FOOD

FDLI’S

and DRUG
P O L I C Y F O R U M

SHOULD FDA UNDERTAKE MORE THAN

A “MINISTERIAL” ROLE WITH RESPECT TO
PATENT INFORMATION?

Brian J. Malkin
Partner, Frommer Lawrence & Haug LLP
Andrew S. Wasson
Associate, Frommer Lawrence & Haug LLP

VOLUME 1, ISSUE 4 // FEBRUARY 23, 2011

THE FOOD AND DRUG LAW INSTITUTE

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 FDLI’S FOOD AND DRUG POLICY FORUM
Michael D. Levin-Epstein, J.D., M.Ed. Abby C. Foster, Esq. Aliza Yudkoff Glasner, Esq.
Editor-in-Chief Managing Editor Editor

EDITORIAL ADVISORY BOARD

William Vodra (Chair) Joe Fink (Vice Chair)
Senior Counsel, Arnold & Porter LLP Professor of Pharmacy, University of Kentucky

Associations

American Enterprise Institute Medical Device Manufacturers Association

John E. Calfee, Resident Scholar Brendan Benner, Director of Public Affairs

Consumer Healthcare Products Association Personal Care Products Council

David Spangler, Senior Vice President, Policy & International Affairs Mark Pollak, Senior Executive Vice President

Drug Information Association PhRMA

Lisa Zoks, Director of Marketing and Communications Lori Reilly, Vice President, Policy and Research

International Dairy Foods Association United Fresh Produce Association

Peggy Armstrong, Vice President of Communications Robert Guenther, Senior Vice President of Public Policy

Individuals

Christina L. Anderson
Senior Legal Counsel, Medtronic, Inc. Carolina Heavner
Senior Associate, K&L Gates LLP
Marice Ashe
Executive Director, Public Health Law and Policy Mary Clare Kimber
Manager, Regulatory Policy, Plasma Protein Therapeutics Association
James E. Dillard III
Senior Vice President, Altria Client Services, Inc. Patricia Maloney
Director, Medical Regulatory Affairs, Quest Diagnostics
Sandra Eskin
Director, Food Safety Campaign, The Pew Charitable Trusts Gary Messplay
Partner, Hunton & Williams LLP
Eric Feldman
Deputy Dean for International Affairs & Law Professor, Tim Schmidt
University of Pennsylvania Attorney, Johnson Controls

Paul Franz Sheila D. Walcoff

Vice President and Associate General Counsel, Founding Principal, Goldbug Strategies LLC
The Procter & Gamble Company
Pamela Wilger
Lawrence Gostin Corporate Food Safety & Regulatory Affairs, Cargill
Professor of Global Health Law and Director of the O’Neill Institute,
Georgetown University

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 TA B L E O F C O N T E N T S

I. Introduction.................................................................................1
Policy Recommendations
II. Major Issues: Current FDA Policy..........................................3
III. Recommendations....................................................................5
A. Legal Justification
B. Impact
C. Potential Counterarguments
IV. Conclusion....................................................................................8

Citations................................................................................................9
About the Authors..........................................................................12
About the Policy Forum................................................................12
About FDLI.........................................................................................12

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 Should FDA Undertake More Than a “Ministerial” Role With
Respect to Patent Information?
Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP
Andrew S. Wasson, Associate, Frommer Lawrence & Haug LLP*

I. INTRODUCTION

The U.S. Food and Drug Administration (FDA) has taken the position that it will not substantively review patents for
compliance with the Federal Food, Drug and Cosmetic Act (FDCA), as amended by the Drug Price and Competition and
Patent Term Restoration Act of 1984 (generally known as the Hatch-Waxman Amendments or simply Hatch-Waxman).1 FDA
calls its responsibility vis-à-vis patents, “ministerial.”2 It is FDA’s position that Hatch-Waxman does not explicitly direct FDA to
engage in substantive patent review. What is more, FDA has stated that it lacks the expertise and resources to review patent
information.

FDA’s hands-off policy with regard to patents, however, creates a vacuum often filled by parties with vested interests.
For instance, FDA declines to engage in an independent analysis of whether a New Drug Application (NDA) holder may
properly include a patent in FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations (known as
the Orange Book). Listing in the Orange Book sets the complex machinery of Hatch-Waxman into motion and can result
in a 30-month stay of approval for an abbreviated new drug application (ANDA) or an NDA submitted under section
505(b)(2) of the FDCA (also known as a 505(b)(2) NDA).3 In another example, under its current policy, FDA determines
whether an applicant could appropriately submit “carved-out” labeling based on only the NDA holder’s description of patent
claims (a “use code narrative”): it will not review the method-of-use patent claims directly when determining whether an 1
application meets the requirements of Hatch-Waxman. Indeed, FDA’s current policy encourages NDA holders to incorrectly
list patents in the Orange Book to obtain 30-month stays. Likewise, FDA’s policy incentivizes NDA holders to draft use code
narratives that are inappropriately broad to force applicants to file Paragraph IV certifications.

