Copyright And Trademark Issues In The Pharmaceutical Industry Generic Compliance Or Brand Drug ImitatingCopycat Or Compliance

By ROSEANN B. TERMINI,* Montgomery County Member of the Pennsylvania Bar AND AMY MIELE**

TABLE OF CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . COPYRIGHT ISSUES . . . . . . . . . . . . . . . . . Generic Labeling . . . . . . . . . . . . . . . . . . Counterfeit Drugs . . . . . . . . . . . . . . . . . 34 35 36 38 TRADEMARK ISSUES . . . . . . . . . . . . . . . . Generic Use of Pill Shape and Color . . Trademark Genericide . . . . . . . . . . . . . . CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . 38 39 44 46

ABSTRACT
Imitation is the sincerest form of flattery; that is , unless the imitation is of a product produced by a multi billion-dollar industry. Then, imitation has the potential to involve intellectual property litigation. For the pharmaceutical industry, the majority of intellectual property litigation stems from the interplay between generic or imitator drug and brand name or pioneer drug manufacturers.1

INTRODUCTION
Initially, a brand name drug is covered under a patent, and thus may be the only one of its type on the market. When a patent expires and generic drugs enter the
Special thanks to patent and trademark attorney Manny Pokotilow, partner at Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd.,Philadelphia, PA for his excellent recommendations and review. Mr. Pokotilow has extensive trial experience in patent and trademark issues involving pharmaceuticals. mpokotilow@crbcp.com http://www.crbcp.com. * Roseann B. Termini, Esq., has extensive experience in food and drug law and a particular interest in this topic. She teaches several food and drug law courses at Widener University School of Law. She served as corporate counsel for a pharmaceutical company and as a trial and appellate senior deputy attorney general for the Pennsylvania Office of Attorney General. Ms. Termini recently published new editions of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products, a separate CD and Instructors Manual (2012). www.fortipublications.com, rbtermini@widener.edu. ** Amy Miele sparked her avid interest in intellectual property while interning in Viacoms Music and Media Licensing department. She earned her Bachelors degree from Rutgers University and J.D. from Widener University School of Law. amylmiele@gmail.com. 1. See William R. Warner & Co. v. Eli Lilly & Co., 265 U.S. 526 (1924); Shire US Inc. v. Barr Labs. Inc., 329 F.3d 348 (3d Cir. 2003); SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharm., Inc., 211 F.3d 21 (2d Cir. 2000), cert. denied, 531 U.S. 872 (2000); Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631 (2d Cir. 1979); Norwich Pharmacal Co. v. Sterling Drug, Inc., 271 F.2d 569 (2d Cir. 1959), cert. denied, 362 U.S. 919 (1960); Upjohn Co. v. Schwartz, 246 F.2d 254 (2d Cir. 1957); Smith, Kline & French Labs. v. Clark & Clark, 157 F.2d 725 (3d Cir. 1946); Smith, Kline & French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976 (S.D.N.Y. 1950).

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Electronic copy available at: http://ssrn.com/abstract=2212473

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marketplace at a lower price the brand name manufacturer loses profits.2 Often brand name manufacturers have no recourse due to federal drug law regulations.3 In an effort to have the brand name drug be the only one of its type on the market for longer, and thus profit more, brand name manufacturers pursue injunctions against generic manufacturers. A legal basis for these injunctions is copyright and trademark claims.4 Copyright and trademark law protect creativity whereas patent and trade secret law protect inventions. Specifically, copyright law protects an authors creative expression of their idea.5 Patent law and trade secret law protect the idea itself (trade secrets protect commercial information).6 Trademark A high creativity law protects symbols firms use to indicate their prod7 threshold exists for ucts or services. This article creates a dichotomy bebrand name drug tween the scientific and the creative and addresses companies to only copyright and trademark issues within the pharmaceutical industry. achieve and mainA discussion of how similar a generic drugs label tain copyright and can be to the brand name drug without infringing the trademark protecbrand names copyrighted label is first. Second, a new tion in their labeldevelopment in counterfeit drugs crossing the border ing, pill shape, color is addressed. Next, the main issue of whether a generic and trade names. drug can be manufactured in the same shape and colors as the brand name drug without infringing on the brand names trademark is explored. That involves a discussion of functional features, what is considered trade dress, and whether substitution of generic drugs for brand name amounts to passing or palming off. The final discussion involves the genericide of trademarks; that is, who has and has not fallen victim.

