Intellectual Property
The Patent Portfolio
Bavarian Nordic has successfully built its patent portfolio on
and around its core technology; MVA-BN®. A strong patent
portfolio underpins Bavarian Nordic's competitive position in
MVA-based vaccines. Bavarian Nordic's patent portfolio directed to
aspects of MVA consists of 30 patent families. Each of these patent
families consists of numerous corresponding issued/granted foreign
patents, pending applications, continuations and divisional
applications. The patent portfolio comprises more than 300 pending
patent applications and more than 650 granted/issued patents.
Moreover, Bavarian Nordic seeks to avoid possible design-around
attempts by competitors through a proactive patent strategy.
Besides its core IP, Bavarian Nordic has obtained protection
for, and continues to file further applications to protect relevant
supporting technologies. Bavarian Nordic has also acquired
exclusive rights to non-MVA technologies including other viruses
and production processes from other patent holders.
The MVA Platform
Bavarian Nordic's competitive IP protection gives exclusive
rights to manufacture, sell and market its MVA-based technology
globally. Six patents have been issued thus far to Bavarian Nordic
in the United States and one for the European countries within the
patent family covering an MVA virus variant referred to as
MVA-BN® exhibiting an improved safety profile compared to other
MVA viruses. These patents cover the MVA-BN® virus and
derivatives thereof, IMVAMUNE® (Bavarian Nordic's smallpox
vaccine), and its use as vector technology.
Acambis (now a wholly-owned subsidiary of Sanofi Pasteur) took a
license to the MVA-BN® patents in 2007 thereby ending a legal
dispute on matters relating to MVA based smallpox vaccines. Under
the agreement, Bavarian Nordic granted a license to some of its MVA
patents in return for Acambis making an undisclosed upfront
payment. Acambis will also make royalty and milestone payments
should it develop or commercialize certain MVA products in the
future.
Patent protection for the vaccination of infants with MVA-based
vaccines has also been obtained. Further applications on aspects of
the MVA vaccine technology are pending for rapid and immediate
immune responses.
Recombinant MVA-based Vaccines
The MVA-BN® patents cover the use of recombinant vaccines as
a vector to deliver antigens for various indications. Bavarian
Nordic's exclusive rights further cover certain aspects of
recombinant MVA vaccines for cancer, HIV and other infectious
indications created by inserting foreign genes into the MVA genome
and effective promoters for doing so.
Cancer Vaccines
In the cancer field, Bavarian Nordic's US subsidiary BN
ImmunoTherapeutics Inc. (BNIT) has acquired exclusive rights to
material IP covering PROSTVAC™. The core patents that are
exclusively licensed for PROSTVAC™ provide BNIT with
exclusive rights covering claims issued to the relevant
prostate-specific antigen ("PSA"), PSA oligo-epitope peptides and
analogs thereof used in PROSTVAC™, including various
immunogenic compositions comprising the relevant PSAs and pox virus
vectors expressing peptide agonists of PSA. In addition, BNIT has
non-exclusive rights to related technologies relevant for this
project.
To strengthen its patent portfolio in the cancer therapy field
and to secure freedom to operate for its MVA-BN®-HER-2-Neu
vaccine candidate, BNIT has also acquired the previously
in-licensed patented technology in the field of cancer vaccines,
covering the HER-2-Neu DNA AutoVac™ construct and related
technology.
Vaccine Manufacturing
The current manufacturing process used for Bavarian Nordic's
MVA-based vaccines, including the smallpox vaccine production, is
primarily protected as a trade secret and is therefore not
disclosed to competitors.
