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At the time the study was begun, there was a strong

regulatory incentive for Warner-Lambert to fund a large

investigation of this type. Under the new drug provisions contained in Section 505 of the Federal Food, Drug, and

Cosmetic Act (the ED&C Act) and implementing FDA policy, as

they existed at that time,

a new drug for which FDA approved

an NDA subsequent to enactment of the Drug Amendments of 1962

could not be the subject of generic competition.

For a

post-1962 new drug, EDA required that any generic copy must

undergo the same regulatory requirements as the pioneer drug.

For Lopid, this meant that any future competitor

would be required to duplicate both the animal and the human

studies that Warner-Lambert had undertaken to obtain FDA

approval of the NDA.

The animal studies had begun in 1969 and

had extended several years.

The human studies had begun in

1971 and extended for 10 years, just to obtain the initial

narrow claim for adult patients with elevated triglycerides at

risk for pancreatitis.

The Helsinki Heart Study required an

additional two years to plan and six years to conduct, to

justify the broader claim for use in reducing the risk of

heart disease.

Thus, even without any patent protection, the

FD&C Act and the FDA policy in the early 1980s would clearly

have provided an absolute minimum of five years of marke :

protection, and probably closer to 10 to 15 years, after a

competitor decided to begin the required studies.

6

At that time, the research-based pharmaceutical

industry as a whole took the position that a generic competitor could not lawfully begin either the animal testing or the human investigation of a patented new drug, in order to satisfy the FDA regulatory requirements, until the patent had

in fact expired.

That position was being litigated at the

time, and the industry position was ultimately upheld in the Bolar case.' Thus, the market protection that Warner-Lambert expected Lopid to enjoy as a result of the ED&C Act and FDA

policy would begin when the Lopid patent expired, in 1989.

The generic drug industry had attempted to overturn

the FDA interpretation of the FD&C Act, but the EDA position was initially upheld in the influential United States Court of

Appeals for the Second Circuit in 1980? and ultimately by the

Supreme Court in 1983. '

Thus, there was no reason for

Warner-Lambert to believe that the regulatory protection

afforded by the ED&C Act would be changed.

In July 1983, however, Representative Henry Waxman

introduced legislation to amend Section 505 of the ED&C Act to

permit abbreviated NDAs for generic copies of post-1962 new

1

Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (C.A.E.C. 1984), certiorari denied, 469 U.S. 856 (1984).

2

Premo Pharmacoutical Laboratories, Inc. v. United States, 629 F.2d 795 (2d Cir. 1980).

United States v. Generix Drug Corp., 460 U.S. 453 (1983).

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drugs. After more than a year of hearings, negotiations, and

debate, this legislation was ultimately enacted as the Drug Price Competition and Patent Term Restoration Act of 1984 (the

1984 Act).'

The 1984 Act sought to achieve two purposes.

First,

it authorized FDA approval of generic drugs, through abbre

viated NDAs, after expiration of the patent and a specified period of market exclusivity. Second, it authorized extension

of patents for drugs approved subsequent to the enactment of

the 1984 Act, as partial compensation for the length of time

required for compliance with the regulatory requirements im

posed by EDA on new drugs.

IV.

The Lack of Market Protection for the New
Lopid Indication Under the 1984 Act.

Under the 1984 Act, any new drug approved by EDA

between January 1, 1982 and September 24, 1984 (the date of

enactment) received 10 years of market exclusivity, during

which an abbreviated NDA could not be approved for a generic

copy of the drug.

Because the NDA for Lopid was approved on

December 21, 1981, Lopid was not eligible for this 10 years of

market exclusivity.

The 1984 Act also provided for up to five

years of patent term restoration for a new drug approved after

H.R. 3605, 98th Cong., 1st Sess. (July 19, 1983).

P.L. 98-417, 98 Stat. 1585 (1984). For an overall analysis of the 1984 Act, see E.j. Flannery & P.B. Hutt, Balancing Competition and Patent Protection in the Drug Industry: The Drug Price Competition and Patent Term Restoration Act of 1984, 40 Food Drug Cosm. L.J. 269 (1985).

8.

the date of enactment of the statute, but only if it was the

first approved use.

Thus, Lopid was not eligible for patent

term extension for its initial use and will not be eligible

for patent term extension for the second use that will be

based upon the results of the Helsinki Heart Study.

The 1984 Act did provide one type of market protec

tion that will be applicable to Lopid when the new indication

is approved by FDA based on the Helsinki Heart Study, but that protection will be illusory and, in fact, will provide no actual protection at all. The 1984 Act provides a three-year

period following EDA approval of a supplemental NDA for a new

indication, during which a generic copy cannot be approved

through an abbreviated NDA for that same indication.

In the situation faced by Lopid, however, this pro

vision is a dead letter.

Once the Lopid patent expires, in

1989, a generic competitor will be able to obtain EDA approval

of an abbreviated NDA for a generic copy with the use that was

approved by EDA in December 1981, i.e., for adult patents with

elevated triglycerides at risk for pancreatitis.

Generic

competitors will therefore be able to market gemfibrozil

throughout the country for this use.

Once the Helsinki Heart Study results are published and FDA approves a much broader use for Lopid, moreover, every doctor in the country will be free to prescribe the generic

copies of the drug for that broad new use, even though the

generic copies are approved only for the narrow initial use.

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EDA has long taken the position that physicians may lawfully

prescribe an approved new drug for any unapproved use, without

violating Federal law..

Particularly because Lopid will

already have been approved for the broader use, physicians

will unquestionably regard generic copies as equally accept

able.

Thus, the fact that FDA is precluded from approving

generic copies of the drug for the broad new use, for a period of three years, provides no protection whatever for Lopid. If

generic copies are permitted on the market, they can be

prescribed for the broad new use as well as for the initial

narrow use.

V.

The Unique Status of Lopid.

Lopid is the only new drug that falls within the

unique set of circumstances described above.

For that reason,

I fully support legislation that would provide five years of

patent term extension for this drug, conditioned upon EDA

approval of a supplemental NDA for a broader use of Lopid to

reduce the risk of heart disease, based upon the results of

the Helsinki Heart Study.

Let me briefly recapitulate the

unique circumstances that apply to Lopid and only to Lopid.

First, it is the only drug whose approval by FDA for

an initial narrow indication was conditioned by EDA upon

undertaking an extraordinarily large Phase IV study to

37 Eed. Reg. 16503 (August 15, 1972).

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