20-6 Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GSK

U.S. DEPARTMENT OF JUSTICE
Antitrust Division
MAKAN DELRAHIM

Assistant Attorney General

Main Justice Building
950 Pennsylvania Avenue, N.W.
Washington, D.C. 20530-0001
(202) 514-2401 / (202) 616-2645 (Fax)

July 23, 2020
By Electronic Mail

Thomas O. Barnett
Covington & Burling
One CityCenter
850 Tenth Street, NW
Washington, DC 20001-4956
tbarnett@cov.com
RE: Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and
GSK Expedited Business Review Request Pursuant to COVID-19 Expedited Procedure
Dear Mr. Barnett:
This letter responds to your request, on behalf of Eli Lilly and Company, AbCellera
Biologics, Amgen, AstraZeneca, Genentech, and GSK (“the Requesting Parties”), for the
issuance of a business review letter under the Department of Justice’s Business Review
Procedure, 28 C.F.R. §50.6. Specifically, the Department understands that your request is made
under the expedited, temporary review procedure as detailed in the Joint Antitrust Statement
Regarding COVID-19 dated March 2020 (“Joint Statement”).
1
You have requested a statement
of the Department’s current antitrust enforcement intentions with respect to the Requesting
Parties’ efforts to exchange limited information about the manufacture of monoclonal antibodies
that may be developed to treat COVID-19 (“Proposed Conduct”).
2
Based on the representations
1
Dep’t of Justice & Fed. Trade Comm., Joint Antitrust Statement Regarding COVID-19 (Mar. 2020),
https://www.justice.gov/atr/joint-antitrust-statement-regarding-covid-19 [hereinafter Joint Statement].

2
Letter from Thomas O. Barnett, Covington, James Ford, GSK, Jonathan Graham, Amgen, Anat Hakim, Eli Lilly,
Sean Johnston, Genentech, Jeff Pott, AstraZeneca, and Tryn Stimart, AbCellera Biologics, to Makan Delrahim,
Ass’t Att’y Gen., Antitrust Div., U.S. Dep’t of Justice (July 15, 2020) [hereinafter Request Letter] at 1. The
Department understands that some aspects of the proposed conduct already have been underway to begin to
facilitate scale up for the manufacture of monoclonal antibodies that may treat COVID-19 patients. Although the
Department typically does not review ongoing conduct, given the President’s declaration of a national emergency
and the current exigencies, we have determined that, in these circumstances, it is appropriate to consider the request.

Letter to Thomas O. Barnett
July 23, 2020
Page 2
you provided and after an expedited review, the Department presently does not intend to
challenge the Proposed Conduct, as it is described in this letter.
Pursuant to the Joint Statement, the Department’s statement of its current enforcement
intentions as set out in this letter will be in effect for one year from the date of this letter. The
Parties may subsequently ask the Department to reiterate its current enforcement intentions using
this expedited, temporary procedure if more time is necessary or additional collaboration is
needed to make these critical treatments available to patients during this unprecedented COVID-
19 pandemic.
I. Background
This request arises in the context of a pandemic caused by a novel coronavirus that
threatens the health, safety, and security of millions of Americans. President Donald J. Trump
recognized as much by declaring a national emergency on March 13, 2020.
3
Major disasters
were declared in all 50 states, the District of Columbia, and several territories. Moreover, as the
Division previously recognized, “[m]easures to mitigate the spread of COVID-19 . . . have taken
a dramatic toll on the United States economy.”
4
Although states have gradually begun reopening
with different health and safety measures, the pandemic continues to pose significant risks for
Americans across the country.
Diagnostics, treatments, and vaccines are critical for mitigating the effects of this
pandemic. Through an initiative called Operation Warp Speed, the federal government is
working to accelerate and support the development, manufacture, and distribution of these
therapeutic tools.
5
Treatments and vaccines incorporating monoclonal antibodies (or “mAbs”)—
copies of naturally occurring proteins that can directly target viruses and other pathogens—are a
particularly promising option being pursued by Operation Warp Speed and the pharmaceutical
industry generally.
6
3
Proclamation No. 9994, 85 Fed. Reg. 15,337 (Mar. 13, 2020); see also Letter from President Trump to Chad Wolf,
Acting Sec’y, Dep’t of Homeland Sec., Steven Mnuchin, Sec’y, Dep’t of Treasury, Alex Azar II, Sec’y, Dep’t of
Health and Human S ervs., and Pete Gaynor, Admin’r, Fed. Emergency Mgmt. Agency (Mar. 13, 2020),
https://www.whitehouse.gov/wp-content/uploads/2020/03/LetterFromThePresident.pdf.

