Ravgen v. Biora Therapeutics: cfDNA Prenatal Screening Patents Dismissed With Prejudice
Ravgen, Inc. asserted two patents covering cell-free DNA analysis for noninvasive prenatal screening against Biora Therapeutics’ Innatal® and Resura® prenatal tests. After 1,358 days of litigation in Delaware, the parties stipulated to dismissal with prejudice — with neither side paying the other a cent.
A lengthy cfDNA patent battle ends quietly — no winner, no payment
Filed in December 2020 before Judge Jennifer L. Hall in the District of Delaware, this case saw Ravgen, Inc. assert US7727720B2 and US7332277B2 — two patents covering methods of analyzing cell-free DNA (cfDNA) from maternal blood samples for prenatal genetic screening — against Biora Therapeutics (formerly Progenity). The accused products included the Innatal® Prenatal Screen, targeting chromosomal aneuploidies, and the Resura® Prenatal Test for monogenic disease, both relying on cfDNA extracted from maternal blood using Streck collection tubes.
The case closed on September 9, 2024, via a stipulated dismissal under Federal Rule of Civil Procedure 41(a)(1)(A)(ii). Ravgen’s infringement claims were dismissed with prejudice — meaning Ravgen cannot re-file the same claims against Biora. Biora’s counterclaims, however, were dismissed without prejudice, preserving Biora’s ability to reassert them in future proceedings. Critically, no money changed hands and each party absorbed its own legal costs.
The case ran for nearly 3.7 years before reaching this zero-sum resolution, suggesting the parties likely exhausted significant discovery and pre-trial proceedings before arriving at a negotiated exit. The simultaneous asymmetric dismissal structure — plaintiff’s claims with prejudice, defendant’s counterclaims without — is consistent with a negotiated settlement or strategic withdrawal rather than a litigated outcome, though the public record is silent on any confidential terms. What drove Ravgen to accept a with-prejudice dismissal without compensation remains unknown from the docket.
Filing to Dismissed with Prejudice in 1358 days
1,358 days — nearly 3.7 years from filing to stipulated dismissal in Delaware District Court
Asymmetric dismissal: what the stipulated exit means for both parties
Rule 41 stipulated dismissal — what it means in practice
A Rule 41(a)(1)(A)(ii) dismissal requires both parties’ agreement and takes effect upon filing — no court order needed. Here, Ravgen’s claims were extinguished with prejudice, creating a final adjudication bar on those specific claims. Biora’s counterclaims survived dismissal without prejudice, leaving them legally intact for potential future use.
Consensual exit, no merits rulingRavgen forfeits its claims permanently against Biora
Dismissal with prejudice of Ravgen’s infringement claims operates as a final judgment on those claims. Ravgen cannot reassert US7727720B2 or US7332277B2 against Biora for the accused Innatal® and Resura® products. With no payment received, the economic rationale for Ravgen’s concession is not apparent from the public record — this may reflect a strategic portfolio decision or undisclosed terms.
Claims permanently barred vs. BioraBiora retains live counterclaims and avoids any payment
Biora emerged without any monetary obligation and with its counterclaims — likely invalidity challenges — preserved without prejudice. This structure suggests Biora retains optionality: it could reassert invalidity arguments in a future proceeding if Ravgen asserts the same patents elsewhere. The without-prejudice status of Biora’s counterclaims is a meaningful negotiating outcome.
Counterclaims survive for future usecfDNA prenatal testing IP remains contested — Ravgen’s portfolio still active
This dismissal resolves only the Biora dispute. Ravgen’s patents remain in force and enforceable against other cfDNA prenatal screening providers. Companies offering similar noninvasive prenatal testing relying on maternal blood cfDNA analysis — particularly those using comparable blood collection and processing methods — should treat this resolution as a signal that Ravgen continues to actively pursue its IP portfolio.
Patents remain live vs. third partiesFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Ravgen, Inc. | Company | Prenatal genomics IP licensor — holder of US7727720B2 and US7332277B2 covering cfDNA methodsSearch in Eureka ↗ |
| Defendant | Biora Therapeutics, Inc. | Company | Biora Therapeutics, Inc. — developer of Innatal® and Resura® noninvasive prenatal screening testsSearch in Eureka ↗ |
| Plaintiff counsel | Ashley DaBiere | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Benjamin N. Luehrs | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Brian D. Matty | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Brian E. Farnan | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Deborah J. Mariottini | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Frederick J. Ding | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Gillian F. Moore | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Jamie L. Kringstein | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Jennifer M. Przybylski | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | John M. Desmarais | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Joze Welsh | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Julianne M. Thomsen | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Jun Tong | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kerri-Ann Limbeek | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kevin Goon | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kyle G. Petrie | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Michael J. Farnan | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Michael Ling | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Peter Zhu | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William B. Nichols | Attorney | Counsel for Ravgen, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Farnan LLP | Law Firm | Representing Ravgen, Inc.Search in Eureka ↗ |
| Defendant counsel | Alexandra M. Joyce | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Amanda L. Major | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Daniel M. Silver | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Ian Robert Liston | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Kristina A. Hanson | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Michael J. Summersgill | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Nicholas Halkowski | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Sarah A. Siedlak | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | Tung-On Kong | Attorney | Counsel for Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant law firm | McCarter & English, LLP | Law Firm | Representing Biora Therapeutics, Inc.Search in Eureka ↗ |
| Defendant law firm | Wilson Sonsini Goodrich & Rosati PC | Law Firm | Representing Biora Therapeutics, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Jennifer L. Hall | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated verdict text is precise in its asymmetry: Ravgen’s infringement claims are dismissed with prejudice while Biora’s counterclaims are dismissed without prejudice. The explicit statement that ‘neither party is paying any amount’ rules out any confidential royalty payment, though it does not preclude other forms of commercial arrangement. The Rule 41(a)(1)(A)(ii) mechanism means no judicial finding on infringement or validity was made — the patents’ legal status vis-à-vis Biora is determined solely by the claim preclusion effect of the with-prejudice dismissal, not any merits ruling.
