Regenxbio Inc. et al v. Aldevron, LLC
ORDER by Chief Judge Peter D. Welte granting in part and denying in part 18 Motion to Dismiss; denying 17 Motion for Hearing; denying 32 Motion for Hearing. (TH)
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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NORTH DAKOTA
REGENXBIO, Inc., and,
The Trustees of the University of
MEMORANDUM AND ORDER
Case No. 3:20-cv-171
Before the Court is Defendant Aldevron, LLC’s (“Aldevron”) “Motion to Dismiss Under
Rule (12)(b)(6) and/or for a More Definite Statement Under Rule 12(e)” filed on November 9,
2020. Doc. No. 18. Plaintiffs REGENXBIO, Inc. (“REGENXBIO”) and The Trustees of the
University of Pennsylvania (the “University”) (REGENXBIO and the University together, the
“Plaintiffs”) filed a response in opposition to the motion on November 30, 2020. Doc. No. 29.
Aldevron filed a reply on December 14, 2020. Doc. No. 35. Plaintiffs and Aldevron also each
filed a motion for a hearing. Doc. Nos. 17 and 32. For the reasons discussed below, Aldevron’s
motion to dismiss is denied in part and granted in part, and the motions for hearing are denied.
The factual background, which the Court must accept as true for the purposes of this
motion, is taken from the Plaintiffs’ Complaint. Doc. No. 1.
This case involves a claim of patent infringement in the biotechnology field.
REGENXBIO is a Delaware clinical-stage biotechnology corporation, with its principal place of
business in Rockville, Maryland.
Id. ¶¶ 4-5.
The University is a Pennsylvania nonprofit
corporation located in Philadelphia, Pennsylvania. Id. The University is an institution of higher
education and research, as well as an academic medical center. Id. ¶¶ 2-3. Aldevron is a North
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Dakota biotechnology limited liability company located in Fargo, North Dakota.
Id. ¶ 7.
Aldevron, among other things, acts as a biotechnology manufacturer and is in the business of
providing products and services to companies and research institutions, including plasmid and
minicircle DNA production, protein production, and antibody generation. Id.
At issue in this case is a specific patent assigned to the University. On March 17, 2020,
United States Patent Number 10,590,435 (the “’435 Patent”) was issued and ultimately assigned
to the University. Id. ¶ 12; Doc. No. 1-1. Through a series of licenses, sublicenses, and
assignments, REGENXBIO holds an exclusive worldwide right and license to the ’435 patent,
including all past, present, and future infringement claims. Id. ¶¶ 13-17.
The ’435 Patent, titled “Adeno-associated virus (AAV) serotype 8 [(AAV8)] sequences,
vectors containing the same, and uses therefor[[,]” protects cultured host cells containing
recombinant nucleic acid molecules with sequences encoding AAV8 capsid protein(s) and a
heterologous non-AAV sequence. Id. ¶¶ 1, 32. As stated in the Complaint:
The ’435 Patent provides nucleic acid and amino acid sequences, with each unique
sequence accompanied by a sequence identification number (“SEQ ID NO”). The
claims of the ’435 Patent specifically cover host cells containing a recombinant
nucleic acid that (a) either (1) encodes for AAV8 capsid proteins with an amino
acid sequence as defined by SEQ ID NO: 2 in the ’435 Patent (or subset thereof) or
(2) has a sequence as defined by nucleotides 2121 to 4334 so SEQ ID NO: 1 in the
’435 Patent (or subset thereof) and (b) contains a heterologous non-AAV sequence.
The ’435 Patent also covers host cells containing nucleic acids at least 95%
identical to nucleotides of SEQ ID NO: 1 and host cells containing nucleic acid
molecules encoding capsid proteins having an amino acid sequence at least 95%
identical to SEQ ID NO: 2, and a heterologous non-AAV sequence.
Id. For the purposes of this motion, the Court refers to the above as the “’435 Patented
Biotechnology.” The ’435 Patent also includes the following independent claims:
A cultured host cell containing a recombinant nucleic acid molecule
encoding an AAVI vp1 capsid protein having a sequence comprising amino acids
1 to 738 of SEQ ID NO: 2 (AAV8) or a sequence at least 95% identical to the full
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length of amino acids 1 to 738 of SEQ ID NO: 2, wherein the recombinant nucleic
acid molecule further comprises a heterologous non-AAV sequence.
