Orange Book News for Vol. 42/Supp. 11 and Purple Book Update

Supp. 11 added 34 new patents to the FDA’s Orange Book. That includes three new patents for the current patent listing champ, AUVELITY?. You can see all of the changes to the Orange Book that occurred in Supp. 11 by going to the Orange Book Companion? public home page and clicking on the prominent “What’s New” link. You can also see all ninety-six AUVELITY?patents by clicking the sample link for trademarks that begin with "A" and then scrolling down to?AUVELITY.

?A patent labeled as a “drug substance” patent, 11,499,050, was listed for a drug called BLUDIGO?, which is a diagnostic dye. The sole claim of the patent is not directed so much to what the drug is, but rather to what it is not. The limitations of the claim are mainly directed to impurity specs that should not be exceeded.

Another interesting patent, 11,497,737, claims a “commercial batch” of a pharmaceutical composition. The drug is FYARRO? (sirolimus) from AADI. After reading the first 29 claims directed to the commercial batch, one might wonder if there would be a claim to a “drug product” that could be used to treat patients and also dispel any question about the patent’s eligibility for listing in the Orange Book. But there it is in the very last claim in which the commercial batch is contained in “a plurality of vials associated with a unit dosage label.” A good example of dotting all the i’s and crossing all the t’s!

?I updated the free beta version of my Purple Book Companion? through the end of November. The big change was the addition of 9 patents for Regeneron’s drug, EYLEA? (aflibercept) which is indicated for wet Age Related Macular Degeneration among other eye issues. That brings EYLEA’s Purple Book patent portfolio up to thirty-nine patents.