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This marks the first issue of WilmerHale’s The
Interplay: Key Decisions at the Intersection of Antitrust &
Life Sciences, a monthly bulletin that will highlight
developments in the antitrust and life sciences space. We will
cover important decisions in the appellate courts, dispositive
decisions from district courts and relevant updates and
developments from the FTC. This will serve as a reliable and
informative resource for readers who wish to stay current on this
dynamic area of litigation. Beginning this month, you will receive
digestible summaries of these decisions and other recent
developments.
Federal Trade Commission v. Amgen,
Inc. (N.D. Ill.) – FTC and State AGs
End Challenge to Amgen/Horizon Deal. On September 1, the
FTC announced it has agreed to a proposed consent
order with Amgen, settling its suit to block Amgen’s proposed
acquisition of Horizon Therapeutics. In May 2023, the FTC and six
state attorneys general alleged that the deal would enable Amgen to
use its extensive drug portfolio to offer bundled discounts that
would make it difficult or impossible for future competitors to
challenge Horizon’s monopoly in two drug markets. This was the
first time in over 40 years that a US antitrust agency has
challenged a transaction based on a “conglomerate” theory
of competitive harm. The proposed order will, among other things,
prohibit Amgen from bundling Tepezza and Krystexxa with an Amgen
product. This is the first time in more than 5 years that the FTC
had agreed to accept a behavioral remedy to address competitive
concerns. The proposed consent order is subject to a notice and
comment period. For more information on the FTC’s challenge,
see WilmerHale’s alert here.
Federal Trade Commission v. Endo Pharms.
Inc. (D.C. Cir.) – D.C. Circuit Affirms
Denial of FTC Challenge to “Standard Exclusive Licensing
Agreement.” On August 25, the D.C. Circuit affirmed dismissal of the FTC’s suit
against Endo Pharmaceuticals and Impax Labs. Endo and Impax
originally reached an agreement in 2010 that granted Impax a
license to launch a generic version of Endo’s pain medication
Opana ER (extended release oxymorphone) in January 2013, under a
license covering Endo’s patents for oxymorphone ER, and
including (in Impax’s view) patents acquired after the
agreement became effective. In 2012, Endo launched a Reformulated
Opana ER designed to prevent abuse and acquired additional patents
related to Opana ER. In 2015, Endo asked Impax to pay an 85 percent
royalty for a license to these additional patents and sued when
Impax refused. During that litigation, Endo withdrew Reformulated
Opana ER, leaving Impax’s generic version of Opana ER as the
only oxymorphone ER on the market. In a 2017 settlement agreement,
the Endo and Impax agreed that Impax would pay royalties for the
additional patents but that the royalty obligation would end if
Endo re-entered the oxymorphone ER market. In 2021, the FTC
challenged the 2017 agreement as an allegedly anticompetitive
exclusive licensing arrangement. The district court and D.C.
Circuit, however, found that the 2017 agreement was a
“standard exclusive license” that is lawful under the
Patent Act. While the FTC argued that the 2017 agreement was an
illegal non-compete agreement because the 2010 agreement allegedly
gave Impax a license to Endo’s patents, the D.C.
Circuit—applying circuit precedent recognizing the legality
of “standard exclusive licensing agreements” when they
“restrain[] trade only to the extent traditionally recognized
by patent law”—affirmed the district court’s finding
that the FTC failed to explain why the 2017 agreement, on its own,
was not a Congressionally-sanctioned “standard exclusive
license.”
Jacksonville Police Officers and Fire Fighters
Health Insurance Trust v. Gilead Sciences, Inc., et al. (N.D.
Cal.) – Court Dismisses Allegations of Antitrust Injury That
Are “Speculation and Conjecture.” On August 28,
a court in the Northern District of California granted Gilead’s motion to dismiss the
second amended complaint, holding that plaintiffs failed to allege
an antitrust injury. Plaintiffs alleged that Gilead entered
anticompetitive reverse-payment settlement agreements involving
Gilead’s HIV medications. The court found that the
plaintiffs’ “allegations about whether Cipla, or any other
generic manufacturer, intended to seek approval for a [generic]
version of Truvada are based on speculation and conjecture and are
insufficient to plausibly allege their theory of injury.” That
is, the court found plaintiffs had failed to adequately allege that
but for the alleged reverse payment settlement, one or more
generics would have entered the market, thereby creating
competition for Truvada. The district court gave the plaintiffs one
final opportunity to amend their complaint.
In re Suboxone Antitrust Litigation (E.D. Pa.)
– Court Denies Motion For Legal Determination of Relevant
Market. On August 30, a court in the Eastern District of
Pennsylvania denied plaintiffs’ motion for partial
summary judgment in a monopolization case that the “relevant
market” should be defined as the market for Suboxone (an
opioid dependence drug) and its AB-rated generic equivalents.
Defendants contended that the relevant market should include a
broader array of opioid dependence therapies. The district court
found that the defendants had introduced evidence of the functional
interchangeability of, real-world switching between, and
cross-price elasticity of demand between Suboxone and other opioid
dependence drugs. The court therefore held that the relevant
antitrust market, “particularly in this convoluted
pharmaceutical market, is more properly decided by a jury” and
denied plaintiffs’ motion.
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