Acambis, a UK biotechnology company, is fighting a patent-infringement lawsuit that may bar it from a $1.9bn contract to provide smallpox vaccines to the US government. Acambis is bidding for a US Government contract to supply an emergency-use stockpile of MVA.

Currently, the company is fighting a three-front battle with Danish vaccine maker Bavarian Nordic, which alleges that Acambis’ MVA vaccine infringes its treatment, which is based on the same smallpox strain.

First, Bavarian Nordic is seeking an exclusion order in an International Trade Commission (ITC) trial, which would in effect stop any vaccines at the border. The MVA vaccine is potentially a major product. Together with Baxter, Acambis submitted a bid for a US Government stockpiling contract for MVA in October 2005 in response to a Request for Proposals issued by the Department of Health and Human Services for making up to 20 million doses of MVA and advanced clinical testing up to and including obtaining a product license. It also includes options for the purchase of up to 60 million additional doses of MVA and warm-base manufacturing over the longer term.

Second, Acambis has filed an opposition to European Patent No. 1335987 issued to Bavarian Nordic A/S (Bavarian Nordic) on 28 December 2005 by the European Patent Office. The patent relates to Bavarian Nordic’s MVA technology, MVA-BN®. MVA is an attenuated smallpox vaccine, Modified Vaccinia Ankara, which has been used in Europe since the late 1970s. Acambis opposes the patent on the grounds that the patent is invalid. Acambis’ partner, Baxter Healthcare SA, which manufactures Acambis’ MVA vaccine, MVA3000, in Austria, has also filed an opposition to the European patent on the grounds that the patent is invalid.

And third, Bavarian Nordic has filed suit against Acambis in the US alleging that Acambis has used its trade secrets in developing MVA3000 and that it is infringing its patents. Acambis says the allegations are without foundation. A further suit was filed in Austria in February 2006. BN alleges that we have used its trade secrets in the development of our MVA3000 vaccine and that we are infringing its patents.

Acambis’ view is that BN’s patents are invalid and unenforceable believing it can show evidence that MVA-BN is not novel, that the patent is unenforceable through lack of enablement, that BN failed to provide the US Patent and Trademark Office with prior art related to its patent claims; and that the patents rely on scant scientific evidence. Acambis stated that MVA-BN is not novel because all MVA viruses, including MVA-BN and prior art strains, have similar replication characteristics.

On the question of the use of misappropriation, Acambis contends that Dr. Mayr of BN provided an MVA strain to the NIH/NIAID and the NIAID then provided a version of that strain to Acambis for use as the basis of MVA3000. Dr. Mayr did not place in writing any restriction on the NIH’s use of the transferred MVA virus and did not restrict the use of the MVA strain he provided to the NIH. When the NIH released its first RFP, it made the NIH MVA strain publicly available, stating that “collaborative opportunities from NIAID are available to all legitimate parties and include: the availability of a master seed stock of MVA from NIAID…”. Acambis requested and received the NIH MVA under a Material Transfer Agreement that granted Acambis “worldwide, non-exclusive rights to make, have made, and use” the NIH MVA “to sell and have sold, and to offer to sell Commercial Products in the Field of Use of Smallpox Vaccines”. During the procurement process for the first MVA contract, although it did not undertake a comprehensive review of intellectual property in the MVA field and encouraged us to undertake our own analysis, the NIAID stated that “prior to distribution of the material NIAID determined that it is within its rights to transfer the material to other parties”.

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