(INDIANAPOLIS) - Eli Lilly and Company has filed a $500 million international lawsuit against the Canadian government.
Lilly says Canada unfairly shortened the life of patents for its best-selling drugs.
The case was filed Thursday under the rules of the North American Free Trade Agreement.
Lilly says Canadian courts unfairly threw out the patents when challenged by the generic drug manufacturers.
The legal fight will move to the next stage after the two sides failed to settle their differences during a 90-day consultation process which ends Friday.
Doug Norman, general patent counsel for Lilly, released the following statement:
"Patent decisions in Canada over the last decade not only fly in the face of long-established international standards, but they're subjective and completely unpredictable. The standard seems to be that there is no standard. The Notice of Arbitration (NOA) is the next natural step in Lilly's continuing efforts to address financial losses from improper invalidation of our Strattera and Zyprexa patents under Canada's 'promise utility doctrine.'
"The promise doctrine is a creation woven from federal court decisions made since 2005. It's impossible to know what specific "promise" can be implied from an application, and how much data are needed to support it. If this pattern persists, the already challenging business of medical innovation will become all the more difficult in Canada, producing painful consequences for Canadian patients and the economy at a time when its domestic biopharmaceutical industry is suffering job losses and undergoing extensive restructuring. The NOA is a necessary step in this important process."
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