`
`No. 23-60167
`
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FIFTH CIRCUIT
`–––––––––––––––––––––––––––––––––––––––––––––
`ILLUMINA, INC. AND GRAIL, INC.,
`Petitioners,
`v.
`FEDERAL TRADE COMMISSION
`Respondent.
`–––––––––––––––––––––––––––––––––––––––––––––
`OPPOSITION OF THE FEDERAL TRADE COMMISSION TO
`PETITIONERS’ MOTION TO EXPEDITE APPEAL
`–––––––––––––––––––––––––––––––––––––––––––––
`
`
`
`
`
`ANISHA S. DASGUPTA
`General Counsel
`JOEL MARCUS
`Deputy General Counsel
`MATTHEW M. HOFFMAN
`Attorney
`FEDERAL TRADE COMMISSION
`600 Pennsylvania Avenue, NW
`Washington, D.C. 20580
`(202) 326-3097
`mhoffman@ftc.gov
`
`
`
`
`
`
`
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`
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`Case: 23-60167 Document: 45-1 Page: 2 Date Filed: 04/17/2023
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`Petitioners Illumina, Inc. and GRAIL, Inc. (collectively, “Illumina”) have
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`moved to expedite this case, in which they seek review of an order of the Federal
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`Trade Commission requiring Illumina to unwind its 2021 acquisition of Grail. That
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`requirement does not take effect until judicial review is complete; in the meantime,
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`the Commission has ordered Illumina to continue operating Grail as a separate
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`company. Expedition should be denied because Illumina fails to show that the
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`hold-separate order presents any good cause to expedite this case. See 5th Cir. R.
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`27.5. To the contrary, Illumina’s motion makes clear that there is no urgency here.
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`The European Commission, which conducted its own antitrust review and found
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`that the transaction violated European competition laws, has independently ordered
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`Illumina to hold Grail as a separate company pending further proceedings. That
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`order bars Illumina and Grail from combining operations regardless of what
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`happens in this case, and Illumina concedes that the European order will remain in
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`effect at least through the end of 2023 (and it will likely be even longer given the
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`anticipated timing of the European proceedings). That gives the parties plenty of
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`time to complete briefing in the ordinary course.
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`Furthermore, given the number and complexity of the issues that Illumina
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`intends to raise (including both substantive antitrust issues and multiple
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`constitutional challenges), an expedited briefing schedule would be highly
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`prejudicial to the FTC. That is especially true of the lopsided and unfair schedule
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`Case: 23-60167 Document: 45-1 Page: 3 Date Filed: 04/17/2023
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`proposed by Illumina, which would give the company 66 days from when it
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`received the decision to prepare its opening brief and require the FTC to respond in
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`a mere 21 days. Even if Illumina were not independently barred from combining
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`operations with Grail, that schedule would be manifestly unfair on its face.
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`The Court should give no weight to Illumina’s speculative arguments that
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`allowing the companies to combine operations will save lives by accelerating
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`Grail’s ability to gain regulatory approval for its medical tests. As the company
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`admits, the FDA has not yet even approved Grail’s test, insurance companies will
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`not reimburse for it, and its cost is prohibitive for most Americans. The
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`Commission found that Illumina’s argument that the merger would somehow
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`speed up regulatory approval or commercial acceptance of the test were based on
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`nothing more than vague and unsupported speculation by Illumina executives. And
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`it further found that keeping the companies separate would likely save more lives
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`than the merger could because it would encourage competition in the development
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`of early-stage cancer detection tests. The Commission’s findings are amply
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`supported by the record evidence and are entitled to conclusive weight in this
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`Court. The motion should be denied.
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`2
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`Case: 23-60167 Document: 45-1 Page: 4 Date Filed: 04/17/2023
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`BACKGROUND
`
`A.
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`Procedural History
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`This case involves an emerging class of innovative blood tests known as
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`multi-cancer early detection (“MCED”) tests, which can detect multiple forms of
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`cancer in asymptomatic people. Grail developed one such test, called Galleri,
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`which has been clinically shown to detect seven types of early-stage cancer in
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`asymptomatic populations.1 Commission Opinion (“Op.”) 13.2 Several other
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`companies are competing to research, develop, and commercialize other innovative
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`MCED tests. Op. 14-18. All of these tests rely on next-generation gene sequencing
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`(“NGS”) platforms manufactured by Illumina; there is currently no viable
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`substitute for Illumina’s NGS technology. Op. 7.
