Bioprinting: A life sciences and legal innovation


The patent eligibility of bioprinted products and processes has not been squarely addressed by the legislature or tested in the courts. Arlene Chow and Nitya Anand of Hogan Lovells explain what could be done in the future.

The medical industry is undergoing a radical transformation, thanks to recent advances in 3D (otherwise known as additive) printing. 3D printing creates three dimensional objects by building up layers of material. A commonly-used analogy is the building of a structure with layer upon layer of lego bricks. Bioprinting, in turn, takes the basic premise of 3D printing and applies it in the context of human cells and tissues—one of bioprinting’s most dramatic applications is the layered printing of living cells to form a 3D organ structure.

The hope is that such 3D printed organs can sidestep rejection (a major concern for organ transplants) and function as well as the original organ within a human. As with many cutting edge technologies, it is unclear whether innovators in this space can adequately protect their inventions with patents and more specifically, whether certain bioprinting products and processes are even eligible for protection.

The current patent eligibility framework

Section 101 of the US Code’s Title 35 defines patent-eligible subject matter as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. To be eligible for a patent, an invention typically must fall under one of these four categories. Historically, courts have concluded that laws of nature, natural phenomena and abstract ideas are not patent-eligible subject matter. In the 1980 Diamond v Chakrabarty case, the Supreme Court declared that §101 covers anything “under the sun that is made by man”, and that a man-made and genetically engineered living organism could nonetheless be patented. The Chakrabarty court contrasted patentable new bacterium, comprising of “markedly different characteristics from any found in nature” and a product of Chakrabarty’s “handiwork”, from a patent-ineligible mixed culture in the 1887 Hartranft v Wiegmann case, where the patentee’s effort in combining bacteria caused no unnatural change in their species, their utility, or their effect.

Following Chakrabarty, in evaluating patent eligibility of a living organism, a court initially evaluates whether the invention is naturally occurring, and then whether the invention is a product of human ingenuity.

In two recent Supreme Court decisions, Mayo v Prometheus of 2012 and Association for Molecular Pathology v Myriad of 2013, the court shed light on circumstances under which inventions implicating a naturally occurring organism may be susceptible to a patent-eligibility challenge under §101. In Mayo, the court decided that a set of specific steps in a diagnostic method were patent ineligible because the claimed process simply reflected a law of nature. In reaching this outcome, the court declared that if “a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolise the law of nature itself”.

Similarly, in Myriad, the court found that an isolated but naturally occurring DNA segment was patent ineligible. However, in that same case, the court found that cDNA—a type of manipulated DNA with certain regions removed—was patent eligible because it implicated a new, non-naturally occurring, structure. In the aftermath of these two decisions, the US Patent and Trademark Office (USPTO) proceeded to reject substantial numbers of pending patent applications involving nature or natural phenomena pursuant to §101.

Application of current framework to bioprinting

The full ramifications of Mayo and Myriad are unclear, but those the Supreme Court decisions may have a positive impact on the patent eligibility of bioprinting innovations. In their current state, bioprinting processes and methods will likely be deemed patent eligible under the court’s framework. Like the patent-eligible cDNA in Myriad, bioprinted tissues and organs are manmade and distinguishable from naturally occurring organisms. As of now, a bioprinted organ is not an exact replica of the naturally occurring organ from which it is based. As a result, the bioprinting process is creating a new product that is merely modelled on something that is naturally occurring. Similar to cDNA, which the court found to be “distinct from the DNA from which it was derived”, the bioprinted organ is distinct from the organ from which it was derived.

Ironically, perfecting bioprinting could negatively affect patent eligibility under §101. In litigation focusing on cloned sheep, the Court of Appeals for the Federal Circuit found in 2014 that the “Dolly” clone was “an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature’”. Citing Myriad, the court found there was not enough man-made genetic modification of Dolly in relation to the original sheep, so the patent for the clone failed as per §101.

Analogously, although the bioprinting process is the result of human ingenuity, a perfectly bioprinted organ could be considered a clone of the original, naturally occurring organ, since it would contain the same DNA structure without additional, synthetic alterations to that genetic information. Currently, bioprinted tissues and organs are not sophisticated enough to be considered a clone, but this anticipated development may be a future complication, patent-wise.

Implications of America Invents Act

35 USC §101 is not the only statute bearing on patent eligibility of bioprinting. The recent patent reform statute, the Leahy-Smith America Invents Act (AIA), specifically addresses the patent eligibility of naturally occurring technologies. Section 33(a) recites: “Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” Notably, there is no legislative guidance on the undefined terms “directed to” and “human organism”.

