The patent was originally issued to Genentech in 2001 following a lengthy interference dispute with Celltech. In 2005, the PTO issued a preliminary initial action, which rejected the claims of the Cabilly II patent, a move that Genentech said at the time was “routine and expected” in the re-examination case. However, in the present examination the proceedings did not favour Genentech either, after the PTO rejected the patent on grounds of “obvious-type double patenting”. This occurs when the patent claims in question are covered in an earlier patent and other scientific prior art. In this instance, the prior art was the previous Genentech patent US 4,816,567 or Cabilly I, which expired in March 2006. Examiners also asserted that Genentech's past action during opposition proceedings in the European Courts undermined the evidence that the company was presenting in its defence in this case.
The '415 patent has been the subject of other legal proceedings recently. In January 2007, MedImmune, which licenses Genentech's antibody technology for use in its respiratory drug Synagis, won a Supreme Court case, which ruled that MedImmune could challenge the validity of the patent without being accused of infringement. Other products that are made under licence from the revoked patent are reported to include Centocor's Remicade, Wyeth/Amgen's Enbrel and Abbott's Humira. However, Genentech might not lose out on royalties — which were thought to be over US$100 million in 2006 — in the immediate future. The '415 patent remains valid throughout any appeals process, which Genentech says it will pursue, and could take at least 2 years. MedImmune and other companies licensing the antibody technology must, in the meantime, continue to pay royalty fees.
