Julie L. Langdon Attorney Dunlap Codding
A Review of Recent Court Decisions Provides Insight into Patent Eligibility of 3D Organs
The intellectual property protection of 3D organs may eventually prove harder than the science itself. By way of over-simplified background, 3D organs are created through bioprinting using a 3D bioprinter. Specifically, a blueprint of an organ is created and uploaded into the 3D bioprinter, and then the bioprinter deposits bio-ink (living human cells and gel-based material) layer by layer onto a substrate according to the blueprint. Cell layers are then allowed to grow and self-organize into complex tissue structures, and ultimately, 3D organs.
Under U.S. Patent Law, any inventor can file a patent application containing patent claims defining an invention. A patent will issue when those patent claims meet the statutory requirements of utility (as defined in Section 101), novelty, non-obviousness, written description, and enablement. Section 101 of the Patent Act determines patent-eligibility and states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new or useful improvement thereof, may obtain a patent therefor…”i
Even if we assume that a 3D organ is a manufacture under Section 101ii, at least two unknowns have recently arisen that question their patentability. One—whether 3D organs are prohibited “human organisms” under the Section 33(a) of the America Invents Act (AIA), and two— whether 3D printed organs are patent-eligible subject matter under recent Supreme Court interpretations of 35 U.S.C § 101.
Are 3D Organs “Human Organisms” under Section 33(a) of the AIA?
Section 33(a) of the AIA states “[n]otwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.”iii This term is undefined in the statute and the legislative history does not provide any insight into its meaning.iv On its own, the term “human organism” is ambiguous. “Organism” means “an individual form of life”(e.g. plant, fungus, or animal).v Did Congress intend to change the meaning by adding the word “human”? If we rely on the Patent Office’s guidance issued to its examiners in 2011, then a 3D organ is patentable. The Patent Office indicated that Section 33(a) “does not change existing law or long-standing USPTO policy that a claim encompassing a human being is not patentable.”vi But, the courts, not the Patent Office, have the final word on what is patentable. So, this issue is likely to be litigated.
Are 3D Organs and/or Bioprinting Patent-Eligible?
In 1980, the U.S. Supreme Court held that human-made microorganisms are not excluded from patent protection.vii In distinguishing these human-made microorganisms from laws of nature and physical phenomenon, the Court found, first, they had “markedly different characteristics from any [microorganisms] found in nature” and second, they were man-made.viii In the same decision, the Court noted that there are exceptions to patentable subject matter: laws of nature, physical phenomenon, and abstract ideas.ix
For more than 30 years, Chakrabarty was our sole guidance on the issue of biotech patent-eligible subject matter, leading to a vibrant biotech industry. Then, within the past three years the Supreme Court issued two decisions that limited patent eligibility of biotech inventions. First, the Supreme Court determined that there is a two-part process in determining whether claims contain patent-eligible subject matter. The Mayo test requires a determination of (1) whether the claims are directed to a patent-ineligible concept, and (2) if so, whether the elements of the claim, individually, and as an ordered combination, transform the nature of the claim into patentable subject matter.x Second, in Myriad, the Supreme Court determined that patent claims directed to a product of nature (e.g. an isolated DNA fragment) are not patent-eligible if there is nothing new— nothing markedly different.xi
So, what is patent-eligible in biotech? The Court of Appeals for Federal Circuit (the patent-related appellate court) provided some guidance earlier this year when, based on the teachings of Mayo and Myriad, it reasoned that claims were not patent-eligible because they were directed to detecting a natural phenomenon—the existence of fetal DNA in maternal plasma, and the additional method steps of “amplifying” and “performing nucleic acid analysis” were “well-understood, routine, and conventional activity.”xii The outcome of this decision was surprising to many, and it is likely that Sequenom will seek Supreme Court review.xiii
In view of these cases, are claims directed to a 3D organ or claims directed to bioprinting patent-eligible subject matter?
3D organs are likely patent-eligible subject matter because they have “markedly different characteristics” than organs found in nature because they are not as complexly organized as the real thing. For example, the 3D organ will not have the vasculature or nervous structure of a naturally occurring organ. Ironically, as 3D organs advance due to human ingenuity and become more like natural organs, the less likely they may be eligible for patent protection. Inventors and their patent agents/attorneys should be mindful of these issues in drafting patent applications and claims in order to maximize the opportunities for protection and investment.
Bioprinting relies on naturally occurring cell growth, replication, and differentiation, but the additional steps of bioprinting are likely patent-eligible. For example, there is no way to create 3D organs from living cells without the use of man-made materials, and so, the remaining steps of any method claim directed to creating a 3D organ will likely transform the claim into patentable subject matter. Inventors and their patent agents/attorneys should consider these issues in drafting patent claims. For example, method claims directed to bioprinting should include the use of a man-made feature (e.g. bio-ink or scaffolding), include transformative steps, and not solely be directed to the naturally occurring bioprinting steps.
It appears that neither Section 33(a) of the AIA or Section 101 of the Patent Act will interfere with patent claims directed to 3D organs or bioprinting; however, as the laws continue to evolve, and 3D organs become more advanced and more like real organs, these are issues that should be re-visited.
i 35 U.S.C. § 101
ii Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980).
iii Leahy-Smith America Invents Act § 33(a)(2012).
iv Id.; 157 CONG. REC. E1177, E1177; see also, Yaniv Heled, On Patenting Human Organisms or How The Abortion Wars Feed Into the Ownership Fallacy, 36 Cardozo L. Rev. 241, 260-273 (2014).
v See e.g. “organism” Merriam-Webster.com. 2015. (4 Dec 2015); “organism” Dictionary.com. 2015. (4 Dec 2015).
vi See www.uspto.gov/sites/default/files/aia_implementation/human-organism-memo.pdf.
vii Diamond v. Chakrabarty, 447 U.S. 303 (1980).
viii Id. at 310. For an analysis of the application of Chakrabarty to 3D organs
ix Id. at 309.
x Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1297-99 (2012).
xi Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-19 (2013).
xii Ariosa Diagnostics, Inc. v. Sequenom, Inc.,788 F.3d 1371, 1375-78 (Fed. Cir. 2015)
xiii On December 2, 2015, the Federal Circuit rejected Sequenon’s request to reconsider its decision.
Julie L. Langdon (firstname.lastname@example.org) is an attorney in Dunlap Codding's Chicago office. She practices intellectual property law, including litigation, licensing, counseling, and asset protection of copyrights, trademarks, patents, and trade secrets