Monday, May 18, 2020

Direct Infringement of Product "For Use" Claim; No Inducement of Corresponding Use Claim

Janssen Inc v Teva Canada Ltd 2020 FC 593 Manson J
             2,655,335 / paliperidone palmitate / INVEGA SUSTENNA

Last Friday’s post gave an overview of this decision. As noted, the 335 patent relates to dosing regimens for long acting injectable paliperidone palmitate formulations for treatment of schizophrenia. The 335 patent has three sets of claims: product claims (to prefilled syringes adapted for administration according to the claimed dosing regimen; use claims (“use of a dosage form” etc); and Swiss claims (“use. . . for the manufacture of a medicament”). Yesterday’s post discussed induced infringement of the use claims. This post considers the direct infringement of the product and Swiss claims.

In respect of the product claims — the prefilled syringes — Teva argued that it could not directly infringe because they all require administration in accordance with the claimed dosing regimens; and alternatively, Teva submitted even if administration to patients was not required, Teva did not direct use in accordance with the claimed dosing regimens [234].

Manson J rejected these arguments after reviewing all the essential elements of product claim and finding they were all incorporated in Teva’s proposed product [252]. Claim 1 is to “Prefilled syringes containing a depot formulation of paliperidone . . . for administration by intramuscular injection to a psychiatric patient in need of treatment for schizophrenia.” As I see it, the key issue was the meaning of “for”. Teva’s argument seems to turn on the view that this means that the syringe had to actually be used for the specified purpose for the claim to be infringed. Manson J noted that the product was “capable, approved and intended” for the specified purpose, and that was enough to bring it within the claim. That makes sense as a matter ordinary grammar: I am boiling water “for tea” if I intend to use the water for tea, even if I get distracted and never actually make myself a cup of tea. The intended use was discerned primarily from Teva’s PM. I note that this approach to a claim “for” a purpose is essentially the same as that adopted by Lord Briggs (Lord Hodge concurring) and Arnold J (as he then was) in Warner-Lambert [2018] UKSC 56 var’g [2016] EWCA Civ 1006 var’g [2015] EWHC 2548 (Pat) Arnold J: see here.

Here is a key point (my emphasis):

[253] The Teva PM teaches that the prefilled syringes to be sold by Teva can be administered in combination according to the claimed dosing regimen. While this information may not rise to the level of “instructions to infringe” sufficient to induce practitioners to prescribe and use the syringes according to the claimed dosing regimen, it is sufficient to establish direct infringement of the product claims.

That is, claims to a product for a use are different from the corresponding use claims because the PM may establish intent to influence physicians to use the product in the specified manner, even if the PM does not in fact cause the physicians to use the product in the specified manner; the former is all that is necessary to establish direct infringement of a claim to a product “for” a specified purpose, while the latter is necessary to establish induced infringement of a use claim.

Turning to the Swiss-form claims, it is well known that Swiss claims were first developed as an end-run around the prohibition in European law on patenting methods of medical treatment. In form, they are a claim to a product, though they are intended to protect a use. As a result, in Novartis 2013 FC 985 Hughes J held that the court “should disregard the artificial nature of a Swiss claim and look at what is the real subject matter of the claim” [101]. In effect, Hughes J held that a Swiss claim should be construed as a use claim, even though, on its face, it is a product claim. Consequently, Hughes J held the claims at issue to be unpatentable methods of medical treatment [101]. In this case, Manson J took a different approach. He held that Swiss claims should be construed on the same principle as any other claim, namely as it would be understood by a skilled person [161], and consequently “The Swiss-type claims are capable of infringement if the medicament is adapted for administration to a psychiatric patient in need of treatment, according to the claimed dosing regimen” [163]. Consequently, the Swiss claims of the patent were directly infringed for the same reason that the product claims were directly infringed [256]. Manson J’s approach strikes as preferable. To the extent that Swiss form claims are objectionable as being an end-run around the prohibition on patenting methods of medical treatment, this should be addressed in the substantive law of subject-matter eligibility, rather than through a distorted construction of the claim itself.

With that in mind, there are two other minor points worth noting.

First, Manson J reiterated the need for clarification of the prohibition on patenting methods of medical treatment, though he noted that nothing turned on it in this case [143].

Second, Manson J admitted evidence of the prosecution history to rebut Janssen’s proposed claim construction on a particular point [140-42]. However, this had no effect on the result, as the plain meaning of the claim language supported the same construction as the prosecution history [140]. In effect, the claim on its face said X, during prosecution Janssen asserted that it meant X, the patent examiner evidently accepted that it meant X, but at trial Janssen asserted that it meant Y. This illustrates why the use of prosecution history can add needless complexity to a case; in establishing that a claim does indeed mean what it says on its face, it is not particularly helpful to go back and show that during prosecution the patentee agreed that it meant what it says on its face.

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