I 
111TH CONGRESS 
1ST SESSION H. R. 1427 
To amend the Public Health Service Act to provide for the licensing of 
biosimilar and biogeneric biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 11, 2009 
Mr. WAXMAN (for himself, Mr. PALLONE, Mr. DEAL of Georgia, and Mrs. 
EMERSON) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend the Public Health Service Act to provide for 
the licensing of biosimilar and biogeneric biological prod-
ucts, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Promoting Innovation 
and Access to Life-Saving Medicine Act’’. 
SEC. 2. DEFINITIONS. 
(a) LICENSURE.—Section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i)) is amended— 
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(1) by striking ‘‘In this section, the term ‘bio-
logical product’ means’’ and inserting the following: 
‘‘In this section: 
‘‘(1) The term ‘biological product’ means’’; and 
(2) by adding at the end the following: 
‘‘(2) The term ‘abbreviated biological product 
application’ means an abbreviated application for a 
license of a biological product that relies in part on 
data or information in an application for another bi-
ological product licensed under this section or ap-
proved under section 505 of the Federal Food, 
Drug, and Cosmetic Act. 
‘‘(3) The term ‘reference product’ means the 
single licensed biological product, approved under 
subsection (a) or (k), against which a biological 
product is evaluated for demonstration of safety, po-
tency, or purity. 
‘‘(4) The term ‘final action’ means, with respect 
to an abbreviated biological product application, the 
Secretary’s issuance of a final action letter to the 
sponsor of an abbreviated biological product applica-
tion which— 
‘‘(A) approves the application; or 
‘‘(B) disapproves the application and sets 
forth in detail an enumeration of the specific 
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deficiencies in the particular application and of 
the specific, enumerated actions the sponsor 
would be required to take in order for the spon-
sor to receive a final action letter that approves 
such application. 
‘‘(5) The term ‘final action date’ means, with 
respect to an abbreviated biological product applica-
tion, the date by which the Secretary must take a 
final action on the application pursuant to sub-
section (k)(13). 
‘‘(6) The term ‘reviewing division’ means the 
division responsible for the review of an application 
for approval of a biological product (including all sci-
entific and medical matters, chemistry, manufac-
turing, and controls).’’. 
(b) FEES.— 
(1) RULE OF CONSTRUCTION.—The definition 
of a human drug application in section 735(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g(1)) shall be construed to include applications 
under section 351(k) of the Public Health Service 
Act, as added by section 3, in addition to applica-
tions under section 351(a) of such Act. 
(2) SUPPLEMENT.—Section 735(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
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379g(2)) is amended by adding at the end the fol-
lowing: ‘‘Notwithstanding the preceding sentence, 
any request for an interchangeability determination 
under section 351(k) of the Public Health Service 
Act shall be treated as a supplement for purposes of 
this part, irrespective of whether such request is in-
cluded in an application for licensure of a biological 
product or a subsequent submission.’’. 
SEC. 3. REGULATION OF BIOSIMILAR AND BIOGENERIC BI-
OLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262), as amended by section 2, 
is further amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘under 
this subsection or subsection (k)’’ after ‘‘biologics li-
cense’’; and 
(2) by adding at the end the following sub-
section: 
‘‘(k) REGULATION
OF
BIOSIMILAR
AND
INTER-
CHANGEABLE BIOLOGICAL PRODUCTS.— 
‘‘(1) BIOSIMILAR.—In this subsection, the term 
‘biosimilar’ or ‘biosimilarity’, in reference to a bio-
logical product, means no clinically meaningful dif-
ferences between the biological product and the ref-
erence product would be expected in terms of the 
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‘‘(A) Information demonstrating that the 
biological product and reference product contain 
highly similar molecular structural features, 
notwithstanding minor differences in hetero-
geneity profile, impurities, or degradation pat-
terns. 
‘‘(B) Information demonstrating that the 
biological product is biosimilar to (as defined in 
paragraph (1)) or interchangeable with (as de-
fined in paragraph (2)) the reference product 
for the condition or conditions of use pre-
scribed, recommended, or suggested in the pro-
posed labeling based upon, in the discretion of 
the Secretary— 
‘‘(i) information derived from chem-
ical, physical, and biological assays, and 
other non-clinical laboratory studies; and 
‘‘(ii) information from any necessary 
clinical study or studies sufficient to con-
firm safety, purity, and potency. 
Any studies under clause (ii) shall be designed 
to avoid duplicative and unethical clinical test-
ing. 
‘‘(C) Information demonstrating that the 
biological product and reference product utilize 
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the same mechanism or mechanisms of action 
for the condition or conditions of use pre-
scribed, recommended, or suggested in the pro-
posed labeling, but only to the extent the mech-
anism or mechanisms of action are known for 
the reference product or can reasonably be de-
termined. If the applicant seeks to rely on a 
demonstration of biosimilarity or interchange-
ability for a single condition of use to support 
approval of additional conditions of use that 
share the same mechanism or mechanisms of 
action, information demonstrating that such re-
liance is scientifically appropriate. 
