Hi Michael,

The challenge with 3D printing will be the international nature of sharing of information. Intellectual property rights that require registration are protected only within the country of registration.

Copyright will apply to designs. I am aware of some people who create and sell their designs online. Copyright is automatic upon creation and does not require registration, although in the US the government copyright register does provide greater protection for digital products sold in the US market. Copyright in the original design, whether represented electronically or on paper, is likely to be the cheapest and quickest form of protection.

Design protection is the most common form of IP protection for 3D objects, but again, requires registration and is limited by jurisdiction.

Patents may also be available, are more involved and expensive than design protection, and are again limited by jurisdiction.

It is also possible to trade mark a shape in some countries, again, limited by jurisdiction. Trade marking is also limited by the category in which the application is made, but as you are talking about medical devices, it may be possible to seek registration in the class applicable to medical devices and apparatus.

In all instances, the protection sought and obtained in the first place will require investment to maintain protection. For any interest holder who does not take appropriate steps to protect their product, regardless of which area of protection they choose, failure to take timely action to protect (when you know there is copying) can lead the courts to find that there is no interest to be protected.

I hope that helps.
Jeanette

3D printing is a process for making an object or part. If the resulting object, or an assembly of such objects, produces an article of manufacture or machine that falls within a claim, then it would infringe that claim regardless of how it is produced.
3D printing is rather limited as to what materials can be used in the process. If there is a product-by-process claim such that the object can't be made any other way, then you have a problem.

In my view, the key advantage of 3DP is the ability to create a 'customised' solution for a specific patient, based around that patient's own anatomy.

Strangely, the current uses of 3DP don't use this advantage and rather they are just the process of choice based on the material properties, surface finish, additional process requirements, etc. I feel that the reason for this is because of IP. I think it would be somewhat difficult to protect a patient-specific design. Rather, the fact that such a device hasn't gone through a suitable validation process would be what prevents it's use.

We may see a future where parts are built in a hospital specifically for an individual patient. If we do then it will be design/build process that will be validated, along with the basic design. What you may then see is IP being tied to the base design, which will be purchased from companies like Stryker, which can then be processed within a set of predefined constraints on a particular machine in a facility that has been ISO approved so that it can be customised to provide the best medical solution.

I agree with the previous points. I don’t think it radically changes things. In healthcare, copying should be less of an issue as products are also protected by regulatory processes as well as IP. Having said that, a concern not directly relating to IP is the risk of counterfeit goods that may look like original products but present risks around poor materials and product quality. To me that is a much bigger concerned than IP.

Agree, and another tack on this is the issue of invalidating the Certifications (i.e. CE-marks) and Warrranties on your medtech devices if you start reproducing spare parts and it opens up for liabilities.

Early on, in our 3DP journey at the hospital, the possibility to reproduce spare parts was in fact a topic that was discussed as a possible pro. Our medtech dept did rather quickly, and wisely, come to the conclusion that this would be a bad idea and too risky for the hospital.

Hi Michael,

With additive manufacturing (3D printing) becoming more ubiquitous in the healthcare industry, what concerns can we expect from an intellectual property standpoint?

• As other responses have indicated, the mode of manufacture should not bring new concerns. However, should is the operative word. As other responses indicate concerns, whether well founded or not, will undoubtedly arise.

Moreover, as IP relates to medical devices and 3D printing allows for the easy replication of parts, what can we expect from companies attempting to protect their IP?

• Enterprises are seeking methods to add a digital watermark and ensure genuine products. However, I think we are still quite some way from "easy replication" of medical devices. For example titanium hip cups made by Arcam or the recent FDA approved spinal cages both require prohibitively expensive machinery to make. Securing the logistics chain for these items is likely to be the same as existing practices.

Hi. I am doing a lot of legal work in this area given its newness. FDA has approved devices and drugs that are printed. So even FDA is getting down with improving the regulatory legal aspects of 3d printing. Lets break down "IP" into its common parts and then speak about them. IP is usually considered to be patents, trademarks, and copyrights. We'll go in reverse order here.
Copyrights: some of the major copyright issues is the creation of something that is copyrighted. Or even if the thing itself is not copyrighted, what about creating the CAD image of it. Copyright can exist in objects without formal registration. So if one scans a medical device, creates the CAD plans of it, then begins selling that CAD plan from an internet store for mass use, that could be considered a copyright violation for enabling/inducing/contributing to the ultimate infringement.
Trademarks: kind of the same thing here. Is there something about the device that has trademark rights?
Patents: on the patent side there are lots of issues. First is the plain making of the object. If patented, then it infringes just because it exists. Now patentees may have trouble finding the one-off infringer and may not be too inclined to do so, but the patentee could go after the "store" that induced the infringement. Also, if the printer begins larger scale, then the patentee may chase the person. Esp. if the part or piece printed is not considered a repair but is considered a reconstruction.

As always, legal issues are always bound to pop up.

The big play will be in systems and chemistries linked to 3D printing that solve challenges uniquely, effectively and appropriate cost. Enable those three, and I see clear opportunities for powerful IP protection. One dimensional inventions present all the issues noted above.

We have materials that can do amazing thing slinked to 3D printing and can likely be done at speeds as fast as the best laser printers. Exciting space.