Canada’s pernicious ” Promise Doctrine” has been upheld by a NAFTA tribunal in which Eli Lilly claimed that Canada’s unique judicially-created “promise doctrine” by which patented subject matter is strictly held to the application predicted specifics of its patent application claim even though new uses have emerged since its development and use. In contrast to SCOTUS “over-broad” concerns underlying continuing US patent eligibility, Canada’s unique requirement that the “promise” (i.e. its described future post development use) creates and absolute limitation on its enforceability for any other use. So, if a patent claim describes a process to prevent apples from quickly turning brown when cut can be similarly used for pears, its patent protection applies only to apples.
Driven by Canadian generic drug makers seeking to narrow patent protection, the doctrine is inconsistent with AIA mandated First to File patent prosecution requirements which compel early applications to assure patent protection for early stage innovation. But often during its development and use the method to accomplish A. is later found to accomplish B as well. In virtually all other patent venues the A. Patent would provide exclusivity protection to its applicability to B.
It has long been hoped that Canada’s new regime would find a way to settle this dispute before its doctrine’s “absolute specificity” spreads to countries like India where generics also exercise huge influence. Combined with Canada’s refusal to exercise supervisory concern over counterfeit foreign-made drugs passing through its borders on the way to US distribution, which, by the way, Sen. Sanders seeks to sanction with his “importation” bill, proposal”) Canada’s patent finagling has become a threat to US commerce as well as US citizen health and safety.
(See Politico Report below)
” CANADA SCORES ISDS VICTORY OVER ELI LILLY: Canada has prevailed over pharmaceutical giant Eli Lilly in a long-running investor-state dispute the drug company filed under NAFTA’s investment chapter, a Canadian government spokeswoman confirmed to POLITICO.
“The government of Canada welcomes the tribunal’s decision in this case,” a foreign ministry spokeswoman said in a statement.
The full decision of the tribunal, which was rendered on March 16, and the amount it awarded Canada in the case hasn’t been released yet. What’s clear is Eli Lilly failed to successfully challenge Canada’s law compelling drug companies to prove “utility” or usefulness of a pharmaceutical in the face of a patent challenge from a generic competitor.
Eli Lilly, which sought $500 million in damages, had not merely challenged the law but rather the way courts set the legal standard for utility on two of its pharmaceutical products. The Indianapolis-based company argued that the Canadian courts are creating too high of a standard for companies to prove the “usefulness” of their products when their patents are challenged by other firms seeking to produce their own versions of drugs. Usefulness is a common benchmark for establishing or maintaining a patent. Read some background on the case here. “