Mr. KASTENMEIER. Thank you, Dr. Young. We will have some questions for you, but I think it might be useful also to hear a brief statement from Rene Tegtmeyer, representing the Patent Office as the Assistant Commissioner for Patents.

Mr. TEGTMEYER. Thank you, Mr. Chairman. I have a more complete statement that I would like to ask be submitted for the record and give an abbreviated form of that to eliminate some detailed comments that would otherwise be covered.

Mr. KASTENMEIER. Without objection, your statement will be received and be made part of the record, and you may proceed as you wish.

Mr. TEGTMEYER. Thank you, Mr. Chairman.

I am pleased to testify on H.R. 3074, the Lopid Patent Term Extension and Fairness Act of 1987. It is our understanding that this legislation, which would amend Title 35 of the United States Code, is for the purpose of extending the patent term of one specific patent. The Lopid patent is drawn to a pharmaceutical compound which the Food and Drug Administration approved for marketing in 1981, although for a limited use. The FDA requested, however, that the developer of the drug undertake a post-marketing human study to obtain additional information about certain aspects of the effectiveness and long-term safety of the drug.

While the company was undertaking this study, Congress enacted Public Law 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984. As we understand it, the company is unable to take advantage of the provisions of this law regarding patent term extension, and the market exclusivity offered by Public Law 98-417 would also not be helpful. Conversely, however, this law adversely affects the company's exclusive market expectations because Public Law 98-417 introduced abbreviated procedures for the marketing approval of competing generic products.

As a general rule, the Department of Commerce does not favor the enactment of legislation making individual exceptions to the general patent laws, except in the most extraordinary circumstances. We do not have sufficient information on whether the facts surrounding the approval process of the patented compound and the company's business decisions taken prior to enactment of Public Law 98-417 call for equitable relief by way of patent term extension. Accordingly, we are unable to address the merits of this bill as at least a private relief bill.

Further, we have not been able to ascertain whether Lopid is the only pharmaceutical affected in this manner. The Department of Health and Human Services, as Dr. Young just indicated, does not have information available on what other pharmaceutical products were in the same or similar situation as Lopid, with the general time frame of enactment of Public Law 98-417.

Should Congress determine it appropriate to extend the Lopid patent on the basis of the circumstances peculiar to this case, we would prefer that this be accomplished by way of a private bill, specifically identifying the patent and the conditions under which its term is to be extended. Amending the patent laws generally to carve out an exception for only one patentee is not desirable, in our opinion. Title 35 already contains two sections of this nature which were enacted in 1983, prior to enactment of Public Law 98

417. We would have preferred that the terms of the patents extended by those sections had been extended by way of private relief legislation.

We hold this view not only because of statutory neatness, but it has been our experience that general statutory language, even if interspersed with factual requirements, does not always limit patent term extension only to the patent intended. For example, when Congress amended Title 35 by adding Section 155, it included several rather specific conditions intended to limit patent term extension to only one or two patents drawn to an artificial sweetener. When everything was said and done, however, 31 additional patents qualified for patent term extension under the provisions of Section 155. Even though the legislation proposed by H.R. 3074 provides for five specific conditions which must be met before a patent is eligible for extension, we are not assured that the only intended patent would meet these criteria. Only the intended patent-that is, the Lopid patent-would meet these criteria.

Aside from our preference that relief for the Lopid patent be made by way of a private bill, there are several provisions in H.R. 3074 which leave in doubt exactly how this legislation should be administered. They may also result in some unintended consequences. My prepared statement deals with these provisions in some detail to avoid the problems we see there as well as the possibility of extending the terms of other patents unintentionally. We would prefer that any relief which Congress deems desirable be made the subject of a private relief bill.

This completes my statement, Mr. Chairman. I would be pleased to answer any questions which you or other members of the Subcommittee may have.

[The statement of Mr. Tegtmeyer follows:]

STATEMENT OF RENE D. TEGTMEYER

ASSISTANT COMMISSIONER FOR PATENTS
BEFORE THE

SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES AND THE
ADMINISTRATION OF JUSTICE

OF THE

COMMITTEE ON THE JUDICIARY

U.S. HOUSE OF REPRESENTATIVES

OCTOBER 8, 1987

Mr. Chairman and Members of the Subcommittee:

I am pleased to testify on H. R. 3074, the "Lopid Patent Term
Extension and Fairness Act of 1987."