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`Illumina originally formed Grail in 2016 but spun it off as a separate
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`company in February 2017, with Illumina ultimately retaining a 12% stake. Op.
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`10-11. In September 2020, Illumina changed its mind and decided to acquire the
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`remainder of Grail for $8 billion. Op. 11. Although Illumina and Grail do not
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`compete with each other, the acquisition raised antitrust concerns because Grail’s
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`competitors rely on Illumina’s technology, and Illumina would have the ability and
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`1 Illumina states that Galleri can detect 50 types of cancer, but as the Commission found, that
`has not been shown to be true with regard to screening for early-stage cancers in asymptomatic
`populations, which is the purpose of an MCED test. Op. 13.
`2 The public version of the Commission’s decision is attached as Exhibit A. It has been
`redacted to protect confidential business information.
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`3
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`Case: 23-60167 Document: 45-1 Page: 5 Date Filed: 04/17/2023
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`incentive to favor Grail over its rivals if the companies were combined.
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`Accordingly, both the FTC and the European Commission’s Directorate General
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`for Competition carefully reviewed the proposed transaction.
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`In March 2021, the FTC issued an administrative complaint alleging that the
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`combination of Illumina and Grail may substantially lessen competition in the
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`market for research, development, and commercialization of MCED tests, leading
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`to diminished innovation, higher prices, and reduced choice and quality of MCED
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`tests available to consumers. As a result, the complaint alleged, the transaction
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`would violate Section 7 of the Clayton Act, 15 U.S.C. § 18, and Section 5 of the
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`FTC Act, 15 U.S.C. § 45. Under the Administrative Procedure Act and the FTC’s
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`rules, such complaints are prosecuted by agency staff known as “Complaint
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`Counsel,” who are walled off from the Commission itself. Discovery and trial are
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`conducted before an administrative law judge, whose factual findings and legal
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`conclusions are subject to de novo review by the Commission. See 5 U.S.C.
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`§ 554(d)(2); 16 C.F.R. Pt. 3.
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`In April 2021, the European Commission opened its own investigation into
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`the proposed merger upon referral from several member states.3 Illumina
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`challenged the EC’s jurisdiction to review the merger in the European General
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`3 EC Press Release, Mergers: Commission opens in-depth investigation into proposed
`acquisition of GRAIL by Illumina (July 22, 2021), https://ec.europa.eu/commission/presscorner/
`detail/en/IP_21_3844.
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`4
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`Case: 23-60167 Document: 45-1 Page: 6 Date Filed: 04/17/2023
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`Court.4 The EC’s investigation, which continued despite the jurisdictional
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`challenge, triggered a standstill obligation under European law, but in August 2021
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`Illumina closed on the sale anyway.5 To allay concerns about the closing, Illumina
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`committed to the EC that it would hold Grail as a separate entity until either the
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`General Court ruled that the EC lacked jurisdiction or the EC approved the merger.
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`See Ex. B. The EC thereafter imposed its own binding hold-separate obligation on
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`Illumina and Grail while it continued its review.6 In July 2022, the General Court
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`rejected Illumina’s challenge to the EC’s jurisdiction. Illumina appealed this
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`decision to the European Court of Justice (“ECJ”), which is effectively the
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`European Union’s Supreme Court.
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`Meanwhile, the FTC case went to trial before the ALJ. The trial lasted
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`several weeks and yielded an extensive factual record, including testimony from 56
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`fact witnesses and 10 expert witnesses and more than 4,500 exhibits. In September
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`2022, the ALJ issued an Initial Decision in favor of Illumina, holding that
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`4 Illumina Press Release, Illumina Files Action for Annulment of European Commission’s
`Decision Asserting Jurisdiction to Review GRAIL Transaction (Apr. 29, 2021),
`https://investor.illumina.com/news/press-release-details/2021/Illumina-Files-Action-for-
`Annulment-of-European-Commissions-Decision-Asserting-Jurisdiction-to-Review-GRAIL-
`Acquisition/default.aspx
`5 EC Press Release, Mergers: Commission alleges Illumina and GRAIL breached EU merger
`rules by early implementation of their acquisition (July 19, 2022),
`https://ec.europa.eu/commission/presscorner/detail/en/ip_22_4604.
