649 
metic Act, as added by subsection (a)), including 
with respect to assessing pH adjusters. 
(2) PROCESS.—In issuing guidance under this 
subsection, the Secretary of Health and Human 
Services shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
(C) after considering any comments re-
ceived and not later than one year after the 
close of the comment period on the draft guid-
ance, publish final guidance. 
(c) APPLICABILITY.—Section 505(j)(3)(H) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), applies beginning on the date of enactment 
of this Act, irrespective of the date on which the guidance 
required by subsection (b) is finalized. 
SEC. 904. TITLE 35 AMENDMENTS. 
(a) IN GENERAL.—Section 271(e) of title 35, United 
States Code, is amended— 
(1) in paragraph (2)(C), in the flush text fol-
lowing clause (ii), by adding at the end the fol-
lowing: ‘‘With respect to a submission described in 
clause (ii), the act of infringement shall extend to 
any patent that claims the biological product, a 
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method of using the biological product, or a method 
or product used to manufacture the biological prod-
uct.’’; and 
(2) by adding at the end the following: 
‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 
if the sponsor of an approved application for a reference 
product, as defined in section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i)) (referred to in this para-
graph as the ‘reference product sponsor’), brings an action 
for infringement under this section against an applicant 
for approval of a biological product under section 351(k) 
of such Act that references that reference product (re-
ferred to in this paragraph as the ‘subsection (k) appli-
cant’), the reference product sponsor may assert in the 
action a total of not more than 20 patents of the type 
described in subparagraph (B), not more than 10 of which 
shall have issued after the date specified in section 
351(l)(7)(A) of such Act. 
‘‘(B) The patents described in this subparagraph are 
patents that satisfy each of the following requirements: 
‘‘(i) Patents that claim the biological product 
that is the subject of an application under section 
351(k) of the Public Health Service Act (42 U.S.C. 
262(k)) (or a use of that product) or a method or 
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product used in the manufacture of such biological 
product. 
‘‘(ii) Patents that are included on the list of 
patents described in paragraph (3)(A) of section 
351(l) of the Public Health Service Act (42 U.S.C. 
262(l)), including as provided under paragraph (7) 
of such section 351(l). 
‘‘(iii) Patents that— 
‘‘(I) have an actual filing date of more 
than 4 years after the date on which the ref-
erence product is approved; or 
‘‘(II) include a claim to a method in a 
manufacturing process that is not used by the 
reference product sponsor. 
‘‘(C) The court in which an action described in sub-
paragraph (A) is brought may increase the number of pat-
ents limited under that subparagraph— 
‘‘(i) if the request to increase that number is 
made without undue delay; and 
‘‘(ii)(I) if the interest of justice so requires; or 
‘‘(II) for good cause shown, which— 
‘‘(aa) shall be established if the subsection 
(k) applicant fails to provide information re-
quired under section 351(k)(2)(A) of the Public 
Health Service Act (42 U.S.C. 262(k)(2)(A)) 
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that would enable the reference product sponsor 
to form a reasonable belief with respect to 
whether a claim of infringement under this sec-
tion could reasonably be asserted; and 
‘‘(bb) may be established— 
‘‘(AA) if there is a material change to 
the biological product (or process with re-
spect to the biological product) of the sub-
section (k) applicant that is the subject of 
the application; 
‘‘(BB) if, with respect to a patent on 
the supplemental list described in section 
351(l)(7)(A) of Public Health Service Act 
(42 U.S.C. 262(l)(7)(A)), the patent would 
have issued before the date specified in 
such section 351(l)(7)(A) but for the fail-
ure of the Office to issue the patent or a 
delay in the issuance of the patent, as de-
scribed in paragraph (1) of section 154(b) 
and subject to the limitations under para-
graph (2) of such section 154(b); or 
‘‘(CC) for another reason that shows 
good cause, as determined appropriate by 
the court. 
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‘‘(D) In determining whether good cause has been 
shown for the purposes of subparagraph (C)(ii)(II), a 
court may consider whether the reference product sponsor 
has provided a reasonable description of the identity and 
relevance of any information beyond the subsection (k) ap-
plication that the court believes is necessary to enable the 
court to form a belief with respect to whether a claim of 
infringement under this section could reasonably be as-
serted. 
‘‘(E) The limitation imposed under subparagraph 
(A)— 
‘‘(i) shall apply only if the subsection (k) appli-
cant completes all actions required under paragraphs 
(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 
section 351(l) of the Public Health Service Act (42 
U.S.C. 262(l)); and 
‘‘(ii) shall not apply with respect to any patent 
that claims, with respect to a biological product, a 
method for using that product in therapy, diagnosis, 
or prophylaxis, such as an indication or method of 
treatment or other condition of use.’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) shall apply with respect to an application sub-
mitted under section 351(k) of the Public Health Service 
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