US7727720B2 & US7332277B2 — cfDNA prenatal screening methods from maternal blood
US7727720B2 (application no. 11/212812) and US7332277B2 (application no. 10/661165) are foundational patents in the cell-free DNA prenatal diagnostics space, covering methods of isolating and analysing fetal cfDNA from maternal blood samples to detect chromosomal abnormalities and genetic variants. Their application dates place them among the early-generation intellectual property in what became the commercial noninvasive prenatal testing (NIPT) market, giving the claim language a breadth that can capture subsequent workflow implementations using modern collection systems such as Streck BCT tubes.
These patents sit at the intersection of molecular diagnostics, obstetrics, and genomics — a sector that has seen rapid commercialisation since the mid-2010s. Because the core technical step of extracting cfDNA from maternal blood is common to virtually all commercial NIPT platforms, the claim scope of these patents poses structural licensing risk to a wide range of providers. Ravgen’s willingness to litigate across multiple defendants in Delaware suggests an active enforcement programme, and the survival of these patents through this case — without any invalidation ruling — leaves their enforceability intact.
Should your NIPT product be cleared against US7727720B2 and US7332277B2?
Any organisation developing, commercialising, or licensing a noninvasive prenatal test that relies on cfDNA extracted from maternal blood — including chromosomal aneuploidy screens and monogenic disease panels — should treat these two Ravgen patents as primary FTO targets. The accused products in this case used Streck blood collection tubes and standard cfDNA extraction workflows, meaning the patent claims are not limited to exotic processing methods. Labs, diagnostics companies, and test kit suppliers should each independently assess their exposure.
PatSnap Eureka’s FTO Search Agent enables R&D and IP teams to map claim scope against specific collection, extraction, and analysis protocols — surfacing prior art, claim limitations, and file history estoppels that may define the boundaries of these patents. Running a targeted FTO against US7727720B2 and US7332277B2 before product launch or partnership with a NIPT provider is a material risk-reduction step, given the active enforcement posture Ravgen has demonstrated in Delaware.
Run a freedom-to-operate analysis on US7727720B2 to assess your product’s exposure
Run FTO in Eureka →Related cfDNA prenatal screening patent cases in Delaware District Court
Explore other Ravgen cfDNA patent enforcement actions and comparable noninvasive prenatal testing IP disputes filed in Delaware District Court.
What this case signals for the noninvasive prenatal testing IP landscape
Ravgen’s litigation posture across multiple defendants makes this dismissal a data point — not an endpoint — for the cfDNA prenatal IP market.
Ravgen’s cfDNA patents remain enforceable against NIPT competitors
The with-prejudice dismissal of Ravgen’s claims covers only Biora. US7727720B2 and US7332277B2 remain asserted or assertable against other noninvasive prenatal testing providers. Any company offering cfDNA-based prenatal screening from maternal blood should assess exposure to these patents before expanding product lines.
The asymmetric dismissal structure warrants close reading by cfDNA market entrants
Biora’s counterclaims were preserved without prejudice — an unusual outcome that may reflect contested validity positions not resolved on the merits. Competitors or licensees evaluating the validity of Ravgen’s patents should note that no court has ruled on the merits of any invalidity argument in this case.
Ravgen v Biora — key questions answered
Ravgen asserted US7727720B2 and US7332277B2, both covering methods of isolating and analysing cell-free fetal DNA from maternal blood samples for noninvasive prenatal genetic screening. The accused products were Biora’s Innatal® Prenatal Screen and Resura® Prenatal Test.
The case was resolved via a stipulated dismissal under FRCP 41(a)(1)(A)(ii). Ravgen’s infringement claims were dismissed with prejudice — permanently barring Ravgen from re-asserting those claims against Biora. Biora’s counterclaims were dismissed without prejudice, preserving Biora’s right to reassert them. No payment was made by either party.
No. The dismissal was stipulated and contains no merits ruling on infringement or patent validity. The patents remain in force and are enforceable against other parties. Biora’s counterclaims — which likely included invalidity arguments — were dismissed without prejudice, meaning no court adjudicated their validity.
The accused products were the Innatal® Prenatal Screen, a noninvasive prenatal test for chromosomal aneuploidies using cfDNA from maternal blood with Streck BCT tubes, and the Resura® Prenatal Test for Monogenic Disease, which detects single-gene disorders using cfDNA extracted from maternal blood.
Ravgen has filed multiple patent infringement actions in Delaware District Court against cfDNA-based prenatal testing providers, asserting the same or related patents. This pattern is consistent with a systematic licensing enforcement programme targeting the commercial NIPT market. The Biora dismissal without payment does not indicate an abandonment of this strategy against other defendants.
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