3D printing – also known as additive manufacturing – is set to revolutionise a large number of industries, allowing for innovative product designs and near-instant, decentralised manufacturing. At present, 3D printing processes struggle to compete with traditional methods of mass production on price. However, in industries such as medtech and medical devices – where products are far more likely to be bespoke to an individual patient – additive manufacturing has several potential applications. This puts medical device manufacturers at the forefront of what many believe will be the next step-change in manufacturing.
Despite regulatory hurdles, a considerable amount of innovation has already taken place in the field. The US Food and Drug Administration (FDA) recently gave regulatory approval for Aprecia Pharmaceuticals’ 3D printed epilepsy drug Spritam. Manufacture of medicine with the properties exhibited by Spritam had not previously been possible, with the fast dissolution properties of the drug having only been realised by harnessing the inherent properties of the 3D printing process itself. Spritam may be the first 3D printed drug to be granted FDA approval but it is unlikely to be the last. The FDA has gone through a number of iterations of drafting guidelines for the assessment and approval of medical inventions that use additive manufacturing and clearly expects a considerable amount of innovation to take place in this field in the near future.
While 3D printing opens up new technical, the route to market for 3D printed medtech devices is costly and requires significant investment. Ensuring inventions – and by extension investments – are adequately protected will therefore be key to success in this market. Not only is it disappointing when others copy inventions, but copying also risks return on investment. If not managed adequately, this may preclude investment being secured in the first place.
Securing intellectual property (IP) on pioneering inventions can be challenging. It requires technological foresight in an area that is likely to change in character over the medium or even short term (and most certainly over the 20-year term of a patent). There is also the possibility that new business models associated with the new technology will be of a nature that is, at present, not adequately covered by standard methods of protecting the associated IP. For example, in certain cases the distribution of a 3D printing file for a product may not be covered by a patent to the product itself.
In itself this is not unusual, and legal systems by their very nature often react to change rather than anticipate it. As such, it can be expected that the manner in which the legal systems perceive and deal with IP in the additive manufacturing field will change over time to the advantage of rights owners.
In the meantime it is critical that the IP protection written today is crafted well, and with an eye on the legal issues that are likely to arise in the future. This will ensure that patents drafted now are suitable for protecting today’s innovation over the entirety of a 20-year patent term.
If high quality IP protection is achieved as part of a well-crafted IP strategy, the opportunities for innovators can be limitless. For example, the limited availability of ‘prior art’ allows broad monopoly protection that covers not only innovators’ businesses but also provides the possibility of acquiring valid, relevant monopolies in ancillary, non-competing industries. This can form a basis for independent licensing revenue streams without risking an innovator’s own business dealings and can significantly boost ROI.
Alongside these general IP strategies, 3D printing will generate legal questions particular to the medtech and medical devices sector. 3D printing might impact industries reliant on mass production (affecting not only companies that use 3D printing but also those that use traditional methods of manufacturing), however this is a whole new area to explore beyond the scope of this article. The challenges posed to an industry, in which individualisation of goods is important, are worthy of consideration.
In a market where bespoke products are key, for example, the current centralised manufacturing model, will be less attractive than the kind of localised manufacture that 3D printing makes possible. In the future this could lead to 3D printers being located close to clusters of high patient density, possibly in specialised hospitals or pharmacies where devices and/or drugs can be printed at the touch of a button. While advantageous for patients, these techniques also bring new liability issues to the fore, with operators of 3D printers possibly being less well trained than their counterparts in large factories. Quality assurance and the maintenance and calibration of 3D printers will be challenged, and solving these in a manner that meets regulatory standards will in itself give rise to considerable innovation.
The challenge of protecting such distributed systems is well understood from other sectors, which rely upon networked solutions. That said, mistakes in protecting such innovation are made and many have learnt lessons the hard way when trying to enforce patents against infringing computer systems distributed across different localities or even countries. But this is avoidable with the relevant degree of foresight and experience.
3D printing opens the door to the possibility of assembling living structures for patient implantation for example, and pioneering techniques are being realised in the lab that few dared dream of only a few years ago. Once such structures are assembled on the patient (for example in the form of replacement skin printed onto patient’s wounds using the patient’s own harvested cells), protecting the innovation can get tricky. This is because inventions that include substantial intervention with the human body have traditionally been the province of the medical practitioner, not to be disturbed by legal monopolies.
While this system has served society well in certain instances (for example a method for hyperpolarised 126Xe MRI) in other situations the opposite view has been taken. Many believe that the availability of new and innovative techniques in a system where monopolistic business may increase the costs of the technique is preferable to a dearth of investment stifling the innovation in the first place.
These are just some of the issues that innovators will need to take into consideration in the medtech space as the possibilities of 3D printing become ever more myriad. With detailed knowledge of the legal boundaries applicable to protecting inventions of this nature, paired with a thorough understanding of what’s technically possible, a path to useful IP protection can be charted. This will make patent applications drafted today fit for purpose in the future and maximise the chances of success, should the invention be one that challenges existing legal systems to catch up with the technical realities.
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