Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
2979 words
HEADLINE: PREPARED STATEMENT OF
CAROLE
S. GOLDFINE BEN-MAIMON, MD
SENIOR VICE PRESIDENT FOR RESEARCH AND
DEVELOPMENT
AND SCIENTIFIC AFFAIRS
TEVA PHARMACEUTICALS, INC.
BEFORE
THE SENATE JUDICIARY COMMITTEE
SUBJECT - S. 1172
"DRUG
PATENT TERM RESTORATION
REVIEW PROCEDURE ACT OF 1999"
BODY:
Testimony for the Hearing before the
Senate Judiciary Committee
Regarding S. 1172 "Drug Patent Term Restoration
Review Procedure Act of 1999" August 4, 1999
Carole S. Goldfine Ben-Maimon,
MD
Good morning. Thank you for inviting me to appear before the Senate
Judiciary Committee today and for giving me the opportunity to share with you
the genetic pharmaceutical perspective on S. 1172. Before I begin to address the
specific legislation at hand, I would like to take a moment to tell you a little
about my background. My name is Carole Goldfine Ben-Maimon and I am a physician,
board certified in Internal Medicine, who has worked in research and development
in the pharmaceutical industry since 1991. Currently, I am Senior Vice President
for Research and Development and Scientific Affairs at Teva Pharmaceuticals,
Inc. Teva is a manufacturer of both pharmaceutical products and raw materials
with facilities in Pennsylvania, New Jersey and Missouri. Teva is a member of
the Generic Pharmaceutical Industry Association and the National Pharmaceutical
Alliance and my testimony today is on behalf of both trade organizations.
My
responsibilities at Teva have included the development of both brand name drug
products and generic drug products. As Senior Vice President of Research and
Development, I manage the entire development process for our pharmaceutical
products. This has included obtaining the approval of a multitude of generic
products as well asworking with the FDA to obtain approval for several new and
novel orphan drag products, specifically a product called Copaxone for the
treatment of Multiple Sclerosis and a product called Galzin for the treatment of
a very rare and terminal disease, Wilson's Disease. I make this point because it
is important and relevant to understand that many genetic manufacturers, such as
Teva, are engaged in the development and innovation of new medicines in addition
to the development of more affordable genetic medicines.
My work in research
and development for the pharmaceutical industry has allowed me to participate in
some of the most exciting research occurring today. As a physician committed to
advancing the health care profession's ability to significantly impact disease,
there is nothing more rewarding than providing quality pharmaceutical products
to the patients who need them. With this as my background and interest, I hope
my testimony will provide the committee with a somewhat unique view on the
issues presented in S. 1172.
When one talks about the pharmaceutical
industry, one must keep in mind that decisions made relating to drug development
have a direct impact on a very large and vulnerable subset of consumers; those
who are ill, those who are looking to pharmaceuticals sometimes to save their
lives and almost always to improve the way they feel and thus their quality of
life. As we all know, these necessary pharmaceuticals can be very costly, all
too often forcing a patient to choose between spending their limited income on
the drug or some other essential or desired commodity. We all also know that
senior citizens are often the ones forced to make these unfortunate choices.With
this in mind, in 1984 Congress tackled the task of balancing the public need for
cost- competitive generic drug products while providing incentives to encourage
innovation and creativity by the brand industry. The result was passage of the
landmark Hatch-Waxman Act. The Act was carefully and
thoughtfully drafted to strike a balance between the brand industry and the
generic industry and to serve the public interest. The generic industry relies
on the brand industry for its lifeblood. It is only through the brand
industries' continued research and development that new products ultimately
become available for the generic industry to develop and market. Thus, we
understand the need for strong intellectual property tights and the importance
of incentives to stimulate the costly research and development that is required
to bring new, safe and effective drugs to market. Therefore, we emphatically
support the protection of these rights. As I stated earlier, many genetic
companies actually have patents of their own and many also market branded
products themselves. Thus, there is no controversy over the importance of
adequate and appropriate patent protection, the question is only when does the
patient deserve access to more affordable medicines.
One can easily see the
success of Hatch-Waxman worked when financial data is reviewed.
Since 1984 brand sales have increased steadily, exceeding $80 billion in 1998.
Last summer, the Congressional Budget Office concluded that, "Between 1983 and
1995, investment in R&D as a percentage of pharmaceutical sales by brand
name drug companies rose from $17 billion to $57 billion, thus demonstrating
that the brand industry is not only continuing to invest in the development of
novel pharmaceuticalproperties but it is increasing its commitment." During this
time of escalating R&D, genetic market share increased from 13% to 41%. This
is proof that genetic competition is the motivation for innovation.
Let's be
realistic the brand industry is not developing new products out the goodness of
their hearts. They are doing this because of the profits that are realized when
a novel product is introduced to the market place.
In light of what I have
just said, let's consider the specific issue at hand, whether or not so called
"pipeline drugs" are entitled to seek additional patent life. Let me be clear.
