MRNA IP 2022 Year In Review: Pioneers Clash In Major Patent Litigations – Patent

Substantial patent litigation activity occurred in the mRNA
space in 2022, involving nearly all of the major mRNA and lipid
nanoparticle (LNP) pioneers. Since this is the most significant
happening in this space with respect to IP in 2022, this post will
provide an overview of that activity as well as a summary exposure
analysis. 

Summary of 2022 Litigation Activity

On February 28, lipid pioneer Arbutus and its
exclusive licensee Genevant sued mRNA pioneer Moderna in the U.S.
District Court for the District of Delaware. The 
complaint contains allegations that Moderna infringed U.S.
Patent Nos. 
8,058,069, 
8,492,359, 
8,822,668, 
9,364,435, 
9,504,651, and 
11,141,378 through, inter alia,
Moderna’s sales of its Spikevax® vaccine product. The key
patents-in-suit relate to four-lipid delivery systems designed
to 
protect fragile mRNA “payloads” post-injection
and release them once inside a recipient’s cells. Moderna moved
to dismiss certain claims relating to Spikevax® made and sold
to the U.S. government (the motion was based on 28 U.S.C.
§ 1498, which requires patent-holders to seek redress from
the U.S. government in the U.S. Court of Federal Claims whenever an
invention covered its patent “is used or manufactured by or
for the United States without a license”). The court denied
the motion, Moderna answered the complaint on November 30, and
discovery has not yet commenced.

On March 17, lipid and SiRNA pioneer Alnylam
sued Moderna and Pfizer separately in the District of Delaware. The
respective complaints contain allegations that of 
Moderna and 
Pfizer each infringed U.S. Patent No. 
11,246,933 by using Alnylam’s claimed cationic lipids
in their vaccine products. On July 12, 2022, Alnylam filed new
separate suits against Moderna and Pfizer (and
this time including Pfizer’s collaborator and mRNA pioneer
BioNTech) also in the District of Delaware, for infringement of
U.S. Patent No. 
11,382,979, which issued the same day the suit was filed and
has claims directed to lipid nanoparticles and related methods of
preparation. The March and July Moderna and Pfizer/BioNTech cases
were each separately consolidated and discovery has commenced in
each case. Similar to the Arbutus case, in the Alnylam v.
Moderna case, Moderna moved to dismiss certain claims
under 28 U.S.C. § 1498 but the court has not ruled on that
motion to date.

On March 18, a day after the initial Alnylam
lawsuits were filed, lipid pioneer Acuitas 
sued Arbutus and Genevant in the U.S. District Court for
the Southern District of New York seeking a declaratory judgment
that the BioNTech and Pfizer vaccine product Comirnaty® does
not infringe the six Arbutus patents asserted in the Moderna case
plus three other Arbutus-owned patents directed to LNPs (U.S.
Patent Nos. 
9,006,417, 
9,404,127, and 
9,518,272) and that the subject Arbutus patents are invalid.
Acuitas alleged that Comirnaty® contains “the lipids
and lipid nanoparticles innovated by Acuitas” that are
grounded in certain LNP-based collaborations between Acuitas and
BioNTech and Pfizer. Since Acuitas has itself apparently not been
accused of infringement and does not sell the Comirnaty®
product, one of the key early issues in this case is whether
Acuitas has standing to sue. Arbutus and Genevant have moved to
dismiss on these grounds; that motion is pending and discovery has
not yet commenced.

Several months later, on July 7, mRNA
pioneer CureVac 
sued BioNTech (but not Pfizer) in the Regional Court of
Düsseldorf Germany for infringement of one European Patent (
EP1857122B1) and three German patents (DE202015009961U1, 
DE202021003575U1, and 
DE202015009974U1). CureVac has alleged that its patent
portfolio “protects multiple inventions that are considered
essential to the design and development of” Comirnaty®
“including sequence modifications to increase stability and
enhance protein expression, as well as mRNA vaccine formulations
specific to SARS CoV-2 vaccines.”

