"Disclosure" for selection: Is it the same as "disclosure" for anticipation?

By:  Geoffrey Mowatt and Ryan Evans

A version of this article was published by LexisNexis in The Lawyers Weekly, 2 September 2011
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One of the tenants of our patent regime is that an invention must be “new”—it must not have been previously disclosed to the public. According to the Supreme Court in Apotex v. Sanofi, 2008 SCC 61, a patent claim will be anticipated if: a) the subject matter of the claim was previously disclosed, and b) the disclosure would have enabled a person skilled in the art to practice the subject matter disclosed therein.

As set out in Sanofi, the Canadian test for anticipation is premised on the approach recited in Synthon BV v. SmithKline Beecham plc, [2005] UKHL 59. However, recent jurisprudence in the U.K. appears to have shifted this approach, resulting in a ‘disclosure’ requirement that is challenging to apply and may lead to untenable results.

For pharmaceutical inventions, even if a chemical compound has been disclosed, a patentee may nonetheless be able to procure patent protection by showing that the compound has surprising and unexpected properties that warrant a ‘selection’ and a corresponding patent monopoly.

The invention in a selection resides in the surprising and unexpected properties of the selected compounds. As stated by the Federal Court of Appeal in Eli Lilly v. Novopharm, 2010 FCA 197: “If a property, quality or use in relation to one or more members of the genus is subsequently discovered, that discovery may be an invention”.

Relying on I.G. Farbenindustrie (1930), 47 R.P.C. 289 (Ch.D.), the SCC formulated three criteria for a valid selection: a) the selection must secure a substantial advantage or avoid a disadvantage; b) all of the selected members possess the advantage; and c) the selection is in respect of a character peculiar to the selected compound(s).

In this context, the first stage of an anticipation analysis is concerned with disclosure of the claimed invention—not disclosure of the selected compound, per se. As explained in Sanofi, “the person skilled in the art is reading the prior patent to understand whether it discloses the special advantages of the second invention … If … the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent”.

In Dr. Reddy’s Laboratories v. Eli Lilly, [2008] EWHC 2345 (Pat), Justice Floyd considered whether olanzapine was “disclosed” by a genus patent that generally described more than “10 billion billion” compounds. Although part of a narrower subset of preferred compounds, olanzapine was not individually identified.

Adopting the European Patent Office’s (EPO) approach concerning items previously described by a genus under the European Patent Convention, Floyd J. held that “a general formula with multiple substituents chosen from lists of some length will not normally take away the novelty of a subsequent claim to an individual compound”. Rather, a disclosure of the compound in “individualised form” would be necessary for anticipation.

Affirming Floyd J.’s decision, Lord Justice Jacob equated any potential disclosure of olanzapine within the original genus to hiding a leaf in a forest—“It is, at least faintly, ridiculous to say that a particular leaf has been made available to you by telling you that it is in Sherwood Forest. Once identified, you can of course see it. But if not identified you know only the generality: that Sherwood Forest has millions of leaves”. However, Jacob L.J. declined to go into what is sufficient to amount to an “individualised description” ([2009] EWCA Civ 1362).

By focusing on the disclosure of an individual compound, rather than its advantages, the U.K. courts appear to have adopted a troublesome approach to the issue. For instance, quantifying how narrow the originating genus must be to comprise an “individualised description” on a case by case basis becomes a subjective, if not arbitrary, task.

Further, the jurisprudence in both the U.K. and Canada has held that a selection patent is no different than any other patent. To reconcile this view with the Dr. Reddy’s approach means that an “individualised description” is a necessary element of any anticipation analysis. Indeed, Floyd J. has recently suggested, albeit in obiter, extending the same approach to claims in which a range of values are specified (e.g. the amount of an excipient in a composition) in H. Lundbeck v. Norpharma, [2011] EWHC 907 (Pat). In particular, Floyd J. opined that, absent clear directions in a prior reference to use a specific value within a range, there would be no anticipating disclosure even if the range overlaps with that in a claim. Interestingly, the EPO has taken a different approach to this issue, considering whether the skilled person “would find it difficult to carry out the prior art teaching in the range of overlap”.

A key shortcoming in Dr. Reddy’s is exposed by restating the anticipation question: “what would infringe if later, anticipates if earlier” (see Abbott Laboratories v. Canada, 2006 FCA 187). The converse should also hold true. Thus, using the Dr. Reddy’s approach, a genus claim that is held not to disclose a specific compound within its scope must also not be infringed by the manufacture or use of that compound. If this were so, countless genus claims would have little, if any, value to patentees.

Fortunately, the “individualized description” approach appears to have little applicability in Canada. In fact, the Federal Court specifically rejected this approach. Instead, Justice Gauthier held that the requirements for anticipation of a selection stood somewhere between the spectrum of simply disclosing a class that includes a compound and specifically identifying the selected compound (2007 FC 455).

Another consideration is that, in affirming Floyd J.’s decision, the Court of Appeal noted that I.G. Farbenindustrie was concerned with the common law before the U.K. Patent Act was amended “to be interpreted in accordance with the EPC”. However, this jurisprudence is still applied to the selection question in Canada. Although the Court of Appeal felt it unnecessary to analyse the “nature of the approach taken in IG Farbenindustrie”, it is clear that the approach to the question of selection is no longer grounded on the same legal foundation in Canada and the U.K.