wasson associates corner
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48 w w w . f d l i . o r gUpdate July/August 2011
ASSOCIATE CORNER
Revisiting the Debate on an Orange Book for the
Biologics Price Competition and Innovation Act
By Andrew S. Wasson 1
President Obama signed the Biologics Price Competition
and Innovation Act (BPCIA) into law more than a year
ago, yet industry stakeholders, lawyers and academic
commentators continue to actively debate key provisions o the
statute. Te BPCIA authorizes FDA to approve an application
under new subsection 351(k) o the Public Health Service Act
(a subsection (k) application) to market a biological product
on the basis o an earlier nding o saety, purity, potency andeectiveness, as long as the applicant can demonstrate at least
biosimilarity to the earlier application.2 It is difcult to debate
the merits o the BPCIA, however, without using the Hatch-Wax-
man Amendments to the Federal Food, Drug and Cosmetic Act
(Hatch-Waxman) as a point o reerence. Notably, Hatch-Wax-
man directs FDA to publish patent inormation associated with
drug products that it receives rom new drug application (NDA)
holders on a regular basis (this publication is known as the Or-
ange Book).3 Te BPCIA contains no analogous provision.
Te lack o an Orange Book-like publication or BLA prod-
ucts will likely have signifcant ramifcations. Tis article con-
cludes that urther regulatory or legislative action is necessary
to require the publication o BLA patent inormation because:
(1) a scheme that lacks such a publication may discourage com-
petition, (2) original concerns about gaming the system may be
unwarranted given the current structure o the BPCIA and (3) a
reasonable, but ostensibly unconfrmed, hypothesis underpins
the rationale or leaving out such a publication rom the BPCIA.
The Orange Bookunder Hatch-Waxman
Patent information plays a central role in the regulatory andlitigation scheme established by Hatch-Waxman. Hatch-Wax-
man states that an applicant who les an NDA must include the
patent number and expiration of any patent claiming the product
and to which a claim of patent infringement could reasonably
be asserted if a person not licensed by the owner engaged in
the manufacture, use, or sale of the drug.4 The statute fur-
ther states, [u]pon approval of the application, the Secretary
shall publish information submitted under the two preceding
sentences.5 Elsewhere in the statute, Hatch-Waxman species
additional parameters for this publication. Hatch-Waxman also
provides that the Secretary shall revise the list every 30 days
to include all drugs approved within the last 30-day period.6
FDA elaborated on its vision of this publication in an early
set of proposed rules.7 FDA stated that, [a]though not required
by the act, the list, as published, also identies all drug products
that qualify under the act for periods of exclusive marketing,
regardless of patent status, and states therapeutic equivalenceevaluations for approved multisource prescription drug prod-
ucts.8 FDA also stated, [a]s a general rule, FDA intends to
use the list and its supplemental updates as the primary means
of announcing information regarding patent status, exclusivity,
type of bioequivalence study needed, and eligibility for con-
sideration in an ANDA.9 Thus, even though Hatch-Waxman
provided FDA with minimal guidance, it still broadly author-
ized the publication of patent information.
The Orange Bookis critical to Hatch-Waxman patent litiga-
tion. For example, an applicant who submits an application
under either Section 355(j) or 355(b)(2) of Hatch-Waxman
must address each patent submitted by the NDA-holder (each
ultimately published in the Orange Book).10 Under the infamous
Paragraph IV Certication, a generic applicant can certify
that a patent is invalid or will not be infringed by the manu-
facture, use, or sale of the new drug for which the application
is submitted.11 Effectively speaking, the generic applicant
reviews the Orange Bookand les the appropriate certication
with regard to each patent listed for the reference listed drug.
Litigation often ensues after the generic ler sends the NDA
holder and patentee notice of its Paragraph IV Certication andits legal and factual basis for challenging each patent.12 If an
NDA-holder les suit after the statutory 45-day period, FDA
cannot approve the ANDA for a period of 30 months from the
date of receipt of the Paragraph IV Certication(s) by both the
NDA holder and patentee (known as the 30-month stay.)13
While the Orange Booklooms large in Hatch-Waxman litiga-
tion, it is important to separate the role it plays as a source of
information versus the role played by patent information gener-
ally in the statute.
Posted with permission of the Food and Drug Law Institute (FDLI) 2011. Originally published in FDLIs Update.
