AAMI News June 2018

Why Is Protecting Intellectual Property Important? A Patent Lawyer Explains

Christopher Lonegro
Christopher Lonegro

Intellectual property (IP) is the core of any business, whether you are manufacturing medical devices or developing standards. At AAMI, technical committees, working groups, and other volunteers dedicate their time to developing standards, technical information reports (TIRs), recommended practices, and other resources for the benefit of the healthcare technology community. All of these documents are considered IP and are the result of significant investments in time and financial resources, according to Christopher Lonegro, an attorney with Baker Donelson’s Intellectual Property Group.

“These costs are significant, and without the protections provided by IP law, AAMI would not be able to marshal the resources needed to undertake and continue the work of developing new standards, practical support, and guidance,” Lonegro said.

AAMI News sat down with Lonegro to help AAMI members—and nonmembers—better understand the ins and outs of the complicated subject of copyright protections.

Q: Which materials and resources produced by AAMI are considered IP?

All of the standards, TIRs, and recommended practices produced through the efforts of AAMI’s technical committees and working groups are IP that is protected by the copyright laws of the U.S. and other countries. The same is true for standards and related materials developed by other organizations and offered to AAMI members through license agreements between AAMI and those other organizations. AAMI maintains similar copyright ownership of all the practical information, support, and guidance developed by AAMI and offered to assist AAMI members. These may be in the form of books, periodicals, and newsletters or courses, conferences, and continuing education programs—in both physical and electronic forms.

In short, virtually all of the resources offered to AAMI members are products of the mind (i.e., intellectual property) and need to be protected to ensure their longevity and availability. AAMI’s IP represents much of the value that AAMI offers to its members and to the greater medical device industry.

Q: Can I reference an AAMI standard or program in a lecture or an article without asking for permission?

It is permissible and encouraged for AAMI members and nonmembers alike to reference the name of an AAMI standard or program in a lecture or article. While the content expressed in a standard or program is generally protected by copyright, their names and titles typically are not. Names and titles are how people identify the things they are talking or writing about and to prevent someone from using the name of something to identify it would make public conversation about or reference to that thing exceedingly difficult.

Q: When do I need permission to use AAMI’s materials?

While names and titles are not protected by copyright, the content of AAMI materials typically is. This protection applies equally to copying a chapter, quoting a paragraph, or reproducing a figure or table. However, copyright law does allow for limited use of copyright-protected works without permission in certain circumstances under what is termed the “fair use doctrine.” Unfortunately there is no clear-cut rule as to what is or is not “fair use,”

Fortunately, AAMI members often do not need to get into the complexities of the fair use doctrine to quote, print, or otherwise communicate limited portions of an AAMI standard because AAMI permits such use by members so long as the use is not for commercial or for-profit purposes and does not divert income from AAMI. AAMI relies on income from sales of standards and related materials and programs to support its standards development program and so cannot permit uses that may divert or diminish that income. For that reason, members and nonmembers alike may not reprint the entire standard or substantially all of the relevant provisions of a standard or other material without AAMI’s express written permission. Nonmembers are not so fortunate when it comes to quoting or reproducing even a limited portion of a standard because the permission AAMI grants to members is not extended to them.

Nonmembers must always seek AAMI’s express permission to quote or reproduce a portion of a standard, or they must rely on the fair use doctrine. Many reams of paper have been consumed by lawyers arguing over what is or is not a fair use. Typically, fair use is found for socially important purposes such as comment, criticism, news reporting, teaching, and research, but each case must be decided on an individual basis. Factors considered to determine fair use include the purpose of the use, the nature of the copyrighted work, the amount and substantiality of the portion used, and the effect of the use on the potential market value of the work as a whole.

When in doubt, it is recommended to consult with legal counsel or to avoid the uncertainty altogether and request permission.

Q: Whom should I contact for permission to use AAMI’s materials?

For permission regarding the use of AAMI copyrighted content, use the AAMI Reprint Permission Form, which can be found at www.aami.org/reprintpermission, or contact Sean Loughlin, AAMI’s vice president of communications and marketing, at sloughlin@aami.org.

Q: If I buy a copy of a standard, can I photocopy it and distribute it to others or place it on an internal computer system for others to use?

No. An individual or company purchasing a single copy of a standard, whether in paper or electronic form, is not permitted to copy and distribute the standard to others—even within the same organization. Making paper photocopies quite obviously falls within this prohibition, but placing an electronic document onto a computer network where multiple users can access it at the same time has the same effect and is similarly prohibited. If multiple individuals within an organization need to access the standard simultaneously, then the organization should buy a copy for each user or should contact AAMI about broader use rights for the entire organization.

Q: What are the possible consequences of violating an organization’s or company’s IP?

It’s never fun to contemplate all of the really bad things that can happen as a result of violating—or infringing—someone else’s IP. This why AAMI takes great care to respect the IP rights of others and why members should do the same. As with so many things in law, the particular consequences for any given infringement are determined on a case-by-case basis. Typically, an infringer will be ordered to stop the infringing activity, may be required to pay monetary damages, and may also be required to destroy any products or materials utilizing the infringing IP. Copyright infringement carries the added risk of statutory damages of up to $150,000 per infringement and the potential for an infringer to be responsible for an IP rights holder’s attorney fees. Perhaps equally bad is the damage that infringement can do to business relationships and the trust between industry partners.

More information about using AAMI’s intellectual property can be found at www.aami.org/ip_faqs.