DCT
1:22-cv-11202
BioNTech Se v. CureVac AG
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiffs: BioNTech SE, BioNTech Manufacturing GmbH (Germany), and Pfizer Inc. (Delaware)
- Defendant: CureVac AG (Germany)
- Plaintiffs’ Counsel: Saul Ewing Arnstein & Lehr LLP; Paul Hastings LLP; Willkie Farr & Gallagher LLP
- Case Identification: 1:22-cv-11202, D. Mass., 07/25/2022
- Venue Allegations: Plaintiffs allege venue is proper in the District of Massachusetts because Defendant CureVac AG is a foreign corporation subject to personal jurisdiction in the district, where it maintains an office, conducts business, and sent communications concerning its patent rights.
- Core Dispute: Plaintiffs seek a declaratory judgment that their COMIRNATY® COVID-19 vaccine does not infringe three of Defendant’s U.S. patents related to mRNA stabilization, structure, and formulation.
- Technical Context: The technology at issue is messenger RNA (mRNA) vaccines, which became a critical platform for developing rapid responses to the COVID-19 pandemic.
- Key Procedural History: The complaint states this action follows threats of patent infringement by CureVac, which failed to bring its own mRNA COVID-19 vaccine to market. The filing occurred after CureVac initiated patent litigation in Germany against BioNTech on June 29, 2022, asserting European counterparts to the patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2000-00-00 | CureVac founded |
| 2001-06-05 | ’312 Patent Priority Date |
| 2014-12-12 | ’278 Patent Priority Date |
| 2020-05-05 | First participants dosed in Phase 1/2 clinical trial for the Pfizer-BioNTech vaccine |
| 2020-11-13 | ’493 Patent Priority Date |
| 2020-12-11 | FDA grants Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine |
| 2021-06-16 | CureVac's vaccine candidate (CVnCoV) fails to meet statistical success criteria in a pivotal trial |
| 2021-08-23 | FDA grants full approval for the Pfizer-BioNTech vaccine (COMIRNATY®) |
| 2021-10-05 | ’312 Patent Issued |
| 2021-10-19 | ’278 Patent Issued |
| 2021-10-00 | CureVac withdraws its vaccine candidate from the European Medicines Agency approval process |
| 2022-02-08 | ’493 Patent Issued |
| 2022-02-00 | CureVac contacts BioNTech to initiate licensing discussions |
| 2022-06-29 | CureVac files patent infringement complaint against BioNTech in Germany |
| 2022-07-25 | Complaint for Declaratory Judgment filed in D. Mass. |
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 describes the inherent instability of RNA molecules, which are rapidly degraded by enzymes both outside and inside cells, posing a significant challenge to their use as therapeutic agents or vaccines (Compl. ¶98; ’312 Patent, col. 1:36-2:42).
- The Patented Solution: The invention proposes modifying an mRNA molecule to solve this problem by systematically increasing the proportion of guanine (G) and cytosine (C) nucleotides in the protein-coding region. This "G/C content" increase is performed without altering the amino acid sequence the mRNA produces, a technique made possible by the redundancy of the genetic code. The patent asserts that sequences with higher G/C content are more stable than those with higher adenine (A) and uracil (U) content (’312 Patent, col. 4:11-27).
- Technical Importance: This approach represents a strategy to enhance the therapeutic potential of mRNA by engineering its fundamental chemical stability, rather than relying solely on delivery vehicles or external stabilizing agents (’312 Patent, col. 4:11-27).
Key Claims at a Glance
- The complaint identifies independent claim 1 (Compl. ¶99).
- The essential elements of Claim 1, a method claim, are:
- A method for producing a stabilized mRNA molecule encoding a polypeptide.
- The stabilized mRNA molecule comprises a coding sequence with an increased Guanine/Cytosine (G/C) content relative to the original coding sequence.
- The relative 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 molecule 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 need for robust protein expression from therapeutic RNA, noting that expression is regulated by various structural features of the mRNA molecule, including the 3’-untranslated region (3’-UTR) that follows the protein-coding sequence (’278 Patent, col. 3:1-4:54).
