578 F.Supp.3d 642
D. Del.2022Background
- Amarin owns patents covering use of icosapent ethyl (VASCEPA) to reduce cardiovascular (CV) risk; VASCEPA is marketed for both severe hypertriglyceridemia (SH) and CV risk reduction.
- Hikma obtained FDA approval to market a generic icosapent ethyl limited to the SH indication under a section viii “skinny label” carve‑out (i.e., omitting the CV indication).
- Amarin alleges Hikma’s label plus press releases and website statements (e.g., calling the product “generic equivalent” and “AB rated”) nonetheless instruct or encourage CV‑risk uses and thus induce infringement of Amarin’s method patents.
- Amarin also alleges Health Net (an insurer) induces infringement by placing Hikma’s generic on a preferred formulary tier and using prior‑authorization forms that facilitate substitution for VASCEPA, lowering copays and encouraging generic substitution for all VASCEPA prescriptions.
- Procedural posture: Magistrate Judge issued a Report & Recommendation on motions to dismiss; the District Court adopted in part: granted Hikma’s motion to dismiss Amarin’s First Amended Complaint, denied Health Net’s motion to dismiss, and dismissed Hikma’s original motion as moot. The Federal Circuit’s GSK v. Teva decision issued during briefing and informed the analysis.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Hikma's label (including alleged omission of a CV‑use limitation and warning language) plausibly alleges inducement of CV‑risk use | Hikma's label is “not skinny enough”: omission of CV limitation and other label language will be understood to teach CV‑risk use | Hikma: the warning is not an instruction; silence (removal) is not an affirmative instruction to infringe | Court: Label does not plausibly instruct CV‑risk reduction; warnings are not instructions and omission of a limitation is insufficient to plead inducement — Hikma dismissed |
| Whether Hikma's public statements (press releases, website, AB‑rating, “hypertriglyceridemia” category) plead inducement | These statements, taken together with label, point physicians to use the generic broadly including patented CV uses | Hikma: advertising AB rating or calling itself Vascepa’s generic equivalent is not enough; cited sales data go to intent, not an inducing act | Court: Hikma’s press releases/website do not plausibly encourage the patented CV use (distinguished from GSK where press releases referenced the patented use); no inducement pleaded based on these statements |
| Whether omission or “silence” on the label creates a duty to discourage infringing use | Amarin: silence functions as an affirmative statement that generic is proven for CV risk and thereby encourages use | Hikma: no duty to add negative statements; courts do not require generics to include disclaimers | Court: Silence does not equate to encouragement; plaintiffs must plead affirmative steps to induce and did not do so as to Hikma |
| Whether Health Net’s formulary placement and prior‑authorization practices plausibly plead induced infringement (knowledge and specific intent) | Health Net’s preferred tier and prior‑auth forms (which reference the patented CV indication) encourage substitution of Hikma’s generic for VASCEPA, and Amarin’s pre‑suit letter plus Orange Book availability gave Health Net patent knowledge | Health Net: mere payer actions, formularies are automatic/ministerial; lacking specific knowledge of patents and not an affirmative act to induce | Court: Complaint plausibly alleges Health Net had knowledge and took affirmative acts (formulary placement, prior‑auth form) with specific intent to induce; factual causation questions remain for later stages — Health Net denial of motion to dismiss sustained |
Key Cases Cited
- GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) (partial/“not skinny” label plus press releases found to support inducement; AB‑rating/advertising can point physicians to an infringing label when the label fails to carve out patented uses)
- MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369 (Fed. Cir. 2005) (elements of induced patent infringement: direct infringement, knowledge, and intent to induce)
- Grunenthal GMBH v. Alkem Lab'ys Ltd., 919 F.3d 1333 (Fed. Cir. 2019) (a broad therapeutic‑category indication that includes both infringing and non‑infringing uses does not necessarily encourage infringing uses)
- Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (no inducement where defendant does not promote or encourage the patented use; physician’s independent decision can negate inducement)
- Takeda Pharms. U.S.A., Inc. v. W‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. 2015) (generics are not required to include a clear statement discouraging patented uses; inducement requires affirmative steps to induce)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (pleading must raise claim above speculative level)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (facial plausibility standard for pleadings)
- Otsuka Pharm. Co. v. Torrent Pharm. Ltd., 99 F. Supp. 3d 461 (D.N.J. 2015) (warnings are not instructions and generally do not constitute inducement)