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September 1, 1945

CLARK & CLARK et al.

The opinion of the court was delivered by: FORMAN

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, January 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 Hey, published in 1930 in the Journal of 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 by Edeleano was purely a chemical attempt and involved no physiological testing. Edeleano's statement relating to the solubility of the salts of the phenylisopropylamine base did not carry with it the procedure for the preparation of any salts of the base he described, nor did it describe any salt of phenylisopropylamine.

 Alles makes no claim that he was the first discoverer or inventor of the base of this composition. Edeleano stated that he prepared the composition, provided a method for such preparation and described the completed product in certain respects. There is no question that Edeleano did prepare the base of this substance. He made no reference whatsoever to its use for any purpose. There appears no reason, nor the suggestion of one, that he worked with this base other than purely from a chemical standpoint. He entitled his article 'On a Few Derivatives of the Phenylmeth-Acrylic Acid and of the Phenyl-Iso-Butyric Acid' and under the heading 'Method of Preparation of Phenylmethacrylic Acid' set forth an account of what he did in his laboratory. He said nothing that gave rise to an inference that the substance had any effect or that it was useful for any purpose. Edeleano stated that the salts of the base were easily soluble in water, while the platinum double salts were soluble with difficulty.

 From this the defendants ask us t infer that Edeleano actually prepared the identical salt of this base which Alles claims as a patent. It is obvious that Edeleano prepared certain salts of the base, but it is quite impossible to determine which salts he prepared. He did not describe the method of preparation of the 'easily soluble' salt of the base with any characteristics by which it could be identified as a particular salt.

 It appears that certain salts of this base are easily soluble in water, some are not so soluble and others are not soluble at all. Hence, there is no disclosure by Edeleano of any particular salt of the base. We cannot say that Edeleano experimented with the salts, much less that he particularly prepared a salt which would be useful for therapeutic purposes.

 At this point, however, it is urged that the addition of sulphuric acid or hydrochloric acid to a base, in order to convert it into a salt, is a method used commonly by chemists, and that with the base described by Edeleano, together with the application of this well-known method of conversion, any skilled chemist could arrive at the composition which is the subject of this patent claim. A skilled chemist, following Edeleano's methods as described in his paper and applying the knowledge of his profession and of the art prior to Alles, might very well be able to produce a salt of 1-phenyl-2-aminopropane, but not a substance having the effects of the Alles' compound for therapeutic purposes. To prepare such a substance requires original experimentation on the part of the chemist as to effect of the substance upon animals and man. Edeleano's disclosure taught only the manner by which the base of the compound could be prepared and referred incidentally to two salts thereof without further identification. It is insufficient as an anticipation of a disclosure of effect and therapeutic usefulness of a certain salt of the base.

 2. Beilstein -- 1896

 As evidence of an ancient disclosure of the patent, the defendants directed attention to 'The Handbook of Organic Chemistry,' compiled by Beilstein, an encyclopedia of organic compounds, 1896 edition, in which was listed the base of phenylisopropylamine as follows:

 '12 -- (a) -- Aminopropylbenzol (Phenisopropylamine) C6H5.CH2.CH(NH2).CH3. B. Beim Behandeln des Amids der Methylbenzylessigsaure mit (1 Mol.) Brom und (5 Mol.) Kalilauge (von 4%), unter Abkuhlen (Edeleano, B.20,618). -- Flussig. Siedep.: 203 degrees.'

 Substantially the same content of the listing appears in the 1929 Edition of Beilstein. No mention is made in this later listing, the last to be published prior to the Alles patent, of the salt of phenylisopropylamine. Of course, these are only references to the paper by Edeleano and add nothing to the prior art.

  Adrenaline or Epinephrine 1895 to 1910

 In 1895, two English scientists, Mather and Schaffer, published a paper concerning the effects produced by the introduction into animals of an extract of the suprarenal glands. This extract consisted of a salt solution of the tissues of the glands that lie at the upper pole of the kidney. They described as effects a marked rise of blood pressure, which stimulated a great deal of interest at the time. Several physiologists and chemists succeeded within a few years in the isolation in relatively pure form of a solution containing the active principle of this extract. By the year 1901 it became known as adrenaline or epinephrine. A chemical composition for these compounds was soon developed and it became possible to produce them in the laboratory synthetically instead of taking them from the animal body.

 Adrenaline was one of the first of the sympathomimetic amines. It had the disadvantages, for purposes of therapeutic use, of being ineffective orally and of having no prolonged action. The work in this field was therefore directed toward finding a compound of greater intensity of action, i.e., one that acts upon the sympathetic nervous system in smaller doses.

 3. Barger and Dale -- 1910

 In 1910, Barger and Dale published their article in The Journal of Physiology (Cambridge University Press, London, Vol. XLI, 1910-1911, p. 19 et seq.), wherein they described a series of tests of a large number of synthetic derivatives of this type in which they set up certain specifications that have stood the test of time. These compounds are known by the term 'sympathomimetic amines,' which was introduced by Barger and Dale and defined by them as 'a term which indicates the relation of the action to innervation by the sympathetic system, without involving any theoretical preconception as to the meaning of that relation or the precise mechanism of the action.' Their experiments were done upon animals whose spinal cords were cut at the base of the axis vertebra and the neural arch of the vertebra was removed. The brains of the animals were completely destroyed.

 In their article Barger and Dale make the following statement:

 'Taking B-phenylethylamine as our starting point, we investigated first the effect of varying the length of the side-chain. It was shown that lengthening the carbon chain of the purely aliphatic bases up to a certain point was attended with increase of activity. In the case of the fatty-aromatic base, however, we found that the side-chain of two carbon atoms gave the optimum of activity. Aniline, which has no side-chain, and is therefore a purely aromatic base, had none of the specific action; benzylamine had a mere trace; and aphenylethylamine, in which, again, only one carbon atom intervenes between the amino-group and the aromatic ring, was also very feebly active. Increasing the side-chain beyond two carbon atoms also resulted in a decline of activity, phenylpropylamine being much less active than phenylethylamine (Fig. 4). The optimum constitution of a fatty-aromatic amine for the production of the sympathomimetic action is, therefore, that which is found in adrenine itself, viz. a benzene ring with a side-chain of two carbon atoms, of which the second bears the amino group.' At p. 29, supra.

 They arrived at the following conclusions, among others, as a result of their experiments:

 '(1) An action simulating that of the true sympathetic nervous system is not peculiar to adrenine, but is possessed by a large series of amines, the simplest being primarily fatty amines. We describe all such amines and their action as 'sympathomimetic.'

 '(2) Approximation to adrenine in structure is, on the whole, attended with increasing intensity of sympathomimetic activity, and with increasing specificity of the action.

 '(3) All the substances producing this action in characteristic manner are primary and secondary amines. The quarternary amines corresponding to the aromatic members of the series have an action closely similar to that of nicotine.

 '(4) The optimum carbon-skeleton for sympathomimetic activity consists of a benzene ring with a side-chain of two carbon-atoms, the terminal one bearing the amino-group. Another optimum condition is the presence of two phenolic hydroxyls in the 3:4 position relative to the side-chain; when these are present, an alcoholic hydroxyl still further intensifies the activity. A phenolic hydroxyl in the 1 position does not increase the activity.' Pp. 58, 59, supra.

  Defendants claim that there is an insignificant distinction between the disclosure by Barger and Dale and the Alles compound. In conclusion No. 4, above, Barger and Dale showed that optimum activity in pressor amines is found in those structures which have a benzene ring and a carbon side-chain with the amino group attached to the second carbon atom in the chain. They investigated the varying length of the carbon chain to determine the optimum constitution of the fatty-aromatic amine for the production of sympathomimetic activity. They concluded that phenylethylamine, the structure of which consists of a benzene ring with a side-chain of two carbon atoms with the amino group on the second carbon atom constituted this optimum structure. It was determined by them that specifically an increase in the side-chain beyond two carbon atoms resulted in a decline of activity. This was proved when phenylpropylamine was used which has a chemical structure including a side-chain of three carbon atoms with the amino group attached to the terminal carbon.

 Alles found optimum activity in phenylisopropylamine (1-phenyl-2-aminopropane) which is a chemical structure in which is included a side-chain of three carbon atoms, but the amino group is attached to the middle carbon atom. This structure is different from that of phenylpropylamine and was not considered by Barger and Dale in their experimentation. They omitted to investigate the potentiality of the compound constructed by Alles. They fell short of disclosing the optimum activity later developed by Alles when he proved that phenylisopropylamine had a greater pressor activity than any other compound theretofore considered. They confined their research to sympathetic effects in the field of sympathomimetic amines.

 It must also be observed that no intimation as to effects on the central nervous system is given by Barger and Dale. Their experiments precluded any such effects because they worked on animals devoid of central nervous systems.

 4. Percy May -- 1921

 In 1921, a volume entitled 'The Chemistry of Synthetic Drugs' was published (Longmans, Green and Co., London). The author, Percy May, in a chapter concerning 'Adrenaline and Other Derivatives of Ethylamine,' summarized the literature on the subject. He added no new data but quoted the conclusions of Barger and Dale in their entirety.

 5. Chen and Schmidt -- 1923

 In the year 1923, Dr. Carl F. Schmidt, presently Professor of Pharmacology at the University of Pennsylvania, went to Peking, China, to take temporary charge of the Department of Pharmacology in the Peking Medical College. His work involved research in Chinese drugs. Several Chinese drugs were studied with no noteworthy results.

