Bayer AG v. Mylan NV — Federal Circuit Splits Decision on Cardiovascular Patent
Bayer AG challenged a patentability ruling covering US10828310B2, directed at reducing cardiovascular event risk, against generic manufacturers Mylan NV, InVagen Pharmaceuticals, and Teva Pharmaceuticals USA. After 726 days, the Federal Circuit issued a mixed outcome: affirmed-in-part, vacated-in-part, and remanded for further proceedings.
A Fractured Federal Circuit Ruling Keeps Bayer’s Cardiovascular Patent in Play
Filed on 28 September 2023, Case No. 23-2434 brought Bayer AG before the Court of Appeals for the Federal Circuit to contest a lower-level patentability determination regarding US10828310B2 — a patent directed at reducing the risk of cardiovascular events. The defendants — generic manufacturers Mylan NV, InVagen Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc. — had challenged the patent’s validity through an invalidity or cancellation action, a procedural path common in ANDA-linked pharmaceutical disputes.
After 726 days of appellate proceedings, the Federal Circuit issued a compound ruling: affirmed-in-part, vacated-in-part, and remanded. This means the court upheld some aspects of the lower tribunal’s findings, nullified others, and returned the outstanding issues for reconsideration. The basis of termination notes the appeal was dismissed in part, suggesting certain claims or parties were procedurally eliminated before the merits were fully reached. The outcome leaves Bayer’s patent partially intact but the validity question not fully resolved.
A 726-day appellate timeline is consistent with complex pharmaceutical patent disputes where claim construction, obviousness, and validity grounds each require separate treatment. The split disposition — affirm, vacate, remand — typically signals the appellate panel found the lower tribunal correct on some grounds but identified legal error on others. What remains unclear from the public record is the precise scope of which claims were affirmed versus vacated, and what specific issues the remand requires the lower tribunal to address, leaving competitive uncertainty for all generic defendants.
Filing to Appeal Dismissed in Part in 726 days
726 days at the Federal Circuit — well above the median CAFC patent appeal duration of roughly 18–24 months
Federal Circuit’s split ruling: what affirmed-in-part, vacated-in-part means
What ‘affirmed-in-part, vacated-in-part, remanded’ means
A split appellate disposition means the Federal Circuit did not accept or reject the lower tribunal’s decision wholesale. Portions it affirmed stand as settled law between these parties. Portions it vacated are nullified — as if never decided — and the remand directs the lower tribunal to re-examine those issues under corrected legal guidance. This is among the more complex outcomes in patent appeals, as it preserves uncertainty on remanded issues.
Partial appellate reversalBayer retains partial wins but faces continued proceedings
For Bayer AG, the affirmed portions of the ruling represent validated positions — potentially including certain claim constructions or validity findings in their favour. However, the vacated-and-remanded portion means US10828310B2’s full enforceability against the generic defendants is not yet finally determined. Bayer must re-litigate the remanded issues, sustaining cost and competitive risk. The partial dismissal of the appeal may have narrowed the field of contested issues.
Patent survival — partial, remand pendingGeneric defendants win partial vacatur but face renewed proceedings
Mylan NV, InVagen Pharmaceuticals, and Teva Pharmaceuticals USA obtained vacatur on at least some aspects of the lower ruling — a meaningful result that prevents those findings from being used against them definitively. However, the affirmance of other portions limits the scope of their win. On remand, the generic defendants must again contest the outstanding validity or patentability questions before the lower tribunal, meaning market entry for any generic cardiovascular product remains uncertain.
Partial win — remand exposure remainsCardiovascular generic market entry remains legally blocked pending remand
Until remand proceedings conclude and a final judgment issues, the commercial pathway for generic cardiovascular risk-reduction products covered by US10828310B2 remains contested. Pharmaceutical companies monitoring this space should note that a partial vacatur without a final invalidity finding does not open the market. The remand could take additional years, extending Bayer’s effective exclusivity window and maintaining pricing pressure on the branded product.
Generic entry delayed — monitor remandFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Bayer AG — multinational pharmaceutical innovator; holder of US10828310B2 for cardiovascular risk reductionSearch in Eureka ↗ |
| Defendant | Mylan, NV | Company | Mylan NV, InVagen Pharmaceuticals, and Teva Pharmaceuticals USA — generic drug manufacturers challenging patent validitySearch in Eureka ↗ |
| Co-Defendant | Invagen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Teva Pharmaceuticals USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Alexander Steinway Zolan | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Ben Picozzi | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Dov Philip Grossman | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff law firm | Williams & Connolly LLP | Law Firm | Representing Bayer AGSearch in Eureka ↗ |
| Defendant counsel | Kelsey Catina | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Matthew Greinert LTC | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Richard Torczon | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Tasha Thomas | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Wendy L. Devine | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Mylan | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Wilson, Sonsini, Goodrich & Rosati, PC | Law Firm | Representing Mylan, NVSearch 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 disposition — ‘AFFIRMED-IN-PART, VACATED-IN-PART, AND REMANDED’ — reflects application of a de novo standard of review to legal questions of patentability and potentially a clear-error standard on factual findings. The panel’s decision to vacate portions rather than simply reverse suggests identified legal errors in the tribunal below that do not compel a final outcome favouring either party, but instead require corrected analysis. The affirmed portions carry full precedential weight between these parties and cannot be reopened on remand. The remanded issues remain live, meaning the patentability of US10828310B2 is not fully settled.
