*1 major changes activity generally the FDA “activi- followed changes readily ty-based” five-year that are not to drug approach exclusivity predicted.... contrast to most under the Hatch-Waxman Amendments. changes necessary go the covalent structure of a We do not consider it to into molecule, the of a salt prior formation or these details of decisions. None ester, is not complex, or of an intended grant them rendered the FDA’s of ex- cannot, generally alter the clusivity Vyvanse basic to arbitrary capri- toxicologic or pharmacologic properties cious. of molecule.... grant summary The district court’s pressed are to We hard second- judgment to the FDA Shire and to view, especially guess the FDA’s since it affirmed. agency’s “rests on evaluations of scien So ordered. expertise.”
tific within its data area Labs., Shalala, Inc. v. Serono 158 F.3d (internal (D.C.Cir.1998) quota omitted). best,
tion marks At Actavis has
offered evidence that some covalent struc changes
tural prop do not alter the basic drug question
erties of and that
some changes noncovalent structural do. agencies may
But “employ bright-line rules for reasons of administrative conven America, Appellee UNITED STATES ience, long so as those rules fall within a reasonably zone of reasonableness explained.” Emily’s v. Fed. List Election JONES, Appellant. Antoine (D.C.Cir.
Comm’n, 22 n. 20 2009). Nos. 08-3030. The FDA explained has its policy in part “difficulty is based Court Appeals, States determining molecule, precisely which District Columbia Circuit. molecule, portion responsible aof for drug’s effects.” Nothing record es Nov. approach tablishes un FDA’s complexity reasonable. Given the McLeese, III, Roy W. Esquire, Assis- statutory regime, to agency’s we defer Attorney, Geise, tant U.S. John Vincent Found, interpretation. Cmty. See Care Lieber, Rachel Carlson Assistant U.S. At- (D.C.Cir. Thompson, torney, Office, Attorney’s Washing- 2003). ton, DC, Appellee. for Leckar, Stephen C. Shainis & Peltzman Ill Chartered, DC, Washington, Appellant. has other arguments designed
Actavis show grant five-year LLP, Prywes, Bryan FDA’s Daniel I. Ar- Cave exclusivity Vyvanse thur “arbitrary Barry was Spitzer, [and] American Liber- Civil 706(2)(A). capricious.” § Area, U.S.C. Pri- ties Union of the National Capital mary among Vyvanse these is that David Lane Sobel Law David L. Office Of past DC, decision tension agency Sobel Curiae Washington, Amicus which, decisions, claims, Appellants. Actavis establish *2 satisfied. the Government SENTELLE, which Judge, elements Chief BEFORE: Pennsylvania (quoting HENDERSON, GINSBURG, and Labron, 938, 940, BROWN, GARLAND, TATEL, ROGERS, (1996)). Second, L.Ed.2d 1031 KAVANAUGH, Circuit GRIFFITH, and complains that petition the Government’s Judges. calls into “implicitly the court’s important practices common and question ORDER and surveillance such sustained banc rehearing en for petition Appellee’s public places,” photographic response thereto and No. correct. The is not Pet. court, a vote full and circulated were “This ease does not noted: explicitly court Thereafter, majority of requested. we do and therefore require us did not participate eligible to judges instance of hypothetical whether decide Upon consid- petition. in favor of the vote be a would visual surveillance prolonged it is foregoing,, eration of requirement subject to the warrant search denied. petition ORDERED Fourth Amendment.” * Judges and Circuit Sentelle Judge Chief grant Kavanaugh would and Brown SENTELLE, Judge, joined Chief rehearing en banc. petition BROWN, HENDERSON, * Ginsburg, Judges A statement Circuit KAVANAUGH, Judges, dissenting Circuit denial concurring Tatel, and Griffith en banc: rehearing from the denial attached. rehearing en banc case held in this Sentelle, by Chief *A statement use of a warrantless government’s Henderson, Judges by Circuit
joined
(“GPS”)
system
device
positioning
global
dissenting from
Brown,
Kavanaugh
appellant
public
to track
rehearing en banc
attached.
the denial
approximately
vehicle
Jones’s
Antoine
*
Judge Kava-
by Circuit
A statement
search
was an unreasonable
four weeks
of re-
from the denial
dissenting
naugh
of Jones’s Fourth
violation
is attached.
hearing en banc
view,
should
my
question
In
rights.
en banc because
GRIFFITH,
by the court
be reviewed
GINSBURG,
TATEL
decision is inconsistent
panel’s
concurring
the denial
Judges,
Circuit
circuit which has
every other federal
with
rehearing en banc:
case,
importantly,
more
considered
peti-
to the Government’s
response
precedent
Supreme Court
controlling
First,
matters.