4
Letter from the Honorable Makan Delrahim, Assistant Attorney General for Antitrust, U.S. Dep’t of Justice to
Martin M. Toto, National Pork Producers Council (May 15, 2020) at 2 (quoting Exec. Order No. 13,1917, 85 Fed.
Reg. 26, 313 (April 28, 2020)) (internal quotations omitted).

5

Dep’t

of Health and Human Serv’s, Trump Administration Announces Framework and Leadership for ‘Operation
Warp Speed’, (May 15, 2020),

https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-
framework-and-leadership-for-operation-warp-speed.html.

6

Hearings on Operation Warp Speed: Researching, Manufacturing, & Distributing a Safe & Effective Coronavirus

Vaccine Before the Subcomm. on Labor, Health and Human S

erv’s., Educ., and Related Agencies, 116th Cong. at 6
(July 2, 2020) (statement of

Hon. Francis

S. Collins, Dir. of

the Nat’l Insts. of Health); Dr. Anthony

Fauci, Dir.

of
the Nat’l Inst.

of

Allergy and Infectious

Diseases, Remarks at Stanford Medical School (July 14, 2020),

http://med.stanford.edu/news/all-news/2020/07/anthony-fauci-in-conversation-with-lloyd-minor.html; see

also
Dep’t of Health and Human

Serv’s,

HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing

Letter to Thomas O. Barnett
July 23, 2020
Page 3
Producing mAbs involves several steps.
7
First, a cell line that produces the desired
antibody has to be identified and cultivated. This cell line is then grown into larger and larger
containers and, ultimately, into steel bioreactors (ranging from 5,000L to 20,000L in size). In
these bioreactors, the cells consume nutrients, multiply, and produce antibodies. Eventually, this
mixture is harvested from the bioreactor and purified to remove other cells, impurities, or
contaminants. The remaining antibodies are then formulated into an injectable drug.
8
Once
injected, the antibodies can help a patient’s immune system identify and destroy a specific virus,
e.g., the novel coronavirus.
There are a limited number of facilities in the world that can carry out this process at
industrial scale.
9
Moreover, calibrating existing facilities to produce a particular monoclonal
antibody can take several months.
10
Companies therefore “typically wait until a drug or vaccine
is in the advanced stages of testing, and looks like it will succeed,” before beginning this effort.
11
The Requesting Parties have indicated that undertaking the development and calibration in
parallel may accelerate and ultimately expand the production of mAb therapeutics once they
prove effective against COVID-19.
II. The Requesting Parties’ Proposed Information Exchange
The Requesting Parties are pharmaceutical companies engaged in the research,
development, and manufacture of biologic products, including mAbs, which target a wide array
of diseases, including asthma, cardiovascular, neurological, oncological, and rheumatic
Demonstration Project of COVID-19 Investigational Therapeutic Treatment, (July 7, 2020),
https://www.hhs.gov/about/news/2020/07/07/hhs-dod-collaborate-regeneron-large-scale-manufacturing-
demonstration-project-covid-19-investigational-therapeutic-treatment.html.

7
The process described here is provided only as a summary of how the process typically takes place. In m any cases,
the process varies by manufacturer, cell line, and other factors. See also Isha Sharma, et al, COVID-19
Manufacturing for Monoclonal Antibodies, Duke Univ. Margolis Center for Health Policy ( June 2020),
https://healthpolicy.duke.edu/sites/default/files/2020-06/Issue%20Brief%20-%20COVID-
19%20Manufacturing%20of%20Monoclonal%20Antibodies_0.pdf [hereinafter Duke Study] (providing an overview
of the manufacturing process).

8

The amount of antibodies included in a particular dose varies depending on a variety of factors. Early

evidence
suggests,

however, that

monoclonal antibody treatments

for COVID-19 may require a significant amount of

antibodies to be effective. This

would further strain production capacity.