 At the end of that year a young Chinese scientist, K. K. Chen, a graduate in chemistry of the University of Wisconsin, went to Peking to work with Dr. Schmidt. Although the Chinese thought that their drugs were potent, Dr. Schmidt had been unable to confirm this conception. At one of his family conclaves in China Dr. Chen's uncle, a druggist, upon hearing this view, became rather indignant and stated that he knew from personal experience that there was at least one Chinese drug that was potent -- ma huang.

 Dr. Chen brought some of this drug with him to Peking and an extract of it was injected into an animal, producing a sharp rise in blood pressure. This action was surprising, for the experiments conducted by Dr. Schmidt involving the injection of many plant extracts into animals always produced a drop in blood pressure.

 Dr. Chen succeeded in isolating crystals from the plant, ma huang, which crystals he identified as an alkaloid. Several experiments were made with the crystals and it was found that the active principle was a sympathomimetic substance. Experiments with the drug upon patients proved that it was effective and had a relatively low toxicity.

 A search for a name for the drug resulted in the discovery that it had already been isolated in 1887 by a Chinese chemist named Nagai, who had called it ephedrine. The drug was brought to the United States in 1924 and results of various clinical studies were published by Chen and Schmidt from time to time thereafter. (References to these publications may be found in the bibliography of a lengthy article published by them in Medicine, Volume IX, No. 1, February 1930.) Since 1924 the drug has been in use quite extensively.

 Although ephedrine was isolated and its chemical structure known for many years, it was regarded as a very toxic substance until it was introduced in this country by Chen and Schmidt. It had several advantages over the other drugs in the field, like adrenaline or epinephrine, in that it produced the same effects when taken orally and its duration of action was a matter of hours rather than minutes. Physiologically, ephedrine stimulates the peripheral parts of the sympathetic nervous system, resulting in constriction of blood vessels, acceleration of the heart, dilation of the pupils, decreased movement of the gastro-intestinal tract and relaxation of that tract and the bronchi. It has certain stimulant effects upon the central nervous system previously not described in compounds of this series. These effects upon the brain cells are comparable with that of caffeine. They manifest themselves in restlessness, nervousness, tremors, anxiety, insomnia in some individuals, and in an appreciable number of cases, particularly in women inclined to be nervous, may lead to nausea and vomiting. A depressant action upon the heart muscle, similar to myocardial depressants, imposes a limitation upon the therapeutic usefulness of the drug. It is extensively used to shrink mucous membranes when congested. Ephedrine, being orally effective and possessing a duration of action, displaced adrenaline. Prior to its discovery, there existed no better compound having the action which adrenaline had upon the peripheral sympathetic nervous system. Compounds of the same general type which had been made and tested were found to be weaker than adrenaline.

 This work in ephedrine produced for the first time in the field of sympathomimetic amines not only effects upon the sympathetic nervous system but concomitant effects upon the central nervous system. However, it did not result in encouraging the exploitation of the latter effects, but rather regarded them as deleterious and to be diminished as far as possible or eliminated.

 6. Jones and Wallis -- 1926

 The next publication to be considered in the prior art of the Alles compound is a paper appearing in 1926 in the Journal of the American Chemical Society (J. Am. Chem. Soc., 48:169, January-June 1926), entitled 'The Beckmann Rearrangement Involving Optically Active Radicals' by Jones and Wallis. This paper is based upon a thesis submitted by Wallis in partial fulfillment of the requirements of Princeton University for his degree of doctor of philosophy.

 Jones and Wallis purported to have isolated the dextro-rotatory form of benzylmethyl-methylamine hydrochloride. The latter is the chemical equivalent of the hydrochloride of the dextro form of Bphenylisopropylamine or dextro amphetamine hydrochloride. They describe the properties of the product they allege they obtained as follows:

 'd-Benzylmethyl-methylamine Hydrochloride, (C7H7)(CH3)CH.NH3Cl. -- When 1.296 g. of d-benzylmethylmethyl-isocyanate was placed in a small flask, together with 4 cc. of concd. hydrochloric acid a reaction started immediately, but progressed slowly. The flask was kept cool by allowing water to play over it. After an hour the two layers had disappeared, and carbon dioxide ceased to be evolved. Near the end of the reaction the flask was warmed to 38 degrees. The solution was diluted with water and extracted thrice with ether to remove any unchanged isocyanate. The ether extract gave no residue of isocyanate upon evaporation. The solution gave a rotation of .88 degrees in a 200 mm. tube at 20 degrees.

 'The water solution was evaporated to dryness. A white, crystalline, hygroscopic salt was left. This was washed with ether and dried in the oven at 80 degrees. The amount of chloride obtained was 1.25 g., melting at 147 degrees. 1.20 g. dissolved in 25 cc. of water gave a rotation of .60 degrees in a 200 mm. tube at 20 degrees, (a)20 degrees = .6 degrees.' at p. 180, supra.

 The defendants contend that Jones and Wallis in this work described the d-form of the hydrochloride of phenylisopropylamine and that it was known to Alles when he claimed to be the first to produce a salt of 1-phenyl-2-aminopropane. Furthermore, they claim that this disclosure sufficiently described a salt of 1-phenyl-2-aminopropane, so that any chemist could produce it from the directions of Jones and Wallis and the Edeleano publication.

 A sharp issue is raised by the plaintiff on the question of whether Jones and Wallis actually obtained the substance they describe as d-benzylmethyl-methylamine hydrochloride. Alles testified that he produced d-benzylmethyl-methylamine hydrochloride, but that the constants in his compound were a melting point of 156 degrees to 157 degrees and an optical rotation of .6 degrees at 20 degrees, as against a melting point by Jones and Wallis of 147 degrees and an optical rotation of .6 degrees at 20 degrees.

  He further testified that there were errors in the Jones and Wallis article which made it impossible for him to follow their directions and get the product they contend they produced. Alles' testimony is corroborated in detail by Dr. George H. Connitt, a research organic chemist in the employ of the plaintiff.

 Opposed to the above we have the testimony of Philip Sadtler, a consulting chemist on behalf of the defendants. He conceded that he had a financial interest in the termination of the case in favor of the defendants. It was his opinion that a skilled chemist would have had no difficulty in following the directions of Jones and Wallis and that they described accurately a process to produce dextro-benzylmethyl-methylamine, although he had not personally attempted to produce it according to their formula.

 The work of Jones and Wallis, like that of Edeleano, consisted of chemical tests of compounds for chemical and not for physiological purposes. They gave no intimation in their article of effects of their preparations or of therapeutic uses therefor.

 The evidence on the accuracy or inaccuracy of the disclosures of Jones and Wallis comes from Alles, the plaintiff's employee Connitt, the financial intimate of the defendants, Sadtler, and the disinterested witness Dr. Schmidt, who also was queried as to the accuracy of the Jones and Wallis disclosure on his cross-examination by plaintiff's counsel.

 When Dr. Schmidt was first approached upon this subject with the question: 'Well, from your examination of the abstract would you have any doubt that Jones and Wallis described the preparation of the hydrochloride of 1-phenyl-2-aminopropane?' His answer was: 'I would have none; I think they did, yes.' (Record, p. 294)

 Later in the same cross-examination Dr. Schmidt answered questions as follows:

 'Q. The claim of the patent as originally issued called for a new composition of matter, a salt of 1-phenyl-2-aminopropane. Now, if Jones and Wallis in 1926 had produced the hydrochloride of 1-phenyl-2-aminopropane wasn't that a salt of 1-phenyl-2-aminopropane?

 'The Witness: May I answer that in my own way?

 'Q. You may. A. I would like to start out the answer by saying this was, as far as I know these were purely chemical attempts, it involved no physiological testing.

 'The Court: You mean the attempts of Jones and Wallis?

 'The Witness: And of Edeleano. A. (continuing) The compounds were made as purely chemical substances for chemical purposes, but not as far as I know for physiological purposes.

 'Now, to decide on whether they were or were not identical with the Alles compound would involve specialized information about their chemical constants, such things as optical rotation, melting point and the different precipitation and solubility reactions. On that I am not competent to state even if I did have the information, which I have not, so the answer, I am afraid, would have to be I don't know.' (Record, p. 299)

 Again, on redirect, Dr. Schmidt testified as follows:

 'Q. Dr. Schmidt, with reference to the dextro compound named in the Jones and Wallis abstract to which you were referred, do you know the boiling point of that compound? A. No, I do not, Mr. Harding.

  'Q. Do you know its optical rotation? A. Only it must be to the right.

  'Q. That is, you don't know what the figure would be? A. I do not, no, sir.

  'Q. You only assume that Jones and Wallis probably referred to the compound that they named because they say so, then, is that true? A. Yes.

  'Q. In other words, the constants they give, boiling point and rotation, may be incorrect? A. They may be, yes, sir.' (Record, pp. 307, 308)

  It would seem that Dr. Schmidt's categorical answer as to the Jones and Wallis disclosure, first given by him, was considerably weakened by his further testimony.

  The attack upon the disclosure, it is true, comes from interested witnesses, Alles and Connitt, but they seem to be competent, qualified and able scientists, whereas the sole support for the defense comes from Sadtler, the quality of whose testimony is not impressive. Alles and Connitt supply the technical information of boiling points and optical rotations which Dr. Schmidt lacked. They are different from the constants of the Jones and Wallis disclosure in material aspects. Aside from the testimony of Sadtler, who admitted he did not attempt to make the Jones and Wallis product, we have no testimony to contradict Alles and Connitt. We are convinced that a skilled chemist, following the directions of Jones and Wallis, would not have obtained what they said they produced, and we are unable to find proof of anticipation upon their part of the Alles' hydrochloride of 1-phenyl-2-aminopropane and certainly no statement of uses or effects.

