CME: The Basics

Alliance for Continuing Medical Education

July 27, 28 2001, Chicago, Illinois

Current Issues in Intellectual Property Law for CME Providers

Reference Materials

Rick Morris, J.D. LL.M.


Part 1 – Copyright Basics

Part 2 - Internet Issues

Part 3 – Good Practices

Copyright arises when a work of authorship in any tangible medium of expression is fixed in a tangible form. This can be by writing, recording, digital storage or other means. Ideas, procedures, processes, systems, methods of operations, etc. are not copyrightable. 17 U.S.C.S § 102.

Explanation: In order to be copyrighted, lecture or presentation must be fixed in a tangible form. This would usually happen via recording, preparation of lecture notes, etc.

Ideas are not copyrightable; however, expressions of ideas are copyrightable. For example, the idea that a medical procedure might be effective is not subject to copyright. However, the lectures, medical journal articles, and other communications explaining the procedure are copyrightable. Procedures, processes, systems, etc., to the extent that they meet the legal requirements, may be patentable.


Once something is "copyrighted," what rights does a copyright owner have? The rights are substantial:

§ 106 Exclusive Rights in Copyrighted works

Subject to sections 107 through 120, the owner of copyright under this title has

the exclusive rights to do and to authorize rights to do and to authorize any of

the following:

(1) to reproduce the copyrighted work in copies or phonorecords;

(2) to prepare derivative works based upon the copyrighted work;

(3) to distribute copies or phonorecords of the copyrighted work to the public by the sale or other transfer of ownership, or by rental,

lease, or lending;

(4) in the case of literary, musical, dramatic, and choreographic works, pantomimes, and motion pictures and other audiovisual works, to perform the copyrighted work publicly; and

(5) in the case of literary, musical, dramatic, and choreographic works, pantomimes, and pictorial, graphic, or sculptural works, including

the individual images of a motion picture or other audiovisual work, to

display the copyrighted work publicly; and

(6) in the case of sound recordings, to perform the copyrighted

work publicly by means of a digital audio transmission. 17U.S.C.S §106.

Who Owns a Copyright?

A copyright is owned by the author of the work. If there is more than one author, then the copyright is owned jointly by the authors.

If the work is created in an employer-employee relationship, it will usually be a "work-made-for-hire." Freelancers normally own the copyright in the material they create unless there is a written agreement that the work shall be a "work-made-for-hire." The agreement with the publisher or purchaser usually either details the rights purchased or that both parties agree that the work was made for hire, or else the contract of sale includes an outright written transfer of copyright.

Examples: An employee of a CME organization creates the flyer for a CME event – the copyright is owned by the CME organization and not the employee.

A medical doctor is a considered a "freelancer"(ie non-employee) and creates a writing for presentation at a CME event – the copyright vests in the doctor-author. The author can grant whatever rights they may wish to the CME organization.

The doctor-author is one of several co-authors of a paper – you only need permission of the one doctor, any of the co-authors can give permission for all.

The CME organization wants to own a course of study created by a non-employee author. The copyright is owned by the author and the CME organization should require a written transfer of copyright at the time they purchase the course materials.

The CME organization specially commissions a work for use in CME materials. This is a good opportunity to use the "work-made-for-hire" clause. The CME organization will usually state in the written contract that this is a "work-made-for-hire" and will then own all rights in the work.

The CME organization publishes a book on the topic of the conference with the permission of all of the authors who have work included as chapters in the book – the book itself is copyright of the CME organization, but the underlying chapters usually still remain the property of the authors.




Duration of Copyright

Since enactment of the Sonny Bono Copyright Term Extension Act of 1998, copyright terms have been extended to lengths that make it unlikely that you will ever be dealing with uncopyrighted materials. The duration of the copyright depends on whom the original creation is attributed to, whether the copyright was properly maintained, and whether the work was published.

Individual author: Life of the author plus 70 years, if joint authors, life of the last living author plus 70 years.

A "work made for hire," or an unpublished work: 95 years after publication, or if unpublished, 120 years.

A "work made for hire" is usually a work that is created pursuant to one’s normal job and within the scope of employment, or made subject to a clause on collaborative works, or else agreed to in writing that it will be a "work made for hire."

What happens when a copyright expires? It falls into the "public domain," and all are free to use it. The 1909 Act had different terms for Copyright, as did the 1976 Act until several modifications. Determining whether something is in the public domain usually requires a detailed record search. As a practical matter, assume that anything created after 1989 (the date that the U.S. conformed its law to international conventions) is copyrighted now and for a long time going forward. If you have material from before 1989, you should consult a lawyer if you need a definite determination of its copyright status.