9

See, e.g., Duke Study at 3; Carolyn Y. Johnson,

Operation Warp Speed is pushing for covid-19 therapeutics by

early fall, Washington Post (July 13, 2020),

https://www.washingtonpost.com/health/2020/07/13/operation-warp-
speed-is-pushing-covid-19-therapeutics-by-early-fall/

[h ereinafter Johnson, OWS (July 13, 2020)].

10

Request

Letter at 2.

11

Id.

Letter to Thomas O. Barnett
July 23, 2020
Page 4
conditions. Some of the Requesting Parties compete with each other to provide biologics for the
same condition, such as asthma, cervical cancer, and leukemia.
12
The Requesting Parties are currently independently developing monoclonal antibody
agents that may be used to treat COVID-19 and planning for mass production of safe and
effective mAb therapeutics.
13
The extraordinary circumstances of the COVID-19 pandemic have
necessitated that the Requesting Parties ramp-up their production capacity much earlier in the
research and development process.
14
The Requesting Parties point out that one recent article
noted, “[i]n a pandemic, [manufacturers] can’t wait to start making [their] investment in the
manufacturing until [they’re] sure [they] have a product. . . . To be ready to make large volumes
of the products, companies must begin preparing their plants now. They need to secure supply
chains for key ingredients[,] install new equipment, and find contract manufacturers who can
help.”
15
Additionally, the demand for whichever mAb treatments ultimately prove effective will
likely dwarf the capacity available to any one manufacturer. One recent report estimated that in
2019 “approximately 53 million standard units (i.e., doses) of mAbs were sold . . . in the United
States, many of which treat severe illnesses that address otherwise unmet medical needs.”
16
The
report then estimates that the “lower bound for . . . the true demand” for a COVID-19 mAb
treatment is over 25 million doses, in other words, nearly half of all mAb treatments
administered annually in the nation.
17
Even if a pharmaceutical company chose to devote all of
its capacity to COVID-19 mAB treatments, this lower bound estimate of demand is still more
than any one manufacturer could produce.
Given the need for expedited production of any approved COVID-19 mAb treatments
and capacity constraints facing the industry, the Requesting Parties propose to exchange
information regarding “manufacturing facilities, raw materials, and supplies that could be used to
produce COVID-19 mAb treatments, specifically global capacity that has been reserved
internally or through third parties for the potential production of COVID-19 mAb treatments.”
18
12
All facts set forth in this letter regarding the Requesting Parties, background, and the Proposed Conduct are based
on the Requesting Parties’ representations to the Department, our limited investigation, and publicly available
sources.

13
Eli Lilly and AbCellera are collaborating on the development of an effective monoclonal antibody to treat
COVID-19 that is beyond the scope of this review. See AbCellera and Lilly to Co-develop Antibody Therapies for
the Treatment of COVID-19 (Mar. 12, 2020), https://investor.lilly.com/news-releases/news-release-details/abcellera-
and-lilly-co-develop-antibody-therapies-treatment.

14

Request

Letter at 2-3.

15

Request

Letter at 2

(quoting

Peter Loftus

& Joseph Walker,

Drugmakers Scale Up for Virus Treatments, Wall St.

J. (Apr. 24, 2020)) (internal quotations omitted).

16

Duke

Study at 1.

17

Id. at 2.

18

Request

Letter at 3.

Letter to Thomas O. Barnett
July 23, 2020
Page 5
The Requesting Parties intend, by exchanging such information, to “identify ways to expand
production of any approved treatments beyond the level that each could achieve on its own.”
19
Exchanging this information before regulatory approval of the COVID-19 mAbs would allow the
Requesting Parties to “reduce the lead time” necessary to prepare their facilities for production of
these treatments.
20
In short, exchanging this information is intended to bring more COVID-19
mAb treatments to the market and in a shorter timeframe.
Specifically, the Requesting Parties foresee that they may need to exchange the following
relevant categories of information to accomplish this objective:
• Technical details regarding a company’s relevant manufacturing facilities,
including total potential capacity [ that it would consider making a vailable
for COVID-19 mAbs
21
], technical specifications (such as the type of
bioreactors), time period(s) during w hich the facilities would be available,
and whether the facility is owned by the company or by a third party.