P O L I C Y R E C O M M E N D AT I O N S

• Develop an internal competency to review patents beyond the “ministerial” requirements of its current
regulations.

• Review patents submitted for listing in the Orange Book for accuracy and proactively refuse to list patents
that do not meet FDA’s listing criteria.

• In the event that an applicant submits carved-out labeling, confirm that the listed method-of-use patent
“does not claim a use for which the application is submitted.” FDA should retain use code narratives for
informational purposes only.

• Hire patent attorneys, who are registered with the U.S. Patent and Trademark Office (the Patent Office), and
preferably who have a pharmaceutical or medical background, to accomplish these recommendations.

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 Therefore, we examined whether FDA should revisit its hands-off policy on patents, with a focus on these two situations. We
reviewed the regulatory record, as well as the case law, and conclude that FDA should undertake more than a “ministerial”
role with regard to patent issues. In this vein, we recommend that FDA develop internal procedures to confirm that an NDA
holder can validly list and maintain a patent in the Orange Book. Similarly, we recommend that FDA should independently
compare the method-of-use patent scope to the generic labeling. We believe that it would be relatively straightforward
for FDA to develop a competency in these areas and would involve hiring only a small staff of patent attorneys. We believe
that by taking these steps, FDA can more directly and efficiently administer the Hatch-Waxman Amendments to the FDCA.

The Hatch-Waxman Amendments created a framework that allows an applicant to rely on a previous FDA finding of safety
and efficacy for a reference listed drug (RLD). Hatch-Waxman also included new provisions to address the patent rights of
NDA holders. For example, Hatch-Waxman required an NDA holder to file with its original application:

[T]he patent number and the expiration date of any patent which claims the drug for which the applicant
submitted the application or which claims a method of using such drug and with respect 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

For method-of-use patents, FDA requires an NDA holder also to submit “specific information on the approved methods of
use protected by a submitted patent” (called a “use code narrative”).5 In turn, FDA publishes this information (i.e., the patent
number, the expiration date and use code narrative) for an NDA product in the Orange Book. Critically, adhering to its
ministerial role, FDA does not review patent information for accuracy.

The Hatch-Waxman Amendments require an applicant to include a certification in its application that refers to each patent
listed by the NDA holder. An applicant may include, for example, a certification that it will not market its product until

2
the applicable patent expires (a “Paragraph III certification”), or “that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is submitted” (a “Paragraph IV certification”).6 FDA may
not approve an application containing a Paragraph IV certification for 30 months, if the applicant provides the NDA holder
and patent assignee with notice of the certification and its underlying bases and the applicant is sued within 45 days of
receipt.7 Applicants may forgo submitting a certification under Paragraphs I-IV if the NDA holder submits a method-of-use
patent, “which does not claim a use for which the applicant is seeking approval.”8 Instead, generic applicants submit a
statement that the method-of-use patent does not claim such a use—called variously a “Section viii statement,” a “little-
eight statement,”9 a “carve-out” or a “skinny-label.”

The Hatch-Waxman Amendments created a role for FDA with regard to patent information in a number of places. As
described above, 21 U.S.C. § 355(b)(1) dictates the contents of an NDA and requires applicants to submit patent information
to FDA.10 Further, “[u]pon approval of the application, the Secretary shall publish information submitted under the two
preceding sentences.”11 Likewise, the act also provides for the ongoing submission of patent information, including the
situation where the patent issues after the application has been approved. The act states:

[I]f the holder of an approved application could not file patent information under subsection (b) of this
section because no patent had been issued when an application was filed or approved, the holder shall
file such information under this subsection not later than thirty days after the date the patent involved is
issued. Upon the submission of patent information under this subsection, the Secretary shall publish it.12

FDA has relied on section 355(c)(2) as support for its contention that its role is purely ministerial, as described infra.

Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359 (Fed. Cir. 2010) exemplifies one situation where FDA’s decision to
assume nothing more than a ministerial role led to the inefficient administration of the Hatch-Waxman Amendments. In
Novo Nordisk, the Federal Circuit refused to grant Caraco’s petition for an injunction to compel Novo Nordisk to change its

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 use code narrative for U.S. Patent No. 6,677,358 (“the ’358 patent”), listed in the Orange Book for Prandin® (repaglinide). Each
independent claim of the ’358 patent requires the administration of repaglinide with metformin (another active ingredient).
Novo Nordisk’s original use code narrative for the ’358 patent designated the “use of repaglinide in combination with
metformin to lower blood glucose” (U-546). FDA initially compared this use code narrative with Caraco’s proposed labeling,
which “carved out” the patented use (combination with metformin). Consequently, FDA initially approved Caraco’s use of a
Section viii statement and could approve Caraco’s application as soon as it completed its scientific review. Novo Nordisk later
requested that FDA broaden the use code narrative for the ’358 patent to read: “a method for improving glycemic control
in adults with type 2 diabetes mellitus” (U-968). FDA again compared the use code narrative to Caraco’s proposed labeling
(which lacked instructions to administer with metformin). Because the broader, revised use code narrative submitted by
Novo Nordisk overlapped with Caraco’s proposed label, FDA disallowed Caraco’s carved-out labeling, and forced Caraco
to mirror Novo Nordisk’s labeling. Because Caraco already stipulated that it would infringe the ’358 patent if it marketed a
product with such labeling, FDA’s action could potentially prevent Caraco from marketing its proposed repaglinide product
until the ’358 patent expires.

The court in Novo Nordisk did not address FDA’s ministerial role. Rather, the court considered whether Caraco could
properly compel Novo Nordisk to change the use code narrative back to its original form by invoking the counterclaim
procedure under 21 U.S.C. § 355(j)(5)(C)(ii)(I).13 This provision allows a generic applicant to assert a counterclaim “seeking
an order requiring the holder to correct or delete the patent information” if the patent does not claim either “(aa) the drug
for which the application was approved; or (bb) an approved method of using the drug.” The Federal Circuit construed
the counterclaim provision narrowly, finding that Caraco could not use it to force Novo Nordisk to change the use code
narrative. In particular, the Federal Circuit found that the Orange Book patent indeed claimed “an approved method of
using the drug,” even though it did not cover every method.14 What is more, the Federal Circuit similarly construed “patent
information” to only cover the patent number and expiration date of the patent: it did not encompass use code narratives.15
Caraco petitioned the Supreme Court for a writ of certiorari on December 23, 2010, and it remains to be seen whether the
Supreme Court will take up the issue. The upshot of this decision is that generic applicants are left with effectively no way
to challenge inappropriately broad use code narratives.
3
II. MAJOR ISSUES: CURRENT FDA POLICY

FDA has long taken the position that despite the amendments made to the FDCA by Hatch-Waxman and the MMA, FDA has
no responsibility to review patents substantively. While this policy takes shape in many forms, we focus on two particular
instances that have been the subject of considerable amounts of dispute. First, FDA has taken the position that the FDCA
does not call upon it to police whether or not a patent qualifies as a type that can be appropriately listed in the Orange Book.
Second, FDA has taken the position that the FDCA does not call upon it to police whether use code narratives accurately
reflect patent claim scope.

FDA’s position has been based on a mixture of prudential concerns and statutory interpretation. Responding to an early
call to police generic applicants’ use of the Section viii pathway, FDA declined, and based its refusal on two grounds.16 First,
FDA stated that “[b]ecause FDA has no expertise in the field of patents, the agency has no basis for determining whether
a use patent covers the use sought by the generic applicant.”17 Second, FDA stated that “the 1984 Amendments [Hatch-
Waxman Amendments] are plainly structured to allow any patent disputes to be litigated in federal court.”18 Even going
further, FDA eventually determined, “[i]n the absence of explicit statutory language, we believe an approach that requires
the NDA applicant or holder or patent owner to identify the approved methods of use protected by the patent is most
consistent with the general balance adopted in Hatch-Waxman.”19 Thus, use code narratives come directly from the NDA
holder without any FDA input or review.

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 FDA came to the same conclusion in the patent listing context, stating, “FDA does not have the expertise to review patent
information. The agency believes that its scarce resources would be better utilized in reviewing applications rather than
reviewing patent claims.”20 FDA codified its interpretation in its regulations:

Correction of patent information errors. If any person disputes the accuracy or relevance of patent
information submitted to the agency under this section and published by the FDA in the list [the Orange
Book], or believes that an applicant has failed to submit required patent information, that person must
first notify the agency in writing stating the grounds for disagreement … The agency will then request
of the applicable new drug application holder that the correctness of the patent information or omission
of patent information be confirmed. Unless the application holder withdraws or amends its patent
information in response to FDA’s request, the agency will not change the patent information in the list.21

Thus, FDA has squarely adopted a hands-off attitude when approaching its role in reviewing patents.

