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Canadian pharmaceutical giant Apotex alleges it was defamed and seeks $500-million damages over restriction that was quashed by the Federal Court.

Peter Power/The Globe and Mail

Canadian pharmaceutical giant Apotex is suing the federal government and former health minister Rona Ambrose over a 2014 import ban that was deemed unfair by the Federal Court and quashed.

In a statement of claim filed Friday, Apotex alleges it was defamed in press releases and information published on websites of Health Canada and the minister. The country's largest drug maker, Apotex is seeking $500-million in damages in its suit, which names as defendants the federal Crown, the Attorney General of Canada, Ms. Ambrose and several Health Canada officials.

Apotex president and chief executive officer, Jeremy Desai, said the legal action was necessary to protect the company and its reputation.

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"The previous government, under the then-minister of health, Ms. Rona Ambrose, acted improperly and without justification to ban our imports from India and caused Apotex very serious financial and reputational damage," Dr. Desai said in a statement e-mailed to The Globe and Mail.

The federal government plans to fight Apotex's claims. In a statement Sunday, Health Canada spokesman Eric Morrissette said the legal matter is being reviewed thoroughly to determine next steps. There is a 30-day window to file statements of defence.

"Health Canada's priority – first and foremost – is to protect the health and safety of Canadians. We will continue to oversee and enforce laws and regulations in place to do just that," Mr. Morrissette said. "There are currently no import restrictions on products or ingredients made at the" two Apotex Indian manufacturing facilities. "Both sites have a compliant rating," he added.

Ms. Ambrose, interim Conservative leader, could not be reached for comment Sunday.

The import ban, announced on Sept. 30, 2014, prohibited Apotex from bringing in drug products from two of its manufacturing facilities in India. At the time, Health Canada said it had "significant concerns" with the manner in which research data were collected and reported at those facilities. But, it noted, there were "no specific safety issues" with products on the market from those plants.

Apotex challenged the Health Canada decision. In October, 2015, a Federal Court judge ruled that the ban was unfair and motivated by an "improper purpose" – to ease pressure mounting on the then-health minister as a result of a string of media stories about Apotex. The judge ordered the lifting of the ban and retraction of statements from the minister and department published online.

Mr. Morrissette noted that Health Canada has updated its website. But Apotex claims defamatory content remains. In its lawsuit, the company is asking for removal of additional online postings. It also wants the data-integrity requirement lifted from its abbreviated new drug applications.

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