botany will study the case and make a report. Then the report is forwarded back to the Patent Office.

As I said, practically every case is forwarded. A few are not where the patent would be refused for other reasons, and there is no point in going through the work.

Senator KEFAUVER. All the technical and legal problems you work out in the Patent Office?

Mr. FEDERICO. The legal problems of applying the information that is supplied, we work out. Of course, we have to observe rules of evidence and observe decisions of the courts and so forth, so it may happen occassionally that a report contains material that we cannot use or that we cannot follow, but, as a rule, practically every report is followed.

The examiners in the office that work on these cases and the people in the Department that work on the other end, they have all gotten to know each other and they call up for information or to ask questions, and there is a very close cooperation.

Now, of course, the only analogy there is the routines, because the particular points that they work on would be different than the points in this other situation.

Senator KEFAUVER. Suppose the applicant is not satisfied with the opinion of the Department of Agriculture's biologist. Does he take the matter up with them or does he discuss the matter with the Agriculture people, or is all that done in your office?

Mr. FEDERICO. No.

If he is dissatisfied, because the patent law requires him to answer in 6 months and give his arguments, so a carbon copy of the arguments is sent over with the form to check whatever comments they want to make, we have to carry the burden of establishing the legal arguments, and if the applicant is dissatisfied and appeals, we must handle the appeal and prove the case in the appeal.

Senator KEFAUVER. Then you may use the Agriculture experts as witnesses?

Mr. FEDERICO. Theoretically, yes, but that issue has not arisen yet, because usually things get resolved without it. But theoretically we could.

Senator KEFAUVER. And you think the same system would be helpful in connection with HEW?

Mr. FREDERICO. My own reaction to that system is that there would be an enormous benefit is just the ability to freely talk with specialists and ask them questions and confer with them, as well as the formal reports.

A little conversation or asking a few questions might clear up some points with a formal report on another point and in another case, and

so on.

That is where I personally see the value in having established connections.

Senator KEFAUVER. Anything else, Mr. Turner?

Mr. TURNER. No, I have no further questions.
Senator KEFAUVER. Mr. Chumbris?

Mr. CHUMBRIS. I have no questions, Mr. Chairman.

Senator KEFAUVER. Mr. Raitt?

Mr. RAITT. I have no questions, Mr. Chairman.

Senator KEFAUVER. Is there anything else you wish to add, Com-
missioner Ladd?

Mr. LADD. Not at all.

I wish to thank the committee for its courtesy throughout this
hearing.

Senator KEFAUVER. We want to thank you very much for the time,
study, and interest you have given to this matter, you and all who
are associated with you.

Mr. LADD. We remain at your disposal, sir.

Senator KEFAUVER. We will be calling on you for technical assist-
ance, advice, and guidance as we go along. I think it is important, to
me it is important, that you do see value in some method of cooperation
with the Department of Health, Education, and Welfare in connec-
tion with passing upon the utility and usefulness of applications for
ethical drugs.

I think it is somewhat distressing to learn, on molecular modifica-
tions, that the tests are on animals largely and not on human beings
to whom the medicine is going to be given, and that also the courts
have not backed you up in connection with your decision as to the
usefulness of some of the drugs that you have passed on.

We thank you very much for coming and being with us.
Mr. LADD. Thank you, sir.

(Exhibit 3 follows:)

LIST OF PAPERS (PROVIDED BY THE U.S. PATENT OFFICE)

1. Note on classification of patents relating to medicine.

2. Number of patents relating to medicine, 1955–60.

3. Patents relating to medicine issued in fiscal years 1960, 1961.

4. Same. Assignment status at time of issuance.

5. Same. Country of origin of foreign inventors.

6. Nature of 970 patents relating to medicine issued during fiscal year 1961.

7. List of patents relating to medicines issued during fiscal year 1961 which
were involved in interference during their pendency.

8. Data on 48 interferences in which 44 of the 970 patents relating to medicines,
issued during fiscal year 1961, were involved.

9. List of patents relating to medicines issued during fiscal year 1961 in which
there was a decision by the Patent Office Board of Appeals.

10. Length of pendency of patents, 1960-61.

11. Decisions of the Court of Customs and Patent Appeals in ex parte patent
appeals.

12. Adjudicated medical patents, 1940-61.

NOTE ON CLASSIFICATION OF MEDICAL PATENTS RELATING TO MEDICINE
Patents, and hence patent applications, relating to medicines would be classi-
fied primarily in two classes of the Patent Office classification, with a smaller
number in a third class. These are as follows:

Class 167, medicines, poisons, and cosmetics. Subclasses 50 to 84.5 in-
clusive, and 95.