Teva and other members of the generic industry oppose patent extensions. There
is a cost associated to patent extensions and it is the American consumer who
ultimately pays the price. While the generic industry opposed patent extensions
back in 1984, it was provisions like the Bolar safe harbor and the abbreviated
new drug application process that rallied the generic industry behind passage of
the Hatch-Waxman Act. The cost of the patent extension
provisions were balanced out with the tremendous savings consumers would reap
from having access to more affordable generic medicines the day after a patent
expired.
A pipeline drug is a drug for which a patent had been issued and an
investigational new drug application (IND) or a new drug application (NDA) was
pending at FDA before the enactment date of the Hatch-Waxman
Act. While there were over 100 drugs in the FDApipeline back in 1984, S. 1172
applies to only seven. The most notable of which is Claritin, Schering-Plough's
multi-billion dollar drug for allergy sufferers.
Congress specifically
addressed the brand industry's concerns that their expected returns on their
investment in these pipeline drugs would be diminished by the accelerated
generic competition stemming from changes in the law. This would have led them
to abandon the development of these products. Thus, they were awarded a two year
extension as an incentive to bring the products to market. Let me reiterate that
the intent of the Hatch-Waxman Act was to encourage future
investment in research and development, not to reward past investment. This is
why the Act provides new chemical entities with the opportunity to seek up to
five years of additional patent life when drugs like Claritin were limited to
the two-year patent extension.
It is also important to note that that in
addition to the two-year extension, Claritin enjoys a 22.5-month extension under
the General Agreement on Trade and Tariffs (GATT). As a result of past
extensions, in June 2002, Claritin will have enjoyed patent life of
approximately 21 years - four years beyond the original patent term.
I would
ask that today you consider the alternative. What if Schering's patents were
permitted to expire? In our view it would accomplish exactly what Congress
intended when they passed the Hatch- Waxman Act.First,
Hatch-Waxman provided the initial incentive to continue to
development Claritin and ultimately bring it to market. Second, American
consumers will finally have access to more affordable generic versions of the
drug without additional costly delay. Third, and most importantly, allowing
patents to expire stimulates and encourages the development of new, improved,
and novel approaches to disease. Allowing the brand industry to rely on profits
from an aging product line is not only inconsistent with the intent of
HatchWaxman, it undermines the incentive to seek needed advancements in the
treatment of disease. The knowledge that the Claritin patent will expire sooner
rather than later has encouraged Schering to invest in new products like the
metabolite of Claritin, desloratadine or better known as "Super Claritin", whose
patent will not expire until 2014. This product according to Richard J. Kogan,
Chief Executive of Schering-Plough is in late stage human testing. Hopefully
this product will provide some advantages over Claritin, thus advancing medical
therapy. At the end of the day Schering has rightfully profited from Claritin
sales of approximately $30 billion.
I'd like to address some of the other
issues in S. 1172. The bill accurately acknowledges some of the widely debated
issues surrounding the 180-day "generic exclusivity" provided for in the
Hatch-Waxman Act. As you may know, this exclusivity was created
to encourage generic companies to challenge or circumvent weak patents and thus
bring lower cost pharmaceuticals to the market earlier. This provision has been
surrounded by controversy. One of the mechanisms by which the brand industry
manipulates the 180day exclusivity clause is by abusing the listing of patents
in the Orange Book. Although the generic industry whole-heartedly supports
"cleaning up" the Orange Book,unfortunately the proposal contained in S. 1172 as
written is completely inadequate to achieve that goal and may even exacerbate
the problem.
FDA has taken the position that they do not have the expertise
to oversee the listing of drug patents, and has accepted for listing in the
Orange Book any patent that the sponsor of a reference listed drug has
submitted. This has resulted in a situation where inappropriate patent listings
have become a major obstacle to the lawful market entry of competitive genetic
drug medicines. For example:
A patent covering "multifracationable tablets
with bisectable/trisectable structures" has been listed for the drug trazadone,
even though the patent does not refer to trazadone or any other specific drug
product. Because of this listing, a genetic applicant was forced to file a
paragraph W certification to the patent, precipitating litigation that triggered
the statutory 30-month stay on final ANDA approval, and causing substantial
delay and expense.
A listed patent coveting Terazosin drug products was held
to be expired in a 1996 federal district court case. thstanding that decision,
the patentholder insisted on maintaining the listing for the expired patent
until specifically ordered by the court to request FDA to delist it, an order
that was upheld by the Federal Circuit on appeal. Meanwhile, genetic applicants
were forced to incur additional expense and delay contesting a patent that had
been held expired and ordered to bedelisted. The reference drug sponsor ended up
enjoying a de facto extension of patent protection for well over a year after
the actual expiration date of the patent.
