Over the past decade, therapeutic antibodies have become
an important class of molecule in the immunotherapy
space.
In Australia, the therapeutic goods regulator, the Therapeutic
Goods Administration, has evaluated therapeutic antibodies for use
in a host of diseases, including various cancers, asthma, psoriasis
and, recently, as a treatment for COVID-19.1
In this article, we briefly consider selected patent claims
protecting therapeutic antibodies that have been the subject of
cases in Australia and the United States.
Keytruda litigation: claims to antibodies with a
cross-competition function
In 2014, Merck Sharpe & Dohme Corp (MSD)
commenced proceedings2 to invalidate certain claims of
an Australian patent3 co-owned by Ono Pharmaceutical Co.
and E.R. Squibb & Sons (Ono). MSD's
proceedings were in anticipation of the commercialisation of
'Keytruda', now an important immunotherapy for the
treatment of a number of cancers.