On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Apotex for its lisdexamfetamine (LDX) product (Shire’s VYVANSE) until the expiry of Canadian Patent No. 2,527,646 (646 Patent): Apotex Inc v Shire LLC, 2018 FC 637. The prohibition application had been consolidated with Apotex’s action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in the action. In addition to granting the Order of prohibition, the Court dismissed both Apotex’s action for impeachment of the 646 Patent and Shire’s counterclaim for infringement based on Apotex’s experimental/RxIP - Regulatory use defence. Under the current PMNOC Regulations, which took effect on September 21, 2017, such “dual” litigation no longer exists.
LDX is a prodrug of amphetamine. The 646 Patent claims LDX, compositions containing LDX, and uses of LDX, and addresses the need for a sustained release dosage form of amphetamine that is resistant to abuse.
Shire’s VYVANSE is approved for treatment of Attention Deficit Hyperactivity Disorder and Binge Eating Disorder in adults.
Foreign proceedings not “instructive”
Shire encouraged the Court to view proceedings in other jurisdictions addressing the validity of patents corresponding to the 646 Patent as “instructive”. Justice Fothergill declined to rely on these decisions, accepting Apotex’s view that the Court must decide the issues “in accordance with the factual record and Canada’s own laws.”
The validity analysis below applies equally to Apotex’s action for impeachment of the 646 Patent and Shire’s application for a prohibition order.
Anticipation: The Court found that the claims at issue were not anticipated by Australian Patent No. 54168/65, which disclosed a “very large class of d-, l-, and dl-amphetamine amino acid conjugates”, including LDX. LDX fell within the “advantageous” subgroup, but not the “especially advantageous” subgroup of compounds in the Australian patent. It was unclear whether the skilled person would understand the compounds in the Australian patent to be prodrugs; they were never manufactured or tested and the patent did not address how they would function. No manufacturing process for LDX was disclosed. The advantageous properties of LDX (sustained release and reduced potential for abuse) were not discussed in relation to the compounds in the Australian patent.
The Court held that while it was “left in some doubt” whether the patent was a selection patent, nothing turned on this point.
Obviousness: The Court concluded that the claims at issue were not obvious.
Justice Fothergill determined the inventive concept of the claims at issue, expressly declining the opportunity to construe the claims instead (as suggested by the Federal Court of Appeal in Ciba Specialty Chemicals Water Treatments Limited v SNF Inc, 2017 FCA 225 (Ciba)), finding that Ciba did not overturn the Supreme Court’s decision in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, by discarding “inventive concept”. The Court found the inventive concept of the claims at issue could be “grasped without difficulty”: “a sustained release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse.”
The Court concluded that the key difference between the state of the art and the inventive concept is the compound LDX and its advantageous properties. At the relevant time, “no prodrug had yet been developed as a means of reducing abuse potential”, and there was no suggestion in the prior art that prodrugs could solve this problem. Even to the extent that prodrugs were known, “use of prodrugs to achieve sustained release was unpredictable and complex.” Prodrug development was “expensive and time-consuming”, consistent with the “extensive work” performed by the inventors. LDX was not obvious to try because its properties could not be known without testing, whether or not such testing was “routine”.
Insufficiency: Apotex argued that the 646 Patent was insufficient for failing to teach that only certain forms of the hydrochloride salt of LDX can be isolated and only the mesylate salt was likely to be useful for solid oral dosage forms. The Court disagreed, finding that the compounds captured by the claims at issue could be made by the skilled person following the 646 Patent. The invention “does not relate to scale-up synthesis or to a particular crystal form of LDX” and the skilled person would be capable of making the compounds simply by following the patent.
While not impacting the prohibition application, Shire’s counterclaim for infringement was dismissed on the basis that Apotex satisfied the exception for experimental or RxIP - Regulatory use. The Court accepted Apotex’s evidence that it obtained LDX for experimental or RxIP - Regulatory purposes, despite the large number of capsules made by Apotex and the fact that it retained an inventory of close to 1 million capsules. According to Apotex’s witness, the remaining inventory would be used for research and demonstration batches and, per an internal policy, not sold commercially.
Apotex may appeal, as of right.
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