355 
‘‘(ii) any patent, or any claim with re-
spect to a patent, included on the list pur-
suant to this paragraph with respect to the 
biological product subsequently determined 
to be invalid or unenforceable, within 30 
days of a determination of patent inva-
lidity. 
‘‘(2) PUBLICATION OF INFORMATION.— 
‘‘(A) IN GENERAL.—Within 1 year of the 
date of enactment of the Fair Care Act of 
2020, the Secretary shall publish and make 
available to the public a single, easily search-
able, list that includes— 
‘‘(i) the official and proprietary name 
of each biological product licensed under 
subsection (a) or (k), and of each biological 
product application approved under section 
505 of the Federal Food, Drug, and Cos-
metic Act and deemed to be a license for 
the biological product under this section on 
March 23, 2021; 
‘‘(ii) with respect to each biological 
product described in clause (i), each patent 
submitted in accordance with paragraph 
(1); 
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‘‘(iii) the date of licensure and appli-
cation number for each such biological 
product; 
‘‘(iv) the marketing status, dosage 
form, route of administration, strength, 
and, if applicable, reference product, for 
each such biological product; 
‘‘(v) the licensure status for each such 
biological product, including whether the li-
cense at the time of listing is approved, 
withdrawn, or revoked; 
‘‘(vi) any period of any exclusivity 
under subsection (k)(7)(A) or subsection 
(k)(7)(B) of this section or section 527 of 
the Federal Food, Drug, and Cosmetic 
Act, and any extension of such period in 
accordance with subsection (m) of this sec-
tion with respect to each such biological 
product, and the date on which such exclu-
sivity expires; 
‘‘(vii) information regarding any de-
termination related to biosimilarity or 
interchangeability for each such biological 
product; and 
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‘‘(viii) information regarding approved 
indications for each such biological prod-
uct, in such manner as the Secretary de-
termines appropriate. 
‘‘(B) UPDATES.—Every 30 days after the 
publication of the first list under subparagraph 
(A), the Secretary shall revise the list to in-
clude— 
‘‘(i)(I) each biological product licensed 
under subsection (a) or (k) during the 30- 
day period; and 
‘‘(II) with respect to each biological 
product described in subclause (I), the in-
formation described in clauses (i) through 
(viii) of subparagraph (A); and 
‘‘(ii) any updates to information pre-
viously published in accordance with sub-
paragraph (A). 
‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 
In this section, a ‘patent required to be disclosed’ is 
any patent for which the holder of a biological prod-
uct license approved under subsection (a) or (k), or 
a biological product application approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act and deemed to be a license for a biological prod-
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358 
uct under this section on March 23, 2021, believes 
a claim of patent infringement could reasonably be 
asserted by the holder, or by a patent owner that 
has granted an exclusive license to the holder with 
respect to the biological product that is the subject 
of such license, if a person not licensed by the holder 
engaged in the making, using, offering to sell, sell-
ing, or importing into the United States of the bio-
logical product that is the subject of such license.’’. 
(b) 
DISCLOSURE
OF
PATENTS.—Section 
351(l)(3)(A)(i) of the Public Health Service Act (42 
U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 
in the list provided by the reference product sponsor under 
subsection (o)(1)’’ after ‘‘a list of patents’’. 
(c) RESTRICTION ON CLAIMS OF PATENT INFRINGE-
MENT.—Section 271(e) of title 35, United States Code, 
is amended by adding at the end the following: 
‘‘(7) The owner of a patent that should have 
been included in the list described in section 
351(o)(1) of the Public Health Service Act (42 
U.S.C. 262(o)(1)), including any updates required 
under subparagraph (C) of that section, but was not 
timely included in such list, may not bring an action 
under this section for infringement of the patent.’’. 
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359 
(d) REGULATIONS.—The Secretary of Health and 
Human Services may promulgate regulations to carry out 
subsection (o) of section 351 of the Public Health Service 
Act (42 U.S.C. 262), as added by subsection (a). 
