Armour and Company v. Wilson & Co.

• Decision Date: 21 November 1958
• Docket Number: No. 56 C 1206.,56 C 1206.
• Citation: 119 USPQ 365,168 F. Supp. 353
• Court: U.S. District Court — Northern District of Illinois
• Parties: ARMOUR AND COMPANY, Plaintiff, v. WILSON & CO., Inc., Defendant.

168 F. Supp. 353

119 USPQ 365

ARMOUR AND COMPANY, Plaintiff, v. WILSON & CO., Inc., Defendant.

No. 56 C 1206.

United States District Court N. D. Illinois, E. D.

November 21, 1958.

Horace Dawson and Timothy L. Tilton, Dawson, Tilton, Fallon & Lungmus, Chicago, Ill., for plaintiff.

R. Howard Goldsmith, Schneider, Dressler, Goldsmith & Clement, Chicago, Ill., R. T. McLean, Adams, Forward & McLean, New York City, Thomas Freeman, Chicago, Ill., for defendant.

PERRY, District Judge.

This matter came on to be heard on the complaint and the answer thereto.

Involved in this action are two patents, namely, Patent No. 2,669,537, known as the Thompson patent, and Patent No. 2,669,536, known as the Bunding patent.

The court has heard the testimony of the witnesses, has examined and considered the exhibits offered and received in evidence, and has heard oral argument of counsel. Upon careful consideration of the record in this cause, as well as of the plaintiff's objections to proposed Findings of Fact and Conclusions of Law submitted herein by defendant, the court finds as follows:

Findings of Fact — Thompson Patent

1. Plaintiff owns the Thompson patent in suit, No. 2,669,537, which issued on February 16, 1954 (P. Ex. 1A) on a continuation-in-part application, filed December 27, 1952 (P. Ex. 1C) which was partly based on an earlier application filed August 14, 1950 (P. Ex. 1B).

I. There Is No Invention In The Thompson Patent

2. The hormone ACTH was known long prior to the Thompson patent (Tr. 925; 1174), but the medical profession was unaware of a use for ACTH until Dr. Hench of the Mayo Clinic published his Nobel prize-winning work in the spring of 1949 showing the usefulness of ACTH in the treatment of rheumatoid arthritis (Tr. 926; 1174).

3. Shortly thereafter, in June, 1949, Dr. Klein of the Wilson Laboratories discussed with Dr. Wolfson the use of gelatin with ACTH to prolong its activity and thereby increase its effectiveness (Tr. 927-928; 1267-1268).

4. Long prior to the Thompson patent, gelatin was well known as a vehicle to increase the effectiveness of drugs, being used "as a vehicle for subcutaneous injections when slow absorption of a drug is desired" (D. Ex. 7, p. 496; Tr. 1332-1342; 165-166). Gelatin was used as a retarding agent both with and without additional ingredients just as in the Thompson patent. Examples of the use of gelatin without additional ingredients were shown in the literature with respect to insulin (D. Ex. 60), epinephrine (D. Ex. 64) amphetamine (D. Ex. 66), pollen extracts (D. Ex. 68), penicillin (D. Ex. 71; D. Ex. 75), heparin (D. Ex. 75) and tubocurarine (D. Ex. 75). Examples of the use of gelatin along with other ingredients were shown in the literature with respect to epinephrine (D. Ex. 62; D. Ex. 67; D. Ex. 69; D. Ex. 80), heparin (D. Ex. 65; D. Ex. 70; D. Ex. 73; D. Ex. 74; D. Ex. 78; D. Ex. 80), tubocurarine (D. Ex. 76), codeine and morphine (D. Ex. 77; D. Ex. 79; D. Ex. 80), suprarenin (adrenalin), digitalis, ephedrine, morphine, codeine, strychnine, strophanthin, belladonna, caffein, pituitrin, antuitrin, pitressin, pitocin and "substantially all water soluble drugs suitable for subcutaneous and intramuscular injection" (D. Ex. 81).

5. The gelatin so used (both with and without other ingredients) was long known to cause between twofold and eightfold increase in effectiveness of the drugs (Tr. 1025-1035; D. Ex. 47 & 47A; D. Ex. 48 & 48A).

6. The action of gelatin with ACTH is satisfactorily explained solely on the basis of retardation of absorption (Tr. 977; 1342-1343; 501). Dr. Thompson in a communication within the Armour organization stated:

"The effect of gelatin on ACTH action can be quite satisfactorily explained on the basis of absorption control alone" (Tr. 660-661; D. Ex. 15, p. 1).

7. Gelatin acts in the same manner with ACTH as it was long known to act with other drugs. Dr. Cluxton, plaintiff's then director of medical research, stated in an internal memorandum:

"Gelatin is such a well known substance that only the pertinent qualities of this vehicle as concerns ACTHAR will be briefly mentioned. It may be administered intramuscularly or subcutaneously. Among the outstanding physical properties of gelatin is its stability in extreme temperatures and its broad solvent properties. It is an excellent viscous colloid permitting prolonged action of ACTHAR as well as heparin and other pharmaceutical products." (D. Ex. 58, p. 2).

8. The Thompson patent describes and claims the use of ACTH with gelatin with or without additional ingredients. Examples I-III of the patent describe compositions containing ACTH, gelatin and phenol; Example IV describes an ACTH preparation with aluminum phosphate and the well known Pitkin's menstruum (gelatin, dextrose, and acetic acid-D. Ex. 81; Tr. 638-642); Examples V-VII describe ACTH-gelatin preparations which include procaine hydrochloride, Chlorobutanol trisodium phosphate, aluminum phosphate and polyvinyl pyrrolidone (PVP).

