Ethics of Patenting Human Embryo Cells under the U.S law

Every Frankenstein movie, book, comic strip, and television show demonstrates that, in biotechnology, “just because something can be done does not mean that it should be done.” Scientific progress in the fields of tissue engineering and organ transplantation have far surpassed Mary Shelley’s crude description of stitching body parts together to form a human being.

We are living in an era where yesterday’s scientific fiction has become today’s reality. In 1998, James Thompson successfully cultivated embryonic stem cells in a culture dish, helping to further scientific claims that human embryonic research could provide the cures for fatal diseases and the means for embryonic editing. Dolly the sheep, human-pig chimeras, and human genome editing for therapeutic purposes are all inventions driven by scientific reasons, but they unavoidably spur a debate on the ethics, morality, public acceptance and philosophical foundations of such inventions. When these inventions are patented, the discussion on different interests and values underlying these inventions transposes into patent law.

To promote scientific advancement, the Framers drafted the Patent Clause as a means of rewarding the labor of inventors. The Patent Clause grants Congress the power “to promote the Progress of Science and useful Arts, by securing for limited Times to . . . Inventors the exclusive Right to their . . . Discoveries.” Congress exercises this power through a patent system overseen by the U.S Patent and Trade Office(USPTO). In exchange for disclosure of the details of an invention, an inventor receives a patent from the government. Depending on the patent, a patent grants its holder a fourteenor twenty-yearright to exclude others from making, using, or selling the patented invention. If the invention is a process, the patent also grants its holder the right to exclude others from making, using, or selling the products of the patented invention.

Biotechnology companies continue to submit various patent applications for the process of human embryo editing and for the resulting human clones.Seeking to avoid the debate on patenting embryos, the U.S. Patent & Trademark Office (PTO) will state only that it “does not issue patents drawn to human beings” because the Thirteenth Amendment prohibits such patents. Commentators believe, however, that it will not be long before the PTO does grant patents on human embryos. Others believe that the PTO has already granted such patents.

In this paper, we will discuss the legal precedent that paved the way for patent law, where the law stands legislatively and judicially: what is patentable? Additionally, we will review Supreme Court cases and recent guidance issued by the U.S. Patent and Trademark Office that impose new limitations on patent-eligible subject matter and thereby limiting the patentability of human embryo in the United States.

BACKGROUND SECTION

A patent is a “special privilege designed to serve the public purpose of promoting the ‘Progress of Science and useful Arts.’” To receive a patent, the inventions must be useful, novel, and nonobvious. And must fall within a category of patentable subject matter.

Before considering the question of whether human embryos are patentable via gene editing, one must first determine the biological status of an embryo. What is an embryo? The term “embryo” refers to “the unborn human from fertilization to 8-10 weeks gestation.” Fertilization creates an embryo possessing the forty-six chromosomes that “mark the human species.” That human being is the embryo. Biology confirms that the embryo is a human being. Nonetheless, some may argue that abortion jurisprudence suggests otherwise.

After determining the status of the human embryo, one can then consider the applicability of relevant law to the patenting of human embryos. The relevant law is primarily constitutional that devolves into statutory law. Relevant to the question of whether human embryos can be patented are patent law, abortion law, and Thirteenth Amendment law. For that reason, this paper will discuss the application of both constitutional and statutory law to the patenting of human embryos.

Where the Law Stands Legislatively: What is Patentable?

In delineating patentable subject matter, Congress has created several categories of patents. The category most relevant to our discussion is the utility patent. Under 35 U.S.C. § 101, utility patents are granted to “a process, machine, manufacture, or composition of matter or any new and useful improvement thereof.” Of the different patents, the utility patent covers the broadest subject matter because the words “machines, manufactures, and compositions of matter” have “a meaning as broad as the human mind can range.”

In 1974, the PTO rejected patent applications for microorganismsand multicellular organisms. Stating that “35 U.S.C. 101 must be strictly construed,” the PTO Board of Appeals held that strict construction “precludes the patenting of a living organism.”

Legislative actions have also limited patentable subject matter categories, particularly through codifying policies in the United States Patent and Trademark Office (“USPTO”). The USPTO has an internal policy that human beings at any stage of development are not patentable subject matter under 35 U.S.C. the Thirteenth Amendment is a legal barrier that prevents inventors from patenting human-embryo technologies.

