Intellectual Property: Patent war over smallpox vaccine

15 Mar 2006 | News
Battle lines are drawn in an expensive, distracting and unedifying legal fight between two vaccine manufacturers. Nuala Moran investigates.

Nuala Moran

At a meeting in June 2002 two of Europe’s leading independent vaccines companies were thinking of a possible collaboration on smallpox vaccines. Three-and-a-half-years later battle lines are drawn in an expensive, distracting and unedifying legal fight over who has rights to Modified Vaccinia Ankara, (MVA) originally developed over 40 years ago by a German academic, Anton Mayr.

At stake is a $1 billion contract to supply the vaccine to the US stockpile for use in the event of a bioterrorism attack, due to be awarded later this year, plus the potential to secure similar business with other governments.

What is Modified Vaccinia Ankara?

The MVA vaccine is a highly attenuated strain that cannot replicate in human cells. It is intended to protect people with weakened immune systems or skin conditions such a dermatitis, who cannot tolerate the full strength vaccine. This includes babies, old people, those with immune system diseases such as AIDS. In the US this estimated to cover 20 percent of the population.

MVA was developed by Anton Mayr, a German academic, in the 1960s and registered in Germany in 1976. More than 120,000 people are said to have been vaccinated with the product before smallpox was eradicated and vaccination programmes ceased in the 1980s.

Last week saw the first detailed rebuttal from the UK company Acambis to three lawsuits filed by Bavarian Nordic of Kistgard, Denmark, with Acambis saying it was confident of defending the freedom to operate.

Gordon Cameron, CEO of Acambis, said the charges concerning its vaccine, MVA3000 are “without foundation” as he outlined his company’s detailed response at an analysts’ meeting in London. “We have always believed and continue to believe that any patents awarded or pending do not restrict our freedom to operate in the field of MVA,” he said. He expects the cases to cost Acambis £3 million over the next year.

And Cameron accused Bavarian Nodic of trying to disrupt and frustrate competition in the MVA procurement process, both in the US and elsewhere.

The most recent lawsuit, filed in the Commercial Court in Vienna, Austria, follows the granting of a European patent to Bavarian Nordic in December 2005. In two suits under way in the US, Acambis is accused of stealing trade secrets at the US Federal District Court in Delaware, and of patent infringement at the US International Trade commission in Washington, DC.

In addition to two US patents and one European one, Bavarian Nordic has licensed rights from Mayr.

Commenting on the need for legal action Peter Wulff, President and CEO of Bavarian Nordic noted the company has made a substantial investment in developing its MVA-BN vaccines. “This legal action [in Europe], along with those we have instituted in the U.S., is being taken to protect our assets.”

While Bavarian Nordic claims its technology forms the basis of MVA3000, Acambis says it got the all important samples and rights through a Material Transfer Agreement with the US National Institute of Allergy and Infectious Diseases (NIAID).

NIAID for its part acknowledges that the sample came from Mayr, but says that he did not place any restrictions on its use.

Cameron said Cambridge-based Acambis believes Bavarian Nordic’s patents are invalid and unenforceable. “We have always believed and continue to believe that any patents awarded or pending do not restrict our freedom to operate in the field of MVA.”  

Is it novel?

Bavarian Nordic’s patents claim that other MVA viruses replicate in human cell lines, but that its MVA-BN does not. Acambis said its believes the patents are invalid and unenforceable on four grounds:

  • MVA-BN is not novel
  • The patent is unenforceable through lack of enablement
  • Bavarian Nordic failed to provide the U.S. Patent and Trademark Office with prior art related to its patent claims
  • The patents rely on scant scientific evidence

Cameron said Acambis will demonstrate that MVA-BN is not novel because all MVA viruses, including MVA-BN have similar replication characteristics. And in any case, he added, under the contract with NIAID, Acambis is authorised by the US government to research and develop MVA3000 regardless of third party US patents, to the extent necessary to perform the NIAID contracts.

The suit alleging theft of trade secrets relates to the meeting between the two companies in June 2002. Cameron said Acambis will present evidence that information provided at the meeting was not secret, but that in any case Acambis made no use of it in developing MVA3000, relying instead on its own expertise and information published on MVA over the past 30 years.

Acambis plans also to file oppositions to Bavarian Nordic’s European patent, granted in December 2005.

The expert discovery process in the ITC case was completed last week and the hearing is scheduled for May 8, while the first hearing of the Delaware case is not due until June 2007.

Acambis and Bavarian Nordic are the only serious contenders for the U.S. stockpile business. It remains to be seen if either side blinks when NIAID awards the contract.

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