9. Claims 1 and 2 of the Thompson patent are directed to ACTH-gelatin compositions broadly, i. e. with or without additional ingredients; claims 3-7 are directed to ACTH-gelatin compositions plus additional ingredients such as PVP or aluminum phosphate.

10. Thus, the subject matter described and claimed in the Thompson patent is nothing more nor less than the use of the well known vehicle — gelatin — with ACTH, the therapeutic usefulness of which had become known through Hench's work but a short time before. Such use of a well known vehicle did not constitute invention.

11. This finding of no invention is in full accord with the testimony of witnesses for both the plaintiff and defendant. These witnesses, all men skilled in the art, agreed that the use of gelatin with ACTH was "common sense, simply because everybody knew about the possibility of using gelatin as a long-acting agent" (Wolfson — Tr. 1298-1299; Forsham —Tr. 165; Frawley — Tr. 420; Fisher — Tr. 859; and Hier — Tr. 1043). Dr. Leake, defendant's expert who spent his distinguished career working with pharmaceutical products (Tr. 1330-1331), and the only witness who was not cross-examined, testified to the same effect (Tr. 1342).

12. It was not inventive to do the obvious, i. e., use common sense, and the Thompson patent represents nothing more than this.

II. Thompson Was Not An Original And First Inventor

13. As a result of the discussion between Klein and Wolfson in June of 1949 (See Finding 3), Dr. Wolfson requested non-antigenic gelatin from Dr. Klein by a letter dated July 26, 1949 (D.Ex. 32) and Dr. Klein shipped such gelatin to Dr. Wolfson on September 12, 1949 (Tr. 930-931; 1270; D.Ex. 34).

14. The first clinical use of gelatin with ACTH was made by Dr. Wolfson on his patient Loidl on September 27, 1949 (Tr. 1273-1274; D.Ex. 59).

15. About October 1, 1949, Dr. Thompson was informed of Dr. Wolfson's work with long acting ACTH and started cooperative work with him (Tr. 591-593; D.Ex. 8, p. 2).

16. On October 20, 1949, Dr. Thompson's notebook reveals that "Dr. Wolfson suggested combining all the known effective delaying agents, trying the combination clinically and, by elimination, try to arrive at an effective preparation" (D.Ex. 10, p. 157-158).

17. Dr. Thompson's first written entry suggesting the possible use of gelatin with ACTH appears in his notebook on November 22, 1949 (Tr. 601; D.Ex. 10, p. 166; D.Ex. 8, p. 2). This was after several discussions with Dr. Wolfson and after Dr. Wolfson's use of gelatin with ACTH on his patient, Loidl.

18. The common sense concept of using gelatin with ACTH was known to Dr. Klein and Dr. Wolfson prior to any such concept by Dr. Thompson, and an ACTH-gelatin preparation was used by Dr. Wolfson on his patient Loidl prior to the preparation of any such composition by Dr. Thompson.

19. Dr. Thompson was not an "original and first inventor"¹ of gelatin with ACTH.

III. The First Commercially Accepted Product Was Developed By Defendant

20. In June, 1951, Dr. E. B. Astwood published a paper teaching the use of a method of purifying ACTH with oxycellulose (Tr. 825-826; 1189-1190; D. Ex. 57). Prior to Dr. Astwood's publication, defendant had been working with Dr. Astwood and knew of the oxycellulose method of purification (Tr. 934-935; 1188-1190).

21. On June 20, 1951, Wilson prepared an ACTH preparation containing gelatin, Astwood ACTH and 0.5% phenol (Tr. 934-936). This material was sent for clinical testing to Dr. Wolfson on October 1, 1951 (Tr. 937) and to Dr. Forsham on December 17, 1951 (Tr. 936).

22. In the fall of 1951, Armour marketed an ACTH preparation containing crude ACTH, gelatin, trisodium phosphate and propylene glycol (Tr. 549; 552-553; 42). This preparation (known as ACTHAR GEL — Tr. 834) was unsatisfactory (Tr. 171; 839; 1315; D.Ex. 53).

23. On December 27, 1951, plaintiff was advised by Dr. Forsham that the Wilson gelatin-ACTH preparation was far superior to Armour's ACTHAR GEL (Tr. 171-176; D.Ex. 22; D.Ex. 53).

24. Immediately thereafter, early in January, 1952, Armour obtained from Dr. Wolfson samples of the Wilson ACTH -gelatin preparation (Tr. 831-835; D. Exs. 23, 24, 25 and 26).

25. Commercial gelatin preparations of the type presently marketed, which contain Astwood ACTH, gelatin and phenol were prepared by Wilson prior to any preparation of such products by Armour, and were prepared by Armour only after Armour had received a sample of the Wilson product from Dr. Wolfson.

IV. The Thompson Patent Is Barred By The Statute

26. The original Thompson application filed on August 14, 1950 (P. Ex. 1B) contained no example of the use of gelatin and ACTH without either aluminum phosphate or PVP (Tr. 1457-1458). Not until December, 1952, when Dr. Thompson filed his continuation-in-part application (P. Ex. 1C) did any patent application of Dr. Thompson contain examples of ACTH, gelatin and phenol without other ingredients (Tr. 1457-1460), and by that time, the Wilson...