OUTLINE AND BIBLIOGRAPHY
CHARLES E. LYON
Page 1 of 3
“PHARMACEUTICAL TRADE DRESS – CONSUMER PROTECTION OR
CONSUMER CONFUSION?”
Outline
The trade dress (size, shape and color) of branded prescription drugs products (Viagra,
Prilosec, Nexium, etc.) is being used increasingly by big pharma to block competition
from generics after patent expiration. Generics want to use the same trade dress as the
branded drug and big pharma will do all it can to stop them. The recent case law in the
US (and in Canada) has swayed between favoring the two extremes.
In Part 1, I will describe the basics of trade dress law in the US and then specific issues
that have been raised in the context of prescription drug products (with some
comparisons with the Canadian approach):
a. Trade dress law in general:
i.
ii.
iii.
iv.
v.
§ 43(a) of Lanham Act
Product packaging v. Product design
Functionality
Secondary meaning
Likelihood of confusion
b. Trade dress law as applied to prescription drug products focusing on the 3rd
Circuit (where most big pharmas have their HQs):
i.
ii.
iii.
iv.
Product packaging v. Product design (is it even discussed by courts?)
Functionality esp. in context of color – safety, compliance/acceptance
of generics by public (i.e., break the deception/stigma)
Secondary meaning – promotes advertising to public that pushes prices
even higher?
Likelihood of confusion – public as consumer vs. doctor/pharmacy
c. Comparison with Canadian law re: prescription drugs
In Part 2, I will comment on whether it is appropriate to give strong trade dress protection
for prescription drugs. In particular I will note the following fundamental issues that (I
think) suggest that they should not be treated like regular consumer products:
a. If trademarks are supposed to ensure that the consumer can associate a given
product with quality (via a single source) then this assumes that the consumer
can actually judge the quality of the trademarked product. I would argue that
regular consumers cannot judge the “quality” of prescription drugs in the
same way that they can judge the quality of a shoe. Consider the “placebo
effect” or the fact that the public is prepared to pay twice as much for a brand
drug even after the generic is on the market. A brand name’s ability to keep
OUTLINE AND BIBLIOGRAPHY
CHARLES E. LYON
Page 2 of 3
the trade dress of generics as different as possible simply perpetuates what I
would argue is consumer deception and thus contrary to traditional trademark
policy.
b. The FDA regulates generic drugs to ensure that they are equivalent to the
branded drug, i.e., the two products are essentially the same. The situation is
therefore different from one involving a new shoe company making a shoe
that looks just like a Nike shoe from the outside but is (a) of lower quality or
(b) different internally. In addition, the FDA is continuously monitoring for
issues that would require the generic to be pulled. There is no such regulatory
watchdog in the shoe industry.
c. When a consumer buys a drug he or she does not act alone. A doctor, a
pharmacist and possibly an insurer are also involved and may actually make
all of the decisions for the consumer. There are no such “external influences”
in the shoe buying scenario. Also the consumer never actually sees the trade
dress of the drug product before buying it at the pharmacy – isn’t this
significant vs. shoes that are on display and optionally tried on before
purchase?
d. The owners of brand drugs will typically hold a patent on the active ingredient
that will exclude ALL competing products in the area for a considerable
amount of time. In contrast, many consumer products are either not patented
or patented in a way that does not create such a total monopoly in a given
area. Thus, even if Nike acquired a patent on some new type of sole this
would not remove ALL competition from the running shoe market. Generics
on the other hand are up against a drug that had a 10-15 year monopoly in the
competitive field.
Bibliography:
US Case Law
Inwood Laboratories, Inc. v. Ives Laboratories, Inc., 456 U.S. 844 (1982)
Two Pesos, Inc. v. Taco Cabana, Inc., 505 U.S. 763 (1992)
Qualitex Co. v. Jacobson Prods. Co., 514 U.S. 159 (1995)
Wal-Mart Stores, Inc. v. Samara Bros., Inc., 529 U.S. 205 (2000)
TrafFix Devices, Inc. v. Marketing Displays, Inc., 532 U.S. 23 (2001)
Smith, Kline & French Laboratories v. Clark & Clark, 157 F.2d 725 (3d Cir.1946)
SK&F, Co. v. Premo Pharmaceutical Laboratories, Inc., 625 F.2d 1055 (3d Cir.1980)
American Home Prods. Corp. v. Chelsea Labs., Inc., 722 F.2d 730 (3d Cir.1983)
Ciba-Geigy Corp. v. Bolar Pharm. Co., 719 F.2d 56 (3d Cir.1983)
Ciba-Geigy Corp. v. Bolar Pharm. Co., 747 F.2d 844 (3d Cir.1984)
American Home Products Corp. v. Barr Laboratories, Inc., 834 F.2d 368 (3d Cir.1987)
Shire US Inc. v. Barr Laboratories, Inc., 329 F.3d 348, (3d Cir. 2003)
OUTLINE AND BIBLIOGRAPHY
CHARLES E. LYON
Page 3 of 3
Foreign Case Law
Ciba-Geigy Canada Ltd. v. Novopharm Ltd., [1992] 3 S.C.R. 120 (CA)
Eli Lilly & Co. v. Novopharm Ltd., [2000] FCJ No 2090 (CA) (QL)
Secondary Sources
Darrel C. Karl, “Look-alike” Capsules, Generic Drug Substitution, and the Lanham Act:
The Elusive Contributory Infringement Standard of Inwood Laboratories, Inc. v. Ives
Laboratories, Inc., 32 Cath. U.L. Rev. 345 (1982)
Karin S. Schwartz, “It Had to be Hue: The Meaning of Color ‘Pure and Simple’”, 6
Fordham Intell. Prop. Media & Ent. L.J. 59 (1995)
Laura R. Visintine, The Registrability of Color Per se as a Trademark After Qualitex Co.
v. Jacobson Products Co., 40 St. Louis L.J. 611 (1996)
David B. Tongg, “The Qualitex Quandary: Was Trademark Protection for Color Per Se
Clearly Resolved?,” 18 Hawaii L. Rev. 445 (1996)
Ronald E. Dimock, Intellectual Property Disputes: Resolution and Remedies, Chapter 7.
Pharmaceuticals
Aaron M. Pile, What's in Your Bottle?: Shire US Inc. v. Barr Laboratories Inc. and Its
Effect on Prescription Drug Trade Dress Protection in the Third Circuit, 8 PGH J. Tech.
L. & Pol'y 2 (2004)
1 Food and Drug Admin. § 15:10 (2005) - James T. O'Reilly, Chapter 15. Drug
Economic and Advertising Issues § 15:10. FDA and drug advertising: Overview and
remedies