NOC Cases

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited, 2015 FC 770
Drug: EXJADE®  deferasirox

Novartis has obtained an order prohibiting the Minister from providing an NOC to Teva for EXJADE®. At the hearing, the issues were narrowed by Teva who alleged the patent was invalid for inutility, obviousness and insufficiency.

The Court declined to find a single explicit and overarching promise that the compounds described in it have been found to be useful in treating iron overload disorders in humans. Instead, the promise of the compound claims was found to be more modest: the compounds markedly bind to iron, are soluble and induce excretion of iron in animal tests. Although Teva’s promise was a possible construction, it was not found to be the most likely.

On the other hand, the claims to the use to treat humans were considered to contain an explicit promise of a specific result. This was not found to have been demonstrated or soundly predicted as of the filing date, and therefore the use claims fell.

The patent was also not found to be obvious. Some of the alleged prior art was found to have been published in obscure journals and likely would not have been located by the skilled person looking for iron chelators. In any event, although it was possible some of the prior art compounds could have bound to iron, it would not be obvious that they would do so. The Court also noted that the inventors spent many years testing hundreds  of compounds. This also suggested to the Court that the inventive concept was far from obvious, and there was nothing in the prior art that would suggest that this class of compounds was even obvious to try.

Lastly, the patent was found to be sufficient. The Court found that the patent described the invention and told the skilled person how to put it into practice. Although a rat died after taking one of the claimed compounds, there was no evidence that the compound was toxic. In the absence of evidence of toxicity, the Court held that the inventors had no obligation to inform the skilled reader about that isolated event.

Infringement  Cases

AstraZeneca Canada Inc. v. Apotex Inc., 2015 FC 671
Drug: omeprazole

The parties moved under Rule 397 to modify the terms of the judgment in the proceeding, previously reported as 2015 FC 322 and summarized in our newsletter the week of April 13, 2015.

The judgement refers to Apotex’s infringing composition as “Apo-Omeprazole”, which is the trade name for Canada. To avoid any confusion that the judgment may have intended to limit AstraZeneca’s claims to damages solely to Canada, the Court replaced “Apo-Omeprazole” with “its Omeprazole capsule products, including its coated Omeprazole pellets”.

Other changes included the mention of AstraZeneca’s right to elect profits or damages, the dismissal of the claim to punitive damages, and providing that the determination of any interest paid will be left to the consolidated hearing Judge.

Other Industry News

The amendments to the Patented Medicines (Notice of Compliance) Regulations are now in force. The RIAS states in part that, “the purpose of these amendments is to restore the policy intent of the PM(NOC)Regulations by providing rules for the interpretation of the eligibility requirements for listing patents on the patent register in respect of combination drugs in a manner that is consistent with the purpose of the PM(NOC)Regulations and the authority under which they are made.”

CIPO has released revised Chapters 5, 6, 13, 20 and 24 of the MOPOP.

CIPO has published a Patent Notice: Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02.

Health Canada has published a Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products. The consultation period is stated to be open until August 25, 2015.

Health Canada has published a Consultation on the Draft Guidance Document: Harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application. The consultation period is stated to be open until August 1, 2015.

Health Canada has published a Notice: Adoption of ICH Footnote 1 Guidance: E7 Q&A: Studies in Support of Special Populations: Geriatrics, Questions & Answers and a Guidance Document.

Health Canada has published a Notice: Interim Policy on Health Canada’s Interpretation of Medicinal Ingredient.

Health Canada has published a Guidance Document – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Impurities in New Drug Products ICH Topic Q3B(R2).

Health Canada has adopted the ICH Guidance: Q5E: Comparability Of Biotechnological/Biological Products Subject To Changes In Their Manufacturing Process.

Health Canada has published a Policy on Changes in Manufacturer’s Name and/or Product Name.

Health Canada has finalized the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

Authors

Chantal Saunders 
CSaunders@blg.com
613.369.4783

Beverley Moore 
BMoore@blg.com
613.369.4784

Adrian J. Howard 
AJHoward@blg.com
613.787.3557

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