A more thorough public debate of FDA’s position occurred when FDA began the process to amend its patent listing
regulations to clarify the types of listable patents.22 At the same time, FDA clarified what sort of patent information NDA
holders were required to submit to FDA in their NDA applications. FDA proposed amended regulations, in part, because
of recent disputes that addressed “whether the patent meets the regulatory requirements for listing in the Orange Book.”23
Along with clarifying which types of patents could be listed in the Orange Book, FDA also proposed that NDA applicants
provide, “a more detailed declaration that would act as a ‘checklist’ that would focus on patent claims and would ensure that
applicants submit only appropriate patent information and stand behind the accuracy of that information.”24

FDA hoped that by forcing NDA applicants to substantiate the basis behind listing a patent—to show their work so to
speak—it would make it less likely that the system would be abused. FDA stated in its proposed rules, “[w]e designed

4
this declaration to help ensure that appropriate patents are listed and to preclude any need on our part to decide patent
issues because we lack the patent expertise, resources, and statutory mandate to scrutinize patent listings.”25 FDA also
stated that the additional requirements “will prompt NDA holders and NDA applicants to make careful and well-considered
representations in their patent declarations and produce greater compliance with our patent listing requirements.”26 FDA,
however, also acknowledged that, “[t]his declaration may be insufficient in practice to prevent NDA applicants and NDA
holders from attempting to list inappropriate patents.”27

At the end of the comment period for its proposed regulations, FDA declined to adopt the suggestions of some comments
that FDA hire patent attorneys to substantively review patent listings or that FDA should establish an administrative process to
challenge patent listings.28 In its response to comments, FDA set forth four main arguments. First, FDA argued that the proposed
rules (which lacked a mechanism for substantive review) were consistent with a “fundamental assumption” of the Hatch-
Waxman Amendments, which, according to FDA, delegated disputes about “scope and validity of patents” to the courts, rich
in the “experience, expertise, and authority”to address complex patent law issues. Second, FDA argued that the short, statutory
timeframes for patent publication in the Orange Book (30 days) provided strong evidence that Congress did not intend FDA to
undertake anything more than a ministerial role.29 Third, FDA argued that its longstanding position based on lack of expertise
has been upheld by a number of courts, including the D.C. Circuit, the Fourth Circuit and the Federal Circuit (cases discussed in
greater detail, infra). Finally, FDA argued that as a practical matter FDA’s decisions would “inevitably” lead to increased litigation
against the agency and that there was no guarantee that a more robust procedure would lead to facilitated generic entry.

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 I I I . R E C O M M E N D AT I O N S

While courts have uniformly upheld FDA’s “ministerial” patent policy as reasonable, it has been noted that FDA’s policy
comprises “poorly conceived administration of the laws.”30 We believe that FDA should internally review patents beyond
the ministerial requirements of its current regulations to more efficiently administer the balance between NDA-holder and
generic applicant. We believe that this internal review should have certain limits. In particular, FDA should: 1) review patents
submitted for listing in the Orange Book for accuracy and should proactively refuse to list patents that do not meet FDA’s
listing criteria; and 2) in the event that an applicant submits carved-out labeling, confirm that the listed method-of-use
patent “does not claim a use for which the application is submitted.” FDA should retain use code narratives for informational
use only. To implement this scheme, we recommend that FDA hire a small staff of patent attorneys who are registered with
the Patent Office, preferably who have a pharmaceutical or medical background. Thus, while FDA may not currently have
the competency to make substantive patent determinations, we believe that FDA could readily gain this competency.

A. Legal Justification

While FDA has stated that “[c]ourts have upheld our determination that our role with respect to patent listing is ministerial,”31
the case law, as discussed infra, also supports an expanded view of FDA’s role. For example, aaiPharma v. Thompson contains
one in-depth examination of FDA’s interpretation that FDA must play only a ministerial role in listing patents.32 On the one
hand, FDA argued that 21 U.S.C. § 355(c)(2) indicated that the NDA holder “bears the sole responsibility” for filing patent
information and that FDA’s role is “completely passive.”33 On the other hand, aaiPharma argued “that Congress intended FDA
to “play some role in ensuring that all eligible patents are listed in the Orange Book” and pointed to 21 U.S.C. § 355(d)(6) and
(e)(4) for support.34