  7. Hey -- 1930

  There remains to be considered a publication by Donald Holroyde Hey, entitled 'dl-B-Phenylisopropylamine and Related Compounds,' which appeared in the Journal of the Chemical Society, London, in the year 1930 (J. Chem. Soc., p. 18, 1930).

  Alles applied for his patent on September 2, 1930, and the plaintiff objects to the admission of the Hey publication for the reason that only the year '1930' appears in evidence as the date thereof. The plaintiff argues that it may have been published on any day in 1930 subsequent to the date of the Alles' application and therefore is not properly admissible in evidence. At the termination of the article appears the notation '(Received, November 1st, 1929.)'

  The publication is offered for the purpose of showing that Alles knew of the Jones and Wallis publication, for in an article written by him on the subject of 'd1-Beta-Phenylisopropylamines,' which appeared in the Journal of the American Chemical Society in 1932 (Am. Chem. Soc., 54:271, January-April, 1932), at page 273, he cited the Hey article as a report of a melting point of d1-b-phenylisopropylamine which was obtained from the reduction of phenylnitropropylene. Although the plaintiff may be technically justified in its objection, we prefer to consider the article as proffered by the defendants.

  Alles claims that although he cited Hey as reporting a particular melting point for a certain compound, he was not cognizant of the publication's reference to Jones and Wallis at that time. If we assume that Alles knew of the reference in the Hey publication to Jones and Wallis, we fail to see how that strengthened the anticipatory effect of the Jones and Wallis publication, since its effectiveness or ineffectiveness as a publication of prior art anticipatory of Alles' claim does not depend upon the knowledge of Alles.

  History of the Alles' Patent -- 1930

  Gordon A. Alles, the patentee, obtained his degree of doctor of philosophy at the California Institute of Technology in 1926. He has worked in the fields of chemistry, physiology, pharmacology, experimental therapeutics, biology, and experimental medicine.

  He became interested in making adrenaline derivatives in 1923 prior to the publications of the work of Doctors Chen and Schmidt. In 1924 he became associated as a research chemist with two doctors in Los Angeles who specialized in the field of allergic diseases, including hay fever and asthma.

  After 1926, when the work of Chen and Schmidt had become publicized and ephedrine had been made available in small amounts, Alles turned his attention toward the preparation of compounds that could be used as synthetic substitutes of ephedrine in order to make a greater supply of such materials available with the objective of ascertaining whether a useful drug had been found in allergic diseases that filled the clinical needs of the doctors with whom he was associated. He made a survey of the literature then existent and concluded that it would be possible to make a chemical compound of phenylethanolamine which would produce similar results to ephedrine in therapy. However, when prepared in a pure state and suitable for therapeutic purposes, it was found that it produced the peripheral effects of ephedrine but failed in that it did not have its duration of action and its oral effectiveness. No effect upon the central nervous system was observed when the compound was administered, even in very large dosages.

  Alles returned to the work after a lapse of a year spent in other research, reviewed the literature and set out to make another type of compound. This time he prepared the compound 1-phenyl-2-aminopropane in the form of its salts of a purity suitable for therapeutic purposes. He carried out experiments in 1928 in the Department of Physiology at the University of California and discovered 1-phenyl-2-aminopropane salts when injected into dogs and rabbits produced a blood pressure rise of long duration. He also noted that, unlike corresponding nearly related derivatives studied at the same time, this compound was orally effective in animals.

  He was well acquainted with the effects of ephedrine sulfate and ephedrine hydrochloride because he had administered them to himself on several occasions and was acquainted with the action on both the blood pressure and with regard to its other actions in the body.

  Accordingly he self-administered 50 milligrams of 1-phenyl-2-aminopropane hydrochloride which he had prepared and also administered the same dosage to his associate. They observed that the effect upon the circulation consisted of a rise in blood pressure upon the first administration which was made by subcutaneous injection. This rise was both marked and prolonged, lasting for a period of about 8 hours. Alles found that when he went home he could not fall asleep and was awake the whole night. His blood pressure, taken upon his arrival at the laboratory the following morning, had returned to normal.

  A few days later the experiment was repeated. This time Alles took the same dosage orally and his blood pressure and circulation were watched by his associate, Dr. Miller. Again there was a similar rise in blood pressure of long duration. After a day of observation he again failed to get any sleep during the night. This made him realize that the drug had a waking effect that was many times that which he had observed with ephedrine in similar dosage.

  After these preliminary observations on himself Alles directed his interest toward the trial of the drug in asthma, which was the principal purpose for which he had been working upon it. Two asthmatic patients placed themselves at his disposal. They had been victims of the disease for long periods of time. The first one had suffered for the previous three years and Alles administered to him 50 milligrams of 1-phenyl-2-aminopropane hydrochloride by mouth. After an hour his blood pressure started to rise and continued at a high level during the period of observation of the next six hours. The patient was very wakeful and alert, talked a great deal, and his blood pressure was taken from time to time. At the end of the day he was sent to his home and requested to return the next morning. He reported that he had not slept at all during the night but that he felt very well in spite of the lack of sleep. His asthma had been relieved during the whole afternoon and night, apparently as a result of the administration of the drug.

  The second asthmatic patient, a woman with a consistent asthmatic attack covering the previous year, also found relief from the asthma and a marked wakefulness as a result of the administration of the drug. It was necessary to administer phenobarbital to this patient to induce sleep.

  From his experimental work Alles says he clearly recognized that this was the first time in any compound other than ephedrine that there was evidence of two kinds of effect, typical of ephedrine from the standpoint of pharmacology and therapeutics, namely, that the compound exerted an effect upon the peripheral sympathetic nervous system, and also a very marked effect upon the central nervous system. This was in contrast with all previously known adrenaline-like compounds.

  Later Alles experimented with four individuals, including himself, to determine the amount of 1-phenyl-2-aminopropane salt that was required to stimulate the central nervous system to effects that would persist through the day only and allow the individual to sleep at night. He administered 5 and 10 milligram dosages of 1-phenyl-2-aminopropane salts, daily, in the morning, and observed the changes of behavior during the course of the day. It was found that such dosages produced a tendency to stay awake later at night, but all of the individuals, including Alles, found that they were able to sleep successfully through the night. Such dosages on later experimentations with asthmatics were disappointing in the effect because they were insufficient to obtain effect upon the peripheral sympathetic mechanisms to satisfactorily relieve the asthma. Further experiments were made to study other peripheral sympathetic effects of 1-phenyl-2-aminopropane salts in relation to its toxicity in animals and to ascertain its ability to counteract the depression of barbitol hypnoses. Various other types of experiments were performed.

  At about this time it was reported that ephedrine had some slightly beneficial effect in the treatment of narcolepsy. Alles induced his co-worker at the University of California Medical School to make a study of the effect of his compound in the disease of narcolepsy. It was found that the 1-phenyl-2-aminopropane salt in this condition had therapeutic advantages far exceeding that which could be demonstrated by ephedrine salts.

  From this course of experimentation Alles concluded that he had discovered a useful therapeutic compound having effects similar to ephedrine with regard to its action upon the peripheral sympathetic mechanism and the central nervous system.

   The file wrapper discloses that on August 29, 1930, Alles applied for the patent.

  On April 18, 1931 the Examiner rejected all of his claims on the basis of two method patents (Buckner 700670, May 20, 1902, and Cole 1,378,939, May 24, 1921) and the Edeleano article in the Berichte der Deutschen Chemischen Gesellschaft.

  On September 18, 1931, Alles amended his application by cancelling all of the method claims and certain words and phrases and inserting other words and phrases. This apparently satisfied the Patent Office, for on April 19, 1932, he was advised that his application would be allowed with two claims. On September 27, 1932, his patent with the two claims was allowed.

  On August 29, 1934, there was recorded in the Patent Office the receipt of Alles' disclaimer.

  Description and Claims

  It is the contention of defendants that Alles failed to 'particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery' pursuant to the provisions of the statute governing applications for and issue of patents. 35 U.S.C.A. § 33.

  The claims, when read in the light of the specifications in order to determine their meaning, lead to the obvious conclusion that Alles claims the sulfate and the hydrochloride of 1-phenyl-2-aminopropane as a new composition of matter useful for therapeutic purposes. The therapeutic purposes are further explained in the specifications by the description that the salts of the base 'are physiologically active and produce effects in animals and man similar to the effect of the salts of ephedrine.'

  A consideration of the contention of defendants must be directed to the meaning and descriptive quality of the words 'physiologically active and produces effects in animals and man similar to the effects of salts of ephedrine,' as applied to a new composition of matter useful for therapeutic purposes.

  Although it is difficult to dismiss from one's thoughts the present-day knowledge of the effects and uses of amphetamine sulfate and all that has been learned about the drug since Alles' application for a patent, it must be done in order to equitably determine whether Alles sufficiently described his discovery in 1930 to come within the requirements of the patent law.

  The discovery lies in the field of chemistry and therapeutics, more specifically in the field of compounds that act upon the central and sympathetic nervous systems of animals and man. The closest allied field known to the art in 1930 was that field in which compounds described as sympathomimetic amines were classified. Ephedrine was considered at that time to be one of those compounds. However, despite its effectiveness as a substance exhibiting sympathomimetic activity, it was the only drug in this field possessing the capacity to affect the central nervous system. In this respect it was not comparable to any other known drug and since the art considered these effects undesirable, no emphasis was placed upon these characteristics of the drug.

  A comparison of the sympathomimetic and central activity of ephedrine and amphetamine sulfate results in the conclusion that they are similar insofar as sympathomimetic action is concerned and both drugs possess a like degree of potency or intensity. With reference to action upon the central nervous system they are likewise similar, except that with respect to potency or intensity the action of amphetamine sulfate is considerably stronger than that of ephedrine.

