3D Printed Human Organs and the Debate on Applicable Patent Law

By Andrew Armstrong
October 7, 2015

kidney-organ-medical-335According to the non-profit group, United Network for Organ Sharing, there are over 122,000 individuals currently waiting for a life-saving organ transplant in the United States. Unfortunately for many of those on that wait list, a suitable donor will never be found for them, and they will succumb to their ailment or condition as a result. However hope may be on the horizon, as 3D printed human organs are coming increasingly close to being a reality according to several reports.

In addition to potentially saving thousands of lives every year, this ground-breaking technology raises issues related to patent law that cannot be ignored. Are human organs and/or tissues that are created through 3D printing process that use naturally-occurring cells eligible for patenting? Or are such organs and tissues considered to be products of nature and therefore ineligible for patenting?

The Technological Challenge of 3D Printing Human Organs

When attempting to use 3D printing-based technology to artificially create human organs, there are a number of inherent and significant challenges. Perhaps the most significant of these challenges involves the human biology, and the need to integrate patient-specific data to model and engineer a tissue structure that will not be rejected by the host body. In an article on Line//Shape//Space, pioneering 3D organ printing technology involving Tissue Structure Information Modeling (TSIM) software and a “BioAssemblyBot” six-axis 3D printer is presented a viable solution to overcoming these roadblocks.

TSIM is an intuitive design software that allows biologists and investigators to model in a 3D biological format. It lets designers import and integrate common patient-specific data such as CT scans and MRIs to aid the modeling. This element is significant because it allows scientists to continuously improve tissue-engineering “recipes” that enable assembly of biological material in a way that creates a functional tissue structure, and ultimately an entire organ.

Aside from the ramifications of such technology coming to fruition for patients awaiting organ transplants, there is a significant potential market size to consider. According to Nature.com, 3D printed body parts, namely comprised of comparatively simple structures like titanium replacement hip joints, already bring in an estimated $537m (US) annually.

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The Patentability of 3D Printed Human Organisms

With so much money at stake, inevitably there will be a rush to patent the technology that enables 3D printed organs, which brings the debate over applicable patent law to the forefront. As previously reported on IPWatchdog, the America Invents Act (AIA) included changes to the law so that “no patent may issue on a claim directed to or encompassing a human organism.” However, there is no given definition of what constitutes a “human organism,” meaning that ultimately the courts may be left to decide how the law should be interpreted.

However, there may be existing precedent to conclude that bioprinted materials, such as a 3D printed human heart, are in fact patentable. In the 1980 Diamond v. Chakrabarty Supreme Court Case, it was determined that genetic engineer Ananda Mohan Chakrabarty’s patent application on a bacterium capable of breaking down crude oil was valid because it was “non-naturally occurring,” and because it was a “product of human ingenuity.” A May 2015 article published in Genetic Engineering & Biotechnology News argues that innovations in the field of bioprinting would be eligible for patenting based upon the first prong of the two prong test established by the Chakrabaty ruling.

The first prong of the Chakrabarty test asks whether or not a bioprinted organ is a naturally occurring manufacture. The Supreme Court has defined the term “manufacture” as “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.”9 Based on this definition, a bioprinted organ is a “manufacture,” but is it also naturally occurring? Given the current state of bioprinting of organs and tissues, the answer to this question is a resounding “yes”.

Patent Attorneys Weigh In From Both Sides of the Atlantic

The case made by Judith L. Toffenetti, Ph.D. and Atabak R. Royaee, Ph.D. in Genetic Engineering & Biotechnology News is compelling, but the debate may not be so easily resolved according to patent law professionals I spoke with from both the U.S. and U.K.

Christopher Peil, a San Francisco and Silicon Valley-based patent practitioner who has an extensive background in biotech and technology, agrees with Toffenetti and Royaee that a 3D bioprinted organ satisfies the two prongs of the Chakrabarty test. In Peil’s view, a bioprinted organ is a synthetic organ, constructed from human stem cells, which is an approximate analog of a living organ, but, as Toffenetti and Royaee point out, there are so many structural differences between the printed organ and the live organ that it is clearly a non-natural manufacture. Also, the manufacture of the organ occurs only as a result of a manufacturing process, designed completely by humans, that assembles the cells into the final product, removing the bioprinted organ even further from the natural world.

Peil also concurs that bioprinted organs are a product of human ingenuity, noting that the stems cells do not spontaneously organize themselves into the organ as an organ is only achieved by laying down cell clusters in layers through the use of a precision electro-mechanical instrument driven by a human-written computer program. The entirety of the process requires an enormous amount of human ingenuity in his estimation.

However, Peil also countered that Chakrabarty is not the only test that must be satisfied, due to the passage of the America Invents Act (AIA) alluded to earlier. In our discussions he alluded to the problems inherent with the ambiguity in the language of the statute itself.

The big problem is that the language of the statute is ambiguous. Nobody really knows what it means. This particular section of the AIA uses language that hasn’t been used in the law before. Because the language has never been used in the law before, there is no common understanding of what a law means that includes such language.

