New Cocaine Patent, No Exclusivity for Label Expansion Based on Real World Data, and Other Musings About Supp. 4

This blog entry for Orange Book Supplement 4 (April 2019) may be late, but the Supp. 4 update of my Orange Book Companion® was not! In this case, my updating was already complete by the day that the FDA’s “CDER New” newsletter announced the update.

So, what was new in the Orange Book in April? A new patent was listed for GOPRELTO (cocaine HCl 4%). The claims cover the aqueous cocaine solution in an amber bottle. I checked the file and did not find any specific reason for the bottle color limitation. There is now also a stability limitation. Not too surprisingly the claims were rejected, among other things, for obviousness-type double patenting over a previous patent and a pending application. That was overcome by a terminal disclaimer.

Last month I mentioned that it would be interesting to see if Pfizer’s IBRANCE would receive three-year exclusivity for a label expansion to include treating breast cancer in men. This label expansion was based predominately on the latest hot buzz-phrase, “real-world data.”

The Supp. 4 data did not include a new exclusivity for IBRANCE. This may be evidence that the FDA does not interpret the term “new clinical investigations” in the statute to include the laborious data collection and analysis that Pfizer carried out to support the label expansion. Although it would be good to hear from the FDA about that. The Supp. 4 data did, however, include a new use code (U‑2515) for 7,456,168 that includes the male breast cancer indication (the word “men” was added to the old use code in one part, and “women” was replaced by the broader word “patients” in another part).

Is it my imagination, or are the bibliographic sections of patents becoming longer, and longer, and longer? Patent 10,258,630 that was newly listed for IMVEXXY from TherapeuticsMD® has a 19 page bibliographic section. Then there is 10,259,791 that was newly listed for LENVIMA from Eisai that has a 38 page bibliographic section. Wow!

The LENVIMA ‘791 patent is interesting because it made me create a new claim type category: “Impurity content limitation.” It does not claim a compound per se, nor does it claim a composition such as an active ingredient plus a pharmaceutically acceptable carrier. Here is what the independent “substance” claim says:

1. A methanesulfonate salt of a compound represented by formula (IV), wherein the content of a compound represented by formula (A-1) is 60 ppm by mass or less.

 So moving forward, I will be using “impurity content limitation” as the claim type in my Orange Book Companion for the above type of claim.

Four patents were delisted in April. However, there should be no surprise about any of them. Three of them, two for CIALIS from Lilly (6,821,975 and 7,182,958) and one for FIASP FLEXTOUCH from Novo Nordisk (7,686,786) had been previously tagged in the Orange Book as being the subject of a delisting request. The fourth patent, 6,642,210 that was listed for LEXISCAN from Astellas, was reissued and replaced by RE47,351.


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