IN RE SELENIOUS ACID LITIGATION
2:24-cv-07791
| D.N.J. | Jul 8, 2025Background
- American Regent holds an NDA for selenious acid injection formulations (NDA No. 209379) and obtained two later-issued Orange-Book patents: U.S. Patent No. 11,998,565 (composition) and U.S. Patent No. 12,150,957 (methods of use).
- Multiple generic manufacturers filed ANDAs or Paragraph IV certifications seeking approval to market generic selenious acid injections; because the patents issued after many ANDAs were filed, the statutory 30‑month FDA stay did not apply.
- Central claim limitation: the patents recite “fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL,” while specification passages use units expressed as µg/kg/day; defendants contend this unit mismatch defeats the §112 written‑description requirement and thus raises a substantial question of invalidity.
- Plaintiff’s experts offered circumstantial and expert evidence (groundwater fluoride prevalence, likely manufacturing additions, and label similarity) to show defendants’ products likely meet the fluoride limitation and would induce method claims under the proposed labeling.
- The Court held an evidentiary hearing, found defendants failed to raise a substantial question of invalidity or non‑infringement, concluded plaintiff would likely suffer irreparable harm if generics launched, and granted a preliminary injunction subject to a bond.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Validity: written description for fluoride range (§112) | Original claims and specification (and examiner allowance) convey possession of 0.0001–2.7 µg/mL fluoride; POSA would read dosage/volume disclosures together to yield the claimed range. | Spec discloses fluoride only as µg/kg/day (dose per bodyweight), not µg/mL; converting units yields very different concentrations and lacks blaze marks — substantial question of invalidity. | Court: No substantial question; written description adequate because specification and original claims, plus prosecution history and specification context, would convey possession to a POSA. |
| Infringement: literal (composition) | Circumstantial expert evidence (groundwater fluoride levels, likely manufacturing inputs, and purification limits) makes it likely ANDA products contain fluoride in the claimed range; other claim elements are met. | Plaintiff has no quantitative testing of defendants’ ANDA products or source water; available data show regional fluoride variability and purification could remove fluoride — infringement speculative. | Court: Plaintiff likely to prove literal infringement; defendants’ arguments insufficient, and circumstantial expert evidence (unrebutted) is probative at the preliminary stage. |
| Induced infringement (method claims & labels) | ANDA labels are materially identical to plaintiff’s and would instruct administration that practices the claimed methods; thus defendants intend to induce. | Not meaningfully contested as to labels; defenses focus on composition dispute. | Court: Likely to succeed on induced‑infringement claims because labels would instruct practitioners to perform claimed methods and predicate direct infringement is likely. |
| Irreparable harm & equities | Entry of one or multiple generics will cause price erosion, loss of market share, erosion of contracts and goodwill, and downstream portfolio harms not fully compensable by money damages; plaintiff will suffer disproportionately. | Harms are economic and quantifiable; plaintiff can calculate damages from historical sales and thus monetary relief is adequate; defendants will suffer sunk costs and lost opportunity if enjoined. | Court: Irreparable harm likely (price erosion, loss of customers/goodwill, causal nexus established); equities and public interest tip modestly in favor of plaintiff. |
Key Cases Cited
- F.T.C. v. Actavis, Inc., 570 U.S. 136 (2013) (summarizing Hatch‑Waxman ANDA/Paragraph IV framework and market effects)
- eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) (no presumptive entitlement to injunction; patentee must prove irreparable harm)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written‑description standard: specification must show possession to a POSA)
- Titan Tire Corp. v. Case New Holland, 566 F.3d 1372 (Fed. Cir. 2009) (preliminary injunction validity inquiry; substantial question standard)
- Tinnus Enters., LLC v. Telebrands Corp., 846 F.3d 1190 (Fed. Cir. 2017) (patentee must show likelihood of proving infringement at preliminary stage)
- Vanda Pharm. Inc. v. West‑Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) (ANDA proposed labeling can support induced infringement finding)
- Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896 (Fed. Cir. 2025) (support for claimed numerical ranges may be found where specification makes bounds workable and conveyed to POSA)
- Metabolite Labs., Inc. v. Lab. Corp. of Am., 370 F.3d 1354 (Fed. Cir. 2004) (prosecution history/examiner statements can support written‑description sufficiency)
- Indivior Inc. v. Dr. Reddy’s Labs., 18 F.4th 1323 (Fed. Cir. 2021) (numerical subrange written‑description analysis)
- Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922 (Fed. Cir. 2012) (examples of irreparable harms: price erosion, lost goodwill, loss of business opportunities)
- Robert Bosch LLC v. Pylon Mfg. Co., 659 F.3d 1142 (Fed. Cir. 2011) (patentee bears burden to show monetary damages would be inadequate)
- Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358 (Fed. Cir. 2017) (balance of hardships and difficulty of quantifying customer loss supports injunctive relief)