Orange Book Vol. 42/Supps. 7 and 8 News, Plus an Interesting Type of Claim for VASCEPA

The Vol. 42/Supp. 7 of the FDA’s Orange Book contained only 36 newly listed patents. Maybe July is a slow month? Also, there were no patent delistings. 

The Vol. 42/Supp. 8 of the FDA’s Orange Book contained only 33 new patents. Two months in a row with less than forty new patents? Maybe it’s the summer doldrums? There was a delisting request for a patent that was reissued. Ho hum!

However, if you are a fan (or not a fan) of listing patents that claim a mechanical part of a drug administration device, there is something for you. Teva Branded Pharmaceutical Products listed 11,395,889 for several of their metered dose asthma inhalers. The ‘889 patent claims a dosage counter for the inhalers. You can see all of the changes by looking at the free “What’s New” for Supp. 8 that is available from a link on my Orange Book Companion home page.

“Interesting” Method Claims

I have been looking into the Paragraph IV certifications and Section viii statements that Hikma made in their ANDA for Amarin’s VASCEPA® (icosapent ethyl). There were fifty-four patents listed in the Orange Book when Hikma filed their ANDA so there is a lot to wade through. In the meantime, I happened to notice an interesting aspect to the claims of 8,314,086 which is listed for VASCEPA.

Independent claim 1 of the ‘086 patent is directed to a method for lowering both VLDL-C and triglycerides in a “subject” who received VASCEPA as compared to a “second subject” with a similar triglyceride level who did not receive VASCEPA. In other words, the claim is directed to a method for establishing the efficacy of VASCEPA for lowering both VLDL-C and triglycerides in a subject.

I first must note that the lowering of both VLDL-C and triglycerides is not an approved use of VASCEPA, so the ‘086 patent should not have been listed in the Orange Book. But forgetting that for a moment, the claims are not ones whose infringement could be induced by a generic company who copied the VASCEPA label. That is because there is nothing in the label that would cause or encourage a prescribing physician to carry out a comparison between two subjects! 

Moreover, there is no reason for an ANDA applicant to carry out the claimed method in order to obtain approval. An ANDA applicant merely must test for bioequivalence between their proposed drug and the reference drug. They have no reason to carry out a comparison between one subject using their proposed drug and a matched second subject not using their proposed drug.

There are a number of Amarin method patents listed in the Orange Book for VASCEPA in which the claimed method requires the use of a “second subject,” a “second patient population”, a “second group of subjects,” or a “placebo control.” These patents are mainly found in Family 42102041 in the patent family list for VASCEPA patents applicable to the Hikma ANDA that I have made available.

#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights #orangebookcompanion #vascepa


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