`6 EC Press Release, Mergers: Commission adopts interim measures to prevent harm to
`competition following Illumina’s early acquisition of GRAIL (Oct. 29, 2021),
`https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5661.
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`5
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`Case: 23-60167 Document: 45-1 Page: 7 Date Filed: 04/17/2023
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`Complaint Counsel had not shown that a likelihood of harm to Grail’s rivals was
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`sufficiently probable or imminent to warrant relief. Op. 21-22.
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`The EC, however, reached the opposite conclusion in its review. It barred
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`the transaction, finding that if the merger were completed, “Illumina would have
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`had the ability and the incentive to engage in foreclosure strategies against
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`GRAIL’s rivals”—for example, by refusing to supply them with NGS systems,
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`increasing prices, degrading quality, or delaying supplies—and that this would
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`have a “significant detrimental effect” on competition in the emerging MCED test
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`market.7 Illumina sought review of the EC’s merits determination in the General
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`Court. The EC subsequently indicated that it intends to require Illumina to unwind
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`the acquisition of Grail; the hold-separate obligation remains in place in the
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`meantime.8
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`In the FTC proceeding, the Commission conducted a de novo review of the
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`record, and on March 31, 2023, issued the Opinion and Final Order under review
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`in this case. See Ex. A. By a 4-0 vote, the Commission concluded that the merger
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`7 EC Press Release, Mergers: Commission prohibits acquisition of GRAIL by Illumina (Sept.
`6, 2022), https://ec.europa.eu/commission/presscorner/detail/en/IP_22_5364.
`8 See EC Press Release, Mergers: The Commission adopts a Statement of Objections outlining
`measures to unwind Illumina’s blocked acquisition of GRAIL (Dec. 5, 2022),
`https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7403; EC Daily News, Commission
`renews interim measures to ensure Illumina and GRAIL continue to be kept separate following
`the prohibition decision (Oct. 28, 2022), https://ec.europa.eu/commission/presscorner/detail/en/
`mex_22_6467.
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`6
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`may substantially lessen competition in the United States market for the research,
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`development, and commercialization of MCED tests. To remedy the violation, the
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`Commission ordered Illumina to divest Grail, but that provision does not become
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`final and take effect under the FTC Act until the conclusion of judicial review. See
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`15 U.S.C. § 45(g)(4); 16 C.F.R. § 3.56(a). In the meantime, the Commission
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`ordered Illumina to continue holding Grail as a separate entity—essentially the
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`same requirement the EC has already imposed.9
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`B.
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`The Commission Decision
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`Although it disagreed with the ALJ’s ultimate legal conclusions, the
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`Commission agreed with and adopted many of the ALJ’s factual findings. In
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`particular, it agreed with the ALJ that the research, development, and
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`commercialization of MCED tests constitutes a relevant product market, and that
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`currently and in the near future, Illumina is the only viable supplier of NGS
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`platforms that are a critical input for MCED test developers. Op. 21, 24-34, 36-40.
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`The Commission concluded that a fully merged Illumina-Grail combination would
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`have both the ability and an increased incentive to foreclose competition in the
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`9 On April 4, 2023, Petitioners moved the Commission to stay the Final Order, including the
`hold-separate provision, pending review by this Court. Complaint Counsel did not oppose the
`request to stay certain portions of the Order, including the divestiture requirement, but argued
`that the remaining portions, including most of the hold-separate provisions, were necessary to
`preserve the status quo, protect competition during the pendency of this Court’s review, and
`preserve potential post-appellate relief. The Commission has not yet ruled on the motion.
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`7
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`Case: 23-60167 Document: 45-1 Page: 9 Date Filed: 04/17/2023
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`MCED test market. The Commission explained that the combined company would
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`have an enormous financial incentive to use its leverage to ensure that its own
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`subsidiary wins the MCED test innovation race because Illumina would earn more
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`profit from the sale of Grail’s tests than it would by supporting rival test
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`developers. Id. at 44. And Illumina has several ways to act on that incentive. For
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`example, it could raise costs for Grail’s rivals or withhold or degrade rivals’ access
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`to supply, service, or new technologies. Id. at 43-44. Id. The Commission further
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`found that real-world evidence of Illumina’s past behavior reinforced the
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`likelihood of competitive harm. Id. at 52. The threat to competition was not
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`mitigated by Illumina’s “Open Offer” to engage in supply agreements with its
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`customers, which did not substitute for a competitive marketplace. Id. at 61-73.