COPYRIGHT ISSUES
Copyright law protects an authors creative expression(s) of ones ideas, yet not the ideas themselves.8 If an individual author holds a copyright it lasts for the life of the author, plus seventy years.9 If a corporation holds a copyright it lasts for 120 years from creation or ninety-five years from publication, whichever expires first.10 To obtain a copyright, you need not register for one, but registration does confer certain benefits.11 Copyrights are created as soon as an original expression is fixed in a tangible medium.12 The natural rights theory of copyright law says that when you put time into creating something, you should own the rights to it.13 Another policy justification behind copyright law is that the public must retain the ability to benefit from existing copyrighted works, and use those works to create new ones.14
2. See Watson, 211 F.3d at 26. 3. Id. 4. See Shire, 329 F.3d 348; Watson, 211 F.3d 21; Ives, 601 F.2d 631. 5. See Watson, 211 F.3d at 29. 6. See, e.g., Craig Allen Nard & David W. Barnes & Michael J. Madison, The Law of Intellectual Property 10, 15 (Vicki Been et al. eds., 2nd ed. 2008). 7. Id. at 2. 8. Id. at 7. 9. 17 U.S.C. 302(a) (2012). 10. Id. at 302(c) 11. Nard et. al, supra note 6, at 7. 12. 17 U.S.C. 102(a) 13. Watson, 211 F.3d at 29. 14. Id.

Electronic copy available at: http://ssrn.com/abstract=2212473

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Although the bulk of this paper contemplates trademark issues in the pharmaceutical field, a brief foray into copyright issues is warranted. Copyrights are about artistic creative expression so copyright law does not overlap much with the pharmaceutical field. One important area the fields do overlap in is drug labeling. Suffice it to state that copyright protection can only be achieved for labels if something is added to the labels which is creative and which is beyond FDA requirements. Although copyright does protect labeling to the extent it contains more than just data that may be sufficient for a brand owner that is creative in making its labels. After labeling is discussed one of the most recent developments in the pharmaceutical industry is mentioned as are the copyright issues it presents.

Generic Labeling
A generic label verbatim copying a brand label is not copyright infringement because it is necessary under FDA mandates and hence approval of generic drugs and does not impede on copyright laws underlying principals.15 Before generic drugs come to market manufacturers must submit an Abbreviated New Drug Application (ANDA).16 ANDA submissions are quite comprehensive yet do not entail the rigors of the brand name application.17 The focus of the application is bioequivalence ensuring the generic is identical to the brand in dose, safety, strength, method of administration, quality, and performance.18 In addition to these requirements the Federal Food, Drug and Cosmetic Act and accompanying regulations also mandate that generic drugs comply with labeling guidelines.19 Succinctly stated, labeling is defined as a display of written, printed, or graphic matter upon the immediate container of any article or accompanying such article.20 The FDA broadly interpreted this to include brochures, booklets, sound recordings, and similar pieces of printed, audio, or visual matter descriptive of a drug.21 The labeling at issue in SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharm, Inc., was a guide and tape accompanying plaintiff SmithKlines over-thecounter (OTC) Nicorette-brand gum.22 The tape included music and, along with the guide and gum, was a method that aided the consumer in quitting smoking.23 Brand manufacturers are required to include samples of their labeling in their new drug applications (NDA).24 Pursuant to this requirement SmithKline submitted its tape and guide to the FDA, spent two and a half years, and made approximately seventy modifications to meet FDA-approved labeling requirements.25 Watson, the generic company defendant, sought to obtain FDA approval for a generic gum.26 The Hatch-Waxman Amendments required the labeling for generics be the same as the labeling approved for the brand.27 Thus, Watsons initial guide and tape were almost identical to SmithKlines, until SmithKline instituted this ac-

15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

Id. 21 U.S.C. 355(j)(1). See, e.g., 21 U.S.C. 355(j). Id. at (j)(2)(A)(iv). Id. at (j)(2)(A)(v). 21 U.S.C. 321(k) & (m). See, e.g., 21 C.F.R. 202.1. Watson, 211 F.3d. Id. 21 U.S.C. 355(b)(1)(F). Watson, 211 F.3d at 23. Id. 21 U.S.C. 355(j)(2)(A)(v).

