By Haopeng Wang ‑ April 11, 2017
Medical techniques can be personalised through technology, accelerating drug discovery and reducing development costs. What opportunities will 3D printing afford the pharmaceutical industry?
Drug research and development (R&D) can be drastically improved by 3D printing and the technology could even be used to print human organs and tissue. This would allow companies to test drugs cheaply – without compromising safety – and reduce outgoing development costs. As a result of improved target selection, preclinical tests, clinical trials, chemical synthesis, and product management – research should become more efficient.
Take the recent decision by the US Food and Drug Administration (FDA) to approve SPRITAM - an anti-epilepsy medication. SPRITAM employs 3D printing methods to produce its “porous formulation that rapidly disintegrates with a sip of liquid.” Thought to be the first 3D-printed pharmaceutical on the American market, SPRITAM allows epileptic patients with swallowing difficulties to medicate themselves.
SPRITAM was developed by Aprecia Pharmaceuticals, a company that has built a significant IP portfolio to support the 3D printing of drugs. With patents such as US 8,888,480 for “Three-Dimensional Printing System and Equipment Assembly” and US 9,492,380 for a “Rapidly Dispersible Dosage Form of Topiramate”. The company has an exclusive worldwide license for 3D printing technology, originally developed at the Massachusetts Institute of Technology (MIT) for use in pharmaceutical applications.
One of the most cited patents in the 3D printing field is US 5,518,680 for “Complex drug delivery systems and cell regeneration templates provided by computer aided design of solid free-form fabrication processes to form sequential polymeric layers”. This patent was originally filed by MIT.
3D printing techniques also have the potential to drastically widen the distribution of drugs in developing countries and lower the cost of drug production.
3D printing is the process of making three dimensional solid objects from a digital file. Once the initial product has been engineered, it can be cloned on a large scale. However, the mass reproduction of 3D printed drugs and products is a growing concern for IP owners. The commercialisation of 3D printing will lead to a large number of small-scale manufacturers and this will make policing IP increasingly complex.
Will 3D printing amount to infringement of IP? And will home-users themselves face confusion as to what they can and cannot legitimately print?
Most branded drugs are patented so manufacturers can recover the billions of dollars invested in R&D during drug development. After 20 years these patents expire and – in a process overseen by the FDA - generic drug makers can clone the medicine. However, empowering individual pharmacies and smaller entities to clone drugs through 3D printing jeopardises this patent protection. The chemical compounds that make up drugs can potentially be reverse engineered and cloned very quickly without expensive manufacturing.
If a pharmaceutical company licenses a drug to other healthcare providers, it will be impossible to ensure the efficacy of every 3D printing operation. Based on its role in providing a product’s blueprint, the firm could be held partially liable for any adverse incidents or if a product defect were to occur. The FDA is not able to regulate every instance of 3D printing. Determining the safety of products and responsibility for adverse events is a murky legal area.
3D printing also increases the threat of counterfeit medicines. Printers are much more vulnerable to hackers than traditional manufacturing processes, and the incredibly short production time magnifies this risk.
The pharmaceutical industry relies on innovation to create medical treatments. Through the adoption of technology, the pharmaceutical industry is producing new medical offerings, improving its internal R&D processes and cutting costs. If pharmaceutical companies embrace the benefits of technology investment they will reduce unnecessary outgoings and pharmaceutical companies will reap rewards in the future.
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