By 1865, “virtually everyone understood slavery as chattelism,” the idea that human beings can be property. The abhorrence of that idea fueled the abolitionist movement. The recognition that slavery rested upon “a dehumanizing philosophy” of chattelismunderscored the movement to abolish slavery.

Some may argue that the framers of the Amendment intended the term “human being” to be defined by law rather than by science. Those accepting this idea would argue that the framers intended the term “human being” to include only post-natal human beings.

For example, they might propose that the framers defined “human being” as “a post-natal member of the species homo sapiens.” According to that definition, the Thirteenth Amendment would prohibit ownership of post-natal human beings but would allow ownership of pre-natal human beings. Thus, ownership of human embryos would not violate the Thirteenth Amendment.

Such an argument is insupportable for two reasons. First, history provides no support for the argument that the framers intended to define “human being” as post-natal human beings. No relevant sources--neither public commentary, congressional debates, nor federal jurisprudence suggest that the framers determined to alter the definition of human being from its scientific meaning.

Second, historical sources show that the framers understood “human being” to include pre-natal human beings. The 1800s introduced a period of increased awareness about the physiological processes of the female body, particularly the reproductive process. The literature of the day reveals that the medical community and the general public believed the unborn child to be a human being. That belief arose from “a new understanding of fetal development as continuous from the moment of conception.” Both reproductive literature and abortion commentary describe the unborn child as a human being.

Where the Law Stands Judicially: What is Patentable?

In recent years, both legislative action and judicial interpretation have imposed additional subject matter limitations through an interpretation of the four categories in 35 U.S.C § 101. Recently, transitory forms of signal transmission, contractual agreements between parties, data per se, and, most notably, a human per se are all outside the four statutory categories of 35 U.S.C. § 101.

To explore the future of 35 U.S.C. § 101 as applied to human gene editing, the cases of Diamond v. Chakrabarty, Mayo Collab. Services v. Prometheus Labs., and Association for Molecular Pathology v. Myriad Genetics must be discussed. These cases collectively show that not only is the Supreme Court capable of judicially interpreting the four categories of subject matter, but the Court has actively and recently added to judicial exceptions of both method and product patents.

In 1980, the Supreme Court reviewed the PTO's interpretation of 35 U.S.C. § 101 in Diamond v. Chakrabarty. A five-to-four decision held that an organism could be a “manufacture” or “composition of matter” within the meaning of § 101. The Court reasoned that “the relevant distinction [is] not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.” Noting that Congress drafted the section in “expansive terms,” the Court stated that the statutory subject matter “include[s] anything under the sun that is made by man.”

With those words, the Court made an absolute statement, presumably exempting nothing. Human beings would seem to fall within the Court's holding. Human embryos can be man-made through genetic manipulation. Increasingly, embryologists manipulate embryos by adding or removing genes. Each of those specifically created embryos would seemingly satisfy the Chakrabarty requirements for patentability.

Although the Court used absolutist language, the PTO found an exemption. In 1987, the PTO stated that “[a] claim directed to or including within its scope a human being will not be considered to be patentable subject matter” because “[t]he grant of a limited, but exclusive property right in a human being is prohibited by the Constitution.”

Though Chakrabarty showed that micro-organisms made by man can be patented under 35 U.S.C. § 101, the ruling in Association of Molecular Pathology v. Myriad Genetics limited the decision.Myriad Genetics determined the validity of gene patents under United States law, specifically looking at isolated DNA sequences.These DNA sequences were used for diagnostic breast cancer examinations. The Court held, much like in Mayo v. Prometheus, that the human intervention necessary to produce the isolated DNA sequences did not, in itself, render the subject matter patentable. Justice Thomas explained that Myriad’s claims were not “saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule.”

The Relevance of Abortion Law

Abortion law is another area of case law relevant to the question of patenting human embryos. Although some may argue that abortion law bears on the question, those who make such an argument often confuse a legal question with a biological question. They confuse the terms “person” and “human being.” Before examining the relevance of abortion law, one must define those terms. “Person” is a legal term; “human being,” a biological term. “Person” is defined by law; “human being,” by science. “Person” has a meaning that changes through time; “human being,” a meaning that remains constant through time.