(e) RULE OF CONSTRUCTION.—Nothing in this Act, 
including an amendment made by this Act, shall be con-
strued to require or allow the Secretary of Health and 
Human Services to delay the licensing of a biological prod-
uct under section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
SEC. 362. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the 
end the following: 
‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT 
TO PATENTS.— 
‘‘(1) APPROVED APPLICATION HOLDER LISTING 
REQUIREMENTS.— 
‘‘(A) IN GENERAL.—Beginning on the date 
of enactment of the Fair Care Act of 2020, 
within 60 days of approval of an application 
under subsection (a) or (k), the holder of such 
approved application shall submit to the Sec-
retary a list of each patent required to be dis-
closed (as described in paragraph (3)). 
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‘‘(B) 
PREVIOUSLY
APPROVED
OR
LI-
CENSED BIOLOGICAL PRODUCTS.— 
‘‘(i) PRODUCTS
LICENSED
UNDER 
SECTION
351
OF
THE
PHSA.—Not later 
than 30 days after the date of enactment 
of the Fair Care Act of 2020, the holder 
of a biological product license that was ap-
proved under subsection (a) or (k) before 
the date of enactment of such Act shall 
submit to the Secretary a list of each pat-
ent required to be disclosed (as described 
in paragraph (3)). 
‘‘(ii) PRODUCTS
APPROVED
UNDER 
SECTION 505 OF THE FFDCA.—Not later 
than 30 days after March 23, 2020, the 
holder of an approved application for a bio-
logical product under section 505 of the 
Federal Food, Drug, and Cosmetic Act 
that is deemed to be a license for the bio-
logical product under this section on 
March 23, 2020, shall submit to the Sec-
retary a list of each patent required to be 
disclosed (as described in paragraph (3)). 
‘‘(C) UPDATES.—The holder of a biological 
product license that is the subject of an applica-
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361 
tion under subsection (a) or (k) shall submit to 
the Secretary a list that includes— 
‘‘(i) any patent not previously re-
quired to be disclosed (as described in 
paragraph (3)) under subparagraph (A) or 
(B), as applicable, within 30 days of the 
earlier of— 
‘‘(I) the date of issuance of such 
patent by the United States Patent 
and Trademark Office; or 
‘‘(II) the date of approval of a 
supplemental application for the bio-
logical product; and 
‘‘(ii) any patent, or any claim with re-
spect to a patent, included on the list pur-
suant to this paragraph, that the Patent 
Trial and Appeal Board of the United 
States Patent and Trademark Office deter-
mines in a written decision to cancel as 
unpatentable, within 30 days of such deci-
sion. 
‘‘(2) PUBLICATION OF INFORMATION.— 
‘‘(A) IN GENERAL.—Within 1 year of the 
date of enactment of the Fair Care Act of 
2020, the Secretary shall publish and make 
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362 
available to the public a single, easily searchable 
list that includes— 
‘‘(i) the official and proprietary name 
of each biological product licensed, or 
deemed to be licensed, under subsection (a) 
or (k); 
‘‘(ii) with respect to each biological 
product described in clause (i), each patent 
submitted in accordance with paragraph 
(1); 
‘‘(iii) the date of licensure and appli-
cation number for each such biological 
product; 
‘‘(iv) the marketing status, dosage 
form, route of administration, strength, 
and, if applicable, reference product, for 
each such biological product; 
‘‘(v) the licensure status for each such 
biological product, including whether the li-
cense at the time of listing is approved, 
withdrawn, or revoked; 
‘‘(vi) with respect to each such bio-
logical product, any period of exclusivity 
under paragraph (6), (7)(A), or (7)(B) of 
subsection (k) of this section or section 
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363 
527 of the Federal Food, Drug, and Cos-
metic Act, and any extension of such pe-
riod in accordance with subsection (m) of 
this section, for which the Secretary has 
determined such biological product to be 
eligible, and the date on which such exclu-
sivity expires; 
‘‘(vii) any determination of biosimi-
larity or interchangeability for each such 
biological product; and 
‘‘(viii) information regarding approved 
indications for each such biological prod-
uct, in such manner as the Secretary de-
termines appropriate. 
‘‘(B) UPDATES.—Every 30 days after the 
publication of the first list under subparagraph 
(A), the Secretary shall revise the list to in-
clude— 
‘‘(i)(I) each biological product licensed 
under subsection (a) or (k) during the 30- 
day period; and 
‘‘(II) with respect to each biological 
product described in subclause (I), the in-
formation described in clauses (i) through 
(viii) of subparagraph (A); and 
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364 
‘‘(ii) any updates to information pre-
viously published in accordance with sub-
paragraph (A). 
‘‘(C) 
NONCOMPLIANCE.—Beginning 
months after the date of enactment of the Fair 
Care Act of 2020, the Secretary, in consultation 
with the Director of the United States Patent 
and Trademark Office, shall publish and make 
available to the public a list of any holders of 
biological 
product 
licenses, 
and 
the 
cor-
responding biological product or products, that 
failed to submit information as required under 
paragraph (1), including any updates required 
under paragraph (1)(C), in such manner and 
format as the Secretary determines appropriate. 
If information required under paragraph (1) is 
submitted following publication of such list, the 
Secretary shall remove such holders of such bio-
logical product licenses from the public list in a 
reasonable period of time. 
‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 
In this section, a ‘patent required to be disclosed’ is 
any patent for which the holder of a biological prod-
uct license approved under subsection (a) or (k), or 
a biological product application approved under sec-
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tion 505 of the Federal Food, Drug, and Cosmetic 
Act and deemed to be a license for a biological prod-
uct under this section on March 23, 2020, believes 
a claim of patent infringement could reasonably be 
asserted by the holder, or by a patent owner that 
has granted an exclusive license to the holder with 
respect to the biological product that is the subject 
of such license, if a person not licensed by the owner 
engaged in the making, using, offering to sell, sell-
ing, or importing into the United States of the bio-
logical product that is the subject of such license.’’. 
(b) 
DISCLOSURE
OF
PATENTS.—Section 
351(l)(3)(A)(i) of the Public Health Service Act (42 
U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 
in the list provided by the reference product sponsor under 
subsection (o)(1)’’ after ‘‘a list of patents’’. 
(c) REVIEW AND REPORT ON NONCOMPLIANCE.— 
Not later than 30 months after the date of enactment of 
this Act, the Secretary shall— 
(1) solicit public comments regarding appro-
priate remedies, in addition to the publication of the 
list under subsection (o)(2)(C) of section 351 of the 
Public Health Service Act (42 U.S.C. 262), as added 
by subsection (a), with respect to holders of biologi-
cal product licenses who fail to timely submit infor-
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366 
mation as required under subsection (o)(1) of such 
section 351, including any updates required under 
subparagraph (C) of such subsection (o)(1); and 
(2) submit to Congress an evaluation of com-
ments received under paragraph (1) and the rec-
ommendations of the Secretary concerning appro-
priate remedies. 
(d) REGULATIONS.—The Secretary of Health and 
Human Services may promulgate regulations to carry out 
subsection (o) of section 351 of the Public Health Service 
Act (42 U.S.C. 262), as added by subsection (a). 
(e) RULE OF CONSTRUCTION.—Nothing in this Act, 
including an amendment made by this Act, shall be con-
strued to require or allow the Secretary of Health and 
Human Services to delay the licensing of a biological prod-
uct under section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
SEC. 363. ORANGE BOOK MODERNIZATION. 
(a) SUBMISSION
OF PATENT INFORMATION
FOR 
BRAND NAME DRUGS.— 
(1) IN
GENERAL.—Paragraph (1) of section 
505(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(b)) is amended to read as follows: 
‘‘(b)(1)(A) Any person may file with the Secretary 
an application with respect to any drug subject to the pro-
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visions of subsection (a). Such persons shall submit to the 
Secretary as part of the application— 
‘‘(i) full reports of investigations which have 
been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; 
‘‘(ii) a full list of the articles used as compo-
nents of such drug; 
‘‘(iii) a full statement of the composition of 
such drug; 
‘‘(iv) a full description of the methods used in, 
and the facilities and controls used for, the manufac-
ture, processing, and packing of such drug; 
‘‘(v) such samples of such drug and of the arti-
cles used as components thereof as the Secretary 
may require; 
‘‘(vi) specimens of the labeling proposed to be 
used for such drug; 
‘‘(vii) any assessments required under section 
505B; and 
‘‘(viii) the patent number and expiration date, 
of each patent for which a claim of patent infringe-
ment could reasonably be asserted if a person not li-
censed by the owner engaged in the manufacture, 
use, or sale of the drug, and that— 
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‘‘(I) claims the drug for which the appli-
cant submitted the application and is a drug 
substance patent or a drug product patent; or 
‘‘(II) claims the method of using the drug 
for which approval is sought or has been grant-
ed in the application. 
‘‘(B) If an application is filed under this subsection 
for a drug, and a patent of the type described in subpara-
graph (A)(viii) that claims such drug or a method of using 
such drug is issued after the filing date, the applicant shall 
amend the application to include such patent informa-
tion.’’. 
(2) GUIDANCE.—The Secretary of Health and 
Human Services shall, in consultation with the Di-
rector of the National Institutes of Health and with 
representatives of the drug manufacturing industry, 
review and develop guidance, as appropriate, on the 
inclusion of women and minorities in clinical trials 
required under subsection (b)(1)(A)(i) of section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), as amended by paragraph (1). 
(b) CONFORMING CHANGES TO REQUIREMENTS FOR 
SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 
Section 505(c)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(c)(2)) is amended— 
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369 
(1) by inserting before the first sentence the 
following: ‘‘Not later than 30 days after the date of 
approval of an application under subsection (b), the 
holder of the approved application shall file with the 
Secretary the patent number and the expiration date 
of any patent described in subclause (I) or (II) of 
subsection (b)(1)(A)(viii), except that a patent that 
is identified as claiming a method of using such 
drug shall be filed only if the patent claims a meth-
od of use approved in the application. The holder of 
the approved application shall file with the Secretary 
the patent number and the expiration date of any 
patent described in subclause (I) or (II) of sub-
section (b)(1)(A)(viii) that is issued after the date of 
approval of the application, not later than 30 days 
after the date of issuance of the patent, except that 
a patent that claims a method of using such drug 
shall be filed only if approval for such use has been 
granted in the application.’’; 
(2) by inserting after ‘‘the patent number and 
the expiration date of any patent which’’ the fol-
lowing: ‘‘fulfills the criteria in subsection (b) and’’; 
(3) by inserting after the third sentence (as 
amended by paragraph (1)) the following: ‘‘Patent 
information that is not the type of patent informa-
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370 
tion required by subsection (b)(1)(A)(viii) shall not 
be submitted under this paragraph.’’; and 
(4) by inserting after ‘‘could not file patent in-
formation under subsection (b) because no patent’’ 
the following: ‘‘of the type required to be submitted 
in subsection (b)(1)(A)(viii)’’. 
(c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) 
of section 505(j)(7) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(7)) is amended by adding at 
the end the following: 
‘‘(iv) For each drug included on the list, the Sec-
retary shall specify any exclusivity period that is applica-
ble, for which the Secretary has determined the expiration 
date, and for which such period has not yet expired 
under— 
‘‘(I) clause (ii), (iii), or (iv) of subsection 
(c)(3)(E) of this section; 
‘‘(II) clause (iv) or (v) of paragraph (5)(B) of 
this subsection; 
‘‘(III) clause (ii), (iii), or (iv) of paragraph 
(5)(F) of this subsection; 
‘‘(IV) section 505A; 
‘‘(V) section 505E; 
‘‘(VI) section 527(a); or 
‘‘(VII) subsection (u)’’. 
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371 
(d) ORANGE BOOK UPDATES WITH RESPECT TO IN-
VALIDATED PATENTS.— 
(1) IN GENERAL.— 
(A) AMENDMENTS.—Section 505(j)(7)(A) 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(7)(A)), as amended by sub-
section (c), is further amended by adding at the 
end the following: 
‘‘(v) In the case of a listed drug for which the 
list under clause (i) includes a patent for such drug, 
and where the Under Secretary of Commerce for In-
tellectual Property and Director of the United States 
Patent and Trademark Office have cancelled any 
claim of the patent pursuant to a decision by the 
Patent Trial and Appeal Board in an inter partes 
review conducted under chapter 31 of title 35, 
United States Code, or a post-grant review con-
ducted under chapter 32 of that title, and from 
which no appeal has been taken, or can be taken, 
the holder of the applicable approved application 
shall notify the Secretary, in writing, within 14 days 
of such cancellation, and, if the patent has been 
deemed wholly inoperative or invalid, or if a patent 
claim has been cancelled, the revisions required 
under clause (iii) shall include striking the patent or 
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372 
information regarding such patent claim from the 
list with respect to such drug, as applicable, except 
that the Secretary shall not remove a patent from 
the list before the expiration of any 180-day exclu-
sivity period under paragraph (5)(B)(iv) that relies 
on 
a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV) with respect to such patent.’’. 
(B) APPLICATION.—The amendment made 
by subparagraph (A) shall not apply with re-
spect to any determination with respect to a 
patent or patent claim that is made prior to the 
date of enactment of this Act. 
(2) NO EFFECT ON FIRST APPLICANT EXCLU-
SIVITY
PERIOD.—Section 505(j)(5)(B)(iv)(I), as 
amended by the preceding sections, is amended by 
adding at the end the following: ‘‘This subclause 
shall apply even if a patent is stricken from the list 
under paragraph (7)(A), pursuant to paragraph 
(7)(A)(v), provided that, at the time that the first 
applicant submitted an application under this sub-
section containing a certification described in para-
graph (2)(A)(vii)(IV), the patent that was the sub-
ject of such certification was included in such list 
with respect to the listed drug.’’. 
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373 
SEC. 364. MODERNIZING THE LABELING OF CERTAIN GE-
NERIC DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 503C the following: 
‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 
DRUGS. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘covered drug’ means a drug ap-
proved under section 505(c)— 
‘‘(A) for which there are no unexpired pat-
ents included in the list under section 505(j)(7) 
and no unexpired period of exclusivity; 
‘‘(B) for which the approval of the applica-
tion has been withdrawn for reasons other than 
safety or effectiveness; and 
‘‘(C) for which, with respect to the label-
ing— 
‘‘(i) new scientific evidence is available 
regarding the conditions of use of the 
drug; 
‘‘(ii) there is a relevant accepted use 
in clinical practice that is not reflected in 
the approved labeling; or 
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374 
‘‘(iii) the labeling of such drug does 
not reflect current legal and regulatory re-
quirements. 
‘‘(2) The term ‘period of exclusivity’, with re-
spect to a drug approved under section 505(c), 
means any period of exclusivity under clause (ii), 
(iii), or (iv) of section 505(c)(3)(E), clause (ii), (iii), 
or (iv) of section 505(j)(5)(F), or section 505A, 
505E, or 527. 
‘‘(3) The term ‘generic version’ means a drug 
approved under section 505(j) whose reference drug 
is a covered drug. 
‘‘(4) The term ‘relevant accepted use’ means a 
use for a drug in clinical practice that is supported 
by scientific evidence that appears to the Secretary 
to meet the standards for approval under section 
505. 
‘‘(5) The term ‘selected drug’ means a covered 
drug for which the Secretary has determined 
through the process under subsection (c) that the la-
beling should be changed. 
‘‘(b) IDENTIFICATION
OF COVERED DRUGS.—The 
Secretary may identify covered drugs for which labeling 
updates would provide a public health benefit. To assist 
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in identifying covered drugs, the Secretary may do one or 
both of the following: 
‘‘(1) Enter into cooperative agreements or con-
tracts with public or private entities to review the 
available scientific evidence concerning such drugs. 
