Here is the SG brief. Unfortunately, their position is that the safe harbor is not limited to preapproval and that Amphastar v. Momenta was correctly decided.
For Opinion See 133 S.Ct. 50
Supreme Court of the United States.
GLAXOSMITHKLINE, Petitioner,
v.
CLASSEN IMMUNOTHERAPIES, INC.
No. 11-1078.
December 13, 2012.
On Petition for a Writ of Certiorari to the United
States Court of Appeals for the Federal Circuit
Brief for the United States as Amicus Curiae
David J. Horowitz, Deputy General Counsel, Elizabeth
H. Dickinson, Chief Counsel, Food and Drug,
Division, Eric M. Blumberg, Deputy Chief Counsel,
Litigation, Wendy S. Vicente, Associate Chief
Counsel, Department of Health and, Human Services,
Silver Spring, Md. 20993.Cameron F. Kerry,
General Counsel, Michelle O. McClelland, Assistant
General Counsel for, Finance and Litigation.
Shraddha A. Upadhyaya, Attorney, Department of
Commerce, Washington, D.C. 20230.Donald B.
Verrilli, Jr., Solicitor General, Counsel of Record,
Stuart F. Delery, Principal Deputy Assistant, Attorney
General, Malcolm L. Stewart, Deputy Solicitor
General, Lewis S. Yelin, Assistant to the Solicitor,
General, Scott R. McIntosh, Mark R. Freeman, Attorneys,
Department of Justice, Washington, D.C.
20530-0001, SupremeCtBriefs@usdoj.gov, (202)
514-2217.Bernard J. Knight, Jr., General Counsel,
Raymond T. Chen, Solicitor, Nathan K. Kelley,
Deputy Solicitor, Farheena Y. Rasheed, William
LaMarca, Associate Solicitors, Patent and Trademark
Office, Alexandria, Va. 22313.
QUESTION PRESENTED
Under 35 U.S.C. 271(e)(1), it is not an act of patent
infringement to use a patented invention “solely for
uses reasonably related to the development and submission
of information under a Federal law” that
regulates the manufacture, use, or sale of drugs.
The question presented is as follows:
Whether Section 271(e)(1)'s safe harbor encompasses
activities undertaken after the Food and
Drug Administration has approved a drug for marketing.
*III TABLE OF CONTENTS
Statement ... 1
Disscussion ... 10
Conclusion ... 24
TABLE OF AUTHORITIES
Cases:
Abtox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed.
Cir. 1997) ... 17
Bennett v. Spear, 520 U.S. 154 (1997) ... 21
Bilski v. Kappos, 130 S. Ct. 3218 (2010) ... 6
Classen Immunotherapies, Inc. v. Biogen Idec, 304
Fed. Appx. 866 (Fed. Cir. 2008) ... 6
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661
(1990) ... 2, 12, 15, 16
Merck KGaA v. Integra Lifesciences I, Ltd., 545
U.S. 193 (2005) ... 2, 3, 11, 21, 20
Momenta Pharmaceuticals, Inc. v. Amphastar
Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir.
2012) ... 9, 10, 20
Oncale v. Sundowner Offshore Servs., Inc., 523
U.S. 75 (1998) ... 16
Proveris Scientific Corp. v. Innovasystems, Inc.,
536 F.3d 1256 (Fed. Cir. 2008) ... 21
Statutes and regulations:
2012 WL 6206566 (U.S.) Page 1
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
301 et seq.:
21 U.S.C. 321(g)(1)(B) ... 2
21 U.S.C. 331 ... 2
21 U.S.C. 355(a) ... 2, 3, 14
*IV 21 U.S.C. 355(b)(1) ... 3
21 U.S.C. 355(d) ... 2, 14
21 U.S.C. 355(e) ... 13
21 U.S.C. 355(i) ... 2
21 U.S.C. 355(i)(1)(A) ... 3
21 U.S.C. 355(j)(2)(A) ... 3
21 U.S.C. 355(j)(8)(B) ... 3
21 U.S.C. 355(o)(3)(A) (Supp. V 2011) ... 13, 18
21 U.S.C. 355(o)(3)(E)(ii) (Supp. V 2011) ... 13
21 U.S.C. 355(o)(4)(A) (Supp. V 2011) ... 13
21 U.S.C. 355(o)(4)(E) (Supp. V 2011) ... 13
21 U.S.C. 355c(a)(2) ... 13
21 U.S.C. 356 ... 13
21 U.S.C. 356(b)(2)(A) ... 13
Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. No. 98-417, § 202, 98
Stat. 1585 ... 1
Public Health Service Act, 42 U.S.C. 262-263 ... 2
42 U.S.C. 262(a)(2)(D) (Supp. V 2011) ... 2, 14
42 U.S.C. 262(j) (2006 & Supp. V 2011) ... 2
35 U.S.C. 101 ... 6, 8, 21, 22
35 U.S.C. 271(a) ... 1
35 U.S.C. 271(b) ... 22
35 U.S.C. 271(c) ... 22
35 U.S.C. 271(e)(1) ... passim
21 C.F.R.:
Section 312.23(a)(5) ... 3
Section 312.23(a)(8) ... 3
Section 314.50 ... 3
Section 314.70(b) ... 14
Section 314.70(b)(3)(iv)-(v) ... 14
*V Section 314.80 ... 18
Section 314.500 ... 13
Section 600.80 ... 18
Miscellaneous:
Frank DeStefano et al., Childhood Vaccinations,
Vaccination Timing, and Risk of Type 1 Diabetes
Mellitus, 108 Pediatrics, Dec. 2001 ... 4
FDA, Postmarket Requirements and Commitments,
http://
www.accessdata.fda.gov/scripts/cder/pmc/index.cf
m (database last updated Nov. 2, 1012) ... 14
H.R. Rep. No. 857, 98th Cong., 2d Sess. (1984) ...