  Prior to Alles' discovery there existed no drug capable of having the central nervous effect of amphetamine sulfate. Initially, it was used to achieve the same effects therapeutically as ephedrine, only in greater intensity.

  Amphetamine sulfate was found to be decidedly superior to ephedrine in its action upon the central nervous system when used for therapeutic purposes, such as counteracting the effects of barbitol which depresses the central nervous system, in narcolepsy, in post-encephalitic parkinsonism, in producing mood, in decreasing the appetite, in obtaining the effect of wakefulness, and in alleviating fatigue and similar states where the central nervous system stimulant effect is the primary activity. With varying degree ephedrine had been used prior to the introduction of amphetamine sulfate for each of these therapeutic purposes. Therefore, ephedrine had been completely replaced by amphetamine sulfate wherever it had been used for central stimulation. The two drugs, as far as sympathetic effects are concerned, are similar. Even as to these sympathetic effects, in many respects and for many uses, amphetamine sulfate had been found to be more effective and superior.

  It should be noted that amphetamine sulfate has the same high sympathetic effect of ephedrine along with a central effect produced with small dosage. In order to produce a central effect with ephedrine a large dose must be administered, which invariably results in a pronounced peripheral effect. The peripheral effect, so magnified, may be harmful to the patient to such an extent as to outweigh any advantages of the central effect. However, ephedrine, prior to the advent of amphetamine sulfate, was used for its central effects although cautiously. The same symptoms of anxiety complex (central effect) often produced by ephedrine could be obtained by large doses of amphetamine sulfate. Qualitatively the effects of both drugs are similar. Quantitatively, the effects are different. There are certain dissimilarities, such as the inability of ephedrine to produce warmth, well-being or a euphoric effect. Thus far we have considered the effects of both drugs on man. The effects of the drugs on animals are even more similar in so far as they are ascertainable.

  In 1930, amphetamine sulfate was used as a substitute for the salts of ephedrine for the reason that it produced the effect of the salts with greater intensity. Its capacity to produce these similar effects resulted in its use for practically the same therapeutic purposes as the salts of ephedrine, or to use the phrase of an expert witness, it was used for its 'ephedrinelike' action. Alles intended to claim those effects that were similar to the salts of ephedrine. At that time the definition of the salts of ephedrine in contradistinction to the definition of the salts of adrenaline, the only other compound close to it in effect, meant effects upon the sympathetic and central nervous systems. His description of his discovery was based upon the art at that time. Alles then had no better way to describe his discovery to those skilled in the art in 1930. There was no confusion in the minds of skilled chemists, doctors or pharmacologists of the effect of the salts of ephedrine, and when told that a particular composition is physiologically active and has similar effects in animals and man, they would know the exact effects of such compound. Therefore, the objection by the defendants -- inadequacy in description -- directed towards the claims originally made by Alles, fails.

  Defendants submit that if the Alles' patent is declared valid the public will be excluded from the use of amphetamine sulfate for effects which are not similar to the 'practical' effects of the salts of ephedrine. The defendants persist in making comparisons between the effects of amphetamine sulfate and the 'practical' effect of the salts of ephedrine. They say that the salts of ephedrine have no 'practical' effect in obesity and for other clinical uses, and hence there is no comparison between amphetamine sulfate and the 'practical' effect of the salts of ephedrine.

  We cannot agree with this position because we feel that the qualitative effects of amphetamine sulfate and the salts of ephedrine are similar. We agree that the central effect of the salts of ephedrine are quantitatively lacking in intensity compared with the effects of amphetamine sulfate. We also agree that salts of ephedrine for 'practical' purposes are not as useful as amphetamine sulfate. Consequently the use of the compound is governed by the quantity of the qualitative effect desired in so far as effects are concerned.

  Our considerations are based upon the similarity of the qualitative effect in both compounds in the light of their therapeutic action as they have to do with sympathetic and central effects of the nervous system.

  We cannot presently concern ourselves with future discoveries of uses of this compound in fields unrelated to the effects it may have other than on the central and sympathetic nervous systems. We are now concerned only with what Alles has claimed as a new substance for certain therapeutic purposes. If other uses should develop for the compound and patents are claimed for those uses, the issue will then concern an old compound for an allegedly new use.


  The defendants attack the propriety of the disclaimer under the patent laws on the theory that it changed the nature of the claimed invention. They point out that if the disclaimer is improper it voids the entire patent and nothing remains to be adjudicated with reference to the charge of patent infringement in this action.

  In support of this proposition the cases of Milcor Steel Co. v. George A. Fuller Co., 2 Cir., 122 F.2d 292, affirmed 316 U.S. 143, 62 S. Ct. 969, 86 L. Ed. 1332, and Altoona Theatres v. Tri-Ergon Corporation, 294 U.S. 477, 55 S. Ct. 455, 79 L. Ed. 1005, are submitted. The disclaimer involved in each of these cases was considered improper because it added a new element to the original claim of invention rather than limiting the original claim to that part of it which the patentee claimed as his invention. The patent in the Milcor case related to the construction of a wall which included a base member, a ceiling member, upstanding wall supports vertically movable and the means operative to prevent tilting. The inventor disclaimed any scope for these claims except, as to the ceiling member, a 'vertical depending perforated flange, one side of which is overlapped by metal lathe' (122 F.2d 293) and, as to the base member, 'composed of a longitudinal strip having recesses to receive the lower ends of the webs of channel wall supports, the flanges of the channel wall supports overlapping the base member adjacent the recesses.' The court concluded that the limitation of the original claims by the disclaimer to the construction of the members was an addition to the original claim. The novelty consisted of the combination set out in the claims and the abandonment of a part of each claim resulted in transforming the combination into a new and different combination which the disclaimer statute could not be invoked to justify.

  Similarly, in the Altoona case, claims for a method of translating sound or similar vibrations to or from a film record and an apparatus for reproducing sound from vibrations recorded on a film by the use of light varied in accordance with the sound, were disclaimed so as to cover the combination only when used in conjunction with a flywheel. The court found that the flywheel was added as a new element to each of the combinations described in the claim so as to transform the original combination into a new and different combination.

  These cases draw a distinction between a disclaimer which limits the original claim, in that the invention claimed is a part of the original combination or composition which then can be severed from the whole without altering the combination which is claimed as an invention, and a disclaimer which although it narrows the original claim, in so doing adds an additional or new element to the original claim so as to alter or completely change a part of the original combination or composition which destroys its identity. The latter (not a valid disclaimer) is illustrated in the aforementioned cases by the addition of the flange to the ceiling and to the base members of the wall and the addition of the flywheel to the film record.

  In effect, the invention claimed originally and that claimed after the disclaimer must be the same invention except that it may be limited or diminished in scope and/or its parts particularized as long as the combination or composition is not altered. The decisions sustaining disclaimers as valid bear out this proposition. It is illustrated in the case of Johnson Laboratories, Inc., v. Meissner Mfg. Co., 7 Cir., 98 F.2d 937, where to a claim for a compressed comminuted magnetic material with individual insulated particles, a disclaimer was added including the specifications that the particles should be of a particular minute size and of a specified 'apparent permeability,' which disclaimer was sustained by the court, no new elements having been added and the residue including enough to support the claim. It was stated in the opinion:

  ' * * * Obviously, if a disclaimer purports to widen the invention and to make the claim broader, it is invalid. It cannot be used to change the character of the invention or to make a new patent. But if the reasonable intendment of the specifications is to disclose that the part disclaimed is separable from that retained, then the part disclaimed, if no new element is added, will not affect the residue provided the latter includes enough to support the claim of invention. A disclaimer is proper when the patentee has been wrong in asserting that the whole claim is new but right as to a part which constitutes invention and which does not depend upon what he disclaims.' 98 F.2d at pages 944, 945.

  Therefore, in the case of Cincinnati Rubber Mfg. Co. v. Stowe-Woodward, Inc., 6 Cir., 111 F.2d 239, a disclaimer of the words, 'and elsewhere,' which had the effect of confining a patent relating to rolls in paper making to paper making machines, was declared valid, for it limited the claim by the exclusion of a part to a field which it might in its original form have covered. The case of Byrne Mfg. Co. v. American Flange & Manufacturing Co., 6 Cir., 87 F.2d 783, cited by the court in the Cincinnati case, was another instance where the validity of a disclaimer was sustained as not adding a new element. The original claim in that case related to the method of applying bushing to metal containers. Certain annular bushings and certain methods of applying bung rings to the metal containers were disclaimed and the disclaimer did not constitute a new element.

  In the instant case the original claims are (1) a salt of 1-phenyl-2-aminopropane and (2) the hydrochloride of 1-phenyl-2-aminopropane as new compositions of matter. These claims are disclaimed to the extent that they are in excess of acting as a physiologically active therapeutic agent capable of producing effects in animals and man similar to the effect of salts of ephedrine. The composition to produce this effect is stated in the disclaimer to be a salt of 1-phenyl-2-aminopropane and the hydrochloride of 1-phenyl-2-aminopropane, which are the identical compositions originally claimed. The limitation or restriction of the disclaimer adds no new or additional element to the original claim of composition nor does it alter the original claim of composition so as to destroy its identity. The same invention is claimed.

  The authority for filing a disclaimer is found in the following statute:

  'Whenever, through inadvertence, accident, or mistake, and without any fraudulent or deceptive intention, a patentee has claimed more than that of which he was the original or first inventor or discoverer, his patent shall be valid for all that part which is truly and justly his own, provided the same is a material or substantial part of the thing patented; * * * .' 35 U.S.C.A. § 65.

