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4 February 2021Big PharmaMuireann Bolger

Boehringer hits China’s Qilu with cancer drug patent suit

Chinese drug maker Qilu’s proposed generic version of a cancer treatment infringes three patents, according to a lawsuit filed by Boehringer Ingelheim.

In the complaint filed at the US District Court for the District of New Jersey on February 2, the German company alleged that Qilu had infringed US patent numbers RE43,431, 8,426,586, and 10,004,743.

The patents cover a treatment used in the first-line treatment of metastatic non-small cell lung cancer, which Boehringer markets under the brand name Gilotrif (afatinib).

According to the complaint, Qilu submitted an Abbreviated New Drug Application to the US Food and Drug Administration in December to obtain approval to manufacture and sell afatinib tablets before the expiration of the patents-in-suit.

Boehringer is seeking a court order blocking copies until the patents have expired and cash compensation if copies are made before then.

In 2019, Boehringer also sued MSN Laboratories and Novartis subsidiary Sandoz at the same court alleging that the companies had infringed the ‘586 and ‘431 patents. But the court closed the case after MSN settled with Boehringer in December 2020.

According to a report published by Marketresearch.com, Gilotrif sales are expected to increase from $53 million upon launch in 2013 to $688 million in 2022 from sales in seven markets, including China and India.

Boehringer Ingelheim achieved net sales of around $21.3 billion in 2019, the German biotech confirmed.

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More on this story

Big Pharma
17 March 2020   The US Court of Appeals for the Federal Circuit has rescued one Boehringer Ingelheim patent, covering a type 2 diabetes treatment, from invalidation but affirmed a New Jersey district court’s cancellation of two others.
Big Pharma
11 February 2021   China has introduced new measures to enforce a patent linkage system and proposed draft rules on how a patent owner can challenge the approval of a drug.
Asia-Pacific
24 May 2022   The Federal Court of Australia has refused an appeal request in a decade-long case brought by Boehringer Ingelheim Animal Health against MSD subsidiary, Intervet International.