DCT
1:11-cv-10484
University Of Utah v. Max Planck Gesellschaft zur Foerderung der Wissenschaften Ev
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: The University of Utah (Utah)
- Defendants: Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V.; Max-Planck-Innovation GmbH; Whitehead Institute for Biomedical Research; Massachusetts Institute of Technology; University of Massachusetts; and Alnylam Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Pepper Hamilton LLP
- Case Identification: 1:11-cv-10484, D. Mass., 03/22/2011
- Venue Allegations: Venue is alleged as proper in the District of Massachusetts pursuant to 28 U.S.C. § 1391(b) and (d).
- Core Dispute: Plaintiff seeks correction of inventorship under 35 U.S.C. § 256 for two patents, alleging that its researcher, Dr. Brenda Bass, was the sole or joint inventor of the claimed subject matter and was improperly omitted from the patents.
- Technical Context: The technology is RNA interference (RNAi), a fundamental biological process for gene silencing, and specifically concerns the structure of short interfering RNA (siRNA) molecules used to trigger the effect.
- Key Procedural History: The complaint alleges that the core inventive concept at issue—the structure of siRNA molecules with 3’ overhangs—was the central focus of a prior, contentious litigation among several of the defendants (Max-Planck et al. v. Whitehead Institute for Biomedical Research et al.). That litigation reportedly settled shortly before the filing of this complaint, and Plaintiff alleges that documents produced in that case revealed Dr. Bass's contribution.
Case Timeline
| Date | Event |
|---|---|
| 1993-01-01 | Complaint alleges Dr. Bass first understood the Dicer enzyme cleaves dsRNA to create 3' overhangs. |
| 1998-01-01 | RNA interference (RNAi) phenomenon first reported by Drs. Fire and Mello. |
| 2000-03-21 | Dr. Bass allegedly begins drafting a review article describing her conception of siRNAs having 3' overhangs. |
| 2000-03-30 | The "First Tuschl I Provisional" application is filed by inventors associated with Defendants. |
| 2000-04-11 | Dr. Bass allegedly presents her conception of 3' overhangs at the Banbury Conference, attended by Dr. Zamore. |
| 2000-04-28 | Dr. Bass's review article, setting forth her conception, is published in the journal Cell. |
| 2000-05-01 | Dr. Bass's laboratory allegedly completes experiments reducing to practice the conception that Dicer is essential for RNAi. |
| 2000-08-01 | Dr. Bass allegedly presents her work at the Uppsala Workshop, attended by named inventors Tuschl and Elbashir. |
| 2000-12-01 | Priority date for the '704 and '196 patents, based on European Application EP 00126325. |
| 2006-06-06 | U.S. Patent No. 7,056,704 issues. |
| 2006-07-18 | U.S. Patent No. 7,078,196 issues. |
| 2011-03-15 | A settlement is reportedly reached in the related Whitehead litigation. |
| 2011-03-22 | Complaint is filed. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,056,704 - "RNA interference mediating small RNA molecules"
The Invention Explained
- Problem Addressed: The patent's background describes the biological phenomenon of RNA interference (RNAi), where the introduction of double-stranded RNA (dsRNA) into a cell causes the specific silencing of genes with a matching sequence. However, the precise molecular mechanism and the specific structures that could be used to reliably trigger this effect for therapeutic or research purposes were not fully elucidated ('704 Patent, col. 1:20-35).
- The Patented Solution: The patent discloses that short, 19-25 nucleotide dsRNA fragments, termed "short interfering RNAs" (siRNAs), are the key mediators of RNAi. The invention specifically describes that these siRNAs are duplexes with short, single-stranded 3' overhangs at their ends. The patent demonstrates that chemically synthesized dsRNA molecules with this specific size and 3' overhang structure are highly effective at guiding the cleavage of a target messenger RNA (mRNA) ('704 Patent, Abstract; col. 2:8-24).
