New Biologics, Old Principles

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

This decision comes via Alan Macek’s IPPractice, who reports that it is “the first biologic patent infringement trial decision of the Federal Court.” [But see update below] Despite the new subject matter, the decision is a fairly straightforward application of old principles.

The invention relates to human antibodies that bind human interleukin 12 (“IL-12"). Interleukins generally, and IL-12 in particular, were known to be implicated in immune system function [14]. Consequently, methods for inhibiting the activity of IL-12 were known to be likely candidates for treating diseases related to immune system disorders. Antibodies are components of the immune system which are capable of binding with great specificity to particular targets, such as IL-12, so one known strategy to inhibit the effect of IL-12 was to develop antibodies which would bind to IL-12, thereby blocking its function.

AbbVie’s ‘281 patent indicates that both murine and chimeric (half-human, half-murine) anti-IL-12 antibodies had previously been developed, but these antibodies themselves could provoke an undesirable immune response. Thus the problem described by the patent was to produce an entirely human anti-IL-12 antibody (p 3):

The present invention provides human antibodies that bind human IL-12. The invention also relates to the treatment or prevention of acute or chronic diseases or conditions whose pathology involves IL-12, using the human anti-IL-12 antibodies of the invention. (See similarly p 44ff)

AbbVie solved this problem. The particular antibody developed, and which is described in the patent, is referred to as J695. Accordingly, Claim 1 claims

An isolated human antibody . . . that binds to human IL-12 [with specified affinity].

However, the only claims at issue, 143 and 222, with their asserted references [45], are both to the use of anti-IL-12 antibody “to treat psoriasis” [46], [47]. Psoriasis was known to be an immune-mediated skin disease.

Janssen’s allegedly infringing product, STELARA, is a fully human anti-IL-12 antibody for use in treating psoriasis. As compared with J695, both are human anti-IL-12 antibodies with similar affinity and potency, but they were developed independently using entirely different technologies, and they have different amino acid sequences, different variable region binding sites, and they bind to different epitopes [85].

Claim construction and infringement were straightforward. Janssen argued that the claims should be construed to be restricted to antibodies created by the particular method used by AbbVie, but Hughes J had no difficulty holding that there was nothing in the claims to so restrict them [100]. This point really goes to overbreadth, not claim construction; that is, the real objection here is that if they are not so restricted, they should be invalid as overbroad, and that point was separately argued. Given this claim construction, infringement was essentially conceded [103].

Turning to obviousness, Hughes J emphasized that “the inquiry as to obviousness, includes the identification of the inventive concept of the claims” [123, his emphasis]. He concluded that “the inventive concept of claims 143 and 222 of the '281 patent is that psoriasis may be treated by the use of human antibodies that bind to human IL-12,” with the specified affinity and potentcy. I must say that I often find the Windsurfing / Pozzoli obviousness analysis not entirely helpful, in part because, as here, the identification of the inventive concept so often amounts to little more than a paraphrase of the claims. In this case, the really crucial question is, what exactly was it that was inventive about treating psoriasis with human anti-IL-12 antibodies? Was it the “human” part, or the “psoriasis” part?

So, as described above, the patent on its face suggests that the inventive step was to discover how to make human IL-12 antibodies, chimeric and murine antibodies already being known. One might imagine a world in which it was known that anti-IL-12 antibodies would treat psoriasis (perhaps because this had been done using a chimeric version), and the real trick was creating human anti-IL-12 antibodies that could treat psoriasis without an immune reaction. If that was the case, and  if the method AbbVie used to create the human anti-IL-12 antibodies was obvious, then the claimed invention, namely using those antibodies to treat psoriasis, would also be obvious. Accordingly, given the focus of the specification as a whole on the development of human antibodies, Janssen’s evidence was apparently largely directly to showing that AbbVie had used standard techniques to develop its antibodies [116].

However, this evidence was beside the point, because on the facts it turned out that there was an inventive step in discovering that anti-IL-12 antibodies would treat psoriasis. This discovery had been made, apparently fortuitously, when one of the subjects in a study looking at the effects on arthritis and related disorders had noticed that their psoriasis had disappeared [73], [136]. While this effect was understandable ex post, at least in general terms, given that psoriasis is an immune-mediated disorder, it could not have been predicted or expected ex ante, given the number and variety of cytokines which might be implicated in any particular immune disorder [133]-[137]. Thus the invention of the asserted claims was not obvious [140], because even if the creation of human anti-IL-12 antibodies was obvious, their use in treating psoriasis was not. Whether creating human anti-IL-12 antibodies was inventive was left open, as it was only the claims to the use in treating psoriasis that were in issue.

This brings us to the main question, whether the asserted claims were overbroad. Janssen’s argument here turned on the “hair on bald man” statement of Binnie J in Free World Trust 2000 SCC 66, [32]

[T]he ingenuity of the patent lies not in the identification of a desirable result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desirable result. It is not legitimate, for example, to obtain a patent for a particular method that grows hair on bald men and thereafter claim that anything that grows hair on bald men infringes.

An earlier dictum to the same effect is that of “roads to Brighton”:

It is extremely desirable that when a beneficial idea has been started by one man, he should have the benefit of his invention, and that it should not be curtailed or destroyed by another man simply improving upon that idea; but if the idea be nothing in the world more than the discovery of a road to attain a particular end, it does not at all interfere with another man discovering another road to attain that end, any more than it would be reasonable to say that if one man has a road to go to Brighton by Croydon another man shall not have a road to go to Brighton by Dorking.

Curtis v Platt (1863), 3 Ch D 135, quoted in (1995) 61 CPR(3d) 499 (FCA).

The particular technology used by AbbVie to create its human anti-IL-12 antibody was known as phage-display. Janssen’s STELARA was derived using transgenic mouse technology [85]. Janssen argued that AbbVie had developed one “road to Brighton,” but was now attempting to claim them all.

[168] Janssen argues, as a policy issue, whether “functional claiming” should be allowable. It argues that, having discovered one antibody that binds to IL-12 so as to treat psoriasis, can AbbVie claim any antibody that binds to IL-12 and treats psoriasis?

But as Hughes J pointed out:

This argument does not come to grips with the fact that AbbVie was the one who confirmed that if an antibody did bind to IL-12, then psoriasis could be treated. Before AbbVie’s confirmation there was only hope or speculation, numerous other cytokines or a combination of one or more of them might have been the proper target [168].

Returning to our metaphors, growing hair on a bald man and going to Brighton are both known to be desirable, so if there is anything inventive, it is in the particular method. In this case, in contrast, it was not known that psoriasis could be treated by IL-12, and recognizing this was the inventive step. The “hair on a bald man” statement from Sanofi begins by saying “[t]he ingenuity of the patent lies not in the identification of a desirable result but in teaching one particular means to achieve it” (my emphasis). In this case, in contrast, the ingenuity of the patent did lie in the identification of a desirable result. Rather than being a road to Brighton, it was the equivalent of an eighteenth century road from Europe to Australia. With a little historical licence, we might say that if Captain Cook was the first to discover a route to Australia, it would not be so unreasonable to give him a monopoly over all routes to Australia, given that it was not the route he really discovered, so much as the fact that Australia existed at all.

[Update: Alan has updated his blog with the following note:
[Update Jan 23, 2014: It has come to my attention that this isn't the first biologics trial decision from the Federal Court. Fifteen years ago in Kirin-Amgen Inc. v. Hoffmann-La Roche Ltd. (1999), 87 CPR (3d) 1 (FCTD), aff’d (2000), 11 CPR (4th) 78 (FCA) a patent on erythropoietin was found valid and infringed.]]