So, my last blog
post was on 3D printing technology in general, and I somewhat focused on the
stereolithography part since some of those patents were expiring very soon-- in
the next five days! I wanted to stick
to a similar topic for my second blog post this week, and wanted to talk about
3-D printing in tissue engineering applications. Usually, there are many
arguments with patents that are in the health and biology area (such as patents
on genetic sequences), because it is important to differentiate the human
innovation versus something made by nature.
The article I read
is titled, "A Look at The Patentability of 3-D Printed Human Organs".
Bioprinting is the intersection of 3D printing and inkjet printing to print
layers of living cells. Multiple layers of cells are stacked within a gel-based
material to form functional living tissue. As a bioengineer, I think this is
really interesting and exciting area. As of today, scientists have already
created functional 3D human blood vessels and mini-livers using this
technology. There is also the potential to generate entire human-sized living
organs (although there are some scientific challenges to overcome that I won't
get into here-- but feel free to ask me in person!).
In class, we all
have learned that patent protection is extremely important, for it allows
inventors to fully capitalize on their investment, by discouraging or delaying
competition. In this blog, I wanted to focus on some issues related to
patenting artificially created living human tissue. The patent office and Congress rule that
patens on human organisms are not eligible for patent protection. However,
according to the article, inventors have successfully been able to "obtain
protection for genetically engineered animals by narrowing the claim scope to
'nonhuman' subjects" [1]. One
example of this is U.S. Patent No. 8,088,968, which claims:
"a
'non-human mammal' with a particular genome composition where the nonhuman
mammal is a mouse. A 'tissue' of such nonhuman mammal is also separately
claimed."
Also, it is
important to note, that while the above is deemed patentable, the USPTO has
rejected patent claims on a human embryo under 35 U.S.C. Section 101 and also
because it violates Section 33(a) of the Leahy-Smith America Invents Act.
Back to bioprinting
human organs. The previous argument was for patenting animals other than
humans. What are some arguments in favor of patents for bioprinted organs?
"Rather
than viewed as products of nature, bioprinted organs and tissue may be
considered to be manmade living materials artificially arranged in accordance
with a particular printing geometry that facilitates any naturally occurring
cell behavior"[1].
One similar example
is U.S. Patent No. 8,394,141, which includes claims directed to an implant
created from "fibers of defatted, shredded, allogeneic human tissue"
such as "tendon, fascia, ligament, or dermis" and further including a
"growth factor" (which helps in the differentiation of cells to the
desired cell type). Allogenic tissue is basically tissue not from the same
individual (which would be autologous), but from the same species. Thus, if
patents on tissue-
engineered implants
are allowed, so should patents on bioprinted organs.
So, what do you guys
think? Do you think patents on bioprinted organs should be allowed or not?
Please respond in the comments below!
I really enjoy the bioprinting focus on your article. However, I do believe it is difficult to truly determine whether certain bioprinted organs are culturally acceptable in society. As the field of bioprinting and 3D-printing are constantly evolving, the laws also change sometimes on a case basis. It also depends on the type of patent. It would be understandable if the process or material preparation was patented.
ReplyDeleteFrom the example patent in this article, the claim is on transgenic animals and not humans. If the printed cells were human, there would be much controversy since the nature of the patent relates to a polarized issue depending on how the cells are used. The fact that the patent does relate to the issue of using live cells could not be beneficial in court depending on the jury. It would be interesting to see how the UPSTO plays this out.
I love the depth of technicality that some of these claims go into. "Rather than viewed as products of nature, bioprinted organs and tissue may be considered to be manmade living materials artificially arranged in accordance with a particular printing geometry that facilitates any naturally occurring cell behavior"[1]. That's ridiculous. Seems like this particular one is trying hard to reassure itself that this isn't a copy of nature
ReplyDeletePatenting the technology and process for bio-printing an organ should be allowed. When a tissue or organ is bio-printed it's done on a synthetic scaffold which is a polymer. So, if we're printing on a scaffold, this is definitely different from a normal organ. With bio-printing an organ, it's a completely different device. Furthermore, a bio-printed organ is functionally the same thing as a device. And, of course patenting a device is allowed. So, why not allow patents on technologies in this area? I believe this is what many research labs are now in the process of doing, given the growth in the area of regenerative medicine and tissue engineering.
