Orange Book V43, Supp. 1 news
Happy Orange Book New Year! Volume 43, Supp. 1 added 41 new patents to the FDA’s Orange Book. That includes three new patents for the current patent listing champ, AUVELITY® which now has 103 patents listed. You can see all of the changes to the Orange Book that occurred in Vol. 43/Supp. 1 by going to the Orange Book Companion® public home page and clicking on the prominent “What’s New” link. If are a gluten for punishment, can also see all 103 AUVELITY patents by clicking the sample link for trademarks that begin with "A" and then scrolling down to AUVELITY.
A device for making a drug does not claim the drug, itself
Three particularly interesting patents were listed in the Orange Book as part of Volume 43/Supplement 1. All three patents claim devices for making the approved drug. They do not claim the approved drug, itself, or a method of using the approved drug. Yet all three were listed as “drug product” patents. In each case, the approved product is a gas that is converted from another gas in the claimed device. In the case of Polarean’s XENOVIEW, Xe129 is converted to hyperpolarized Xe129 by the device claimed in one of the listed patents. The other listed patent for XENOVIEW claims a specific part of the device that had been claimed in the first patent. In the case of Vero Biotech’s GENOSYL, nitrogen dioxide is converted to nitric oxide by the claimed device.
There are no claims in any of the three patents that are directed to the drug product produced by the devices. Just because a claim in a patent mentions your approved drug does not mean that your approved drug is a claimed invention of the patent. For example, the claimed invention in one patent listed for XENOVIEW is described as a “system for producing hyperpolarized gas” that contains a “pre-saturation chamber” containing an alkali metal, and a heat source for heating the pre-saturation chamber to 140° to 300° C. Those are not claim elements that in any way encompass the approved active ingredient of XENOIEW, hyperpolarized Xe129.
In the case of GENOSYL, the claimed invention is “a system” that contains a “pressure regulator” element and an element described as a receptacle having a “surface-active material coated with an aqueous solution of an antioxidant.” Similarly to XENOVIEW, those are also not claim elements that in any way encompass the approved active ingredient of GENOSYL, nitric oxide.
You can find links to the three patents by going to the Orange Book Companion® public home page and clicking on the prominent “What’s New” link. From the “What’s New” page, scroll down to GENOSYL or XENOVIEW for links to their patents.
Make sure that your patent listings are accurate
Once again I want to warn everyone to make sure that you check any new Orange Book listings that your company submits. Astellas obtained approval of a new, lower strength version of their antifungal product, CRESEMBA in November. However, as I reviewed the Orange Book Companion’s “What’s New” for Orange Book Supplement 12, I noticed that one of the patents listed for this new strength of CRESEMBA (10,122,238) had a strange sounding title for an antifungal drug: “Configurable reference signals” (my Orange Book Companion provides the title of every patent, and so makes it easier to spot strange patents). When I compared that patent number to one listed for the higher strength of CRESEMBA (6,122,238), it was easy to see what had happened. In this case, the replacement of a “6” with a “10” may have been made in the 3542 form, or it could have occurred during data entry at the FDA. Regardless, if you are in any way responsible for your company’s Orange Book listings you cannot simply submit a 3542 form and forget about it. Always check to make sure that the listing is correct.
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