  As originally filed, Alles' claims were for new compositions of matter. Literally as such they were meaningless, except to name chemical compositions. As mentioned heretofore, in the specifications of the patent, Alles set forth its purposes and further particularized those purposes. These references in the specifications must be read together with the claims of the patent to determine the real meaning of the claims, since nothing to which reference has been made in the specifications enlarges the claims.

  'The claims of a patent are always to be read or interpreted in the light of its specifications, Hogg v. Emerson, 11 How, 587, 13 L. Ed. 824; Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 22 S. Ct. 698, 46 L. Ed. 968; Smith v. Snow, 294 U.S. 1, 55 S. Ct. 279, 79 L. Ed. 721; * * * .' Schriber Co. v. Cleveland Trust Co., 311 U.S. 211, at page 217, 312 U.S. 654, 61 S. Ct. 235, at page 238, 85 L. Ed. 132.

  See, also, numerous cases following 35 U.S.C.A. § 33, notes 143-148, inclusive.

  When the claims of this patent are read with the specifications, they plainly indicate that the compounds are useful therapeutically as physiologically active in producing effects in animals and man similar to the effect of the salts of ephedrine.

  The disclaimer added nothing to the claims of the original patent and it may be said that it did not diminish the claims of the original patent when read in the light of the specifications. It indicated that the exact claims made by the patentee by disclaiming all in excess of 'a physiologically active therapeutic agent capable of producing effects in animals and man similar to the effect of salts of ephedrine * * * .' At most, the disclaimer left the claims of the patent where they were, but did not invalidate them.

  A further argument advanced by the defendants in support of their motion proceeds on the theory that the admissions of the plaintiff invalidate the original claim of invention leaving nothing to adjudicate with reference to the patent. The defendants contend that 'the presumed prima facie validity of the present patent is entirely overcome by the fact that the disclaimer admits that the subject matter originally claimed was not the invention of Gordon A. Alles and that it was necessary to change the claims after the patent issued in order to distinguish what Gordon A. Alles claimed to have invented from what was admittedly old.' It is argued that the disclaimer rewrote the claims and what was originally alleged to be a new composition is now claimed to be a new use for an admittedly old composition which is not recognized as a patent under the law.

  The defendants point to the plaintiff's answer to defendants' request for admission under Rule 36 of the Federal Rules of Civil Procedure, 28 U.S.C.A.following section 723c, in which --

  ' * * * plaintiff admits that on August 29, 1934, Gordon A. Alles knew that the subjects-matter:

   "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.' respectively, included that of which he was not the inventor and avers that said Gordon A. Alles was the first inventor of a salt of 1-phenyl-2-aminopropane and of the hydrochloride of 1-phenyl-2-aminopropane, respectively, as physiologically active therapeutic agents capable of producing effects in animals and man similar to the effect of salts of ephedrine.'

  In brief, the defendants urge that as a result of the disclaimer and the admissions made by plaintiff, it is relegated to the position of claiming a new use for an old composition and that such a claim cannot be the subject of a valid patent.

  A disclaimer does not have the effect of conceding that which is disclaimed is in the prior art nor does a disclaimer admit that the patent would be void in its absence. Payne Furnace & Supply Co. v. Williams-Wallace Co., 9 Cir., 117 F.2d 823; United Chromium v. International Silver Co., 2 Cir., 60 F.2d 913; N. O. Nelson Mfg. Co. v. F. E. Myers & Bro. Co., 6 Cir., 56 F.2d 512; Permutit Co. v. Wadham, 6 Cir., 13 F.2d 454.

  The admissions of the plaintiff, under Rule 36, standing alone, concede only that the patentee was not the first inventor of the base of the composition and assert that he was the first inventor of a salt of 1-phenyl-2-aminopropane and the hydrochloride of 1-phenyl-2-aminopropane, respectively, physiologically active therapeutic agents capable of producing effects in animals and man similar to the effect of salts of ephedrine. This statement does not imply, without further proof, that the patent, as disclaimed, is invalid.

  Validity of the Patent

  A summary of the prior art at the time of Alles' discovery reveals that the base 1-phenyl-2-aminopropane was produced by Edeleano in 1887; that this base was listed as produced by Edeleano in Beilstein's encyclopedia of organic compounds in 1896 and the substantially identical listing appeared in the 1929 edition; that the substance known as adrenaline or epinephrine was chemically synthesized and its effect on the sympathetic nervous system studied and that this work was considered to be in the field of sympathomimetic amines after the experiments of Barger and Dale in 1910; that Percy May summarized this work in 1921 in a chapter of his book dealing with adrenaline and other derivatives of ethylamine; that ephedrine was introduced by Chen and Schmidt in 1924 as a drug which was therapeutically useful for its effects upon the sympathetic nervous system as well as effects upon the central nervous system; that Jones and Wallis experimented with the hydrochloride of 1-phenyl-2-aminopropane in 1926 with questionable results; that Hey referred to Edeleano and Jones and Wallis respectively as having obtained the base and hydrochloride of the d-form of b-phenylisopropylamine.

  Throughout the entire period during which the field of sympathomimetic amines was explored prior to Alles' discovery, the investigation and experimentation limited itself exclusively to the effects upon the peripheral or sympathetic nervous system. Any effect upon the central nervous system was considered to be for the most part disadvantageous and undesirable.

  The articles dealing with chemical analyses exclusively are those of Edeleano, Jones and Wallis and Hey. As has been said Edeleano synthesized the base of amphetamine sulfate and provided the art with the formula thereof. Jones and Wallis, like Edeleano, engaged in chemical testing alone and attached no use to the results of their experiments. The Hey publication was a reference to the works of Jones and Wallis. Those facts did not preclude a patent for the discovery of a derivative thereof for a therapeutic use.

  In the case of Kuehmsted v. Farbenfabriken of Elberfeld Co., 7 Cir., 179 F. 701, at page 705, certiorari denied 220 U.S. 622, 31 S. Ct. 724, 55 L. Ed. 613, the court said:

  'Hoffmann has produced a medicine indisputably beneficial to mankind -- something new in a useful art, such as our patent policy was intended to promote. Kraut and his contemporaries, on the other hand, had produced only, at best, a chemical compound in an impure state. And it makes no difference, so far as patentability is concerned, that the medicine thus produced is lifted out of a mass that contained, chemically, the compound; for, though the difference between Hoffmann and Kraut be one of purification only -- strictly marking the line, however, where the one is therapeutically available and the others were therapeutically unavailable -- patentability would follow. In the one case the mass is made to yield something to the useful arts; in the other case what is yielded is chiefly interesting as a fact in chemical learning. Merrill v. Yeomans, 94 U.S. (568), 569, 24 L. Ed. 235; Badische v. Kalle, 2 Cir., 104 F. 802, 44 C.C.A. 201; Badische (Anilin & Soda Fabrik) v. (A.) Klipstein (& Co.), C.C., 125 F. 543.'

  The court said in the case of Eastman Kodak Co. v. Coe, D.C., 40 F.Supp. 891:

  'I think that the production of a new chemical compound, even though some one has stated that such a compound may exist is an invention within the meaning of the patent laws and that the plaintiff is entitled to the relief sought.' 40 page 891.

  The articles dealing with effect as well as chemical analysis, as distinguished from those dealing with chemical analysis exclusively, are those written by Barger and Dale, Percy, May, and Chen and Schmidt.

  Barger and Dale's experiments on animals with the central nervous system destroyed is evidence that their attention was not directed towards effects upon that system. Barger and Dale experimented with compounds having chemical structures similar to adrenaline or epinephrine (and close to that of amphetamine sulfate), but with a view towards reporting optimum sympathomimetic action, or action similar to the effects of adrenaline or epinephrine.

  Percy May's review of the information gathered in the art incorporated bodily the work of Barger and Dale in this field. Nowhere in either of these publications does it appear that the art was even remotely interested in compounds which would produce central effect or that any one ever discovered such a compound, much less that compounds closely resembling in chemical structure those being studied for sympathomimetic action existed or could be produced which would possess the capacity to achieve central effect. The art was not sufficiently advanced at the time of these publications to recognize the possibilities of central effect in medicine. Efforts to remove these effects were made continuously. Indeed, the chemical structure of compounds exhibiting central effect were not known prior to Alles' work in the field. Even in the case of ephedrine, considered by Chen and Schmidt, that part of its chemical structure responsible for the central stimulating effect of the drug was unexplainable and unknown. However, from Barger and Dale to the time of Alles it was considered that the maximum activity occurred in compounds of significantly useful sympathomimetic amines, the structures of which consisted of a benzene ring with a side chain of two carbon atoms and the amino group attached to the second carbon atom. An infinite number of compounds could be made on this structure. In ephedrine we have, for the first time, in a drug belonging to the field of sympathomimetic amines, a distinct stimulation of the central nervous system when given in large doses or in ordinary doses to sensitive individuals. This effect was considered incompatible with its action on the sympathetic system.

  Some of the conventional rules governing patent law are succinctly stated in the case of Strong-Scott Mfg. Co. v. Weller, 8 Cir., 112 F.2d 389, at page 394, where the court said:

  'The issuance of a patent is prima facie evidence of both novelty and utility. When one attacks a patent, he must make good his attack with reasonable clearness. The burden of proof is upon him, and every reasonable doubt will be resolved against him. While commercial success cannot convert mechanical skill into invention, it may, in doubtful cases, constitute evidence of invention. Simplicity alone cannot be relied upon as indicating that an improvement is the result of mechanical skill rather than inventive genius. If the description in the patent is such that one skilled in the art can follow it and produce the result which the patent claims, the description is sufficiently certain. These rules are sustained by an abundance of authority, as pointed out in Donner v. Sheer Pharmacal Corporation, 8 Cir., 64 F.2d 217, 220-222.'

