Orange Book Vol. 42/Supp. 4 News

Orange Book Insights No. 33 – Orange Book Vol. 42/Supp. 4 News

For those who have not checked yet, in mid-May I posted a link to my free Orange Book Companion “What’s New” for Orange Book Vol. 42, Supp. 4 on my public Orange Book Companion home page. Supp. 4 added 52 new patents to the FDA’s Orange Book, and showed the delisting of two patents. 


One of the delisted patents was 7,323,463, that had been listed for Allergan’s COMBIGAN®. The’463 patent had been the subject of a patent delisting request. So the FDA has now acted on that request. The other delisted patent, 9,593,100, had been listed for Array Biopharma’s MEKTOVI® (binimetinib). The MEKTOVI ‘100 patent had not been the subject of a delisting request.


As I categorized the claims of the fifty-two newly listed patents in order to include that information in my Orange Book Companion, I noticed one set of claims that was particularly interesting. The patent was 11,311,515 listed for an ophthalmic drug called UPNEEQ® (oxymetazoline hydrochloride) from RVL Pharmaceuticals. UPNEEQ is indicated for the treatment of blepharoptosis (a.k.a.,  ptosis), which is “a drooping of the upper eyelid that may affect one or both eyes. The eyelid may droop only slightly or may droop enough to cover the pupil and block vision.” [].


What I found interesting about the ‘515 patent is that the preamble of each claim starts  with  “a/the child-resistant packaging” or “a/the child resistant foil pouch.” By now, most attorneys practicing in the Hatch-Waxman arena know that “packaging patents” are not eligible for listing in the Orange Book.


However, as I read through the claims it became apparent that this was not a patent that claimed a type of child-resistant packaging. What the claims of the ‘515 patent appear to be directed to is a “finished dosage form that contains a drug substance, a.k.a., a “drug product” per 21 CFR 314.3(b). My thought was based on the claim elements: 1) a single-use container that 2) comprises a preservative-free eye drop formulation that includes oxymetazoline. Such claims should not have any trouble making a patent eligible for listing since they are very much like an ordinary capsule oral dosage form that is made up of 1) a capsule shell that is 2) filled with a drug formulation. 


So, is there any need to rely upon the “child-resistant packaging” or the “child-resistant foil pouch” terms in the preamble of the independent claims in order to construe those claims as covering a “drug product”? If not, there is room for an argument that those preamble terms about the packaging or pouch should be considered to be “non-limiting.” As such, the argument would be that the eligibility of this patent for listing in the Orange Book should be judged by the drug product elements of the single-use container and drug formulation that the independent claims contain, and not by their packaging or pouch terms.



#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights #orangebookcompanion  


Popular posts from this blog

Make sure that your patent exists before submitting a 3542 form for the patent to the FDA

Orange Book V43, Supp. 1 news

The Chicken Sandwich Conundrum: Parts is Parts . . . or Not