‘‘(D) Information to show that the condi-
tion or conditions of use prescribed, rec-
ommended, or suggested in the proposed label-
ing for the biological product have been pre-
viously approved for the reference product. 
‘‘(E) Information to show that the route of 
administration, the dosage form, and the 
strength of the biological product are the same 
as those of the reference product. 
‘‘(F) Information demonstrating that the 
facility in which the biological product is manu-
factured, processed, packed, or held meets 
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standards designed to ensure that the biological 
product continues to be safe, pure, and potent. 
‘‘(4) OTHER APPLICATIONS.—Any person, in-
cluding a person who has not conducted and does 
not have a right of reference to the studies in the 
application for a reference product, may submit an 
abbreviated biological product application under this 
paragraph for a biological product that differs from, 
or incorporates a change to, the reference product 
with respect to one or more characteristics described 
in subparagraphs (A) through (E) of paragraph (3), 
including a difference in safety, purity, or potency, 
so long as the application contains sufficient infor-
mation to establish the safety, purity, and potency of 
the biological product for its proposed condition or 
conditions of use. 
‘‘(5) APPROVAL
OF
BIOSIMILAR
OR
INTER-
CHANGEABLE BIOLOGICAL PRODUCTS.— 
‘‘(A) 
DETERMINATION
OF
BIOSIMI-
LARITY.—Upon review of an application sub-
mitted under paragraph (3) for a biological 
product and any other information available to 
the Secretary, including information in the ap-
plication for the reference product, the Sec-
retary shall issue a biosimilar biological product 
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license for the conditions of use prescribed, rec-
ommended, or suggested in the proposed label-
ing for the product, unless the Secretary finds 
and informs the applicant (including provision 
of a detailed explanation) that— 
‘‘(i) information submitted in the ap-
plication and any other information avail-
able to the Secretary is insufficient to show 
that the biological product and the ref-
erence product contain highly similar mo-
lecular structural features, notwithstanding 
minor differences in heterogeneity profile, 
impurities, or degradation patterns; 
‘‘(ii) information submitted in the ap-
plication and any other information avail-
able to the Secretary is insufficient to show 
that the biological product is biosimilar to 
the reference product for the condition or 
conditions of use prescribed, recommended, 
or suggested in the labeling proposed in 
the application; 
‘‘(iii) information submitted in the ap-
plication and any other information avail-
able to the Secretary is insufficient to show 
that the biological product and reference 
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product utilize the same mechanism or 
mechanisms of action for the conditions of 
use prescribed, recommended, or suggested 
in the proposed labeling for the biological 
product, unless the mechanism or mecha-
nisms of action are not known and cannot 
reasonably be determined for the reference 
product for such condition or conditions; 
‘‘(iv) if the applicant has dem-
onstrated biosimilarity for a single condi-
tion of use sharing the same mechanism of 
action as other conditions of use of the ref-
erence product, and has sought approval of 
one or more such other conditions of use 
on the basis of such demonstration, infor-
mation submitted in the application and 
any other information available to the Sec-
retary is insufficient to show the safety, 
purity, and potency of one or more such 
other conditions of use; 
‘‘(v) information submitted in the ap-
plication and any other information avail-
able to the Secretary is insufficient to show 
that the route of administration, the dos-
age form, and the strength of the biological 
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product are the same as those of the ref-
erence product; 
‘‘(vi) information submitted in the ap-
plication and any other information avail-
able to the Secretary is insufficient to show 
that the condition or conditions of use pre-
scribed, recommended, or suggested in the 
proposed labeling for the biological product 
are limited to one or more of the same use 
or uses as have been previously approved 
for the reference product; 
‘‘(vii) information submitted in the 
application and any other information 
available to the Secretary shows (I) the in-
active ingredients of the biological product 
are unsafe for use under the conditions 
prescribed, recommended, or suggested in 
the proposed labeling for the biological 
product, or (II) the composition of the bio-
logical product is unsafe under such condi-
tions because of the type or quantity of in-
active ingredients included or the manner 
in which the inactive ingredients are in-
cluded; 
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‘‘(viii) information submitted in the 
application and any other information 
available to the Secretary fails to dem-
onstrate that the facility in which the bio-
logical product is manufactured, processed, 
packed, or held meets standards designed 
to ensure that the biological product con-
tinues to be safe, pure, and potent; 
‘‘(ix) the Secretary has, for reasons of 
safety, purity, or potency, other than rea-
sons that are unique to the reference prod-
uct— 
‘‘(I) withdrawn or suspended the 
license of the reference product; 
‘‘(II) published a notice of oppor-
tunity for hearing to withdraw such li-
cense; or 
‘‘(III) determined that the ref-
erence product has been withdrawn 
from sale; or 
‘‘(x) the application contains an un-
true statement of material fact. 
