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Parts is Parts? A few thoughts about some of the comments that were submitted to the FDA about Orange Book listings

The deadline for submitting comments to the FDA about patent listings in the Orange Book has long passed. The result was the submission of seventeen comments by a variety of organizations.   A big issue discussed in the comments is the eligibility for listing in the Orange Book of patents that claim a drug administration device or a part thereof. This issue can be broken down into:   1) for a patent claiming the device as a whole, does there have to be a claim that recites the presence of a drug (or “the” drug) in the device in order to make the patent eligible for listing in the Orange Book?   2) is a patent that claims only an individual part of the device eligible for listing in the Orange Book?   Presence of “a” drug or “the” drug ?                Presence of “a” drug ?   Yes, patent attorneys have drafted claims for patent administration devices that, even when they know that the device was designed with a particular active ingredient in mind, do not include a drug as an element i

Speculation about the delisting of a “part” patent from the Orange Book

After updating my  Orange Book Companion ®  (“OBC”) Orange Book information subscription service each month, I usually first check the “What’s New” page that contains the changes in patent and exclusivity listings from the previous month. For the most recent update, Volume 40, Supplement 6, the first thing I saw at the top of the page was a patent delisting for Otsuka’s Abilify MyCite ®  Kit (aripiprazone oral tablets). Aripiprazole is classified by the FDA as an atypical antipsychotic.   The  Abilify MyCite  Kit is a very interesting product. The kit includes a tablet that contains the aripiprazole along with some circuitry that transmits an electromagnetic signal when activated by gastric juices in the patient’s stomach. Yes, each tablet is like a little radio transmitter!   The other part of the kit is a skin patch that contains a receiver for the signal sent by the tablet. The data received by the patch can be accessed via a smartphone app. In this way the patient or their caregive

Why a biologic was still in the Orange Book months after all others were transitioned to BLAs

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) contained a provision that would change the NDAs for biological products to BLAs after the tenth anniversary of the BPCIA’s enactment. [See section 7002(e)(4) of the BPCIA]. As I discussed in my last blog posting, the FDA deleted, on schedule, all of the biologic products that were listed in the Electronic Orange Book (“EOB”). Except for Sanofi’s two insulin glargine products, LANTUS and LANTUS SOLOSTAR.    I sent a message to the Orange Book Staff about their retention of the Sanofi products in the EOB, and they responded by referring me to legislation called the  Further Consolidated Appropriations Act, 2020  (“FCAA”) that was passed by Congress just before their holiday recess on December 20, 2019. Three pages of the 715 pages of the FCAA, pp. 594-596 ( Sections 605-607 ) contain amendments to the Public Health Service Act (“PHSA”) and BPCIA provisions that involve biological products.   Through a cursory search I

Big Change to the Orange Book

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) contained a provision that would change the NDAs for biological products to BLAs after the tenth anniversary of the BPCIA’s enactment. [See section 7002(e)(4) of the BPCIA]. Well, March 23 was that 10th anniversary! In honor of that event, the FDA deleted all of the biologic products that were listed in the Electronic Orange Book. Poof, gone! (Except, for some reason, Sanofi’s LANTUS and LANTUS SOLOSTAR (insulin glargine) products are still showing up in an EOB search for "insulin." I have a question about that pending with the Orange Book staff). Also in honor of this event, the FDA issued a new version of Volume 40 of the Orange Book in PDF format. That new version, dated March 20, 2020, freezes in time all of the Orange Book listings that existed just days before the deletion of the biologic products. So if you want a snapshot of biologic products prior to the switch from NDA to BLA, you should downloa

A non-Corona Virus Posting: Teaching a really ancient drug a new trick

But First, the Cocaine Saga Continues In Supplement 10 of Orange Book Volume 39 Genus Lifesciences listed another patent ( 10,420,760 ) for its cocaine hydrochloride product, GOPRELTO. It is the fourth method patent listed for GOPRELTO that is directed to a method of inducing local anesthesia. In this case, the inventors added the patient’s glomerular filtration rate as a new limitation in the claims.  Teaching a Really Ancient Drug a New Trick We all know of a really ancient drug (think back to biblical times!) that is still widely used today. That is ethyl alcohol (a.k.a. “ethanol” or simply “alcohol”). Of course, it is used mainly as a recreational drug. But then again, you may have known or heard of people who imbibed a distilled spirit on a regular basis strictly for “medicinal purposes.” I can still recall seeing my dad taking a single shot of some sort of whiskey every evening after dinner. Although I do not think I ever knew his medicinal purpose. I recently di