A cultured host cell containing a recombinant nucleic acid molecule
nucleotides 2121 to 4334 of SEQ ID NO: 1 or a sequence at least
95% identical to nucleotides 2121 of 4334 of SEQ ID NO: 1,
nucleotides 2532 to 4334 of SEQ ID NO: 1 or a sequence at least
95% identical to nucleotides 2532 to 4334 of SEQ ID NO: 1, or
nucleotides 2730 to 4334 of SEQ ID NO: 1 or a sequence at least
95% identical to nucleotides 2730 to 4334 of SEQ ID NO: 1,
wherein the recombinant nucleic acid molecule further comprises a heterologous
(“Independent Claims 1 and 7”). Id. ¶ 51.
REGENXBIO is a client of Aldevron. Id. ¶ 40. As a part of their business relationship,
REGENXBIO has ordered, and does order, a variety of plasmids1 from Aldevron. Id. According
to Plaintiffs, the business relationship works as follows. REGENXBIO initially provides a small
amount of starting plasmid material to Aldevron. Id. Aldevron then takes and produces host cells
that contain specific plasmid material. Id. Once Aldevron makes the host cells, Aldevron
functions as a manufacturer and “amplifies,” or mass produces, the same specific plasmid material.
Id. Aldevron then returns the amplified plasmid material to REGENXBIO. Id.
As mentioned above, over the course of their business relationship, REGENXBIO has
ordered a variety of plasmids from Aldevron and has used Aldevron to amplify a variety of plasmid
material. Relevant to this motion, some of the starting plasmid material provided by REGENXBIO
to Aldevron to amplify contains the ’435 Patented Biotechnology. Id.
A plasmid is a small, circular piece of DNA found within a cell.
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With the background of the two companies’ business relationship, the Complaint alleges
that after REGENXBIO provided the plasmid material containing the ’435 Patented Biotechnology
to Aldevron, Aldevron “made and used cultured host cells that contain plasmids compromising
recombinant nucleic acid molecules encoding AAV8 capsid proteins and a heterologous non-AAV
sequence on behalf of third parties not authorized by REGENXBIO[.]” Id. ¶ 42. Said another
way, Plaintiffs allege Aldevron, after having access to the ’435 Patented Biotechnology, began
producing the same ’435 Patented Biotechnology for third parties without authorization.
The Complaint identifies and documents four specific examples of Aldevron producing
AAV8 plasmid material for third parties, including (1) Freeline Therapeutics plc and its United
States Securities and Exchange Commission (“SEC”) Form F-1; (2) the University of Tubingen
and its report to the European Commission; (3) an article from Human Gene Therapy Clinical
Development by Tobias et al.; and, (4) an article from the American Society of Gene and Cell
Therapy by Nathwani et al. Id. ¶ 42. Each of the four examples identifies Aldevron as the largescale producer of the third party’s AAV8 plasmid material. Id. Plaintiffs allege the plasmid
material produced by Aldevron for these third parties contains the ’435 Patented Biotechnology.
Id. ¶¶ 52-53. Specifically, Plaintiffs allege the material produced for the identified third parties
infringes on, at a minimum, Independent Claims 1 and 7 of the ’435 Patent. Id. Additionally,
Plaintiffs allege Aldevron’s infringement is continuous and ongoing. Id.
Plaintiffs initiated this patent infringement case against Aldevron on September 16, 2020,
alleging a single patent infringement claim in violation of 35 U.S.C. § 271(a). Doc. No. 1. In
response to the Complaint, Aldevron filed the instant motion to dismiss under Federal Rule of
Civil Procedure 12(b)(6) and/or for a more definite statement under Federal Rule of Civil
Procedure 12(e). Doc. No. 18.
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LAW AND ANALYSIS
Aldevron seeks to dismiss Plaintiffs’ Complaint for failure to state a claim upon which
relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). According to Aldevron,
Plaintiffs’ Complaint fails to plausibly plead a claim for direct patent infringement. Aldevron
argues the Complaint “does not provide sufficient factual content to determine what Aldevron
products allegedly infringe on the ’435 Patent and how any allegedly infringing products
correspond to the claims of the ’435 Patent.” Doc. No. 19. Plaintiffs respond that their Complaint
meets the plausibility standard required by Twombly and Iqbal.
