Lack of Obviousness in Methods for Cancer Treatment
May 28th, 2019 by William Reid | News | Patent Related Court Rulings |
The ‘209 Patent includes method claims where folic acid and a methylmalonic acid lowering agent (e.g., vitamin B12) are administered prior to treatment with the antifolate pemetrexed disodium, a chemotherapy agent.[3] The folic acid and methylmalonic acid are used to ameliorate the toxic effects of the pemetrexed.[4] The heart of the Board’s conclusion was that although it was known to use folic acid to reduce the toxicity of antifolates such as pemetrexed, there was no reason to pretreat with vitamin B12 and folic acid prior to treatment with pemetrexed for cancer.[5] On appeal, the Petitioner’s obviousness arguments related to the EP005 reference, which taught use of folic acid in conjunction with vitamin B12 to reduce homocysteine levels for all purposes.[6] Homocysteine is an amino acid, and when present in high levels is predictive of pemetrexed toxicity.[7] On its face this appears to be a solid case for obviousness. Indeed, those arguing against motivation to combine during patent prosecution have almost certainly encountered an Examiner’s response referencing MPEP 2144IV at one time or the other:
