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The Week That Was In Skinny Labels

  • August 9, 2021
  • Article

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This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.

Vascepa® currently has two FDA-approved indications: (1) treatment of severe hypertriglyceridemia (the “SH indication”); and (2) cardiovascular risk reduction (the “CV indication”). Only the CV indication is protected by patents.

The ‘537 patent claim 1 reads:

A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:

identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,

wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:

identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,

wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and

wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium.

The ‘077 patent claims 1 and 8 recite:

1. A method of reducing triglycerides in a subject with mixed dyslipidemia on statin therapy comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%, by weight of all fatty acids, docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels in the subject.

8. The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control.

The ‘861 patent claims 1 and 2 recite:

1. A method of reducing risk of cardiovascular death in a subject with established cardiovascular disease, the method comprising administering to said subject about 4 g of 5 ethyl icosapentate per day for a period effective to reduce risk of cardiovascular death in the subject.

2. The method of claim 1, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and a fasting baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.

At the time Hikma filed its ANDA the the only approved use was the SH indication.  The Vascepa®  label, copied by Hikma, provided that, and up until 2019, the Vascepa®  label contained the following “limitation of use” regarding the CV indication: “The effect of VASCEPA®  on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.” Upon FDA approval of the CV indication Amarin amended to the label to add the CV indication and removed the limitation on use and added the patents to the Orange Book. After Amarin received approval for the CV indication and listed the patents in the Orange Book, Hikma submitted Section viii statements for the listed patents. Hikma did not add the CV indication to its label keeping only the SH indication but did remove the CV limitation of use from the label it had originally proposed prior to approval of Vascepa® ’s CV indication. After Amarin received approval for the CV indications, the majority of Vascepa® ’s sales were for these uses, a fact known to Hikma. Hikma issued two press releases stating “Vascepa®  is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia” (emphasis added) and stating the 2019 “Vascepa® sales were approximately $919 million” which Hikma knew included sales for the CV indication.  Both press releases were available on Hikma’s website as of the filing of the litigation.

The Magistrate in making her recommendation noted that she could not weigh the evidence but must take the allegations as true and determine “whether a complaint plausibly alleges inducement in a pharmaceutical case is thus no different than the analysis in any other case. The court must determine whether the complaint plausibly alleges that the generic manufacturer “offer[ed] a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement.” DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1305-06 (Fed. Cir. 2006) (en banc in relevant part).” She rejected Hikma’s argument that it could not be liable for inducement absent the FDA approval for its product for the CV indications citing AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045-46 (Fed. Cir. 2010).

Health Net was dragged in as a defendant because of its insurance scheme. Like most insurance companies it has various tiers for prescription drug compensation for insureds.  In this case Health Net Placed generic Vascepa® in Tier one which had the lowest copay and branded Vascepa® in Tier 3 which had a higher copay. This might not have caused a problem except that some of Health Net’s plans required “Prior Authorization” before it will cover and pay for either Vascepa or Hikma’s generic version. To obtain the authorization the patient’s medical dotor must submit documentation demonstrating that the prescription is being given for either the SH or the CV indication which maps to either the SH or CV use of Vascepa®.  Amarin had provided notice to Health Net that Vascepa®’s for CV would infringe its patents. Amarin in its complaint that the prior authorization and different tiers for the brand and generic provides encouragement to doctors to prescribe Hikma’s product. This is a novel inducement theory at least in ANDA cases but the Magistrate recommended denying Health Net’s motion to dismiss.

The recommendation to deny the motions to dismiss was based on the Magistrate’s conclusion that the complaint stated a plausible claim against both Hikma and Health Net

The decision underscores the need for a generic to be careful in its press releases and in label carve outs. Also, that sometimes and insurer may request too much information before approving coverage especially where it has been advised of the existence of patent protection.

The second case is the second round of GlaxxoSmithKline LLC. v. Teva Pharm. USA, Inc., 2018-1976, 2018-2023.  The first round is discussed here with a more complete recitation of the facts. [Click through the links here to read the past Skinny Label blog posts: GSK vs. Teva: Induced Infringement, Skinny Labels and Fat DamagesGSK v Teva - The Federal Circuit's First Look at Skinny Labels and 35 U.S.C. 271(b); and GlaxoSmithKline v. Teva - Not a Skinny Label?] In this decision the majority cited to additional evidence that Teva had engaged marketing that touted its generic product’s use for the patented indication of heart failure.  One of the more important points is that the jury had found Teva’s “skinny label” was not so skinny. GSK’s Carvedilol was approved for three indications, hypertension, congestive heart failure (CHF) and reducing cardiovascular mortality in patients with left ventricular dysfunction following a myocardial infarction (“post-MI LVD”). Teva had carved out CHF indication but not the post-MI LVD indication. The jury found that Teva had induced infringement of the CHF claims with the label recitation of post-MI-LVD a decision Judge Stark overturned on JMOL. The Federal Circuit reversed the Judge Stark on this point because, according to the Court, Judge Stark had treated it as a question of law and not fact which it was.  GSK had introduced evidence that the post-MI LVD indication would cause doctors to use the generic product for the CHF indication as well.

The per curiam opinion reflects Judge Newman’s often expressed belief that judges should not supplant the jury’s function by re-weighing the evidence. 

The majority acknowledges that there is evidence supporting Teva’s position that it did not induce infringement.  However, it is the jury’s function and not the court’s to weigh the evidence.  From the tenor of the opinion, it seems that if this had been a bench trial, Judge Stark’s finding of no inducement would have been affirmed. For the branded drug companies this may counsel careful consideration of filing an infringement suit under 35 U.S.C. § 271(e)(2) where a jury trial is not available when the question of inducement is a close one as here.  While there is a significant advantage to the automatic 30 month stay that comes with a § 271(e) suit, if the patent has significant life, a § 271(b) suit may be better since it can be filed about 10 months before the earliest FDA approval date.

For generics, the Amarin and GSK litigations are a red flag that skinny labels are no guarantee of clear sailing. Further, that the skinny label ad press releases must be carefully considered from the viewpoint induced infringement.