15
United States Patent:
No. 5,723,283 (filed Mar. 3, 1998) ... 3
No. 5,728,385 (filed Mar. 17, 1998) ... 5
No. 6,420,139 (filed July 16, 2002) ... 3, 22
No. 6,638,739 (filed Oct. 28, 2003) ... 3, 4, 22
No. 7,008,790 (filed Mar. 7, 2006) ... 5, 22
2012 WL 6206566 (U.S.) Page 2
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
*1 This brief is filed in response to the Court's order
inviting the Solicitor General to express the
views of the United States. In the view of the
United States, the petition for a writ of certiorari
should be denied.
STATEMENT
1. a. In general, “whoever without authority makes,
uses, offers to sell, or sells any patented invention
*** during the term of the patent therefor, infringes
the patent.” 35 U.S.C. 271(a). In 1984, as part of
the Drug Price Competition and Patent Term Restoration
Act (Hatch-Waxman Act), Congress created
an exemption from that general rule for certain
uses of patented inventions in the federal regulatory
process. Pub. L. No. 98-417, § 202, 98 Stat. 1585.
As amended, that exemption provides:
It shall not be an act of infringement to make, use,
offer to sell, or sell within the United States *2 ***
a patented invention *** solely for uses reasonably
related to the development and submission of information
under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary biological
products.
35 U.S.C. 271(e)(1).
b. The Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. 301 et seq., is a federal law that
“regulates the manufacture, use, or sale of drugs.”
See 21 U.S.C. 331, 355(a); Merck KGaA v. Integra
Lifesciences I, Ltd., 545 U.S. 193, 196 (2005); Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 668
(1990). Under the FDCA, a new drug may not be
introduced into interstate commerce until the Food
and Drug Administration (FDA) has determined
that the drug is both safe and effective. 21 U.S.C.
355(a) and (d). To enable the FDA to make that determination,
the drug's manufacturer must develop
and submit a variety of information to the agency.
See Merck, 545 U.S. at 196.[FN1]
FN1. This case involves vaccines, which
are regulated as “biological products” under
the Public Health Service Act, 42
U.S.C. 262, 263. The distinction between
drugs and biological products is not important
here, however, because a vaccine is
also a “drug” within the meaning of the
FDCA, see 21 U.S.C. 321(g)(1)(B), and
the Public Health Service Act relies extensively
on the FDCA's scheme governing
approval of new drugs by the FDA, see 42
U.S.C. 262(a)(2)(D) and (j) (2006 & Supp.
V 2011). The Public Health Service Act is
therefore another “Federal law which regulates
the manufacture, use, or sale of
drugs.” 35 U.S.C. 271(e)(1); see Eli Lilly,
496 U.S. at 668.
To obtain marketing approval for a new drug, a
manufacturer must first submit to the FDA an
“investigational” new drug application for approval
to conduct clinical trials (i.e., tests on humans). *3
21 U.S.C. 355(i). The application must include data
from pre-clinical research, including pharmacological
and toxicological studies, “adequate to justify
the proposed clinical testing.” 21 U.S.C.
355(i)(1)(A); see 21 C.F.R. 312.23(a)(5) and (8). If
the application is granted and clinical trials succeed,
the manufacturer must submit a “new drug”
application for approval in order to bring the drug
to market. 21 U.S.C. 355(a). That application must
include “full reports of investigations which have
been made” to establish the safety and effectiveness
of the drug, including all relevant clinical studies
and pre-clinical research. 21 U.S.C. 355(b)(1); see
21 C.F.R. 314.50.
A manufacturer wishing to market a generic equivalent
of a drug previously approved by the FDA
may file an abbreviated new drug application
(ANDA). 21 U.S.C. 355(j)(2)(A). Although the
ANDA process does not require the applicant to
make an independent showing of safety and effectiveness,
the applicant must submit information
demonstrating that the proposed generic product
has the same active ingredients, dosage form, route
of administration, and strength as the approved
drug, and that the generic and approved drugs are
2012 WL 6206566 (U.S.) Page 3
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
bioequivalent. 21 U.S.C. 355(j)(2)(A) and (8)(B);
see Merck, 545 U.S. at 196 n.1.
2. a. Respondent holds several United States patents
relating to methods of optimizing vaccine immunization
schedules, including United States Patent
Nos. 6,638,739 (filed Oct. 28, 2003) (the '739 patent);
6,420,139 (filed July 16, 2002) (the '139 patent);
and 5,723,283 (filed Mar. 3, 1998) (the '283
patent). Pet. App. 4a. According to the patents,
which identify Dr. John Barthelow Classen as the
sole inventor, the timing of infant immunizations
can affect the later development*4 of certain chronic
disorders, including diabetes, asthma, hay fever,
cancer, multiple sclerosis, and schizophrenia. Ibid.;
see, e.g., '739 patent, col. 7 ll. 39-45. The '739 and
'139 patents claim methods of immunization in
which potential schedules for administering a vaccine
are compared, the schedule associated with the
least risk of developing later occurring chronic disorders
is identified, and the vaccine is administered
to a mammalian subject according to that schedule.
Pet. App. 5a; see id. at 5a-6a (reproducing a representative
claim). The '283 patent claims the first
steps of that method - i.e., reviewing and comparing
information on the effects of different immunization
schedules - without the final step of administering
a vaccine. See id. at 7a.
b. In the late 1990s, in response to articles published
by Dr. Classen positing a relationship
between the timing of certain childhood vaccinations
and the onset of type 1 diabetes, the Centers
for Disease Control and Prevention (CDC)
sponsored an epidemiological study to evaluate Dr.
Classen's claims. In the study, researchers examined
the vaccination records and medical histories
of more than 1000 children who had received
medical care from four different HMOs. See generally
Frank DeStefano et al., Childhood Vaccinations,
Vaccination Timing, and Risk of Type 1 Diabetes
Mellitus, 108 Pediatrics, Dec. 2001 (the CDC
study) (C.A. App. A220-A225). A hepatitis B vaccine
manufactured by petitioner was among the
vaccines that had been administered to those children.
The resulting paper, published in 2001, found no
association between childhood vaccines and diabetes,
and it rejected as “unfounded” Dr. Classen's
contention “that diabetes risk in humans may be
altered by *5 changes in the timing of vaccinations
.” C.A. App. A225. In 2003, based in part on the
CDC study, the FDA denied a citizen petition submitted
by Dr. Classen, which requested that the labels
of certain childhood vaccines be amended to
warn of diabetes risk. Id. at A229-A237.
3. a. In 2004, respondent brought this patent infringement
action against petitioner and others. The
complaint alleged that the defendants had infringed
the '739, '139, and '283 patents by “participat[ing]
in, facilitat[ing] and/or otherwise conduct[ing]” the
CDC study, and by using the results of that and other
studies “to determine the administration protocol
for vaccinations.” C.A. App. A64 (Am. Compl.
para. 7).[FN2] Respondent additionally alleged that
the defendants had infringed its patents “through
the manufacture and supply of vaccines and by
providing instructions and/or recommendations on
a proper immunization schedule for vaccines and
by administration of vaccines according to the patented
method.” Id. at A72 (Am. Compl. para. 27).
[FN3]
FN2. Respondent also initially asserted infringement
of United States Patent No.
5,728,385 (filed Mar. 17, 1998), see C.A.
App. A73, but later dismissed that count
from the complaint, see 04-cv-2607 Docket
entry No. 92 (D. Md. Sept. 16, 2005). In
2012, after the court of appeals remanded
the case to the district court, respondent
amended its complaint to add infringement
claims under a fifth patent, United States
Patent No. 7,008,790 (filed Mar. 7, 2006)
(the '790 patent). See Docket entry No.
172.
FN3. Dr. Classen subsequently asserted in
a declaration that the CDC also infringes
2012 WL 6206566 (U.S.) Page 4
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
respondent's patents whenever the agency
evaluates the safety of vaccine administration
schedules. See Docket entry No.
135-1, at para. 7.
The district court dismissed respondent's claims
against petitioner on the ground that petitioner's *6
principal alleged acts of infringement concerned the
CDC study, which the court concluded was protected
conduct under Section 271(e)(1). Pet. App.
61a-64a. Citing this Court's then-recent decision in
Merck, the district court reasoned that petitioner's
“participation in a study evaluating risks associated
with various vaccination schedules was reasonably
related to the development and submission of information”
under the FDCA. Id. at 63a-64a.
The district court later granted summary judgment
in favor of all defendants, ruling that respondent's
patents are invalid under 35 U.S.C. 101 because
they are not directed to patent-eligible subject matter.
Pet. App. 10a. The court reasoned that the patents
describe little more than the abstract, mental
process of comparing the risks posed by different
vaccination schedules. Ibid.
b. The court of appeals affirmed the district court's
invalidity ruling in an unpublished order. 304 Fed.
Appx. 866 (2008). Because the court of appeals
held the patents invalid, it did not address the district
court's non-infringement ruling under Section
271(e)(1). Respondent filed a petition for a writ of
certiorari (No. 08-1509). While that petition was
pending, this Court issued its decision in Bilski v.
Kappos, 130 S. Ct. 3218 (2010). The Court subsequently
granted respondent's petition, vacated the
court of appeals' judgment, and remanded for reconsideration
in light of Bilski. 130 S. Ct. 3541
(2010).
4. A divided panel of the court of appeals affirmed
in part, vacated in part, and remanded to the district
court. Pet. App. 1a-57a.
a. The court of appeals first addressed the question
of patent-eligibility under 35 U.S.C. 101. Pet. *7
App. 4a-23a. The court affirmed the judgment of
invalidity as to the '283 patent, explaining that the
claimed method does not involve any practical application
of human knowledge but rather is
“directed to the abstract principle that variation in
immunization schedules may have consequences
for certain diseases.” Id. at 21a. The court reversed
the district court's invalidity ruling as to the '139
and '739 patents, however, because the methods
claimed in those patents “require the further act of
immunization in accordance with a lower-risk
schedule, thus moving from abstract scientific principle
to specific application.” Ibid.
