Introduction
The litigation between Amarin Pharma, Inc. and West-Ward Pharmaceuticals Corp, among other defendants, is a complex and multifaceted case that involves patent infringement, generic drug approvals, and the interpretation of patent claims. Here, we will delve into the key aspects of this case, including the drug in question, the patents involved, the legal issues, and the outcomes.
The Drug and Patents in Question
The central drug in this litigation is Vascepa, an oral formulation of ethyl-eicosapentaenoic acid (EPA) developed by Amarin Pharma. Vascepa is approved by the FDA for reducing triglyceride levels in adult patients with severe hypertriglyceridemia. The patents-in-suit include U.S. Patents Nos. 8,293,728, 8,318,715, 8,357,677, 8,367,652, 8,431,560, and 8,518,929, all of which cover methods of treating hypertriglyceridemia using EPA[3].
Nature of the Case
Amarin Pharma sought to prevent West-Ward Pharmaceuticals and other defendants from launching generic versions of Vascepa. The case was filed in the District Court of Nevada and involved several key issues:
Contributory Infringement
The defendants argued that their proposed generic drugs could be used in substantial non-infringing ways, specifically reducing triglycerides in less than 12 weeks. The court granted summary judgment of no contributory infringement, as the defendants' drugs could indeed be used for this non-infringing purpose, even if it occurred only about 5% of the time[3].
Inducement of Infringement
Amarin argued that the defendants' labeling would induce infringement of the asserted claims because it could be interpreted as requiring treatment for at least 12 weeks. However, the court denied summary judgment of no inducement, as Amarin's expert provided a plausible interpretation that doctors would understand the labeling as requiring treatment for at least 12 weeks[3].
Claim Construction
A significant part of the litigation involved the construction of disputed claim terms. The court addressed several key terms:
"Concurrent/Concomitant Lipid Altering Therapy"
The court had to interpret the meaning of "concurrent/concomitant lipid altering therapy" as used in various claims. This term was crucial in understanding the scope of Amarin's invention and whether the defendants' actions would infringe upon it[4].
"Orally Administering/Administered"
The parties disputed the meaning of "orally administering/administered." The court ultimately adopted Amarin's construction, which included the doctor prescribing the medication and the medication being delivered into the patient's body at the doctor's direction[4].
LDL-C Terms
The court also addressed the construction of LDL-C (low-density lipoprotein cholesterol) terms. While Amarin proposed constructions, the defendants argued that these terms were indefinite. However, the court found that Amarin's constructions were based on intrinsic evidence and did not render the claims indefinite[4].
Obviousness and Invalidity
A critical aspect of the case was the defendants' argument that Amarin's patents were invalid for obviousness. The District Court found that all of the claims of Amarin's asserted patents were invalid for obviousness, a decision that was later affirmed by the Federal Circuit under Rule 36[1].
Appeal and Further Litigation
Amarin appealed the District Court's decision, arguing that the court erred in establishing the prima facie case of obviousness before considering secondary considerations and that the court engaged in hindsight bias. However, the Federal Circuit upheld the District Court's decision[1].
Skinny Label Issues
In related litigation, Amarin also faced issues with "skinny labels," where generic manufacturers received FDA approval for non-patented indications of Vascepa. Amarin alleged that Hikma and other defendants induced infringement by promoting their generic products for patented indications despite only having approval for non-patented uses[5].
Key Takeaways
- Patent Invalidity: The Federal Circuit affirmed that Amarin's patents were invalid for obviousness, significantly impacting Amarin's ability to prevent generic competition.
- Claim Construction: The court's interpretation of key claim terms was crucial in determining the scope of Amarin's patents and whether the defendants' actions constituted infringement.
- Generic Drug Approvals: The case highlights the complexities of generic drug approvals, especially when there are both patented and non-patented indications involved.
- Litigation Strategy: Amarin's litigation strategy included challenging the validity of the generic labels and arguing inducement of infringement, but ultimately faced significant setbacks.
FAQs
What was the main issue in Amarin Pharma, Inc. v. West-Ward Pharmaceuticals Corp?
The main issue was whether West-Ward Pharmaceuticals and other defendants could launch generic versions of Vascepa without infringing Amarin's patents.
Why were Amarin's patents found invalid?
Amarin's patents were found invalid for obviousness by the District Court, a decision that was later affirmed by the Federal Circuit.
What is a "skinny label" in the context of this litigation?
A "skinny label" refers to a generic drug label that only includes non-patented indications, despite the branded version having both patented and non-patented indications.
How did the court interpret the term "orally administering/administered"?
The court interpreted "orally administering/administered" to include the doctor prescribing the medication and the medication being delivered into the patient's body at the doctor's direction.
What was the outcome of Amarin's appeal to the Federal Circuit?
The Federal Circuit upheld the District Court's decision that Amarin's patents were invalid for obviousness.
Cited Sources
- Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. - JDSupra
- Petition to the Supreme Court of the United States - Supreme Court of the United States
- Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd. - Robins Kaplan
- Amarin Pharma, Inc. v. W.-Ward Pharms. Corp. - Casetext
- 20-1630.pdf - District of Delaware