  In the instant case there is nothing in the file wrapper or in the evidence to deny to the patent the presumption of validity which arises on its issuance.

  We have heretofore referred to evidence given by experts at the trial without attributing specific portions of it to specific witnesses. It appears to be sufficient to say that the plaintiff produced the testimony of Dr. Carl F. Schmidt, collaborator with Dr. K. K. Chen in the introduction of ephedrine; Dr. Abraham Myerson, authority in the field of neuropsychiatry; Dr. Edwin C. Reifenstein, experienced as a physician and research investigator. The defendants called Dr. Harry Gold, physician and pharmacologist of experience and standing.

  All of these witnesses were inclined to inspire confidence by their statements. They were of a common opinion, in which even Dr. Gold agreed substantially, on the general effects of ephedrine and amphetamine sulfate in the fields of pharmacology and medicine.

  Other witnesses who testified on behalf of the plaintiff on the patent side of the case were Doctors Gordon A. Alles and George H. Connitt and for the defendants Dr. Samuel W. Kalb, Charles L. Morris and Philip Sadtler.

  Alles, as plaintiff's assignor, and Morris, as one of the defendants, of course, have opposing interests in the outcome of the litigation. Connitt is an employee of the plaintiff, while Sadtler has a financial interest and concern in the success of the defendants' position. Dr. Kalb, a large user of amphetamine sulfate in his extensive practice in obesity, conceded that he could buy the drug much cheaper from the defendants than from the plaintiff, and to such extent was also an interested witness.

  We are convinced of the credibility of the testimony offered by the plaintiff and that the weight of the evidence, insofar as its witnesses as mentioned above were concerned, is with it where they were a factor in sustaining the burden of proof by a preponderance of the evidence.

  To the extent that the burden of proof falls upon the defendants as the attackers of the patent, we are convinced that they have failed to sustain it, particularly in the light that all reasonable doubts should be resolved against them.

  There is no dispute as to the successful commercial exploitation of the patent nor that one skilled in the art could follow the instructions of the Alles' patent and obtain the result.

  From the evidence adduced at the trial it appears that up to 1924, when ephedrine was introduced by Chen and Schmidt, no substance was known to have exhibited any marked effect upon the central nervous system. Even this addition to the art stimulated no apparent interest in the study of central nervous effects with respect to compounds of this type. Alles was the first to explore the possibilities leading to a compound which produced a marked central effect. In the construction of his compound Alles was the first to use a benzene ring with a side chain of three carbon atoms with the amino group attached to the middle carbon atom, a combination completely overlooked in the work of Barger and Dale in their test for optimum activity. He was the first to consider that a drug which produced such an effect would be of therapeutic use, and it is not material that he might not have realized the far-reaching results that eventually came about. The thought and experimentation involved in this work were original with Alles.

  The art up to Alles' work did not serve as a basis for the discovery of Alles that the compound amphetamine sulfate would have central effects.

  It eventually developed that the discovery of the utility of amphetamine sulfate has been recognized as an outstanding contribution to science and a great benefit to humanity. Some of the principal clinical uses of the drug which are known today follow: In narcolepsy, for the purpose of counteracting barbiturate poisoning, for hang-over produced by alcohol, for mood, neurosis and the nervous diseases of the mentally sick, in post-encephaletic Parkinson's disease, to control appetite in obesity, for use in emergency where alertness and similar reactions are desired, for shock by the lifting of blood pressure, in epilepsy, in connection with the care of problem children, in X-ray work to relax the spasm and to relax the gastro-intestinal and genito-urinary tracts. It may be noted that all these uses are concerned with central effects, except the last two relating to the effects of relaxation which are sympathetic effects.

  Its many uses have made it possible to cure ills and save life. It has opened up a new field of medicine. The possibilities of the use of this drug in the therapeutic care of neuropsychiatric disorders are inexhaustible. It has replaced drugs which were formerly used for the treatment of human ills. It is the first time that a drug has been found which has the capacity to successfully affect mood, temperament and emotion, an unexplored field of medicine. It has also opened up a vista of chemical research which may lead to new and more efficient compositions having the capacity to produce effects upon the central nervous system.

  The present case has many distinctions over the innumerably reported cases. Alles as a research investigator was embarked on a mission to find a chemical compound that would be as helpful as ephedrine but in more abundance. In this quest he made a compound which produced the qualitative results of ephedrine but in varying quantitativeness, particularly as regards the central effects of ephedrine. This very quantitativeness of effect was new and surprising to Alles. He came upon it not by means of routineering in which one step prepared the way for the next but rather by spontaneous trials and attempts. He produced a compound that was not simply an exercise in chemistry but one that had definite therapeutic effects relatively qualitative in action to that of ephedrine, and in his patent he sought to tell the world of that which he had discovered.

  This was not a case of knowing in advance what result would be achieved. This was not a case of searching for the missing element which would accomplish that result nor a case where an improvement over the present state of the art was being sought to make it more practical or cheaper. Neither did Alles' work fall into the class of cases described by the court in the case of Potts v. Coe, 78 U.S.App.D.C. 297, 140 F.2d 470, where the court related the practice of mammoth corporations to engage many of their employees in research toward a given patent objective. Alles worked alone or was assisted by colleagues, the usual manner in which chemists conduct their experiments. While he assigned his patent to the plaintiff, a relatively large pharmaceutical house, it is but one of a number of pharmaceutical houses and not a patent owner having the almost complete monopoly of patents as attributed to the patent holder in the Potts case. *fn1"

   Congress is aware of the burning controversies that rage over the alleged inadequacies and inefficiencies of our antiquated patent law. It is common knowledge that its committees as well as other governmental agencies have been and are investigating practices in the field of patents with a view to formulating recommendations for substantial revisions and changes to be enacted in the patent system.

  It remains for the lawmaking body to courageously and intelligently take up its responsibilities to amend and clarify and synchronize the patent system with the times and the technological age in which we live and not for this court to judicially legislate its individual ideas of the appropriate social and economic practices that should prevail in the light of the modern age as substitutes for stabilized regulation by statute.

  We believe we have shown that neither Edeleano, nor Jones and Wallis anticipated Alles by their publications. However, if we should concede that Edeleano demonstrated these salts of the base or that Barger and Dale accurately disclosed the optimum activity of this chemical structure or that Jones and Wallis produced this hydrochloride of the base we would still regard Alles as entitled to the protection of the patent law. None of the scientists who worked before him attached to their work any of the elements or factors that would give it status as having inventiveness, for none connected it with its effects upon the human organism. It was here that Alles departed from the step by step testing of chemicals and by his experimentation struck the spark of genius when he discovered the therapeutic use which the effect of his compound would have upon the human central nervous system.

  It is easy to say, looking at the results of Alles' findings through hindsight, that any skilled chemist could arrive at the composition which is the subject of the patent claims. To the extent that a skilled chemist might reproduce the base by the method described by Edeleano and convert that base into a salt by a method known to the art, that statement is correct, but the fact is, that although these methods had been available to the art for almost a half century, no one reproduced the base or produced the salt thereof for any therapeutic use whatsoever, for the reasons that no therapeutic use had ever been known for the composition and that the central effects of compounds of similar structure had been considered undesirable. No one exercised any original thought by which a possible use for the composition could be found. The original thought and experimentation were added to the art by Alles. No use was ever advanced or suggested for the base of the compound produced by Edeleano or for the use of compounds of similar chemical structure in the art prior to the contribution of Alles. He did not find a new use for an old known composition, but for the first time he found a salt of a composition and the effects of it. The base of the composition was known and the salt was obtainable by a known method, although there is no evidence to show that it was ever produced for, or that it was ever suspected of, therapeutic use.

  Although not conclusively proven, there is some evidence to believe one skilled in the field of sympathomimetic amines might forecast from the chemical structure of a compound whether it possessed sympathomimetic activity, but even that prediction is admittedly a guess. When we speak of sympathomimetic activity we speak of the exhibition of such activity to a certain degree. In order to find that degree, experimentation is essential. Furthermore, whether the compound exhibiting the sympathomimetic activity upon experimentation, whatever its degree, may be used therapeutically, requires further experimentation. The chemical structure indicates no more than assumption of its sympathomimetic activity to one skilled in the art, but the type of action, the oral effectiveness of the compound, the duration of action, the undesirable side effects, and the effects it might have on the central nervous system -- considered undesirable prior to Alles -- are some of the factors that had to be determined before any use could be found for the compound.

  There is no evidence to show that from chemical structure alone a skilled chemist could assume or predict that a compound so constructed would have any effect upon the central nervous system. Not only does the evidence fail to show that any one prior to Alles considered a use for amphetamine sulfate, or a compound of similar chemical structure, but it does not disclose that any one ever considered the therapeutic use of any drug exhibiting effects upon the central nervous system. This experimentation was accomplished by Alles. The results were overwhelmingly successful. His reports based upon these experiments furnished the art with evidence of the accomplished effects and therapeutic uses of amphetamine sulfate so that it might be successfully used with beneficial results.

   In order to arrive at findings based upon originality and novelty to a degree that may be termed invention in a legal sense, the only method available in the fields of chemistry and therapeutics is experimentation. Experimentation to find the new in composition must be, of necessity, with known elements.