Rule 12(b)(6) Standard
A brief word on the history of the pleading standard for direct patent infringement claims
is necessary from the outset. On December 1, 2015, Federal Rule of Civil Procedure 84 and Form
18 were abrogated, and no longer govern the pleading standard for claims of direct patent
infringement. Most district courts apply the Twombly and Iqbal pleading standard to claims of
direct patent infringement. See Battle Sports Science, LLC v. Shock Doctor, Inc., 225 F. Supp.
3d 824, 835 (D. Neb. 2016) (collecting cases and applying the Twombly and Iqbal plausibility
standard for direct patent infringement claims); e.Digital Corp. v. iBaby Labs, Inc., No. 15-CV05790-JST, 2016 WL 4427209, at *3, *4 (N.D. Cal. Aug. 22, 2016) (noting that a majority of
courts have adopted the plausibility standard for direct patent infringement claims). The Court
will therefore apply the Twombly and Iqbal standard here.
Federal Rule of Civil Procedure 8(a) requires a pleading only to contain “a short and plain
statement of the claim showing that the pleader is entitled to relief.” Nevertheless, a complaint
may be dismissed for “failure to state a claim upon which relief can be granted,” and a party may
raise that defense by motion. Fed. R. Civ. P. 12(b)(6). To survive a Rule 12(b)(6) motion, a
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complaint must contain “sufficient factual matter, accepted as true, to state a claim to relief that is
plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). A plaintiff must show that
success on the merits is more than a “sheer possibility.” Id.
Plausibility is established when the plaintiff pleads factual content that allows the
court to draw the reasonable inference that the defendant is liable for the
misconduct alleged. Threadbare recitals supported by conclusory statements,
however, do not suffice to meet the plausibility requirement.
Brookins Hybrid Drive Sys., LLC v. M.A.C., Inc., 3:12-CV-101, 2013 WL 12086636, at *2
(D.N.D. May 2, 2013) (cleaned up). A complaint does not need detailed factual allegations, but it
must contain more than labels and conclusions. Bell Atl. Corp. v. Twombly, 551 U.S. 544, 555
As noted above, the Court must accept all factual allegations in the complaint as true,
except for legal conclusions or “formulaic recitation of the elements of a cause of action.” Iqbal,
556 U.S. at 681. The determination of whether a complaint states a claim upon which relief can
be granted is “a context-specific task that requires the reviewing court to draw on its judicial
experience and common sense.” Id. at 679. “[T]he complaint should be read as a whole, not
parsed piece by piece to determine whether each allegation, in isolation, is plausible.” Wilson v.
Ark. Dep’t Human Servs., 850 F.3d 368, 371-72 (8th Cir. 2017). “Specific facts are not necessary;
the statement need only give the defendant fair notice of what the . . . claim is and the grounds
upon which it rests.” Disc Disease Sols. Inc. v. VGH Sols., Inc., 888 F.3d 1256, 1260 (Fed. Cir.
2018) (cleaned up). The burden is on the moving party to prove that no legally cognizable claim
for relief exists.2
When considering a motion to dismiss under Rule 12(b)(6), courts generally must ignore
materials outside the pleadings, but they may consider “some materials that are part of the public
record or do not contradict the complaint,” as well as materials that are “necessarily embraced by
the pleadings.” Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079 (8th Cir. 1999) (citation
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Direct Patent Infringement Claim
Plaintiffs plead a single patent infringement claim in violation of 35 U.S.C. § 271(a) against
Aldevron. The statute states, in part: “[W]hoever without authority makes, uses, offers to sell, or
sells any patented invention, within the United States or imports into the United States any patented
invention during the term of the patent therefor, infringes the patent.” 35 U.S.C. § 271(a).
Aldevron primarily argues that the Complaint does not provide enough facts to determine
what products allegedly infringe on the ’435 Patent or how any allegedly infringing product
corresponds to the claims of the ’435 Patent. The Court disagrees.
At this stage of the litigation, the sole question before the Court is whether Plaintiffs have
pleaded a plausible direct patent infringement claim against Aldevron. Accepting as true the
allegations in the Complaint, Plaintiffs have provided sufficient facts to put Aldevron on notice of
what products are alleged to be directly infringing on the ’435 Patent. Aldevron argues Plaintiffs
must identify the specific products that directly infringed on the ’435 Patent.