- Technical Importance: This disclosure provided a concrete, reproducible molecular structure that transformed RNAi from an observed phenomenon into a predictable and powerful tool for "knocking down" the expression of specific genes.
Key Claims at a Glance
The complaint seeks to correct inventorship for all claims of the patent (Compl. ¶¶ 86, 90). Independent claim 1 is representative:
- A method for preparing a double stranded RNA molecule which mediates the cleavage of an mRNA in a mammalian cell, comprising:
- (a) synthesizing two RNA strands each having a length from 19-25 nucleotides, and
- (b) combining the synthesized RNA strands under conditions suitable to form a double stranded RNA molecule,
- wherein said double stranded RNA molecule has a double stranded region of 14-24 nucleotides in length and one or two 3' overhang regions of 1-5 nucleotides in length.
U.S. Patent No. 7,078,196 - "RNA interference mediating small RNA molecules"
The Invention Explained
- Problem Addressed: As with the '704 Patent, the technical challenge was to define and claim the specific molecular agent responsible for RNAi to enable its use as a practical tool ('196 Patent, col. 1:20-35).
- The Patented Solution: The '196 Patent, which is from the same family as the '704 Patent, claims the composition of matter itself. The invention is an isolated double-stranded RNA molecule for mediating RNA interference. The key structural features claimed are a length of 19-25 nucleotides per strand and the presence of at least one 3' overhang of 1-5 nucleotides ('196 Patent, Abstract; col. 2:35-43).
- Technical Importance: This patent claims the physical molecule—the "tool" itself—that is central to the application of RNAi technology in research and drug development.
Key Claims at a Glance
The complaint seeks to correct inventorship for all claims of the patent (Compl. ¶¶ 94, 98). Independent claim 1 is representative:
- An isolated double stranded RNA molecule which mediates the cleavage of an mRNA in a mammalian cell,
- wherein each RNA strand has a length from 19-25 nucleotides,
- wherein said RNA molecule is capable of target-specific nucleic acid modifications and
- wherein at least one strand has a 3'-overhang of 1-5 nucleotides.
III. The Accused Instrumentality
Product Identification
The subject of the dispute is not an infringing product but the patents-in-suit themselves: U.S. Patent Nos. 7056704 and 7078196 (the "Tuschl II Patents") (Compl. ¶¶ 17, 85, 93).
Functionality and Market Context
The "functionality" at issue is the patented subject matter, which the complaint alleges was invented by Dr. Bass. This includes methods of making and compositions of double-stranded RNA molecules having a length of approximately 19-25 nucleotides and featuring at least one 3' overhang of 1-5 nucleotides for the purpose of mediating gene silencing in mammalian cells (Compl. ¶69; '704 Patent, claim 1; '196 Patent, claim 1). The complaint alleges this technology is the "core technology required by the Alnylam business to consolidate and control RNAi therapeutics" and is a "chief source of the value of the company and the income it has generated" (Compl. ¶¶ 67, 74). The patents are alleged to be foundational to Alnylam's entire U.S. patent estate (Compl. ¶74).
IV. Analysis of Inventorship Allegations
The complaint does not allege infringement but rather that the named inventors derived the core inventive concepts from Dr. Brenda Bass without naming her as an inventor. The following table summarizes the allegations of derivation for the representative independent claims.
No probative visual evidence provided in complaint.