Works of the U.S. government are not copyrighted and are generally free for use. 17 U.S.C. §105. Be careful, however, because studies performed for the U.S. government may be copyright of the research institution that prepared the document.


Limitations on Copyright

There are a number of limitations on copyright, including provisions for libraries, for direct classroom teaching by a nonprofit educational institution, for cable companies under limited circumstances, for ephemeral recordings, etc. An important limitation for your consideration is Section 107, Fair Use.

Fair use is defined as follows in the Act:

§ 107 Limitations on exclusive rights: Fair use

Notwithstanding the provisions of Sections 106 and 106A, the fair use of a copyrighted work, including such use by reproduction in copies or phonorecords or by any other means specified by that section, for purposes such as criticism, comment, news reporting, teaching (including

multiple copies for classroom use), scholarship, or research, is not an

infringement of copyright. In determining whether the use made of a work in

any particular case is a fair use the factors to be considered include -

1) the purpose and character of the use, including whether such use is of

a commercial nature or is for nonprofit educational purposes;

2) the nature of the copyrighted work;

3) the amount and substantiality of the portion used in relation to the

copyrighted work as a whole; and

4) the effect of the use upon the potential market for or value of the

copyrighted work.

The fact that a work is unpublished shall not itself bar a finding of fair use if such a finding is made upon consideration of all of the above factors. 17 U.S.C.S. §107.

Explanation and commentary: Fair use is what permits the absolute of copyrights to be moderated. If absolute copyright were enforceable, creativity and intellectual growth would be stifled. The ability to use small amounts of another’s work is what scholarship and news reporting is all about. Although all four factors must be considered in each case, most often the amount of use and the potential effect on the marketplace for the work seem to be decisional factors. In most cases a small use (50 words, a part of a page, a "tiny portion of a book,") is considered fair use. A large use (92% of an article, more than half of a manuscript, extensive quoting) has often been held to not be fair use.

Even so, relatively tiny amounts of works have also been held to be not fair use because of the other factors. The use of only bars of a song was not fair use as the use of the most identifiable part of the song ("the hook") affect the marketplace for the song.

Fair use is what permits scholarship to thrive. It is the ability to quote prior work and prior art that lets scholars and researchers put their work and ideas in context. Further, fair use permits public discussion of copyrighted material – it permits journalism to function, and commentary and criticism to use portions of copyrighted material.

Derivative Works

Section 101 of the Act defines a derivative work as:

…a work based on one or more preexisting works, such as a translation, musical arrangement, dramatization, fictionalization, motion picture version, sound recording, art reproduction, abridgement, condensation, or any other form in which a work may be recast, transformed, or adapted. A work consisting of editorial revisions, annotations, elaborations, or other modifications which, as a whole, represent an original work of authorship, is a 'derivative work'.

Creation of a derivative work requires the permission of the author of the underlying work. For example, a movie studio will get permission from a book author to transform a novel into a motion picture.

If a re-use of another’s work goes too far (beyond fair use), it might be a copyright infringement. If it goes too far and is transformative in nature (ie from live presentation to an annotated web transcript), it could also be an infringing derivative work.

CME organizations themselves may want to create derivative works – CD-ROMs, books of "conference proceedings," "CME on the web" sessions, etc. In that case, the CME provider should get permission from the author to create the derivative work.

Some case decisions on fair use: Horgan v. Macmillian, Inc., 789 F.2d 157 (2d Cir. 1986) The plaintiff was the estate of George Balanchine, the co-founder of the New York City Ballet in 1948 and the creator of a version of The Nutcracker that became famous as the "Balanchine Nutcracker." Macmillian had the right from the New York City Ballet to take pictures of the Ballet and publish them in a book. They used 60 pictures of the ballet. Infringement was found even though the number of pictures was fairly small and the medium was different (live dance vs. book).

For the most part, taping of a copyrighted broadcast for later commercial use is impermissible under the fair use doctrine. Taping news clips has been held to violate fair use as has taping motion pictures for distribution throughout a school system, and the use of sports highlights without permission. However, if the copy is performed by a private party and used for time-shifting, the taping and re-use of a copyrighted motion picture has been held by the US Supreme Court to be fair use in Sony Corp. v. Universal City Studios, Inc., 464 U.S. 417 (1984).

