I am excited to announce the publication of the Intellectual Property Owner (IPO)’s paper on Patent Marking regarding Software Medical Devices

The paper provides an in-depth analysis of patent marking laws as they apply to software and medical devices. It covers multiple jurisdictions, including the United States, the United Kingdom, France, and Germany. The paper addresses various types of medical devices and software platforms, such as external, implantable, cloud-based devices, and third-party devices. 

I contributed as an author and also in my capacity as chair of the IPO’s Software Medical Device subcommittee. I had the honor of working with fellow authors and committee members Dominik Franz (Plasseraud IP), Christopher George (Hanley, Flight & Zimmerman LLC), Christopher Karlen (Medtronic PLC), Mal Kind (Fenwick & West LLP), and Nikesh Patel (AA Thornton).

The paper covers various topics, which are summarized below.    

U.S. Patent Marking Perspectives

In the U.S., patent holders can give constructive notice by marking products with the patent number or a URL linking to patent information. See 35 U.S.C. § 287. The absence of such marking limits the recovery of damages for infringement to periods after actual notice is given. The Federal Circuit requires that substantially all patented products be consistently marked, using a “rule of reason” approach to assess sufficiency. Maxwell v. J. Baker, Inc., 86 F.3d 1098, 1111 (Fed. Cir. 1996). The primary goal is to inform the public about the intellectual property status of products. See, e.g., Bonito Boats, Inc. v. ThunderCraft Boats, Inc., 489 U.S. 141, 162 (1989).

  1. Software in an External Device

This section explores the marking of software in external medical devices through the McKesson Automation Inc. v. Swisslog Holding AG case. The case highlights that incorrect marking, such as marking the wrong product, can preclude the recovery of damages. For example, in McKesson, the court found that plaintiff McKesson’s failure to mark the Robot-Rx product, which practiced the patent claims, while marking a different software product (Connect-Rx), was insufficient under 35 U.S.C. § 287.

  1. Software in an Implantable Device

Implantable medical devices present unique challenges for patent marking due to their size, shape, and visibility constraints. The Global Traffic Technologies LLC v. Morgan case is discussed, which supports the marking of packaging when the device itself cannot reasonably be marked. The case emphasizes evaluating the “character of the article” to determine the appropriate marking approach.

  1. Cloud-based Medical Device Software System

This section discusses the complexities of marking cloud-based software, where physical media is not delivered to customers. Virtual marking, allowed under the America Invents Act (AIA), is presented as an effective method, typically involving a URL linking to a patent information webpage. Court cases, such as Lexos Media IP LLC v. Jos. A. Bank Clothiers Inc., support that software can be subject to marking requirements, and virtual marking on user interfaces or webpages is deemed sufficient.

  1. Third-party Devices Having Medical-based Software

This section addresses the marking of software distributed on third-party devices. For pre-installed software, it is prudent for patentees to require third-party manufacturers to mark the hardware. When software is installed from the cloud, marking within the software or its documentation is necessary. The McKesson Automation Inc. v. Swisslog Italia S.P.A. case is cited to illustrate that marking must clearly indicate that the hardware configured by the software is covered by the patent.

European Patent Marking Perspectives

The European Patent Convention and related frameworks do not specifically address patent marking, requiring country-specific assessments. The section provides detailed examples for the UK, France, and Germany.

  1. United Kingdom

In the UK, while marking is not mandatory, it effectively puts potential infringers on notice. Marking should include the patent number or a relevant internet link, and false marking is an offense. Effective marking can provide legal advantages but must be updated as patent status changes.

  1. France

France does not legally require patent marking, but it can help in cases where prior knowledge of infringement is required. Misleading marking can be considered unfair competition. Acceptable abbreviations for marking include “Brevet” for granted patents and “brevet déposé” or “brevet demandé” for pending applications. No specific provisions exist for virtual patent marking in France.

  1. Germany

In Germany, patent marking is not required for compensation, but it can support arguments of malicious infringement. Misleading marking is sanctioned under unfair competition rules. Common abbreviations include “D.B.P” for “Deutsches Bundespatent” and “patentiert” for granted patents. No specific provisions exist for virtual patent marking in Germany.


If you would like a copy of the publication, please let me know. I look forward to working on this year’s upcoming paper to advance these or other topics in the Software Medical Device field further. 


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