The opinion of the court was delivered by: BIUNNO
Merck & Co. (Merck) manufactures and markets a pharmaceutical medication, amitriptyline HCL, under the trade name ELAVIL n*. The medication is described as a white or practically white crystalline powder freely soluble in water. Merck has marketed it since April, 1961.
Biocraft Laboratories, Inc., (Biocraft) a generic drug competitor, also markets amitriptyline HCL (though it does not manufacture the active ingredient as Merck does).
The medication is an antidepressant with an anxiety-reducing, sedative component to its action, although the mechanism by which it functions is not precisely known. It is indicated for the relief of symptoms of depression, particularly endegenous depression, and depression accompanied by anxiety. As disclosed by the text of Physician's Desk Reference (PDR), there are a number of conditions which contraindicate its use, as well as a number of potential side effects in particular patients (i.e., those with urinary retention, angle-closure glaucoma or increased intraocular pressure, pregnancy, etc.), and potential adverse reactions and precautions which call for close professional monitoring of such patients.
Because of the potentially harmful effect and the collateral measures necessary to its use, 21 U.S.C. § 353(b)(1)(B), the drug container, before dispensing, must bear on its label the statement: "Caution. Federal law prohibits dispensing without prescription", absent which the drug is deemed "misbranded", 21 U.S.C. § 353(b)(4).
It is also a prescription drug under New Jersey law, N.J.S.A. 45:14-6, 45:14-14, 45:14-26.1, and it does not come within the exception for "non-poisonous patent or proprietary medicine" or "simple nonpoisonous domestic remedy", N.J.S.A. 45:14-29.
Aside from claims and counterclaims involving the validity and infringement of a Merck "use" patent, and other issues, the case involves a dispute on issues of unfair competition and violation of the Lanham Act, and it is these latter issues only that were brought before the court on Merck's motion for summary judgment.
The motion was originally filed March 24, 1980, returnable April 14, 1980. It was continued to May 12, then to June 9, and to June 16, 1980 when an entire day was devoted to the hearing.
Merck markets ELAVIL*in two forms. One is a clear, colorless solution in vials of 10 milliliters (cc) each, in a concentration of 10 mg. per ml., for injection. The other form is in round, film coated tablets in various dosages: 10 mg. are blue, 25 mg. are yellow, 50 mg. are beige, 75 mg. are orange, 100 mg. are mauve. A 150 mg. tablet is capsule shaped, film coated, in blue. (See PDR, 1980). The 10 mg. and 25 mg. dosages were the first ones marketed by Merck. The 50 mg. dose was marketed in 1967, and the 75 mg. and 100 mg. doses were marketed by Merck in 1975. These dates appear in the stipulation of the parties. The 150 mg. dose, in capsule shaped blue tablet, appears to have been marketed by December, 1976, judging from information in the 1979 PDR.
In any event, Biocraft began marketing amitriptyline HCL from about March, 1977, in round, film coated tablets as close as possible to the sizes and colors of Merck's. There is no question that the trade dress copying was deliberate, in view of the testimony of Biocraft's president on deposition.
It is also a fact not in dispute that Biocraft markets its product as a generic substitute for ELAVIL *. It has obtained an abbreviated NDA as a "me-too" drug, and it appears in the Pennsylvania formulary as a generic, under the name amitriptyline HCL. Although Biocraft does not manufacture the active ingredient but only the tablets, it is listed as a "manufacturer" supplying various distributors identified as Spencer-Mead, Vanguard Labs, Theda Corp., H. L. Moore Drug Exchange, Rugby Labs, West-Ward, United Research Labs, Steri-Med, Geneva Generics, Lederle Labs, Towne Paulsen, Parmed Pharmaceuticals, Three P Products and Purepac Pharmaceutical. It also shows that Phillips Roxane manufactures for SK & F.
In the New Jersey formulary, second edition, October, 1979, acceptable manufacturers of amitriptyline HCL are listed as Barr, Biocraft and Merck. The February, 1980 supplemental bulletin lists Phillips Roxane and Roche as additional acceptable manufacturers.
The large chart with actual samples of the tablets marketed by various sources shows that four pharmaceutical companies market this medication under their brand and trade-name. These are: Roche (Endep)*, Parke-Davis (Amitril)*, Squibb (Amitid)* and Merck (Elavil)*. While each of these uses a different color for each dosage, none uses the same colors as any other. The same is true of SK & F, which markets as a generic. It uses different colors than any of the others.