Pacific & Southern Co. v. Duncan, 744 F.2d 1490 (11th Cir. 1984). Pacific and Southern Co. (WXIA-TV) sued Carol Duncan (doing business as TV News Clips) for infringing on its copyrights by videotaping its news broadcasts and selling tapes to the subjects of the reports. TV News Clips claimed fair use of the material. The appeals court held that the service was not a fair use because the use was for commercial reasons.

Harper & Row Publishers, Inc. v. Nation Enterprises, 471 U.S. 539 (1985) in an opinion by Justice O'Connor, the court held as not a fair use, the excerpt of only 300 words from the autobiography of Gerald Ford The Nation magazine used part of the book, the most important part, containing Ford’s thoughts when he pardoned Nixon. The Court found that The Nation had used, for blatant commercial purposes, important original thoughts of the author, and this use had a tangible effect on the market for the original and the defendant's claim of fair use was not allowed.

National Basketball Association v. Motorola, (2nd Cir 1998) Motorola manufactured a line of pagers called Sports Trax and a company named STATS supplied scoring information to NBA games. STATS collected its information by watching broadcasts of the games. Scoring information was updated every 2 or 3 minutes. The games themselves are copyrighted. However, the facts underlying the games are not copyrighted.

Sporting events are spontaneous and are not "authored." A sporting event is not copyrightable. However, the broadcast of such an event is a work of authorship and is copyrighted. Note that this result might be different if the underlying work was one of more original authorship.

Practical Advice

Some Methods for Non-infringing use: A person may use copyrighted material

1) If it is not copyrighted (i.e.: has fallen into the public domain, or is a government publication),

2) If they receive the consent of the copyright holder, the permission can be free or by negotiation of a fee.

3) If they find an exception for their use in the Copyright Act (Fair Use, others).

4) If they pay an agent of the copyright holder (performing rights societies, others).


Part 2 – Internet Issues for CME Materials

Possibly the most important case to CME providers is one that is still in the courts. The U.S. Supreme Court has taken the case of New York Times Inc. v. Tasini, No. 00-201 U.S. Supreme Court. This case involves freelancers to the NY Times who sold articles to the Times those same articles were later included in compilations of the Times that were posted to database services such as Lexis-Nexis. The question goes toward compensation – are the freelancers entitled to compensation for this second use? The Second Circuit Court of Appeals said "yes," and the Supreme Court currently has the case under consideration.

International laws and standards vary from country to country: While the copyright laws will certainly have some minor variations in terms and conditions, posting of content might subject a website to liability in another country. The leading cases involve posting information about holocaust materials, speech that the nation-state considers illegal, or libelous material. Courts in France, Germany, and Italy have all handed down rulings against speech that might be offensive, yet protected in the U.S. A U. S. Court has now taken up the matter of whether such a judgment can be enforced against a U.S. company in light of the U.S. Constitution’s protections for free speech. Yahoo! v. LICRA, Case 00-21275JF (N.D. Calif June 7, 2001). Issues in trans-national speech could be a significant problem for medicine-related websites.

Free speech and websites: Planned Parenthood v. American Coalition of Life Activists, 99-35320 et. al. (9th Cir Mar 28 2001). Anti -abortion activists intimidated abortion providers by publishing their names and addresses on posters. They mailed one such list to Neal Horsley, an anti-abortion activist who posted the list on his website. The doctors sued alleging violations of the Freedom of Access to Clinics Act of 1994, the Racketeer Influenced and Corrupt Organizations Act, The jury awarded 107 million in actual and punitive damages. The appeals court reversed the jury verdict, holding that the First Amendment protects such speech. The Court found that this type of speech does not directly incite imminent violence, so it is protected under the doctrines of NAACP v. Claiborne Hardware Co. and Brandenberg v. Ohio.

Copyright infringement is copyright infringement, even if you don’t actually "touch" the material: A&M Records v. Napster, 2001 U.S. App. LEXIS 5446 (9th Cir. Feb 12, 2001), Napster provided a database and software that permitted users to exchange files by peer-to-peer networking. Although the infringing material never passed through Napster’s servers, the appeals court rejected Napster’s four arguments that they were not violating the copyright of various recording artists and their record companies. In particular, the court rejected Napster’s arguments that what they were doing was not contributory infringement, was a valid claim of fair use, that the were permitted to make such copies by the Audio Home Recording Act, and that they were protected by the Digital Millennium Copyright Act. The appeals court remanded to the district court for further action to protect the record copyright owners’ rights.

