Friday, July 20, 2012

What Is the Difference Between Dosage Form and a Device?

Novartis Pharmaceuticals Canada Inc v Canada (Attorney General) 2012 FC 836 Martineau J
Pat No. 2,304,819; Tobi Podhaler®

My previous post discussed the product specificity aspect of this decision. An interesting point is also raised in respect of para 4(2)(c), which allows listing if the patent contains a claim for the dosage form. According to the RIAS to the 2006 amendments introducing the new listing requirements, a claim for a dosage form

must contain a claim that includes within its scope the approved medicinal ingredient. This latter requirement is meant to ensure that a patent directed solely to a device, such as an intravenous stand or a syringe, does not meet the definition of "dosage form" and remains ineligible for listing.

The ‘819 patent does claim a medicinal ingredient in generic terms such as “bioactive agent” and “antibiotic,” and presumably the product specificity requirement would have been satisfied if it had explicitly listed tobramycin. But even apart from the requirement of product specificity, there is still the question of whether the ‘819 patent claims a dosage form. To my mind, the perforated microparticles of the ‘819 patent are somewhere near the boundary of a dosage form and a device. Martineau J addressed this by saying:

[64] There is no doubt that the approved dosage form of Tobi Podhaler is more complex and more nuanced than an intravenous stand or a syringe. However, the rationale remains the same because the delivery system on the grounds of which the applicant seeks to list the ‘819 patent, including its different components, is one that can be used in association with a broad range of medicinal ingredients and is therefore insufficient to help the ‘819 patent qualify under paragraph 4(2)(c) of the Regulations.

This indicates that a broadly applicable delivery vehicle cannot be listed, even if it specifically refers to medical ingredients. This is a reasonable interpretation of the provision. Presumably the intent of the Regulations is that a patent for a new syringe could not be listed, even if it was claimed “for the purpose of delivering a bioactive agent.” But on the other hand, the RIAS explains that para 4(2)(c) was included because

the Government has come to the view that inventions in this area merit the special protection of the PM(NOC) Regulations. This is particularly true where biologic drugs are concerned, as effective administration of the medicinal ingredient is often dependent on the development of new and innovative delivery mechanisms.

If new and innovative delivery mechanisms are worthy of protection under the Regulations, why is a new and innovative delivery mechanisms excluded from listing simply because it can be used with a wide range of drugs? Arguably a delivery system that can be widely used is even more deserving of protection that one that is tailored to a particular drug. Perhaps the objection is that it would be wrong to allow a patent for a new delivery system to trigger the statutory stay for every new drug, simply because the drug could be delivered by that delivery system. This is a fair point, but it seems to me that it could be accommodated by a requirement that the delivery system would certainly or almost certainly be used (and so infringed) in order to be listed against a particular product. It must also be acknowledged that simply because the NOC Regulations exist, does not mean that they should apply to every type of patent, even if it is one that would necessarily be infringed, as the patent holder can always turn to an infringement action. But these kinds of questions make it difficult to see what general principle underlies the listing requirements.

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