Class 260, chemistry, carbon compounds.

Class 195, chemistry, fermentation.

The portions of class 167 mentioned would include patents for medicinal com
positions and processes for making or using the same. This class is assigned
to division 43, but this division also includes classes not relating to medicines
Class 260 includes organic chemical compounds and processes for making
them. Patents for new chemical compounds, even though the compound is
indicated as having a medicinal utility or property, are classified in this class
according to the chemical structure of the compounds. Class 260 is a very large
class and is distributed among eight different examining divisions. Divisions 6,
38, 50, and mech. A (mechanical division A) are entirely devoted to portions
of class 260 and divisions 31, 46, 60, and 63 include portions of class 260 as well
as other classes in the same divisions. Chemical compounds having medicinal
properties might be classified almost anywhere in the class depending upon the
chemistry involved. The majority of such patents would go to division 6, a
smaller proportion to mechanical division A, a still smaller proportion in divi-
sion 38, and a yet smaller proportion in division 63. Only a scattered few
would be found in the portions of class 260 in the other divsions.

There is some overlapping with class 167; for example, a case containing
claims for a new chemical compound would be placed in class 167 instead of in
class 260, if it also included claims for a medicinal mixture or application of the
chemical.

Class 195 relates to fermentation chemistry. This class would include proc
esses for obtaining substances by means of fermentation, including substances
having medicinal properties, distributed among its various subclasses. However,
a case with claims for a fermentation process for producing a substance having
medicinal process, such as an antibiotic, would be classified in class 167 or class
260 if it also included claims which would take the case in either of these
classes. Class 195 is assigned to division 63 in the Patent Office, which division
also has a part of class 260 and another class.

A random few other patents might be found in other chemical classes.
Number of patents relating to medicines, 1955–60

1955.
1956.

1957.

1958.

1959.

1960.

1 Calendar years.

2 For 1960, actual count as described in another note. For 1955-59 estimates made by (a) count of patents
in class 167, and (b) count of all patents in classes 260 and 195, and applying percentages obtained from 2-year
collection.

Excludes designs and reissues.

Patents relating to medicine issued during 2 years (fiscal), 1960 and 1961

NOTE.-Printed copies of the total number of patents indicated above have been supplied to the sub-
committee, except in a few instances in which the specification was out of print, in which case a dummy
was inserted pending reprinting. The patents were located as follows: All the patents in the subclasses
of class 167 indicated in item 1 were taken. All the patents issued in classes 260 and 195 during the 2-year
period were scanned by an examiner familiar with the field and the following were selected: patents for
new chemical compounds in which the specification indicated that the compound was intended for a medi-
cinal use or was stated to have physiological or other properties which would suggest a medicinal use, and
those which stated or appeared to be used as intermediates for making either of the above; patents for pro-
cesses for making or obtaining chemical compounds or other substances which were of the same nature as
indicated above. See item 6 for a breakdown of the patents in the 2d of the 2 years.

Assignment status at time of issue, 2 years, fiscal years 1960, 1961

Assignment status at time of issue, 2 years, fiscal years 1960, 1961—Continued

Spofa, spojene farmaceuticke zavody, narodni podnik (Czechoslovakia).
Strong, Cobb & Co

Sumitoma Chemical Co., Ltd. (Japan)

Synergistics, Inc.

Tanabe Seiyaku Co., Ltd. (Japan).

Union Carbide Corp...

Union Chemiques Belge, S.A. (Belgium).

Vitamins Lt. (England)

The Wander Co..

Whitmoyer Laboratories, Inc..

AB Ferrosan (Sweden).

A/B Kabi (Sweden).

Aktiebolaget Bofors (Sweden)

Aktiebolaget Pharmacia (Sweden).

Aktiebolaget Reip (Sweden).

Aktieselskabet Pharmacia (Demnark)

American Potash & Chemical Corp.

American Scientific Labs., Inc..

The Anchoe Chemical Co., Ltd. (England).

Aplin & Barrett Ltd. (England).

Aschaffenburger Zellstoffwerke (Germany)

Bariatric Corp.

Baxter Labs., Inc..

Bioferm Corp..

The Borden Co..

122011-O2223-0300--OONONONN-2210-~~~~~~100212221

211322023IILO230

1

20200-00-21000000122010

1

1

1

0