8/6/2019 Wasson Associates Corner

1/3

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.

8/6/2019 Wasson Associates Corner

2/3

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.

8/6/2019 Wasson Associates Corner

3/3