‘‘(B) DETERMINATIONS ON INTERCHANGE-
ABILITY.—Subject to subparagraph (C) and 
paragraph (11), upon issuing a product license 
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for a biological product under subparagraph 
(A), the Secretary shall make and publish one 
of the following determinations: 
‘‘(i) Such product is interchangeable 
with the reference product for one or more 
specified conditions of use prescribed, rec-
ommended, or suggested in the labeling of 
the biological product. 
‘‘(ii) Interchangeability has not been 
established, but the approved product is as 
safe and effective for its approved uses as 
the reference product. 
‘‘(C) DETERMINATION OF INTERCHANGE-
ABILITY
OF
SUBSEQUENT
BIOLOGICAL
PROD-
UCT.—If the Secretary determines that an ap-
plication meets the approval requirements of 
subparagraph (A), and, prior to the issuance of 
a product license, the Secretary has made a de-
termination of interchangeability of another bio-
logical product and the reference product for 
which the exclusivity period under paragraph 
(11) has not expired, the Secretary shall— 
‘‘(i) issue the product license for the 
subsequent biological product; and 
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‘‘(ii) defer issuing any determination 
of interchangeability as to the subsequent 
biological product and the reference prod-
uct until the exclusivity period under para-
graph (11) has expired. 
‘‘(6) DESIGNATION OF OFFICIAL NAME.— 
‘‘(A) IN GENERAL.—If, pursuant to section 
508 of the Federal Food, Drug, and Cosmetic 
Act, the Secretary determines that designation 
of an official name for a biosimilar biological 
product is necessary or desirable in the inter-
ests of usefulness or simplicity, the Secretary 
shall designate the same official name for the 
biosimilar biological product as the Secretary 
designated for the reference product. 
‘‘(B) LIMITATION.—This paragraph shall 
not apply to products approved under para-
graph (7). 
‘‘(C) REPORT
TO
CONGRESS.—Not later 
than 5 years after the date of the enactment of 
this subsection, the Comptroller General of the 
United States shall submit a report to the Con-
gress on public health and economic impacts as-
sociated with practices for designating the offi-
cial names of biosimilar biological products in 
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the United States and in other countries that 
approve biosimilar biological products. 
‘‘(7) OTHER APPROVAL PROVISIONS.—The Sec-
retary shall approve an application for a license sub-
mitted under paragraph (4) if the application and 
any other information available to the Secretary, in-
cluding information in the application for the ref-
erence product, are sufficient to establish the safety, 
purity, and potency of the biosimilar biological prod-
uct for the proposed condition or conditions of use 
for such product. 
‘‘(8) ESTABLISHING INTERCHANGEABILITY FOR 
BIOSIMILAR BIOLOGICAL PRODUCTS.— 
‘‘(A) IN GENERAL.—In an original applica-
tion or a supplement to an application under 
this subsection, an applicant may submit infor-
mation to the Secretary to demonstrate the 
interchangeability of a biosimilar biological 
product and the reference product. An applicant 
may withdraw a request for an interchange-
ability determination at any time. A request for 
an interchangeability determination submitted 
after the filing of an application shall be consid-
ered a major amendment to the application. Ex-
cept as provided in paragraph (11), nothing in 
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this subsection shall be construed to prohibit 
the Secretary from making a determination of 
interchangeability at any time after approval. 
‘‘(B) GUIDANCE.—Within 2 years after en-
actment of this subsection, the Secretary shall 
issue guidance regarding standards and require-
ments for interchangeability. The Secretary is 
authorized to make determinations of inter-
changeability under paragraph (5)(B) prior to 
issuing guidance under this subparagraph. 
‘‘(9) INTERCHANGEABILITY
LABELING
FOR 
INTERCHANGEABLE
BIOLOGICAL
PRODUCTS.—Ex-
cept as provided in paragraph (11), upon a deter-
mination of interchangeability, the Secretary shall, 
at the request of the applicant, provide for the label 
of the interchangeable biological product to include 
a statement that the biological product is inter-
changeable with the reference product for the condi-
tions of use prescribed, recommended, or suggested 
in the labeling for which interchangeability has been 
established. 
‘‘(10) DELAY OF APPROVAL.— 
‘‘(A) APPLICABLE DELAY PERIOD.— 
‘‘(i) 5-YEAR PERIOD.—If an applica-
tion under this subsection refers to a bio-
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logical product described in clause (i) of 
subparagraph (B), the Secretary may not 
approve such application before the expira-
tion of— 
‘‘(I) the 5-year period beginning 
on such product’s approval date; or 
‘‘(II) such period, as extended 
under subparagraph (D). 
‘‘(ii) 3-YEAR PERIOD.—If an applica-
tion under this subsection refers to a bio-
logical product described in subparagraph 
(C), the Secretary may not approve such 
application for the conditions of approval 
of such product before the expiration of— 
‘‘(I) the 3-year period beginning 
on such product’s approval date; or 
‘‘(II) such period, as extended 
under subparagraph (D) 
‘‘(B) NO MAJOR SUBSTANCE PREVIOUSLY 
APPROVED.— 
‘‘(i) IN GENERAL.—A biological prod-
uct is described in this clause if— 
‘‘(I) an application is submitted 
for such product under subsection (a); 
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‘‘(II) no major substance of the 
product, nor any highly similar major 
substance, has been approved in any 
other application under subsection (a); 
‘‘(III) the application submitted 
for such product is approved after the 
date of the enactment of this sub-
section; and 
‘‘(IV) the application submitted 
for such product could not and did 
not rely on any clinical safety, purity, 
or potency study in any other applica-
tion approved under this section or 
any clinical safety or effectiveness 
study in any application approved 
under section 505 of the Federal 
Food, Drug, and Cosmetic Act. 
‘‘(ii) EXCLUSIONS.—Biological prod-
ucts not described in clause (i) include the 
following: 
‘‘(I) Protein biological products 
that differ in structure solely due to 
post-translational events, infidelity of 
translation or transcription, or minor 
differences in amino acid sequence. 
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‘‘(II) Polysaccharide biological 
products with similar saccharide re-
peating units, even if the number of 
units differ and even if there are dif-
ferences in post-polymerization modi-
fications. 
‘‘(III) Glycosylated protein prod-
ucts that differ in structure solely due 
to post-translational events, infidelity 
of translation or transcription, or 
minor differences in amino acid se-
quence, and if they had similar sac-
charide repeating units, even if the 
number of units differ and even if 
there were differences in post-polym-
erization modifications. 
‘‘(IV) Polynucleotide biological 
products with identical sequence of 
purine and pyrimidine bases (or their 
derivatives) bound to an identical 
sugar backbone (ribose, deoxyribose, 
or modifications of these sugars). 
‘‘(V) Closely related, complex 
partly definable biological products 
with similar therapeutic intent, such 
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as live viral products for the same in-
dication. 
The Secretary may by regulation identify 
additional biological products not described 
in clause (i). 
‘‘(C) MAJOR SUBSTANCE PREVIOUSLY AP-
PROVED.—A biological product is described in 
this subparagraph if— 
‘‘(i) an application is submitted for 
such product under subsection (a); 
‘‘(ii) such product includes a major 
substance that has been approved in an-
other application under subsection (a), or 
any highly similar major substance; 
‘‘(iii) the application submitted for 
such product is approved after the date of 
the enactment of this subsection; 
‘‘(iv) the application submitted for 
such product contains reports of new clin-
ical investigations (other than pharmaco-
kinetic or pharmacodynamic studies) es-
sential to the approval of the application 
and conducted or sponsored by the appli-
cant; and 
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‘‘(v) the product represents a signifi-
cant therapeutic advance, which may in-
clude demonstration of safety, purity, and 
potency for a significant new indication or 
subpopulation, other than a pediatric sub-
population. 
‘‘(D)(i) SUPPLEMENT.—If a supplement to 
an application approved under subsection (a) is 
approved no later than 1 year before the expira-
tion of a period to which the applicant is enti-
tled under subparagraph (A), the period de-
scribed in subparagraph (A) shall, except as 
provided in clause (ii), be extended by 6 months 
if— 
‘‘(I) the supplement contains reports 
of new clinical investigations (other than 
pharmacokinetic 
or 
pharmacodynamic 
studies) essential to the approval of the 
supplement and conducted or sponsored by 
the person submitting the supplement; and 
‘‘(II) the change provides a significant 
therapeutic advance, which may include 
demonstration of safety, purity, and po-
tency for a significant new indication or 
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subpopulation, other than a pediatric sub-
population. 
‘‘(ii) ADJUSTMENT.—Any period of market 
exclusivity extended under subclause (I) or (II) 
of clause (i) for a biological product shall be re-
duced by 3 months if the organization des-
ignated under subparagraph (E) notifies the 
Secretary that, with respect to any major sub-
stance contained in the biological product, the 
combined annual gross sales in the United 
States for all biological products— 
‘‘(I) containing the major substance; 
and 
‘‘(II) owned or marketed by the appli-
cant or its affiliates; 
exceeded $1,000,000,000 in the calendar year 
preceding approval of the supplement involved. 
‘‘(iii) LIMITATION.—Only one extension 
under this subparagraph may be granted for 
any biological product. 
‘‘(E)(i) 
DESIGNATION.—The 
Secretary 
shall designate an organization other than the 
Food and Drug Administration to make the de-
termination of combined annual gross sales de-
scribed in clause (ii). Prior to designating such 
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organization, the Secretary shall determine that 
such organization is independent and is quali-
fied to evaluate the sales of pharmaceutical 
products. The Secretary shall re-evaluate the 
designation of such organization once every 3 
years. 
‘‘(ii) 
NOTIFICATION.—The 
organization 
designated under clause (i) shall— 
‘‘(I) determine, with respect to each 
major substance contained in each biologi-
cal product that is the subject of a pending 
supplement under subparagraph (D)(i), the 
amount of the combined annual gross sales 
in the United States in the preceding cal-
endar year for all biological products— 
‘‘(aa) containing the major sub-
stance; and 
‘‘(bb) owned or marketed by the 
applicant or its affiliates; and 
‘‘(II) notify the Secretary of such de-
termination. 
‘‘(F) DEFINITION.—In this paragraph, the 
term ‘approval date’ means the date of approval 
of an application for the biological product 
under subsection (a). 
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‘‘(11) EXCLUSIVITY.— 
‘‘(A) IN GENERAL.—Upon review of an ab-
breviated biological product application relying 
on the same reference product for which a prior 
biological product has received a determination 
of interchangeability for any condition of use, 
the Secretary shall not make a determination 
under paragraph (5)(B) that the second or sub-
sequent biological product is interchangeable for 
any condition of use, and no holder of a biologi-
cal product license approved under subsection 
(a) shall manufacture, market, sell, or dis-
tribute a rebranded interchangeable biological 
product, directly or indirectly, or authorize any 
other person to manufacture, market, sell, or 
distribute a rebranded interchangeable biologi-
cal product, for any condition of use, until the 
earlier of— 
‘‘(i) 180 days after the first commer-
cial marketing of the first interchangeable 
biological product to be approved as inter-
changeable for that reference product; 
‘‘(ii) one year after— 
‘‘(I) a final court decision in 
favor of the applicant on all patents in 
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suit in an action instituted under 
paragraph (18)(C) against the appli-
cant that submitted the application 
for the first approved interchangeable 
biological product; or 
‘‘(II) the dismissal with or with-
out prejudice of an action instituted 
under paragraph (18)(C) against the 
applicant that submitted the applica-
tion for the first approved inter-
changeable biological product; or 
‘‘(iii)(I) 36 months after approval of 
the first interchangeable biological product 
if the applicant has been sued under para-
graph (18)(C) and such litigation is still 
ongoing within such 36-month period; or 
‘‘(II) one year after approval in the 
event that the first approved interchange-
able biological product applicant has not 
been sued under paragraph (18)(C). 
For purposes of this subparagraph, the 
term ‘final court decision’ means a final 
decision of a court from which no appeal 
(other than a petition to the United States 
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Supreme Court for a writ of certiorari) has 
been or can be taken. 
‘‘(B) REBRANDED INTERCHANGEABLE BI-
OLOGICAL PRODUCT.—For purposes of this sub-
section, the term ‘rebranded interchangeable bi-
ological product’— 
‘‘(i) means any rebranded inter-
changeable version of the reference product 
involved that the holder of the biological 
product license approved under subsection 
(a) for that reference product seeks to 
commence marketing, selling, or distrib-
uting, directly or indirectly; and 
‘‘(ii) does not include any product to 
be marketed, sold, or distributed— 
‘‘(I) by an entity eligible for ex-
clusivity with respect to such product 
under this paragraph; or 
‘‘(II) after expiration of any ex-
clusivity with respect to such product 
under this paragraph. 
‘‘(12) HEARING.—If the Secretary decides to 
disapprove an abbreviated biological product applica-
tion, the Secretary shall give the applicant notice of 
an opportunity for a hearing before the Secretary on 
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the question of whether such application is approv-
able. If the applicant elects to accept the opportunity 
for hearing by written request within 30 days after 
such notice, such hearing shall commence not more 
than 90 days after the expiration of such 30 days 
unless the Secretary and the applicant otherwise 
agree. Any such hearing shall thereafter be con-
ducted on an expedited basis, and the Secretary’s 
order thereon shall be issued within 90 days after 
the date fixed by the Secretary for filing final briefs. 
‘‘(13) FINAL ACTION DATE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
take a final action on an abbreviated biological 
product application by the date that is 10 cal-
endar months following the sponsor’s submis-
sion of such application, or 180 days following 
the Secretary’s notification to the applicant that 
its application has been accepted for filing, 
whichever is earlier. 
‘‘(B) EXTENSION.—The final action date 
provided by subparagraph (A) with respect to 
an application may be extended for such period 
of time as is agreed to by the Secretary and the 
applicant in a jointly executed written agree-
ment that is counter-signed by the Secretary 
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and the applicant no later than 30 days prior 
to— 
‘‘(i) such final action date; or 
‘‘(ii) the date on which any prior ex-
tension under this subparagraph expires. 
‘‘(14) REQUEST
FOR
DELAY
OF
FINAL
AC-
TION.—Subject to paragraph (19)(A)(i) and not-
withstanding any other provision of law, the Sec-
retary shall not fail or refuse to take a final action 
on an abbreviated biological product application by 
the final action date on the basis that a person, 
other than the biosimilar biological product appli-
cant, has requested (in a petition or otherwise) that 
the Secretary refuse to take or otherwise defer such 
final action, and no court shall enjoin the Secretary 
from taking final action or stay the effect of final 
action previously taken by the Secretary, except by 
issuance of a permanent injunction based upon an 
express finding of clear and convincing evidence that 
the person seeking to have the Secretary refuse to 
take or otherwise to defer final action by the final 
action date— 
‘‘(A) has prevailed on the merits of the 
person’s complaint against the Secretary; 
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‘‘(B) will suffer imminent and actual irrep-
arable injury, constituting more than irrecover-
able economic loss, and that also will threaten 
imminent destruction of such person’s business; 
and 
‘‘(C) has an interest that outweighs the 
overwhelming interest that the public has in ob-
taining prompt access to a biosimilar biological 
product. 
‘‘(15) REPORT ON EXTENSIONS OF FINAL AC-
TION DATE.—The Secretary shall prepare and sub-
mit to the President, the Committee on Energy and 
Commerce of the House of Representatives, and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a report regarding any jointly 
executed written agreement to extend the final ac-
tion date under this Act within 15 calendar days 
after the joint execution of any such written agree-
ment. 
‘‘(16) REPORT ON FAILURE TO TAKE FINAL AC-
TION.—The Secretary shall prepare and submit an-
nually to the President, the Committee on Energy 
and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate a report detailing the specific 
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and particularized reasons enumerated by the re-
viewing division for each instance of the Secretary’s 
failure to take final action by the final action date 
in the previous year. 
‘‘(17) REGULATIONS.—The Secretary shall es-
tablish, by regulation within 2 years after the date 
of the enactment of this subsection, requirements for 
the efficient review, approval, suspension, and rev-
ocation of abbreviated biological product applications 
under this subsection. The Secretary may not use 
the absence of final regulations as a basis for the 
Secretary to fail to act on an application submitted 
under this subsection. 
‘‘(18) PATENTS.— 
‘‘(A) REQUEST
FOR
PATENT
INFORMA-
TION.— 
‘‘(i) IN GENERAL.—At any time, in-
cluding at the initial stages of develop-
ment, an applicant or a prospective appli-
cant under this subsection may send a 
written request for patent information to 
the holder of the approved application for 
the reference product. The holder of the 
approved application for the reference 
product shall, not later than 60 days after 
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the date on which the holder receives the 
request, provide to the applicant or pro-
spective applicant a list of all those patents 
owned by, licensed to, or otherwise under 
the control of, the holder of the approved 
application that the holder believes in good 
faith relate to the reference product, in-
cluding patents that claim the approved bi-
ological product, any formulation of such 
product, any method of using such prod-
uct, any component of such product, or 
any method or process that can be used to 
manufacture such product or component, 
regardless of whether that method or proc-
ess is used to manufacture the reference 
product. 
‘‘(ii) UPDATES.—For a period of 2 
years beginning on the date on which the 
holder of the approved application for the 
reference product receives the request for 
information, the holder shall send to the 
applicant or prospective applicant updates 
of its response to the request for informa-
tion by identifying all relevant patents 
issued or licensed to the holder after the 
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initial response under clause (i). Any such 
update must be provided, in the case of a 
new patent, not later than 30 days after 
the date on which the patent is issued and, 
in the case of a license, not later than 30 
days after the date on which the holder ob-
tains the license. 
‘‘(iii) ADDITIONAL
REQUESTS.—The 
applicant may submit additional requests 
under clause (i) for patent information, 
and each such request shall be subject to 
the requirements of this paragraph. 
‘‘(iv) 
NOTIFICATION
TO
PATENT 
HOLDER.—Within 30 days of receiving a 
request under this subparagraph, the hold-
er of the approved application for the ref-
erence product shall give notice of such re-
quest to the owner of any patent licensed 
to, or otherwise under the control of, the 
holder that is identified by the holder pur-
suant to clause (i). 
‘‘(B) PATENT
NOTIFICATIONS.—At any 
time after submitting an application under this 
subsection, the applicant may provide a notice 
of the application with respect to any one or 
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‘‘(I) has not brought an action 
for infringement under subparagraph 
(C); or 
‘‘(II) has brought an action for 
infringement under subparagraph (C), 
but subsequently dismissed that ac-
tion without prejudice; 
the applicant may bring an action for a de-
claratory judgment under section 2201 of 
title 28, United States Code, that such 
patent is invalid or not infringed by the bi-
ological product at issue. 
‘‘(ii) CASE
OR
CONTROVERSY.—The 
courts of the United States shall have, and 
shall exercise, subject matter jurisdiction 
to hear such an action to the full extent 
permitted by Article III of the Constitu-
tion. 
‘‘(F) DISCRETION
OF
APPLICANTS.—An 
applicant or prospective applicant for a bio-
similar biological product under this subsection 
may not be compelled, by court order or other-
wise, to initiate the procedures set forth in this 
paragraph. Nothing in this paragraph requires 
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an applicant or a prospective applicant to in-
voke the procedures set forth in this paragraph. 
‘‘(19) PETITIONS AND CIVIL ACTIONS REGARD-
ING APPROVAL OF CERTAIN APPLICATIONS.— 
‘‘(A) IN
GENERAL.—With respect to a 
pending application submitted under paragraph 
(3) or (4), if a petition is submitted to the Sec-
retary that seeks to have the Secretary take, or 
refrain from taking, any form of action relating 
to the approval of the application, including a 
delay in the effective date of the application, 
the following applies, subject to subparagraph 
(E): 
‘‘(i)(I) The Secretary may not, on the 
basis of the petition, delay approval of the 
application unless the Secretary deter-
mines, within 30 days after receiving the 
petition, that a delay is necessary to pro-
tect the public health. Consideration of a 
petition shall be separate and apart from 
the review and approval of the application. 
‘‘(II) With respect to a determination 
by the Secretary under subclause (I) that 
a delay is necessary to protect the public 
health: 
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‘‘(aa) The Secretary shall publish 
on the Internet site of the Food and 
Drug Administration a statement pro-
viding the reasons underlying the de-
termination. 
‘‘(bb) Not later than 10 days 
after making the determination, the 
Secretary shall provide notice to the 
sponsor of the application and an op-
portunity for a meeting with the Com-
missioner to discuss the determina-
tion. 
‘‘(ii) The Secretary shall take final 
agency action on the petition not later 
than 180 days after the date on which the 
petition is submitted. The Secretary shall 
not extend such period, even with the con-
sent of the petitioner, for any reason, in-
cluding based upon the submission of com-
ments relating to the petition or supple-
mental information supplied by the peti-
tioner. 
‘‘(iii) The Secretary may not consider 
the petition for review unless it is signed 
and contains the following verification: ‘I 
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certify that, to my best knowledge and be-
lief: (a) this petition includes all informa-
tion and views upon which the petition re-
lies; (b) this petition includes representa-
tive data and/or information known to the 
petitioner which are unfavorable to the pe-
tition; and (c) I have taken reasonable 
steps to ensure that any representative 
data and/or information which are unfavor-
able to the petition were disclosed to me. 
I further certify that the information upon 
which I have based the action requested 
herein first became known to the party on 
whose behalf this petition is submitted on 
or about the following date: [lll]. I re-
ceived or expect to receive payments, in-
cluding cash and other forms of consider-
ation, from the following persons or orga-
nizations to file this petition: [lll]. I 
verify under penalty of perjury that the 
foregoing is true and correct.’. 
‘‘(B) DENIAL
BASED
ON
INTENT
TO 
DELAY.—If the Secretary determines that a pe-
tition or supplement to the petition was sub-
mitted with the primary purpose of delaying the 
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licensure or the approval of a condition of use 
for a biological product, the Secretary may deny 
the petition at any point based on such deter-
mination. The Secretary may issue guidance to 
describe the factors that will be used to deter-
mine under this subparagraph whether a peti-
tion is submitted with the primary purpose of 
delaying the approval of an application. 
‘‘(C) EXHAUSTION
OF
ADMINISTRATIVE 
REMEDIES.— 
‘‘(i) FINAL AGENCY ACTION WITHIN 
180 DAYS.—The Secretary shall be consid-
ered to have taken final agency action on 
a petition referred to in subparagraph (A) 
if— 
‘‘(I) during the 180-day period 
referred to in clause (ii) of such sub-
paragraph, the Secretary makes a 
final decision within the meaning of 
section 10.45(d) of title 21, Code of 
Federal Regulations (or any successor 
regulations); or 
‘‘(II) such period expires without 
the Secretary having made such a 
final decision, in which case the peti-
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tion shall be deemed to have been de-
nied. 
‘‘(ii) DISMISSAL
OF
CERTAIN
CIVIL 
ACTIONS.—If a civil action is filed with re-
spect to a petition referred to in subpara-
graph (A) before final agency action within 
the meaning of clause (i) has occurred, the 
court shall dismiss the action for failure to 
exhaust administrative remedies. 
‘‘(D) APPLICABILITY OF CERTAIN REGULA-
TIONS.—The provisions of this section are in 
addition to the requirements for the submission 
of a petition to the Secretary that apply under 
section 10.30 or 10.35 of title 21, Code of Fed-
eral Regulations (or any successor regulations). 
‘‘(E) ANNUAL REPORT ON DELAYS IN AP-
PROVALS PER PETITIONS.—The Secretary shall 
annually submit to the Congress a report that 
specifies— 
‘‘(i) the number of applications under 
this subsection that were approved during 
the preceding 12-month period; 
‘‘(ii) the number of such applications 
whose effective dates were delayed by peti-
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tions referred to in subparagraph (A) dur-
ing such period; and 
‘‘(iii) the number of days by which the 
applications were so delayed. 
‘‘(F) EXCEPTION.—This paragraph does 
not apply to a petition that is made by the 
sponsor of an application under this subsection 
and that seeks only to have the Secretary take 
or refrain from taking any form of action with 
respect to that application. 
‘‘(G) DEFINITION.—For purposes of this 
paragraph, the term ‘petition’ includes any re-
quest to the Secretary, without regard to 
whether the request is characterized as a peti-
tion. 
‘‘(20) AUTHORIZATION OF APPROPRIATIONS.— 
To carry out this subsection, there are authorized to 
be appropriated such sums as may be necessary for 
fiscal years 2010 and 2011.’’. 
(b) ADDITIONAL AMENDMENTS.— 
(1) VENUE.—Section 1404 of title 28, United 
States Code, is amended by adding at the end the 
following: 
‘‘(e) VENUE IN CERTAIN PATENT INFRINGEMENT 
DISPUTES.— 
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‘‘(1) IN GENERAL.—In any action for patent in-
fringement brought by the holder or owner of the 
patent pursuant to section 351(k)(18)(C) of the 
Public Health Service Act, the defendant may move 
to transfer the action to any other district in which 
jurisdiction is proper. 
‘‘(2) TIMING.—The schedule applicable to a 
motion under paragraph (1) is as follows: 
‘‘(A) A motion under paragraph (1) shall 
be filed by the defendant no later than 45 days 
after service of the complaint. 
‘‘(B) A response to such a motion, if any, 
shall be filed no later than 20 days after service 
of the motion. 
‘‘(C) A reply to such response, if any, shall 
be filed no later than 10 days after service of 
the response. 
‘‘(D) The schedule set forth in this para-
graph may be modified only by agreement of all 
parties. 
‘‘(3) RESOLUTION.—When ruling on any mo-
tion filed under paragraph (2), the greatest weight 
shall be given to the following factors: 
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‘‘(A) The interest in identifying a district 
court in which the case will be adjudicated ex-
peditiously. 
‘‘(B) The strong public interest in obtain-
ing prompt judicial resolution of patent dis-
putes so that the biological product which is the 
subject of the patent dispute may be brought to 
market as expeditiously as possible, consistent 
with fair and prompt resolution of patent dis-
putes. 
‘‘(4) NO DELAY.—An action described in para-
graph (1) shall proceed as expeditiously as possible 
while the court considers a motion under this sub-
section, and the court may not stay the proceedings 
because a motion under this subsection has been 
filed.’’. 
(2) PATENTS.—Section 271(e) of title 35, 
United States Code, is amended— 
(A) in paragraph (2)— 
(i) by striking ‘‘or’’ at the end of sub-
paragraph (A); 
(ii) by adding ‘‘or’’ at the end of sub-
paragraph (B); 
(iii) by inserting after subparagraph 
(B) the following: 
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‘‘(C) 
a 
notice 
described 
in 
section 
351(k)(18)(B) of the Public Health Service Act, 
but only with respect to a patent identified in 
such notice,’’; and 
(iv) in the matter following subpara-
graph (C) (as inserted by clause (iii) of 
this subparagraph), by inserting before the 
period the following: ‘‘, or if the notice de-
scribed in subparagraph (C) is provided in 
connection with an application to obtain a 
license to engage in the commercial manu-
facture, use, or sale of a biological product 
claimed in a patent or the use of which is 
claimed in a patent before the expiration of 
such patent’’; 
(B) by adding at the end the following 
paragraph: 
‘‘(6)(A) This paragraph applies in the case of 
a patent— 
‘‘(i) which is disclosed in a response to a 
request for patent information pursuant to sub-
paragraph (A) of section 351(k)(18) of the 
Public Health Service Act; 
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‘‘(ii) with respect to which a notice was 
provided pursuant to subparagraph (B) of such 
section; and 
‘‘(iii) for which an action for infringement 
of the patent— 
‘‘(I) was brought after the expiration 
of the 45-day period described in subpara-
graph (C) of such section; or 
‘‘(II) was brought before the expira-
tion of the 45-day period described in sub-
clause (I), but which was dismissed with-
out prejudice or was not prosecuted to 
judgment in good faith. 
‘‘(B) In an action for infringement of a patent 
described in subparagraph (A), the sole and exclu-
sive remedy that may be granted by a court, upon 
a finding that the person who submitted the notice 
described in subparagraph (A)(ii) infringed the pat-
ent, or that any person induced or contributed to in-
fringement of the patent, shall be a reasonable roy-
alty. 
‘‘(C) The owner or licensee of a patent that 
should have been disclosed in response to a request 
for patent information made by an applicant pursu-
ant to subparagraph (A) of section 351(k)(18) of 
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the Public Health Service Act, but that was not 
timely disclosed under that subparagraph, may not 
bring an action under this title for infringement of 
that patent.’’; 
(C) in paragraph (5)— 
(i) by adding ‘‘(A)’’ in front of 
‘‘Where’’; and 
(ii) by adding the following subpara-
graph: 
‘‘(B) Where a person has provided a notice 
described in subparagraph (B) of section 
351(k)(18) of the Public Health Service Act, 
and neither the holder for the approved biologi-
cal product or the owner of a patent identified 
in the notice brought an action for infringement 
of such patent before the expiration of 45 days 
after the date on which the notice was received, 
the courts of the United States shall, to the ex-
tent consistent with the Constitution, have and 
exercise subject matter jurisdiction in any ac-
tion brought by such person under section 2201 
of title 28 for a declaratory judgement that 
such patent is invalid or not infringed.’’; and 
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