Mylan v. Janssen: Federal Circuit Affirms Invega Trinza® Patent — Case 23-2042
Mylan NV challenged Janssen Pharmaceuticals’ US10143693B2 covering Invega Trinza® paliperidone palmitate, a long-acting injectable antipsychotic for schizophrenia. The Federal Circuit affirmed the lower court’s ruling on 28 March 2025, after 647 days of appellate proceedings, leaving Janssen’s patent protection intact.
Federal Circuit closes Mylan’s challenge to Janssen’s Invega Trinza® patent
Mylan NV filed this appeal at the United States Court of Appeals for the Federal Circuit on 20 June 2023, contesting a ruling in favour of Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., and Janssen Research & Development, LLC. The dispute centred on US10143693B2 (application no. US15/090889), a patent covering paliperidone palmitate formulations underlying Invega Trinza®, a three-monthly long-acting injectable antipsychotic approved for schizophrenia treatment and marketed by Janssen.
On 28 March 2025, the Federal Circuit issued a summary order affirming the decision below. An affirmance at this level means the appellate panel found no reversible error — whether legal or factual — in the lower court’s reasoning or outcome. For Janssen, the ruling preserves the enforceability of US10143693B2 and sustains the exclusivity position underpinning Invega Trinza®. For Mylan, appellate options at the Federal Circuit are exhausted; further challenge would require a petition for certiorari to the Supreme Court or a distinct IPR or validity challenge proceeding.
The 647-day duration from filing to disposition is broadly consistent with contested pharmaceutical patent appeals before the Federal Circuit, which routinely involve complex claim construction, clinical data, and regulatory exclusivity arguments. The basis of termination is recorded as ‘Appeal Dismissed,’ though the court’s operative order reads ‘AFFIRMED,’ suggesting the affirmance was entered alongside or through a procedural dismissal mechanism. The precise factual and legal grounds for affirmance are not fully apparent from the public docket excerpt, and the absence of a detailed opinion — if any was issued — limits external assessment of the panel’s reasoning.
Filing to Appeal Dismissed in 647 days
647 days from filing to Federal Circuit disposition — consistent with complex pharma patent appeals
Federal Circuit affirms: what the ruling means for both parties
What ‘AFFIRMED’ means at the Federal Circuit
An affirmance by the Federal Circuit means the appellate panel reviewed the record and found no reversible error in the lower tribunal’s decision. The court does not re-try facts; it applies deferential standards to factual findings (clear error) and de novo review to legal questions such as claim construction. ‘AFFIRMED’ signals that every ground Mylan raised on appeal was either rejected or insufficient to disturb the outcome below.
No reversible error foundJanssen’s US10143693B2 survives appellate challenge
The affirmance leaves US10143693B2 fully enforceable. Janssen can continue to assert this patent against generic entrants seeking to market paliperidone palmitate three-monthly injectables. The ruling reinforces the patent’s presumption of validity and raises the practical bar for any would-be challenger contemplating a parallel ANDA litigation or IPR petition against the same claims.
Patent enforceable — exclusivity intactMylan’s appellate route is exhausted at this level
With the Federal Circuit affirming, Mylan’s options at the appellate level are closed. A petition for certiorari to the US Supreme Court remains theoretically available but is rarely granted in patent matters absent a clear circuit split or constitutional question. Mylan could separately pursue inter partes review at the USPTO if not already time-barred, though estoppel risks from the district court proceedings may constrain available grounds.
Further challenge significantly constrainedStrengthened exclusivity raises the bar for long-acting injectable generics
The affirmance signals to other generic manufacturers that the Federal Circuit has scrutinised and upheld Janssen’s paliperidone palmitate patent position. Any competitor targeting this market segment — including biosimilar or generic injectable antipsychotic developers — faces a strengthened prior art and validity landscape. The decision is consistent with the Federal Circuit’s pattern of deferring to district court fact-finding in complex pharmaceutical formulation disputes.
Higher barrier for generic market entryFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Mylan, NV | Company | Generic pharmaceutical company — appellant challenging holder of US10143693B2Search in Eureka ↗ |
| Defendant | Janssen Pharmaceuticals, Inc. | Company | Janssen Pharmaceuticals group — innovator patent holder, marketer of Invega Trinza® paliperidone palmitateSearch in Eureka ↗ |
| Co-Defendant | Janssen Pharmaceutica, N.V. | Individual | Search in Eureka ↗ |
| Co-Defendant | Janssen Research & Development, LLC | Company | Search in Eureka ↗ |
| Plaintiff counsel | Deepro Mukerjee | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff counsel | Eric Thomas Werlinger | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff counsel | Jillian Schurr | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff counsel | Jitendra Malik | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff counsel | Lance Soderstrom | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff counsel | Timothy H. Gray | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Plaintiff law firm | Katten Muchin Rosenman LLP | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Andrew D. Cohen | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Aron Russell Fischer | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Barbara Mullin | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Collin Hong | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | J. Jay Cho | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Joyce Nadipuram | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Lachlan S. CampbellVerduyn | Attorney | Counsel for Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant law firm | Patterson Belknap Webb & Tyler LLP | Law Firm | Representing Janssen Pharmaceuticals, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit’s order — ‘AFFIRMED’ — is unqualified, indicating the panel found no reversible error on any ground raised by Mylan. In affirming, the court applied de novo review to legal questions (including any claim construction disputes) and clear-error review to factual findings. The absence of a detailed written opinion, if confirmed, is consistent with Federal Circuit Rule 36 summary affirmances, which carry precedential weight for the parties but do not create binding circuit precedent on the underlying legal questions.