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tion.28 Initially, Watson was enjoined from selling its product relying on a letter from the FDA to Watson stating that the labeling does not have to be identical and defendants can design their own.29 Subsequently, Watson revised its guide and tape to deviate from plaintiffs but still be comparable.30 The FDA rejected it and required verbatim compliance with the brand labeling materials.31 The court held verbatim compliance would not be copyright infringement. First, they analyzed the purpose of the Hatch-Waxman Amendments, which was to facilitate, rather than impede, the approval of OTC drugs.32 It took the brand name over two years to get their labeling up to specifications. Although the defendant has an example, and is not starting from scratch, a lengthy period of modifications would surely ensue. Since the generic drug cannot be approved until its labeling is, patients would be without it longer and price competition in the market would be delayed.33 Next, the court looked to conflict of laws canons that a later date of enactment and specificity over broadness should be given priority. Since the Copyright Act was enacted previous to and was broader than the Hatch-Waxman Amendments, the court gave the latter deference.34 The court aimed to adhere to adopt the interpretation that preserves the principal of each law.35 Delaying a generics entry into the market contravenes the goal of the Hatch-Waxman Amendments.36 The purpose of copyright laws is to encourage creative expression by bestowing ownership rights to that expression.37 This purpose is unharmed by allowing brand labeling to be copied verbatim by generics because the creative expression (labeling) is not just encouraged but required. Brand names require labels and those labels must meet FDA approval.38 The period of exclusivity also bestows exclusive ownership rights for that duration. Generics do not have that period of exclusivity on the market. That period is what makes it acceptable for brand names to expend resources for labeling. It is an important period because it develops the good will of the company, allows consumers to associate the brand with the drug, as its the only one of its kind on the market, and provides a period of exclusive profit. This scenario creates a difficulty for brand name manufacturers to protect themselves from copyright infringement. In the alternative it could be opined that this case makes it very easy as it essentially eliminates copyright infringement as a cause of action for generic label copying. Aside from putting flashy, superfluous markings on their labeling materials that extend beyond the scope of FDA requirements without interfering with them, brand manufacturers cannot do much to avoid generic copying. Watson illustrates the complexity between copyright law and compliance with federal drug law regulation. Copyright issues may arise; however Watson illustrates that federal drug law compliance will trump copyright law. If a generic drugs market entry is unduly delayed, the consumer benefit of lower costs and choice are stymied.
28. Watson, 211 F.3d at 23-24. 29. Id at 24. 30. Id. 31. Id. 32. Id. at 25. 33. Id. at 26. 34. Id. at 28, Copyright Act of 1976, 17 U.S.C. 101-805 (2012). 35. Watson, 211 F.3d at 27-28. 36. Id. at 28, Drug Price Competition and Patent Restoration Act (Hatch Waxman Amendments) 505(j), 21 U.S.C. 355(j). 37. Watson, 211 F.3d at 29. 38. Id.

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Counterfeit Drugs
Counterfeit drugs entering the United States have widespread effects for copyright infringement and public health. United States v. Articles of Drugs, distinguished between a counterfeit drug and an imitation drug under the Federal Food, Drug, and Cosmetic Act (FDCA). The court noted the FDCA was designed to protect public health and consumers and its terms are interpreted broadly to achieve those purposes.39 An imitation drug is one that passes off one substance in imitation of another. A counterfeit drug is a drug that simulates anothers label, container and/or identifying marks.40 However, United States Customs Officials cannot always differentiate between legitimate and counterfeit goods.41 To solve that difficulty, goods bearing the labels of others are presented to the rights holders for inspection, to determine if infringement is occurring.42 It could be argued that rights holders are entitled to this practice, to be given the opportunity to ensure only legitimate goods of the quality they have established are put to market. Alternatively, it could be argued that rights holders will always claim infringement, even if none exists, in an effort to monopolize the industry. Around 2007-2008 United States Customs took the latter approach and enforced an initiative that had been in effect, but not adhered to, Customs Directive 23100081.43 This required the removal of all identifying information and marks from samples before providing those samples to the copyright holders for verification.44 However, this led to substantial delays in determining whether shipments were counterfeit or legitimate. It also delayed legitimate goods from getting to market, as they too had to be veraciously inspected.45 In 2012, H.R. 4216 was introduced which would overrule Customs Directive 2310008.46 This proposed legislation would require supplying copyright holders with unredacted samples to determine infringement.47 Yet, passage does not appear imminent.48 Of course these policies have ramifications for a wide variety of goods, yet the consequences of counterfeit drugs are far more severe than that of a pair of sneakers or a video game. These counterfeit drugs may have the same labels and markings as brand name or American generics, but they have not been FDA approved. This means that they have not undergone rigorous requirements.

TRADEMARK ISSUES
As aforementioned, trademark law protects the symbol(s) a firm uses to indicate their products and/or services.49 A trademark, unlike a patent, or a copyright, does

39. United States of America v. Articles of Drugs, 601 F.Supp. 392, 398 (D. Neb. 1984). 40. Id. at 397. 41. Mark Elliot, Saving Trade Secrets (Mar. 28, 2012, 8:58 AM) http://www.politico.com/news/stories/ 0312/74585.html (last visited July 9, 2012, 4:05 PM). 42. Id. 43. Id. 44. Id. 45. Id. 46. Foreign Counterfeit Prevention Act H.R. 4216 112th Congress (refd to Committee Mar. 20, 2012). 47. Id. 48. US Gov. Database of Federal Legislation, H.R. 4216112th Congress: Foreign Counterfeit Prevention Act, http://www.govtrack.us/congress/bills/112/hr4216 (last visited July 9, 2012 4:11 PM). 49. Nard, et. al., supra note 6 at 2.

