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“(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use,

or sale of an approved drug, and

"(C) damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, or sale of an approved drug.

8 The remedies prescribed by subparagraphs (A), (B), and (C) 9 are the only remedies which may be granted by a court for an 10 act of infringement described in paragraph (2), except that a 11 court may award attorney fees under section 285.".

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SEC. 203. Section 282 of title 35, United States Code,

13 is amended by adding at the end the following:

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"Invalidity of the extension of a patent term or any

15 portion thereof under section 156 of this title because of the

16 material failure

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"(1) by the applicant for the extension, or

"(2) by the Commissioner,

19 to comply with the requirements of such section shall be a 20 defense in any action involving the infringement of a patent 21 during the period of the extension of its term and shall be 22 pleaded. A due diligence determination under section 23 156(d)(2) is not subject to review in such an action.".

Amend the title so as to read: "A bill to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications and to amend title 35,

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United States Code, to authorize the extension of the pat

ents for certain regulated products, and for other purposes.".

In response to your letter of July 6, 1984, I am enclosing answers to questions on patent term extension legislation which you have accressed to me. I hope that my responses are helpful when you consider H.R. 3605.

. Proponents of this bill claim that it will lead to "cheaper drugs today, better drugs tomorrow". Your testimony seems to imply a disagreement with that conclusion at least insofar as you criticize the limited grant of patent extension for drugs. Would you support this bill, and recommend a Presidential signature if it passed as reported by the Energy and Commerce Committee?

A. My major criticism of H.R. 3605 is its complexity due to the efforts by its drafters to cure the alleged problem of drug companies' prolonging their market position by obtaining a chain of patents generally relating to the same product. I have not seen credible evidence that such a problem exists. The policy reflected in H.R. 3605 would permit extension usually only for the earliest product patent and not for new uses, such as cancer treatments, discovered and patented later. To carry out this policy, the Patent and Trademark Office would be required to make determinations which our examiners are not trained to make at this time. These involve determinations on infringement, rather than patentability, and are usually made by the courts. While I have critized the bill because of those and other shortcomings, I remain strongly in favor of the overall compromise, of establishing ANDA procedures and patent term restoration. However, contrary to representations by others, H.R. 3605, as presently worded, would not permit the Patent and Trademark Office to perform only ministerial functions. Should the bill be passed as reported by the Energy and Commerce Committee, without at the very least providing that the PTO only engage in purely ministerial functions rather than the complex determinations now required by the bill, it would be extremely difficult for us to recommend to the President that he sign this legislation.

What historical precedent is there for Congress modifying the terms of a patent during its term? Did Congress make any similar changes --- i.e. contraction of the rights of a patent holder -- when it enacted the 1952 Patent Act?

I am not aware of any instance in which Congress narrowed or otherwise modified the scope of a patent during its term. When Congress enacted the patent laws in 1952, it basically codified patent laws then in existence and modified some provisions in view of prevailing court decisions. In the area of defining what constitutes an infringement, the 1952 act increased, or at least clarified, patentees' rights.

Under the terms of the bill the PTO will be permitted to charge fees for patent term extensions equal to the costs of administrating the program. What is a ball-park guess about what these costs will be?

Due to the many assumptions which have to be made to guess what the level of work may have to be in the individual case, it is difficult to arrive at a firm cost estimate of administering this program. However, the fee may be in the range of $1500 to $2000 per case.

A.

It is my understanding that Congressman Waxran's staff gave your office a series of examples of supposed abuses which would occur if Congress were to permit patent term extension under the same conditions as were found in H.R. 6444 (the Judiciary Committee reported version from last Congress). Does this information support the rather complex rules found in H.R. 3605?

Please see the attached analysis