be-
tion,
two
we underline
in United States
set forth
did not argue
the Government
cause
be measured invader’s but preme jurisprudence Court and with the an invasion does not occur unless there is application of the Fourth Amendment expectation. such a reasonable circuits, by similar other circumstances importance this Lest this decision warrants en banc consider- underestimated, respectfully I would note that the in- ation. I de- dissent panel in the vasion found was not use nial. device, aggregation the GPS KAVANAUGH, Judge, Circuit Presumably, of the information obtained. dissenting rehearing from the denial of en
had the GPS device been used for hour banc: perhaps day, period or whatever I agree Judge with a nor- with Chief Sentelle that panel believed was consistent surveillance, panel opinion mal conflicts with the Su- evidence obtained 770 information,
preme Court’s United States v. order to obtain that intrusion decision 75 constitute a violation of the Fourth U.S. S.Ct. also share Chief even if the same information L.Ed.2d panel concern about been Sentelle’s could-have obtained other means.” opinion’s aggregation approach 286, 103 novel to 460 U.S. at S.Ct. analysis.
Fourth Amendment
Brennan noted in
As Justice
however,
I think
say,
That is not to
precedent
perhaps
that is
necessarily
prevail
the Government
property-based argu-
most relevant to this
case.
defendant contended
ment
the Court’s
1961 deci-
unanimous
Fourth Amendment
was violated
sion in
v. United
Silverman
surveillance without
734. In
L.Ed.2d
(the
panel
warrant
issue addressed
Silverman,
Court concluded
initial in-
opinion)
also
listening
stallation
device on the de-
on his car
stallation
the GPS device
property (by accessing heating
fendants’
a warrant. The
without
did
duct in
shared
wall
the defendants’
not address the defendant’s alternative
house)
subject
row
to the Fourth
*5
Fourth
and narrower
property-based
Amendment. The
that
Court reasoned
concerning
in-
argument
Amendment
applied
Fourth Amendment
because of the
my judgment,
stallation.
the defen- police’s physical contact with the defen-
poses
dant’s alternative submission also
an
property,
variously
dants’
which the Court
important question and deserves careful
physical
characterized as: “unauthorized
en
consideration
banc Court.
penetration
premises,”
into the
“unautho-
physical
rized
encroachment within
con-
has stated that
area,”
stitutionally protected
“protects
“usurping
property
Fourth Amendment
as
office,”
part
petitioners’
of the
house or
privacy.”
Cnty.,
well as
Soldal v. Cook
Ill.,
62,
“actual
56,
538,
constitutionally
intrusion into
506 U.S.
113
121
area,”
(1992).
protected
“physically
and
en-
L.Ed.2d 450
As the defendant
out,
trenching]
into a man’s office or home.”
rightly points
here
Id. at
771 wall heating in a shared on a duct person If a device post-Nate era: theme Silverman, 510, relationship U.S. house. 365 or has a close a row property owns owner, judge usu has con property access 679. One circuit 81 S.Ct. his reasonable that the Fourth Amendment does ally violates cluded Kerr, Models Four Orin S. device: privacy.” to installation of a GPS Ab apply Protection, 60 Stan. Amendment Fourth police’s compliance with Fourth sent the (2007) Soldal, 503, 506 (quoting are requirements, “people en L.Rev. 538); Bond v. 64, see also keep police hands and titled to officers’ 334, 120 S.Ct. 529 U.S. States off their vehicles.” United tools (2000) (squeezing L.Ed.2d 365 (9th Cir.1999) McIver, bag subject to Fourth outer surface (Kleinfeld, J., Without full concurring). Amendment). yet I briefing argument, do know agree with that conclusion. whether law, and I see good is still
If Silverman touching or police’s mere ma Whether that it is then Silverman no indication car of the outside of one’s is a nipulating alterna- relevant defendant’s encroachment within constitu concerning “physical argument tive fuller tionally protected requires area” del of the GPS device. Cars stallation event, impor Fourth it is under text of the iberation.* “effects” Amendment, question, v. Chad- one that the see United States tant and close en wick, along banc Court should consider (1977), “constitu- are thus separate issue raised Chief Sen L.Ed.2d purposes tionally protected areas” telle.
Silverman. question, key Silverman-based
therefore, installa- is whether the car is device on one’s
tion of a GPS with- physical encroachment
“unauthorized constitutionally protected area” listening way as installation of
same [*] beTo applies to the otherwise attach clear, simply GPS devices demonstrate that their actions even if the Fourth Amendment installation, must first obtain suspects’ police a warrant or cars. still reasonable under warrant warrant’s Indeed, in this but then temporal case, failed the Fourth Amendment. geographic limits. police comply obtained a