For example, the phrase “directed to” is a term of art that is commonly used by patent attorneys when they are referring to a patent claim’s scope or to the subject matter of a patent claim. But it’s really just Patent Office/patent attorney jargon that has no commonly-accepted meaning.

The phrase “human organism” is another problem.   To me, a human organism means a human being, but reasonable minds can differ. One author pointed out that one reasonable dictionary definition of “human organism” could include “any living entity containing one or more cells belonging to the species homo sapiens.” This definition would arguably include our bioprinted organ within its scope, effectively rendering the bioprinted organ ineligible for patenting.

Because the AIA contains no explanation or definition of the statutory language, there is little clarity about what the law means, and it doesn’t provide the USPTO and/or the courts with much guidance in understanding and applying the law.

In Peil’s estimation, it will likely be left to the courts to decide what the law means, and the biases or beliefs of the ruling judge or judges may come into play. He continued that a better alternative would be for Congress to revisit this section of the AIA and fix the defects in the current law by supplying clear definitions of the statutory language.

For a second opinion on the matter, I contacted Tim Mount, legal counsel for Innovate Product Design of London. In Mount’s view, past decisions and precedents from cases involving genes, cloning, and pharmaceuticals may be informative in predicting the outcome of this issue.

Whilst patent protection is arguably the main driver for innovation in the medical field, it will always prove a problem to balance the competing (a) private interests of rewarding innovation, and (b) public needs for cost-effective treatment.

This is compounded by the pace of change and the nature of legal precedent. According to this, future developments and present decisions need to be referenced back to past decisions. This can be difficult to predict and navigate for courts. Similar issues have however arisen in the past, with reference to genes, cloning and even pharmaceuticals. And in general the balance has fallen in favor of the private on the basis that the public benefit. But some estimates assert that a fifth of the human genome is currently subject to patent claims. This seems to assert a philosophical view that discovery equals invention, and it is hard to say that private ownership seems appropriate.

In the increasingly global world though, it is worth noting that fights in the US (where questions continue over patented genomes) and India (where generic drugs seem to be undermining patent law) are over precisely this balance.

From a legal perspective, there is clearly ambiguity over the intent of the America Invents Act with respect to this issue, although the concept of 3D printed human organs would seem to meet both prongs of the Chakrabarty test. The public benefit of such bioprinted organ technology is without question given the thousands of lives that could potentially be saved. However, the financial interests of private entities involved in the development and production of such technology is by no means insignificant and will undoubtedly loom large in any future legal proceedings.

The Author

Andrew Armstrong

Andrew Armstrong is a technology enthusiast and digital marketing adviser based in the San Francisco Bay Area. A graduate of U.C. Berkeley in 2003, Andrew now lives in San Mateo, California with his wife and young son. Follow him on Twitter at @kickstartsearch

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 16 Comments comments.

  1. Night Writer October 7, 2015 9:24 pm

    This brings up the issue of whether a file that contains the information to print a 3D object is patent eligible.

  2. Anon October 8, 2015 6:20 am

    Is there not a recent denture case…?

  3. Night Writer October 8, 2015 9:16 am

    I think there was. I am not sure which case that was though. Need more traffic on this blog…

  4. Mr. V October 8, 2015 10:29 am

    I don’t see how disqualifying 3D printed organs from falling under 35 USC 101 could be reconciled with AMP v. Myriad (where cDNA was found to be patent eligible because of the level of human ingenuity required to generate DNA strands with only exons).

    Nevertheless, the AIA language is ambiguous and it will be interesting to see how this plays out as both the law and 3D printing technology continue to develop.

    Thanks for sharing.

  5. Andrew A. October 8, 2015 2:16 pm

    Mr. V – Thanks for bringing up the example of AMP v. Myriad. That is a useful precedent to look at, and is one I was not familiar with. – Andrew

  6. Gene Quinn October 8, 2015 2:22 pm

    Mr. V-

    The Supreme Court decision in Myriad did not say that all cDNA is patent eligible. The Court specifically said that cDNA is patent eligible unless it is identical to DNA. That is very problematic. cDNA can only be man made. So if man made cDNA is identical to nature then no patent. The whole goal of personalized medicine is to make something, such as an organ, identical to what occurs in nature. So if man were to achieve perfection it could not be patented. That can’t be the right outcome in my opinion.

    -Gene

  7. Mr. V October 8, 2015 2:43 pm

    Thanks for the distinction Gene. I agree with you and hope that will not be the outcome.

    Andrew – You’re welcome. I really enjoyed this article.

    – Mr. v

  8. curious October 8, 2015 3:33 pm

    Query, is not what is being 3-D printed in most cases merely a fine porous “scaffolding” material, suitable to grow live tissue on? That is, not actually 3-D ejection of live cells on top of other live cells to form a living organism? If so, is the subject here still academic?

