Wednesday, March 23, 2022

What Does “For” Mean?

Allergan Inc v Apotex Inc 2022 FC 260 Kane J

2,602,188 / risedronate / ACTONEL DR

As noted in my last post, the 188 patent at issue in this case claims a dosage form of a bisphosphonate “for use with or without food” in treating osteoporosis. The product monograph for Apotex’s product—like Allergan’s—provided that it was to be taken with food. Consequently, Allergan argued that “for” product claim is normally construed as meaning “suitable for”, relying on MacOdrum, Fox 5th ed ch 8.9(c) (§ 8:57 in 2/2022 update I have) and cases cited therein [182], [901]. The idea is that Apotex’s product is suitable for administration with or without food, in the sense that it would be effective in treating even if, in light of the product monograph, it are not intended for that purpose. Kane J rejected this, essentially on the basis that even if “for” is normally interpreted as “suitable for”, that is not strict rule, but rather, as MacOdrum notes, it is at best a generalization that should be cautiously applied [903]. Instead, as discussed in my last post, she held that in the context of the 188 patent, “for” should be construed as effectively meaning ‘intended for’. That’s enough to dispose of the point in this case, but since I read a number of cases on the interpretation of “for”, in this post I will discuss the issue more broadly.

The cases reveal a few possible meanings for “for”:

(1) suitable for;

            (2) actually used for;

(3) intended for;

            (4) suitable and intended for.

I’ll argue that many of the authorities cited for the proposition that “for” means ‘suitable for’, actually stand for the proposition that “for” does not mean ‘actually used for’. Such holdings are not inconsistent with construing ‘for’ as meaning ‘intended for’ or ‘suitable and intended for.’ While I did not exhaustively review the cases, the cases I did read can largely be reconciled by interpreting ‘for’ as meaning ‘suitable and intended for.’

There does not appear to be much Canadian authority explicitly addressing the meaning of “for” (though there are of course many Canadian cases construing claims with “for” in them). All of the authorities cited by MacOdrum are English. The conventional view in UK law is that “for” means ‘suitable for’, with an exception for second medical use claims, where “for” means ‘intended for’: see Virgin v Delta [2011] EWCA Civ 162 [19]–[23], providing a list of cases; FNM v Drammock [2009] EWHC 1294 (Pat) [56]-[74]; EPO Guidelines § 4.13.1. The second medical use exception is explained as an ad hoc departure from the general rule because of the need to allow second medical use claims: see FNM [2009] EWHC 1294 (Pat) [60]–[72]; EPO Guidelines § 4.13.1 last sentence.

As noted in Zeno [2009] EWHC 1829 (Pat) [26], the origin of the rule appears to be Adhesive Dry Mounting v Trapp (1910) 27 RPC 341 (Ch) 352–53. In Adhesive Dry Mounting, the question is whether “for” should be construed as meaning ‘suitable for’ or as meaning ‘when actually used for.’ The claim was “For carrying into practice the process [specified] a pellicle [as specified]” and the question was

whether it claims the pellicle therein described, or merely the use of this pellicle in the process claimed in the first Claiming Clause. If the former, the Letters Patent would entitle the Patentees to prevent the use of such a pellicle by others, whatever might be the purpose for which it was used. If the latter, the Letters Patent would only entitle the Patentees to restrain the use of such a pellicle in any process substantially the same as the process referred to in the first Claiming Clause.

Parker J chose the former construction, in part because another claim was to the process, and the claim at issue would be largely redundant if it was to the pellicle only when used in the process. Of the cases listed in Virgin v Delta, Insituform v Inliner [1992] RPC 83 (Pat) 95–96, Coflexip v Stolt [2000] EWCA Civ 242 [23]–[27] and Vericore v Vetrepharm [2003] EWHC 1877 (Ch) [15] were also cases in which the question was also whether “for” should be construed as meaning ‘suitable for’ or as meaning ‘when actually used for,’ and in all cases the court held “suitable for” was correct. I have not read any case in which “for” on its own was construed as meaning ‘when actually used for’ and this point seems well-established, at least as a strong presumption.

