Bavarian Nordic Sues Acambis for Infringing MVA Smallpox Vaccine Patent

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Bavarian Nordic Sues Acambis for Patent Infringement

Bavarian Nordic A/S (Copenhagen, Denmark) has filed suit with the US District Court in Delaware accusing Acambis plc (Cambridge, UK) of infringing Bavarian Nordic’s intellectual property for its modified vaccinia Ankara (MVA) smallpox vaccine strain. The two companies are competing for a contract to supply the US Department of Health and Human Services (HHS, Washington, DC) with as many as 60 million doses of this highly attenuated version of the smallpox vaccine under Project BioShield.

The suit filed in Delaware (#1:05-CV-00614-UNA) accuses Acambis of “misappropriation of trade secrets,” saying that Acambis received, without permission from Bavarian Nordic, a proprietary Bavarian-Nordic MVA strain and dosing information, and used them to develop a competing MVA smallpox vaccine.

Acambis spokeswoman Lindsay Wright says the company licensed its MVA strain from the National Institutes of Health in February 2003, but would not elaborate on the details of the deal or the case itself. In a company statement issued Monday, Acambis said it “believes the claims are without foundation” and that the company will be “vigorously defending its legal position.”

In addition to the federal suit, Bavarian Nordic also filed a patent infringement action against Acambis’s MVA smallpox vaccine products with the US International Trade Commission in Washington, DC. Bavarian Nordic received a US patent (No. 6,913,752) on July 5 for its attenuated smallpox strain and its derivatives, including “IMVAMUNE,” Bavarian Nordic’s attenuated smallpox vaccine.

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In its company statements, Bavarian Nordic has said that if its legal actions are successful, the company will be able to stop Acambis from importing any infringing products into the United States, or to seek a royalty for each infringing dose of vaccine imported into the country.

Li Westerlund, PhD, director of intellectual property rights for Bavarian Nordic, says the legal actions were not initiated to discredit Acambis’s bid for the HHS contract. “We are committed to ensur[ing] that these legal proceedings in no way impact the pace of US smallpox vaccine stockpiling,” she said, adding that Bavarian Nordic has “ample vaccine production capacity” to provide levels “well beyond” those sought in the government’s request for proposals.

–Laura Bush