The variola virus that causes smallpox, magnified x65,000. Image courtesy CDC.
Potentially there is a lot of cash at stake here: TroVax was the subject of a $690 million commercialisation deal agreed between Oxford BioMedica and Sanofi-Aventis SA in April 2007.
The Danish company owns several US patents relating to an attenuated strain of smallpox, modified vaccinia Ankara, MVA-BN. This is the basis for its smallpox vaccine, Imvamune, for which it holds a $1.6 billion contract with the US Department of Health and Human Services.
Along with a number of other companies, Bavarian is also using MVA as the delivery vehicle for vaccines against other infectious diseases and cancer. There are at least six products currently in clinical trials that use MVA as the basis for treatments against HIV infection, melanoma, flu and malaria, among others.
What is in dispute in this lawsuit is Oxford BioMedica’s use of MVA as the vector for genes for the cancer antigen 5T4, in TroVax, a treatment for solid tumours.
“The claim in this case is that the defendants have infringed [our] patents by commercialising the patented technology in ways that have yielded large payments from Sanofi-Aventis under the agreement between them for the development and commercialisation of TroVax,” Bavarian Nordic said in a statement announcing the suit.
Oxford’s defence
Oxford BioMedica said it would defend the suit, claiming that the US Patents cited in the case correspond to Bavarian Nordic’s European Patent No. 1335987, which is currently the subject of multiple oppositions, all asserting the invalidity of the claimed technology.
The company said Bavarian Nordic’s US litigation is without merit. “Oxford BioMedica is confident in its position, is fully prepared to oppose this action vigorously, and will seek all appropriate relief against Bavarian Nordic,” it said in a statement.
Peter Nolan, the company’s Senior Vice President of Commercial Development, said, “Throughout our 11-year history, Oxford BioMedica has been diligent to ensure that it has freedom to operate for all its development programmes and is entirely respectful of the intellectual property that has been developed by others.”
He added, “We believe that Bavarian Nordic’s claim is unwarranted and we have a high degree of confidence that this action will prove fruitless.”
For its part, Bavarian Nordic licensed its right to MVA from Anton Mayr, of the Ludwig Maximilians University in Munich, Germany, who developed the attenuated vaccine in the 1960s.
Anders Hedegaard, President and CEO of Bavarian Nordic, said the suit is a, “necessary step” to enforce the company’s intellectual property rights. “We have built a strong patent portfolio on the MVA technology, which we seek to utilise to expand and support our business through licensing agreements. However if these cannot be obtained, we will vigorously defend our IP position to prevent infringement.”
Just under a year ago on 25 July 2007, Bavarian Nordic reached an agreement with the UK vaccines company Acambis plc ending the patent dispute between the two over MVA. Bavarian Nordic granted a licence to some of its MVA patents in return for Acambis making an undisclosed upfront payment. Acambis also agreed to make royalty and milestones payments should it develop or commercialise certain MVA products in the future.
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