- The Patented Solution: The invention claims an artificial RNA molecule engineered with a specific 3’-UTR architecture. This architecture includes at least two distinct poly(A) sequences (stretches of adenine nucleotides) that are separated from each other by a non-poly(A) nucleic acid spacer of a defined length. This configuration is purported to improve protein expression from the RNA molecule (’278 Patent, col. 19:10-22).
- Technical Importance: The technology focuses on engineering non-coding RNA structures to control biological outcomes, suggesting that a segmented or interrupted poly(A) region can enhance protein production more effectively than a traditional single poly(A) tail (’278 Patent, col. 19:10-22).
Key Claims at a Glance
- The complaint identifies independent claim 1 (Compl. ¶101).
- The essential elements of Claim 1, a method of treatment claim, are:
- A method of treating or preventing an infectious disease by administering an RNA molecule.
- The RNA molecule comprises an open reading frame (ORF) encoding a pathogen's antigen.
- The RNA molecule also comprises a 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 for protecting against coronavirus infection. The claimed invention is a composition comprising an mRNA that encodes a SARS-CoV-2 spike protein, where the mRNA is complexed with a lipid nanoparticle (LNP) carrier made of a specific combination of four lipid types in defined molar ratios (Compl. ¶103; ’493 Patent, col. 101:48-102:18).
Asserted Claims
The complaint identifies independent claim 1 (Compl. ¶103).
Accused Features
The complaint asserts that the COMIRNATY® vaccine does not infringe because it does not comprise the claimed composition, including the specific requirement that the mRNA is "complexed or associated with lipid nanoparticles" as recited in the 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
COMIRNATY® is an mRNA-based vaccine indicated for active immunization to prevent COVID-19 (Compl. ¶66). The complaint states it was the first mRNA drug product and the first COVID-19 vaccine to receive full FDA approval in the United States (Compl. ¶65). It further alleges that over three billion doses were manufactured in 2021 (Compl. ¶63).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’312 Patent Infringement Allegations
Because this is a declaratory judgment action for noninfringement, the "Alleged Infringing Functionality" column reflects the Plaintiffs' assertion that their product does not practice the claimed element.
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for producing a stabilized mRNA molecule... | The complaint alleges that the COMIRNATY® vaccine is not manufactured by a method that meets the limitations of any claim of the ’312 patent. | ¶107 | col. 30:41-42 |
| ...comprises a coding sequence that has an increased Guanine/Cytosine (G/C) content relative to the original coding sequence... | The complaint asserts that the method used to manufacture the COMIRNATY® vaccine does not synthesize an mRNA with the claimed increased G/C content. | ¶107 | col. 30:46-50 |
| ...said relative G/C content being increased by at least 7 percentage points compared to the original coding sequence... | The complaint's general denial of infringement suggests that the COMIRNATY® vaccine mRNA, if it has any G/C increase, does not meet the "at least 7 percentage points" threshold. | ¶107 | col. 30:50-53 |
| ...wherein said increase in relative G/C content results in the elimination of at least one destabilizing sequence element (DSE)... | The complaint does not specifically address this limitation, but its blanket denial of infringement implies that this required result of the G/C increase does not occur. | ¶107 | col. 30:58-61 |
Identified Points of Contention
- Factual & Definitional Question: The dispute appears to be primarily factual, centering on the specific characteristics of the mRNA used in the COMIRNATY® vaccine. A key question for the court will be whether the COMIRNATY® mRNA has a G/C content that is at least 7 percentage points higher than the wild-type SARS-CoV-2 spike protein mRNA, and if so, whether this increase results in the elimination of a "destabilizing sequence element" as that term is defined by the court.
- Technical Question: What constitutes a "destabilizing sequence element (DSE)" will be a critical issue. The analysis will require determining if the specific sequence of the COMIRNATY® mRNA lacks any sequences that fall within the patent's definition of a DSE which were present in the original viral sequence.
