Replies to post #262300 on Amarin Corp Plc (AMRN)

[JDUR]

I don't think that is in-factual. If the examiner granted the patents due to secondary conditions on the basis of APO-B reductions and Kurabayashi suggested that EPA reduced Apo-B, it is a reasonable assumption to assume the examiner overlooked it.

Monday could be bad. Look up Hikma's ANDA 208339. The FDA granted approval 3 days after the ruling against J&J's Zytiga, despite a pending appeal waiting. Generics want to claim the 180 exclusivity so they all will rush file.

[amarininvestor]

The patent office knew about Kurabayashi and still issued the patent. So I am not sure why defendants can make a convincing case that the patent officer ignored or did not acknowledge it. [Thanks to anyone that can explain that to me]

I find that final sentence however more interesting:

Nor did the examiner address that Lovaza was frequently administered with statins to address LDL-C increases.

Now look at what the judge wrote in the ruling:

The Court is persuaded that there was a long-felt need for a drug like Vascepa that
10 could reduce TG levels without raising LDL-C levels, primarily because both sides’ experts
11 testified that patients are more likely to comply with a prescribed treatment regime when
12 they only have to take one pill, rather than two—and the Court relied on this evidence in
13 finding a POSA would be motivated to combine the Lovaza PDR with the finding from Mori
14 that EPA did not raise LDL-C levels.22 (See supra Section IV.B.2(a).) It is better to take
15 one pill than two if taking that one pill will give you all the same benefit. Moreover, there is
16 no real dispute that some patients may not be able to tolerate statins. (ECF No. 367 at
17 660-61.) Thus, the Asserted Claims represent an improvement—albeit a prima facie
18 obvious one—over the prior art. And this secondary consideration therefore weighs slightly
19 in favor of finding the Asserted Claims nonobvious.

If you put together the above plus the undisputed commercial success, then it is unclear to me why that was not sufficient to maintain Amarin's patents.

[alm2]

This is a vital and fatal error
As is the error in Mori
Send this post to Covington. Amarin’s lawyers
Brilliant work
Alm

[sts66]

That is an assertion made by the defendant (Hikma), and to me, the judge relied on it without verifying the accuracy of the claim

Wait a second - are you saying that Hikma claimed the USPTO did not review Kurabayashi before granting the patents and the judge just believed them w/o verifying? Or that Hikma didn't make the claim but the judge unilaterally decided the examiner didn't consider Kurabayashi (or Mori)?

Kurabayashi is mentioned in the '715 patent too, and Mori is the very first publication listed in it:

https://patents.google.com/patent/US8318715B2/en