Pharmaceutical inventions have been the subject of special provisions in the past, the likes of which have not been applied to other inventions. Furthermore, pharmaceuticals are the subject of much government regulation outside of the patent system.
Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, 2015 FC 770 - Novartis was able to uphold its patent against allegations of invalidity from Teva, but not without the Federal Court making a number of razor thin distinctions between what the patent promised and what it did not.
Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 - The FCA rejected the notion adopted by the Federal Court that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction, bringing the law in line with Industry Canada proposed amendments.
AstraZeneca Canada Inc v Apotex Inc, 2015 FCA 158 - The FCA acknowledged that the word “will” often refers to an expectation or goal rather than a promise, but still held that the FC did not err in finding that a promise was made when reading the patent as a whole from the eyes of a skilled reader.
AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 - Claim 1 was worded general enough to capture Apotex’s subcoating layer even though Apotex’s subcoating layer was generated by an in situ chemical reaction, a process that the patentee had not contemplated.
ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 - The FCA confirmed that paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance Regulations) requires that a patent listed on the register requires an “exacting threshold of specificity” between what is claimed in the patent and what has been approved in the Notice of Compliance. However, proposed amendments to the PM(NOC) Regulations would reverse this holding.
Lundbeck Canada Inc v Canada (Health), 2014 FC 1049 - How should overlapping expert costs be allocated? Three parties each sought a Notice of Compliance (NOC) for the same drug, and the innovator relied on much the same expert evidence in each proceeding but costs were not precisely allocated among the three proceedings.
Eli Lilly Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 - Mylan did not infringe the ‘948 Patent because the Mylan’s tadalafil compound did not have the claimed particle size distribution and the formulation did not contain the claimed concentration of hydrophilic binder. The Court rejected two purposive arguments by Eli Lilly in favour of a more literal reading of the patent.
Alcon Canada Inc v Cobalt Pharmaceuticals Company, 2014 FC 149 - The Court examined in detail a number of experiments disclosed in the patent that were said to establish the claimed utility, but the experiments did not demonstrate or soundly predict utility for the broad ranges of molecular weight and chemical concentration claimed.
Eli Lilly Canada v Canada (Attorney General), 2014 FC 152 - This decision clearly states that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction.