Patenting Bioprinting

Patent Bioethics Digest Symposium

“Patenting tends to get people's juices flowing when you put the word 'gene' and the word 'patent' in the same sentence.”—Francis Collins

 Alas, naturally occurring genes are not patentable.[1]But what about bioprinting?

Dr. Anthony Atala recently gave two TED talks, Growing New Organs[2] and Printing a Human Kidney[3], presenting that bioprinting, the3D-printing living tissues, is real and may be widely available in the near future. This emerging technology has generated controversies about its regulation; the Gartner analyst group speculates a global debate in 2016 about whether to regulate bioprinting or ban it altogether.[4]

Another equally important issue is whether bioprinting is patentable. The U.S. Patent and Trademark Office (Patent Office) has already granted some bioprinting patents and many more patent applications are pending.[5]Although these patents are presumed valid, their validity will likely be litigated and the U.S. Supreme Court might have to settle this issue in due course.

One might intuitively assume that bioprinting is not patentable because the law generally prohibits patenting human organisms.[6]However, the issue is not so simple. This Article breaks down this complex issue and analyzes the patentability of bioprinting given the current landscape of patent law.

This Article concludes that bioprinting is patentable and that bioprinting process claims are easier to patent than bioprinting product claims. Current bioprinted human living tissues are functionally similar but structurally different than real human living tissues. Until scientists can bioprint structurally similar living tissues, bioprinted products are in the clear to be patent-eligible subject matter.

However, regardless of whether bioprinting is patentable, an interesting question to consider is whether bioprinting should be patentable. After weighing both sides’ arguments, this Article proposes a potential compromise: granting patents for only bioprinting process claims, not product claims. This proposal aligns well with the current landscape of patent-eligible subject matter—bioprinting process claims are being patented whereas bioprinting product claims would likely run into opposition and challenges.

This article proceeds in four parts. Part I discusses bioprinting and cloneprinting, and the current landscape of patent subject matter eligibility. Part II explores how bioprinting can be patentable, whereas Part III explores whether bioprinting should be patentable. Part IV concludes.

I. Bioprinting &The Patent Landscape

A. Bioprinting& Cloneprinting

The author discussed the science behind bioprinting extensively in his other Article.[7]In short, bioprinting uses synthetic biology’s basic building blocks and the 3D printer’s mechanics to form functional living tissues by stacking multiple layers of cells within a gel-based material. The author coined the term “cloneprinting” to denote the bioprinting of an entire copy of an organism, either naturally existing or man-made.

B. The Patent Landscape: Patent Subject Matter Eligibility

Patent-eligible subject matters include “process, machine, manufacture, [or] composition of matter,” but not “laws of nature, physical phenomena, and abstract ideas.”[8]Essentially, “anything under the sun that is made by man” is patentable.[9]For example, the Patent Office has granted patents for nonhuman organisms such as plants and animals.[10]However, “no patent may issue on a claim directed to or encompassing a human organism.”[11]Thus, the patentability of human bioprinting is more complex than bioprinting of nonhuman organism.

II. BIOPRINTING CAN BE PATENTABLE

A. Bioprinting Product Claims

1. No “Product of Nature” Claim: Chakrabarty’s Two-Prong Test

To avoid the “product of nature[’s]” hammer, a claim must satisfy a two-prong test: (1) a product of human ingenuity and (2) nonnaturally occurring.[12]The Supreme Court held in Diamond v. Chakrabarty that oil-eating bacteria are patent-eligible subject matter because such bacteria were man-made and could not be found in nature.[13]Conversely, the Supreme Court held in Association for Molecular Pathology v. Myriad that an “isolated” DNA fragment was not patent-eligible subject matter. [14] Because its genetic information was neither created nor altered, it did not qualify as a product of human ingenuity and because isolating DNA from its surrounding genetic material did not significantly add to DNA’s natural state, it did not qualify as nonnaturally occurring.[15]

Accordingly, bioprinting’s patentability depends on whether a bioprinted product is a product of human ingenuity and nonnaturally occurring. Technically, anything related to bioprinting is a result of human ingenuity: both bioprinting processes and bioprinted products are man-made. The more difficult-to-satisfy prong is proving that a bioprinted product is nonnaturally occurring. If a bioprinted organism or its living tissue is an exact replica of a naturally occurring organism or its living tissue, then that bioprinted product is not patent-eligible subject matter. Conversely, if a bioprinted organism or its living tissue is a complete redesign of another naturally occurring organism or its living tissue, then that bioprinted product can be patentable.

Current state of the art of bioprinting products falls into in the latter category. Current bioprinted human living tissues are functionally similar but structurally different than real human living tissues. Until scientists can bioprint structurally similar living tissues, bioprinted products are different enough from their naturally-occurring analogs to be patent-eligible subject matter.

2.No “Human Organism” Claim: The AIA § 33(a)

Bioprinting claims must face another scrutiny from the AIA § 33(a), which forbids issuance of patents “directed to or encompassing a human organism.”Courts could potentially construe § 33(a) broadly to derail patent eligibility of many inventions, including bioprinting.[16]But until the legislature or courts interpret “directed to or encompassing a human organism,” the Patent Office can reject any bioprinting claim “directed to” or “encompassing” human under the broadest reasonable interpretation.[17] Patent prosecutors must carefully draft bioprinting claims to avoid falling into this pothole. One possible way is to couch bioprinted human living tissues as implants or medical devices to use in a human body. For example, U.S. Patent No. 8,394,141 claims an implant formed from “fibers of defatted, shredded, allogeneic human tissue” including a “tendon, fascia, ligament, or dermis” and a “growth factor” (to induce cell growth).

B. Bioprinting Process Claims

Even if bioprinting did not pass the gatekeeper of § 101, bioprinting can still be patentable as process claims rather than products claims. Rather than focusing on the forbidden products, a bioprinting process claim can be directed toward the printing activities. As long as a bioprinting process claim does not depend on bioprinted products i.e., avoiding mentioning the forbidden products, such claim can be patentable. For example, U.S. Patent No. 7,051,654 claims a method of “forming an array of viable cells”; U.S. Patent No. 8,691,974 claims a method of “producing 3-D nano-cellulose based structures.” Put simply, although 3D-printed cells could theoretically be used in unpatentable products later, the 3D printing process itself does not per se violate the principle of no patent for human organisms.

Several recent Supreme Court cases addressing patentable subject matter seem, at first, relevant to discussing bioprinting: (1) Mayo v. Prometheus, which clarified the patentability of process claims; and (2) Alice v. CLS Banks, which discussed the patentability of computerized algorithms. Neither case, however, preempts the patentability of bioprinting. In Mayo v. Prometheus, the Supreme Court held that when a claimed process was merely a law of nature, the result was not patentable.[18]Because bioprinting’s processes were created by scientists and not found in nature, bioprinting does not qualify as a “law of nature.” Therefore, Mayo does not apply to bioprinting process claims. Unfortunately, besides Mayo, there is no closer case where the process was patentable despite being closer to a law of nature than bioprinting is. Meanwhile, Alice v. CLS Banks scrutinized the patentability for software patents. 3D printing and bioprinting do not fundamentally depend on software, but print using an electronic blueprint—i.e., a Computer-Aided Design file (“CAD file”). Thus, Alice does not necessarily affect the patentability of 3D printing and bioprinting. [19]

C. Cloneprinting

The Federal Circuit in In re Roslin Institute found that a clone which was the exact genetic copy of a naturally existing animal (in this case, a sheep) was not patent-eligible subject matter.[20] There is no reason to expect that a clone made by any other process would be treated differently.[21] However, in the wake of Chakrabarty, numerous patents have been filed on transgenic organisms. For example, U.S. Patent No. 8,088,968 claims a transgenic animal (e.g., a mouse) and its tissues. Accordingly, cloneprinting of a naturally existing organism is likely not patentable, but cloneprinting of a man-made organism (i.e., a genetically engineered animal) could likely be patentable.

III. SHOULD BIOPRINTING BE PATENTABLE?

A. Why Bioprinting Should Be Patentable

The reasons for bioprinting to be patentable mirrors the rationale of having a patent system and granting patents in the first place: to promote innovation and to incentivize inventors to recoup their investments.

The patent system exists to promote innovation. Inventors disclose their inventions to the public in exchange,quid pro quo, for a 20-yearmonopoly of that invention.This exclusivity period allows them to recoup their investment in research and developments. Without this exclusivity period, inventors lack the incentive to invent. Therefore, the patent system existsto promote innovation.

Bioprinting is still in its infancy.[22] Without further research and development, bioprinting would likely not mature and such technology would plateau, much like, for example, cloning or stem cell research technology did.[23] Granting bioprinting patents would encourage research and development because patents incentivize inventors to innovate.

Granting bioprinting patents has both benefits and drawbacks. Granting bioprinting patents allows more bioprinting advances and thus, makes bioprinting available sooner. However, granting bioprinting patents would likely drive up the cost to bioprint because a portion of that cost would go into paying for inventors’ patent rights. On one side, at least some people would be able to afford to bioprint, whereas on the other side, everyone would have to wait longer until the bioprinting technology becomes available. One of these outcomes is clearly preferable; every day without bioprinting results in real people having diminished quality of life or even dying, and there is simply no time to waste in bringing the bioprinting technology to the market. Because time is the more important variable between cost and time, bioprinting should be patentable.

B. Criticism of Patenting Bioprinting: Condoning Humans “Playing God”

Granting bioprinting patents condones and validates humans “playing God.” To play God is to disregard creation, and to meddle with things that are “natural.”[24]“Playing God” is a common religious criticism to modern biotechnology.