The Fourth Circuit upheld FDA’s policy as a matter of administrative law. In particular, the Fourth Circuit employed the
two-step test articulated by Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).35 First, the court found
5
that Congress did not clearly express its intent as to FDA’s role, citing the conflict between subsections (c)(2), (d)(6) and (e)
(4).36 Second, given this ambiguity, the court found FDA’s interpretation was reasonable, convinced, at least in part, by FDA’s
argument that it has “no expertise in making patent law judgments.”37 Critically, however, aaiPharma does not hold that
FDA must adopt a ministerial role in addressing patents. In fact, the Fourth Circuit was not “unsympathetic” to aaiPharma’s
position,38 which it characterized as having “some force.”39 Thus, if FDA had interpreted the statute as authorizing at least
some patent review, the court in aaiPharma may have similarly found this interpretation reasonable.

Judge Williams articulated this concept in his concurrence in Teva Pharms., USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008).
Judge Williams cautioned that the Fourth Circuit’s reasoning in aaiPharma stood for two propositions: 1) “the FDA’s ministerial
role in the Orange Book listing process is not mandated by the statute,” and 2) “third-party patent holders have rights under
Hatch-Waxman which are currently at the mercy of the NDA holder and which the FDA could vindicate by taking a more
active role in the listing process.”40 Based on these propositions, Judge Williams reasoned, “[i]t seems quite likely, then, that
had the FDA adopted the plaintiff’s position and sought to protect third-party patent holders, the aaiPharma court would
have viewed that construction of the statute as reasonable too.”41 Judge Williams concluded that “to read the majority
opinion as implying that the statute locks the FDA into a ministerial role would be inappropriate.”42

Judge Plager’s concurrence in Apotex v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003) registers a common-sense middle ground.
In facing a patent listing issue that implicated FDA’s ministerial role, Judge Plager agreed that the act did not explicitly
place a duty on FDA to police Orange Book listings. However, he had strong words for the scheme, finding that it was,
“fundamentally at odds with my notion of proper administration of the law.”43 Judge Plager observed that placing the listing
power solely in the hands of the NDA holder—the party most interested in discouraging or delaying generic applications—

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 was, if not “improper delegation of government power,” at very least, “poorly conceived administration of the laws.”44 Judge
Plager offered one promising solution:

It does not seem to me to be an unreasonable expectation that the FDA have on its staff a handful of
competent patent analysts, along with its multitude of scientific specialists, who, at a minimum, could
make an initial judgment about the propriety of a listing, consistent with the statutory requirement that
the NDA holder file required patent information.45

Characterizing FDA as a “neutral arbiter,” Judge Plager suggested that “it is a relatively straightforward step to ensure that
those patents that obviously should not be listed are not.”46

Thus, a close reading of the case law suggests that Hatch-Waxman does not prohibit FDA from internally reviewing patents
for compliance with listing requirements or approval of carved-out uses claimed in listed patents.47 While a number of
courts have upheld that FDA’s current policy is reasonable, they have reached that step as a matter of administrative law,
because of the FDCA’s failure to clearly manifest the intent of Congress with regard to FDA’s relationship vis-à-vis patents.48
Consequently, if FDA were to adopt a different conclusion favoring an expanded review as proposed by this paper, there is
nothing to suggest that a court would not find that interpretation reasonable as well.

B. Impact

A chief benefit of this proposal is that it allows FDA to better hold applicants accountable for submitting inaccurate
information to FDA, by allowing FDA to act as a “neutral arbiter.”49 An expanded role by FDA in delisting patents takes this
power out of the hands of an interested party and places it into the hands of a “neutral arbiter” and thus “provide some

6
balance between these competing interests.”50 This reasoning applies with equal force to FDA’s role in determining whether
an applicant can carve-out or skinny label a product. Instead of the NDA holder being the sole judge of patent scope and
therefore potentially blocking a non-infringing labeled 505(b)(2) NDA or ANDA, FDA would assume the decision-making
role. What is more, we believe that the number of questionable patent listings and use code narratives would decrease
under this policy, because NDA holders would be less likely to submit inappropriate patent listings or use code narratives
knowing that this information would face a substantive FDA review.

Another benefit is that FDA’s expanded role is not as extensive as the agency might fear. FDA does have some experience
determining complex patent issues. For example, responding to FTC’s call to clarify types of patents appropriately listed in
the Orange Book,51 FDA made a fine-grained determination that patents claiming active ingredients, formulations, methods
of use, products-by-process and polymorphs could be listed in the Orange Book, while patents claiming metabolites,
packaging, intermediates and processing could not be listed in the Orange Book.52 Thus, FDA is already familiar with the
hallmarks and characteristics of different types of pharmaceutical patents, and it is only a minor step to determine whether
any given patent is a token of that type.53 FDA has established categories of listable patents, and it is not unreasonable or
onerous for FDA to determine whether submitted patent information meets these criteria.