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`The Commission rejected Illumina’s arguments that the merger would
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`generate efficiencies and procompetitive benefits that would outweigh its potential
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`anticompetitive effects. Op. 74-87. Those claims were “unverified, not merger-
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`specific and, to the extent that they might somehow come to pass, not likely to
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`benefit the public.” Op. 76. In particular, the Commission rejected the contention
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`that the merger would save lives by enabling faster regulatory approval and greater
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`acceptance by insurance companies. The claim rested “on the unsupported and
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`vague assertions of management personnel,” and other evidence “shows that
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`standalone GRAIL had the incentive and ability to achieve acceleration through
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`8
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`Case: 23-60167 Document: 45-1 Page: 10 Date Filed: 04/17/2023
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`means short of this anticompetitive Acquisition.” Op. 78. Illumina thus “failed to
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`show that the Acquisition, as opposed to the Galleri test, would save any lives.”
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`Op. 78. To the contrary, expert testimony showed that “innovation competition [in
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`the MCED test market] could save substantially more lives” than those posited by
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`Illumina’s experts in their speculative acceleration calculation. Op. 83. The
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`Commission concluded that “the course that Congress clearly enunciated in the
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`antitrust laws is to let competition spur innovation among MCED test providers
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`and thereby save lives,” because “[w]hen competition is allowed to flourish,
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`consumers benefit.” Id.
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`ARGUMENT
`Fifth Circuit Rule 27.5 provides that the Court may expedite an appeal “only
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`for good cause.” Illumina has not made any showing of good cause, and the
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`schedule it proposes is manifestly unfair to the FTC. The request for expedition
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`therefore should be denied.
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`I.
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`THERE IS NO GOOD CAUSE FOR EXPEDITION BECAUSE ILLUMINA
`ADMITS IT CANNOT COMBINE OPERATIONS WITH GRAIL WHILE
`THE EC HOLD-SEPARATE ORDER REMAINS IN EFFECT.
`Expedition is not warranted in this case because Illumina acknowledges that
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`whatever happens here, it cannot combine operations with Grail while the EC’s
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`hold-separate order remains in effect. Although Illumina has a pending challenge
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`to the EC’s jurisdiction over the merger before the European Court of Justice, it
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`9
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`makes no showing that it is likely to prevail, and concedes that it does not expect a
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`decision from the ECJ before “late this year or early next year.” Mot. 5. The FTC’s
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`understanding is that ECJ is not hearing the case on an expedited basis, and a
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`decision is more likely to come in early to mid-2024. Either timeline would allow
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`the parties to brief this case on an ordinary schedule. There is no need to rush.
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`Moreover, even if there were evidence supporting Illumina’s claim that the merger
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`will somehow save lives—which, as discussed below, there is not—that would not
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`be a reason to expedite this case as long as the EC’s order prevents Illumina and
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`Grail from combining operations anyway.
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`Furthermore, given the complexity of this case, an expedited briefing
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`schedule would be extremely prejudicial to the FTC. The voluminous trial record
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`contains testimony from 56 fact witnesses and 10 expert witnesses and more than
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`4,500 exhibits. The Commission’s decision is 98 single-spaced pages, and the
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`ALJ’s decision runs another 197 pages with more than 1,000 factual findings.
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`Illumina has indicated the intent to raise a smorgasbord of legal challenges to the
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`order, including four substantive antitrust arguments and another four
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`constitutional arguments. Such a complex case should not be briefed on a truncated
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`schedule, for the Court’s sake as well as the parties’. Indeed, given the size of the
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`record and the number of issues, the FTC may need extra time to adequately
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`prepare its brief. The Court’s rules acknowledge that extension is appropriate when
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`10
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`Case: 23-60167 Document: 45-1 Page: 12 Date Filed: 04/17/2023
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`a matter is “so complex that an adequate brief cannot reasonably be prepared when
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`due.” 5th Cir. R. 31.4.2(b). Even with an extension, this case can be resolved
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`before the ECJ issues a decision.10
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`Regardless, the specific schedule Illumina proposes is manifestly unfair on
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`its face. Illumina proposes to file an opening brief on June 5, 2023, 61 days after
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`the petition was filed and 66 days after the Commission decision. But Illumina’s
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`proposed schedule would accord the FTC only 21 days to file (until June 26) to file
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`its response brief. 11 That imbalance is fundamentally unfair.