ReplyDeleteI think the scaffolding itself can be patented, but not the organ itself or the resulting tissue. The method of cell deposition can be patented because it is also novel and has multiple applications. The organ itself is too modeled after something made by nature in my opinion. It's like growing an orange using a new type of fertilizer. You may be able to patent the fertilizer compound, but not the orange itself. Thoughts?
Delete"How about them apples?"
While I agree with Rahul, I think there needs to be more clarity on the issue. For example, the scaffold material composition can be patented, but the design should not be. There can be many ways to manufacture the scaffold such as a rib bone, but the design of the rib bone itself is derived from nature.
ReplyDeleteLikewise, there have been many published examples of 3d printed living ears, bladders, lungs and more. We know how they function and what kinds of cells are there based of biological analysis, so the organ should not be patentable, but the method of depositing the cells can be. Also, there has been study that specific scaffolding structures and layout can boost the survivability and growth of the cells, but since these are based on observations of cell growth on organs or similar, so the layout perhaps cannot be patented unless it is tagged to the material used. Otherwise, the monopoly held might be too great and turn others away from researching the same organ.
Wow, this was one of the most fascinating blog posts I read this week (it's especially cool because we're learning about the fundamentals of FDM (fused deposition modeling--the basis of 3D printing), but for completely different applications). I think it's an incredibly slipper slope that the USPTO will have to navigate. While there should not be any patents allowed on human organisms (well, they're "technically" man-made, but I suppose not in the eyes of the USPTO), clones and genetic engineering are very much man-made. I think the USPTO should take look at the issue from the following perspective: if there was no "man" there's no way these new techniques to generate artificial living organisms could be generated. It was because of man's ingenuity, hard work, and research that someone was able to develop the technology to produce living organisms. It would be terribly silly if the USPTO were not to award patents for these ideas. Having said that, I think that being able to use 3D printing machines to print organs is absolutely fascinating. I had no clue that was possible and will definitely read up on it!
ReplyDeleteI agree with Norman in the fact that the controversy somewhat holds in the level of acceptance society would have on patenting bioprint organs. Although the object is in no doubt a "man-made" object, it is essentially a clone of a very "nature made" part. Allowing this object to be patented would approach on slippery slope that the USPTO would have to establish very specific rules for. At the same time, I do believe that there should be a patent process in order to give credit to the people who have made an investment to achieve these bioprint products. What I would argue should be implemented, is an understanding of the process and identify where in the process the innovation is and allowing the patent of that. What I mean by the process, similar to what Jun Yi mentions, is the scaffolding structures that boost the sustainability and growth of the cells that is based on research and observations
ReplyDeleteYeah, I agree with Osama that is exactly what they are trying to do-- reassure others that this isn't a copy of nature. It is as if they are using geometry and math to do so also, and then saying that the functionality that is comes from the unique mathematical combination is just a byproduct of the design. The logic Rahul presented is also interesting-- that a bioprinted organ is normally made on a polymer, so it is not exactly the same as a normal organ. I think Jun also brought up an interesting point, especially since we learned about design patents versus utility patents in class. The layout of the ear is similar for all humans, so if one company decides to patent that, it would be a problem since other companies cannot work on the ear also. Also Jega-- yes, I agree it is a fascinating subject and you should definitely read up more about it if you are interested!
ReplyDeleteFascinating, Manali! This brings to mind the Myriad genetics gene patent case of 2012, in which the court ruled that since laws of nature cannot be patented, the biotech company could not patent the breast cancer genes they had isolated for breast cancer diagnosis. This set up a question of whether such innovative PROCESSES (as opposed to natural segment of gene) could warrant patent protection because it is actually novel, except the process is not tangible. With the claim struck down, venture capitalists are less willing to invest in small biotech startups because there lacks secure patent protection.
ReplyDelete