DCT
2:23-cv-00222
CureVac Se v. BioNTech Se
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: BioNTech SE, BioNTech Manufacturing GmbH (Germany), and Pfizer Inc. (Delaware/New York)
- Defendant: CureVac AG (Germany)
- Plaintiff’s Counsel: Saul Ewing Arnstein & Lehr LLP; Paul Hastings LLP (for BioNTech); Willkie Farr & Gallagher LLP (for Pfizer)
- Case Identification: 1:22-cv-11202, D. Mass., 07/25/2022
- Venue Allegations: Venue is asserted on the basis that Defendant is a foreign corporation subject to personal jurisdiction in the district due to its systematic contacts, including maintaining an office in Boston and sending communications regarding the dispute into Massachusetts.
- Core Dispute: Plaintiffs seek a declaratory judgment that their COMIRNATY® COVID-19 vaccine does not infringe three of Defendant’s patents related to mRNA sequence optimization, structure, and formulation.
- Technical Context: The technology at issue is messenger RNA (mRNA) vaccines, which became a cornerstone of the global public health response to the COVID-19 pandemic.
- Key Procedural History: The complaint alleges that after Defendant’s own COVID-19 vaccine candidate failed in clinical trials, it initiated licensing discussions with Plaintiffs. Following unsuccessful negotiations, Defendant filed a patent infringement lawsuit in Germany against Plaintiffs concerning European counterparts of the patents-in-suit. This declaratory judgment action was filed in the U.S. in response to Defendant's actions.
Case Timeline
| Date | Event |
|---|---|
| 2001-06-05 | ’312 Patent Priority Date |
| 2014-12-12 | ’278 Patent Priority Date |
| 2019-12 | Reports of pneumonia outbreak in Wuhan, China |
| 2020-01 | BioNTech initiated "Project Lightspeed" to develop a COVID-19 vaccine |
| 2020-05-05 | First participants dosed in U.S. Phase 1/2 clinical trial for COMIRNATY® |
| 2020-11-10 | ’493 Patent Priority Date |
| 2020-11-20 | Emergency Use Authorization (EUA) request submitted to the FDA |
| 2020-12-11 | FDA granted EUA for the Pfizer-BioNTech COVID-19 vaccine |
| 2021-06-16 | CureVac's vaccine candidate (CVnCoV) trial showed low efficacy |
| 2021-08-23 | FDA granted full approval for the COMIRNATY® vaccine |
| 2021-10 | CureVac withdrew its vaccine candidate from the European regulatory process |
| 2021-10-05 | U.S. Patent No. 11,135,312 Issued |
| 2021-10-19 | U.S. Patent No. 11,149,278 Issued |
| 2022-02 | CureVac contacted BioNTech regarding potential licensing |
| 2022-02-08 | U.S. Patent No. 11,241,493 Issued |
| 2022-06-29 | CureVac filed an infringement complaint in Germany against BioNTech |
| 2022-07-25 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,135,312 - "Pharmaceutical Composition Containing a Stabilised mRNA Optimised for Translation in its Coding Regions"
The Invention Explained
- Problem Addressed: The patent's background describes the inherent instability of RNA molecules, which are susceptible to rapid degradation by enzymes (RNases) both in solution and within cells. This instability presents a significant obstacle to using RNA as a reliable therapeutic agent or vaccine (ʼ312 Patent, col. 1:59 - col. 2:32).
- The Patented Solution: The invention proposes methods to stabilize mRNA and optimize its translation by modifying the nucleotide sequence of its protein-coding region. A primary strategy is to increase the relative content of guanine (G) and cytosine (C) nucleotides compared to the naturally occurring sequence. This G/C-enrichment is accomplished by substituting codons with alternative codons that encode the same amino acid but have a higher G/C content, thereby enhancing the mRNA's structural stability without altering the resulting protein (ʼ312 Patent, Abstract; col. 3:6-20).
- Technical Importance: This technology provided a systematic approach to engineer mRNA molecules with improved stability and translational efficiency, addressing a fundamental challenge that had limited the viability of mRNA-based medicines (ʼ312 Patent, col. 2:1-4).
Key Claims at a Glance
- The complaint discusses independent claim 1 (Compl. ¶99).
- Essential elements of independent claim 1 include:
- A method for producing a stabilized mRNA molecule encoding a polypeptide.
- The stabilized mRNA comprises a coding sequence with an increased Guanine/Cytosine (G/C) content relative to the original coding sequence.
- The G/C content is increased by at least 7 percentage points.
- This increase in G/C content results in the elimination of at least one destabilizing sequence element (DSE).