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not expire (with exceptions).50 Trademarks are a product of state and federal law.51 However, federal law governs almost all pharmaceutical trademarks, because when a mark is used in interstate commerce, federal law governs it. Trademarks do not necessarily need to be registered, although registration does confer certain benefits that extend beyond the scope of this article. A trademark can be obtained through common law use.52 The primary policies behind trademark law are twofold. The first is to prevent consumer confusion and reduce consumer search costs.53 In the pharmaceutical field, more so with Over- the-Counter or OTC (OTC) purchases, this is especially important. Consumers come to know a brand by their trademark. If the brand is one a consumer identifies with, the mark begins to stand for quality. This is referred to as the good will of the mark owner- making a reliable, quality product. Due to the fact that mark owners know consumers will eventually associate their mark with quality, trademarks also promote a consistent level of quality among trademark owners.54 The next policy behind trademark law is encouraging competitors to develop their own trademarks and not free load.55 Trademark law prevents free loading and protects the good will of mark owners by creating causes of action for infringement, dilution, and the like. These two policies are exemplified in the first issue discussed below, whether generic drugs should be able to bear the same colors and shapes as the brand name drug. The next issue, genericide, addresses what happens, not when others try to use an established mark, but when a mark owner does not protect their own mark.

Generic Use of Pill Shape and Color

A brand name drug company manufactures its drug in a certain shape or color for a variety of reasons. It may be cost effective, easier to swallow, an advertising gimmick, or any number of other reasons, or maybe no reason at all.56 Generic drugs are sometimes manufactured in the same shape and color as the brand name drugs.57 The main issue that arises is whether generic drug companies can manufacture their generic drugs in the same shape and color as the brand name drug while avoiding trademark liability. If the color and/or shape of the drug is functional, or in the alternative is nonfunctional and has not acquired secondary meaning, then the color and/or shape of the drug is not protected as a trademark and generic manufacturers may manufacture the generic drug in the same color and/or shape unless they know or have reason to know that manufacturing facilitates passing off by a pharmacist.58 This section addresses each part of this rule and consequences stemming from it: when the shape and color of a drug is considered functional, when secondary mean50. Id. 51. Id. at 3. 52. Id. 53. Id. at 19. 54. Id. 55. Id. 56. See Smith, Kline & French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976 (S.D.N.Y. 1950); Smith, Kline & French Labs. v. Clark & Clark, 157 F.2d 725 (3d Cir. 1946). 57. Id. 58. See William R. Warner & Co. v. Eli Lilly & Co., 265 U.S. 526 (1924); Shire US Inc. v. Barr Labs. Inc., 329 F.3d 348 (3d Cir. 2003); Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631 (2d Cir. 1979); Smith, Kline & French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976 (S.D.N.Y. 1950); Smith, Kline & French Labs. v. Clark & Clark, 157 F.2d 725 (3d Cir. 1946).

