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HDGabor

01/01/20 11:52 AM

#238063 RE: venus537 #238055

v-

First of all: this post isn't about the outcome of the case / trial, isn't an opinion but a summary of the status (history, fact). Just to avoid the genius(es) jump in …

Didn't the judge set the parameters of this case to the MARINE label? Didn't the judge dismiss the rest of their other arguments?

Nope (for both).

- ANDAs were filed in 2016. They were submitted with labeling request (proposal) significantly similar to Vascepa label (at the time of the ANDA submission) … MARINE label. It does not prove anything about generics intention, they had not a choice: MARINE indication only was on the label at that time. (If somebody missed it: R-IT indication was approved on December 13, 2019. If any generic would like to include R-IT indication, could request it "on" or after Dec 13, 2019 only … not in 2016 or anytime on or before December 12, 2019) … and they file a Paragraph IV notice regarding the OB'd patents (stated no infringement exist).

- Amarin filed the Complaints (within 45 days from the date of the Paragraph IV notice) claiming indirect infringement: contributory and inducement)

- Generics filed Answers & Counterclaims (patents are not valid)

- YTD "result":
(i) Amarin claim of contributory infringement was denied, no contributory infringement exist
(ii) Generics invalidity claim (other than obviousness) was denied

- trial: inducement and obviousness will be discussed

I don't understand why the entire case wasn't thrown out

Since no decision regarding inducement and obviousness.

Best,
G