Every case must be read in light of the arguments before the court, and cases holding only that “for” should be construed as meaning ‘suitable for’ rather than ‘actually used for’, are not good authority for the proposition that it should be construed as meaning ‘suitable for’ rather than ‘intended for.’ The caselaw is more equivocal on the whether “for” means ‘suitable for’, or ‘intended for’—or perhaps even ‘suitable and intended for’. This was acknowledged by the EWCA in Virgin v Delta at [23], in which Jacob LJ noted that “in Zeno Lewison J seemed a little sceptical about this rule of construction. He wondered, having only been shown Adhesive Dry Mounting and Coflexip, whether for might not be construed as intended for at least in some cases depending on the specification as a whole.” The EWCA went on to note that in second medical use cases it usually does mean ‘intended for’, and then remarked that “even then the claim would mean suitable and intended for” [23]. The EWCA did not explore the possibility further, as it made no difference on the facts.

The EPO Guidelines § 4.13.1 does say that “for” means ‘suitable for’, but the main point is that an apparatus which is not suitable for the stated purpose “is normally not considered as anticipating the claim.” It is sensible to say that a claim “for” some purpose does not encompasses a thing that is unsuitable for that purpose; but that does not imply that “for” means ‘suitable for’. In particular, that view is also consistent with construing “for” as ‘suitable and intended for.’ (There is a separate question as to what ‘suitable for’ means–see eg Bühler v Satake [1997] RPC 232, 239-240—and much of the discussion in MacOdrum is taken up with this point.)

If “for” means ‘suitable and intended for’, both terms play a role. A device that is intended for the claimed purpose but is not suitable for it, would neither infringe nor anticipate. That much seems uncontroversial. A device that is suitable for the claimed purpose would not infringe unless also intended for that purpose. Leaving aside medical use claims for the moment, would a product or apparatus that was suitable for a particular use, but not intended for that use, anticipate a claim to the product or apparatus for that particular use, if the use of the product for that purpose was new and non-obvious? The EPO Guidelines § 4.13.1 say it would—“if the known product is in a form in which it is in fact suitable for the stated use, though it has never been described for that use, it deprives the claim of novelty”—but cites no cases. Moreover, the Guidelines then go on to acknowledge that a claim to a known substance for medical use is an exception—an exception which largely swallows the rule. And as a matter of principle, if disclosure of a compound does not anticipate a claim to the use of that compound for a medical use, why would it anticipate a claim to the use of that compound for a non-medical use? If Compound X is known in the prior art, but no uses are known, it is a bit odd to say that a claim to “Compound X for use in treating psoriasis” is valid, but “Compound X for use as a herbicide” is invalid. Drawing a distinction between a compound and a device seems similarly unprincipled.

This point was tangentially addressed in Adhesive Dry Mounting. Parker J held at 353 that “for” was to be interpreted as meaning ‘suitable for’ and consequently, he held that the claim was anticipated by a prior art patent which disclosed the same type of pellicle, even though the prior art did not suggest that it could be used for the specified purpose:

But after [the prior art patent] it was open to all the world to make and sell such a material. The idea of using an old material for an entirely new purpose, not being analogous to purposes for which it has theretofore been used, may be good subject-matter, but such idea, however ingenious, can hardly justify a claim for the material itself.

But if “for” is construed as ‘suitable and intended for’, then a claim to an old material for a new use is not a claim to the material itself. Parker J seems not to have contemplated the possibility that it might be construed to mean ‘intended for’.

While second medical use claims are now well-established, second use claims more generally are also established, though less common in practice. In the well-known cases of Hickton's Patent (1909) 26 RPC 339 (CA), cited with approval in Shell Oil [1982] 2 SCR 536, 550, the invention was for a method of equalizing thread usage on lace making machines. Some sections of lace are thick with thread while others are quite open, with the result that some bobbins would use up their thread more quickly than others. Equalization had previously been accomplished by interchanging the bobbins by hand, but this saved thread only by wasting time. Hickton’s invention was to equalize by occasional “shogging” or sideways shifting of the bobbins relative to the carriers, so that a bobbin initially used for a thick part of the pattern would be shifted to a more open section. Shogging itself was not new, as it was used in some types of machines to create the lace pattern itself. Hickton’s innovation was to realize that shogging could be used to equalize thread usage. Claim 1 was to shogging “for the purpose of” equalising [thread consumption], and Claim 2 was to a “means” for the same purpose; in other words, to an old process and old device for a new purpose. These claims were held to be valid.

Zeno [2009] EWHC 1829 (Pat) also raises the issue. The patent claimed a device “for the local thermal treatment of insect stings” by means of heat. The allegedly infringing ‘Zeno’ device was for the treatment of acne by means of the application of heat, with a specified temperature range and time interval. The argument was that the Zeno infringed because it was suitable for the treatment of insect stings, even though it was not intended for that purpose. In the circumstances, it is understandable that Lewison J expressed skepticism of the rule that “for” should be interpreted as ‘suitable for’. While he was “content” to proceed on that assumption, he found that the Zeno was non-infringing because it was not capable of being operated within the specified range and time interval [59]–[65]; we should not infer that he would necessarily have been content to accept that construction if it had affected the outcome.

