Canada’s pharmaceutical industry is characterized by continuous innovation, strong market competition and significant government regulation. The industry is a key contributor to Canada’s overall economy through its development and manufacturing of medicines, which include both small molecule drugs and, increasingly, complex biopharmaceuticals (biologics). Industry participants are subject to myriad legislation prescribed under the Food and Drugs Act, Patented Medicine Prices Review Board (PMPRB) guidelines and Patented Medicines (Notice of Compliance) regulations, amongst others, all of which are continually evolving and being amended. As well, due to the significant amount of investment in commercialized products, enforcement of intellectual property plays an important role in the sector and there is a considerable degree of litigation between pharmaceutical patent holders and generic/biosimilar manufacturers.
CHS has routinely acted as financial experts in disputes involving the world’s largest pharmaceutical companies. We have been retained in numerous pharmaceutical patent cases to prepare analyses of both damages/lost profits and accounting of defendant’s profits resulting from the infringement or alleged infringement. We have also been retained on numerous Section 8 PM(NOC) proceedings in Canada for which we prepared an expert report quantifying the generic pharmaceutical company’s lost profits. Our involvement in these matters has included assisting with identification of relevant financial documents, providing questions related to financial/accounting issues for discovery, preparing exposure assessments, preparing expert witness reports including critique of findings/conclusions from opposing experts and providing expert testimony at trial.
Some of the noteworthy remedies cases with which we have been involved and which are a matter of public record include Janssen v. Teva (Levaquin), Astrazeneca v. Apotex (Losec), Servier and ADIR v. Apotex (Perindopril), Apotex ats Sanofi-Aventis (Ramipril), Teva ats Sanofi-Aventis (Ramipril), and Apotex ats Merck (Alendronate).
2017 FC 726Patent infringement and Section 8 matters involving the pharmaceutical drug LOSEC (active pharmaceutical ingredient – omeprazole) heard in the Federal Court of Canada.Learn More
2012 FC 552 / 2012 FC 553Quantification of generic pharmaceuticals’ lost profits under Section 8 of PM(NOC) Regulations involving pharmaceutical drug ALTACE (active pharmaceutical ingredient – ramipril).Learn More
2017 ONSC 1323; 2019 ONCA 23Major damages assessment involving the Defendant’s breach of contract in failing to provide proper bioequivalence studies which caused delays in the Plaintiff’s entry into the U.S. market for certain ...Learn More
Detailed review of Claimant’s disclosures made in support of calculations and characterizations of royalties earned on sales of ground-breaking pharmaceutical products.Learn More