US10828310B2 — Cardiovascular Event Risk Reduction Therapy
US10828310B2, filed under application number US16/264032, protects a pharmaceutical method directed at reducing the risk of cardiovascular events. The patent sits within the high-value cardiovascular therapeutics domain, a sector where formulation and method-of-treatment patents are frequently the subject of ANDA-linked validity challenges by generic manufacturers. The patent’s claim scope — and the contested validity grounds before the Federal Circuit — centre on patentability, likely encompassing obviousness and written description questions standard in this field.
Cardiovascular risk-reduction patents represent some of the most commercially significant assets in the pharmaceutical sector, given the scale of patient populations and the long commercial tails associated with branded therapies. US10828310B2 being contested by three separate generic manufacturers simultaneously — Mylan NV, InVagen, and Teva — signals that the commercial stakes associated with generic entry are substantial. Competitors and licensees operating in cardiovascular therapeutics should track the remand proceedings closely, as a final invalidity finding would materially alter the competitive landscape.
Should your cardiovascular product team run an FTO against US10828310B2?
Any company developing, manufacturing, or launching a pharmaceutical product in the cardiovascular risk-reduction space — particularly those targeting the same indication as the compound covered by US10828310B2 — should assess freedom-to-operate exposure. The Federal Circuit’s mixed ruling means the patent is neither fully invalidated nor fully confirmed enforceable; the remand creates a window of uncertainty that does not eliminate litigation risk for potential market entrants. R&D teams formulating competing therapies or generics should not assume vacatur of some claims creates clear operating space.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map claim scope across US10828310B2 against their specific product candidates, flag overlapping claim language, and monitor the remand proceedings in real time. Given the multi-party nature of this litigation, Eureka can also surface related Bayer cardiovascular patents that may present parallel infringement risk — ensuring your FTO covers the full portfolio, not just the asserted patent.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Related Federal Circuit pharmaceutical patent validity appeals
Cases involving cardiovascular method-of-treatment patents challenged by generic manufacturers at the Federal Circuit, with comparable affirm-vacate-remand dispositions.
What this case signals for the pharmaceutical patent IP landscape
A Federal Circuit split disposition in a pharmaceutical validity challenge signals that neither innovators nor generic manufacturers can assume clean outcomes on appeal.
Split CAFC rulings extend uncertainty — plan for remand timelines
Affirmed-in-part, vacated-in-part dispositions at the Federal Circuit are not clean wins for either side. IP teams at pharmaceutical companies should model scenarios where remand proceedings add 12–36 additional months before final resolution, directly affecting product launch timelines and licensing negotiations.
Generic defendants should audit which claims survived affirmance
Where a Federal Circuit ruling affirms some patentability findings and vacates others, generic manufacturers must immediately identify which specific claims or grounds were upheld. Claims affirmed on appeal carry heightened authority and will be harder to dislodge at the lower tribunal on remand.
Bayer v Mylan — key questions answered
The Federal Circuit issued a split decision: affirmed-in-part, vacated-in-part, and remanded. This means some aspects of the lower tribunal’s patentability findings on US10828310B2 were upheld, others were nullified, and outstanding issues were returned for further proceedings. The appeal was also dismissed in part on procedural grounds.
The patent in dispute is US10828310B2, filed under application number US16/264032. The patent is directed at a pharmaceutical method for reducing the risk of cardiovascular events. The validity of this patent was challenged by Mylan NV, InVagen Pharmaceuticals, and Teva Pharmaceuticals USA through an invalidity/cancellation action.
Vacatur means the Federal Circuit nullified specific portions of the lower tribunal’s ruling — those findings have no legal force. Remand directs the lower court or tribunal to reconsider those issues under corrected legal standards. For US10828310B2, this means the patent’s validity is not finally decided; further proceedings are required before a definitive enforceability determination can be made.
Pharmaceutical patent challenges by generic manufacturers commonly proceed jointly when multiple ANDA filers target the same branded drug. Mylan NV, InVagen Pharmaceuticals, and Teva Pharmaceuticals USA each had commercial interest in invalidating US10828310B2 to enable generic market entry, making consolidated appeal proceedings before the Federal Circuit a procedurally efficient approach.
The case ran for 726 days from filing on 28 September 2023 to closure on 23 September 2025. This duration is consistent with complex pharmaceutical patent appeals at the Federal Circuit, which typically involve multiple claim validity grounds, extensive briefing, and potentially oral argument. The split disposition — affirmed-in-part, vacated-in-part, remanded — reflects the complexity of the underlying patentability questions.
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