“[plaintiffs] need not prove [their] case at the pleading stage.” Nalco Co. v. Chem-Mod, LLC, 883
F.3d 1337, 1350 (Fed. Cir. 2018) (cleaned up). “The complaint must place the ‘potential infringer
. . . on notice of what activity . . . is being accused of infringement.’” Id. (quoting K-Tech
Telecomms. v. Time Warner Cable, Inc., 714 F.3d 1277, 1284 (Fed. Cir. 2013)).
In this case, K-Tech Telecommunications v. Time Warner Cable and Disc Disease
Solutions, Inc. v. VGH Solutions, Inc., 888 F.3d 1256 (Fed. Cir. 2018) are instructive. First, in KTech, the complaint identified K-Tech’s patents and its patent-protected material, which consisted
and internal quotation marks omitted). Both parties filed affidavits and documents in support of
their respective briefs. The Court finds the affidavits and documents are not “embraced by the
pleadings,” and as such, the Court will not consider the documents in deciding the Rule 12(b)(6)
motion to dismiss.
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of particular identifying systems and methods for modifying major or minor television channel
numbers to identify a television program. 714 F.3d at 1284. In its complaint against Time Warner
Cable, K-Tech alleged Time Warner Cable and DirecTV infringed on K-Tech’s patents by
“making, selling, and offering to sell, in this judicial district, systems and methods for modifying
a major channel number, a minor channel number, and/or a carrier frequency to identify a
television program[.]” Id. The district court granted Time Warner Cable’s motion to dismiss for
failure to state a claim upon which relief can be granted, but the Ninth Circuit reversed. Id.
Although K-Tech was decided by the Federal Circuit under the now-abrogated Form 18
pleading standard, the rationale explained by the court in reaching its decision holds true here and
is helpful in applying the Iqbal and Twombly plausibility standard. The Federal Circuit ultimately
concluded K-Tech had met the direct infringement pleading standard because “DirectTV and TWC
know what K-Tech’s patents claim, and they know what K-Tech asserts their systems do, and why.
K-Tech has alleged that DirecTV and TWC must and do modify or ‘translate’ digital signals they
receive, and it has alleged that they do so using K-Tech’s methods and systems.” Id. at 1287.
So too here. Aldevron knows what Plaintiffs’ patent claims; Aldevron also knows what
third party-client plasmid material it produced that Plaintiffs claim infringes on the ’435 Patent
and why. Plaintiffs have alleged that Aldevron, after having access to Plaintiffs ’435 Patented
Biotechnology, produced the same ’435 Patented Biotechnology for four third parties. Accepting
as true the allegations in the Complaint, that is enough to state a plausible claim for direct patent
Additionally, and contrary to Aldevron’s arguments, Plaintiffs need not so specifically
identify the infringing products. To do so would essentially require proof of direct infringement
at the pleading stage, which is not required under Iqbal and Twombly. See Nalco Co., 883 F.3d
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at 1350 (citations omitted) (noting a plaintiff need not “prove [their] case at the pleading stage.”).
Moreover, as well-explained by the Federal Circuit in K-Tech:
That K–Tech cannot point to the specific device or product within TWC’s or
DirecTV’s systems that translates the digital television signals each receives—
especially when the operation of those systems is not ascertainable without
discovery—should not bar K–Tech’s filing of a complaint. A defendant cannot
shield itself from a complaint for direct infringement by operating in such secrecy
that the filing of a complaint itself is impossible.
Id. at 1286. The same is true in this case. Plaintiffs need not provide specific product names or
lot numbers they certainly cannot obtain without discovery, and that concern remains despite the
abrogation of Form 18. See Air Dynamics Industrial Systems, Inc. v. Lehman, No. 1:19-cv-2073,
2020 WL 6544966, at *6 (M.D. Penn. Nov. 6, 2020) (citing K-Tech and explaining, “We are not
troubled that Air Dynamics is, at this juncture, unable to identify by name or description one of
defendants’ specific products or features that is allegedly infringing its patents. The parties operate
in an industry in which competing products are not available to the general public. The mere
inability of Air Dynamics to purchase, analyze, and identify one of defendants’ products before
filing suit does not, by itself, bar them from filing suit altogether.”). Plaintiffs have alleged four
clients they believe Aldevron produced plasmid product for that contained the ’435 Patented
Biotechnology. Indeed, Aldevron should be able to verify through discovery whether the plasmid
material produced for those four clients did or did not contain the ’435 Patented Biotechnology.
