Replies to post #305834 on Amarin Corp Plc (AMRN)

[iryokabu]

HDG,

"Substantial" is not the question of volume. Any reasonable use is a substantial use, even if not commercially viable.

I think the following sentences are reference:

Unclear What Constitutes “Substantial” Non-Infringing Use: The law is unsettled on meaning of “substantial.” Any reasonable use is a substantial use, even if not commercially viable. “Non-infringing uses are substantial when they are not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Vita-Mix (Fed. Cir. 09/16/09)); accord In re Bill of Lading (Fed. Cir. 06/07/12) (“That practicing the patented method may be the most logical or useful purpose for Appellees’ products does not render the alternative uses ‘unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.’”); Toshiba (Fed. Cir. 06/11/12) (aff’g Summ. J. of no contributory infringement). But see i4i (Fed. Cir. 03/10/10) (upholding verdict of contributory infringement despite three non-infringing ways of using the accused code, based on evidence that those uses would deprive user of the intended benefit of the accused feature), aff’d on other grounds (U.S. 06/09/2011).

https://patentdefenses.klarquist.com/271c-contributory-infringement/

We can only speculate the meaning/interpretation of "substantial" (we do not know how future court will interpret the term "substantial"), but in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed.Cir.2003) case, they were taking about the volume regarding the term "substantial".

I did not say that "the generic equivalent to Vascepa" suggest "B" code ... all I said: it is not the promotion of "AB" code, because the code could be "B" also.
A mere "AB" code (given by the FDA) is not a specific action by the generic ... generic has to definitely / explicitly promote the "AB" code for inducement.

Yes, I agree that Hikma did not say the term "AB" code. However, the term "AB code" may be LESS important than the term "therapeutic equivalent/generic equivalent" which is basically the key.

As a doctor, I did not know FDA rating (A, AB, B codes), but the term "therapeutic equivalent/generic equivalent". I think only pharmacists or insurance companies care FDA rating/codes.

And again, when Hikma said "generic equivalent", it was PR of ANDA approval which normally confirms "therapeutically equivalent", correct? Therefore, it can not be "B" codes.


"B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products.

[ilovetech]

HDG, I agree. Unfortunately, The FDA and the USPTO have proven to be "unreliable parties" to either help or discredit infringement determinations. The same could be said of infringement case law. But, let's assume that the Generics can continue their crusade to launch legally. I've said this many times, medicine doesn't live in a vacuum. Guidelines change, and so has guidance to treat those with "high triglycerides." As of today's guidance, a Doctor "will" treat an >500 trig patient for co-morbitiy. Why? because Reduce-it, which Amarin was "forced" to conduct, now requires Doctors to do so.

Non-infringement= Medical malpractice.

Infringement= Medical compliance.

Explain how legal technicalities enable Generics to skirt around this real world application. I love to see the Generics attorney deliver an OA that can win such a debate.


ILT

[HinduKush]

HDG,related to the discussion on FDA orange book drug codes:
According to the Orange Book 40th edition of therapeutic equivalence:

A Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting
bioequivalence. These are designated AB.

B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence
The code B* is assigned to products previously assigned an A or B code when FDA receives new information that raises a significant question regarding therapeutic equivalence that can be resolved only through further Agency investigation and/or review of data and information submitted by the applicant. The B* code signifies that the Agency will take no position regarding the therapeutic equivalence of the product until the Agency completes its investigation and review.

I submit its time for 2 strategies: (1) Amarin to put the generic compounds (if and when released) to test head to head against Vascepa (12 week trial in ANCHOR or MARINE type patients and show what the Suwa and Kino paper showed and (2) For the FDA to consider the Suwa and Kino paper as categorical evidence that " that raises a significant question regarding therapeutic equivalence that can be resolved only through further Agency investigation and/or review of data and information submitted by the applicant."
There is evidence that AB should be nore appropriately B by default unless these generic companies want to do trials to show true bioequivalence...
best HK