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`II. THERE IS NO BASIS FOR ILLUMINA’S CLAIM THAT EXPEDITION
`WILL SAVE LIVES.
`Even if Illumina and Grail were not barred from combining operations by
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`the EC order, their claim that expedition will “save lives” must be rejected because
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`it is contrary to the Commission’s factual findings. The Commission found that
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`Illumina’s claim that the merger would save lives by accelerating the regulatory
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`approval and commercial acceptance of Galleri was based on unsupported
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`speculation, and that in fact, blocking the merger was likely to save lives by
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`promoting competition in the market for MCED tests, giving consumers access to
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`10 Once briefing is completed, if the ECJ issues a decision in favor of Illumina, the FTC would
`not object to accelerating argument and decision. At present, however, Illumina has failed to
`justify any expedition.
`11 Illumina can begin preparing its brief immediately, but the FTC must wait until it sees
`Illumina’s arguments.
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`11
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`Case: 23-60167 Document: 45-1 Page: 13 Date Filed: 04/17/2023
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`more and better tests. Those findings are supported by substantial evidence and
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`hence are “conclusive” in this Court. 15 U.S.C. § § 21(c), 45(c); FTC v. Indiana
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`Fed’n of Dentists, 476 U.S. 447, 454 (1986).
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`As the Commission correctly determined, the claim of saving lives depends
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`on a chain of speculation. Briefly, Grail currently sells the Galleri MCED test on a
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`limited basis as a “laboratory-developed test,” which does not require FDA
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`approval, at a cost of approximately $949. Op. 12. Illumina admits that the test is
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`not covered by insurance and is “cost prohibitive for most Americans.” Mot. 1. To
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`sell the test more broadly (a necessary event for the life-saving hypothesis), Grail
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`would first need to obtain FDA approval, but it has not even filed an application
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`yet. Even if Grail were to obtain FDA approval for Galleri (itself not a given), it
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`will then need to persuade third-party payors (e.g., Medicare and private health
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`insurers) to cover the test, and then need to convince doctors and patients of the
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`test’s benefits.
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`Illumina tells the Court that a “conservative[e]” estimate is that allowing the
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`companies to combine operations will accelerate Galleri’s adoption by one year.
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`Mot. 12. But as the Commission found, Illumina’s trial expert “did not opine on
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`whether Illumina could accelerate FDA or payer approval” by one year, but instead
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`“simply relied upon Illumina’s own claims that it could achieve such acceleration.”
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`Op. 78. The company’s claim was based in turn on a “vague assertion” by an
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`12
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`executive and not supported by any analysis. Op. 79. Illumina did not “project how
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`specific regulatory milestones for Galleri will actually change as a result of the
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`Acquisition, [or] explain how and when Illumina’s intervention will change them.”
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`Op. 79. Furthermore, the Commission found that Grail had already demonstrated
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`significant experience and expertise in dealing with the FDA, and that Illumina
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`“ha[d] not demonstrated exceptional [FDA premarket approval] expertise that
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`GRAIL could not replicate.” Op. 80. And “[e]ven if GRAIL’s regulatory
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`capabilities were somehow shown to be inadequate,” Illumina “failed to
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`demonstrate that Grail could not or would not expand its capabilities without the
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`Acquisition.” Op. 81. If Galleri represents the lifesaving breakthrough now
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`posited, then “[s]tandalone GRAIL would have a massive incentive to accelerate
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`market acceptance,” e.g., by expanding its own capabilities or contracting with
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`other capable firms. Id. For similar reasons, the Commission found that claims that
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`the merger could accelerate payer acceptance were also unverified and not merger-
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`specific. Op. 81-83.
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`On the other side of the coin, the Commission credited expert testimony that
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`competition in the market to develop and commercialize MCED tests “could save
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`substantially more lives than those posited by” Illumina’s expert based upon the
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`company’s unsupported acceleration claim. The best way to save lives, the
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`Commission found, would be to allow competition to flourish. Op. 83.
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`13
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`Illumina does not even attempt to argue that the Commission’s factual
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`findings on these points are not supported by substantial evidence. Since there is
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`no basis for concluding that the merger will save lives, that argument does not
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`demonstrate any good cause for expediting this case.
