Bayer-Anti-TNF antibodies patent- J&J and Abbott drugs (US & Europe)


Bayer had sued Abbott and J&J for their Anti-TNF antibody drugs Adalimumab (Humira) and Golimumab (Simponi) respectively on Dec 2008 and Aug 2009. The patent involved in these suit, was US5654407 covers Human monoclonal antibodies composition.

According to Bloomberg article, Bayer has terminated both the suits as district court judge constructed the claimed term “Human monoclonal antibodies” specifically as “low affinity, referring to the strength of the antibody’s attachment to TNF, and that don’t neutralize the protein” . Bayer may appeal this claim construction.

Interestingly, the same patent’s equivalent (EP0614984) was involved in post grant opposition proceedings at EPO (Opposed by J&J and Abbott). The ‘984 patent was initially revoked by EPO and the Technical board of appeal had reversed this decision. J&J’s Golimumab (Simponi) was issued marketing authorization on 01/10/2009.

Another interesting thing is Bayer has filed SPC for Golimumab (Simponi) on 07/12/2009 at UK IPO (Link) and this SPC for Golimumab is now granted on ‘984 patent and expires on 20/02/2019.

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About Guna

Interested to learn things around me
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