AUSTRALIA’S AUSTERICO MEDICALS is facing a difficult time after the company posted a record loss for the year in 2017.
On Wednesday, the company announced that the company’s revenue from the US and China has fallen by $50m to $1.3bn and $1bn respectively, with the loss of $51m due to the company failing to get approval for a US patent for its new insulin-based insulin product.
In a statement, the group said the US patent had been granted to “a third party”.
But the company said that it has “agreed to the terms of the proposed US patent” and “will proceed to finalise our pending application to that patent”.
According to Reuters, the US government has refused to grant patents to foreign companies to use US manufacturing facilities, meaning that AAP Pharma cannot obtain a US Patent to manufacture insulin from China.
The company said it is “reviewing all options to resolve the situation”, including “all possible remedies and steps taken in the US regulatory process”.
The US Federal Trade Commission has already issued a notice to the US company and asked it to provide more information about its patent application.
“We continue to cooperate with the Federal Trade Commissioner and our counsel in this matter,” the company added.AAP Pharma has been under pressure since last year when it lost a bid to patent a new insulin that it hoped would become the world’s first to treat people with type 2 diabetes.
The company also lost a patent over its insulin in China.
The Indian government has also expressed concern over the company.
“This case has raised a number of concerns, including that the patent is being used by foreign companies for drugs that are not developed in India, potentially affecting the safety of these medicines,” the government said in a statement.
Indian regulators have also warned that patenting companies are not allowed to use foreign factories to manufacture medicines, as the government does not have jurisdiction over them.
Last year, a federal judge in the southern state of New York ordered AAP Pharma to stop the patent application, but the company has refused.