Eli Lilly & Co. v. Schenley Laboratories, Inc.

112 F. Supp. 296, 1953 U.S. Dist. LEXIS 2764
CourtDistrict Court, S.D. Indiana
DecidedMay 14, 1953
DocketCiv. No. 3034
StatusPublished

This text of 112 F. Supp. 296 (Eli Lilly & Co. v. Schenley Laboratories, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eli Lilly & Co. v. Schenley Laboratories, Inc., 112 F. Supp. 296, 1953 U.S. Dist. LEXIS 2764 (S.D. Ind. 1953).

Opinion

STECKLER, District Judge.

The above entitled cause came on regularly for trial and the Court having duly considered the evidence and the post trial briefs filed by the parties,- and having heard oral arguments in support thereof, and being fully advised in the premises now finds the following:

Findings of Fact.

1. This suit is brought for infringement of United States Patent No. 2,515,898 issued July 18, 1950 to plaintiff on the application of Harley W. Rhodehamel, Jr.

2. Plaintiff Eli Lilly and Company is an Indiana corporation, and defendant Schenley Laboratories, ’ Inc. is a Delaware corporation with a plant at Lawrenceburg, Indiana where it has committed the acts of infringement herein charged.

3. The patent in suit is entitled Procaine Penicillin and Therapeutic Compositions [297]*297and contains ten claims for- solid procaine salt of penicillin and medicinal suspensions of that salt in finely divided form and specified concentrations.

4. It is admitted that the patent was issued to plaintiff and no part of plaintiff’s title has been assigned.

5. Plaintiff charged defendant with infringement by the manufacture, use and sale of procaine penicillin and therapeutic compositions embodying the patented inventions covered by the claims of the patent, and defendant by its Answer admitted:

“That it has made, used and sold, and is now making and selling, therapeutic preparations of procaine penicillin-G including (a) a salt in dry form; (b) a like salt in water, in which the salt present exceeds the soluble quantity and is therefore partly in suspension, and (c) a like salt in suspension in a gelled oil. In these preparations, the procaine penicillin has a strength, when dissolved, in excess of 200,000 units per milliliter, and a particle size less than 40 mesh, and is the product of a reaction, in water solution, between procaine hydrochloride and a salt of penicillin-G.”

6. The evidence establishes that defendant has made, used and sold the solid salt of procaine penicillin and the therapeutic preparations thereof described in the foregoing excerpt from its Answer.

7. No issue of infringement remained for determination by the Court.

8. Defendant’s principal defense has been that the patent in suit is invalid on the ground that Rhodehamel was not the inventor of the subject matter thereof. Defendant also contends that plaintiff should be denied relief for alleged unclean hands in the prosecution of the patent application.

9. Penicillin was discovered by Fleming in 1929, and its capacity for destroying bacteria was determined before World War II. It was first produced in useful quantities during World War II and in time for its extensive use during the war, with such success that it became known as “The Wonder Drug.” Penicillin development was the joint achievement of numberless scientists and the most intensive effort and wholehearted co-operation between the governments, the educational institutions, the medical institutions and the pharmaceutical industry of the Allies.

10. General civilian distribution of penicillin began in 1945 and the drug went into universal use as rapidly as the supply permitted.

11. Practical difficulties arose in the use of penicillin due to the fact that when injected into the human body penicillin was rapidly destroyed and eliminated by normal body processes and therefore remained effective for only about three hours. This required that the drug be administered at three or four hour intervals day and night throughout the period of treatment. This requirement made hospitalization or attendance of a trained nurse almost indispensable. Also, injections of penicillin were painful. In spite of these disadvantages the efficacy of the, drug was so great that it remained the drug of choice and the most widely used drug in the treatment of infections.

12. The practical difficulties of administering penicillin led to extensive medical literature and resort to a number of expedients by which a therapeutically effective penicillin blood level could be maintained in the human body for an extended time to obviate the necessity for frequent painful injections.

13. Among the expedients devised for administering penicillin without the need for frequent injections were the continuous drip method whereby -a penicillin solution was permitted to drip into a needle continuously positioned in the human body; the use of a tourniquet to restrict the circulation of the blood to delay elimination of penicillin; chilling parts of the body to restrict circulation; inj ecting penicillin into out-of-the-way parts of the body, such as behind the knee-cap, from which it slowly diffused into the circulatory system; using a clock operated syringe strapped to the body to make intermittent injections automatically; administering drugs to inhibit [298]*298normal kidney function and thereby delay penicillin excretion; and administration of penicillin in oils and emulsions.

14. The most effective, expedient for the maintenance of therapeutically effective penicillin blood levels was the injection of the penicillin in a mixture of peanut oil and beeswax called “the Romansky formula.” This formula generally permited once-a-day administration of penicillin and went into extensive use between 1946 and 1948, in spite of many disadvantages in the administration and use of the drug. The drug was difficult to administer. Allergic reaction to the Romansky formula was far greater than to penicillin alone, and the beeswax occasionally produced abscesses requiring surgical removal.

15. Use of the Romansky formula came practically to a complete stop in 1948 when procaine penicillin, the subject matter of the patent in suit, became generally available, and several manufacturers, including the defendant, discontinued its manufacture.

16. The problem of producing a preparation of penicillin that would permit the easy administration of the drug and the maintenance for many hours of therapeutically effective blood levels was widely recognized in the fields of medicine and the pharmaceutical manufacturing industry as a serious problem. Considerable effort was devoted to its solution from the earliest days of penicillin therapy.

17. Penicillin in drug form was usually prepared with calcium, sodium, potassium or ammonium as a dry, powdered salt. It was distributed in this dry form, but for administration it was dissolved in aqueous or oily solution. Once the penicillin had been dissolved in water, it would decompose within a few hours. The solution therefore was usually prepared shortly before administration.

18. Procaine hydrochloride, commonly also known as novocaine, is a local anaesthetic which is widely used in the medical field. Because of the great pain which frequently accompanied the injection of early penicillin, a practice developed of administering procaine with penicillin either as a separate inj ection or by mixing a solution of procaine with the penicillin solution and injecting the two together.

19. When solutions of penicillin were prepared, cloudiness or precipitates sometimes appeared; these phenomena sometimes occurred upon the addition of penicillin to distilled water, at times upon the addition of penicillin to normal saline, and at other times upon the addition to penicillin solutions of procaine, other local an-aesthetics, or other drugs.

20.

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Establishment
35 U.S.C. § 1

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Bluebook (online)
112 F. Supp. 296, 1953 U.S. Dist. LEXIS 2764, Counsel Stack Legal Research, https://law.counselstack.com/opinion/eli-lilly-co-v-schenley-laboratories-inc-insd-1953.