patent medicines…

Posted on Monday 14 March 2011

It just seems like every time I have a question about this drug business, I have to go learn something else that I know absolutely nothing about. In this case, I naively begin to thing about patents in my last post, but then I found out that all this talk about patents isn’t the crux of the matter, it’s exclusivity. This, from the FDA:

FAQ on Patents and Exclusivity

1 What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. See 21 C.F.R. 314.108.  Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.
2 How long is a patent granted for?
Patents expire 20 years from the date of filing.  Many other factors can affect the duration of a patent.
3 How long is exclusivity granted for?
It depends on what type of exclusivity is granted.
        Orphan Drug [ODE] – 7 years
        New Chemical [NCE]- 5 years
        Other Exclusivity – 3 years for a change if criteria are met
        Pediatric Exclusivity [PED] – 6 months added to existing Patents/Exclusivity
        Patent Challenge – [PC] – 180 days [this exclusivity is for ANDAs only]
See 21 C.F.R. 314.108 New Drug Product Exclusivity.
4 Why does the exclusivity expire before the patent? Patent before exclusivity? Why does a particular drug product only have patents? Why does the exclusivity expire before the patent? Patent before exclusivity? Why does a particular drug product only have patents? Only have exclusivity? Have neither?
Patents can be expired before drug approval, issued after drug approval, and anywhere in between. Exclusivity is granted upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or none. Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims. Exclusivity is not added to the patent life. Expired patents and exclusivity are not included in the published list.

I read the above and I thought I understood it. So I looked up Seroquel. But when I went to the FDA’s "Electronic Orange Book," it just evaporated. Here are some tables with all of the various codes linked:


N022047 4879288 9/26/2011 U-601 [BPD]
N022047 4879288 9/26/2011 U-814 [SCZ]
N022047 4879288 9/26/2011 U-839 [MDD]
N022047 4879288*PED 3/26/2012  
N022047 5948437 3/28/2017 U-601 [BPD]
N022047 5948437 3/28/2017 U-814 [SCZ]
N022047 5948437 3/28/2017 U-839 [MDD]
N022047 5948437*PED 3/28/2017  

N022047 I – 618 12/02/2012
N022047 I – 576 10/08/2011
N022047 I – 575 10/08/2011
N022047 I – 574 10/08/2011
N022047 D – 117 10/08/2011
N022047 PED 04/08/2012
N022047 PED 11/17/2010
N022047 PED 04/08/2012
N022047 PED 04/08/2012
N022047 PED 04/08/2012


Patent Number: 4879288 5948437
Patent Filed: 03/20/1987 05/28/1997
Patent Approved: 11/07/1989 09/07/1999
FDA Application: N022047 N022047
FDA Approval: 09/26/1997 05/17/2007
Expiration: 09/26/2011 03/28/2017

If you look it over and figure out how the Patent/Exclusivity thing actually works, please enlighten me [and the rest of us]. I find it mystifying. There’s a blog [FDA Matters] that seems to get it, though I don’t understand enough to follow along. Here’s the take-home at my level of confusion. Extending the Patent/Exclusivity dates is the name of the game. The original bill in 1984 was the Hatch -Waxman Act and set all of this up to encourage the development of new drugs while clarifying the issue of Generics. In the three decades since, Patent/Exclusivity has become a specialty in the Law and Pharmaceutical Companies, and Seroquel has used all the tricks. The current one is a new patent on Seroquel XR. AstraZeneca is now on a campaign to convince the world that it’s the drug to use as a way of extending their "profit years."

Why Seroquel XR is better than Seroquel is hard for me to fathom. It isn’t, but it seems that’s the way the game is played.

The reason I was looking into all of this Patent/Exclusivity business had to do with my notion that it might hold a key to the kind of shenanigans we’re so upset by in the PHARMA Industry. Fining them, even with outrageous penalties, hasn’t slowed them down a bit. While their price-gouging is offensive, the real problem is their with-holding vital safety information. By all rights, Eli Lilly and AstraZeneca should have lost their Exclusivity for not making the Weight Gain and Diabetes information available. They can afford to lose a few billion in fines and settlements, but losing their cash-cow drugs would be more than they could bear. If the FDA "giveth," why can’t the FDA "taketh away?" I will persist in going down this garden path, but it’s not easy. Bureaucracy-ese is not my native tongue…
    March 14, 2011 | 2:38 PM

    You explain it as well as anyone…Big Pharma employs hundred (if not thousands) of the best professional manipulators to work every angle possible….this isn’t called the greatest Smoke&Mirrors Con of all time for nothing…

    This series is an absolutely must read for anyone really wanting to know how that pill bottle got to their medicine cabinet…

    Nancy Wilson
    March 17, 2011 | 7:06 PM

    See “Treating Partial Responders to Antidepressant Treatment” by Madhukar H. Trivedi, MD, here:

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