The court of appeals also reversed the district
court's noninfringement ruling under 35 U.S.C.
271(e)(1), concluding that petitioner's role in the
CDC study did not come within the safe harbor provision.
Pet. App. 26a-30a. The court described Section
271(e)(1) as protecting only “activities conducted
to obtain pre-marketing approval of generic
counterparts of patented inventions, before patent
expiration.” Id. at 27a. The court therefore concluded
that the statute “does not apply to information
that may be routinely reported to the FDA,
long after marketing approval has been obtained.”
Ibid.
The court of appeals noted that the legislative history
of the Hatch-Waxman Act is “replete with
statements that the legislation concerns premarketing
approval of generic drugs.” Pet. App. 27a. The
court also observed that judicial decisions construing
Section 271(e)(1) have “appreciated” that the
statute is “directed to premarketing approval of
generic counterparts before patent expiration.” Id.
at 28a. Accordingly, the court of appeals reversed
the dismissal of the infringement claims against petitioner
because *8 petitioner's conduct was “not related
to producing information for” a new or generic
drug application and was “not a ‘phase of research’
possibly leading to marketing approval” of
a drug by the FDA. Id. at 29a.
b. Judge Moore dissented. Pet. App. 38a-57a. As an
initial matter, she would have held all of respond-
2012 WL 6206566 (U.S.) Page 5
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
ent's patent claims invalid under 35 U.S.C. 101. See
Pet. App. 43a (“[T]his case is not even close.”).
Judge Moore emphasized that the patents do not
“claim a method of treating a chronic immune-mediated
disorder by using a new and specific immunization
schedule.” Id. at 47a-48a. Rather, they “seek
to monopolize the process of discovery itself, albeit
limited to a single field.” Id. at 48a.
Judge Moore also dissented from the court of appeals'
conclusion that post-approval activities are
not entitled to the Section 271(e)(1) safe harbor.
Pet. App. 53a-57a. The majority's construction of
the safe harbor as “limited to pre-approval activities,”
she stated, is “contrary to the plain language
of the statute and Supreme Court precedent.” Id. at
53a. Observing that this Court in Merck “repeatedly
underscored the breadth of [Section 271(e)(1)'s]
text,” Judge Moore concluded that “the safe harbor
extends to all uses that are reasonably related to
submitting any information under the FDCA, including
information regarding post-approval uses.”
Id. at 54a.
Judge Moore explained, however, that her reading
of Section 271(e)(1) “dispose[d] of only some of
the allegations against [petitioner]” - those involving
petitioner's reporting of information to the
CDC. Pet. App. 55a-56a. Respondent also accused
petitioner of infringement through “the administration
of vaccines according to the patented method[
s].” Id. at 56a *9 (quoting Am. Compl. para.
27). Judge Moore concluded that, because petitioner
was not required “by law or regulation” to conduct
those vaccinations, such conduct did not
come-within the safe harbor. Ibid.
5. In August 2012, after the Court invited the Solicitor
General to express the views of the United
States in this case, the Federal Circuit issued its decision
in Momenta Pharmaceuticals, Inc. v. Amphastar
Pharmaceuticals, Inc., 686 F.3d 1348
(2012). In Momenta, a divided panel ruled that “the
plain language of [Section 271(e)(1)] is not restricted
to pre-approval activities.” Id. at 1358-1359.
The panel concluded that “post-approval studies
that are ‘reasonably related to the development and
submission of information under a Federal law
which regulates the manufacture, use, or sale of
drugs' fall within the scope of the [Section]
271(e)(1) safe harbor.” Id. at 1359.
In so holding, the court of appeals in Momenta distinguished
its decision in this case as standing only
for the proposition that Section 271(e)(1)'s safe harbor
“does not apply to information that may be
routinely reported to the FDA, long after marketing
approval has been obtained.” 686 F.3d at
1357-1358 (quoting Pet. App. 27a). According to
the Momenta majority, the court of appeals' decision
in this case “did not turn” on any “artificial
distinction” between pre- and post-approval activities.
Id. at 1358. Chief Judge Rader, dissenting in
Momenta, argued that the panel had misconstrued
the reasoning of its prior decision in this case and
had “come out the exact opposite way.” Id. at 1368.
On November 20, 2012, the Federal Circuit denied
rehearing en banc in Momenta. See 2012-1062
Docket entry No. 86.
*10 DISCUSSION
The court of appeals erred in stating that Section
271(e)(1)'s safe harbor encompasses only activities
undertaken to obtain the FDA's pre-marketing approval
of generic products. Congress not only contemplated
that drug manufacturers would conduct
post-approval scientific studies and clinical trials,
but specifically authorized the FDA to require such,
studies in a variety of circumstances. If such postapproval
studies involve the use of patented inventions
solely for uses reasonably related to the development
and submission of information to the FDA,
the plain language of Section 271(e)(1) precludes
any claim for patent infringement.
