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. 2015 Aug 20;7(6):989–1009. doi: 10.1080/19420862.2015.1082019

Table 13.

Abstract of the 2 EPO Appeal decisions that relate to ADC patents

Decision Date Patent/ application Claimed subject matter Outcome
T 0619/01 August 2004 EP0634938A1* conjugate of SMPT linked-humanized M195 antibody and 2-iminothiolane modified gelonin or recombinant gelonin for the treatment of leukemia Claims found unallowable for insufficient disclosure, because the term “term “recombinant gelonin” was not properly defined. The only vague definition (JM105 E. coli expressing optimized gelonin”) would leave the burden of finding out how to arrive at recombinant gelonin entirely upon the skilled reader.
T 1014/01 Nov 2003 EP0439095B1** Antibody-based fusion protein comprising an Ig portion capable of directing the fusion protein to a tumor, an IL2 molecule capable of promoting lymphocyte proliferation, and a modified IgG1 hinge region with the 2 Cys residues replaced by Pro and Serine to permit greater flexibility in the fused molecule. Claim 1 (3rd request) was found inventive because prior art suggested that the hinge feature would avoid the reactive side groups in the AA sequence, not for increasing the flexibility. Further, prior art would contains no pointer to replace Cys with Pro, while prejudice against the use of Pro (“helix-killer”) would exist.
2nd request, which recited, as an alternative, also a natural hinge region, was not deemed inventive.
*

rejected;

**

expired