A layman summary of the patent case
(I) Background
(II) Ongoing litigation
(III) Settlement
(IV) Final thoughts
(I) Background
In the first half of 2014, Amarin received six paragraph IV notices notifying them of accepted ANDAs to the Vascepa 1-gram dose strength under the Hatch-Waxman Amendments. The paragraph IV notices were by:
1. Apotex, Inc. and Apotex Corporation, or collectively, Apotex;
2. Roxane Laboratories, Inc.;
3. Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., or collectively, Dr. Reddy’s;
4. Watson Laboratories, Inc. and Actavis plc, or Watson;
5. Teva Pharmaceuticals USA, Inc.;
6. Andrx Labs, LLC, Andrx Corporation, and Actavis plc, or collectively, Andrx
Amarin filed patent infringement lawsuits against all of them. Amarin voluntarily dismissed the Northern District of Ohio case against (2) Roxane and agreed to dismiss the lawsuit against (4) Actavis plc but not against Watson
The U.S. District Court for the District of New Jersey granted Amarin motion to dismiss all patent infringement litigation related to the 2014 acceptance by the FDA of ANDAs to Vascepa. An appeal of the court’s dismissal was filed by one ANDA filer and, after FDA’s May 2016 grant of Vascepa NCE exclusivity, that appeal was withdrawn by the ANDA filer. This dismissal and terminated appeal ended this patent litigation related to Vascepa.
In September and October 2016, Amarin received paragraph IV certification notices from four companies:
1.) Roxane Laboratories, Inc. and related parties, collectively, Roxane (Roxane transferred its ANDA to West-Ward Pharmaceuticals International Limited later). West-Ward Pharmaceuticals Corp. is a wholly owned, U.S. subsidiary of Hikma Pharmaceuticals PLC (on or before September 21, 2016);
2.) Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., collectively, DRL (on or before September 22, 2016);
3.) Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Limited, or collectively, Teva; (on or before October 7, 2016)
4.) Apotex Inc.
(Note: Watson and Andrx did not file a new ANDA to FDA, did not send a paragraph IV certification notices)
Amarin filed patent infringement lawsuits against three (1.-3.) of these four ANDA applicants. (4) Apotex made a paragraph IV notice as to some, but not all, of the patents listed in the Orange Book for Vascepa. Because Apotex did not make a paragraph IV certification as to all listed patents, Apotex cannot market a generic version of Vascepa before the last to expire of the patents for which Apotex did not make a paragraph IV certification, which is in 2030.
On May 24, 2018, Amarin entered into a settlement agreement with Teva. As part of this settlement agreement, Amarin paid $2.0 million and Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029 (8/9 months the last to expire of the patents which is April 29, 2030) or earlier under certain customary circumstances, including commercial launch by another generic manufacturer under certain circumstances, in which event Teva would pay certain royalties on its generic Vascepa products.
(II) Ongoing litigation
The remaining parties are:
- Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited, aka West-Ward (Defendant)
- Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., aka DRL (Defendant)
- Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd., aka Amarin (Plaintiff(s))
The case is about (i) the patent validity and (ii) infringement. During the course of the litigation, the “topic” was narrowed down to (i) obviousness and (ii) inducement.
(Note: There is no real dispute that Vascepa — and therefore Defendants’ ANDA drugs — are, and can be for legitimate reasons, prescribed for fewer than 12 weeks. That means that reducing triglycerides in less than 12 weeks using Defendants’ ANDA drugs is a substantial non-infringing use of those drugs. The existence of this substantial non-infringing use for Defendants’ ANDA drugs therefore defeats Plaintiffs’ contributory infringement claim. Because there is no genuine dispute of material fact on this issue, the Court granted Defendants summary judgment that, they do not contributorily infringe Plaintiffs’ Asserted Claims.)
(i) Obviousness
It is about whether or not it was “unexpected,” in light of the available prior art, that administering pure EPA to patients with high TG levels would not increase bad cholesterol, while simultaneously reducing Apo-B levels.
The good thing:
(a) The entire primary prior art references relied upon by the generics were previously before the Examiner or discussed by the Examiner during prosecution of the patents.
(b) The burden of proving obviousness is on the generics, and it is a relatively high one. The generics must show that the patents are invalid based upon a “clear-and-convincing-evidence” standard. If the case really comes down to a close call, and the court correctly applies the standard, that suggests that the court should in theory rule against invalidating the patents.