Nevertheless, there is no longer any practical need
for this Court's intervention in light of the Federal
Circuit's subsequent decision in Momenta Pharmaceuticals,
Inc. v. Amphastar Pharmaceuticals, Inc.,
686 F.3d 1348 (2012). The court in Momenta adopted
a narrowing construction of the ruling below
2012 WL 6206566 (U.S.) Page 6
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
and held that post-approval studies performed for
the FDA “fall within the scope of the [Section]
271(e)(1) safe harbor,” id. at 1359. In addition, this
case would provide a poor vehicle for the Court to
consider the application of Section 271(e)(1) to
post-approval activities, both because it is unclear
whether Section 271(e)(1) applies to patented research
methods, and because petitioner is not entitled
to the safe harbor even under a proper reading
of that provision. Further review therefore is not
warranted.
1. Section 271(e)(1) shields from patent-infringement
liability any use of a patented invention
“solely for uses reasonably related to the development
and submission of information under a Federal
law *11 which regulates the manufacture, use, or
sale of drugs.” 35 U.S.C. 271(e)(1). Although “the
contours of this provision are not exact in every respect,”
the statutory language “makes clear that it
provides a wide berth for the use of patented
[inventions] in activities related to the federal regulatory
process.” Merck KGaA v. Integra Lifesciences
I, Ltd., 545 U.S. 193, 202 (2005). In particular,
it is “apparent from the statutory text” that Section
271(e)(l)'s safe harbor “extends to all uses of
patented inventions that are reasonably related to
the development and submission of any information
under the FDCA.” Ibid. “There is simply no room
in the statute for excluding certain information
from the exemption on the basis of the phase of research
in which it is developed or the particular
submission in which it could be included.” Ibid.
The court below nevertheless declared that the statutory
safe harbor is “limited to activities conducted
to obtain pre-marketing approval of generic counterparts
of patented inventions, before patent expiration.”
Pet. App. 27a. That was error. As this Court
recognized in Merck, the statutory text contains no
such limitation. Nothing in the language of the statute
links the availability of Section 271(e)(1)'s safe
harbor to the timing of FDA marketing approval.
See Merck, 545 U.S. at 206 (“Congress did not limit
[section] 271(e)(1)'s safe harbor to the development
of information for inclusion in a submission
to the FDA.”).
Nor does anything in the statutory text limit the
safe harbor to information related to generic drugs.
See Merck, 545 U.S. at 206 (“Congress did not ***
create an exemption applicable only to the research
relevant to filing an ANDA for approval of a generic
drug.”). Indeed, the Court in Merck applied *12
the safe harbor provision to experiments that produced
the type of information required for the
FDA's consideration of new (rather than generic)
drug applications. See id. at 208. In Eli Lilly & Co.
v. Medtronic, Inc., 496 U.S. 661 (1990), the Court
likewise held that Section 271(e)(1) protects research
activities related not only to drugs, but also
to medical devices, which are also regulated under
the FDCA. See id. at 673-674. This Court's decisions
in Merck and Eli Lilly leave no room for the
court of appeals' belief that Section 271(e)(1) protects
only the “development of information for regulatory
approval of generic counterparts of patented
products.” Pet. App. 27a.
2. The court of appeals' conclusion that Section
271(e)(1)'s safe harbor protects only pre-approval
activities is especially misguided because Congress
expressly contemplated that, in a variety of circumstances,
drug manufacturers will conduct postapproval
research and will submit the results to the
FDA, either on their own initiative or in compliance
with FDA requirements. Although it may be more
difficult in the post-approval context to determine
whether a defendant's use of a patented invention
was “solely for uses reasonably related to the development
and submission of information” to the
FDA, 35 U.S.C. 271(e)(1) (emphasis added), nothing
in the statutory text warrants the court of appeals'
categorical exclusion of post-approval activity
from the safe harbor.
a. In some circumstances, Congress has authorized
the FDA to require manufacturers to conduct postapproval
scientific studies or clinical trials. For example,
if a manufacturer proposes a new drug for
the treatment of a serious or life-threatening medic-
2012 WL 6206566 (U.S.) Page 7
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
al condition for which existing treatments are inadequate,
*13 the FDA may designate the drug for
“fast track” review. See 21 U.S.C. 356; 21 C.F.R.
314.500. If preliminary indicia of safety and effectiveness
are present, the FDA may approve the drug
for marketing on an expedited basis, “subject to” a
requirement that the manufacturer “conduct appropriate
post-approval studies” to “validate” the
drug's safety and effectiveness. 21 U.S.C.
356(b)(2)(A). Similarly, if the FDA determines that
an existing drug would offer a meaningful therapeutic
benefit to children if it were appropriately
labeled for pediatric uses, the agency may order the
manufacturer to submit “data *** that are adequate
*** to assess the safety and effectiveness of the
drug” in children, including appropriate dosing regimens.
21 U.S.C. 355c(a)(2)(A).
The FDA may also require post-approval studies
and clinical trials to determine whether, in light of
new safety-related information, existing drugs
should be withdrawn from the market or should
carry different or more prominent warnings. See 21
U.S.C. 355(e) (authorizing Secretary to withdraw
approval based on “new evidence” that drug is not
safe for use); 21 U.S.C. 355(o)(4)(A) and (E)
(Supp. V 2011) (authorizing Secretary to require “a
labeling change as the Secretary deems appropriate
to address” new safety information). Manufacturers
have both business and legal incentives to respond
voluntarily to reports of unexpected safety problems
with their products. Those that undertake studies
and clinical trials to investigate safety-related
issues must file periodic reports with the FDA describing
their investigations. 21 U.S.C.
