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December 23, 2002

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane

Rm. 1061

Rockville, MD 20852

[www.fda.gov/dockets/ecomments](http://www.fda.gov/dockets/ecomments)

RE: **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, Docket Number
> 02N-0417.**

To Whom It May Concern:

Families USA is pleased to submit these comments on the above referenced
proposed rule, published in the Federal Register on October 24, 2002.
Families USA is a consumer advocacy organization. For over 20-years, we
have represented the interests of health care consumers nationwide.

Our interest in this proposed rule stems from our mission: the
achievement of high-quality, affordable health care for all Americans.
Access to affordable prescription drugs is a critical component of
health care. Timely access to generics makes prescription drugs more
affordable for consumers and other health care payers. Brand-name drug
manufacturers' inappropriate manipulation of provisions in the
Hatch-Waxman legislation has delayed the public's access to generic
drugs and cost consumers and the health care system hundreds of millions
of dollars.

Families USA is particularly well positioned to comment on the proposed
rule. We actively monitor pharmaceutical industry practices and have
joined as a plaintiff in lawsuits related to inappropriate Orange Book
listings and abuse of the 30-month stay provision. We represent
consumers' interests only; Families USA receives no funding from the
pharmaceutical industry.

Our comments separately address each of the three areas covered by the
proposed rule: the types of patents that must and must not be listed in
the Orange Book; the Patent Certification Statement; and, the 30-month
stay.

**Types of Patents that Must and Must Not be Listed.**

We commend the FDA for recognizing the need to clarify what patents must
and must not be listed. Specifically, we support the proposal to amend
the current listing regulation to clearly state that patents claiming
metabolites, packaging, and intermediates are ineligible for Orange Book
listing. However, we do not support the inclusion of product-by-process
patents and patents claiming a different form of the approved drug
substance ("polymorph" patents) among the patents that must be listed.
The inclusion of these types of patents is an inappropriate expansion of
the FDA's current interpretation of Hatch-Waxman's listing requirement
and is open to abuse by NDA holders.

*Product-By-Process Patents*

We believe that product-by-process patents must not be listed,
concurring with the Federal Trade Commission's (FTC) interpretation of
Hatch-Waxman.[^1] In its recent report on generic drug entry, the FTC
stated, "the listing regulation and Hatch-Waxman's legislative history
prohibit the listing of process patents, and product-by-process claims
are arguably similar to process patents than are product patents....the
wording of the product-by-process claim more closely resembles that of
the process claim, not the product claim."[^2] The proposal to include
product-by-process patents among patents that must be listed is not only
contrary to the legislative history of Hatch-Waxman, but will likely
lead to confusion among, and abuse by, NDA holders. The potential for
confusion is even noted in the preamble to the proposed rule[^3] and the
potential to use product-by-process patents as a device to list what are
actually process patents is noted in the FTC's report.[^4]

*Patents Claiming a Different Form of the Approved Drug Substance
(Polymorph Patents)*

As noted in the preamble to the proposed rule, it has been the FDA's
longstanding position that patents must claim the [approved]{.underline}
drug product or the drug product that is the subject of the application.
We agree with the interpretation noted in the FTC's report that
different polymorphs

of the approved active ingredient are not part of the approved drug
product.[^5] As such, patents claiming different polymorphs should not
be listed.

The FDA's current interpretation of Hatch-Waxman and current listing
regulation appropriately exclude polymorph and product-by-process
patents from those that must be listed. Given the current abuses in
patent listing---many of which are outlined in the preamble to the
proposed rule---expanding listable patents beyond the FDA's historic
interpretation of Hatch-Waxman is inappropriate and unwise.

**Patent Certification Statement**

Again, we commend the FDA for recognizing that changes are needed to
curb inappropriate patent listings. The Patent Certification Statement
is a first step but does not go far enough. It falls short of a real
review of patent listability.

Current misuse of patent listings shows that real review is necessary.
However, relying on certifications from NDA holders is not enough to
stop abuses. The FDA should go beyond merely requiring a statement from
NDA holders and establish an administrative procedure for real review of
listability, with delisting for those patents that do not meet listing
requirements. Families USA believes that such a process is critical and
that, without such a process, abuses that delay generic entry will
continue.

**The 30-Month Stay**

While it is Families USA's position that no 30-month stay provision is
necessary, we recognize that such a change is beyond the scope of
rulemaking. Within the context of current law, we believe that limiting
NDA holders to one 30-month stay per drug product per ANDA is an
appropriate interpretation of the Hatch-Waxman legislation. However, we
are concerned that the structure of the one 30-month stay as proposed
may result in further delays in consumers' access to generics.