Several method-of-use patents that
cover unapproved uses of bupropion were listed, without use codes. Although ANDA
applicants for bupropion are not seeking approval of such uses, those applicants
were being forced to file paragraph IV certifications to these patents because,
in the absence of use codes, FDA does not recognize them as use patents that may
be omitted from an ANDA that does not seek approval of the corresponding
indications. Subsequent to the innovator being notified and bringing suit these
patents were delisted from the Orange Book.
A patent is listed for the drug
gabapentin that covers only a monohydrate form of the compound not found in the
approved, marketed formulation. Yet because of this listing, generic applicants
will be forced to file paragraph IV certifications to the patent, giving the
patentholder the opportunity to trigger a 30-month stay, and invoking the
180-day exclusivity mechanism, over a patent that does not even claim a compound
in the reference drug itself.
It is clear to us that as a matter of both law
and policy only patents on drug active ingredients (and on methods of using
them) should be listed, and that patents that claim final formulations
incorporating such active ingredients (i.e. drug product patents) should not be
listed in the Orange Book, FDA initially agreed with that approach,
anddocumented it in 1984 in a Letter to Industry from Harry M. Meyer, Jr., MD,
Director, Center for Drugs and Biologics, dated November 16, 1984. "The patents
that FDA regards as covered by the statutory provisions for submission of patent
information are those on the active ingredient or ingredients, or use patents
for a particular indication or method of using the product. The agency will not
publish patents relating to chemical intermediates, methods of manufacturing,
excipients or formulations."
Today, however, FDA lists any patent, and
refuses to even consider ways to remedy the abuse potential its current approach
has engendered.
S. 1172 in its current form, creates additional inequities.
You may not know there are generic drug applications (ANDNs) for these seven
products already pending at FDA. Each of these applicants was forced to certify
to all listed patents, whether or not these patents were appropriately listed.
If S. 1172 is passed in its current form, genetic applications submitted in the
future will not be required to certify to all listed patents, but only to the
compound patent. By reducing the burden of certification for these later-filed
applicants, they could potentially avoid the 30-month approval stay and enter
the market before the other ANDA applicants who filed first. Thus the current
proposal is essentially backwards and creates an unlevel playing field within
the genetic market. Products for which generic applications containing paragraph
IV certifications that are already filed at the FDA should remain untouched,
while innovators should be required to removeirrelevant patents from the Orange
Book for all other products. Resolution of this problem requires a more far-
reaching and all-inclusive approach than that contained in S.1172.
Finally,
we in the generic industry oppose any new process for obtaining patent
extensions. The extension of patents for pharmaceutical products must be
considered in light of the impact on patients who will now be required to pay
more for prescription drugs and who may now have to wait longer for new and
improved drugs as the lack of incentive for their development may delay their
market entry. The Patent Office is not and has never been charged with this
responsibility. They do not possess sufficient knowledge of the FDA and its
processes nor do they possess sufficient knowledge of the impact on the public
good or pharmaceutical policy to justify this delegation of authority. A truly
fair and transparent process would insure that those making the decision would
have complete information available, the expertise to evaluate this information,
and would be capable of fully understanding the impact of the extension on
patients, third party payors and the pharmaceutical industry. It is of the
utmost importance to those of us who use drug products, prescribe them for
others, and rely on generic products to help make ends meet, that requests for
patent extensions be considered in a forum in which knowledgeable parties can
adequately and fairly debate the issue. Given this type of process, we are of
the opinion that there would be no patent extensions except in the most extreme
of situations.Using Claritin as an example, one can clearly see the intensity
with which a company will lobby for these extensions. This is the fourth effort
to extend these patents. In May 1997, Schering attempted to add a patent
extension amendment to the Omnibus Patent Act of 1997. In the closing moments of
the 1997 congressional session, there was another attempt to extend the patent
through the appropriation process, and last year there was an attempt to add
this proposal to the 1998 Omnibus Appropriations Bill. Schering is not the only
company that has made these submarine attempts to extend patents. Debating this
process in Congress has allowed the interests of the public to be kept at the
forefront of the debate and thus has assured an open debate based on the merits.
In contrast, such openness and fairness will be lost under the extension process
proposed in S. 1172.
In summary, as a physician and a representative of the
generic industry, I implore you to consider all the implications of granting a
patent extension for these products. S. 1172 is clearing focused on the
extension of several long-running monopolies at the expense of the patients who
suffer from the diseases these products treat. The improper listing of patents
in the Orange Book definitely needs to be addressed, as must the problems
surrounding the 180-day exclusivity provision. Other important patient oriented
issues such as providing low cost generic biologics must also be confronted.
However, this bill does not remedy any of the above controversially issues while
it focuses on a self-serving strategy that only benefits a few select innovator
companies. I hope that if prior to my testimony, Congress believed that S. 1172
struck a balance, I have convinced you to the contrary. S.1172 provides no such
balance in its current form; it is merely a patent extension for a multi-billion
dollar allergy drug. Thank you for your time.
END
LOAD-DATE: August 5, 1999