This vague wording could negatively affect the patent eligibility of bioprinting innovations. Indeed, the courts could deem bioprinted tissues and organs as “directed to or encompassing a human organism”.

A memo issued by the USPTO provides support for carving out bioprinted tissues and organs from §33(a). Following its passage in 2011, the USPTO issued a memo from Robert Bahr, senior patent counsel and acting associate commissioner for patent examination policy, regarding claims directed to or encompassing a human organism. In that memo, the USPTO explicitly states that §33(a) does not alter current law or USPTO policy that a claim “encompassing a human being is not patentable”. Given that the USPTO applied the term human “being” to explain what is meant by human “organism” as recited in §33(a), an argument can be made that the USPTO has excluded bioprinted tissues and organs from §33(a), such that bioprinting processes and products are still patent eligible.

Later in that same memo, the USPTO references how its policy is reflected in Section 2105 of the Manual of Patent Examining Procedure (MPEP). That provision states that a patent-eligibility rejection pursuant to §101 must be made if “the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism”. The meaning of human “organism” as recited in §33(a) is still subject to judicial interpretation.

To ensure that a bioprinting-related product claim passes §101 scrutiny, the claim should focus on man-made characteristics, qualities, and alterations rather than naturally occurring methods or matter. By focusing on how the product has “markedly different characteristics” from the naturally occurring organ upon which it is based, the bioprinted organ can be viewed as distinct from what occurs in nature and as a product of human ingenuity. As for bioprinting-related process claims, due to concerns stemming from §33(a) and §101, and the current case law, such process patents may be preferred to patents on a bioprinted product. Because scientists create and design bioprinting processes, such processes do not occur naturally and should not fall prey to the “law of nature” complication under Mayo and §101.

Bioprinting processes should pass the Chakrabarty two-prong test as a product of human ingenuity and a non-naturally occurring event. And the bioprinting process cannot be analogised to merely isolating or removing naturally occurring material or processes as in the failed patents in Myriad and Mayo. Although bioprinting attempts to replicate a naturally occurring and living organism, there is nothing natural in the manmade method by which a 3D printer builds layers upon layers of living cells.

Bioprinting has dramatically changed the life sciences landscape with the potential to revolutionise patient care. But the patent eligibility of bioprinted products and processes has not been squarely addressed by the legislature or tested in the courts. Until then, innovators in this space should capture their inventions with a wide variety of patent claims, framed to emphasise the manmade and non-naturally occurring aspects of this cutting edge technology. IPProThe medical industry is undergoing a radical transformation, thanks to recent advances in 3D (otherwise known as additive) printing. 3D printing creates three dimensional objects by building up layers of material. A commonly-used analogy is the building of a structure with layer upon layer of lego bricks. Bioprinting, in turn, takes the basic premise of 3D printing and applies it in the context of human cells and tissues—one of bioprinting’s most dramatic applications is the layered printing of living cells to form a 3D organ structure.

The hope is that such 3D printed organs can sidestep rejection (a major concern for organ transplants) and function as well as the original organ within a human. As with many cutting edge technologies, it is unclear whether innovators in this space can adequately protect their inventions with patents and more specifically, whether certain bioprinting products and processes are even eligible for protection.

The current patent eligibility framework

Section 101 of the US Code’s Title 35 defines patent-eligible subject matter as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. To be eligible for a patent, an invention typically must fall under one of these four categories. Historically, courts have concluded that laws of nature, natural phenomena and abstract ideas are not patent-eligible subject matter. In the 1980 Diamond v Chakrabarty case, the Supreme Court declared that §101 covers anything “under the sun that is made by man”, and that a man-made and genetically engineered living organism could nonetheless be patented. The Chakrabarty court contrasted patentable new bacterium, comprising of “markedly different characteristics from any found in nature” and a product of Chakrabarty’s “handiwork”, from a patent-ineligible mixed culture in the 1887 Hartranft v Wiegmann case, where the patentee’s effort in combining bacteria caused no unnatural change in their species, their utility, or their effect.

Following Chakrabarty, in evaluating patent eligibility of a living organism, a court initially evaluates whether the invention is naturally occurring, and then whether the invention is a product of human ingenuity.

In two recent Supreme Court decisions, Mayo v Prometheus of 2012 and Association for Molecular Pathology v Myriad of 2013, the court shed light on circumstances under which inventions implicating a naturally occurring organism may be susceptible to a patent-eligibility challenge under §101. In Mayo, the court decided that a set of specific steps in a diagnostic method were patent ineligible because the claimed process simply reflected a law of nature. In reaching this outcome, the court declared that if “a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolise the law of nature itself”.