‘‘(2) Seek public input concerning such drugs, 
including input on whether there is a relevant ac-
cepted use in clinical practice that is not reflected in 
the approved labeling of such drugs or whether new 
scientific evidence is available regarding the condi-
tions of use for such drug, by— 
‘‘(A) holding one or more public meetings; 
‘‘(B) opening a public docket for the sub-
mission of public comments; or 
‘‘(C) other means, as the Secretary deter-
mines appropriate. 
‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 
Secretary determines, with respect to a covered drug, that 
the available scientific evidence meets the standards under 
section 505 for adding or modifying information to the 
labeling or providing supplemental information to the la-
beling regarding the use of the covered drug, the Secretary 
may initiate the process under subsection (d). 
‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 
If the Secretary determines that labeling changes are ap-
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propriate for a selected drug pursuant to subsection (c), 
the Secretary shall provide notice to the holders of ap-
proved applications for a generic version of such drug 
that— 
‘‘(1) summarizes the findings supporting the 
determination of the Secretary that the available sci-
entific evidence meets the standards under section 
505 for adding or modifying information or pro-
viding supplemental information to the labeling of 
the covered drug pursuant to subsection (c); 
‘‘(2) provides a clear statement regarding the 
additional, modified, or supplemental information for 
such labeling, according to the determination by the 
Secretary (including, as applicable, modifications to 
add the relevant accepted use to the labeling of the 
drug as an additional indication for the drug); and 
‘‘(3) states whether the statement under para-
graph (2) applies to the selected drug as a class of 
covered drugs or only to a specific drug product. 
‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 
of receipt of notification provided by the Secretary pursu-
ant to subsection (d), the holder of an approved applica-
tion for a generic version of the selected drug shall— 
‘‘(1) agree to change the approved labeling to 
reflect the additional, modified, or supplemental in-
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formation the Secretary has determined to be appro-
priate; or 
‘‘(2) notify the Secretary that the holder of the 
approved application does not believe that the re-
quested labeling changes are warranted and submit 
a statement detailing the reasons why such changes 
are not warranted. 
‘‘(f) REVIEW
OF
APPLICATION
HOLDER’S
RE-
SPONSE.— 
‘‘(1) IN GENERAL.—Upon receipt of the appli-
cation holder’s response, the Secretary shall prompt-
ly review each statement received under subsection 
(e)(2) and determine which labeling changes pursu-
ant to the Secretary’s notice under subsection (d) 
are appropriate, if any. If the Secretary disagrees 
with the reasons why such labeling changes are not 
warranted, the Secretary shall provide opportunity 
for discussions with the application holders to reach 
agreement on whether the labeling for the covered 
drug should be updated to reflect current scientific 
evidence, and if so, the content of such labeling 
changes. 
‘‘(2) CHANGES
TO
LABELING.—After consid-
ering all responses from the holder of an approved 
application under paragraph (1) or (2) of subsection 
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(e), and any discussion under paragraph (1), the 
Secretary may order such holder to make the label-
ing changes the Secretary determines are appro-
priate. Such holder of an approved application 
shall— 
‘‘(A) update its paper labeling for the drug 
at the next printing of that labeling; 
‘‘(B) update any electronic labeling for the 
drug within 30 days; and 
‘‘(C) submit the revised labeling through 
the form, ‘Supplement—Changes Being Ef-
fected’. 
‘‘(g) VIOLATION.—If the holder of an approved appli-
cation for the generic version of the selected drug does 
not comply with the requirements of subsection (f)(2), 
such generic version of the selected drug shall be deemed 
to be misbranded under section 502. 
‘‘(h) LIMITATIONS; GENERIC DRUGS.— 
‘‘(1) IN GENERAL.—With respect to any label-
ing change required under this section, the generic 
version shall be deemed to have the same conditions 
of use and the same labeling as a reference drug for 
purposes 
of 
clauses 
(i) 
and 
(v) 
of 
section 
505(j)(2)(A). Any labeling change so required shall 
not have any legal effect for the applicant that is 
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