Roche and Amgen agree on temporary Mircera import ban

Home/Policies & Legislation | Posted 20/10/2009 post-comment0 Post your comment

Roche has agreed not to oppose Amgen's request for a limited exclusion order that would block the import of Roche's anaemia drug Mircera into the US Amgen filed a motion recently with the US International Trade Commission (ITC) asking for a summary determination that Roche had violated a section of the Smoot-Hawley Tariff Act by importing the pegylated erythropoietin product Mircera (methoxy polyethylene glycol-epoetin beta), which Amgen claims infringes its patents.

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Roche is conceding defeat at the ITC in a patent battle with Amgen over anaemia drugs, court filings show. Amgen, who markets the anaemia drugs Epogen and Aranesp, accused Roche in 2005 of patent infringement in the production of Mircera.

In a letter to the commission, a frequent venue for patent battles, a Roche lawyer wrote on 1 September 2009 "to advise the commission that respondents (Roche) hereby withdraw their motion for a stay of this investigation." Roche acknowledged on 17 September 2009 that it was dropping the ITC fight, saying in a statement: "If granted, this would conclude the ITC investigation of Mircera." Roche also seemed to expect that Amgen would request a continued ban on the US sale of its anaemia drug Mircera.

“The Boston district court had enjoined Roche from selling Mircera in the US, so this does not represent any change to Roche's current business operations, nor does it have any impact on the business,” the statement said.

“Should the appellate court find the Amgen patents invalid or not infringed, Roche would have the right to ask the ITC to cancel the order, thereby allowing Roche to enter the US market,” Roche said.

The ITC case has been running parallel to a fight that began in a Boston federal court, which barred Roche from selling Mircera in this country. On 15 September 2009, the US Court of Appeals for the Federal Circuit, which hears all patent appeals, issued a split ruling in the case and sent it back to the Boston court, but let stand a ban on the US sale of Mircera, which would have competed directly with Amgen's Epogen.

Conceding at the ITC could mean that the two companies were discussing a potential settlement. “I think that Roche may have been concerned about the strength of their position,” said James Hall, a patent attorney with Squire, Sanders and Dempsey who does a lot of work in life sciences. “I think that there's a possibility that there's a settlement being discussed behind the scenes.” In February 2009, Roche characterized Mircera's sales worldwide as “modest” but “progressing”.

Worldwide sales of Amgen's once top-selling anaemia drug Aranesp, which have seen more than two years of decline over safety concerns and reimbursement restrictions, fell another 16% in the second quarter of 2009 to US$693 million (Euros 473.84 million). Sales of Epogen, an older version of its Aranesp red blood cell booster used primarily in patients with kidney diseases, rose 3% to US$638 million (Euros 436.20 million).

Analysts expect Amgen to earn US$1.26 (Euros 0.86) per share in the third quarter ending 30 September 2009. But Amgen's older biotech drugs, including Epogen and Aranesp, are expected to be among the first to be targeted if US lawmakers approve sale of generic biological medicines or biosimilars. Both Epogen and Mircera, which stimulate production of oxygen-carrying red blood cells, are banned by the International Olympic Committee.

References:
FDAnews Drug Daily Bulletin Vol. 6, No. 181, 17 September 2009.

Reuters 18 September 2009. Roche drops defense against Amgen at ITC.

Source: FDAnews; Reuters

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