Similarly, in Myriad, the court found that an isolated but naturally occurring DNA segment was patent ineligible. However, in that same case, the court found that cDNA—a type of manipulated DNA with certain regions removed—was patent eligible because it implicated a new, non-naturally occurring, structure. In the aftermath of these two decisions, the US Patent and Trademark Office (USPTO) proceeded to reject substantial numbers of pending patent applications involving nature or natural phenomena pursuant to §101.

Application of current framework to bioprinting

The full ramifications of Mayo and Myriad are unclear, but those the Supreme Court decisions may have a positive impact on the patent eligibility of bioprinting innovations. In their current state, bioprinting processes and methods will likely be deemed patent eligible under the court’s framework. Like the patent-eligible cDNA in Myriad, bioprinted tissues and organs are manmade and distinguishable from naturally occurring organisms. As of now, a bioprinted organ is not an exact replica of the naturally occurring organ from which it is based. As a result, the bioprinting process is creating a new product that is merely modelled on something that is naturally occurring. Similar to cDNA, which the court found to be “distinct from the DNA from which it was derived”, the bioprinted organ is distinct from the organ from which it was derived.

Ironically, perfecting bioprinting could negatively affect patent eligibility under §101. In litigation focusing on cloned sheep, the Court of Appeals for the Federal Circuit found in 2014 that the “Dolly” clone was “an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature’”. Citing Myriad, the court found there was not enough man-made genetic modification of Dolly in relation to the original sheep, so the patent for the clone failed as per §101.

Analogously, although the bioprinting process is the result of human ingenuity, a perfectly bioprinted organ could be considered a clone of the original, naturally occurring organ, since it would contain the same DNA structure without additional, synthetic alterations to that genetic information. Currently, bioprinted tissues and organs are not sophisticated enough to be considered a clone, but this anticipated development may be a future complication, patent-wise.

Implications of America Invents Act

35 USC §101 is not the only statute bearing on patent eligibility of bioprinting. The recent patent reform statute, the Leahy-Smith America Invents Act (AIA), specifically addresses the patent eligibility of naturally occurring technologies. Section 33(a) recites: “Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” Notably, there is no legislative guidance on the undefined terms “directed to” and “human organism”.

This vague wording could negatively affect the patent eligibility of bioprinting innovations. Indeed, the courts could deem bioprinted tissues and organs as “directed to or encompassing a human organism”.

A memo issued by the USPTO provides support for carving out bioprinted tissues and organs from §33(a). Following its passage in 2011, the USPTO issued a memo from Robert Bahr, senior patent counsel and acting associate commissioner for patent examination policy, regarding claims directed to or encompassing a human organism. In that memo, the USPTO explicitly states that §33(a) does not alter current law or USPTO policy that a claim “encompassing a human being is not patentable”. Given that the USPTO applied the term human “being” to explain what is meant by human “organism” as recited in §33(a), an argument can be made that the USPTO has excluded bioprinted tissues and organs from §33(a), such that bioprinting processes and products are still patent eligible.

Later in that same memo, the USPTO references how its policy is reflected in Section 2105 of the Manual of Patent Examining Procedure (MPEP). That provision states that a patent-eligibility rejection pursuant to §101 must be made if “the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism”. The meaning of human “organism” as recited in §33(a) is still subject to judicial interpretation.

To ensure that a bioprinting-related product claim passes §101 scrutiny, the claim should focus on man-made characteristics, qualities, and alterations rather than naturally occurring methods or matter. By focusing on how the product has “markedly different characteristics” from the naturally occurring organ upon which it is based, the bioprinted organ can be viewed as distinct from what occurs in nature and as a product of human ingenuity. As for bioprinting-related process claims, due to concerns stemming from §33(a) and §101, and the current case law, such process patents may be preferred to patents on a bioprinted product. Because scientists create and design bioprinting processes, such processes do not occur naturally and should not fall prey to the “law of nature” complication under Mayo and §101.

Bioprinting processes should pass the Chakrabarty two-prong test as a product of human ingenuity and a non-naturally occurring event. And the bioprinting process cannot be analogised to merely isolating or removing naturally occurring material or processes as in the failed patents in Myriad and Mayo. Although bioprinting attempts to replicate a naturally occurring and living organism, there is nothing natural in the manmade method by which a 3D printer builds layers upon layers of living cells.

Bioprinting has dramatically changed the life sciences landscape with the potential to revolutionise patient care. But the patent eligibility of bioprinted products and processes has not been squarely addressed by the legislature or tested in the courts. Until then, innovators in this space should capture their inventions with a wide variety of patent claims, framed to emphasise the manmade and non-naturally occurring aspects of this cutting edge technology.

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