HOWEVER, please notice:
(a) There is precedent of courts invalidating patents based upon prior art previously considered during prosecution.
(b) We do not have all documents, do not know all arguments … but we know - re. the Hayashi study – that the examiner accepted as true Dr. Lavin’s opinion that the prior art did not teach administering purified EPA to patients with triglycerides of at least 500 mg/dL, which the parties now agree was incorrect, Defendants only seek to show that the asserted patents were issued based on factual mistakes about the prior art
(ii) Inducement
Generics applied for full MARINE label (including treatment >12 weeks) they are not looking any „carve-out” of the MARINE label (which is – btw – legally is not possible, generic label has to be the same as - substantially similar to - Vascepa label prior December 13, 2019, aka MARINE label.)
The patents require administering the drug for at least 12 weeks, but the label does not specify any duration for drug administration. It is beyond dispute that the majority (>95%) of the patients took / take / will take Vascepa (and / or gV) longer than 12 weeks. However the topic during the trial (if any) is:
- Defendants' proposed labelling does not encourage prescribing doctors to infringe the Asserted Claims
or
- Defendants' proposed labelling encourage prescribing doctors to infringe the Asserted Claims
It is not about how prescribing doctors / patients use Vascepa but what Defendants' proposed labelling suggests / tell / etc. to prescribing doctors about how to use Vascepa.
Summary: Amarin has to win both arguments - (i) obviousness and (ii) inducement – since without a valid patent no infringement exists … or in case of no infringement the validity of the patents is not relevant. I think Amarin’s chance is good; probability of the win is high … however, it is not a sure thing.
(III) Settlement
Amarin position: I do not think they could get anything more – that is significant - with the Order than with the settlement. The Order will close this case but:
a.) It could be appealed … Order of the Appeal Court will come – more likely – in Q4 2020 / Q1 2021 (as the earliest)
b.) Due to the narrowed down topic of this case, the win will not guarantee that other generic will not try (on a “wider” basis … be more prepared.) … win the case will not shuts all doors …
I am mostly certain Amarin is ready / open for a settlement. However, they have some limitation regarding the term due to Teva settlement. (E.g., I could not imagine they could settle with Hikma / DRL for earlier entry than August 9, 2029 – more likely - it should be later by X months … or if they settle “with” (e.g.) August 9, 2029, it will be resulted in an earlier entry by Teva.)
Generics position:
(a) Hikma was the first (? .. based on Complaint) filer … has (had) 6 months exclusivity … nullified by Teva settlement.
(b) DRL has shown a proclivity not to settle over the past 18 months or so, and Dr. Reddy's management suggested they are not willing to settle … however, it does not mean they will not. (e.g. they settled with Celgene after BYN $74bn offer for $”50” million regarding a multi-billion drug with $15 bn expected peak sales. Please note: that settlement has – at least – two main differences: (1) the trial was not scheduled (2) USPTO turned down Dr. R’s Citizen Petition regarding the patent.)
(c) The current size of the market is not too “sexy” for them (less than $1bn), far away from peak sales … furthermore
(d) If generics will win it would allow other generics to enter the market … the competition will / could be big, meanwhile the market size (currently) is small
(e) We do not know their view about their chance (to win) but 3rd party expert view it as small (less than 15%)
Summary: The settlement would be in the best interest of all parties. I do not see any real reason for the trial … the settlement (if any) more likely will come before January 13, 2020. I do not think the money will be a main issue: more likely generics will request less than the Dr. R & Celgene deal but more than the Amarin & Teva deal (since later entry should be “compensated” somehow).
(IV) Final thoughts
(i) REDUCE-IT: It is relevant as a support against obviousness but nothing other. For clarity: REDUCE-IT patents are irrelevant, since if it is listed in the Orange Book after the generic drug application is filed, then the generic drug applicant need not certify as to the patent. Id. § 314.50(i)(4)(i) (for 505(b)(2) NDAs); id. § 314.94(a)(12)(vi)(A) (for ANDAs).
(ii) Relevance of the litigation regarding a BO / BO Offer (if any): If anybody is interested in a BO, the discussion / negotiation – more likely – is ongoing (maybe since September 24, 2018 afternoon …). Offer could be made – before the end of the case – as we saw in case of Dr. Reddy and Celgene (and BYM) but:
(a) The risk should be valued and more likely it could not be agreed (the difference between a win and a loss is too big).
(b) The solution is at hand … by settlement (anytime) or by Order (March / April 2020).
Best,
G
