Bavarian Nordic's modified Vaccinia Ankara patents infringed

The Administrative Law Judge at the U.S. International Trade Commission (ITC) issued his Initial Determination concluding that Acambis plc's smallpox vaccine product (MVA3000) infringes two of Bavarian Nordic's patents on Modified Vaccinia Ankara (MVA) and furthermore that Bavarian Nordic's patents are enforceable.

While the full decision has not yet been made available to the parties, the Administrative Law Judge also appears to have concluded that one of the two patents is invalid in view of prior art viral strains, while the other is valid in view of the same prior art strains, but yet still invalid. Based on this inconsistency, and others relating to validity, Bavarian Nordic feels confident of having this decision reversed by the full ITC Commission, or by the Court of Appeal for the Federal Circuit.

Bavarian Nordic will file an appeal to the full ITC Commission seeking a reversal on this issue and other matters relating to validity. The company will file its appeal within the standard ten (10) day period as required by the ITC.

Bavarian Nordic further believes that the initial ruling of patent infringement is significant for this case but also in view of the Company's possession of other MVA patents and pending applications in its portfolio.

Commenting on the developments of the ITC case, Peter Wulff, President and CEO of Bavarian Nordic, said: "We are pleased that Administrative Judge found infringement against our patents since this is the core of the case we filed. However, in addition to disagreeing with the initial ruling on patent validity we find that the basis for the decision to be both inconsistent and confusing. We will file an appeal to the full commission and look forward to a positive outcome on the appeal as well as the full case to be decided later this year."

Bavarian Nordic A/S filed a complaint on 19 August 2005 alleging that Acambis plc imported, sold, and/or offered to sell in the USA its MVA-based smallpox vaccines that infringe patents owned by Bavarian Nordic. Bavarian Nordic re­quested in its filing that the ITC issue a permanent cease and desist order to Acambis which would prohibit the company from importing, selling or offering to sell their MVA-based smallpox vaccine in the USA.

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The Administrative Law Judge at the U.S. International Trade Commission (ITC) issued his Initial Determination concluding that Acambis plc's smallpox vaccine product (MVA3000) infringes two of Bavarian Nordic's patents on Modified Vaccinia Ankara (MVA) and furthermore that Bavarian Nordic's patents are enforceable.

While the full decision has not yet been made available to the parties, the Administrative Law Judge also appears to have concluded that one of the two patents is invalid in view of prior art viral strains, while the other is valid in view of the same prior art strains, but yet still invalid. Based on this inconsistency, and others relating to validity, Bavarian Nordic feels confident of having this decision reversed by the full ITC Commission, or by the Court of Appeal for the Federal Circuit.

Bavarian Nordic will file an appeal to the full ITC Commission seeking a reversal on this issue and other matters relating to validity. The company will file its appeal within the standard ten (10) day period as required by the ITC.

Bavarian Nordic further believes that the initial ruling of patent infringement is significant for this case but also in view of the Company's possession of other MVA patents and pending applications in its portfolio.

Commenting on the developments of the ITC case, Peter Wulff, President and CEO of Bavarian Nordic, said: "We are pleased that Administrative Judge found infringement against our patents since this is the core of the case we filed. However, in addition to disagreeing with the initial ruling on patent validity we find that the basis for the decision to be both inconsistent and confusing. We will file an appeal to the full commission and look forward to a positive outcome on the appeal as well as the full case to be decided later this year."

Bavarian Nordic A/S filed a complaint on 19 August 2005 alleging that Acambis plc imported, sold, and/or offered to sell in the USA its MVA-based smallpox vaccines that infringe patents owned by Bavarian Nordic. Bavarian Nordic re­quested in its filing that the ITC issue a permanent cease and desist order to Acambis which would prohibit the company from importing, selling or offering to sell their MVA-based smallpox vaccine in the USA.