A New Dosage Form in the Orange Book & New Patents in the Purple Book

New Dosage Form in the Orange Book


One day in mid-August of the year I turned sixteen I came down with what I thought was the worst cold that I had caught in many years. I had a constant runny nose for two weeks straight. That was accompanied by itchy throat and eyes. Finally, after two weeks of this suffering I went to a doctor. After I described this bad cold to him, he asked me if I ever had pollen allergies. When I told him “no” he answered, “well you have them now”!


That started me on a lifetime of allergy treatments that continue to this day. I did not need corrective lenses for many years. However, when I finally needed them I felt that I should not risk using contact lenses due to itchy eyes during allergy season for which eye drops and oral antihistamines were of limited help.


Now the FDA has approved a new type of contact lens on February 25. 2022 that could have “let me have my cake and eat it, too”! It is Johnson & Johnson’s Acuvue Theravision with Ketotifen contact lenses whose dosage form is a new one in the Orange Book: a “drug-eluting contact lens.” So users can actually wear a contact lens to fight the itchy eyes of pollen allergies. However, it is a little late in life for me, since I lost interest in contact lenses a long time ago.


The Supplement 3 “What’s New” (available for free from a link on my public Orange Book Companion® home page) shows the submission of two patents for the Acuvue Theravision with Ketotifen contact lenses. 9,474,746 claims a formulation that stabilizes the ketotifen. 9,962,376 claims the combination of contact lens and ketotifen which is produced by packaging the lens and ketotifen together, and then sterilizing the combination. I categorized the ‘376 claims as “product-by-process.”


New Patents in the Purple Book


In March, thirty new patents were listed in the FDA’s “Purple Book.” Those patents were all listed for Regeneron’s EYLEA (afibercept). You will find links to the patents, as well as the titles, expiration dates, and types of claims in each patent, listed in a free beta version of my Purple Book Companion.


Additional Orphan Drug info in the Purple Book Companion


I also made a change to the Orphan Drug exclusivity information in my Purple Book Companion as a result of the 11th Circuit’s decision in Catalyst Pharmaceuticals v. Becerra, No. 20-13922 (Sept. 30, 2021).  The Catalyst court held that the scope of the seven-year orphan drug exclusivity is controlled by the FDA’s orphan designation for the drug rather than by the FDA’s approved indication for the drug. (“Thus, the scope of exclusivity under § 360cc(a) is determined by what has been designated under § 360bb.” Slip op. at 16).


You see, the FDA’s spreadsheet of Orphan Drug information (available at https://www.accessdata.fda.gov/scripts/opdlisting/oopd/ when “Search Results” is set to “Only Approved Products” and “Output Format” is set to “Download Excel File”) includes up to three different descriptions for approved orphan drugs and biologics:


1) the orphan designation description,

2) the approved, labeled indication, and

3) the exclusivity protected indication.


In the first iteration of my Purple Book Companion, I listed the narrowest of those three descriptions for each biologic, which was usually “the exclusivity protected indication.”


However, if the FDA’s spreadsheet did not show an “exclusivity protected indication” for a biologic, but showed its “approved, labeled indication,” I included that description. 


I only included the orphan designation description in my Purple Book Companion if neither of the two more specific descriptions were included in the FDA’s spreadsheet that I obtained as described above.


However, the Catalyst decision changed all that by holding that it is the orphan designation description that controls the scope of protection that the seven-year orphan drug exclusivity gives to the NDA or BLA holder for a drug or biologic. As a result of the Catalyst decision, if there is no mismatch between the trademarks displayed in the Purple Book and those in the FDA’s spreadsheet, I now include in my Purple Book Companion the orphan designation description from the FDA’s spreadsheet. In addition, I also include the “exclusivity protected indication” and the “approved, labeled indication,” if they are available. In this way users of my Purple Book Companion will have more information when researching drugs listed in the FDA’s Purple Book. 


So please check out my latest iteration of the Purple Book Companion, and let me know what you think. Thanks.


#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights #orangebookcompanion #purplebook #biologics #purplebookcompanion #BPCIA


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