Recent Developments in Australian & US Patent Law & their Impact ...

Classen Immunotherapies, Inc. v.
Biogen IDEC (Fed. Cir. 2011)
Ausbiotech 2012 – Australian and US Patent Law
1 November 2012
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Federal Circuit found that the statute provided no protection for the activities of accused
infringers Biogen IDEC and GlaxoSmithKline related to timing of vaccinations.
The statute provides safe harbor for the use of a patented invention “solely for uses
reasonably related to the development and submission of information under a Federal law
which regulates the manufacture, use, or sale of drugs . . . . ”
The Court concluded that the safe harbor provision does not apply to information that is
routinely reported to the FDA after marketing approval has already been obtained, such as the
reporting by the accused infringers of vaccine relationships, recommendations in view of
relevant literature, adverse vaccine effects, or other regulation-required information to the
FDA.