'704 Patent Derivation Allegations
| Claim Element (from Independent Claim 1) | Alleged Conception and Contribution by Dr. Bass | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for preparing a double stranded RNA molecule... which mediates the cleavage of an mRNA in a mammalian cell | The complaint alleges this was taught by Dr. Bass's Cell article, which identified the human gene for the Dicer enzyme, implying RNAi could be mediated in mammals. | ¶69b | col. 5:1-6 |
| synthesizing two RNA strands each having a length from 19-25 nucleotides | The complaint notes that a length of 21-23 nucleotides had previously been described in other publications. | ¶69c | col. 2:35-37 |
| wherein said double stranded RNA molecule has... one or two 3' overhang regions of 1-5 nucleotides in length | This is alleged to be the core inventive concept, "exactly as conceived first by Dr. Bass and learned by Tuschl from her (3' overhang of a length of 1-2 nucleotides)." | ¶69d | col. 2:39-40 |
Identified Points of Contention
- Factual Question of Conception: The central dispute will be factual, focusing on priority of invention. A key question is whether Plaintiff can establish, with corroborating evidence, that Dr. Bass conceived of the complete invention—specifically, a short dsRNA molecule with a 3' overhang for use in mediating RNAi—prior to the named inventors. The complaint alleges Dr. Bass conceived of this by March 21, 2000 (Compl. ¶39).
- Factual Question of Communication/Derivation: A related question for the court will be whether Plaintiff can prove that Dr. Bass communicated her complete conception to one or more of the named inventors. The complaint alleges this occurred through various channels, including a draft of her review article, a presentation at the Banbury Conference in April 2000, and discussions at the Uppsala Workshop in August 2000 (Compl. ¶¶ 44, 48-50, 54-57).
- Question of Joint vs. Sole Inventorship: The complaint alternatively pleads that Dr. Bass is either the sole inventor or a joint inventor (Compl., Counts I-IV). This raises the question of what, if any, inventive contribution was made by the named inventors. The case may turn on evidence of whether the named inventors contributed to any element of the claimed invention independently of Dr. Bass's alleged disclosures.
V. Key Claim Terms for Construction
In an inventorship dispute, the primary focus is on the factual origin of the invention rather than claim construction. However, the definition of the central inventive concept is critical.
- The Term: "3' overhang"
- Context and Importance: The complaint alleges that the "3' overhangs were the central focus of a contentious litigation" between the defendants and that this feature is the "key—if not the only—patentable invention in the Tuschl II Patents" (Compl. ¶¶ 63, 67). The determination of who first conceived of applying this specific structural feature to siRNA molecules will be dispositive.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent claims recite a broad range for the overhang, from "1-5 nucleotides" ('704 Patent, claim 1), and the specification provides support for this range, suggesting the invention is not limited to a specific length ('704 Patent, col. 2:39-40).
- Evidence for a Narrower Interpretation: The specification repeatedly identifies a 2-nucleotide overhang as a preferred embodiment ('704 Patent, col. 3:1-3). The complaint itself alleges Dr. Bass conceived of an overhang of "1-2 nucleotides" (Compl. ¶69d). This may raise the question of whether Dr. Bass conceived of the full claimed scope or only a preferred embodiment, which could be relevant to the analysis of sole versus joint inventorship.
VI. Other Allegations
- State Law Claims: In addition to the federal claim for correction of inventorship, the complaint alleges several state law claims against Defendants Max Planck and Alnylam, including conversion, replevin, and unjust enrichment (Compl. ¶¶ 106-121). These claims are based on the allegation that Defendants wrongfully exercised control over Dr. Bass's intellectual property by filing for patents, licensing the technology, and refusing to recognize her as an inventor, thereby profiting from her alleged invention at Plaintiff's expense (Compl. ¶¶ 108, 119).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of priority and derivation: can the Plaintiff provide clear and convincing evidence, corroborated by more than the inventor's own testimony, that Dr. Bass not only conceived of the complete claimed invention—a short, overhanging dsRNA molecule for mediating RNAi—but also communicated that conception to the named inventors before they conceived of it themselves?
- A central evidentiary question will be one of contribution: assuming Dr. Bass made an inventive contribution, does the evidence show that she conceived of the entire invention as claimed, making her the sole inventor, or that her contribution was combined with separate, inventive contributions from the named inventors, which would support a finding of joint inventorship?
- The case may also present a question of judicial estoppel or admissions: to what extent can statements, testimony, and documents from the prior Whitehead litigation, which allegedly focused on the importance of the 3' overhang invention, be used to establish the patentability of that feature and the timeline of its discovery?