Amarin Corp Plc (AMRN)

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Induced infringement is a form of indirect patent infringement where one party (in this case, the generic manufacturer) encourages or induces another party (typically doctors or patients) to infringe on a patent. This concept is particularly relevant in pharmaceutical cases involving skinny labels. Here's a more detailed explanation:
1. Legal Basis:
o Induced infringement is covered under 35 U.S.C. § 271(b) in U.S. patent law.
o It states that whoever actively induces infringement of a patent shall be liable as an infringer.
2. Application to Pharmaceuticals:
o Even if a generic manufacturer omits the patented indication from their label (skinny labeling), they could still be held liable if they're found to induce off-label use for the patented indication.
3. Evidence of Inducement:
o Courts look for evidence that the generic manufacturer intended to encourage infringing uses.
o This can include marketing materials, sales tactics, or other communications that might suggest or promote use for the patented indication.
4. "Substantial Non-Infringing Use":
o The existence of substantial non-infringing uses (like the off-patent indication) doesn't automatically shield a manufacturer from induced infringement claims.
5. Knowledge Requirement:
o To be liable for induced infringement, the generic manufacturer must have knowledge that the induced acts constitute patent infringement.
6. Specific Intent:
o Courts often look for evidence of specific intent to induce infringement, which can be inferred from circumstantial evidence.
7. "Skinny Label" Complications:
o Recent court decisions (e.g., GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.) have shown that even with a skinny label, a generic manufacturer could potentially be liable for induced infringement based on other actions or market circumstances.
8. Burden of Proof:
o The patent holder (in this case, Amarin) would need to prove that the generic manufacturer induced infringement.
9. Potential Defenses:
o Generic manufacturers might argue they took active steps to prevent infringing uses or that any off-label use for the patented indication was not due to their actions.
10. Implications for Industry:
o These cases have significant implications for how generic manufacturers navigate the market, especially when dealing with drugs that have both patented and off-patent indications.

This area of law is complex and evolving, with recent cases adding nuance to how courts interpret induced infringement in the context of skinny labels and generic drugs. The outcomes can have far-reaching effects on both brand-name and generic pharmaceutical companies, as well as on healthcare costs and patient access to medications.



The legal definition of active inducement in patent law is not explicitly defined in statutory language, but it has been shaped by case law and judicial interpretations. Here's a breakdown of how active inducement is generally understood in legal terms:
1. Statutory Basis: 35 U.S.C. § 271(b) states: "Whoever actively induces infringement of a patent shall be liable as an infringer."
2. Key Elements: Courts have interpreted active inducement to generally require: a) An act of encouragement or promotion of infringement b) Knowledge that the induced acts constitute patent infringement c) Specific intent to encourage another's infringement
3. Supreme Court Interpretation: In Global-Tech Appliances, Inc. v. SEB S.A. (2011), the Supreme Court clarified that induced infringement requires knowledge that the induced acts constitute patent infringement.
4. Intent Requirement: The Federal Circuit has held that active inducement requires "specific intent to encourage another's infringement" (DSU Medical Corp. v. JMS Co., Ltd., 2006).
5. Evidence of Inducement: Can include advertising, instruction manuals, product labeling, or any communication that directs, instructs, or encourages infringing use.
6. Circumstantial Evidence: Intent can be inferred from circumstantial evidence (Water Technologies Corp. v. Calco, Ltd., 1988).
7. Substantial Non-infringing Uses: The existence of substantial non-infringing uses does not preclude a finding of induced infringement (Toshiba Corp. v. Imation Corp., 2012).
8. Willful Blindness: The Supreme Court in Global-Tech also held that willful blindness to the existence of a patent can satisfy the knowledge requirement.
9. Affirmative Acts: Mere knowledge of possible infringement is not enough; there must be affirmative acts to encourage infringement (Mentor H/S, Inc. v. Medical Device Alliance, Inc., 2001).

It's important to note that the interpretation of active inducement can vary slightly depending on the specific circumstances of each case and continues to evolve through new court decisions. In pharmaceutical cases, the application of this doctrine is particularly nuanced, especially in situations involving skinny labels and off-label use.