• Technical information regarding a company’s manufacturing
processes/platforms and/or the manufacturing processes/platforms of their
contract manufacturers or their other manufacturing partners.
• Information regarding the source and amount of available raw materials
and supplies that are necessary for the manufacture of COVID-19 mAb
treatments. For purposes of clarity, the Parties would not exchange any
information regarding prices or commercial terms of any arrangements for
raw materials and supplies.
22

In sum, the Requesting Parties propose to share information to expedite and increase the
production of COVID-19 mAb treatments. The information to be exchanged is largely technical
and will not encompass competitively sensitive information about production costs or treatment
prices. The Requesting Parties have also committed to several safeguards, described below,
including limiting the scope and duration of the Proposed Conduct to meet the demand for
COVID-19 mAbs required to respond to the unprecedented COVID-19 pandemic and its
aftermath.
23
19
Id.

20
Id. at 4.

21
As explained below, based on the Requesting Parties’ representations and Request Letter, we understand that they
are proposing to share only the “total potential capacity” that each company would consider making available for the
production of COVID-19 mAbs.

22

Request

Letter at

4.

23

Id. at 4–5.

Letter to Thomas O. Barnett
July 23, 2020
Page 6
III. Legal Analysis
A. Benefits and Harms of Competitive Collaborations and Information Exchanges
The Department has long recognized that “[a] competitor collaboration may enable firms
to offer goods or services that are cheaper, more valuable to consumers, or brought to market
faster than would otherwise be possible.”
24
Collaborations involving information sharing can be
procompetitive and necessary to generating efficiencies.
25
For example, the DOJ-FTC
Collaboration Guidelines explain that participants in a collaboration may combine “know-
how . . . to enable the collaboration to produce a good more efficiently or to produce a good no
one participant could alone produce.”
26
At the same time, information exchanges among
competitors may allow competitors to collude or to tacitly coordinate on price or output in a
manner that harms competition.
27
“Collusion may involve the relevant market in which the
collaboration operates,” here in the manufacturing of COVID-19 mAbs, “or another market in
which the participants in the collaboration are actual or potential competitors,” i.e., in the
development and sale of mAbs for other conditions.
28
The Department concludes that the
Proposed Conduct is unlikely to result in collusion or harm competition in either market, and that
it is likely to generate significant efficiencies.
29
B. The Proposed Information Exchange
The Requesting Parties represent that knowledge about manufacturing facilities,
production capacity, and raw materials will help them scale up manufacturing capability so they
24
U.S. Dep’t of Justice & Fed. Trade Comm’n, Antitrust Guidelines for Collaborations Among Competitors § 3.36
(2000) [hereinafter DOJ-FTC Collaboration Guidelines], https://www.justice.gov/atr/page/file/1098461/download.

25
See United States v. U.S. Gypsum Co., 438 U.S. 422, 441 n.16 (1978) (recognizing information exchanges may
create efficiencies); Maple Flooring Mfrs’ Ass’n v. United States, 268 U.S. 563, 582–83 (1925) (“Competition does
not become less free merely because the conduct of commercial operations becomes more intelligent through the
free distribution of knowledge of all the essential factors entering into the commercial transaction.”); DOJ-FTC
Collaboration Guidelines § 3.31(b) (“[T]he sharing of information among competitors may be procompetitive and is
often reasonably necessary to achieve the procompetitive benefits of certain collaborations.”).

26
DOJ-FTC Collaboration Guidelines § 3.31(a).

27
Id. § 2.2; Phillip Areeda & Herbert Hovenkamp, Antitrust Law: An Analysis of Antitrust Principles and Their
Application, Areeda § 2111c (updated 2020
); see also

Letter from Christine Varney,

Ass’t Att’y

Gen., Antitrust
Div., U.S. Dep’t Justice, to Mit Spears, Ropes & Gray (2010),

https://www.justice.gov/atr/response-pacific-
business-group-healths-request-business-review-letter

(“The central inquiry in analyzing a data sharing arrangement

is

whether it is

likely to facilitate express or tacit collusion resulting in increased prices or reduced quantity or

quality, or otherwise reduce competition among the recipients of the data.”)

