Smith, Kline & French Laboratories v. Clark & Clark

• Decision Date: 01 September 1945
• Docket Number: No. C-2311.,C-2311.
• Parties: SMITH, KLINE & FRENCH LABORATORIES v. CLARK & CLARK et al.
• Court: U.S. District Court — District of New Jersey

62 F. Supp. 971

SMITH, KLINE & FRENCH LABORATORIES v. CLARK & CLARK et al.

No. C-2311.

District Court, D. New Jersey.

September 1, 1945.

COPYRIGHT MATERIAL OMITTED

Grover C. Richman, Sr., of Camden, N. J. (George J. Harding and George A. Smith, both of Philadelphia, Pa., of counsel), for plaintiff.

Morton C. Haight, of Pitman, N. J. (Nelson Littell and V. Alex Scher, both of New York City, of counsel), for defendants.

FORMAN, District Judge.

This is an action brought by Smith, Kline & French Laboratories, a Pennsylvania corporation, assignee of Gordon A. Alles, of Monterey Park, California, to whom United States Letters Patent No. 1,879,003 was issued on September 27, 1932. The plaintiff charges the defendants Clark & Clark, a New Jersey corporation, Charles L. Morris, Robert Brinton Morris trading as Professional Laboratories, David M. Olmstead, Benjamin Zirin and Standard Medical Laboratories, a New Jersey corporation, with infringement of the said patent and unfair competition, and seeks profits and damages arising therefrom.

An answer was filed by Clark & Clark, Charles L. Morris, and Robert Brinton Morris trading as Professional Laboratories, who by way of counterclaim seek injunctive relief and damages against the plaintiff. The suit is not pressed against David M. Olmstead, Benjamin Zirin and Standard Medical Laboratories.

The answering defendants take the position that they did not infringe the plaintiff's patent for the reason that it lacked validity in that: (1) Alles was not the original inventor; (2) the composition claimed was not new or novel in that one skilled in the art could ordinarily produce the same; (3) that the descriptions contained in the letters patent are ambiguous and indefinite and do not disclose the invention in clear and concise terms so as to enable one skilled in the art to produce the same; (4) that the claims of the patent are excessive, vague, ambiguous, and indefinite and (5) that the composition is an unpatentable combination of old and well-known elements produced in an obviously customary manner.

Other contentions raised at the trial were that the disclaimer filed by Alles on August 29, 1934, is invalid; the patent and the claims of the disclaimer are invalid for the reason that no invention is involved to find that an old product works for a known use, particularly in a field where it was known that products of the type involved were useful. The defendants further contended at the trial that if it is assumed that the discovery is patentable as an old product for a known use, then the claims of the disclaimer were invalid because they failed to "particularly point out and distinctly claim" the invention as required by law.

In addition to a denial of infringement upon their part, the defendants likewise denied that they have been guilty of unfair competition as alleged by the plaintiff. Affirmatively, the defendants insist that they are entitled to recover against the plaintiff their provable damages for unfair competitive practices upon the part of the plaintiff, which forms the substance of their counterclaim.

The invention relates to a composition of matter purporting to be useful for therapeutic purposes. The specifications describe the invention and state that the composition is physiologically active and produces effects in animals and man similar to the effect of the salts of ephedrine.

In his patent Alles originally claimed:

"1. As a new composition of matter, a salt of 1 phenyl-2-aminopropane.

"2. As a new composition of matter, the hydrochloride of 1-phenyl-2-aminopropane."

His disclaimer follows:

"He disclaims so much of claim 1 of said patent as is in excess of the following:

"`As a physiologically active therapeutic agent capable of producing effects in animals and man similar to the effect of salts of ephedrine, a salt of 1-phenyl-2-aminopropane.'

"He disclaims so much of claim 2 of said patent as is in excess of the following:

"`As a physiologically active therapeutic agent capable of producing effects in animals and man similar to the effect of salts of ephedrine, the hydrochloride of 1-phenyl-2-aminopropane.'"

The composition 1-phenyl-2-aminopropane is also chemically known as phenylisopropylamine and benzylmethyl carbinamine.

The salts of the composition 1-phenyl-2-aminopropane, which is the subject of the Alles patent and of this action, was in 1938 given the generic name "amphetamine sulfate" by the American Medical Association, by which name it will be generally referred to hereinafter. It is the identical compound which is prepared and sold by the plaintiff under the brand or trade name of "Benzedrine" or "Benzedrine Sulfate."

In Part I of this opinion we will discuss the patent phase of this case and in Part II we will take up the phases of unfair competition.

