Big Molecule Watch
March 8, 2017


On Friday March 3, 2016, in a decision in cases brought by Samsung Bioepsis UK Ltd. and Fujifilm Kyowa Kirin Biologics Co. Ltd., a U.K. court held invalid two European patents owned by Abbvie that purportedly cover Humira® (adalimumab).  The patents relate to certain dosage regimens for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis.  Samsung and Fujifilm have announced that they both intend to market biosimilar adalimumab products in Europe upon expiry of the basic adalimumab patent in 2018, and sought declarations that certain later-expiring AbbVie patents are invalid.  Abbvie abandoned or withdrew the patents in an attempt to avoid a ruling and made an offer for settlement.  Samsung and Fujifilm rejected the offer and asked the court to rule on the declarations to prevent Abbvie from obtaining additional future patents claiming priority to the patents in suit.  The case proceeded to trial and the judge found it in the “interests of justice” to rule on the declarations sought.  The judge reasoned, in part, that Abbvie could not “shield its patent portfolio from scrutiny” by abandoning its patents. The judge granted the declarations, thus rendering the patents invalid.