Medical Implants and 3D Printing: Tomorrow’s Tech Meets Today’s Copyright Act

Irish Typepad/flickr

Irish Typepad/flickr

The U.S. Copyright Office is in the midst of deciding whether to exempt certain emerging technologies from the anti-circumvention provisions of the Digital Millennium Copyright Act. And it’s not too late for you to do something about it.

The following summary is borrowed, with permission, from Attorney Stefan M. Mentzer at White & Case.


Every three years, the U.S. Copyright Office undertakes a rulemaking to determine whether to exempt certain classes of works from the anti-circumvention provisions of the Digital Millennium Copyright Act.  The DMCA prohibits, among other things, the circumvention of technological measures that control access to copyrighted works.  The goal of the Copyright Office rulemaking is to determine whether there are particular classes of works for which users are, or are likely to be, adversely affected in their ability to make noninfringing uses due to the prohibition on circumvention of access controls.  When such classes are identified, a rule is published exempting the classes from the prohibition against circumvention for the succeeding three-year period.

For the current rulemaking, 44 petitions have been submitted requesting various exemptions.  Two of the proposed exemptions implicate novel issues for emerging technologies.

  1. Should the Copyright Office exempt computer programs in medical devices attached to or implanted in patients, where the circumvention is done to seek information generated by a device or to study the safety, security, and effectiveness of such devices?

Medical devices are a growing and thriving U.S. industry.  These devices – which include pacemakers, implantable cardioverter defibrillators, insulin pumps, and continuous glucose monitors – increasingly rely on computer programs to operate and to collect vital patent data.

Supporters of the exemption argue:

  • Researchers need the ability to access the source code and data outputs of medical devices in order to analyze the security and effectiveness of the devices.
  • The use of source code and data for purposes of researching and critiquing them is not an infringement – it is a fair use, or use of unprotectable elements.
  • Allowing anti-circumvention claims in this area would adversely affect medical research.  Independent researchers, not just medical device manufacturers, should be allowed to conduct this research.
  • The petition, and further arguments in support of it, can be read here.

Opponents of the exemption argue:

  • The exemption would allow anybody to access and reverse-engineer the source code in medical devices.  The source code, which is protected by patent and trade secret law, is valuable and proprietary to the manufacturer.  Circumvention facilitates infringement, as source code is easily disseminated on the internet and could be used in knock-off or counterfeit devices.
  • The exemption would allow the collection of data from medical devices without a patient’s consent, potentially violating privacy rights and creating fear in the public that such devices are not safe or protected.  The proposed exemption does not require obtaining a patient’s permission first.
  • Allowing others to access the computer programs in implanted devices like pacemakers could cause them to malfunction, with potentially harmful results.
  • A medical device exemption is premature and requires more study by the Copyright Office and Congress.  This is an important and evolving industry, and allowing circumvention of security features in such health care products could have unintended, harmful consequences for the industry and patients.
  1. Should the Copyright Office exempt 3D printers that are protected by control technologies, where the circumvention is done solely for the purpose of using non-manufacturer approved feedstock in the printer?

3D printing is an exciting new technology that can be used to build physical objects from digital files.  All 3D printers use consumable inputs, or feedstocks, in order to build objects.  The question is whether circumvention should be permitted to allow a 3D printer to accept feedstock that is not approved by the manufacturer.

Supporters of the exemption argue:

  • Preventing circumvention inhibits interoperability, innovation, and consumer value.
  • Congress did not intend for the DMCA to prevent consumers from using lawfully acquired consumer goods.  The Sixth Circuit addressed a similar fact pattern in Lexmark International v. Static Control Components, 387 F.3d 522 (6th Cir. 2004) for paper printers.
  • The petition, and further arguments in support of it, can be read here.

Opponents of the exemption argue:

  • 3D printing is in its infancy, and manufacturers need to be able to maintain sufficient economic remuneration in order to invest in and develop the technology.  An exemption at this stage could significantly undermine this fledgling industry.
  • It should be left to Congress and the courts, not this rulemaking, to decide the scope and applicability of the anti-circumvention provision.  If Lexmark is applicable here, then there is no need for a further exemption.
  • A 3D printing exemption is premature and requires more study by the Copyright Office and Congress.

The final round of public comment on these proposals is due by May 1, 2015.