It is our understanding that this legislation, which would amend title 35 of the United States Code, is for the purpose of extending the patent term of one specific patent. The "Lopid" patent (U.S. Patent No. 3,674,836) is drawn to a pharmaceutical compound which the Food and Drug Administration (FDA) approved for marketing in 1981, although for a limited use. The FDA requested, however, that the developer of the drug undertake a post-marketing human study to obtain additional information about certain aspects of effectiveness and long-term safety of the drug.

While the company was undertaking this study, Congress enacted Public Law No. 98-417, the "Drug Price Competition and Patent Term Restoration Act of 1984." As we understand it, the company is unable to take advantage of the provisions of this law regarding patent term extension, and the market exclusivity offered by Pub. L. No. 98-417 would also be unhelpful. Conversely, however, this law adversely affects the company's exclusive market expectations because Pub. L. No. 98-417 introduced abbreviated procedures for the marketing approval of competing generic products.

As a general rule, the Department of Commerce does not favor the enactment of legislation making individual exceptions to the general patent laws, except in the most extraordinary circumstances. We do not have sufficient information on whether the facts surrounding the approval process of the patented compound and the company's business decisions taken prior to enactment of Pub. L. No. 98-417 call for equitable relief by way of patent term extension. Accordingly, we are unable to address the merits of this bill. Further, we have not been able to ascertain whether "Lopid" is the only pharmaceutical affected in this manner. The Department of Health and Human Services may have information available on what other pharmaceutica: products were in the same or similar situation as "Lopid", within the general time frame of enactment of Pub. L. No. 98-417.

82-542 88 - 2

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Should Congress determine it appropriate to extend the "Lopid" patent on the basis of the circumstances peculiar to this case, we would prefer that this be accomplished by way of a private bill, specifically identifying the patent and the conditions under which its term is to be extended. Amending the general patent laws to carve out an exception for only one patentee is not desirable, in our opinion. Title 35 already contains two sections of this nature which were enacted in 1983, prior to enactment of Pub. L. No. 98-417. We would have preferred that the terms of the patents extended by those sections had been extended by way of private legislation.

We hold this view not only because statutory neatness is a desirable goal. It has been our experience that general statutory language, even if interspersed with factual requirements, does not always limit patent term extension only to the patent intended. For example, when Congress amended title 35 of the United States Code by adding section 155, it included several rather specific conditions intended to limit patent term extension to only one, possibly two, patents drawn to an artificial sweetener. When everything was said and done, however, 31 additional patents qualified for patent term extension under the provisions of section 155. Even though the legislation proposed by H.R. 3074 provides for five specific conditions which must be met before a patent is eligible for extension, we are not assured that only the intended patent would meet these criteria.

·་

Aside from our preference that relief for the "Lopid" patent be made by way of a private bill, there are several provisions in H.R. 3074 which leave in doubt exactly how this legislation should be administered. They may also result in possibly unintended consequences. For example, the provisions of sections 155 (B) (a) and 155 (B) (b)(2) appear to be inconsistent. Section 155 (B) (a) provides that the extended "patent shall have the effect as if originally issued with such extended term. Section 155(B)(b)(2), on the other hand, requires the Commissioner to identify "the composition of matter to which such extension is applicable". Thus, the provision in one section would make the patent enforceable for the full scope of its claims during the extended period, while the provision in the other section seems to indicate that enforceability would be limited to a certain "composition of matter" to be identified by the Commissioner.

Also, the requirement of section 155(B)(b)(2), that the Commissioner identify the composition of matter to which extension of the patent term is applicable, is not clear in light of the fact that the "Lopid" patent is directed to compounds, that is, active ingredients. Compositions of matter, however, may include more than a single compound. Accordingly, it is not clear whether the Commissioner is directed to identify such composition of matter only in terms of the active ingredient of the new drug, or whether

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inactive ingredients of the approved formulation must also be identified. The latter may be difficult to do, as precise formulations of the final pharmaceutical product are usually considered proprietary information by the manufacturer and are not available for identification by the Commissioner.

Further, sections 155 (B) (a) (4) and (5) refer to the submission of a supplemental drug application to the Food and Drug Administration and that agency's determination regarding that application. These provisions do not preclude the submission of more than one supplemental new drug application. Such submissions could keep a supplemental new drug application pending before the Food and rug Administration without a final determination, even though the first supplemental new drug application may long have been disapproved. As the present, wording of H.R. 3074 makes patent term extension dependent upon the final determination regarding a supplemental new drug application, the extended term of the patent could be kept in force for a longer time than intended. To avoid this possible result, the supplemental new drug application could be specifically identified.

These are the problems that we see with the bill, as presently drafted. To avoid these problems, as well as the possibility of extending the terms of other patents unintentionally, we would prefer that any relief which Congress deems desirable be made the subject of a private bill.