- The stabilized mRNA exhibits enhanced expression compared to the original mRNA.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,149,278 - "Artificial Nucleic Acid Molecules for Improved Protein Expression"
The Invention Explained
- Problem Addressed: The patent addresses the challenge of achieving stable and efficient protein expression from RNA molecules used in gene therapy or vaccination. It notes that while RNA avoids the genomic integration risks of DNA, its inherent instability, regulated in part by its 3'-untranslated region (3'-UTR), remains a significant hurdle ('278 Patent, col. 1:58 - col. 2:3).
- The Patented Solution: The invention discloses an artificial nucleic acid molecule designed for improved protein expression by engineering a specific 3'-UTR structure. The core of the solution is a 3'-UTR that comprises at least one poly(A) sequence or a polyadenylation signal, with specific embodiments describing configurations of multiple poly(A) sequences separated by linker sequences ('278 Patent, Abstract; col. 2:42-53).
- Technical Importance: This invention provides a method to enhance mRNA performance by modifying the non-coding 3'-UTR, a critical region for regulating mRNA stability and translation, offering a distinct approach from modifying the protein-coding sequence itself ('278 Patent, col. 2:38-41).
Key Claims at a Glance
- The complaint discusses independent claim 1 (Compl. ¶101).
- Essential elements of independent claim 1 include:
- A method for treating or preventing an infectious disease by administering an RNA molecule.
- The RNA molecule contains an open reading frame (ORF) encoding a pathogen's antigen.
- The RNA molecule has a 3'-untranslated region (3'-UTR) comprising at least two poly(A) sequences.
- At least one of the poly(A) sequences comprises at least 70 adenine nucleotides.
- The two poly(A) sequences are separated by a nucleic acid sequence of 10 to 90 nucleotides.
- The RNA molecule is administered intramuscularly.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,241,493 - "Coronavirus Vaccine"
Technology Synopsis
The patent describes a vaccine composition comprising an mRNA that encodes a SARS-CoV-2 spike protein. The invention is specifically directed to the formulation, wherein the mRNA is complexed with lipid nanoparticles (LNPs) consisting of a particular cationic lipid, a neutral lipid, a sterol (cholesterol), and a PEG-lipid, with each component present in a specified molar ratio range ('493 Patent, Abstract; Compl. ¶103).
Asserted Claims
The complaint discusses independent claim 1 (Compl. ¶103).
Accused Features
The overall composition of the COMIRNATY® vaccine, including its specific mRNA and lipid nanoparticle formulation, is the subject of the non-infringement claim (Compl. ¶117).
III. The Accused Instrumentality
Product Identification
The Pfizer-BioNTech COVID-19 vaccine, marketed under the trade name COMIRNATY® (Compl. ¶¶13, 64).
Functionality and Market Context
The accused product is an mRNA-based vaccine indicated for "active immunization to prevent coronavirus disease 2019 (COVID-19)" (Compl. ¶66). The complaint alleges it was the first mRNA drug product to receive Emergency Use Authorization and later full FDA approval in the United States for COVID-19 (Compl. ¶¶57, 65). It further alleges that over three billion doses were manufactured in 2021 and that the vaccine has been instrumental in the global pandemic response, saving millions of lives (Compl. ¶¶63, 67). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
This is a declaratory judgment action for non-infringement. The following table summarizes Plaintiffs' allegations that their product does not meet the patent claim limitations.