Even beyond K-Tech, Disc Disease and Air Dynamics further support the Court’s
conclusion. As the Federal Circuit explained in Disc Disease, where the court also applied the
Twombly and Iqbal standard, a plaintiff “need only give the defendant fair notice of what the . . .
claim is and the grounds upon which it rests.” The Complaint does that here – it provides Aldevron
fair notice of what the claim is and the ground upon which it rests. At its most basic, and accepting
as true the allegations in the Complaint, Plaintiffs provided Aldevron with access to its patent9
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protected plasmid material. After doing so, Plaintiffs discovered Aldevron began producing
similar patent-protected plasmid material for third parties. Plaintiffs identify the third parties for
Aldevron and what plasmid material they believe infringes on the ’435 Patent, including which
independent claims of the patent the material infringes on. That provides sufficient factual detail
to plausibly plead a patent infringement claim and to provide Aldevron fair notice of the claim and
the grounds upon which it rests. See Air Dynamics, 2020 WL 6544966, at *6 (“Plaintiffs will . . .
survive the Rule 12 stage so long as they offer enough information to put defendants on ‘fair notice
of infringement of the asserted patents.’”).
Construing the Complaint in the light most favorable to Plaintiffs and drawing all
reasonable inferences in their favor, Plaintiffs’ Complaint contains sufficient factual matter,
accepted as true, to state a direct patent infringement claim that is plausible on its face. Iqbal, 556
U.S. at 678. Plaintiffs have shown that success on the merits is more than a “sheer possibility.”
Id. Thus, after applying the Iqbal and Twombly standard, Plaintiffs have stated a plausible direct
patent infringement claim, and the Court denies Aldevron’s motion to dismiss under Federal Rule
of Civil Procedure 12(b)(6).
Failure to State a Claim for Indirect Patent Infringement
Aldevron also challenges Plaintiffs’ claim for indirect infringement. The Complaint
mentions indirect infringement solely in its prayer for relief. Doc. No. 1, ¶ B. Plaintiffs are
agreeable to striking the “or indirectly” language from the Complaint pursuant to Federal Rule of
Civil Procedure 12(f), subject to reserving their right to amend the Complaint should discovery
reveal indirect infringement. Given the parties agreement on this issue, the Court will strike the
words “or indirectly” from the Complaint pursuant to Federal Rule of Civil Procedure 12(f). This
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does not prevent Plaintiffs from exercising their right to amend the Complaint should discovery
reveal the need to do so.
More Definite Statement
In the alternative, Aldevron moves for a more definitive statement under Federal Rule of
Civil Procedure 12(e). Rule 12(e) states:
A party may move for a more definite statement of a pleading to which a responsive
pleading is allowed but which is so vague or ambiguous that the party cannot
reasonably prepare a response. The motion must be made before filing a responsive
pleading and must point out the defects complained of and the details desired. If
the court orders a more definite statement and the order is not obeyed within 14
days after notice of the order or within the time the court sets, the court may strike
the pleading or issue any other appropriate order.
Fed. R. Civ. P. 12(e).
Given the Court’s analysis above, Plaintiffs’ Complaint is not “so vague or ambiguous”
that Aldevron cannot reasonably prepare a response. Indeed, Plaintiffs identify the four clients it
believes Aldevron produced patent-infringing material for. Aldevron knows what the ’435 patent
claims, it knows what products Plaintiffs allege infringe and why. That is not “so vague or
ambiguous” as to warrant a more definite statement under Rule 12(e).
Motions for Hearing
Aldevron and Plaintiffs requested oral argument on Aldevron’s instant motion to dismiss.
Doc. Nos. 17, 32. However, the Court finds that the issues have been well briefed, and there is no
need for oral argument. Thus, the Court denies the motions for hearing.
For the reasons discussed above, Aldevron’s “Motion to Dismiss Under Rule (12)(b)(6)
and/or for a More Definite Statement Under Rule 12(e)” (Doc. No. 18) is DENIED in part and
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GRANTED in part. Aldevron’s Motion for Hearing (Doc. No. 17) and Plaintiffs’ Motion for
Hearing (Doc. No. 32) are DENIED.
IT IS SO ORDERED.
Dated this 16th day of February, 2021.
/s/ Peter D. Welte
Peter D. Welte, Chief Judge
United States District Court
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