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Paven Malhotra Discusses the Latest Legal Issues Surrounding 3D Printing

The Recorder


You can use a 3D printer to make your own "Game of Thrones" figurine … So what? Well, for one thing it means a new crop of lawsuits and deals to regulate intellectual property. Keker & Van Nest IP partner Paven Malhotra says that technology making it easier than ever to copy products is already giving rise to a new set of legal issues.

What work will 3D printing create for attorneys? I think there's a few things. First of all, you're going to have lawyers at companies who now need to start monitoring what's happening online. … You have websites like Shapeways, Thingverse, as well as outlets likes eBay, for example, where products are now being sold that have been manufactured using 3D printing. So lawyers at companies that hold copyrights are now going to start reviewing these websites more carefully to see what is actually being sold. The second is you're going to have transactional lawyers and IP lawyers who are going to start working on deals with third-party sites like Shapeways to allocate rights between the various rights-holders and consumers. … There's a whole number of other legal issues that are going to arise from 3D printing, which include patent issues. But also I think you're going to start seeing in the drug context, regulatory lawyers having to get involved. There's going to be tort issues that also arise from medical devices and implants. So this is going to result in a lot more work for lawyers across the spectrum.

What legal innovations have you seen? In the past few years, there's been a lot of concern that's arisen because of whether and how copyright holders would be able to enforce their intellectual property with 3D printing. In particular there's this concern that if consumers have printers in their homes, or they're able to go to third-party providers like Shapeways, people could print items that infringe the copyright of copyright holders. … Hasbro saw [fan-designed My Little Pony figurines being offered for sale], and rather than just trying to shut down the activity, it felt like what it should do is promote interest in the product with its fans, but try to regulate in some way how their product and their copyright is being used. So they formed a partnership with Shapeways where fans could submit designs to Hasbro, through a site called And when Hasbro approved the design, it was basically giving a limited license to the artist, and [sharing revenue among Hasbro, Shapeways and the artist]. So they started this with My Little Pony, and now they've expanded it to G.I. Joes, Transformers, Scrabble and Monopoly. So this is kind of a new partnership that they've developed, and we'll have to see how it fares. It's promising because this is one of the first examples where you have a company that's allowing its fan base to try to use a copyright in a regulated way, and really in a way where everyone can profit from it.

Why have these issues emerged with the advent of 3D printing, rather than with some other medium? There really is no reason why you couldn't apply this model to any other medium. I think part of the reason why 3D printing has got this attention is just because it is such an innovative manufacturing process. And I think the other reason why copyright holders are more concerned is because with 3D printing, you can take a scan of an existing product. So, for example, if you have a Mickey Mouse figurine, you could scan the Mickey Mouse figurine, create a CAD file, and then use that CAD file to actually print a Mickey Mouse figurine. … You can have more fidelity to the original than you could if somebody is just drawing something by hand, or painting something, or using other kinds of artistic expression.

What kinds of tort issues could arise from medical device applications of 3D printing? In 2013 a hospital was able to print a tracheal splint and provide it to a baby that had a collapsing windpipe. In that case the hospital was able to print it itself. In the U.K., there's a hospital that has started to print skeletal models. So before a surgeon does a complex surgery, [the surgeon can get] CT scans of the particular area where the surgery is going to happen, and they're using those CT scans to build models of the bones. … And the cost of that runs only a couple hundred dollars. So it's really cheap. Long term, what's going to happen is you'll have hospitals and medical practices that'll start buying 3D printers and starting to manufacture implants that will be used in surgeries. And the question is: When the hospital does that, can they be held strictly liable for manufacturing this product if it turns out to be defective? That's where the tort issue is going to arise.

Are there any guidelines for whether they can be held liable? A plaintiff's lawyer would try to hold the hospital strictly liable for a defective device or a defective implant that was printed. And whether they're successful or not, I think, is going to turn upon the degree to which hospitals are printing implants. If you want to hold somebody strictly liable for a defective product, they have to be considered a seller of that product. And a hospital would only be considered a seller of that product if they sold enough of these or if they did it in sufficient volumes to be considered a seller. This is going to be in new realms because hospitals haven't done that before. Hospitals have primarily been involved as service providers, not as product providers.

Will hospitals need to get FDA approval for every product? It all depends. … There have been a number of instances where companies have printed products and gone to the FDA to get approval. So far what the FDA has done is they have just used their traditional regulatory approach for approving these types of products. Because this is a newer area of manufacturing, last October, they held a multi-day conference with professors, people from industry, doctors to try to get a better technical understanding of the kinds of challenges that exist with printed medical device products, with printed implants. I think that's a sign that they're going to be looking much more carefully at this to figure out what kind of process and quality validation they need in order to approved 3D-printed products. Whether they issue formal guidance, or whether they just decide to review these products using the existing channels remains to be seen. But I think they're really beginning to take note of this. And my guess is that they will begin to issue more formal guidance on manufacturing processes, techniques, validation for these kinds of products.

Is 3D printing becoming a hotbed for patent litigation? I think it definitely is. There's been a gold rush to the patent office to get applications filed. … Part of the reason for that is there's a sense that this industry is going to generate a lot of revenue in the future. So it's important now to sort of stake claims on manufacturing processes.