Amarin Corp Plc (AMRN)

[eightisenough]

Letter sent to Singer & JT: Dear Mr. Singer esq. and Mr. Thero ceo,

I reached out to Mr. Singer before he submitted his wonderful Reply brief for Amarin. I appreciate that he incorporated some of my suggestions in the Reply Brief.

I would like to commend you Mr. Singer on the superb performance during the oral argument. Unfortunately, it seems that the (unlucky) panel had made up their decision, prior to the hearing. One aspect I would have done differently, is to lead and focus on the obviousness point, showing that the understanding of the time was that an over 500 population was different from the Mori study. Attacking the ruling with the secondary considerations is an uphill argument, since you have a prima facie finding already...

Regarding the application for full review, I would suggest emphasizing the following arguments:

(1) If the lower court's ruling is not overturned, a detrimental and incorrect precedent, allowing weighing of secondary considerations against another, will be etched in law.

(2) Amarin should file a motion together with the application for full review, to allow Dr. Bhatt's paper as new found evidence (since it was published after the initial appeal brief was filed), that refutes Judge Du's underlying reasoning to find prima facie of obviousness from Mori.

Alternatively, Amarin should expeditiously (since Amarin has 30 days for application for full review) file the motion to allow new evidence with Judge Du, and if/when she rejects the motion, then file it with the appeals application.

(3) The oral hearing seemed not legitimate, as evidenced by Judge Dyk's failure to understand the basic point, that secondary considerations were tainted by weighing them against another (which Judge Du based her finding that secondary considerations were "weak" as a whole).

Lastly, I became aware that Amarin has a powerful and strong option to receive an injunction against the generics from entering the market, because inevitably they will infringe on the Reduce-It patents. Here is a short blurb from an article (written by Terry G. Mahn, the managing principal of Fish & Richardson’s Washington, D.C. office and head of the firm’s Regulatory and Government Affairs Group.a Fish attorney) with the link attached.

In Astra Zeneca LP v. Apotex Inc. (“AstraZeneca”), the Federal Circuit ruled that a pioneer drug manufacturer would be
irreparably harmed by the launch of a generic drug that would “necessarily” be used by “some consumers” in an infringing manner. The generic manufacturer claimed it did not possess the “specific intent” to induce infringement, because it had tried to remove all patented use information from its label, and
in any event, its drug was approved by FDA for various non-infringing uses. Nonetheless, the court held that a manufacturer that intends to place a drug on the market knowing it will be used in an infringing manner by some consumers would be liable for inducing infringement, for which the appropriate remedy is an injunction. The court said it did not matter that the infringing use was mandated by FDA requirements, because the manufacturer had other options for avoiding inducement.

Although the patented use in AstraZeneca involved an on-label instruction for drug dosing, the broad holding in the case could just as easily apply to the widespread generic practice of “skinny labeling.” By industry practice, a generic drug is “skinny labeled” whenever the generic manufacturer omits a patented use from the approved pioneer label to avoid an infringement suit by the pioneer. Despite the omitted use, these drugs are approved by FDA as therapeutically equivalent to and fully “substitutable” for the pioneer and marketed as such by generic manufacturers. Because many state pharmacies are required by law to fill prescriptions with “substitutable” generics regardless of intended use, some consumers will necessarily receive and use “skinny labeled” generics in aninfringing manner. Under the holding in AstraZeneca, this practice now appears to induce patent infringement.

If you have the time please let me know your feelings about the above points and whether I can be of assistance to you in this matter.

Here is the link: https://www.fr.com/files/uploads/attachments/Skinny_Labeling_Inducement_of_Patent_Infringement_Nov-Dec-2010.pdf