28

DOJ-FTC Collaboration Guidelines §

2.2.

29

In light of the considerable efficiencies involved, the Department reviews

this information

exchange under the
rule of reason.

See id.

§§

1.2, 3.3.

Letter to Thomas O. Barnett
July 23, 2020
Page 7
can “move quickly” when safe and effective COVID-19 mAbs are approved.
30
The Department
finds that exchanging this information in this context is unlikely to harm competition because the
likely result is that the information exchange will expand output of these critical treatments.
Furthermore, we conclude that the information exchange is unlikely to result in collusion in the
markets for COVID-19 mAb treatments, or for mAb treatments for other conditions, such as
cancer or rheumatoid arthritis, in which the parties may compete. In addition, the Requesting
Parties have agreed to certain safeguards that will mitigate concerns regarding the potential for
anticompetitive effects. Finally, the Proposed Conduct is unlikely to lessen incentives to invest
or develop critical COVID-19 mAbs.
Significant here is the nature and purpose of the proposed information exchange, which
“is relevant to whether it may cause anticompetitive harm.”
31
To be sure, the Proposed Conduct
has a procompetitive objective. The purpose of the information exchange is to “expedite
production of greater quantities of COVID-19 mAb treatments” once they are deemed safe and
effective.
32
Moreover, the Department understands that the Requesting Parties would face
significant obstacles absent the collaboration because there are a limited number of
manufacturing facilities that produce mAbs at a scale large enough to respond to the pandemic,
and establishing new ones that are appropriately calibrated takes considerable time.
33
Given the
immediate need for effective therapeutics, and the likely demand,
34
the Proposed Conduct, which
is seeking to use production capacity efficiently and enable the rapid, large-scale production of
mAbs, could offer Americans considerable benefits and “provide [them] with products or
services that might not be available otherwise.”
35
Furthermore, the proposed information exchange appears unlikely to harm competition
either in the markets for COVID-19 mAb treatments or for mAb treatments for conditions other
than COVID-19.
With respect to COVID-19 mAbs, most of the information that the Requesting Parties
propose to exchange is highly technical concerning the details regarding a company’s relevant
manufacturing facilities, including the type of bioreactors it could use to produce COVID-19
mAbs (or that are used by the company’s contract manufacturers for this purpose), the technical
specifications for producing a particular COVID-19 antibody injectable, a company’s processes
and platforms, and the source and amount of available raw materials needed.
36
As discussed
30
See Request Letter at 3, 5.

31
DOJ-FTC Collaboration Guidelines § 3.31.

32

See Request

Letter at 5.

33

See, e.g., Duke Study at 3;

Johnson, OWS (July 13, 2020).

34

Doses needed to treat COVID-19 effectively could be very high, and prophylactic use would only increase
demand.

See Request Letter at 3.

35

See

Joint Statement.

36

See

Request

Letter at 5.

Letter to Thomas O. Barnett
July 23, 2020
Page 8
above, the manufacturing process for producing mAbs is complex. Each category of information
appears to be reasonably tailored to facilitate the Requesting Parties’ procompetitive efforts to
prepare for the large-scale production of the most safe and effective COVID-19 mAbs.
Moreover, the sharing of this information is unlikely to result in collusion. For example, in
accordance with the safeguards the Requesting Parties propose to implement, they will not
exchange competitively sensitive information about prices or commercial terms of any
arrangements for raw materials or supplies.
37
They also are not proposing to exchange
information about their research and development plans, sales or marketing strategies, treatment
prices, or capacity or output for the other biologics that they sell.
38
Although sharing information about production capacity can raise antitrust concerns
because it could lead to collusion that would reduce output,
39
the Proposed Conduct is likely to
have the opposite effect. The Requesting Parties here propose to share information about
capacity so that they can enable firms with successful therapeutics to increase output and markets
served, not for the anticompetitive purpose of decreasing output and raising prices.
40
Indeed, the
Requesting Parties have been working with the U.S. Department of Health and Human Services
on how best to address the anticipated demand for effective COVID-19 mAbs. That demand is
expected to be significant and there is likely to be considerable pressure to produce these
therapeutics at rapid pace. We understand that large doses may be needed to make a meaningful
difference in health outcomes. Thus, sharing information about available capacity reserved by
each Requesting Party for the production of COVID-19 mAbs will have the procompetitive
purpose of identifying facilities that can produce needed treatments and reduce the lead time for
preparing that facility, potentially enabling the Requesting Parties to meet the anticipated
demand.
41
The Requesting Parties have also agreed to share information about capacity
dedicated to COVID-19 only as long as necessary to address the pandemic.
42
Moreover, based on the information provided, the sharing of production capacity is
unlikely to harm competition in markets for mAb therapeutics that are used to treat diseases
other than COVID-19. Antitrust concerns can arise if a collaboration requires dedication of
37
See id. See also infra Part III.C. discussing Proposed Safeguards.

