Pharmaceutical Patent

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.

September 16, 2015

FC Finds Novartis Patent Promises a Mechanism of Action, not a Treatment

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.
September 15, 2015

FCA Rejects “Exact Matching” Requirement in PM(NOC) Regulations

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.
September 9, 2015

The Word “will” can Indicate a Patent Promise, not an Expectation

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.
September 2, 2015

In Situ Reaction Cannot Avoid AstraZeneca’s Product Claim

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.
May 21, 2015

FCA Upholds Gilead Product Specificity Requirement

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.
May 20, 2015

PM(NOC) Amendments to Reverse Gilead and Viiv Decisions Regarding Product Specificity Requirement for Combination Drugs

The proposed amendments would dispose of the product specificity requirement that was interpreted by the Federal Court of Appeal in paragraphs 4(2)(a) and 4(2)(b) of the PM(NOC) Regulations.
May 13, 2015

Cobalt gets Overlapping Costs Reduced in PM(NOC) Proceeding

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.
March 24, 2015

Mylan-Tadalafil does not Infringe Eli Lilly’s Formulation Patent in NOC Proceeding

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.
March 3, 2015

Physical Stability Experiments did not Adequately Demonstrate or Soundly Predict Utility for Overbroad Eye Drop 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.
February 25, 2015

Federal Court Upholds Gap between Claim Construction and PM(NOC) Product Specificity Requirement for Combination Drugs

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.