  Experimentation in chemistry upon compositions from the standpoint of therapeutics must reflect effect. The desire to create a certain effect because one believes that effect can be therapeutically useful or the curiosity to discover whether an effect would be a therapeutically valuable one, would impel one to conduct such experiments. It is the effect it produces which brings the composition up to the high standard of invention in therapeutics. Without the useful effect, the composition, although new, is of no value, except possibly academically, and certainly unpatentable. The field of chemistry is filled with formulas and compositions for which no use has yet been found. Are we to discourage the finding of beneficial uses of known formulas and compositions by concluding that the publication of the laboratory method of preparing compositions without declaration of purposes precludes any further findings with regard to that substance from being the subject of a patent? If we were to so conclude, we should deprive the protection of our patent law to the fields of chemistry and therapeutics, fields in which great advances have been made towards the relief of the suffering of mankind and aiding man to a longer and a better life. It is our conclusion that a salt of 1-phenyl-2-aminopropane was produced for the first time by Alles as a physiologically active therapeutic agent capable of producing effects in animals and man similar to the effect of salts of ephedrine and that what he disclosed is a new and useful composition of matter not known or used as such by others in this country, and not patented or described in any printed publication in this or any foreign country before his discovery thereof and which is of inventive character and patentable.


  The defendants are charged with the infringement of claim 1 of the patent involving salts of 1-phenyl-2-aminopropane. No evidence is offered to show any infringement of claim 2 of the patent involving the hydrochloride of 1-phenyl-2-aminopropane. The hydrochloride is involved only as it is concerned in the prior art.

  The testimony shows that defendants furnished druggists with 5- and 10-milligram tablets of amphetamine sulfate with which to fill doctors' prescriptions for the drug. Other tablets were likewise furnished which contained amphetamine sulfate in combination with other drugs, such as thyroid and phenobarbital. The defendants also furnished tablets to doctors so that they could be dispensed directly to patients.

  The defendants concede that they manufactured and sold tablets of amphetamine sulfate, but that the use to which the tablets was put was controlled by the physician who prescribed them and the patient who took them. They submit that unless the patient used them to obtain the effects similar to the effect of the salts of ephedrine, there could be no infringement charged to them, even by way of contribution. They differentiate between the use of amphetamine sulfate and the salts of ephedrine because they say that the results or effects obtained by the use of the latter would not be satisfactory for the purposes desired for which the former only would serve. In obesity, in the treatment of narcolepsy, alcoholism and other uses, their witnesses testified that the effects of the salts of ephedrine were undesirable, whereas the effects of amphetamine sulfate were desired and used.

  The defendants further contend that it is almost impossible to ascertain the extent, if any, of alleged infringement because it would be necessary to follow the use of the amphetamine sulfate to the particular patient to determine for what purpose it had been prescribed and what effects were obtained and whether those effects were similar to the effect of the salts of ephedrine.

  As we have already noted the Alles' patent covered a salt of 1-phenyl-2-aminopropane as a therapeutic agent capable of producing effects similar to the effect of salts of ephedrine. The testimony shows that amphetamine sulfate produces effects upon the sympathetic and central nervous systems. The salts of ephedrine also produce effects on the same systems. The fact that the latter does not produce as much effect on the central nervous system as to give it utility in those conditions where it is desirable to have more intensity of effect upon the central nervous system does not limit the Alles' patent. That grant extends to the use of 1-phenyl-2-aminopropane as a therapeutic agent whenever it produces effects similar to the effect of salts of ephedrine.

  The testimony of the medical witnesses was overwhelming that amphetamine sulfate was used therapeutically at this time for its effects on the sympathetic and central nervous systems and largely for those upon the central nervous system. No other therapeutic purpose was shown to be known for the drug. The defendants manufactured and sold amphetamine sulfate for therapeutic or medicinal purposes to produce effects similar to those produced by the salts of ephedrine. They cannot escape liability for infringement by hiding behind the assertion that the use to which the drug was put by druggists, doctors and patients could not bind them. They enabled all others to violate the rights protected by the patent for they knew that the purchase of the compound was solely for its known effects.

  In this they infringed the Letters Patent No. 1,879,003 assigned by the patentee Alles to the plaintiff.

  Part II -- Unfair Competition

  A. Plaintiff's Charge of Unfair Competition

  Plaintiff is an old established and well-known pharmaceutical house in Philadelphia. It has marketed amphetamine sulfate in tablet form since December of 1935. Tablets containing 5 milligrams and 10 milligrams of the drug are sold in packages of 25 and 250 tablets, each package bearing a label which includes its trademark 'Benzedrine' or 'Benzedrine Sulfate Tablets', and the generic chemical name of the drug (benzylmethyl carbonamine sulfate was used as a generic name up to 1938 and thereafter amphetamine sulfate).

  The price of the plaintiff's product for the 10-milligram tablets since January 1, 1939, has been as follows: $ 8 per dozen for packages of 25 tablets each and $ 5.65 for each package of 250 tablets.

  The 10-milligram amphetamine sulfate tablet produced by plaintiff since September of 1936 may be described as follows: A small white, round tablet with a diameter roughly of about half the diameter of a nickel and a little less than twice the thickness of the same coin. The top surface is crossed by two furrows or grooves which bisect each other at right angles at the center. The top surface is level and rimmed with a small bevel, and the crossed furrows or grooves are set to a depth slightly lower than the lowest edge of the bevel. As one looks at the top surface he finds it divided into four equal wedge-shaped sections. Since the furrows or grooves are V-shaped, they form a distinctive design at the point where they converge at the center of the top of the tablet. The side walls are smooth and seem glossy. The bottom surface of the tablet is a little concave, making it appear as if there were a narrow border around the bottom.

  In 1940 the plaintiff put upon the market a smaller amphetamine sulfate white tablet containing 5 milligrams, the top surface of each being crossed by a single V-shaped furrow or groove which runs from edge to edge across its center. Roughly the diameter of this tablet is about half the diameter of a dime and slightly more than twice as thick as the same coin. Its top surface is flat and rimmed with a small bevel, similar to its 10-milligram counterpart. The V-shaped groove which runs from edge to edge across the center of the surface is set to a depth of a little lower than the lowest line of the bevel. The bottom surface of this tablet is also slightly concave.

  The plaintiff sells the drug at wholesale to hospitals, jobbers and retail outlets. The patient obtains the drug from the doctor or from the pharmacist only upon presentation of a doctor's prescription.

  Since September of 1936 the plaintiff has exploited the distribution of the drug by advertising, educational campaigns, pictorial displays, and acquainting the medical profession with the usefulness of the preparation by distributing sample tablets and reprints of medical papers and articles. It took the customary means of displaying the article at medical conventions and addressing the interested professions by letter and otherwise calling attention to the compound.

  Plaintiff states that it sent its literature to approximately 100,000 doctors in the United States. In each year since September 1936 it claims to have circularized that number, or more, of physicians and to have distributed over 2,000,000 samples since that date.

  The sales of the product over the period of years since its introduction on the market reached approximately 150,000,000 tablets in number or $ 2,800,000 in amount for the 10-milligram amphetamine sulfate tablets. The plaintiff also claims to have distributed the tablet to the consumer through some 7,500,000 physicians' prescriptions, besides which the United States and British governments have bought plaintiff's product in large quantities.

  Since 1935 plaintiff claims to have spent $ 276.750 on research.

  The reception accorded the introduction of the product is evidenced by the large number of articles and papers written and published by physicians and pharmacologists with reference to the effects of the compound.

  Evidence of doctors and druggists was introduced at the trial that they recognized the tablet as amphetamine sulfate, known by its trade name of Benzedrine and as the product of the plaintiff, as a result of the widely circulated information and distribution of the product by the plaintiff. They testified that they identified the tablet by its unique and distinctive appearance.

  Charles L. Morris, one of the defendants, a graduate pharmacist, was proprietor of a drugstore in Roselle, New Jersey. In the fall of 1936 he entered the employ of E. R. Squibb & Sons, a competitor of the plaintiff, as a salesman. In October of 1941 he formed the defendant corporation, Clark & Clark, while still in the employ of Squibb. Together with his wife he has always owned a controlling interest in Clark & Clark, and recently he acquired all the outstanding stock of the corporation. The name of the company is alleged to have had its origin from the maiden name of his wife. He claims his choice of the corporate name was quite arbitrary with the thought that the corporation might in the future come to be referred to as 'C. & C.,' as in the instance of other initials which identify large pharmaceutical concerns.

  Charles L. Morris is the moving figure among the defendants and provides the active and dominating force that influences the corporate defendant and remaining defendant in the case, his brother, Robert Brinton Morris. When we use the name 'Morris' hereinafter, it will be understood that we refer to Charles L. Morris, unless we indicate otherwise.

  In October of 1941, the corporation, Clark & Clark, purchased the machinery and equipment of Standard Medical Laboratories, located at 417 Mickle Street, Camden, New Jersey, and established itself at that address. David Olmstead, a pharmaceutical chemist, was connected with said laboratories. He associated himself with Clark & Clark as vice president when that company took over. Robert Brinton Morris was also active with Clark & Clark, which immediately commenced to manufacture amphetamine sulfate tablets. Olmstead had charge of the production of the tablets and Robert Brinton Morris sold them. However, Morris was active in the sale of these amphetamine sulfate tablets, although at the same time he was still engaged as a salesman for Squibb.

  Apparently the first amphetamine sulfate tablets produced by Clark & Clark were made from the punches and dies taken from the Standard Medical Laboratories. These punches had been used for the purpose of making certain eucathesian tablets. This tablet was scored with two lines crossing at the center of its top surface at right angles. The indentation made by these lines formed only thin grooves in the surface of the tablet. It was round, flat and devoid of any ridges or concavities.