355(o)(3)(E)(ii) (Supp. V 2011). But if the FDA becomes
aware of new safety information indicating
that a drug poses a serious risk to human *14
health, it may require the manufacturer to undertake
post-approval studies and clinical trials if the manufacturer
fails to do so voluntarily. 21 U.S.C.
355(o)(3)(A) (Supp. V2011); see 42 U.S.C.
262(a)(2)(D) (Supp. V 2011). Since 2008, the FDA
has used this authority to require 249 post-approval
safety studies or clinical trials, based on new information
or other reasons. See FDA, Postmarket
Requirements and Commitments, http://
www.accessdata.fda.gov/scripts/cder/pmc/index.cf
m (database last updated Nov. 2, 2012).
Drug manufacturers voluntarily conduct postapproval
scientific studies or clinical trials in other
circumstances as well. For example, manufacturers
conduct such studies in order to prepare
“supplemental” new drug applications - applications
for the FDA's approval to change the formulation,
manufacturing method, or labeling of a drug.
See 21 C.F.R. 314.70(b). Such applications are
used when a manufacturer seeks the FDA's approval
of a new indication of an already approved drug.
The FDA evaluates such applications under the
same standards that apply to a completely new
drug. Thus, drug makers must justify the proposed
label change by submitting data from clinical trials
supporting the safety and effectiveness of the drug
for the new indication. 21 U.S.C. 355(a) and (d); 21
C.F.R. 314.70(b)(3)(iv)-(v). At any given time, a
drug maker therefore may be conducting clinical
trials for a drug and submitting the resulting information
to the FDA, even though the FDA has
previously approved the same drug to be marketed
for a different medical indication.
The FDCA thus unambiguously contemplates that
drug manufacturers will conduct post-approval scientific
studies or clinical trials for the purpose of
developing*15 and submitting information about
their products to the FDA. Such post-approval studies
serve the same essential function in the federal
regulatory process - ensuring the safety and effectiveness
of the drugs consumed by the American
public - as the pre-approval activities that the court
of appeals recognized are shielded by Section
271(e)(1). When the post-approval development
and submission of information to the FDA requires
the use of a patented invention, Section 271(e)(1)
insulates that research from liability for patent infringement.
b. The court of appeals identified nothing in the
statutory text that would justify the court's categor-
2012 WL 6206566 (U.S.) Page 8
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
ical ruling to the contrary. Instead, it rested its interpretation
principally on the legislative history of
Section 271(e)(1). The court emphasized that the
history is “replete with statements that the legislation
concerns premarketing approval of generic
drugs.” Pet. App. 27a; see id. at 27a-28a.
That observation is true but is unsurprising. As this
Court recognized in Eli Lilly, a principal object of
the Hatch-Waxman Act was to eliminate
“distortions” caused by the interaction of the patent
laws with the requirement of FDA pre-marketing
approval for generic drugs. 496 U.S. at 669. The legislative
history of Section 271(e)(1) therefore focuses
on the safe harbor's expected role in facilitating
market entry by generic drug manufacturers.
See, e.g., H.R. Rep. No. 857, 98th Cong., 2d Sess.
15 (1984). In addition, the purpose of the safe harbor
is to immunize conduct that would otherwise
constitute patent infringement. The practical value
of Section 271(e)(1) therefore is likely to be
greatest in the context of efforts by generic drug
manufacturers to obtain FDA approval for generic
*16 versions of other companies' patented drugs.
By contrast, because a brand-name manufacturer's
performance of additional studies on its own approved
drug is less likely to spawn allegations of
patent infringement, the question whether such conduct
falls within the safe harbor may have less
practical significance.
As this Court also recognized in Eli Lilly, however,
“t is not the law that a statute can have no effects
which are not explicitly mentioned in its legislative
history.” 496 U.S. at 669 n.2 (citation omitted). Indeed,
as the dissent below observed, “[n]one of the
legislative history cited by the majority ***
speak[s] to the question at issue here - whether the
statute as enacted also covers post-approval activities.”
Pet. App. 55a. On that question, “[t]he language
Congress chose to enact and that was signed
into law by the President is plain on its face. There
is no ‘pre-approval’ limitation.” Ibid. And “it is ultimately
the provisions of our laws rather than the
principal concerns of our legislators by which we
are governed.” Oncale v. Sundowner Offshore
Servs., Inc., 523 U.S. 75, 79 (1998).
c. Although the court of appeals grounded its holding
in the legislative history rather than in the statutory
text, respondent focuses (Br. in Opp. 9-10) on
the statutory term “solely” in defending the court of
appeals' limitation of the safe harbor provision to
pre-approval activities. In respondent's view, once a
drug maker has obtained the FDA's approval to
market a drug, any post-approval scientific study
concerning that drug cannot be “solely” for purposes
related to the development and submission of
information to the FDA because the drug maker is
also engaged in the ordinary commercial distribution
of the drug. That *17 argument rests on a misinterpretation
of the safe harbor provision.
Section 271(e)(1) states that “t shall not be an act
of infringement to make, use, offer to sell, or sell
*** a patented invention *** solely for uses reasonably
related to the development and submission of
information” under federal laws regulating drugs.
