Changing the Landscape for Device
Manufacturers: Medical Device User Fee
By Perry J. Viscounty, J.D., Amos E. Hartston, J.D., and Heather L. Mayer, J.D.
intellectual property law: copyrights and and attorneys’ fees in any such action.3 important protection for original works In general, a copyright notice consists of of authorship, and trademarks allow owners to distinguish their products and “Copr.,” or “” followed by the date of publication and the name of thecopyright holder. Use of a copyright Copyright
notice is optional for works created afterMarch 1, 1989. Notice is highly Reprinted from
works of authorship” that are “fixed” in protected by copyright, (2) identifies the copyright owner, (3) shows the first year literary, dramatic, musical, and artistic works, as well as to software, brochures, Guide to Intellectual
August, 2005
idea, only the expression of an idea.
Copyright Protection, Notice,
the following items to the US CopyrightOffice: (1) a properly completed and Registration
created after 1978 extends for the life of registration is necessary to file a lawsuit Latham & Watkins operates as a limited liability partnership worldwide with an affiliate in the United Kingdomand Italy, where the practice is conducted through an affiliated multinational partnership. If you wish to update your contact details or customize the information you receive from Latham & Watkins,please visit www.lw.com/resource/globalcontacts to subscribe to our global client mailings program.
This article is reprinted with permission from the August 2005 issue of BioPharm International. Copyright 2005 Latham & Watkins | Article Reprint
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ordered or commissioned anddesignated in writing as a work made for hire—in which case the copyright is (P2P) file-sharing software on the rights such as music in the form of MP3 files.
entertainment, and other businesses.
The most important steps for a copyrightowner to take in protecting copyrighted What Does Copyright
Protection Entail?
registration and providing copyrightnotice. Taking these steps will deter following six exclusive rights: the right investment in the copyrighted works.
to (1) reproduce the work, (2) preparederivative works based upon the work, Trademarks
(3) distribute copies or phonorecords ofthe work to the public by sale or other device, or other designation that is used others. Within certain limits, trademarks can consist of almost any type ofdistinctive matter including a word or Copyright Infringement
phrase, personal name, symbol or logo,design, slogan, product shape, color, or colors, flavors, and shapes of products or registered prior to the infringement),6 or quality, and to protect the public fromconfusion. Trademarks often represent a Latham & Watkins | Article Reprint
not distinguish the source of the goodsand because fairness requires that such Governing Law and
Establishing Trademark
on a dual system of federal and statelaws. The basic federal trademark subject to a pending application, and, to the extent possible, unregistered andforeign marks. Only trademarks that are distinctive areeligible for protection. Distinctiveness means the ability to identify the product i.e., the ability to serve as a source exists in varying degrees. The scale of a trademark’s distinctiveness, from most to constructive notice to others of one’s least distinctive, is described in terms of words used in unexpected ways (e.g., registration, one must apply by filing an (4) descriptive—marks that describe the the product’s characteristics (e.g., Japan mark.15 If the application is accepted as Tires Plus), and (5) generic—words that similar to an existing trademark, it will refer to a class of objects (e.g., aspirin, by the granting of the registration. If no certificate of registration will be issued.16 distinctiveness acquired in commerce,commonly referred to as “secondary Latham & Watkins | Article Reprint
Trademark Infringement
References And Notes
The Copyright Clause of the US Constitution provides Congress with authority “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” US Const Art I, The following works are generally not entitled to copyright protection: titles, names, short phrases or slogans, mere variations of typo- graphic ornamentation, lettering or coloring, Courts have identified several factors as and mere listings of ingredients or contents.
Before 1978, federal copyright rights were generally secured by the act of publication with notice of copyright, assuming compliance with all other relevant statutory conditions.
services, (4) evidence of actual confusion While registration is not required, registration has a number of statutory advantages.
that proprietary materials can be redacted and trade secrets protected under certain facts in a given case that is dispositive.18 was willful, a court may increase the award For drug labels, copyright protection may be Trends and Tips
require generic drug sellers to use the label approved by the FDA; accordingly, copyright liability does not attach. See SmithKline Beecham Consumer Healthcare, LP v Watson Pharmaceuticals, Inc, 211 F3d 21 (2d Cir The Lanham Act is the common name for the Trademark Act of 1946, as amended, 15 USC Federal trademark registration lasts for 10 years subject to indefinite 10-year renewals.
