Orange Book Insights No. 26: Interesting New Patents From FDA''s Orange Book: Vol. 41, Supplement 3

Is a method of preventing certain patients from receiving a drug a “method of using” the drug? Patents directed to computerized methods of preventing a patient from receiving a drug have previously been listed in the Orange Book. Most notable are patents listed by Celgene for their thalidomide product, THALOMID®. Thalidomide can cause significant birth defects if a woman takes the drug while pregnant. The Celgene patents were directed to a computer system meant to prevent a pharmacy from selling THALOMID to a woman who has not had a recent negative pregnancy test. So when I saw that the “What’s New” for Supplement 3 of my Orange Book Companion ® showed that Zogenix had listed a patent with computer system claims for their FINTEPLA® (fenfluramine) product, I thought of one of Yogi Berra’s famous witticisms: “it’s déjà vu all over again”! Why might FINTEPLA have a computer system patent? Fenfluramine was part of an infamous diet drug combo called “fen-phen” in the 1990’s. Fen-phen was bl

Dreams Do Come True: The Purple Book is getting patent listings!

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) did not contain any provisions for patent listings for the products covered by the Act. That was a big difference between the BPCIA and Hatch-Waxman. As an Orange Book patents aficionado and the creator of the   Orange Book Companion ® ( OBC ) , I had dreamed over the years of somehow collecting patents on biologics and creating a Purple Book Companion ™ ( PBC ). My plan would be for the   PBC   to provide enhanced info for biologics patents in the same way that my   Orange Book Companion   provides enhanced info for small molecule drug patents. You can see samples of the   OBC ’s enhanced format on the   OBC  public homepage .   Well, my dream may be about to come true! A January 15, 2021 alert from the  Arent Fox firm  described a three-page section of the 2,124-page “Consolidated Appropriations Act, 2021” (“the Act,” enacted December 27, 2020) which is entitled “Sec. 325 Biological Product Patent Transparency”. At pa

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