Did you know that since 2013 cosmetics giant L’Oreal Group hasn’t tested its products on animals? Instead, it has been relying on “reconstructed human epidermis” — basically bits of skin grown in a lab — to ensure that its products are safe. Scientists have successfully bioprinted various living human organs like the skin, liver, bones, heart valves, stem cells and blood vessels and have a lot of others in the pipeline like kidneys, thyroid gland and eyes.
Tissue culture and engineering has reached a new level with 3D bioprinting. These laboratory designed tissues are expected to speed up drug development, implants and clinical trials, and are hence attracting attention and interest of pharmaceutical and cosmetic companies globally. It is no wonder that L’Oreal is just one of several companies that has partnered with 3D bioprinting company Organovo to procure skin tissues in large volumes. L’Oreal will use Organovo’s NovoGen bioprinting platform to identify key architectural and compositional elements of a targeted skin tissue and create a specially formulated bio-ink or multicellular building block for it. The tissue will be built in vertical layers.
From tissues to a beating heart
3D bioprinting of human tissue has been around since the early 2000s. Today, scientists are moving from printing tiny sheets of tissue to entire 3D organs. Attempts to develop 3D printed complex human organs like heart, liver, kidney, blood vessels and skin grafts are on the rise. Researchers at the Wake Forest Institute for Regenerative Medicine have developed live beating heart tissues called “Organoids” using 3D printing. In fact, Merck & Co., has partnered with Organovo to use 3D printed human liver systems for toxicology testing as a supplement to in-vitro and preclinical animal testing.
Synthesizing stem cells the 3D way
Researchers led by Ali Brivanlou, Robert and Harriet Heilbrunn from the Laboratory of Stem Cell Biology and Molecular Embryology at Rockefeller University took an entirely different approach for synthesizing stem cells. Instead of relying on the conventional synthesis and purification procedures, they used 3D printing. Stem cells bear the capability to turn into any of the 220 different types of cells within the human body posing a great potential for cell repair and regeneration. With 3D bioprinting techniques in place, these cells can be created outside the body as per specifications to quicken medical aid.
Patents protecting bioprinting
Organovo being a dominant leader in this field has filed several patents and pending applications to protect its 3D bioprinting platform. Patent application US 20130164339 claims the method and bioengineered tissue cells produced thereof.
A method for making an implantable tissue or organ comprising a muscle cell-containing layer, the method comprising:
- bioprinting bio-ink comprising muscle cells into a form; and
- fusing the bio-ink into a cohesive cellular structure; provided that the tissue or organ is implantable in a vertebrate subject and not a vascular tube.
A detailed patent landscape analysis report published by Coller IP, suggests that the top applicants in 3D bioprinting are Organovo and Therics, while Drexel University and Massachusetts Institute of Technology are among the top universities working in this field. Universities of Wake Forest, Virginia, Texas and Missouri are the other universities actively researching this technique.
Researchers are primarily focusing on developing 3D printing of biosensors, small medical appliances and implants. There is also a range of patents that describes image analysis techniques to produce printable models, and a significant number of patents describing ink handling. Among bioprinting patents, the majority of patents describe bone printing, or cellular implants that can aid bone healing.
While the US patent office and the Congress view patent claims encompassing a human organism as not eligible for patent protection, patent applicants have been successful in obtaining protection for genetically engineered animals by narrowing the claim scope to non-human subjects like a mouse. A tissue of such a non-human mammal is also separately claimed. However, would claiming a bioprinted collection of human tissue or a human organ be eligible for patent protection?
Several arguments in favour of bioprinting exist. For instance, rather than being viewed as products of nature, bioprinted organs and tissue may be considered as manmade living material artificially arranged in accordance with a particular printing geometry that facilitates any naturally occurring cell behaviour (U.S. Supreme Ruling for Diamond vs Chakraborty case). Additionally, while patent claims including a human embryo have been rejected by the patent office under 35 U.S.C. Section 101 as being directed to a non-patentable human organism, as well as being in violation of Section 33(a) of the Leahy-Smith America Invents Act, stand-alone bioprinted human organs and tissue should not be considered as encompassing a human organism.
The question of whether and to what extent human organs and human-like organisms fabricated in the laboratory can be patented will have to be left to the Supreme Court for future. Until then, we hope 3D bioprinting continues to grow to help the medical fraternity provide quicker relief to patients suffering from what-is-considered-incurable diseases.
(Featured image source: https://commons.wikimedia.org/wiki/File:3Dprinting_2.jpg)