Further, while we concede that the analysis of determining whether a method-of-use patent claims a use for which the
generic application is submitted requires a more refined skill-set than a patent listing determination, we believe that this
analysis would not be beyond the skills of the competent patent attorneys hired by FDA. Indeed, FDA already engages in
an analogous exercise: comparing use code narratives to a proposed generic labeling. It should be noted that we do not
advocate that FDA should abolish use code narratives entirely. Use code narratives could still provide valuable information
to the public about an NDA holder’s view of the patent scope. We do suggest that FDA evaluate an applicant’s “carve-out”
proposal directly, however, by eliminating the use code as a proxy for claim scope.

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 Having a small staff of patent attorneys with scientific backgrounds also would confer other benefits on FDA. These attorneys
could assist with legal interpretations of other complicated scientific issues that have regulatory and legal implications, such
as the new biosimilars legislation or difficult scientific/regulatory issues like some bioequivalence determinations. What is
more, these patent attorneys could work with the Patent Office on the patent term restoration program, which was also
included in the Hatch-Waxman Act, allowing the FDA to engage in more robust and efficient discussions with the Patent
Office on eligibility and regulatory review period determinations. In addition, having individuals on staff with both scientific
and patent backgrounds would allow FDA to react more quickly when unexpected patent issues arise.54

C. Potential Counterarguments

FDA will likely disagree with our recommendations. Indeed, FDA has already once considered and rejected a similar proposal
for it to create an internal procedure for patent review. In its rejection, FDA articulated four main arguments: 1) a division-of-
labor argument, 2) a statutory interpretation argument, 3) a case law argument and 4) a prudential argument. While each
argument has merit, none of these arguments appear to be ultimately convincing.

First, FDA may argue that it should not develop the expanded role outlined above, because disputes relating to the “scope
and validity of patents” most appropriately belong with the courts, given the courts’ “experience, expertise, and authority”
in complex patent matters.55 In other words, “the whole point of the Act’s paragraph IV certification scheme is to let private
parties sort out their respective intellectual property rights through patent infringement suits while the FDA focuses
on its primary task of ensuring that drugs are safe and effective.”56 While it might be the case that the FDCA delegates
determinations of infringement, invalidity and/or unenforceability that arise from Paragraph IV certifications to the courts —
it is not necessarily the case that the Hatch-Waxman Amendments intended a division of labor in every instance, especially

7
with regard to analyses more closely related to FDA’s administration of the statute, such as determining whether a patent
is properly listed in the Orange Book, or determining whether an applicant may properly carve out a use claimed in a listed
patent. Therefore, we believe that FDA’s division-of-labor argument does not undermine our proposal.

Second, FDA may argue that other provisions of Hatch-Waxman counsel for a limited ministerial role. For example, the FDCA
mandates relatively short publication timeframes for patent information. For example, 21 U.S.C. § 355(j)(7)(A)(iii) provides,
“[w]hen patent information submitted under subsection (b) or (c) of this section respecting a drug included on the list is
to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such
drug.” Indeed, clause (ii) requires FDA to revise the list “every thirty days.”57 There is some force to the argument that such a
publication schedule might militate against an interpretation that would require extensive analysis to take place during this
timeframe. Our proposal, however, does not involve extensive analysis or collaboration with another administrative agency.
Therefore, the publication timeframes mandated by Hatch-Waxman do not appear to bar our proposal.

Third, FDA may also argue that it currently lacks the expertise to weigh in on patent issues and that a number of courts,
including the D.C. Circuit, the Fourth Circuit and the Federal Circuit, have ratified FDA’s position. While it is certainly true
that these courts have found FDA’s position to be reasonable, as we have described above, these courts do not appear to
mandate that FDA maintain this policy, especially in light of the circumstances where it is not working or it causes a delay
in the availability of generic products. What is more, despite that FDA likely does not currently have the expertise to make
limited determinations about patents, as a part of executing Hatch-Waxman, we have suggested a straightforward way
to obtain and develop such expertise. It bears repeating that our proposal does not involve FDA determining substantive
issues of infringement, validity or enforceability, but rather only whether a patent submitted for listing in the Orange Book
complies with the statute and FDA’s regulations or whether an applicant can carve-out certain labeling information claimed
by a listed patent.