I note that in Corevalve v Edwards Lifesciences [2009] EWHC 6 (Pat) Mr Prescott QC, stated that “if a piece of prior art is as a practical fact capable of being used for a certain purpose, it may anticipate a patent claim even though it would never occur to anyone so to use it,” citing Adhesive Drive Mounting as an example, and citing no other authority. I suppose it is true to say that a product suitable for a purpose “may” anticipate a claim for that purpose, but it would be wrong to say that it “will” anticipate, as Hickton’s Patent illustrates. As discussed, Adhesive Drive Mounting is weak authority, as it does not consider whether intend might be relevant to a claim “for” a purpose, but simply assumes that it is equivalent to a claim to the product itself. And the discussion in Corevalve was merely preliminary dicta in any event; the defendants device was not only suitable for, but also intended for, the specified purpose, and it was held not to infringe because it did not incorporated an entirely separate element [62]–[65].

To summarize, the cases I have looked at are generally consistent with construing ‘for’ as meaning ‘suitable and intended for.” In Delta v Virgin, for example, the claim was to a passenger seating system “for an aircraft” and the question was whether this encompassed the defendant seating system kits, prior to their actual installation; the EWCA held that it should, on the view that a system “for an aircraft” should be construed as meaning a system suitable for an aircraft, and not as being limited to a system when actually fitted on an aircraft [24]. There was no question that the defendant’s system was intended for use on an aircraft. In FNM v Drammock [2009] EWHC 1294 (Pat) the claim was to a composition for use as a cooling spray [20]. Arnold J construed this as meaning suitable for use as such, but this does not appear to have made any difference to his conclusion that the invention was anticipated, as the anticipatory prior art expressly identified use as a cooling spray, or gave examples to that effect—see [170], [175], [180], [184].

Finally I’ll come back to medical use claims. Three of these were raised in argument, namely Sanofi-Aventis v Novopharm / ramipril 2007 FCA 167, AB Hassle 2001 FCT 1264 affd 2002 FCA 421, and Bristol-Myers Squibb 2017 FC 1061. Kane J distinguished AB Hassle by saying the claims

[878] are not similar to the claims at issue. As noted by the Court, there were no claims for the compound, unlike the present case. The claim at issue in AB Hassle was only the use to treat a condition previously not claimed as a use. AB Hassle dealt with the more typical scenario of a claim for the new use of an existing compound or product.

The discussion of the other two cases was to a similar effect. As I understand it, Kane J’s point is that these are not simply claims to a compound “for” a particular purpose, but claims to the “use. . . for”. (Claim 1 of the 668 patent in AB Hassle and Claim 1 of the Bristol-Myers Squibb 496 patent were Swiss-from to “Use of [compound] for the manufacture / production of a medicament for / effective in the treatment of [specified disorder]. Claim 1 of the Ramipril 089 patent was to a compound “for administration”, which is similar to a use claim.) So, while “for” might be interpreted as ‘suitable or intended’, the “use” or “administration” elements additionally implies actual use. This seems right to me. If “use. . . for” merely meant ‘suitable for’ or ‘suitable and intended for’, a generic selling a drug for the specified purpose, in the sense that the product monograph specified the claimed purpose, would be liable as a direct infringer; but this situation is invariably treated as a matter of inducement, which implies the actual use constitutes the direct infringement.

In any event, I’ve gone on much longer than I had intended on this point, given that Kane J’s holding ultimately turned on her construction of the specific patent, which, as noted in my previous post, is in an somewhat unusual form. I won’t go on to review every case I looked at in detail, and in any event, I didn’t attempt to track down all the relevant cases. What I will say is that the cases I did review are consistent with construing “for” as meaning ‘suitable and intended for.’ This interpretation of “for” has the advantage that second medical use claims need not be seen as an unprincipled outlier, though subject to the observations about the meaning of “use”.

2 comments:

  1. Interesting thoughts on the meaning of "for" in patent claims, although I fear that there will always be a squabble in court on the point. Anyway, for what it is worth, the UK Supreme Court in Warner Lambert v Generics (Mylan) & Actavis (Pregabalin/Lyrica),[2018] UKSC 56, completely agrees with your interpretation, see for instance paragraph 67.

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