Richard Townshend
Intellectual property (IP) protection is a major feature of the additive manufacturing (AM) sector, with the registration of IP rights covering new AM processes, hardware, materials and end products as well as copyright issues over digital files all commonplace.
Yet, while existing IP laws are generally viewed as adequate for current needs, new technological developments have exposed a number of grey areas in the industry, specifically around subsistence of IP rights, infringement and enforceability.
Bioprinting
3D bioprinting is increasingly used to fabricate tissue models for in vitro testing and research, but the long-term goal lies in its application to the field of regenerative medicine. Although many aspects of 3D bioprinting are patentable, bioprinted tissues and organs may face barriers to patentability in the form of excluded subject matter, medical exclusion and public policy.
European and US patent laws exclude a human organism from patent eligibility but conversely do not explicitly rule out patent protection for human organism parts such as tissue and organs. Furthermore, non-human subject matter constitutes patentable subject matter as long as it is synthetic or modified to an artificial state. Accordingly, 3D bioprinted tissue and organs will remain patentable so long as they are distinguishable from natural tissue and organs.
In terms of infringement, identification of an infringing bioprinted product would be less clear-cut and more complicated if it is only distinguished from a natural tissue or organ by its fabrication process and if it is then implanted into the human body.
Moving forward, the level of artificiality in a bioprinted product will be a key point of contention in determining matters of patentability and infringement.
4D printing
4D printing takes existing 3D printing techniques to create, from a digital file, a 3D object with the added ability of transforming its appearance or function over time.
When considering infringement in AM, it is often asked who the infringer might be if the 3D printed object is designed, digitally modelled and printed by different parties. 4D printing further complicates this question because infringement by a party responsible for transforming the 4D printed object may hinge on whether the IP-protected elements of the 4D printed object cover the untransformed object, the transformed object or both.
Protecting the transformed object without covering the untransformed version may lead to future difficulties in catching the infringer in the act of transforming the 4D printed object. Moreover, the 4D printed object in its untransformed state may be initially infringing but over time becomes non-infringing due to shape and structural changes.
Get your FREE print subscription to TCT Magazine.
Exhibit at the UK's definitive and most influential 3D printing and additive manufacturing event, TCT 3Sixty.
Therefore, to maximise the scope of IP protection for 4D printed objects, patents and IP agreements should be carefully worded to incorporate the transformative ability of 4D printed objects in addition to the 3D printing aspects.
Personalised medicines
The 3D printed pharmaceuticals market has attracted the involvement of many major industry players in recent years. Whilst patent and design rights can provide protection for 3D printed pills and production methods, there is the question of the ability to effectively enforce such IP rights.
Under the UK Patents Act, an exemption to infringement exists for the preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered practitioner. This exemption appears to apply to medicine printing performed using AM in a pharmacy based on a prescription. UK patent law also provides an exemption to infringement for acts conducted privately and for non-commercial purposes.
On the other hand, patents may be enforced against infringers supplying the means or materials relating to essential elements for putting the invention into effect. Whilst this might help restrict domestic medicine printing, digital file sharing via the internet could still make IP rights enforcement difficult.
Ultimately, when bioprinting and pharmaprinting become more ubiquitous, IP in these areas is expected to attract the same questions faced by other medical inventions around rewarding innovation versus protecting public interest.