“Playing God” is a rather overplayed criticism, as it has surfaced in such diverse topics as anesthesia, contraception, transplantation, brain death diagnosis, stem cell research, genetic engineering, and synthetic biology.[25]Almost everything humans currently do can be viewed as “playing God.” From building houses for shelter (rather than living in natural caves) to typing up documents (rather than carving on stones), our species excels in using technology to change the status quo. What makes bioprinting different than building houses for shelter? If humans play God, they risk offending many people, including those who belong to established religions. But if humans do not play God, they would not discover, progress, and innovate. On balance, it seems better to play God while keeping this ethical consideration in mind; thus, bioprinting should be patentable.

C. A Compromise: Bioprinting Process, but not Product, Claims Should Be Patentable

After weighing both sides’ arguments, this Article proposes a potential compromise: granting patents for only bioprinting process claims, not product claims. This proposal aligns well with the current landscape of patent-eligible subject matter—bioprinting process claims are being patented whereas bioprinting product claims would likely run into opposition and challenges. For bioprinting, process claims are indeed easier to patent than product claims.

This compromise would likely retain the benefits of promoting innovation and incentivizing inventors—inventors can still recoup their investments by some but not a lot—while only condoning some—but not all—examples of humans “playing God” violation. Furthermore, while granting patents on the product of bioprinting could result in a staggering number of patents – every new permutation on a type of tissue would be eligible – limiting patents to processes for bioprinting would result in a more finite number of patents.

IV. CONCLUSION

This Article discussed whether bioprinting is patentable, how bioprinting can be patentable, and whether bioprinting should be patentable. This Article then proposed a compromise: granting patents for only bioprinting process claims, not product claims. Only time will tell how bioprinting’s patent landscape will play out.



[1] Association for Molecular Pathology v. Myriad Genetics, 133 S.Ct. 2107, 2109–10 (2013).
[2] Anthony Atala, Growing New Organs, TED (Oct. 2009), http://www.ted.com/talks/antho... (presenting that instead of harvesting or transplanting human organs, Anthony Atala’s lab grows human organs—from muscles to blood vessels to bladders, and more).
[3] Anthony Atala, Printing a Human Kidney, TED (Mar. 2011), [hereinafter TED talk: Printing Human Kidney], http://www.ted.com/talks/antho... a 3D printer using living cells to output a transplantable kidney).
[4] Gartner Says Uses of 3D Printing Will Ignite Major Debate on Ethics and Regulation, Gartner.com (Jan. 29, 2014), available at http://www.gartner.com/newsroo... (“Rapid development of 3D bioprinters will spark calls to ban the technology for human and nonhuman use by 2016”). For a discussion on the bioprinting market, see generally Root Analysis Priv. Ltd., 3D Bioprinting Market, 2014–30 (2014).
[5] See, e.g., U.S. Pat. No. 6,942,830; U.S. Pat.No. 7,051,654; U.S. Pat. No. 8,691,274.
[6] See, e.g., Leahy-Smith America Invents Act § 33(a) (2012);Dennis Crouch, Patents Encompassing a Human Organism, PatentlyO (Dec. 2, 2012), http://patentlyo.com/patent/2012/12/ex-parte-kamrava.html.
[7] SeeJasper L. Tran, To Bioprint or Not to Bioprint, 17 N.C. J.L. & Tech. ___ (forthcoming 2015) [hereinafter Tran, To Bioprint], available athttp://ssrn.com/abstract=2562952.
[8] 35 U.S.C. § 101 (2012).
[9] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
[10] SeeRyan Hagglund, Patentability of Human-Animal Chimeras, 25 Santa Clara Computer& High Tech. L.J. 51, 61–66 (2009).
[11] Leahy-Smith America Invents Act § 33(a) (2012).
[12] Chakrabarty, 447 U.S. at 309–10.
[13] Id.
[14] 133 S. Ct. at 2109–10.
[15] Id.
[16] Ava Caffarini, Comment, Directed to or Encompassing A Human Organism: How Section 33 of the America Invents Act May Threaten the Future of Biotechnology, 12 J. Marshall Rev. Intell. Prop. L. 768, 770 (2013).
[17] See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005).
[18] 132 S.Ct. 1289, 1291–92 (2012).
[19] 134 S.Ct. 2347, 2357–59 (2014).
[20] 750 F.3d 1333, 1337 (Fed. Cir. 2014).
[21] See id.
[22] See Mark A. Lemley, IP in a World Without Scarcity, 90 N.Y.U. L. Rev. 460, 471 (2015) (“3D printing is in its infancy”).
[23] See Tran, To Bioprint.
[24] See Peter Dabrock, Playing God? Synthetic Biology as a Theological and Ethical Challenge, 3 Systems & Synthetic Biology 47–54 (2009).
[25] Id. at 48.