U.S. Patent No. 11,135,312 Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method for producing a stabilized mRNA molecule... wherein the stabilized mRNA molecule encoding the polypeptide comprises a coding sequence that has an increased Guanine/Cytosine (G/C) content relative to the original coding sequence... | Plaintiffs allege that the COMIRNATY® vaccine is not manufactured by a method that includes synthesizing an mRNA molecule with the claimed increased G/C content. | ¶107 | col. 4:8-15 |
| said relative G/C content being increased by at least 7 percentage points compared to the original coding sequence... | The complaint alleges that the method used for COMIRNATY® does not meet this limitation of the claim. | ¶107 | col. 4:8-15 |
| wherein said increase in relative G/C content results in the elimination of at least one destabilizing sequence element (DSE)... | The complaint alleges that the method used for COMIRNATY® does not meet this limitation of the claim. | ¶99 | col. 5:45-56 |
| wherein the stabilized mRNA molecule exhibits enhanced expression of the polypeptide compared to mRNA having the original coding sequence... | The complaint alleges that the method used for COMIRNATY® does not meet this limitation of the claim. | ¶99 | col. 4:16-20 |
U.S. Patent No. 11,149,278 Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method for treating or preventing an infectious disease, the method comprising administering an RNA molecule comprising: a) at least one open reading frame (ORF) encoding an antigen from a pathogen... | Plaintiffs administer the COMIRNATY® vaccine, an RNA molecule encoding a SARS-CoV-2 antigen, to prevent COVID-19. | ¶66 | col. 1:19-22 |
| and b) a 3'-untranslated region (3'-UTR) comprising at least two poly(A) sequences... | Plaintiffs allege that the COMIRNATY® vaccine does not comprise an RNA molecule with a 3'-UTR containing at least two poly(A) sequences. | ¶112 | col. 2:42-47 |
| wherein at least one of the poly(A) sequences comprises at least 70 adenine nucleotides... | The complaint's general denial suggests the RNA in COMIRNATY® does not meet this limitation. | ¶112 | col. 2:42-47 |
| wherein the at least two poly(A) sequence elements are separated by a nucleic acid sequence comprising from 10 to 90 nucleotides... | Plaintiffs allege that the COMIRNATY® vaccine does not comprise an RNA molecule with two poly(A) sequences separated by such a linker. | ¶112 | col. 2:42-47 |
Identified Points of Contention
- Scope Questions: The non-infringement allegations for the ’312 and ’278 patents raise the question of whether the actual molecular structure of the mRNA in the COMIRNATY® vaccine falls within the scope of the claims. The complaint's bare assertions of non-infringement provide no technical details, suggesting that the precise sequence and G/C content of the COMIRNATY® mRNA and the specific structure of its 3'-UTR will be central factual disputes to be resolved through discovery.
- Technical Questions: For the ’493 Patent, the core dispute will be a direct factual comparison. The question is whether the specific types and molar ratios of lipids that constitute the LNP delivery system in COMIRNATY® are the same as those recited in claim 1 of the ’493 Patent (Compl. ¶¶103, 117).
V. Key Claim Terms for Construction
For the ’312 Patent
- Term: "destabilizing sequence element (DSE)"
- Context and Importance: Claim 1 requires that the claimed increase in G/C content "results in the elimination of at least one" DSE. The definition of this term is crucial; if the sequence modifications in the COMIRNATY® mRNA do not eliminate a sequence that qualifies as a DSE under the patent's definition, infringement may be avoided. Practitioners may focus on this term because its scope will determine whether routine codon optimization practices necessarily read on the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes DSEs functionally as sequences to which "signal proteins can bind and thereby regulate the enzymatic degradation of the mRNA in vivo" ('312 Patent, col. 5:45-49). This could support an interpretation covering any sequence known to reduce mRNA stability.
- Evidence for a Narrower Interpretation: The specification provides specific examples of DSEs, including "AU-rich sequences ('AURES')" and the sequence "GAACAAG" ('312 Patent, col. 6:58-67). This could support a narrower construction limited to the types of sequences explicitly disclosed.
For the ’278 Patent
- Term: "poly(A) sequence"
- Context and Importance: Claim 1 requires a 3'-UTR comprising "at least two poly(A) sequences." The COMIRNATY® mRNA almost certainly contains a poly(A) tail for stability. The dispute will likely center on whether this tail constitutes one "sequence" or could be construed as "two" sequences. The definition is therefore dispositive for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the general term "poly(A) sequence" without further qualification. A party could argue for its plain and ordinary meaning, which might encompass any stretch composed primarily of adenine, potentially allowing for minor interruptions to delineate separate "sequences."
- Evidence for a Narrower Interpretation: The specification describes the "poly(A) tail" as a "monotonous sequence stretch of adenine nucleotides" ('278 Patent, col. 2:5-6). This language could support an argument that a "poly(A) sequence" must be substantially or entirely composed of adenine, making it more difficult to argue that a single, typical poly(A) tail could be interpreted as two distinct sequences.
VI. Other Allegations
The complaint is for declaratory judgment of non-infringement and does not contain allegations of indirect or willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to center on a direct factual and technical comparison between the patented technologies and the precise composition of the successful COMIRNATY® vaccine. The key questions for the court are likely to be:
- A question of factual correspondence: What is the actual, complete nucleotide sequence of the mRNA and the precise chemical composition and molar ratios of the lipid nanoparticle formulation used in the commercial COMIRNATY® vaccine? The resolution of this core evidentiary question will be essential for comparing the accused product to the asserted claims.
- A question of definitional scope: How should key claim terms such as "destabilizing sequence element" ('312 Patent) and "poly(A) sequence" ('278 Patent) be construed? Whether the COMIRNATY® vaccine's features meet these limitations will depend heavily on the breadth of their legal definition.
- A question of patentability over the prior art (unspoken in the complaint): Given the extensive and rapid global research into mRNA vaccines during the pandemic, a background issue will be the validity of these patents, filed relatively late in the development cycle, over the state of the art that existed at their priority dates.