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ing is acquired; when trade dress protection is achieved. Lastly, if a generic drug can use the same shape and color as the brand name, the question is posed as to whether the generic can be substituted for the brand name without raising palming off issues. Shape & Color as a Functional Feature The shape and color of a drug is a functional feature if it is the cheapest means of production or if it benefits patients in a way other than identifying the source.59 Functional features of a mark are not entitled to trademark protection with exceptions.60 In general, a feature of a mark is functional if it serves a purpose other than identifying the source of the product the mark is affixed to.61 Functional features are utilitarian in nature and are necessary for competitors to use to achieve commercial success.62 If the shape and color are deemed functional, they are not protected trademarks, and generic manufacturers can use them. One of the earliest cases involving generic drug substitution was Smith, Kline & French Labs. v. Clark & Clark. There, defendant Clark & Clark manufactured a generic drug almost identical to the brand name drug.63 The court held the shape, color, and score of the drug were functional because it was the natural shape and color (white) and coating required additional cost.64 In an earlier case, William R. Warner & Co. v. Eli Lilly & Co., chocolate as an additive to quinine was held to be functional in part because it gave the substance a distinctive color.65 In a later decision, Ives v. Darby the plaintiff, Ives, was a brand name manufacturer of a powder it sold in capsules.66 Two doses were sold in two colors: pale blue and, red and blue.67 Defendant generic manufacturer Darby purchased empty capsules of the same colors and put the same corresponding dosage in them.68 The district court held the capsule colors functional for three reasons. First, elderly patients, whom the drug mostly benefited, associated the appearance of a drug with its therapeutic effect. Second, patients taking multiple medications often co-mingled them in one container, and then relied solely on appearance to follow the instructions of the prescribing physician. Third, the color of a drug proved useful in aiding emergency room identification of the type of drug a patient overdosed on.69 In Shire US Inc. v. Barr Labs. Inc., Shire manufactured various doses of the drug Adderall in different colors.70 The generic manufacturer, Barr, made the same doses in the same colors.71 The court held that using different colors to signify different doses was highly beneficial to the type of people who ingested the drug, people diagnosed with ADHD.72 The court held the colors functional because they
59. See Shire US Inc. v. Barr Labs. Inc., 329 F.3d 348 (3d Cir. 2003); Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631 (2d Cir. 1979); Smith, Kline & French Labs. v. Clark & Clark, 157 F.2d 725 (3d Cir. 1946). 60. Ives, 601 F.2d at 643. 61. Id. 62. Id. 63. Clark, 157 F.2d at 727. 64. Id. at 730. 65. Warner, 265 U.S. at 529. 66. Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631, 634 (2d Cir. 1979), remanded 488 F.Supp. 394 (E.D.N.Y. 1980), revd on other grounds 638 F.2d 538 (2d Cir. 1981), revd 456 U.S. 844 (1982). 67. Id. 68. Id. at 635. 69. Ives Labs., Inc. v. Darby Drugs Co., Inc., 488 F.Supp. 394 (E.D.N.Y. 1980), revd 638 F.2d 538 (2d Cir. 1981), revd 456 U.S. 844 (1982). 70. Shire US Inc. v. Barr Labs. Inc., 329 F.3d 348,351 (3d Cir. 2003). 71. Id. 72. Id. at 354.

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aided patients and school nurses, who distribute the medication to several children throughout the day, in correctly identifying dosage strength.73 Additionally, at times, ADHD patients require frequent adjusting concerning the correct dosage amount.74 The court considered the testimony of a pharmacy, which opined that having the generic in the same color as the brand name increases patient acceptance of, and comfort with, generic pharmaceuticals.75 On the other end of the spectrum is Smith, Kline &French Labs. v. Heart Pharm. Corp., where the brand or innovator manufacturer expenditures amounted to approximately $900,000 promoting and stocking its revamped pills.76 The new pills had a distinctive heart shape, a score in the middle, and originated in two distinctive colors based on the dose-pinkish brown and orange.77 In this case, the court held the score was functional as a bevel that aided in breaking the pill for a lower dose; however, the shape and color of the pill were not functional.78 Unlike the above cases, the generic manufacturer was enjoined from using them. The reasoning behind the courts holding was that the distinctive shape and color served no other purpose except to identify the brand manufacturer as the source of the product.79 These types of cases typically arise when the brand name manufacturer institutes a legal proceeding to enjoin the generic manufacturers use of the same shape and colors. The aforementioned cases depict that shape and color of a drug will be held functional, and open for generic use, when they do more than identify the source of the product. The history of the law in this area has been consistent. However, Darby and Shire suggest a presumption of functionality is developing. The reasoning in those cases is very generalcolor is functional in identifying overdose, differentiating doses, and patient/pharmacy recognition of the generic product.80 These justifications could be imposed on almost any set of facts. Additionally, Shire points out that the Supreme Court supports the conclusion of functionality reached in their opinion and in Ives.81 The Supreme Courts most recent trade dress decisions, albeit not regarding pharmaceuticals, caution against over-extension of trade dress protection.82 Shape & Color as Trade Dress Shape and color are protected as trade dress, and unavailable for generic use if they are non-functional and have acquired secondary meaning.83 Trade dress encompasses product packaging and product design and serves to identify a products source.84 The shape and colors of a pill are considered product design.85 The fact that the pill is ingested does not impact.86
73. Id. 74. Id. at 355. 75. Id. 76. Smith, Kline &French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976, 977 (S.D.N.Y. 1950). 77. Id. 78. Id. 79. Id. See also Ciba-Geigy Corp v. Bolar Pharm. Co., 547 F.Supp. 1095 (D. N.J. 1982) where shape and size of drug was held non-functional because no medical or business considerations compelled the choice; and Shire, 329 F.3d at 358 where competitors may be free to copy the color of a pill where the color identifies the kind of medicine the pill is, i.e. a blood thinner. 80. Shire, 329 F.3d at 354; Ives, 488 F.Supp. at 396. 81. Id. at 358. 82. Id. 83. Ives, 601 F.2d at 642-643; Norwich, 271 F.2d at 571; Heart, 90 F.Supp. at 977. 84. Shire, 329 F.3d at 353. 85. Lanham Trade-Mark Act 43(a), 15 USCA1125(a). 86. Id.