Currently, an ANDA applicant provides notice to the NDA holder for each
unexpired patent the NDA holder lists. The NDA holder has 45-days from
receipt of notice to bring a patent infringement suit against the ANDA
applicant. Because a lawsuit triggers the 30-month stay provision, the
NDA holder has an incentive to litigate. However, even if the NDA holder
does not litigate, the ANDA applicant can bring an action for
declaratory judgment. This provides resolution to patent issues by the
time the generic enters the market.

The proposed rule may remove the mechanisms that currently allow ANDA
applicants to have a resolution to legitimate patent disputes before
going to market. The proposed rule eliminates the requirement that an
ANDA applicant provide the NDA holder with notice related to patents
listed after the initial Paragraph IV certification. This may also
eliminate the option for an ANDA applicant to seek a declaratory
judgment if the NDA holder does not initiate a lawsuit, an option
currently available if the NDA holder does not bring suit within 45-days
of notice. Further, since litigation will not trigger a second 30-month
stay, the NDA holder will not have an incentive to file a lawsuit to
provide an early resolution to the patent dispute. With no incentive for
NDA holders to litigate and no option for ANDA applicants to seek
resolution on legitimate patent questions, it is possible that ANDA
applicants may face an open-ended threat of legal action related patents
listed after the initial Paragraph IV certification. Facing such a
threat, ANDA applicants may be hesitant to bring generics to market.

Giving ANDA applicants the option to certify patents listed after the
initial Paragraph IV certification and to seek declaratory judgment if
the NDA holder does not bring suit within a specified time period would
resolve this issue, although that resolution may be beyond the scope of
rulemaking.

**Conclusion**

Although we are pleased that the FDA recognizes the need to address NDA
holders' inappropriate manipulation of current laws, as outlined in our
comments, we are concerned that the proposed rule will not result in
greater access to generics. While the proposed rule provides needed
clarification on the types of patents that can be listed in the Orange
Book, including product-by-process and polymorph patents among listable
patents is inappropriate and could result in continued abuses. The
proposed Patent Certification Statement is a good first step, but it is
insufficient to provide the real review of listability necessary to curb
abuses. While we strongly support the proposed limitation in the
30-month stay provision in principle, we are concerned that, as
structured, it may create uncertainty for ANDA applicants that could
result in even greater delays in generic marketing.

Although the proposed rule can be improved so that it better meets the
goal of ensuring appropriate access to generics, rulemaking alone cannot
correct existing abuses. Legislation is necessary. Current law needs to
be corrected to either remove the 30-month stay or to ensure that the
limitation of one 30-month stay is not challenged in court. While we
believe that this authority does exist in current law, explicit
statutory changes would ensure that this interpretation is followed by
the courts. Limitations on the 30-month stay need to be made in
conjunction with a requirement that NDA holders promptly list patents,
and with provisions for substantive review of listability and a
mechanism for ANDA applicants to challenge Orange Book listings.

Medications are an important part of comprehensive medical care and
millions of Americans are without prescription drug insurance.
Appropriate, timely access to lower-cost generic drugs will make
medicines more affordable for millions of consumers and will help to
reduce health care costs for other payers as well.

The FDA's recognition of the need to correct inappropriate manipulation
of current law is an important first step; however, it falls short of
what is necessary and some of the proposed changes may even increase
barriers to generic entry.

We appreciate the opportunity to submit these comments.

Sincerely,

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Ron Pollack

Executive Director

[^1]: *Generic Drug Entry Prior to Patent Expiration: An FTC Study*,
    Federal Trade Commission (Washington, D.C., July 2002).

[^2]: Federal Trade Commission, op. cit., page A-43.

[^3]: The preamble to the proposed rule states: "We are concerned,
    however, that persons unfamiliar with patent law might confuse
    product by process patents with process patents, and seek to list
    process patents with us." (Federal Register, Vol. 67, No. 206, page
    65452).

[^4]: In its report, the FTC notes the similarities of
    product-by-process and product patents and illustrates how, through
    simple rewording, a process patent could be listed as a
    product-by-process patent. "A *product* patent claim would recite
    'such and such substance.' A related *process* patent claim would
    recite 'a process for making such and such substance by performing
    steps (a) and (b).' A corresponding *product-by-process* patent
    claim would simply rearrange words of the process claim to recite
    'such and such substance made by the process of performing steps (a)
    and (b).' " (Federal Trade Commission, op. cit., pages A-42-A-43.)

[^5]: In its report, the FTC notes two arguments for excluding polymorph
    patents from listable patents: (1) patents claiming the different
    polymorphs do not claim the approved drug product and (2) the
    listing analysis is rooted in patent concepts and because brand-name
    companies can obtain a separate patent on a later polymorph form,
    the approved drug product and the polymorph are not the "same" for
    patent purposes. (Federal Trade Commission, op. cit., page A-41.)