While the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continues to pay fees to Genentech to use the disputed technology to develop the drug Synagis, the U.S. Patent and Trademark Office may have something to add, too. (Medimmune, Inc. v. Genentech, Inc., et al.; S.Ct. No. 05–608).

MedImmune is paying licensing fees to Genentech for an antibody technology used in MedImmune’s pediatric respiratory drug Synagis, while at the same time challenging Genentech’s patent in court. The patents at issue, U.S. Pat. Nos. 4,816,567 and 6,331,415, relate to antibodies and to non-specific immunoglobulins formed by recombinant techniques using host cell cultures. The antibodies can be manipulated at the genomic level to produce chimeras of variants, which draw their homology from species, which differ from each other. They can also be manipulated at the protein level, since all four chains do not need to be produced by the same cell.

Currently, the USPTO is reviewing Genentech’s Cabilly patent under concurrent proceedings for an Inter Partes Reexamination (RE Appl. No. 90/007,542) and an Ex Parte Reexamination (RE Appl. No. 90/007,859). In an earlier ruling, the U.S. Patent and Trademark Office (USPTO) issued an obviousness-type double-patenting rejection and a “Schneller-type” double patenting rejection on the Genentech patent indicating that the patent, awarded in 2001, covered basically the same invention as an earlier Genentech patent that was set to expire next March. Those rejections have now been withdrawn.

On February 16, the USPTO issued a final action rejecting all of the claims as being anticipated under U.S. Pat. No 5,840,545 (Moore et al.) and/or obvious in light of Moore alone or combined with U.S. Pat. No. 4,399,216 (Axel) and/or the Accolla reference. The claims also were rejected under various groupings for nonstatutory obviousness-type double patenting in light of U.S. Pat. No. 4,816,567 (Cabilly I) and various other references.

While appeals through the USPTO and courts may take years, this could eventually cost Genentech severely since several companies, including Abbott Laboratories, Centocor Inc. and Imclone Systems Inc., paid Genentech a combined $105 million in royalties related to the patent last year.

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