38
We understand that the Requesting Parties may need to determine for quality control purposes whether a facility is
producing any products that could contaminate the mAbs. Discussing such information necessary to ensure quality
would not raise antitrust concerns.

39

See

Areeda & Hovenkamp

§ 2111c.

40

See also

Letter from William

J. Baer, Ass’t Att’y Gen.,

Antitrust Div., U.S. Dep’t Justice, to Steven

A. Bowers,

Fish &

Richardson P.C. (Oct. 2, 2014),

https://www.justice.gov/atr/response-cyberpoint-international-br-request-
business-review-letter

(considering the business purpose of the proposed agreement and

nature of the information
shared,

which

was technical and “unlikely to

facilitate tacit or explicit price or

other competitive coordination

among competitors”).

41

See Request

Letter at 3–4.

42

See infra Part III.C.

discussing Proposed Safeguards.

Letter to Thomas O. Barnett
July 23, 2020
Page 9
specialized resources that reduces participants’ ability to compete elsewhere. “[I]f participants in
a production collaboration must contribute most of their productive capacity to the collaboration,
the collaboration may impair the ability of its participants to remain effective independent
competitors regardless of the terms of the agreement.”
43
This antitrust concern is mitigated here
both because the Requesting Parties do not intend to commit their entire capacity to COVID-19
mAbs and because the Requesting Parties have committed to exchange information not on their
total production capacity or output, but on the portion of their production capacity that each firm
independently decides that it can make available to produce COVID-19 treatments, in light of
capacity constraints from the production of each firm’s non-COVID-19 medically critical
mAbs.
44
The Department would be concerned, however, if the collaboration jointly agreed to
shift capacity away from non-COVID-19 mAb treatments in order to reduce output or raise
prices for these treatments, or if the shifting of capacity away from non-COVID-19 treatments
resulted in a market allocation among the Requesting Parties that compete to provide similar
treatments for the same disease. We have no reason to believe the Requesting Parties intend to
engage in this anticompetitive conduct.
45
Finally, the Requesting Parties have represented that they will exchange and use
information for the strictly limited purpose of facilitating the production of COVID-19
treatments. Because the Requesting Parties have represented that they are not exchanging
information about total production capacity or output for all of their mAb treatments, which is
specific to the type of monoclonal antibody produced, collusion is less likely after the pandemic
ends.
C. The Proposed Safeguards
As mentioned above, the Requesting Parties have also proposed a number of safeguards
to further reduce antitrust concerns.
46
“In general, it is less likely that the collaboration will
facilitate collusion on competitively sensitive variables if appropriate safeguards governing
information sharing are in place.”
47
Here, these safeguards include:
• Limiting the Scope of the Information Exchange. The scope of the
Proposed Conduct is limited to only facilitating the rapid production of safe
and effective COVID-19 mAbs. Moreover, the parties are only sharing total
potential capacity that they have independently determined that they will
dedicate or would be willing to make available for the production of COVID-
43
DOJ-FTC Collaboration Guidelines, § 3.34(b) n. 44.

44
Request Letter at 4. See also infra Part III.C discussing Proposed Safeguards.

45
See DOJ-FTC Collaboration Guidelines § 3.31 (“The Agencies . . . consider evidence of the subjective intent of the
participants to the extent that it sheds light on competitive effects.”).
46

See Request

Letter at 4.

47

DOJ-FTC Collaboration Guidelines § 3.34(e).

