BioWorld International Correspondent

With a decision on a U.S. government tender for a stockpile of attenuated smallpox vaccines imminent, Bavarian Nordic A/S has further ratcheted up the pressure on its rival for the contract, Acambis plc, by filing a patent infringement action in the Commercial Court in Vienna, Austria.

It already has two suits under way in the U.S., a patent infringement action at the U.S. International Trade Commission (ITC) in Washington, and a misappropriation of trade secrets case at the U.S. Federal District Court in Delaware.

Li Westerlund, director of intellectual property rights at Kvistg rd, Denmark-based Bavarian Nordic, told BioWorld International that she expects the cases will come to court. "We’re not actively seeking settlement," she said. "Like any other litigator, you would listen [to a proposal]. We’re not stupid, but we’re not actively seeking it."

All three cases concern Acambis’ MVA3000 smallpox vaccine, which is based on a modified vaccinia ankara (MVA) vector. Bavarian Nordic claims that that product was developed using its proprietary MVA strain and dosing information, which Acambis received without its permission. Bavarian Nordic has obtained two patents in the U.S. for its MVA technology and, late last year, received a patent from the European Patent Office in Munich, Germany. It decided to pursue Acambis, of Cambridge, UK, in Austria as that country houses the sole manufacturing site for MVA3000.

The stakes are high for the two companies. They are competing for a contract under the U.S. BioShield program to supply up to 20 million doses of MVA smallpox vaccine, which is safe to administer to groups that are unable to receive conventional vaccine, including HIV-infected individuals and those with autoimmune skin ailments. The request for proposals, issued by the U.S. Department of Health and Human Services last August, also includes options for the supply of an additional 60 million doses and the maintenance of production readiness or warm-base manufacturing. The two companies previously had secured contracts for smaller-scale deliveries of MVA smallpox vaccines and to fund ongoing clinical and process development work. (See BioWorld International, Oct. 6, 2004.).

Factual discovery on the ITC case was completed Monday, Westerlund said, and this will be followed by an expert discovery process.

ITC spokeswoman Peg O’Loughlin said an evidential hearing is scheduled for May 8 through May 17, and the target date for the delivery of initial findings is Aug. 24. These will be subject to review by the commission, which would be required to complete its deliberations by Nov. 24.

The federal court process moves more slowly. An initial hearing has been set for June 5, 2007, Westerlund said.

Bavarian Nordic has not yet decided if it will continue to pursue the actions if it secures the U.S. tender. "That will be a decision [to be taken] at that time," Westerlund said.

Acambis officials previously had stated that Bavarian Nordic’s claims are "without foundation" and that it would vigorously defend its position. "We’re not commenting on any specific legal actions at this point," Lynsday Wright, Acambis’ vice president of communications and investor relations, told BioWorld International.

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