Once you have copyright protection, it is difficult to defeat: Veeck v. Southern Building Code Congress International Inc., 241 F.3d 398; 2001 U.S. App. LEXIS 1428; (5th Cir. Feb 2, 2001), A website copied CD-ROM of standardized building codes. The cities had adopted the standard codes as part of their municipal laws. Court held that this was copyright infringement of the standardized laws notwithstanding the fact that the laws could not be posted in any other authoritative manner. The expression of the law is protected by copyright and the value of the market for model codes would be severely diminished if copyright is not preserved. The court relied on Practice Management Corp. v. American Medical Association, below, in making its decision.

Practice Management Information v. The American Medical Assn., 121 F.3d 516; 1997 U.S. App. LEXIS 20870; (9th Cir. Aug 6, 1997), Cert Denied October 20, 1997. The AMA developed the Physician’s Current Procedural Terminology (the CPT) and claimed a copyright in the system that defines over six thousand procedures and provides a five-digit code for each. The AMA permitted the government to use the CPT without royalty payments, so long as the government did not modify the system. The court found that even though a particular system becomes the "industry standard," and is even mandated by the government, it can still retain its copyright because a competing organization could always develop a "better system."

The effect of the Digital Millennium Copyright Act on websites: Title II of the Digital Millennium Copyright Act protects website hosts (the ISPs) from liability. The original content provider still remains liable for their content. However, another provision of the Act might be of interest to copyright holders. If a person believes that a website is misusing material to which they have the copyright ownership or management interest, they may request that the website "take down" the offending material. These "notice and remove" provisions of the Act can be helpful. However, the Act applies on its face only to those who post information at the "direction of others." Therefore, it applies to material that a CME provider posted to your website without your intervention, but it probably would not provide protection for material that you selected and posted to your website.

The potential effect of "filtering" statutes on CME websites: Numerous statutes requiring "filtering" of Internet sites to protect children and others accessing the Internet from public places have been introduced. The Children Internet Protection Act (CIPA) passed in the last Congress and requires elementary and secondary schools and certain publicly funded libraries to provide filtering. While this probably does not yet affect CME providers, the developments in this area should be watched carefully. Doctors and others can access CME education via online access. Some of this access might eventually be from some of the "protected" sites. The most common example of filtering software causing problems derives from the "list" of banned words. Such software usually blocks sites that use anatomical words such as "breast." Your site could provide information on "breast cancer" and be blocked from some receiving computers located at protected facilities. Filtering software, while conceptually very useful, often creates interesting and unexpected outcomes. Medical websites should be especially vigilant to watch the language and actual effect that future legislation might have on your functioning.


Part 3 – Good Practices

  1. Get the copyright authorization that you need. It is always best to have written permission. However, as a practical matter, for most seminar usage, written permission is not sought. A person who is familiar with the way such seminars are run, and who prepares and delivers materials for such a CME event also, at a minimum, grants you a license to copy the materials and distribute them to participants. However, once you go beyond the basic, face-to-face presentation, it becomes very important to have a written document that gives you rights to use the copyrighted material as you require for your CME activities. This written document could be a few short paragraphs distributed at the same time as you ask about Conflict of Interest. It does not have to be complex, but it should state
    1. That a license was granted, whether it is non-exclusive (typical) or exclusive, the date it was entered into and its duration.
    2. That the license grants you rights to – copy and distribute the materials, edit, make condensations or abridgements, post the materials or any derivative work to your website, include hyperlinking and other technological indexing to the material, creating CD-ROMS of materials, create "event proceedings" books, etc. The rights that you ask for depend on the needs of your organization.
    3. It needs to be signed by one of the authors, or an authorized representative of the company if it is a work-made-for-hire.
    4. I will have additional suggestions during the class session.
  2. Consider other permissions that you might need. Are you videotaping? You should get a release for use of their image and likeness. Are you webcasting, or posting a copy to the Internet? Same advice.
  3. Think ahead: Ask for everything that you even might need. Once the event is over, it might be difficult getting permission to post the work to the web. It is much easier to ask for what you need before the event.
  4. Keep it simple: Don’t frighten away your authors, faculty, or presenters. Use simple documents that give you the permissions you need without sounding like they are taking away all of the author’s rights. This is a balancing act with number three, above.

5) Protect your own hard work: Attach copyright notices at appropriate places, remind people if copying is not OK, post a usage policy on your website.


Copyright 2000-2001, Rick Morris. The author grants permission for the ACME to copy and distribute this material at this seminar.