Wednesday, January 01, 2020 11:52:10 AM
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 …
- 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
Best,
G
"There are some things money can't buy. … For these, there is AMRN."
Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for
Recent AMRN News
- Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual • GlobeNewswire Inc. • 11/11/2024 01:00:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 10/31/2024 08:42:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 10/30/2024 08:10:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2024 08:10:08 PM
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- Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe • GlobeNewswire Inc. • 09/09/2024 11:30:00 AM
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