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Product packaging is inherently distinctive; however, product design is not.87 Inherently distinctive applies if it was selected by the manufacturer to distinguish its product from another manufacturer.88 There is no automatic presumption of distinctiveness for product design because it can be functional.89 However, if it is not functional, product design can acquire distinctiveness through secondary meaning.90 Secondary meaning establishes that there is sufficient consumer recognition of the mark or dress as a source indicator that the source meaning dominates the design or descriptive meaning.91 This is a complex aspect to prove in trademark law.92 Proof of secondary meaning occurs through consumer testimony, surveys, sales figures, as well as circumstantial evidence.93 In the Heart decision where colors and heart shape of pills were found non-functional, the court found secondary meaning.94 Druggists, physicians, students of pharmacy, wholesale distributors, and even laymen, recognize plaintiffs tablets by their combination of shape and colors.95 The case hinged on recognition.96 Yet, in Norwich Pharmacal Co., where defendant used the same pink color for its generic liquid medicine that plaintiff used for its brand name, the court did not grant an injunction.97 Although the color was non-functional it had not acquired secondary meaning as a source indicator and consequently was not entitled to trade dress protection.98 Ives detailed that, imitation of physical details and designs of a competitors product may be actionable, if the particular features imitated are non-functional and have acquired secondary meaning.99 The court examined one of the forms of circumstantial evidence used to show secondary meaning, copying-in-fact. The argument is that defendants copying, in itself, constitutes evidence of secondary meaning because they were trying to trade on the good will the brand built.100 Good will would not exist if consumers did not associate the pill design with the brand manufacturer. One argument a defendant may postulate in these types of cases is that granting protection to shapes and colors creates monopolies.101 It is argued that a generic company would not have color availability.102 This argument was found by multiple courts to be unpersuasive because, along with primary colors, endless color combinations are available.103 Consumers do not receive prescription pills in wholesale packaging; therefore, containers, shape, color, and stamps or markings on pills are the only means of product identification by manufacturers to consumers.104
87. See Two Pesos, Inc. v. Taco Cabana, Inc., 505 U.S. 763 (1992); Wal-Mart Stores, Inc. v. Samara Brothers, Inc., 529 U.S. 205 (2000). 88. Wal-Mart, 529 U.S. at 209. 89. Id. 90. Id. 91. Id. See also Shire, 329 F.3d at 353 where trade dress protection only extends to incidental, arbitrary, or ornamental product features which identify products source. 92. Nard et. al., supra note 6, at 35. 93. Id. 94. Heart, 90 F.Supp. at 977. 95. Id. 96. Id. at 976. 97. Norwich Pharmacal Co. v. Sterling Drug, Inc., 271 F.2d 569 (2d Cir. 1959), cert. denied, 362 U.S. 919 (1960). 98. Id. at 571. 99. Ives, 601 F.2d at 642-643. 100. Id. at 643. 101. Morrissey v. Proctor & Gamble Co., 379 F.2d 675 (1st Cir. 1967). 102. Id. 103. Id.; Ives, 601 F.2d at 643. 104. Ives, 601 F.2d at 643.