States vary as to the terms of trademark 10 Through extensive use and advertising, such and understanding one’s market, one’s terms may take on a “secondary” meaning as target customers, and one’s competitors, 11 Similarly, product features that are functional are not subject to protection as a trademark.
Functional features are protectable, if at all, Trade Commission (FTC) rules, is critical to developing a trademark andadvertising strategy. Latham & Watkins | Article Reprint
12 The ® symbol can be used only with registered preparations”); 3A Louis Altman, Callman on trademarks. The TM symbol can be used with unregistered marks. Use of these symbols is Monopolies §21:10 & nn 121-132 (4th ed 13 Federal registration is critical to any program 19 Examples of recent infringement actions to protect the rights of a trademark owner.
Without it, a third party may obtain federal following: Trovan Limited v Pfizer Inc, 107 registration of the mark, thereby significantly limiting one’s rights. Federal registration also electronic tracking devices for veterinarians gives rise to several important statutory sued Pfizer for marketing antibiotics under its name “Trovan”; held consumer confusion establishing nationwide priority to use the unlikely given goods unrelated, different marketing channels, and purchaser care); 14 The technical requirements of application and Kos Pharmaceuticals, Inc v Andrx Corp, 369 renewal are set forth in Section 1(a) of the F3d 700 (3d Cir 2004) (injunction ordered in Lanham Act, 15 USC §1051, et seq, and in: action by owner of mark “Advicor” used for anticholesterol drug against competitor’s use Examination Procedures (TMEP). 3rd ed.
of “Altocor” mark for similar drug); Eli Lilly & Co v Natural Answers, Inc, 233 F3d 456 (7th Cir 2000) (injunction ordered against use of mark “Herbrozac” for a herbal “mood 15 Federal applications for registration under elevator” due to likelihood of confusion and certain circumstances may be available based dilution of “Prozac” mark); Pfizer, Inc v Y2K upon intent to use a mark, rather than actual Shipping & Trading, Inc, 70 USPQ2d 1592 use of the mark in commerce, which can be (EDNY 2004) (holding mark “Triagra” for important for priority and notice purposes.
“herbs for erectile dysfunction” sold over the 16 Drug names face additional requirements, Internet infringed Pfizer’s “Viagra” mark).
17 Other important causes of action include trademark dilution for famous marks, false Perry J. Viscounty, J.D., is a partner and advertising claims under federal and state global co-chair of the Intellectual Additionally, pharmaceutical manufacturers practice of Latham & Watkins LLP, 650 Town Center Drive, 20th Floor, Costa Mesa, California 92626, 714.755.8288, advertising of drugs, dietary supplements, 18 There have been suggestions that greater care should be taken to avoid confusion in Amos E. Hartston, J.D., is a litigation connection with medication and pharmaceuti- associate at Latham & Watkins LLP, 633 West Fifth Street, Suite 4000, Los consequences of confusion. See Morgenstern Angeles, California 90071, 213.891.8315, Chem Co v GD Searle & Co, 253 F2d 390, 393 (3d Cir 1958) (“In the field of medical products, it is particularly important that great care be taken to prevent any possibility of confusion Heather L. Mayer, J.D., is a litigation in the use of trade-marks” [citations omitted]).
associate at Latham & Watkins LLP, See also Syntex Labs, Inc v Norwich 633 West Fifth Street, Suite 4000, Los Pharmacal Co, 437 F2d 566, 569 (2d Cir 1971) Angeles, California 90071, 213.891.7869, (confusion of drugs could result in physical harm to the consuming public, “[h]ence a stricter standard in order to prevent the likeli- hood of confusion seems desirable”); 5 J and Unfair Competition §23:32 (4th ed 2004) (“proper to require lesser quantum of proof of confusing similarity for drugs and medicinal Los Angeles
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