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 Finally, FDA may argue that FDA’s patent decisions would inevitably lead to increased litigation against the agency. While
this may be true in the short run, we believe that avoiding litigation should not be a guiding principle for sound regulatory
policy. Indeed, FDA is in the business of making substantive decisions: each could potentially end up in litigation. FDA
would be paralyzed if it did not act due to fear of litigation. FDA may also argue that there is no guarantee that a more
robust patent review procedure would lead to facilitated generic entry. However, it seems that a more robust procedure
would have facilitated generic entry in at very least the Novo Nordisk case. In the event that a more proactive FDA would
have determined that the listed method-of-use patent did not claim a use for which the generic applicant submitted its
application, the generic applicant would have been allowed to maintain its statement under subsection viii and would not
have been subject to a needless 30-month stay and unnecessary litigation.

I V. C O N C LU S I O N

The option outlined above is not the only arrangement that would permit FDA to exercise more than a ministerial role with
regard to patents to implement the FDCA as amended by the Hatch-Waxman Act and the MMA. For example, FDA could
enter into a memorandum of understanding (MOU) with the Patent Office, akin to its arrangement for the implementation
of patent term extensions.58 What is more, FDA could establish an administrative procedure that allows aggrieved parties
the opportunity to challenge patent listing or the ability for applicants to carve out labeling for uses claimed in listed patents
and other related patent issues.59 The above proposal, however, provides benefits over these arrangements because of the
lower transaction costs versus establishing a MOU and the ability for faster FDA response times, particularly regarding
listing patents in the Orange Book. The transaction costs of forging an arrangement with the Patent Office, or developing
a new appeal procedure, while not insurmountable, are clearly higher than those involved with hiring and training a small
number of patent attorneys within FDA. Therefore, we conclude that the best policy would be for FDA to internally develop
patent competency in a number of targeted and limited areas within the scope of FDA’s responsibilities under the FDCA,
as amended. 8

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 C I TAT I O N S

* The views, opinions, and statements expressed in this article are those of the authors and do not represent the
views of Frommer Lawrence & Haug LLP or its clients.

1 Congress additionally amended the provisions added by the Hatch-Waxman Amendments in the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (2003)
(generally known as the Medicare Modernization Act or MMA).

2 See, e.g., Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements
and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent
Claiming a Drug Is Invalid or Will Not Be Infringed (“Patent Submission and Listing Requirements”), 68 Fed. Reg.
36,676, 36,683 (June 18, 2003).

3 Throughout this paper, “applicant” refers to an ANDA or 505(b)(2) NDA applicant (with “application” having
correlative meaning), unless otherwise indicated, whereas NDA holder refers to the holder of an NDA product
listed in the Orange Book.

4 21 U.S.C. § 355(b)(1); see also 21 U.S.C. 355 § (c)(1).

5 Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,683.

6 21 U.S.C. § 355(j)(2)(A)(vii)(IV). An applicant may also submit a certification under Paragraph I of the FDCA (“that
such patent information has not been filed”) or Paragraph II of the FDCA (“that such patent has expired”). 21
U.S.C. § 355(j)(2)(A)(vii)(I) and (II).

7 21 U.S.C. § 355(j)(5)(B)(iii). FDA can approve an application with a Paragraph IV certification earlier if a district
court determines that the patent is invalid or not infringed. 9
8 21 U.S.C. § 355(j)(2)(A)(viii). For 505(b)(2) ANDAs this provision is found at 21 U.S.C. § 355(b)(2)(B).

9 “Section viii” and “little-eight statement” both refer to the statutory provision for ANDAs. 21 U.S.C. § 355(j)(2)(A)
(viii).

10 21 U.S.C. § 355(b)(1).

11 Id.

12 21 U.S.C. § 355(c)(2).

13 Novo Nordisk, 601 F.3d at 1360.

14 Id. at 1364-65.

15 Id. at 1366-67.

16 Abbreviated New Drug Application Regulations; Proposed Rule, 54 Fed. Reg. 28,872 at 28,909 (July 10, 1989).

17 Id.

18 Id.

19 Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,682.

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 20 Abbreviated New Drug Application Regulations; Patent Exclusivity Provisions, 59 Fed. Reg. 50,338 at 50,343 (Oct.
3, 1994).

21 21 C.F.R. § 314.53(f ).

22 Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month
Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will
Not be Infringed; Proposed Rule (“Proposed Patent Submission and Listing Requirements”), 67 Fed. Reg. 65,448
(Oct. 24, 2002). The Federal Trade Commission spurred FDA into action by its May 16, 2001, Citizen Petition, FDA
Docket No. 01P-0248, asking for additional clarity about the types of patents appropriately listed in the Orange
Book.

23 Proposed Patent Submission and Listing Requirements, 67 Fed. Reg. at 65,449.

24 Id. at 65,453.

25 Id. (citation omitted).

26 Id.

27 Id.

28 Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,683 (June 18, 2003). FDA ultimately determined
that NDA holders could list patents claiming the active ingredient, formulation, composition and method of
use. Id. at 36,678 and 21 C.F.R. § 314.53(b). On the other hand, FDA found that process patents, patents claiming
packaging, metabolites and intermediates could not be listed in the Orange Book. Id. FDA also determined that

10
NDA holders could list product-by-process patents and polymorph patents, with some restrictions. Id. at 36,679.

29 21 U.S.C. 355(j)(7)(A)(ii) and (iii).

30 Apotex, Inc. v. Thompson, 347 F.3d, at 1353 (Plager J., concurring); see also aaiPharma v. Thompson, 296 F.3d 227
(4th Cir. 2002).

31 Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,683.

32 See aaiPharma, 296 F.3d 227.

33 Id. at 238.

34 Id.

35 Id. at 237-38.

36 Id. at 238.

37 Id. at 241.

38 Id. at 242.

39 Id. at 243.

40 Id. at 107-9.

41 Id. at 109.

42 Id. at 110.

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 43 Apotex, 347 F.3d at 1352-53.

44 Id. at 1353.

45 Id.

46 Id.

47 See also Comments submitted by Teva Pharmaceuticals USA to FDA Docket No. 2002-N-0417 at 8-9 (December
22, 2002).

48 E.g., aaiPharma, 296 F.3d at 238.

49 Apotex, 347 F.3d at 1353 (“The power to impose [various legal duties on ANDA applicants] in any given situation
is thus in the hands of the party, the NDA holder, most interested in imposing them as a way to discourage, or at
a minimum delay, applied-for ANDAs.”).

50 Id.

51 Citizen Petition submitted by the Federal Trade Commission, FDA Docket No. 2001-P-0248 (May 16, 2001).

52 Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,683 (June 18, 2003).

53 See also Comments submitted by Generic Pharmaceutical Association to 2002-N-0417 at 25 (December 23,
2002) (“[i]n short, whether a patent should be listed or delisted is often not a question of patent validity or
patent infringement, but rather whether the patent meets the listing criteria of the FFDCA [FDCA] and FDA’s
regulations.”).

54 The patent issues arising from FDA’s risk evaluation and mitigation strategies (REMS) initiative are one good
example. For example, NDA holders have recently pursued patenting methods related to risk management
systems giving rise to unexpected patent issues when applicants seek to obtain RLD product for testing or to
11
develop a shared REMS or stand-alone risk management programs for generic products.

55 See Patent Submission and Listing Requirements, 68 Fed. Reg. at 36,683 (June 18, 2003).

56 aaiPharma, 296 F.3d at 241.

57 21 U.S.C. § 355(j)(7)(A)(iii).

58 See Memorandum of Understanding Between the Patent and Trademark Office and the Food and Drug
Administration, Notice, 52 Fed. Reg. 17,830 (May 12, 1987).

59 Comments submitted by Teva Pharmaceuticals USA to 2002-N-0417 (December 22, 2002).

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or email policyforum@fdli.org if you would like to write a Policy Forum article.

ABOUT THE AUTHORS

Brian J. Malkin is a Partner in the New York Office of Frommer Lawrence & Haug LLP. Mr. Malkin’s practice areas include
litigation and strategy related to patent validity and infringement as well as food and drug law and, in particular, the
interrelation between patent law and food and drug law. Prior to entering private practice, Mr. Malkin worked as a regulatory
counsel at the U.S. Food and Drug Administration in both the Center for Drug Evaluation and Research and the Office of
the Commissioner, specializing in the areas of intellectual property and exclusivity related to the Hatch-Waxman Act, new
product evaluations, and compliance issues related to clinical investigations. Mr. Malkin is admitted to the Maryland, District
of Columbia, and New York Bars and is registered to practice before the U.S. Patent and Trademark Office.
Andrew S. Wasson is an Associate in the New York Office of Frommer Lawrence & Haug LLP. Mr. Wasson’s practice area
includes patent law, food and drug regulatory law, as well as transactional issues related to the pharmaceutical and biotech
industries. Mr. Wasson received his J.D. from Duke University School of Law, where he was an executive editor of the Duke
Law and Technology Review. He also received his M.A. in Philosophy from Duke University. Mr. Wasson is admitted to the
New York Bar and is registered to practice before the U.S. Patent and Trademark Office.

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