Within weeks of CureVac’s suit in Germany, on
July 25, BioNTech and Pfizer sued CureVac
in the U.S. District Court for the District of Massachusetts for a
declaratory judgment that the companies do not infringe
CureVac’s U.S. Patent Nos. 
11,241,493 (mRNA composition with certain lipid
structures), 
11,135,312 (method for producing a stabilized mRNA
molecule), and 
11,149,278 (method for treating/preventing infectious
disease by administering a specific RNA molecule).
Later, around September, Pfizer and
BioNTech 
reportedly filed proceedings in the High Court of England
and Wales, seeking judgment that their COVID-19 vaccine does not
infringe certain of CureVac’s European patents. In the U.S.
case, discovery has not yet commenced and CureVac has moved to
dismiss or transfer the case to the U.S. District Court for the
Eastern District of Virginia, which Pfizer and BioNTech oppose.
That motion is pending.

Finally, on August 26, Moderna 
sued Pfizer and BioNTech in the District of Massachusetts
for infringement of U.S. Patent Nos. 
10,898,574, (lipid nanoparticle and related method of producing
a polypeptide), 
10,702,600 (mRNA encoding a betacoronavirus S protein
formulated in a lipid nanoparticle), and 
10,933,127 (method of administering mRNA formulated in a
lipid nanoparticle). Moderna indicated it also filed
infringement 
lawsuits against Pfizer and BioNTech that same day in the
Regional Court of Düsseldorf Germany. Moderna’s CEO,
Stéphane Bancel, stated “[w]e are filing these lawsuits
to protect the innovative mRNA technology platform that we
pioneered, invested billions of dollars in creating, and patented
during the decade preceding the COVID-19 pandemic.” In the
U.S. case, Pfizer and BioNTech answered the complaint on December
5, and discovery has not yet commenced.

Summary Exposure Analysis

Importantly, none of the parties that have alleged infringement
are seeking an injunction to stop the sales of Spikevax® or
Comirnaty®. Instead, all such plaintiffs seek monetary damages
based on the sales of those products, which will 
reportedly total over a combined $100 billion globally by
the end of 2022.

Under 35 U.S.C.
§284, a patent-holder may obtain damages “in no event
less than a reasonable royalty” for the subject infringement.
A patent-holder may also obtain compensatory damages in the form of
“lost profits” in situations where it can prove (1) there
is a demand for the patented product, (2) the absence of acceptable
non-infringing alternatives, (3) it had the manufacturing and
marketing capacity to exploit demand for the product, and (4) the
amount of profit it should have made but-for the accused
product. Mentor Graphics Corp. v. EVE-USA,
Inc.,  851 F.3d 1275, 1284-85 (Fed. Cir. 2017) (reciting
the Panduit factors).

With respect to the suits against Moderna, none of Arbutus,
Genevant or Alnylam have alleged lost profit damages. That makes
sense, because it would be difficult for them do so (e.g., none
sells products that compete with Spikevax®). Accordingly, the
potential exposure Moderna faces in the present cases is primarily
at least a “reasonable royalty” applied against
Spikevax® sales, which may be enhanced if Arbutus and Genevant
are successful in their willful infringement
claims. See, e.g., SRI
Int’l. v. Cisco Sys., Inc., 14 F.4th 1323, 1330 (Fed. Cir.
2021) (stating that the showing of “deliberate or intentional
infringement” could establish willful infringement and form
the basis of enhanced damages).

Significantly, not all Spikevax® sales may be implicated in
the damages calculation since, for example, (1) the law surrounding
the availability of reasonable royalty damages awards for
infringement under 35 U.S.C. §271 based on extraterritorial
sales is unclear and it is possible that some foreign sales may not
apply to the subject damage calculation; and (2) Spikevax®
sales made to the U.S. government may not be included in the
damages calculation on the basis of 28 U.S.C. § 1498
(referenced above).

For similar reasons, Pfizer and BioNTech are also subject to
potential exposure from the Alnylam and CureVac suits in the form
of reasonable royalties on sales of Comirnaty®. With respect to
lost profits, (1) Alnylam is similarly situated in the
Pfizer/BioNTech case as in the Moderna case in that it does not
sell competing products; and (2) while CureVac is an mRNA pioneer
that has a deep pipeline, it does not have a competing COVID-19
vaccine on the market to date, and it would therefore not have a
strong lost profits case in the U.S. courts. At this time Alnylam
has not alleged willful infringement against Pfizer or BioNTech, or
for that matter, Moderna. CureVac has not yet answered the Pfizer
or BioNTech complaint in the District of Massachusetts and may have
opportunity to claim willfulness in such a pleading if it has a
basis to do so.

