3D printing is transforming certain industries - so why hasn't it been widely adopted in the pharma sector? There are likely to be a number of barriers to entry for 3D printing in this field, including identifying how to make it economically viable. Whilst a number of the key patents relating to 3D printing have expired and certain 3D printers have become cheaper, the printers and inks required for the 3D printing of pills are not yet readily or cheaply available. In addition, 3D printed pills are still being researched. Even when these challenges are overcome there is the further potential difficulty of changing the supply chain; switching from centralised to local manufacture and the supply of "inks" to enable the 3D printing of a pill instead of the pill itself.
However, as can be seen from some of the opportunities that this technology provides, there doesn't have to be an all-or-nothing adoption of 3D printing; it can be used to complement a company's existing manufacturing techniques.
- Faster pre-clinical evaluation of new drugs – 3D printing allows a product to be customised by amending the CAD file used to print it. It could be used to allow various iterations of a new drug to be manufactured more quickly and cheaply (for example "tweaks" in excipients, salt forms or dosages). In addition, it may be possible to use 3D-bioprinted liver or renal tissue to evaluate the likely excretion profiles of new drugs.
- New formulations for improved drug delivery – the first FDA approved 3D printed pill was for a known drug which when manufactured using conventional techniques was too difficult to swallow. 3D printing it allowed it to disintegrate rapidly in a patient’s mouth, making it easier to take. For a patient with multiple diseases research is underway for a 3D printed "poly-pill" – where multiple active ingredients for different diseases are combined into a single pill. Other research is looking at the effect of the geometry of a tablet on its dissolution.
- Precision/personalised medicine – customising a pill for a particular patient, for example by inputting their renal or kidney function to amend the CAD file used to print the pill. Such a pill could have fewer side effects and improve a patient compliance.
- Local manufacture – instead of a factory mass producing pills then distributing them, 3D printing could lead to pharmacies 3D printing medicines on demand. This could revolutionise the supply chain; potentially lowering costs due to a reduction in inventory and distribution costs.
Even a good medicine will have risks associated with it - 3D printing also has a flip-side.
Here are some of the IP risks:
- Multiple infringers? The potential for a shift from central to local manufacture could lead to multiple infringers that are difficult to find and expensive to sue.
- Who to sue? The extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription is excluded from infringement – so a pharmacist 3D printing a patent infringing pill is likely to benefit from this defence to infringement. A patentee could sue the supplier of the CAD file which is to be used to manufacture the infringing product. However, proving indirect patent infringement could be challenging in view of the need to show that the supply of the "means essential" (CAD file) and the infringement (3D printing the object using the CAD file) actually occurs in the UK.
- CAD files cross borders undetected – this complicates the enforcement of IP rights. Physical goods that infringe IP rights can be seized by Customs.
- What IP can cover a 3D printed pill? A pharma company adopting 3D printing should consider what IP rights could be filed. Their existing patent portfolio may have been drafted to encompass conventional manufacturing techniques of pills rather than 3D printing. However a patent claim for a 3D printed formulation could be invalid for lack of inventive step – so careful consideration is needed.
- Prophylaxis rather than treatment? Pharma companies should act now to evaluate whether 3D printing could add value to their business and consider how their plans might be implemented (for example, by collaboration with researchers). It's called a disruptive technology for a reason; by the time it takes off in a particular sector it may be too late to get on the bandwagon.
Stella Wong is a counsel at Hogan Lovells