At present, 3D printing – or additive manufacturing – struggles to compete with traditional methods of mass production on price. However, in industries such as medtech – where products are far more likely to be bespoke to an individual patient – additive manufacturing is far more applicable, putting medtech at the forefront of what many believe will be the next step-change in manufacturing. The US FDA's recent approval of Spritam, a 3D printed epilepsy drug from Aprecia Pharmaceuticals, is likely to be just the first of many 3D printed medical products to come to market as 3D printing technology gets ever more sophisticated.
The intellectual property implications
Securing intellectual property (IP) on pioneering inventions can be challenging, requiring technological foresight in an area that is likely to change in character over the medium or even short term (and 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 IP.
This in itself 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.
The pioneering nature of this technology also means that the opportunities open to innovators can be limitless. 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, noncompeting industries. This can form a basis for independent licensing revenue streams without risking an innovator's own business dealings and can significantly boost return on investment.
What can be protected by IP?
For each opportunity however, there will also be challenges. 3D printing techniques open the door for example to the possibility of assembling living structures and skin grafts for patient implantation, with techniques being realised in the lab that few dared dream of only a few years ago. Once such structures are assembled on the patient however, 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.
This is just one example of the kind of question that innovators will need to consider 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 however, paired with a thorough understanding of what's technically possible, a path to useful IP protection can be charted.
Investing early in detailed and rigorous IP will ensure patent applications drafted today are future proofed. This will maximise chances of success in cases where an invention is one that challenges existing legal systems to catch up with technical realities.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