Letter to Thomas O. Barnett
July 23, 2020
Page 10
19 mAbs, t aking into account the capacity need for the production of other
critical treatments.
48

• Limiting the Duration of the Collaboration. The exchange of information
is limited in duration to “extend only as long a s necessary to address the
COVID-19 crisis,”
49
which lessens the chance of collusion and makes it more
likely the Requesting Parties will “compete against each other and their
collaboration.”
50

• Independent Decision Making. The Requesting Parties represent that the
information exchange will not limit independent decision making of the
individual participants. For example, the Requesting Parties will not make
joint decisions on whether to deal with certain customers or the terms for
selling finished COVID-19 mAbs. The exchange also will not involve
collaboration on whether any participant will develop or invest in additional
capacity.
51

• No exchange of competitively sensitive information concerning input
prices or commercial terms. The Requesting Parties represent that they will
not share competitively sensitive information “relating to costs of inputs, costs
of production, or prices of the treatments” which could lead to collusion.
52

In addition, we understand that the Requesting Parties will not use the information
exchanged other than to facilitate the production of COVID-19 mAbs, and they represent that
any collaboration or information exchange beyond the Proposed Conduct would be outside the
scope of the business review letter.
53
The Department finds these safeguards sufficiently address
the antitrust concerns raised by the information exchange.
D. Innovation Concerns
Finally, the Department finds the Proposed Conduct is unlikely to lessen incentives to
continue to innovate or invest in COVID-19 mAbs. Innovation related to this treatment is
48
See Request Letter at 3–4.

49
See id. at 5.

50

DOJ-FTC Collaboration Guidelines §

3.34(f).

51

Request

Letter at 5.

52

Cf.

DOJ-FTC Collaboration Guidelines

§ 3.31(a) (“[P]roduction

collaborations

may involve agreements on the

level of output or the use of

key assets, or on the price at

which the product

will be

marketed by the collaboration, or

on other competitively

significant variables,

such as quality, service, or promotional strategies, that can result in

anticompetitive harm.”)

53

See Request

Letter at 5.

54
See Johnson, OWS (July 13, 2020).

55
See Joint Statement (“These sorts of joint efforts, limited in duration and necessary to assist patients, consumers,
and communities affected by COVID-19 and its aftermath, may be a necessary response to exigent circumstances
that provide Americans with products or services that might not be available otherwise.”)

56

See also

Areeda & Hovenkamp § 2111b1

(“[A]ntitrust develops rational rules

for sorting out those

kinds of

information exchanges that are socially

valuable on balance from those posing significant

anticompetitive threats”).

Letter to Thomas O. Barnett
J
uly 23, 2020
Page 11
critical to improving Americans’ health and safety during the COVID-19 pandemic.
54
The
Department finds this collaboration may help to encourage innovation and investment in R&D
because market participants may have found an efficient solution for developing their treatments
and planning for the scale up of production in parallel. Indeed, the collaboration may be
necessary to expand capacity in order to manufacture sufficient doses of COVID-19 mAbs.
55
This is the type of collaboration that the antitrust laws should encourage.
56
Moreover, the
Proposed Conduct does not include a collaboration on R&D, and thus, all Requesting Parties
have the incentive to compete and continue to develop their own safe and effective treatment for
COVID-19 at the lowest cost.
IV. Conclusion
This letter is predicated on the accuracy of the information the Requesting Parties have
provided and expresses the Department’s current enforcement intention in the exercise of its
prosecutorial discretion in the context of the antitrust laws. The letter also reflects the outcome
of an expedited, temporary review procedure that is necessarily less thorough than ordinary
business review procedures and should not be interpreted as applying to any matter other than
the Proposed Conduct as it relates strictly to, or arises directly out of, the COVID-19 pandemic.
This letter is made in accordance with the Department’s Business Review Procedure, 28
U.S.C. § 50.6, and subject to the limitations and reservations of rights therein. Pursuant to its
terms, your business review request and this letter will be made publicly available immediately,
and any supporting data you have submitted will be made publicly available within thirty days of
the date of this letter, unless you request that part of the material be withheld in accordance with
paragraph 10(c) of the Business Review Procedure.
Sincerely,
/s/
Makan Delrahim