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`III.
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`ILLUMINA’S REMAINING ARGUMENTS LACK MERIT.
`Illumina makes a hodgepodge of other arguments for expedited treatment,
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`none of which withstand scrutiny. First, it argues that allowing the two companies
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`to combine operations will save money by eliminating double marginalization and
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`implementation of supply chain and operating efficiencies, and that some of these
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`savings will be passed along to consumers. Mot. 13-14. But any putative benefits
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`flowing from the merger are irrelevant to whether expedited treatment should be
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`granted here, since the EC’s order bars Illumina and Grail from combining
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`operations until at least the end of the year (and likely beyond). In any event, the
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`Commission’s decision found the claimed efficiencies and benefits were vague,
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`unverified, and could be achieved without the merger. Op. 84-85. Furthermore,
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`even if efficiencies could produce cost savings that would be passed along to
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`consumers, that hypothetical benefit must be weighed against the harm to
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`consumers from potential foreclosure of competition in the MCED test market.
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`Illumina’s allegations of constitutional violations likewise do not amount to
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`good cause for expediting this appeal. Illumina cites Elrod v. Burns, 427 U.S. 347
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`14
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`(1976), and Deerfield Medical Center v. City of Deerfield Beach, 661 F.2d 328
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`(5th Cir. 1981), for the broad proposition that “violations of constitutional rights
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`constitute irreparable harm.” Mot. 15. But Elrod holds that “[t]he loss of First
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`Amendment freedoms … unquestionably constitutes irreparable injury,” 427 U.S.
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`at 373 (emphasis added), while Deerfield Medical applied that principle to a
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`deprivation of the constitutional right to privacy, 661 F.2d at 338. Illumina does
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`not allege any ongoing denial of First Amendment rights, privacy rights, or
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`comparable individual liberties. At most, it alleges infirmities in the structure and
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`procedures of the Commission as established by Congress more than 100 years
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`ago. To the extent Illumina alleges that it was harmed by the Commission’s
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`structure or its processes, that harm has already occurred; Illumina has not
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`attempted to show any ongoing deprivation of rights that might justify expedition.
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`Illumina seems to be arguing that merely alleging some form of constitutional
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`violation (e.g., a denial of due process) should enable an appellant to jump the line
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`and have its case heard before other litigants. We know of no authority to support
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`this far-reaching proposition.
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`Finally, Illumina is flatly wrong that expediting the appeal “will harm no
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`one” and will “serve the public interest.” Mot. 16, 17. As discussed above,
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`expediting the appeal would be highly prejudicial to the FTC, given the size of the
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`record and the number of issues that Illumina plans to raise on appeal. Conversely,
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`15
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`as we have shown, denying expedition will not harm Illumina because it cannot
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`combine operations with Grail while the EC hold-separate order remains in effect.
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`And the interests of justice as well as the Court’s own interests will be best served
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`by a full adversary process in which all parties have an adequate opportunity to
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`brief the many issues in this case and the Court has sufficient time to consider and
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`rule upon them.
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`CONCLUSION
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`The Court should deny the motion to expedite.
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`April 17, 2023
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`Respectfully submitted,
`
`ANISHA S. DASGUPTA
`General Counsel
`JOEL MARCUS
`Deputy General Counsel
`
`
`
`
`/s/ Matthew M. Hoffman
`MATTHEW M. HOFFMAN
`Attorney
`FEDERAL TRADE COMMISSION
`600 Pennsylvania Avenue, N.W.
`Washington, D.C. 20580
`(202) 326-3097
`
`16
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`Case: 23-60167 Document: 45-1 Page: 18 Date Filed: 04/17/2023
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`CERTIFICATE OF COMPLIANCE
`I certify that the foregoing response complies the type-volume limit of Fed. R.
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`App. P. 27(d)(2)(A) because, excluding the parts of the document exempted by Fed.
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`R. App. P. 32(f), it contains 3640 words. It complies with the typeface and type-style
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`requirements of Fed. R. App. P. 32(a)(5) and (a)(6) and 5th Cir. R. 32.1 because the
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`text is in 14-point Times New Roman type and the footnotes are in 12-point Times
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`/s/ Matthew M. Hoffman
`Matthew M. Hoffman
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`New Roman type.
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`April 17, 2023
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