’278 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...administering an RNA molecule comprising: ... a 3'-untranslated region (3’-UTR) comprising at least two poly(A) sequences... | The complaint explicitly alleges that the COMIRNATY® vaccine does not comprise an RNA molecule with a 3'-UTR containing at least two poly(A) sequences. | ¶112 | col. 85:56-59 |
| ...wherein at least one of the poly(A) sequences comprises at least 70 adenine nucleotides... | By denying the presence of "at least two poly(A) sequences," the complaint implicitly denies this dependent limitation as well. | ¶112 | col. 85:60-62 |
| ...wherein the at least two poly(A) sequence elements are separated by a nucleic acid sequence comprising from 10 to 90 nucleotides... | The complaint’s denial that the vaccine contains "at least two poly(A) sequences" is a direct rejection of this structural limitation. | ¶112 | col. 85:63-66 |
Identified Points of Contention
- Technical Question: The central dispute is a question of molecular structure. The court will need to determine the precise nucleotide sequence and architecture of the 3'-UTR of the mRNA in the COMIRNATY® vaccine.
- Scope Question: A potential point of contention may be the definition of "at least two poly(A) sequences." The analysis raises the question of whether a single, continuous poly(A) tail that contains imperfections or short non-adenine interruptions could be argued to constitute two or more distinct "sequences" separated by a "nucleic acid sequence" under the claim's definition.
V. Key Claim Terms for Construction
’312 Patent, Claim 1
- The Term: "destabilizing sequence element (DSE)"
- Context and Importance: Infringement of the method claim requires that the claimed increase in G/C content "results in the elimination of at least one" DSE. The definition of this term is therefore dispositive. If the COMIRNATY® mRNA does not eliminate a feature that the court construes as a DSE, the claim is not infringed, regardless of the mRNA's G/C content.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that destabilizing sequences may include "AU-rich sequences ('AURES')" and "sequence motifs recognised by potential endonucleases" (’312 Patent, col. 6:57-67). Parties may argue this language supports a broad definition covering multiple types of sequences known to affect mRNA stability.
- Evidence for a Narrower Interpretation: The specification explicitly provides "AU-rich sequences ('AURES')" as an example of DSEs (’312 Patent, col. 6:57-58). Parties may argue that this specific example should guide the term's construction, potentially limiting its scope to well-defined AURES motifs.
’278 Patent, Claim 1
- The Term: "at least two poly(A) sequences"
- Context and Importance: This term defines the core structural feature of the invention and is the basis for the noninfringement allegation in the complaint. Practitioners may focus on this term because the dispute will likely center on whether the 3'-end of the COMIRNATY® mRNA, which presumably has a poly(A) tail for stability and translation, has a structure that can be characterized as two or more distinct sequences separated by a spacer.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A patentee might argue that any non-adenine nucleotide sequence of 10-90 nucleotides that interrupts a longer stretch of adenine nucleotides creates two distinct "poly(A) sequences" that meet the claim language, even if created unintentionally during synthesis.
- Evidence for a Narrower Interpretation: The claim requires the two sequences to be "separated by a nucleic acid sequence comprising from 10 to 90 nucleotides" (’278 Patent, cl. 1). A party arguing for non-infringement may contend that this requires two structurally and functionally distinct poly(A) elements, not merely a single, continuous poly(A) tail with minor impurities or interruptions that are artifacts of manufacturing.
VI. Other Allegations
The complaint is a declaratory judgment action for noninfringement and does not contain allegations of indirect or willful infringement against the Defendant.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of molecular fact-finding: What are the precise molecular characteristics of the COMIRNATY® vaccine's mRNA? The resolution of the noninfringement claims for the ’312 and ’278 patents will depend entirely on a factual analysis of the mRNA's G/C content and 3'-UTR structure.
- A key question will be one of definitional scope: For the ’312 patent, how broadly will the court construe the term “destabilizing sequence element,” and for the ’278 patent, can a conventional poly(A) tail with interruptions be considered "at least two poly(A) sequences"?
- A third core dispute will concern compositional identity: Does the specific combination and molar ratio of the four lipid components in COMIRNATY®'s lipid nanoparticle delivery system fall within the scope of the composition claimed in the ’493 patent?