35 U.S.C. 271(e)(1). The word “solely” indicates
that, in applying the safe harbor, the court should
focus on the particular “use[]” that is alleged to be
an “act of infringement.” A particular “use[]” may
be “reasonably related to the development and submission
of information,” and therefore may fall
within the safe harbor, even if it serves other purposes
as well. Thus, a researcher's use of a patented
invention in conducting an experiment reasonably
related to the development and submission of information
to the FDA is protected by Section
271(e)(1), even if that experiment also advances
other commercial objectives, such as product development.
See Abtox, Inc. v. Exitron Corp., 122 F.3d
1019, 1030 (Fed. Cir. 1997). By contrast, if a defendant
makes multiple “uses” of a patented invention
(e.g., by selling a patented drug commercially
while simultaneously administering it to research
subjects during a controlled study), one “use []”
may provide a basis for infringement liability even
though the other falls within the safe harbor. See p.
18, infra.
2012 WL 6206566 (U.S.) Page 9
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
In the pre-approval context, determining whether a
defendant's use of a patented invention in drugdevelopment
research was “solely for uses reasonably
related to the development and submission of
information” to the FDA will normally be a
straightforward inquiry. In the post-approval context,
that inquiry*18 may be substantially more difficult
because the drug maker simultaneously may
be engaged in the ordinary commercial manufacture
and sale of the product in question. In such circumstances,
a more nuanced analysis is required. A
drug maker's use of a patented invention in routine
commercial activity is not immune from infringement
liability merely because, for example, the
company may periodically report adverse reactions
to the FDA. See 21 C.F.R. 314.80 and 600.80. That
is because the ordinary commercial exploitation of
a patented invention is not “reasonably related to
the development and submission of information”
for the FDA, even if such exploitation sometimes
generates information useful to the FDA. That conclusion
is reinforced by the ordinary meaning of the
statutory term “development,” which implies more
than merely the collection of information incidental
to commercial transactions.
In some cases, however, post-approval research
activities will fall squarely within the ambit of Section
271(e)(1). If the FDA has approved a drug for
acne, for example, and its manufacturer separately
conducts a clinical trial of the same drug as a treatment
for melanoma, the clinical trial (but not the
routine sales of the drug for acne treatment) will be
protected under the plain terms of the statute. Likewise,
if the FDA directs a manufacturer to conduct
a clinical trial of a blood pressure drug to determine
whether a different dosing regimen would mitigate
dangerous side effects of which the agency recently
became aware, see 21 U.S.C. 355(o)(3)(A) (Supp.
V 2011), that research will be protected from infringement
claims by Section 271(e)(1).
*19 3. Although the court of appeals erred in its interpretation
of Section 271(e)(1), this Court's review
is not warranted. The Federal Circuit has subsequently
interpreted the opinion below narrowly in
a manner that will cabin the adverse impact of that
decision. It is unclear, moreover, whether Section
271(e)(1) applies to patented research methods like
those at issue here. Finally, notwithstanding its
cramped understanding of the safe harbor, the court
of appeals reached the correct result in this case.
a. Although the decision below appeared seriously
to misconstrue Section 271(e)(1), the Federal Circuit
has since clarified that its ruling in this case
does not limit application of the safe harbor provision
to pre-approval activities relating to the marketing
of generic drugs. After the Court invited the
Solicitor General to express the views of the United
States in this case, the court of appeals recognized
that “the plain language of [Section 271(e)(1)] is
not restricted to pre-approval activities.” Momenta,
686 F.3d at 1358-1359; see id. at 1359
(“[P]ost-approval studies that are ‘reasonably related
to the development and submission of information
under a Federal law which regulates the manufacture,
use, or sale of drugs' fall within the scope
of the [Section] 271(e)(1) safe harbor.”). The court
of appeals explained that its decision in this case
“did not turn” on any “artificial distinction”
between pre- and post-approval activities. Id. at
1358. Instead, that decision held only that Section
271(e)(1)'s safe harbor “does not apply to information
that may be routinely reported to the FDA,
long after marketing approval has been obtained.”
Id. at 1357-1358 (quoting Pet. App. 27a).
*20 The Momenta court's interpretation of the opinion
below is not the most natural reading. Nevertheless,
the Federal Circuit has authoritatively construed
its earlier decision and has held, as a matter
of controlling circuit precedent, that Section
271(e)(1) is not limited to pre-approval activities
for generic drugs. See Momenta, 686 F.3d at
1358-1359 (“[T]he plain language of the statute is
not restricted to pre-approval activities.”); id. at
1355; see also 2012-1062 Docket entry No. 86
(Fed. Cir. Nov. 20, 2012) (denying petition for rehearing
en banc). The court of appeals has thus cor-
2012 WL 6206566 (U.S.) Page 10
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
rectly recognized that, if “the use of the patented
invention is done to generate information that will
be submitted pursuant to a relevant federal law, that
use falls within the safe harbor.” Momenta, 686
F.3d at 1360.[FN4] Accordingly, no practical reason
remains for this Court's intervention.
