Friday, January 22, 2016

Role of Product Monograph in Inducing Infringement

Bayer Inc. v. Pharmaceutical Partners of Canada Inc. / moxifloxacin (NOC) 2015 FC 797 Strickland J aff’d 2016 FCA 13 Stratas JA (sub nom Bayer Inc v Fresenius Kabi Canada Ltd) aff’g 2015 FC 388 Lafrenière J
            2,378,424 / moxifloxacin / AVELOX IV

In Wednesday’s post I noted that it was difficult to put FCA’s holding in this case in context, without the benefit of Strickland J’s FC decision. Today, the court has belatedly released Strickand J’s decision, which is indeed very helpful.

As outlined in my previous post, the ‘424 patent is a formulation patent claiming an aqueous formulation of moxifloxacin and from 0.4% to 0.9% (w/v) of sodium chloride [6]. The moxifloxacin for injection product for which PPC (since rebranded to Fresenius Kabi Canada) was seeking an NOC is capable of being used post-sale to make the formulation, though it can also be used for non-infringing uses. In the motion giving rise to this appeal, Lafrenière J struck the portions of Bayer’s application for an order of prohibition alleging infringement or inducing the infringement of the ‘424 patent. Only the inducement issue was appealed [4].

As discussed at length in my post on Lafrenière J’s decision, the law of inducement raises some very difficult issues in a case such as this one where the allegedly infringing product is capable of both infringing and non-infringing uses. On the one hand, the public should not be denied the benefit of competition for non-infringing uses, but on the other hand, the patentee should be able to effectively enforce its patent rights. Because of the first consideration, if a product is capable of substantial non-infringing use, the mere fact that it can also be put to an infringing use, or even that it will inevitably be put to an infringing use in some instances, is not sufficient to establish infringement. As the FCA explained in AB Hassle v Apotex / omeprazole, 2002 FCA 421:

[57] Thus Apotex cannot be prevented from obtaining a NOC solely on the basis that it will sell omeprazole. If it were otherwise, then serious policy issues would arise. If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost.

For this reason, even though the generic’s sale of its product might inevitably result in direct infringement by another party, “something more” is required to establish that the generic has induced infringement [49]. Under the second branch of the test in Corlac v Weatherford 2011 FCA 228, [162], there must be some act by the accused inducer which can be said to be the cause the direct infringement. That act may consist of instructions accompanying the product which direct or instruct the purchaser to use the product in an infringing manner, as with the instruction manual included in the package of parts shipped to the purchaser in Windsurfing, which instructed the purchaser to do only one thing with the enclosed parts, namely to assemble them into an infringing windsurfer.

It is now well established in Canadian law that product instructions can constitute the necessary act of inducement, as in Windsurfing, where the sole and inevitable result of carrying out the enclosed instructions was to construct an infringing windsurfer. But in less extreme cases, where the product has substantial non-infringing uses and the directions are more equivocal, the question as to whether the instructions constitute inducement is fact specific.

In the pharmaceutical context, the product monograph corresponds to the product instructions more generally, and it may suffice to establish inducement: 2007 FCA 167, [11]. But whether a particular monograph does actually constitute inducement is a matter of fact, and there is no bright line rule. Even “subtle” references in a monograph may cumulatively establish inducement, as in Genpharm 2003 FC 1443 [155] aff'd 2004 FCA 413; and see also Abbott Laboratories 2006 FC 1411 aff’d 2007 FCA 251. But on the other hand “an inducement to infringe generally cannot be inferred from a mere reference to the new use in the product monograph, for example, in the course of explaining contraindications or drug interactions, or as part of a list of scientific references” Sanofi-Aventis v Novopharm 2007 FCA 167 [11] rev’g 2006 FC 1547; and see also Lundbeck v Ratiopharm 2009 FC 1102.

In this case, the key passage was one in which the product monograph described PPC’s moxifloxacin injection product as being “compatible” with six different intravenous solutions, one of which, sodium chloride, would have resulting in an infringing formulation:

Moxifloxacin injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:

•→0.9% Sodium Chloride Injection, USP
•→IM Sodium Chloride Injection
•→5% Dextrose Injection, USP
•→Sterile Water for Injection, USP
•→10% Dextrose for Injection, USP
•→Lactated Ringer’s for Injection

Strickland J held that “the PPC Product Monograph does not direct nor does it instruct the co-administration of PPC-Moxifloxacin with 0.9% sodium chloride. It merely identifies that it is compatible with that solution” [61] (and see also [65]), and this therefore did not rise to inducement. Strickland J distinguished Genpharm and Abbott Laboratories on the facts.

While it is always difficult to compare different factual situations, in my view, Strickland J’s finding is consistent with the prior case law. The product monographs in Genpharm and Abbott Laboratories went further toward encouraging or instructing the infringing use, and the statement in this case was closer the passing references disparaged in statements in Sanofi-Aventis.

We now have a number of cases assessing inducement by statements in the product monograph, and it seems to me that on the whole the law is reasonably coherent and consistent, though fact-specific. Statements in a product monograph may suffice to establish inducement, but not any reference to an infringing use will suffice; the references in the product monograph must pass a threshold before they was be sufficient on their own to establish inducement. While there is no specific verbal formulation for that threshold, the cases strike me as being reasonably consistent in that statements that have been held to establish inducement have pointed more strongly to the infringing use that those where the inducement argument has failed.

On a final point, Strickland J made the following remarks almost in passing (my emphasis):

[65] Bayer has also submitted that PPC should have refrained from including 0.9% sodium chloride in the PPC Product Monograph. However, as seen from the above, Dr. Dresser’s Affidavit clearly states that the list of compatibilities with other drugs or solutions “is required to be set out in the Product Monograph” (Dresser Affidavit at para 12). Therefore, omitting this information was not an option open to PPC. Nor do I view the stating of this necessary information as encouraging or directing infringement.

If it is true that the impugned statement is required for marketing authorization, this strikes me as a very strong argument in favour of saying there is no inducement. The central problem of the law of inducement is to ensure that the public is not deprived of the product for the non-infringing uses. If the statement that is relied on as establishing inducement must be included for the product to be sold, then a finding of inducement would mean that the public would necessarily be deprived entirely of the non-infringing uses. In such a case, there is a strong argument that it is better to leave the patentee to its remedy in direct infringement, or to require it to establish inducement by other facts, such as direct marketing.

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