Amarin Corp Plc (AMRN)

[HDGabor]

A layman summary of the patent case / Updated (Part 3; See Part 1 here and Part 2 here)

Generics bear the burden of proving patents are obvious.
Generics have to prove with “clear-and-convincing-evidence(s)”* that ALL patents are obvious.
* The evidence presented by a party during the trial must be highly and substantially more probable to be true than not and the trier of fact must have a firm belief or conviction in its factuality. It is a higher level of burden of persuasion than "preponderance of the evidence"

Amarin bear the burden of proving patent infringement.
Amarin has to prove with “burden of proof”** that Generics will induce infringement of (at least) ONE claim.
** The standard is met if the proposition is more likely to be true than not true. The standard is satisfied if there is greater than fifty percent chance that the proposition is true (preponderance of the evidence).

The Patents-In-Suit (Asserted Claims)

6 patents … 10 Claims are the topic.

U.S. Patent No. 8,293,728 (“the ‘728 Patent”), Claim 1 & Claim 16
U.S. Patent No. 8,318,715 (“the ‘715 Patent”), Claim 14
U.S. Patent No. 8,357,677 (“the ‘677 Patent”), Claim 1 & Claim 8
U.S. Patent No. 8,367,652 (“the ‘652 Patent”), Claim 1
U.S. Patent No. 8,431,560 (“the ‘560 Patent”), Claim 4 & Claim 17
U.S. Patent No. 8,518,929 (“the ‘929 Patent”), Claim 1 & Claim 5


(i) 3 Claims (‘728 Patent Claim 1* & 16, ‘715 Patent Claim 14*) are subject of “without concurrent lipid altering therapy” (*and “achieve the lipid effects required”
(ii) 6 Claims (‘677 Patent Claim 1 & 8, ‘652 Patent Claim 1, ‘560 Patent Claim 4 & 17, ‘929 Patent Claim 5) are subject of “achieve the lipid effects required” (without requirement of “without concurrent lipid altering therapy”)
(iii) All Claims are subject of “at least 12 weeks”;

arguments.

(i) “without concurrent lipid altering therapy”

Meanwhile the label (“14. Clinical Study”) contains information about statin usage (“Twenty-five percent of patients were on concomitant statin therapy”) it is silent about other concurrent lipid altering therapies, e.g., fibrates, niacin, and ezetimibe.
The “Clinical Pharmacology” section of the label reports studies on “Drug-Drug Interactions” between EPA and various concurrently administered drugs and states that EPA did not change the
pharmacokinetics or blood levels of “atorvastatin”. GV can safely be coadministered with a concurrent lipid altering therapy (with statin).
The label do not explicitly or implicitly instruct physicians to administer GV to a patient who is not on concurrent lipid altering therapy.

Generics’ labels do not encourage, recommend, or promote administering GV without concurrent lipid altering therapy. … no inducement exist in case of these (i) Claims.

(ii) “without concurrent lipid altering therapy”

It’s a close call …

- The label does not have to encourage all physicians it is sufficient that Generics' labels will encourage some physicians
- Inducement need not be premised on explicit instructions to perform the infringing method, where the proposed label
- “Indications and Usage” & “Dosage and Administration” section [Sections] vs. full label (package insert)
- plausible interpretation of the labelling that suggests the Court could find induced infringement
See more in Part 2 (here) about these (in connection with “12-weeks”)

Generics’ labels could encourage, recommend, or promote administering GV to achieve the lipid effects.

(iii) “at least 12 weeks”

The remaining claim is the ‘929 Patent Claim 1:

A method of reducing triglycerides in a subject having fasting triglycerides of at least 500 mg/dl comprising, orally administering to the subject daily for at least about 12 weeks a pharmaceutical composition comprising about 4 g ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids.

‘929 Patent Claim 1 is not a subject of the (i) and (ii) arguments … it is the subject of the (iii) “at least 12 weeks” argument only. I detailed (here) why I think Amarin will prevail in case of inducement … why Generics’ labels encourage, recommend, or promote administering GV for at least 12 weeks.

Conclusion: Amarin has to prove with “burden of proof” that Generics will induce infringement of (at least) one claim …

(i) Claims: will fail
(ii) Claims: Meanwhile the arguments is weaker than in case of the “12-week” these Claims could prevail, an inducement could be the case … but is a close call
(iii) Claim: Generics will induce infringement of ‘929 Patent Claim 1.

Best,
G