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The shape and color of a pill are considered product design and product design is a type of trade dress protected by trademark law. Product design is not inherently distinctive, as product packaging is, yet can acquire distinctiveness through secondary meaning. Some courts have in essence rewarded brand name manufacturers who create good will with consumers by granting protection to non-functional pill designs that acquired secondary meaning. Generic Substitution of Pioneer or Brand Name Product Regardless of whether a brand drugs shape and colors are functional, or have acquired secondary meaning, liability might arise for use of the identical shape and color(s) if use results in passing off.105 Passing off is an unfair competition claim encompassing a variety of commercial conduct that is likely to cause confusion about source.106 The cases discussed below involve generic substituting in place of brand products when brand pharmaceuticals were ordered or selling generic drugs yet representing it as brand. This is also termed palming off.107 When a physician writes a prescription either: 1) do not substitute or 2) substitution allowed is checked. This determines how the pharmacist fills the prescription.108 The decision of William R. Warner & Co. v. Eli Lilly & Co., provides an example of directly passing off where generics were sold yet misrepresented as brand.109 Salesmen for Quin Coco, the generic of Coco Quinine, informed pharmacists the generic could be substituted for the brand without danger of detection.110 They also pointed out that doing so would enhance profits because the generic was sold to pharmacists at a lower price; however in representing it to customers as the brand, pharmacists could sell it at a higher price.111 Pharmacists did engage in this practice.112 The court held this was direct inducement.113 Ultimately, generic packaging required labeling which clearly distinguished generic from brand and affirmatively stated that generics could not be sold as brand or used to fill orders that required brand only.114 The court reasoned that, although it was lawful for defendant to imitate the brand goods, they must sell them as their own.115 Generic manufacturers cannot palm their goods off to the public as the goods of their brand competitor because the brand manufacturer is entitled to the good will they created and the public is entitled to distinguish between goods.116 The Heart decision was a case of indirectly passing off.117 Defendants Heart Pharmaceutical and others used pamphlets to advertise the similarity of the generic to the brand and ensured color guaranteed.118 Pharmacists, on several occasions, filled prescriptions that required brand with generic.119 The court found that Heart did pass off the product as a brand and opined, The wrong is in designedly en105. See William R. Warner & Co. v. Eli Lilly & Co., 265 U.S. 526 (1924); Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631 (2d Cir. 1979); Upjohn Co. v. Schwartz, 246 F.2d 254 (2d Cir. 1957); Smith, Kline & French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976 (S.D.N.Y. 1950). 106. Nard et. al., supra note 6, at 193. 107. Id. at 194. 108. William R. Warner & Co. v. Eli Lilly & Co., 265 U.S. 526, 530 (1924). 109. Id. 110. Id. 111. Id. 112. Id. 113. Id. at 531. 114. Id. at 532-533. 115. Id. at 531. 116. Id. 117. Smith, Kline &French Labs. v. Heart Pharm. Corp., 90 F.Supp. 976 (S.D.N.Y. 1950). 118. Id. at 977. 119. Id. at 978.

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abling the dealers to palm off the preparation as that of plaintiff.120 The court reasoned that the possibility of substitution was presented to the pharmacists by the pamphlets.121 Similar to the court in Warner the court here also admonished defendants for trying to avail themselves of the favorable reputation that plaintiffs painstakingly established.122 Subsequently, Upjohn Co. v. Schwartz, 246 F.2d 254 (2d Cir. 1957), presented nearly an identical factual situation. Defendant Schwartz distributed cards to pharmacists listing plaintiff Upjohn Companys brand drugs and alongside the comparable generic Schwartz made.123 There was no proof the pharmacists actually substituted the drugs, and Upjohn Company had not established secondary meaning, nonetheless the court held, as in Heart, this was indirectly passing off.124 The court enjoined Schwartz from indirectly representing that their product may be substituted for Upjohn Companys when the brand is prescribed. They also required a notice be attached to the pill bottles clarifying the contents are not to be sold or dispensed as Upjohn Companys brand product.125 In Ives v. Darby, where capsule colors were deemed functional, defendant Darby promoted their generic as comparable to the brand, specifically referring to the color.126 There were numerous instances of improper substitution by pharmacists.127 The court held the colors made substitution easy and, since Darby could have used alternate colors and did not, the court admonished them for deliberately imitating the brand name.128 Nearly all passing off cases cited Hostetter Co. v. Brueggeman-Reinert Distilling Co., where the court stated, One who induces another to commit a fraud and furnishes the means of consummating it is equally guilty and liable for the injury.129 After the early cases the Lanham Act amended its section on contributory infringement to include this occurrence, stating in relevant part manufacturer [is] liable if he suggested, even if only by implication, that a retailer fill a bottle with the generic capsules and apply brand mark to the label, or continued to sell capsules containing the generic drug which facilitated this to a druggist whom he knew or had reasons to know was engaging in the practices just described.130 A common thread in these cases is to consider the good will and reputation of the brand manufacturer. The court protects those assets, especially when there is evidence that the generic manufacturer deliberately imitated or induced substitution. The passing off unfair competition cause of action prevents that ramification from becoming reality by not allowing substitution unless the generic label has an affirmative disclaimer and the prescribing physician explicitly sanctions.

Trademark Genericide
Trademarks have the potential to last eternally if used continuously, in commerce, and in a source-identifying manner in connection with the same product(s).131
120. Id. 121. Id. 122. Id. 123. Upjohn, 246 F.2d at 256. 124. Id. at 258. 125. Id. at 259. 126. Ives Labs., Inc. v. Darby Drug Co., Inc., 601 F.2d 631, 636 (2d Cir. 1979), remanded 488 F.Supp. 394 (E.D.N.Y. 1980), revd on other grounds 638 F.2d 538 (2d Cir. 1981), revd 456 U.S. 844 (1982). 127. Id. 128. Id. 129. Hostetter Co. v. Brueggeman-Reinert Distilling Co., 46 Fed. 188, 189 (C.C.E.D. Mo 1891). 130. 15 U.S.C.A. 1114. 131. Nard et. al., supra note 6, at 19.