Part I

The Patent

Amphetamine sulfate is the salt of 1-phenyl-2-aminopropane. It is obtained by Alles by means of a method of synthesis described by him in the specifications of the patent and converted into a salt which is pure and suitable for the purpose of therapeutic administration. The conversion of the product into the salt is effected by neutralizing the impure product with an acid. The conventional method of converting bases into salts is by the addition of an acid. Not all bases are capable of such transformation. It is impossible to convert some bases into any solid form such as a salt. Others cannot be so converted by the use of an acid. It is a specific matter for a specific substance and a specific acid as to whether or not the salt thereof is crystallizable or is obtainable in solid form free from other contaminating substances. Experimentation is requisite to determine which method of preparation is suitable to get a desired result.

Amphetamine sulfate may be said to be more closely allied with the field of sympathomimetic amines than with any other field in medicine, pharmacology or chemistry. It is the knowledge of the art in this field that is advanced as the prior art upon which was based the discovery of amphetamine sulfate for therapeutic purposes.

The autonomic nervous system, by which every single structure of the body is brought under a dual control, consists of two branches, the central nervous system and the sympathetic nervous system. There is also a division of the sympathetic nervous system known as the parasympathetic nervous system.

The central nervous system consists of the brain and spinal cord, and some structures of the brain are independent of the sympathetic nervous system. In the central nervous system is generated, among others, mood, feeling of energy, feeling of sleeplessness, capacity to have appetite for food or sex. Examples of diseases of the brain are epilepsy and Parkinson's disease.

The sympathetic nervous system stems from the central nervous system and starts from points of the spinal cord and a structure at the lower part of the brain and winds its way through every organ of the body. It extends peripherally to the eye, to the skin, to every blood vessel, to the heart, to the lungs, to the gastro-intestinal tract and through every portion of the organism.

The parasympathetic nervous system innervates the active organs of the body, such as the stomach, the intestines, the uterus, the prostate or principally those organs which have smooth muscle tissue.

A sympathomimetic amine is a substance which stimulates the peripheral parts of the sympathetic nervous system. Examples of this action are constriction of the blood vessels, increased rate and force of the heart beat, a rise in blood pressure, dilation of the pupils of the eye, relaxation of the bronchial muscles, a rise in blood sugar, increased metabolic rate, decreased activity of the gastro-intestinal tract of the stomach and intestines.

Prior Art

The following literature constitutes the prior art, some of which was offered by the defendants as anticipatory of the Alles' claims:

1. "On a Few Derivatives of the Phenylmeth-Acrylic Acid and of the Phenyl-Iso-Butyric Acid," by L. Edeleano, published in the Berichte der Deutschen-Chemischen Gesellschaft (Ber. Dtsch. Chem. Gesell. 20:616, 1887).

2. "Handbuch der Organischen Chemie," by Dr. F. Beilstein, Dritte, Umgearbeitete Auflage, Verlag von Leopold Voss (Hamburg und Leipzig), 1896 and Vierte Auflage, Die Literatur Bis 1, Januar 1910 Umfassend, Verlag von Julius Springer (Berlin), 1929.

3. "Chemical Structure and Sympathomimetic Action of Amines," by G. Barger and H. H. Dale, published in The Journal of Physiology (Cambridge University Press, London), Vol. XLI, 1910-1911, p. 19 et seq.

4. "Adrenaline and Other Derivatives of Ethylamine," by Percy May, published in The Chemistry of Synthetic Drugs (Third Edition, Revised), 1921 (Longmans, Green and Co., London), p. 129 et seq.

5. References to the publications of Doctors K. K. Chen and Carl F. Schmidt may be found in the bibliography of their article entitled "Ephedrine and Related Substances," published in Medicine, Vol. IX, No. 1, February, 1930.

6. "The Beckmann Rearrangement Involving Optically Active Radicals," by Lauder W. Jones and Everett S. Wallis, published January 8, 1926, in The Journal of the American Chemical Society, Vol. XLVIII, January-June 1926, p. 169 et seq.

7. "dl-B-Phenylisopropylamine and Related Compounds," by Donald Holroyde Hey, published in 1930 in the Journal of The Chemical Society, London (J. Chem. Soc., p. 18 et seq.).

1. Edeleano-1887

In 1887, Edeleano, a German scientist, wrote a paper for the Berichte der Deutschen Chemischen Gesellschaft (Ber. Dtsch. Chem. Gesell. 20:616, 1887), in which he outlined a method of preparation of phenylisopropylamine C6H5CH2CH(CH3)NH2 and its analysis. He stated:

"The salts of the base are mostly very easily soluble in water, while the platinum double salt represents a compound difficultly soluble in water and crystallizing in matted small needles."

The synthesis of this product...