US10143693B2 — Paliperidone palmitate long-acting injectable formulation
US10143693B2, filed under application number US15/090889, protects formulations of paliperidone palmitate configured for three-monthly intramuscular injection — the active pharmaceutical ingredient underlying Invega Trinza®. The patent sits within the speciality pharmaceutical formulation domain, addressing depot injection technology for central nervous system indications. Its claims likely cover concentration, particle size, excipient composition, or dosing regimen elements that distinguish the three-monthly product from earlier one-monthly paliperidone formulations.
Strategically, US10143693B2 is a critical asset in Janssen’s defence of the Invega Trinza® franchise against generic ANDA applicants. Long-acting injectable antipsychotics represent a high-value segment where patent-protected dosing intervals confer significant commercial advantage — three-monthly dosing substantially improves patient adherence over daily oral regimens. Any generic or reformulated competitor seeking to enter this market must design around or invalidate this patent, a task made materially harder by the Federal Circuit’s affirmance.
Should you run an FTO analysis against US10143693B2?
Any company developing, formulating, or commercialising paliperidone palmitate injectables — or long-acting injectable antipsychotics more broadly — should treat US10143693B2 as a high-priority FTO target. Following the Federal Circuit’s affirmance, the patent carries enhanced presumptive validity. R&D and regulatory teams pursuing three-monthly depot formulations, modified dosing regimens, or alternative paliperidone salts should assess claim scope carefully before advancing candidates into IND-enabling studies.
PatSnap Eureka’s FTO Search Agent can map US10143693B2’s claim landscape against your formulation pipeline, identify prosecution history estoppel constraints, surface related Janssen paliperidone patents that may extend exclusivity, and flag prior art that was or was not considered during prosecution. Eureka’s AI-assisted analysis compresses weeks of manual patent review into hours — giving IP and R&D teams the clarity needed to make go/no-go decisions on long-acting injectable programmes.
Run a freedom-to-operate analysis on US10143693B2 to assess your product’s exposure
Run FTO in Eureka →Related pharmaceutical patent appeals at the Federal Circuit
Explore Federal Circuit appeals involving pharmaceutical formulation patents, ANDA challenges, and long-acting injectable antipsychotic IP disputes similar to Mylan v. Janssen.
What this case signals for the pharmaceutical injectable IP landscape
The Federal Circuit’s affirmance in Mylan v. Janssen reinforces how durable well-crafted formulation patents can be against generic appellate challenges.
Formulation patents on long-acting injectables carry strong appellate durability
US10143693B2’s survival through Federal Circuit review suggests that Janssen’s claim drafting and district court record were sufficiently robust to withstand de novo legal scrutiny and clear-error factual review. Companies developing long-acting injectable formulations should note that well-supported formulation patents can resist multi-stage generic challenges.
Generic challengers face compounding estoppel risks after failed appeals
Mylan’s failed appeal may create additional estoppel exposure in any follow-on IPR or ANDA litigation involving overlapping claim grounds. IP teams at generic manufacturers should map estoppel implications before committing resources to parallel USPTO proceedings after an adverse district court outcome and appellate affirmance.
Mylan v Janssen — key questions answered
The Federal Circuit affirmed the lower court’s decision on 28 March 2025, finding no reversible error in the ruling that favoured Janssen Pharmaceuticals. The affirmance leaves US10143693B2, covering Invega Trinza® paliperidone palmitate, fully enforceable against Mylan and other potential generic entrants.
The patent at issue is US10143693B2 (application no. US15/090889), which covers paliperidone palmitate formulations underlying Janssen’s Invega Trinza® — a three-monthly long-acting injectable antipsychotic approved for the treatment of schizophrenia.
A Federal Circuit affirmance — including summary affirmances under Rule 36 — confirms that the lower court’s decision stands. While Rule 36 affirmances do not create binding circuit precedent on legal questions, they are conclusive between the parties. The affirmed patent retains its full presumption of validity and may be enforced as if the appeal had never been filed.
Mylan’s options are significantly constrained. A petition for certiorari to the US Supreme Court is theoretically available but rarely granted in patent matters. Separately, an inter partes review petition at the USPTO may be available if not time-barred and if litigation estoppel does not foreclose the relevant invalidity grounds. Each pathway carries substantial procedural and substantive hurdles.
The appeal ran for 647 days, from filing on 20 June 2023 to disposition on 28 March 2025. This duration is broadly consistent with contested pharmaceutical patent appeals before the Federal Circuit, which typically involve complex claim construction records, clinical data, and multi-party briefing schedules.
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