It is possible that Pfizer and BioNTech will also be sued by
Arbutus and Genevant which, according to the Acuitas 
complaint, have already sent “demand” letters to
Pfizer in 2020 and 2021. The declaratory judgment lawsuit filed by
Acuitas may therefore have been a preemptive attack by the Pfizer
partner and alleged developer of Comirnaty® LNPs. Perhaps if
the Acuitas suit survives the pending motion to dismiss for lack of
standing, Arbutus and Genevant will add infringement counterclaims
against Pfizer and BioNTech, bringing them into that suit. Or, if
Arbutus and Genevant are successful with their motion to dismiss,
they may file a separate patent infringement lawsuit against Pfizer
and BioNTech. It is also possible, of course, that no suit is filed
against Pfizer or BioNTech and that the parties resolve any
disputes without the need for litigation.

Returning to Moderna, its suit against Pfizer and BioNTech is
interesting for a number of reasons. First, Moderna is 
seeking “compensatory damages, including reasonable
royalties and/or lost profit
damages.” See, e.g.,
Complaint, ¶119 (emphasis added). Moderna is also seeking
damages for willful infringement, which could form the basis for
enhanced damages. Id. at ¶118. Moderna has
also 
stated that it “is not seeking damages related to
Pfizer’s sales to AMC 92 [low- and middle-income countries]
countries and is not seeking damages for Pfizer’s sales where
the U.S. Government would be responsible for any damages.
Consistent with Moderna’s 
patent pledge, the Company is also not seeking damages for
activities occurring before March 8, 2022.” See
also Complaint at Page 38 (Prayer for Relief).

Even with these potential limitations, the fact that Moderna is
seeking lost profits increases its leverage since a damages case
based on lost profits could possibly amount to a significantly
higher damages total than a total based solely on reasonable
royalties (e.g., if Moderna can show large totals of sales of
Spikevax® it should have made but for Pfizer’s sales of
Comirnaty®). Accordingly, filing this lawsuit and seeking
significant damages accomplishes at least two major things for
Moderna. First, from an exposure management perspective, it may
serve to mitigate the damages exposure caused by the Alnylam and
Arbutus cases. Second, it applies even more pressure on Pfizer and
BioNTech, Moderna’s direct competitors in at least the COVID-19
vaccine space, adding to the potential exposure those parties face
under three major patent infringement lawsuits, and potentially
four, should Arbutus and Genevant assert infringement claims also.
 Sometimes, a competitor that is sued for patent infringement
by another competitor will assert applicable patent infringement
counterclaims from its own portfolio to increase exposure to the
party that filed the lawsuit, but that did not happen here. Neither
BioNTech nor Pfizer have asserted any patent infringement
counterclaims against Moderna to date.

By asserting their patents, lipid pioneers Alnylam, Arbutus and
Genevant could gain (1) substantial damages awards based on
royalties applied to massive vaccine sales should infringement be
found; or (2) significant settlement revenues. These parties also
run the risk of having their patents invalidated through the
subject lawsuits or cancelled through IPR proceedings. This may not
be as much of an issue for Alnylam, which is asserting patent
claims that it applied for and was granted after it was able to
learn about the configuration of the Spikevax® and
Comirnaty® vaccines (and therefore the subject patents may not
be directly applicable to Alnylam’s commercial operation).
However, with respect to Arbutus and Genevant, should one or more
of the key Arbutus patents become invalidated in connection with
the Moderna or Acuitas cases (or other cases Arbutus and Genevant
may file), this would eliminate the ability for those entities to
leverage licensing revenues under those patents going
forward.  Of course, in their cases, Moderna and CureVac also
run the risk of having their asserted patents invalidated, and the
upside of those cases is the potential to obtain a favorable
damages awards or settlements as well.

Expect More Litigation Activity

In 2022, nearly every major mRNA and lipid nanoparticle pioneer
clashed in significant patent litigation activity. All of those
cases related, in some way, to the sales of Spikevax® or
Comirnaty® and related boosters—the only mRNA-based
products generating revenue at this time.  Moderna has
potential exposure (in the form of reasonable royalty damages) from
the lawsuits filed against it by Alnylam, and Arbutus and Genevant,
while Pfizer and BioNTech have potential exposure from lawsuits
filed by Alnylam, CureVac, and Moderna in the form of reasonable
royalty damages (in the Moderna case, lost profit damages also).
These cases will likely persist through 2023 absent any
settlements, and other suits may be filed in the coming year as
innovators assess their patent portfolios and assert patent rights
against existing and future mRNA-based products approved for
commercialization. 

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