The "Guide to Prescription Costs", issued by the U. S. Department of Health and Human Services, dated April, 1980 contains listings for amitriptyline HCL at pp. 139-140 in the category of "psychotherapeutic drugs", in the sub-class "anti-depressant drugs". The other drugs in the subclass are (1) combinations of amitriptyline HCL and perphenazine, in varying proportions and dosages, (2) desipramine HCL, (3) doxepin HCL, (4) imipramine panioate and (5) nortriptyline HCL. For the specific sub-class amitriptyline HCL, a considerably larger number of "suppliers" is listed than appears in the N.J. and Pennsylvania formularies. This difference in listings may be the result of the fact that some suppliers do not market nationally, or else (if they do) that the State agencies working with positive formularies have not yet had time to pass upon all the allegedly generic substitutes on the market. Another possibility is that some of these suppliers may not yet have succeeded in obtaining FDA approval for abbreviated NDA's to establish therapeutic equivalence, a matter on which HHS does not express any opinion. It merely lists price ranges (prices to the pharmacy, not prices to the consumer) for pharmacological equivalence, not therapeutic equivalence.
In any event, the "Guide" contains a reprint of a booklet published by FDA listing all drug products with approved NDA's with proposed therapeutic equivalence evaluation. The preface, in part D-1, notes the following observation in respect to therapeutic equivalents:
"However, these products may differ in other characteristics, for example in taste, color, packaging, expiration time, and, in some instances, labelling. If such products are substituted for each other, there is a potential for problems such as patient confusion due to differences in color or shape of tablets, better patient acceptance in certain products because of flavor, better stability of one product over another under adverse conditions of storage, or allergic reactions in rare individuals due to a coloring ingredient, as well as the potential for reduced cost to the patient. An FDA evaluation in no way relieves practitioners of their professional responsibilities in prescribing and dispensing such products with due care to individual patients. In these uncommon circumstances where the characteristics of a specific product, other than its active ingredient, are important in the therapy of a particular patient, the physician's specification of that product is appropriate. Pharmacists must also be familiar with the expiration times and labelling conditions for storage, particularly for reconstituted products, to assure that patients are properly advised when one product is substituted for another."
The N.J. Formulary, October, 1979, page V, captioned "To the consumer" says the same thing more simply:
"You should understand that generic products often differ in color, shape or size from the better-known (and usually more expensive) brand name products. Such differences are to be expected; these differences do not affect how well the medication works". (Emphasis in original).
Since the matter comes before the court on motion for summary judgment under F.R.Civ.P. 56, the court must examine the record to determine whether there is a genuine issue as to any material fact, and if not, whether Merck is entitled to a judgment as a matter of law.
Biocraft may not rest upon the mere allegations of its pleading, but its response, by affidavit or otherwise, must set forth genuine issues for trial. Rule 56(e). It presented a number of arguments, dealt with below.
Merck's use of the colors it uses as functional.
Since Merck uses a different color for each dosage, i.e., bright blue (10 mg.), lemon yellow (25 mg.), beige (50 mg.), light orange (75 mg.) and mauve (100 mg.), it is argued that this use of color is functional and so cannot provide a basis for a claim of unfair competition or violation of the Lanham Act.
The argument fails to raise a genuine issue of material fact for trial for a number of reasons.
An inspection of the product identification section of the PDR discloses that color coding (along with other arbitrary features) is widely used by many manufacturers, but also that there is no generally used standard for particular colors in the array. For a few examples, see the photographs listed below:
This list, which is not exhaustive, is based on pharmaceuticals displayed in color in the Product Identification Section of the PDR. It establishes beyond doubt that various manufacturers make use of color codes to identify different dosages for particular medications of their own, but that the colors used for this purpose, as well as their sequence and array, are variegated and non-standard. There is no standard system, for example, to follow the sequence of the spectrum of visible light, which runs from long to short waves, from red, orange, yellow, green, blue, indigo and to violet. See, e.g., Hoadley, "Essentials of Physics" (American Book Co., 1921), § 529, at pp. 473-474, or any other high school physics test or standard reference work. Instead, the particular colors used and their array are entirely arbitrary on the part of each manufacturer.