  One of its first customers was The Lannett Company, jobbers of pharmaceutical supplies in Philadelphia. The negotiations with The Lannett Company were conducted by Morris and his brother, Robert. In December of 1941 negotiations took place between Morris, on behalf of Clark & Clark, and one Cusamano, in New York, which resulted in the production by Clark & Clark of amphetamine sulfate tablets for Cusamano. These tablets were produced from punches and dies which Cusamano provided for the purpose. It was then known to Morris that the tablets Clark & Clark produced for Cusamano and the tablets sold by Cusamano were similar in appearance to the 10-milligram amphetamine sulfate tablets of the plaintiff.

  Morris approached Robert Hart, sales manager in charge of the new products and development department of Squibb, his employer. Morris testified that Squibb was looking for a new specialty product and he suggested to Hart the sale of amphetamine sulfate tablets. He also testified that his intention in making the suggestion to Hart was to ascertain whether the plaintiff's patent was valid or not by having Hart procure an advisory opinion from the attorneys of Squibb. Hart is said by Morris to have told him that Squibb did not believe plaintiff's patent was a valid one, but that it did not intend to go into the amphetamine sulfate tablet market. In addition, Morris stated that, in answer to his questioning of Hart, he was advised that ephedrine-like compounds make very good specialties in the pharmaceutical business; that amphetamine sulfate was an ephedrine-like drug; and that any one entering this business should be able to make a good profit. It is to be noted that at the time of this discussion Morris was actively engaged in producing and selling amphetamine sulfate tablets through his corporation.

  Morris admitted that one of the factors which led to his decision to enter this market was that he knew that plaintiff was marking up its product to such an extent that it was making large profits and concluded that if he went into this field he likewise could profit handsomely.

  In the meantime Cusamano in February of 1942 had associated himself with Ben Zirin and Henry Starr in a concern known as Custazin Products, which continued the sale of amphetamine sulfate tablets in the same form under the name of 'Custazin.'

  Prior to April 1942 the employment relationship between Squibb and Morris was severed, and Morris devoted himself entirely to the business of Clark & Clark.

  In April of 1942 the present 10-milligram amphetamine sulfate tablet of Clark & Clark was produced after a decided change was made in the form and appearance of the tablet used up to that time. These changes were effected in the shape and form of the tablet by a tool maker in New York, named Johnson. Morris took the punches to Johnson and told him he wanted to produce tablets that would be something between his original amphetamine sulfate tablet and the Cusamano tablet. Johnson used a pantograph, an instrument designed to make accurate copies, to produce the punches for Morris.

  The reworked punches produced a tablet strikingly similar to that of the plaintiff. The similarity in appearance between the Clark & Clark tablet and the plaintiff's was brought to the attention of Morris by Olmstead. Morris, in his testimony, confirmed this and stated that he had ascertained that the punches were producing tablets similar to the plaintiff's, but that he did not particularly care.

  Morris employed Benjamin Zirin as a salesman for Clark & Clark in June 1942.

  Morris conceded that the business of Clark & Clark was 'practically exclusively' in amphetamine sulfate and compounds thereof. He stated that it sold a series of tablets of different colors, known as Clarkotabs, and that 50% of the business of his company was done in the sale of these tablets. The tablets contain various mixtures of amphetamine sulfate, thyroid, phenobarbital and other drugs in different quantities and tablets of three different colors are prescribed for different hours in a single day. He claims that the other 50% of his business was divided equally between the sale of straight 10-milligram amphetamine sulfate tablets and amphetamine sulfate tablets of shape, colors and sizes, different from the plaintiff's tablet.

  Clark & Clark's tablets have been sold for as much as $ 12 per 1000 tablets. Morris attempted to keep the price of his company's tablet at $ 9.75 per 1000 tablets and stated that he lowered it whenever it was necessary to meet competition and that when it was necessary to lower it that it had been lowered to as little as $ 3.50 per thousand tablets in some instances. The varying prices of Clark & Clark's tablets were also evidenced by postal cards periodically sent to the trade in many thousands offering the products of Clark & Clark for sale. The postal cards contained various headings as follows: 'Special Offer,' 'Final Sale, 10 Days Only,' '5 Days Only Amphetamine Sulfate,' 'By Popular Demand, 10 Days Only, Amphetamine Sulfate,' '10-Day Special.' A picture of several tablets usually featured the lower portion of each postal card.

  Morris insisted that the reason which caused the change of the form and appearance of the Clark & Clark tablet was because he wanted a deeper groove in the tablet to facilitate its breakage into halves and quarters as the patient required lesser dosage than the whole tablet.

  Clark & Clark also produced 5-milligram amphetamine sulfate tablets. This tablet was likewise changed for the claimed purpose of deepening its single groove.

  The amount of material used in a tablet which contains the drug is usually a very small fraction of the size of the entire tablet, the remainder being a binder. Morris agreed in his testimony that he could make amphetamine sulfate tablets in an infinite number of sizes, shapes and distinctive designs, and these would contain the same dosage and facilitate the breakage equally with the tablet Clark & Clark presently produced, thereby preserving the same advantages of his present tablet.

  A large volume of testimony was introduced to show that where prescriptions calling for benzedrine, benzedrine sulfate, benzedrine sulfate S.K.F. and amphetamine sulfate S.K.F. were tendered to druggists they were filled in part, or in whole, with the tablets of Clark & Clark. Some 25 such prescriptions were described as having been filled by different druggists in New York and 8 in Philadelphia. It is to be noted that the prescriptions usually called for 12 tablets. The cost to the consumer was generally about 75 cents, although in one or two cases the price to fill a prescription was as low as 50 cents and as high as 95 cents. The 33 prescriptions were filled at an aggregate cost to the purchasers of $ 23.85. This cost to the consumer would not appear to reflect any saving to him by reason of the substitution for the prescribed drug.

  In most of the substitutions the prescription was filled by the druggist with all of the tablets of Clark & Clark. In a small number of cases the mixture of tablets put up by the druggists consisted in part of plaintiff's and in part of Clark & Clark's.

  The practice of substituting drugs is regarded by the profession of druggists as highly reprehensible, but apparently the druggists who perpetrated the substitutions, demonstrated in the evidence before us, felt that the tablets were so identical in appearance that they could substitute them with security, even to the extent of mixing the tablets of the plaintiff and Clark & Clark in one package.

  It is also to be noted that any savings effected by the druggist in the purchase of Clark & Clark tablets at a price considerably lower than the price of plaintiff's tablets were not passed on to the ultimate consumer, but benefited either the distributor or the druggist, or both. One of defendants' expert witnesses, a physician specializing in obesity, calculated that approximately 30% of his fee was allocated to the cost of amphetamine sulfate tablets which he personally dispensed to each of his patients. Before purchasing his supply of tablets from Clark & Clark, he obtained them from the plaintiff at a cost of approximately $ 22 per 1000. Later he changed his purchases to Clark & Clark at a cost of only $ 3.50 per 1000. However, he conceded that his fees were not decreased after he had changed his supplier, again demonstrating that any savings on the cost of the tablets were absorbed before they reached the ultimate consumer.

  Through their witness, A. C. Herting, the defendants introduced into evidence a booklet entitled 'Pennsylvania Formulary (P.F.),' consisting of 59 pages, in which were listed 190 prescriptions or remedies. It was published in 1943 and on its inside cover it contained the statement of policy over the signature of the secretary of the 'Joint Comm. of the Penna. Pharm. Assn. and the Medical Society of the State of Penna.' It also contained an introduction signed 'The Joint Committee.' Herting was named as Vice-Chairman of, and Chemist and Pharmacologist for, the Joint Committee.

  Suggestions and recommendations were made to physicians with regard to prescription and dispensing practices, and alphabetical and therapeutical indices preceded the listings of the prescriptions. The following formulas appeared in the order of their numbers: "2 Argentum Iodum Colloidalis * * * * * * "Also it may serve as excellent suspension for ephedrine salts and Pen-Phetamine (1 gr. per oz.) in nasal work." (Italics ours) "4 Capsulae Amphetaminae Capsulae Pen-Phetamine 5 mgm (3/40 gr) Amphetamine Sulf. (See #130) 1 1/2 grs Sacch. Lac 60 grs Fiat Caps No. XX Color Yellow" (Italics ours) "5 Capsulae Amphetaminae Capsulae Pen-Phetamine 10 mgm (3/20 gr) Amphetamine Sulf. (See #130) 3 grs Sacch. Lac. 100 grs Fiat Caps No. XX Color Red" (Italics ours) "28 Capsulae Thyroid. Comp. (1-2-3) No. 1 Thyroid 1 gr Prophetamine Sulf. 1/12 gr Atropine Sulf. 1/360 gr Aloin 1/4 gr Carbo Activat 1/20 gr Sacch Lac 3 1/2 grs Fiat Caps. No. 1 (grey color) Sig--one before breakfast No. 2 Thyroid 1 gr Phophetamine Sulf. 1/12 gr Atropine Sulf. 1/360 gr Sacch Lac 1 1/2 grs Fiat caps. No. 1 (white color) Sig--one before lunch No. 3 Thyroid 1 gr Prophetamine Sulf. 1/12 gr Atropine Sulf. 1/360 gr Sacch Lac 3 1/2 grs Phenobarbitalis 1/4 gr Solution Amaranth-qs to pink color Fiat Caps. No. 1 (pink color) Sig--one at 4 P. M. A controlled and accelerated thyroid therapy of especial value in treating most obesity cases. See monograph #130." (Italics ours) "124 Nebula Sulfo-Pen-Phetamine Penphetamine Sulfate 3/5 gr Sod. Sulfathiazole 11 1/4 grs Sod. Sulfite 9 grs Aqua Dest-qs 1 oz Liq. Carmini qs to deep rose color." (Italics ours)


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