In the United States, the law makes Jane Doe, a non-resident alien not present in the United States, a non-person for purposes of Fifth Amendment law but makes corporation XYZ, Inc. of Delware, a person for purposes of federal statutory law. In contrast with “person,” “human being” is a biological term defined objectively by science. A human being is “a member of the species homo sapiens.” Therefore, non-citizens are human beings, and corporations are not.

Abortion law deals not with the humanity of the embryo but rather with the “personhood” of the embryo. Roe v. Wade answered the following questions: (1) does a woman have a constitutional right to an abortion? and (2) a state's substantial interest in protecting unborn life from the moment of conception. Courts considering the ownership of embryos have agreed that Roe and Casey do not control the decision, neither case addressed the ownership of human beings.

ANALYSIS SECTION

The Framers of the U.S constitution intended the Thirteenth Amendment to apply to human embryos by implicitly adopting the public opinion of the time, which was that the embryo deserved the utmost respect of a human being. The Thirteenth Amendment ended property ownership of human beings, and therefore inventors should not be able to patent human embryos because a human embryo patent would give the patent holder a property interest in a human being.

Outside of the subject matter eligibility requirements under 35 U.S.C. § 101, a person cannot get a patent on something that is not new or novel. Under 35 U.S.C. § 102, if a product or process already exists in nature, it cannot later be patented.

As previously discussed in, naturally occurring human genes, even those isolated from the human body, are not patentable because they are naturally occurring. For the same reason, a fetus would not be patentable. Even if the fetus in question has a combination of genes that would not exist but for the method applied, the method being in vitro fertilization, the result of that method cannot be patented in the wake of Prometheus and Myriad Genetics case law holding. Additional support for not allowing products of in vitro fertilization to be patented can be found in In re Roslin Institute. In this case, the Federal Circuit determined that cloned animals were unpatentable subject matter.

A fetus, likewise, is a product “unaltered by the hand of man.” Because the fertilized egg has not been modified, with the exception of a natural fertilization process, the product of that fertilization is no different than any other fetus or human existing in society. The discovery does not possess “markedly different characteristics from any found in nature.” Therefore, the subject matter is unpatentable.

The second reason that a fetus is unpatentable is spelled out in United States Patent and Trademark Office policy and law. Specifically, section 33(a) does not allow for the patentability of human embryos or fetuses.

Conclusion

The patent of a human embryo grants a property right on a human being and the Thirteenth Amendment prohibits the ownership of human beings; the PTO cannot constitutionally grant patents for human embryos.

Were the framers concerned with patenting the human embryo when passing the Thirteenth Amendment? No.

Is the patenting of human embryos an illustration of the general problem with which the framers were concerned? Yes. Even though the framers of the Amendment probably never reflected its application to human embryos specifically, they did contemplate its application to human beings generally.

At present, the concept of human dignity, morality and social ethics appears to set important limits for the patentability of human embryos. Science is in continuous evolution and the question is not whether society or law will follow, but at what pace?

1 157 CONG. REC. E1178 (daily ed. June 23, 2011) (statement of Rep. Smith).

2 Mary Wollstonecraft Shelley, Frankenstein (Wise house Classics 2015).

3 Tim Friend, Human Cells Grown in Lab for First Time, USA Today, Nov. 6, 1998, at A1.

4 U.S. Const. art. I, § 8, cl. 8.

5 35 U.S.C. §§ 1-2 (2000).

6 Ibid. § 112.

7 Ibid. § 173.

8 See Ibid. § 154.

9 Ibid.

10 Amy Fagan, University's Cloning Patent Raises a “Mammal” Issue, Wash. Times, May 21, 2002, at A12;

11 Neil Munro, The New Patent Puzzle, 34 Nat'l J. 577, 629 (2002).

12 Aaron Zitner, Patently Provoking a Debate, L.A. Times, May 12, 2002

13 Dashka Slater, Legal Aff. (2002).

14 Justin Gillis, A New Call for Cloning Policy, Wash. Post, May 17, 2002.

15 Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 816 (1945).

16 See Ibid. § 101.

17 See Ibid. § 102.

18 See Ibid. § 103.

19 Clarke D. Forsythe, Human Cloning and the Constitution, 32 Val. U. L. Rev. 469, 474 (1998).

20 Bruce M. