FDA Orange Book Vol. 38, Supplement 12 - Comments on December raw data

The FDA recently released their Supplement 12 Orange Book raw data. So I went right to work updating my Orange Book Companion®. Here are a few observations about Supplement 12:

Fifty new patents were listed in the Orange Book. Not out of the ordinary. However, 21 of those patents solely claimed methods of use or of improving a treatment. From my experience, that seems to be a pretty high percentage of method patents.

A new patent on using cocaine was listed. This new patent continues claiming uses of the topical numbing effect of cocaine. In this case the numbing is limited to the nasal mucosa, and there are no restrictions on the patient population as in the previously listed patents.

Another case of transposed digits resulted in a process patent being listed. The patent claimed a method of making a membrane for water purification. When I searched for patents owned by the NDA holder I found one whose number was nearly identical to the listed patent, except two digits were reversed.

The likely correct patent shows how the non-action limitations of a method claim (describing the device and the drug formulation) can support patentability. Claim 1 (which starts off simply with "A method, comprising") has three action steps: take the drug delivery device out of a case, read the instructions, and administer the drug. Interesting.

#orangebook #fda #patents #pharmaceuticals #drugs


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