The Commissioner's Decision Re
In
Earlier this year, in the Commissioner's Decision
The claims at issue in the '100 application are directed to an antibody for treatment in breast cancer, wherein the antibody is administered at an initial dose of 8 mg/kg and a plurality of subsequent doses of 6 mg/kg, wherein the doses are separated by three weeks. In the Final Action, the Examiner asserted that the exercise of a physician's skill and judgment is required to (1) determine the appropriate dose; (2) determine how many subsequent doses to administer; and (3) calculate the dose to be administered and therefore refused the claims on the basis that they encompass unpatentable subject matter.
The description of the '100 application contains the type of broad, generic statements discussing a physician's discretion in selecting an appropriate dosage based on patient-specific factors that are commonly found in applications relating to medical or therapeutic uses. The Board reiterated that medical use claims must be read in the context of the specification as a whole, and in the case of fixed dosage claims it is necessary to consider whether there is evidence indicating that the skill and judgment of the physician would be called on to select an appropriate dose or make any adjustments to the dosage. The Applicant successfully argued to the Board that the broad, generic statements in the description did not pertain to the actual invention as claimed.
Second, the
Finally, the Board agreed with the Applicant that the weighing of a patient and calculation of dose (i.e. number of mg/kg) does not require professional judgment. The Board noted that there was no evidence that monitoring of a patient's weight would be required, and thus the doses are fixed and the mere calculation to convert from mg/kg to a patient-specific dose would not require the skill and judgment of a medical professional.
The allowance of a fixed body weight-dependent dosage regimen is a win for patentees in the pharmaceutical industry, and reaffirms that dosage regimens can be allowable subject matter, so long as no physician skill or judgment is required to exercise the full scope of the claims. While methods of medical treatment remain unpatentable subject matter in
Footnote
1 Yves Choueifaty v Attorney General of
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