FN4. The Momenta court additionally held
that, for purposes of Section 271(e)(1), information
may be deemed “submitted” to
FDA if it is preserved in records that FDA
regulations require a drug manufacturer to
make available for inspection by FDA on
request. See 686 F.3d at 1357. We express
no view on the correctness of that conclusion
or of the court of appeals' ultimate
disposition of Momenta.
b. It is an open question whether Section 271(e)(1)
applies at all to patented research methods of the
kind at issue in this case. Although Section
271(e)(1) on its face encompasses any “patented invention,”
it is unclear whether Congress intended to
shield drug makers from claims of infringement
concerning patented research tools - i.e., devices,
substances, or processes, such as laboratory test
equipment or methods of chemical analysis, that are
used to study other substances*21 in order to generate
useful information. The Court in Merck specifically
reserved that question. 545 U.S. at 205 n.7.
And the Federal Circuit has since held that Section
271(e)(1) does not exempt from infringement
claims the use of a patented research apparatus. See
Proveris Scientific Corp. v. Innovasystems, Inc.,
536 F.3d 1256, 1265-1266 (2008). Respondent
could defend the court of appeals' judgment on that
alternative ground, see, e.g., Bennett v. Spear, 520
U.S. 154, 166 (1997), and resolution of that
threshold question in respondent's favor would obviate
the need (and the opportunity) for the Court to
decide the question presented.
c. Finally, even under a proper construction of Section
271(e)(1), the court of appeals did not err in reversing
the district court's safe harbor ruling.[FN5]
The district court believed that the safe harbor
barred any claim for patent infringement predicated
on petitioner's “participation” in the 2001 CDC
study. Pet. App. 63a-64a. That study, however, involved
only an after-the-fact examination by CDC
scientists of the vaccination records and medical
histories of children who had received vaccines
(including petitioner's vaccine) in the ordinary
course of their medical care. See C.A. App.
A220-A225 (CDC study). Although the CDC scientists'
evaluation was a use “reasonably related to
the development and submission of information” to
the FDA, petitioner “participated” in the study only
in the sense that, by manufacturing and selling the
administered*22 vaccines as part of its regular
business, it generated data that the CDC later examined.
The fact that public health authorities ultimately
gathered data about those sales does not
mean that petitioner's alleged infringement of respondent's
patents retroactively became
“reasonably related to the development and submission
of information” under the FDCA.
FN5. Because petitioner has not sought review
of the court of appeals' holding that
the ‘139 and ‘ 739 patents are valid, the
United States assumes for present purposes
that the patents are directed to patent-eligible
subject matter under 35 U.S.C. 101.
See pp. 6-7, supra.
The court of appeals' unanimous ruling that respondent's
'283 patent is invalid under 35 U.S.C.
101, see Pet. App. 20a-22a; id. at 40a-50a, makes it
particularly unlikely that a decision of this Court
clarifying the proper application of Section
271(e)(1) would affect the ultimate disposition of
this case. Because the methods claimed in the '283
patent did not require the step of actually immunizing
a patient, respondent could plausibly contend
that petitioner had infringed that patent simply by
evaluating the pertinent medical evidence in order
to determine appropriate dosing regimens. See id. at
25a. The court of appeals held the '283 patent invalid,
however, precisely because it claimed only “the
abstract principle that variation in immunization
2012 WL 6206566 (U.S.) Page 11
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
schedules may have consequences for certain diseases,”
without “any movement from principle to
application.” Id. at 21a.
All of the other patents asserted in this litigation require,
as the final step of the claimed methods, the
actual immunization of a patient. See '139 patent
claim 1; '739 patent claim 1; '790 patent claim 1. In
order to establish petitioner's liability for infringing
those patents, respondent must prove, inter alia,
either that petitioner performed actual immunizations,
or that it induced doctors and hospitals to do
so. See 35 U.S.C. 271(b) and (c). Respondent's
amended complaint alleged that petitioner had infringed
respondent's*23 patents “through the manufacture
and supply of vaccines *** and by administration
of vaccines according to the patented method.”
C.A. App. A72 (Am. Compl. para. 27); see
Pet. App. 56a (Moore, J., dissenting).
That allegation, which asserts that petitioner infringed
the patented methods in the routine conduct
of its business, does not implicate Section 271(e)(1)
. If petitioner or others provided actual immunizations
to patients (as opposed to research subjects) in
the course of performing respondent's claimed
methods, those “uses” of the patented invention
were not “ reasonably related to the development
and submission of information under” the federal
drug laws. 35 U.S.C. 271(e)(1). As the dissent below
explained, “[t]he fact that [petitioner] would
have to report to the FDA any adverse reaction after
administering a vaccine does not mean that the administration
itself is noninfringing.” Pet. App.
56a-57a.
Thus, if respondent can ultimately prove the facts
alleged in its complaint, and if those facts would
otherwise support a determination that petitioner infringed
the patents that remain at issue in this case,
Section 271(e)(1) would not insulate petitioner
from liability. This case therefore would not
provide the Court with the opportunity to interpret
Section 271(e)(1) against the backdrop of a genuine
claim of entitlement to the protection of the statutory
safe harbor.
*24 CONCLUSION
The petition for a writ of certiorari should be
denied.
GlaxoSmithKline v. Classen Immunotherapies, Inc.
2012 WL 6206566 (U.S. ) (Appellate Petition, Motion
and Filing )
END OF DOCUMENT
2012 WL 6206566 (U.S.) Page 12
© 2012 Thomson Reuters. No Claim to Orig. US Gov. Works.
AI