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Genericide is the death knell of a trademark. It occurs when there is such general extensive use of the trademark by the consuming public that the trademark no longer serves to identify the source of the product; rather it identifies the product itself.132 The mark becomes a generic word for the product. Genericide is not a victimless occurrence. The company that falls victim to it developed such good will, and marketed so well, that their name became synonymous with the product. However, in essence the exclusive right to use the trademark is lost. In the landmark decision of Bayer Co., Inc., v. United Drug Co., the Bayer company forfeited the right to the exclusive use of the trademark Aspirin to genericide.133 Bayer instituted legal proceedings against United Drug Company to enjoin them from using their trade name Aspirin.134 United had begun using the trade name after Bayers patent for acetyl salicylic acid, the drug associated with Aspirin, expired.135 The court, in an opinion written by Learned Hand, held that Aspirin had become synonymous with the drug itself and thus belonged to the public domain for all to use.136 The test for genericide is what the primary significance of the word is to the purchasing public.137 The court acknowledged that chemists, physicians, and retail druggists associated Aspirin with the source of the drug, Bayer.138 The general consuming public, however, did not. They used the word interchangeably with the name of the chemical compound in requesting it from their physicians. Additionally, the court pointed out that when Bayer began bottling tablets after it made the switch from powder, the bottles were labeled Aspirin and had no indication of the manufacturer from which they came.139 The bottles were modified to include Bayer several years later, however, the court determined the term had already passed into the public domain.140 This was the second time genericide struck Bayer. A lesser-known instance that occurred around the same time was when Bayer lost its trademark for heroin141. Heroin was originally marketed as an OTC cough suppressant. Genericide remains a risk for brands today. However, with the vast expansion of technology since the times of Bayer genericide, it is less of a concern. Companies are aware when their trademarks are crossing from ubiquitous to generic, as Bayer was; however, now there are advertising campaigns to prevent it. Brands resembling Tylenol and Band-Aid still maintain their trademarks despite widespread association of the term with the product. For example, Band-Aid changed its theme song from, Im stuck on Band-Aid to Im stuck on Band-Aid brand.142 The court in Bayer placed emphasis on consumers using Aspirin as the word for the drug because they were not educated enough to pronounce or remember the compound name.143 Perhaps this reasoning would fail today due to consumer sophistication.
132. See Kellogg Co. v. Natl Biscuit Co., 305 U.S. 111 (1938) where brand name Shredded Wheat became generic name for a type of cereal. 133. Bayer Co., Inc., v. United Drug Co., 272 F. 505 (S.D.N.Y. 1921). 134. Id. at 511. 135. Id. 136. Id. at 512. 137. Id. at 510. 138. Id. 139. Id. at 510-511. 140. Id. at 512. 141. Michelle Maltais, Apples iPad could become the next heroin (Apr. 9, 2012), http://articles. latimes.com/2012/apr/09/business/la-fi-tn-ipad-name-becoming-generic-20120409 (last visited July 9, 2012 4:20 PM). 142. The Associated Press, Brand Names: Will iPad become generic word for tablet? (Apr. 8, 2012), http://usatoday30.usatoday.com/money/companies/story/2012-04-07/apple-ipad-generic-name/ 54110024/1 (last visited Oct. 1, 2012 2:00PM). 143. Bayer, 272 F. at 511

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CONCLUSION
Intellectual property permeates pharmaceuticals, protecting the inside, in between, and outside. Patents protect chemical compounds, trademarks protect capsules, and copyrights protect labeling. Intellectual property encourages creativity, even in a science-dominated industry such as pharmaceuticals. However, the mandates of the United States Federal Food, Drug and Cosmetic Act in terms of protecting public health and consumer safety would usually usurp the goals of intellectual property to protect company good will and rights. This point was exemplified in Watson where generic labeling was required to copy brand labeling verbatim in order for FDA approval for eventual marketplace entry. Functionality is presumed, at the expense of brand good will, to make generics uniform with brand, ensuring consumer comfort with the use of generic pharmaceuticals. Of course, the two fields of drug law regulation and intellectual property protection are not constantly at odds, and an interpretation that furthers the goals of each can be achieved. If trade dress is non-functional and consumers identify it with the brand, protection is granted, and safety and reliability will ensue. Deliberate imitation or inducement, without the express authorization by a prescribing physician and an affirmative disclaimer asserting generic status, is not permitted. Ubiquitous trademarks vanish to expand the public domain and avoid consumer confusion. Although the two fields clash, and the Federal Food and Drug mandates may win the day, copyright and trademark law remains integral in the pharmaceutical industry. Trademark issues remain critical regulating functions, securing the identity of brand names consumers have come to trust, and protecting the products they create.