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July/August 2011 UpdateFDLI
The BPCIA Lacks a Publication forPatent Information
The BPCIA does not compel the central compilation or
publication of patent information. Rather, the BPCIA sets out
a series of deadlines where the parties negotiate which patents
will be the subject of litigation. Heres how the process works in
more detail:
FDA noties the subsection (k) applicant that its applica-
tion is accepted for review;
The applicant must provide a copy of its application to the
sponsor within 20 days of this notication;
The sponsor has 60 days to provide the applicant with a list
of patents for which the reference product sponsor believes a
claim of patent infringement could reasonably be asserted
or such other patents exclusively licensed by the sponsor;
Within 60 days of receiving the sponsors list, the applicant
may provide the sponsor with its own list of patents whichit believes could reasonably be asserted;
Within the same time period, the applicant must provide a
detailed statement of its factual and legal basis why each
patent on the sponsors list is invalid, unenforceable, or
will not be infringed by the applicants proposed product,
or alternatively, that the applicant will not market its prod-
uct until the patent expires;
Within 60 days of receiving the applicants statement,
the sponsor must respond with a statement demonstrat-
ing why the proposed product will infringe each patent
on the list and a response to the allegations of invalidity
and unenforceability.
Next, the BPCIA sets out a ramework or patent resolution
negotiations whereby the parties enter into a 15-day period o
good aith negotiations to determine the patents-at-issue. I
the parties ail to agree within this period, then the applicant
and sponsor exchange patent lists once again. First, the ap-
plicant communicates to the sponsor the number o patents it
intends to include in its list. Ten, the applicant and sponsor
exchange lists that contain the initially-determined number opatents. Te sponsor must bring suit with respect to each patent
included in these lists within 30 days. Unlike Hatch-Waxman,
the BPCIA lacks an equivalent provision to a 30-month stay.
Te centralized publication o patent inormation in the
Orange Bookeliminates the need or the rst set o exchanges in
the BPCIA. In the Hatch-Waxman regime, the generic applicant
knows which patents the innovator believes could be reasonably
asserted against generic versions o its product by virtue o the
Orange Book.14 Importantly, this notice occurs at time zero,
so to speak, when the generic applicant is initially evaluating a
proposed product. Further, in the Hatch-Waxman context, the
second set o negotiations is similarly unnecessary: all parties
are well-aware that the NDA-holder may sue the generic appli-
cant on any patent listed in the Orange Bookand possibly addi-
tional patents related to ANDA. Tereore, the BPCIA achieves
in a very convoluted way, the same result that Hatch-Waxman
achieves more efciently with the Orange Book.
Policy AnalysisWhy then, did the BPCIA depart so dramatically rom the
precedent set by Hatch-Waxman? Te rationale appears to be
most cogently documented in remarks made in 2007 by ormer
Commissioner o the Federal rade Commission, Pamela Jones
Harbour.15 Commissioner Harbour stated I would be very
skeptical o a ollow-on biologic approval pathway that included
an Orange Book-like system o patent listings.16 She elaborated
that [e]ach Orange Booklisting represents a new hurdle orwould-be entrants and that it would easier, and more tempt-
ing to game an Orange Bookor biologics.17 In particular, she
noted, biologics manuacturer might make small tweaks to
its manuacturing process, generate new patents, and list them
in a biologic Orange Book at the last minute or make other
questionable Orange Booklistings that would thwart ollow-on
entry plans.18
Commissioner Harbours concern appears to spring rom her
view that the patent landscape or biologics is at core unda-
mentally diferent rom the patent landscape or small molecule
drugs governed by Hatch-Waxman. She stated, [P]harmaceuti-
cal drugs usually are covered by a relatively small number o
patents, owned by a small number o rms but, [b]iologics, in
contrast, may be covered by a much greater number o patents
including research tool patentsowned by multiple entities.19
Tereore, the BPCIA lacks an Orange Book-type publication,
it appears at least in part, out o concern that sponsors would
have an increased opportunity to game the system due to difer-
ences in technology and patenting patterns.
While Commissioner Harbours comments set orth a com-
pelling rationale, several reasons exist why we should revisitthis position. First, Commissioner Harbours vision o an
Orange Book-like publication understandably draws rom
the Hatch-Waxman context, where litigation springing rom
led patent inormation inevitably leads to a 30-month stay.
Critically, however, on a theoretical level, publication o patent
inormation does not necessarily entail a stay o application ap-
proval. Tese concepts can be decoupled. Indeed, in the context
o the BPCIA (which lacks a 30-month stay) the risk o gaming
the system should be no greater than the current risks present in
Posted with permission of the Food and Drug Law Institute (FDLI) 2011. Originally published in FDLIs Update.
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