This arbitrary selection is quite different from color codes adopted as industry standards. For carbon resistors used in radio and other electronic devices, the Radio Manufacturers Association (RMA) long ago adopted a standard RMA color code making use of the spectrum sequence of colors, plus others, with explicitly assigned values. A series of 10 colors was selected, each for a digit from one to ten, as follows:
Bands of color were required to be located around the body of each resistor, starting at one end. The first two indicated the first two significant digits and the third indicated a decimal multiplier from 1 to 10 9. Thus, a 25,000 ohm resistor would display a red band, a green band and an orange band. A fourth band was used to indicate the degree of precision. A gold band indicated accuracy within plus or minus 5%; a silver band indicated accuracy within plus or minus 10%; and the absence of a fourth band indicated accuracy within plus or minus 20%. See Henney, "Radio Engineering Handbook" (McGraw-Hill, 1941) § 24, at pp. 61-63, or any other basic reference work in the field.
The promulgation of an industry standard for color coding is quite a different matter. Its purpose is to encourage all manufacturers to make use of the same color coding system, and effectively places that particular system in the public domain.
Nothing in the record, or for that matter in the Product Identification Section of the PDR, remotely suggests the existence of some industry standardized color code for pharmaceuticals. It shows the exact opposite, namely a wide variety of color codes that differ from manufacturer to manufacturer and from product to product. Hence, while color code systems per se are doubtless in the public domain in the sense that a manufacturer using a color code cannot prevent another manufacturer from using a different color code, the uniqueness of each color code for a given manufacturer and product reflects identity and source, which may not be copied.
By affidavit of Carol P. Einandi sworn to June 2, 1980 and filed, together with an accompanying card on which 20 different tablets are mounted in 3 groups by class of color (Tab 3 of exhibits filed pursuant to Memorandum Order dated June 17, 1980), Biocraft presents samples of various medications by various manufacturers. The groupings are those that are one or another shade of yellow, of peach or salmon, or of orange.
What each medication is indicated for, or contraindicated for, is not explained; it was left to the court to look up each one in the product information section of the PDR. See Transcript of June 16, 1980, p. 125 line 18 to p. 126 line 15. This exhibit was tendered to raise an issue for trial that the colors chosen by Merck for Elavil*are not distinctive. It was said at argument (same transcript passage) that all the samples are of anti-depressants.
As the transcript shows, the exhibit is incomplete. Other exhibits, particularly the large exhibit, C-1, showing the different color arrays used by branded and tradenamed amitriptyline HCL, and the PDR, indicate that the card of samples shows no more than that it is possible to gather and group anti-depressant medications that are generally yellow, or peach/salmon, or orange, but it falls far short of raising a genuine issue for trial on this point.
A fuller inspection shows distinctive differences rather than similarities. Thus, Merck's Triavil*and Schering's Etrafon *, are combination drugs of perphenazine and amitriptyline HCL in four proportions. Each manufacturer uses a different color of each proportion, as follows:
What the exhibit has done is to place in the same group the 4:25 Merck product and the 2:10 Schering product simply because they are yellow, when in fact the table above shows that the comparable dosages are of different colors.
Similarly, Roche's Marplan *, which is placed in the peach group, is marketed in a single 10 mg. dosage and falls into a different category of anti-depressant. The generic active ingredient is iso-carboxazid. It is indicated for use in place of electro-shock therapy for patients when the latter method of treatment is hazardous. It affects many enzyme systems and has a variety of side effects. Its characteristics, contra-indications and cautions are quite different than those of Elavil *, which does not use peach as a color.
Similarly, a sample of Merck's Vivactil*is included. The PDR shows the active ingredient to be protriphyline HCL. It is put up in oval tablets, 5 mg. in orange and 10 mg. in yellow. The 10 mg. Elavil * is blue and the 75 mg. is orange. Beyond that, Vivactil * is for use under close medical supervision, has a more rapid action than amitriptyline HCL, and shows no sedative or tranquilizing action.
Warner/Chilcott's Nardil *, in the orange group, is phenelzine sulfate, described as an anti-depressant and a potent inhibitor of monoamine oxidase (MAO). It is supplied only in a 15 mg. orange tablet.
It is not difficult to page through the Product Identification Section of the PDR to find various tablets that can be grouped as yellow, peach/salmon or orange. For example:
In this case, the exhibits show that Roche, Parke-Davis, Squibb and Merck each market amitriptyline HCL in a series of dosages under unique trade names, and that each uses a different series of colors for the various dosages. It is only the "generic" marketers (except for SK & F) who have copied the trade dress, and they have copied Merck's trade dress, not that of Roche, Parke-Davis or ...