  9. Gene Quinn October 8, 2015 4:24 pm

    curious-

    I have no idea. In the past I have read that there have been some significant breakthroughs used to create the structure of organs using crystal structures that can be essentially washed away once the organic material has been grown (or printed) around what is essentially a crystal scaffolding.

    Apologies for butchering the science here. I’m an Electrical Engineer by training. Can anyone else chime in with a better, true scientific explanation?

    -Gene

  10. A Rational Person October 9, 2015 11:12 am

    Gene,

    Actually, if you could grow or print a man-made organ for an adult human, the man-made organ would strictly speaking not be identical to a natural organ in at least one very important way: the age of the cells in the man-made organ.

    Now, whether a future Supreme Court could grasp the importance of this difference is another question.

    The current Supreme Court could not even grasp that a segment of a DNA molecule is different in at least one important way from a full chromosome including the sequence of the segment: you can duplicate the segment using polymerase chain reaction (PCR), something I do not believe it is technically possible to do with a full chromosome. Plus, if you only want to duplicate a particular segment of DNA using PCR, it would generally be desirable to start with just that segment and not a larger piece of DNA that includes the segment.

  11. Anon October 9, 2015 11:50 am

    ARP,

    “Age” of cells is material in what meaningful way? I think instead of an “important” difference, you have merely provided a difference that lacks distinction. The function is independent of the age.

    One of the problems that I have had with Gene’s views here is to the substance of the claim. Method claims as to creating something that is effectively the same as a natural item are different than manufacture claims to such an item. With manufacture claims, it simply does not matter that you reached the end state through either a natural or man made process, and the natural process fully rules out the man made item. You are free, still, to patent the man-made process, but you may not have an exclusionary right to some THING that nature provides.

    And this maxim applies fully and completely outside of the prior art effect of 102. I see far too many people wanting to make this a “prior art” argument when it is NOT a prior art argument. Nature is NOT static. The universe outside of the hands of man does change. Man may fully create a manufacture that is novel, but if during (or after) the term of that rightful patent, nature ALSO creates that item, then the patent is forfeit, not for a prior art reason, but for the 101 exclusion reason. The problem so many people have is the relative nature of time and cosmic change makes it appear that the universe is static (or merely static for all intents and purposes). Reality is simply different than that “common sense” view because that “commons sense” view while perfectly workable in nearly all situations is not how reality really is.

    Night Writer,

    The denture case was at the ITC:

    http://www.itcblog.com/search?searchword=digital%20models&searchphrase=all

  12. A Rational Person October 9, 2015 1:41 pm

    Anon @11

    The age the cells in the organ could matter. For many organs, the organs take years to reach their full adult size so you’ve got the possibility of mutations of the chromosomes and imperfect cell divisions. With a mature organ in which the cells do not regenerate you have issues with the cells and tissues breaking down due to age, and even the effects of gravity.

    An organ made out of new cells could be more resistant to developing cancer, for example, because the cells that make it are newer.

  13. Anon October 9, 2015 2:12 pm

    ARP,

    No. Young organ still function as organs. Your difference remains a difference without distinction.

  14. Anon October 9, 2015 2:20 pm

    However…

    If you do indeed make an organ that is cancer-proof, that then may very well be a difference in kind that would merit patent protection.

  15. A Rational Person October 9, 2015 2:39 pm

    Anon@13 and 14,

    Are you seriously arguing that the age of an adult organ doesn’t affect its functioning or its likelihood to breakdown? Would you argue that a typical organ in an 80 year old functions the same as the same organ in a 20 year old? With a man-made organ, you could have an adult-sized organ that is just days, weeks or months old and such a “young” adult-sized organ might not exist in nature.

    Also, man-made adult organ could inherently be more cancer resistant than a natural adult organ. From wikipedia:

    “According to cancer researcher Robert A. Weinberg, “If we lived long enough, sooner or later we all would get cancer.”[156] Some of the association between aging and cancer is attributed to immunosenescence,[157] errors accumulated in DNA over a lifetime,[158] and age-related changes in the endocrine system.[159] The effect of aging on cancer is complicated with a number of factors such as DNA damage and inflammation promoting it and a number of factors such as vascular aging and endocrine changes inhibiting it.[160]”

    The cells in a man-made organ would effectively be a different material than the cells that make up a natural organ.

    As just one example of how aging affects an organ, consider human skin. A young person’s skin is an entirely different material than an older person’s skin.

    Also, just the effects of living can change an organ. As I indicated, even the effects of gravity over the years can affect an organ, not to mention such things as the exposure of cells to the oxygen in blood for years and years.

  16. Anon October 11, 2015 12:26 pm

    ARP,

    I do understand what you are trying to claim, but you are not there.

    Your desire to claim a replica of a human organ that is full size, but the age of a new born organ will fail.

    Size alone is not a patentable difference. The new born organ has all the functionality of your replica, with the only difference being one of size.

    You need something more.

    Now if you want to claim a replica organ with different cells (with size not being a factor), then that is a different argument. But you cannot claim a replica organ with human cells that differentiates only in size (new born to adult). Patent law does not permit that.