Back To The Future: 3D-Printed Medical Devices At The International Trade Commission

By Scott Felder, Wiley Rein LLP

Welcome to the first installment of Patent Medicine: An Inside Look at Med Device IP Issues.  Before we get started, though, I have a confession:

Hi, my name is Scott, and I’m a nerd.

I’ve been one for as long as I can remember. The world has changed, though. As I write this, six of the ten highest-grossing films can fairly be characterized as science fiction or fantasy. By the time you read it, Star Wars: The Force Awakens will be on its way to obliterating all of them (you can insert your Death Star/Alderaan pun of choice here). One of the highest-rated comedies on TV centers on the misadventures of two physicists, an aerospace engineer, and an astrophysicist.  And we’ve finally caught up to Marty McFly. Here’s a fun fact to impress your friends at cocktail parties: The Chicago Cubs were eliminated from the playoffs on the very day Back to the Future Part II “predicted” their World Series victory.

In short, being a nerd is cool. Like a bowtie and a fez. Or sonic sunglasses and a Fender Stratocaster.

So it is only appropriate that the topic of my first column probably seems like one of Doc Emmett Brown’s inventions to the ordinary consumer. Yet, 3D printing technology — the creation of a three-dimensional solid object from a digital file, constructed by layering material until the object is complete — is rapidly becoming commonplace in the medical device industry. It allows manufacturers to offer bespoke solutions for everything from hearing aids to prosthetic limbs; indeed, a 3D-printed prosthetic hand was the United Kingdom’s 2015 James Dyson Award winner. Thus, it should come as no surprise that device manufacturers are seeking more opportunities to leverage this cutting-edge technology in their product offerings.

The advent of 3D printing is also having a profound impact on the intellectual property (IP) landscape. Traditional barriers to entry, such as development lead time and capital expenditures, impact less acutely those using 3D printing technology (and related 3D scanning technology). As 3D printers move into the mainstream, potential competitors to original equipment manufacturers (OEMs) might even adopt a do-it-yourself model, furnishing digital files to the masses to print at home. One might even go so far as to say that 3D printing will eventually make counterfeiting, copying, and competing trivially easy, leaving IP owners to find new strategies to combat 3D printing-enabled infringement.

However, as futuristic as 3D printing technology appears to be (additive manufacturing actually dates back more than 30 years), a November decision by the United States Court of Appeals for the Federal Circuit reaches nearly a century into the past to limit the remedies available to patent owners hoping to prevent the creation of infringing articles through 3D printing. In ClearCorrect Operating, LLC v. International Trade Commission, the Federal Circuit concluded that the International Trade Commission (ITC) lacks the authority to regulate electronic files transmitted over the Internet, even if those files contain information that is ultimately used to infringe a patent.

Federal Court Draws Line At Electronic Information Transfer

Setting the stage for the case, Align Technology, Inc. owns several patents related to orthodontic aligners. Aligners are used to straighten a patient’s teeth without traditional metal braces; by using a series of different aligners over a period of time, the patient’s teeth can gradually be moved into the desired final position. ClearCorrect aligners compete with Align’s own Invisalign system. 

Align filed a complaint with the ITC alleging that the manufacturers of ClearCorrect aligners — ClearCorrect Operating, LLC in the United States (ClearCorrect US) and ClearCorrect Pakistan, Ltd. in Pakistan (ClearCorrect Pakistan) — infringed its patents and therefore violated Section 337 of the Tariff Act of 1930. Under Section 337, the ITC can remedy unfair trade acts, including patent infringement, involving the importation of “articles” into the United States.

The way in which ClearCorrect aligners are manufactured is key to understanding this case. Specifically, ClearCorrect US first creates a 3D scan of a physical model of a patient’s teeth. ClearCorrect US then electronically transmits a digital recreation of the physical model to ClearCorrect Pakistan. ClearCorrect Pakistan, in turn, creates digital models of a series of aligners to treat the patient. These digital models are electronically returned to ClearCorrect US, which 3D prints them into physical models. Finally, the physical models are used to create the series of aligners for the patient. 

Align asserted that the creation of the ClearCorrect aligners infringed its patents, and therefore sought an order from the ITC prohibiting ClearCorrect Pakistan from  importing its digital aligner models into the United States to ClearCorrect US. This would effectively prevent ClearCorrect US from creating the infringing ClearCorrect aligners in the United States. The ITC agreed that ClearCorrect had infringed Align’s patents, directed to methods of forming dental appliances and methods of producing digital data sets, and issued a cease and desist order prohibiting the importation of the digital models from Pakistan.

ClearCorrect appealed the ITC’s decision, but it did not contest its infringement of the Align patents. Instead, ClearCorrect’s appeal was limited to whether, under the Tariff Act, the ITC had the power to regulate digital data transmitted electronically (as opposed to, for example, the importation of digital data stored on a physical medium, such as a thumb drive). Resolution of the question depended on whether electronic transmissions of digital data constitute “articles” within the meaning of the Tariff Act. If purely digital data is not considered to be an “article,” then the transmissions from ClearCorrect Pakistan to ClearCorrect US would fall outside the ITC’s authority.

After a detailed analysis, the Federal Circuit concluded that the term “articles” is limited to “material things.” Because purely digital data is, in the court’s view, not a “material thing,” Section 337 does not cover electronic transmissions of the type at issue in ClearCorrect (though it would likely cover importation of the very same data stored on a physical medium). As a result, the ITC lacked jurisdiction to issue the cease and desist order prohibiting ClearCorrect Pakistan from sending the digital aligner models to ClearCorrect US in the United States. 

Although it spent a fair amount of time discussing the definition of “articles” at the time the Tariff Act was passed nearly a century ago, the Federal Circuit did not ignore that times and technology have changed. To the contrary, and over a sharp dissent from Judge Pauline Newman, the Federal Circuit noted that Congress, rather than the court, is best suited to expand the ITC’s power to cover electronic transmissions of purely digital data.

Protecting Your IP On The Information Superhighway

The immediate consequence of the ClearCorrect decision is that the ITC is powerless to stop electronic transmissions at the border, whether those electronic transmissions contain the next Hollywood blockbuster or design instructions for a customized dental implant. It follows that patent owners cannot use Section 337 to prevent the entry of digital files into the United States that are used to infringe a patent (except, perhaps, if those digital files are contained on physical media). Other forms of IP, such as copyright, would likewise offer no solace under the Federal Circuit’s interpretation of Section 337. Thus, the only remaining remedy for the OEM and IP owner is to seek a comparable injunction from a court — a process that may take far longer than an ITC investigation. 

Against this backdrop, a proactive strategy that incorporates a diverse array of IP rights can be very valuable. Device manufacturers should consider utility patents (including not only claims directed to the product itself, but also to various ways of manufacturing it, including via 3D printing), design patents, copyrights, trademarks/trade dress, and trade secrets. 

And, of course, there is no reason that your competitors should be the only ones to benefit from modern technology. 3D technology is disruptive because it is accessible. We’re living in a brave new world. Embrace it.

About The Author

Scott Felder is a partner at Wiley Rein LLP and the head of the Firm’s Patent Prosecution practice. He counsels clients in connection with the acquisition, protection, management, and enforcement of intellectual property rights, including representing clients before the United States Patent and Trademark Office, including the Patent Trial and Appeal Board. Scott received his J.D. from the University of Virginia, Order of the Coif.