. And of course the patent itself must be construed on similar principles. But once the meanings of the prior disclosure and the patent have been determined, the disclosure is either of an invention which, if performed, would infringe the patent, or it is not. The person skilled in the art has no further part to play. For the purpose of enablement, however, the question is no longer what the skilled person would think the disclosure meant but whether he would be able to work the invention which the court has held it to disclose.

Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 [Sanofi]

The Supreme Court of Canada observed that the test for anticipation is not so stringent as to require that the exact invention had already been made and publicly disclosed. As Lord Hoffmann explained in Synthon, the disclosure requirement is satisfied if the prior art discloses subject-matter which, if performed, would necessarily result in infringement of that patent. The person skilled in the art looking at the disclosure must be taken to be trying to understand what the author of the prior patent or other disclosure meant. At this stage, there is no room for trial and error or experimentation by the skilled person. He or she is simply reading or looking at the prior art for the purposes of understanding it.

[23] For the reasons that follow, and in light of recent jurisprudence, I am of the respectful opinion that the applications judge overstated the stringency of the test for anticipation that the exact invention has already been made and publicly disclosed.

[25] [Lord Hoffmann] explains that the requirement of prior disclosure means that the prior art must disclose subject matter which, if performed, would necessarily result in infringement of that patent, and states, at para. 22:

If I may summarise the effect of these two well-known statements [from General Tire and Hills v. Evans], the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. … It follows that, whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied.

When considering the role of the person skilled in the art in respect of disclosure, the skilled person is taken to be trying to understand what the author of the description [in the prior patent] meant (para. 32). At this stage, there is no room for trial and error or experimentation by the skilled person. He is simply reading the prior patent for the purposes of understanding it.

[32] … At this stage, the person skilled in the art is reading the prior patent to understand whether it discloses the special advantages of the second invention. No trial and error is permitted.

Enablement

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Claim by Claim

Zero Spill Systems (Int’l) Inc. v. Heide, 2015 FCA 115 [Zero Spill]

In Zero Spill, the Federal Court held that an entire patent was anticipated because two of the patent’s independent claims were anticipated. The Federal Court of Appeal rejected this reasoning. Instead, novelty must be assessed on a claim by claim basis, since dependent claims can be novel even if the independent claims are not novel. Put another way, a narrower claim (i.e. a dependent claim) can be valid even if a broader claim (i.e. the corresponding independent claim) is invalid.

[90] As already described, the Federal Court held that it was sufficient for the purposes of its analysis to consider the meaning and scope of Claims 1 and 9 because all of the remaining claims were dependent: Reasons of the Federal Court at paragraph 106.

[94] The Federal Court was obliged to consider the validity of the ’064 Patent claim-by-claim. Not doing so was a legal error. Notwithstanding that Claim 13 is actually an independent claim, the nature of dependent cascading claims is to narrow the claims upon which they depend: Purdue Pharma v. Pharmascience Inc., 2009 FC 726, 77 C.P.R. (4th) 262 at paragraph 10. The practical effect of this on anticipation or obviousness is that eventually a claim may be sufficiently narrow to escape these prior art-based attacks, even though the broader claims may be invalid.