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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 FD&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, FDA 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.1 Thus, the market protection that Warner-Lambert expected Lopid to enjoy as a result of the FD&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 FDA 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 FD&C Act would be changed.

In July 1983, however, Representative Henry Waxman introduced legislation to amend Section 505 of the FD&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.F.C. 1984), certiorari denied, 469 U.S. 856 (1984).

2

Premo Pharmaceutical 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 abbreviated 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 imposed by FDA 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 FDA 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).

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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 protection 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 FDA 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 provision is a dead letter. Once the Lopid patent expires, in 1989, a generic competitor will be able to obtain FDA approval of an abbreviated NDA for a generic copy with the use that was approved by FDA in December 1981, i.e., for adult patents with elevated triglycerides at risk for pancreatitis. competitors will therefore be able to market gemfibrozil

throughout the country for this use.

Generic

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.

FDA 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 acceptable.

If

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. generic copies are permitted on the market, they can be prescribed for the broad new use as well as for the initial

narrow use.

ง.

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 FDA 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 FDA upon undertaking an extraordinarily large Phase IV study to

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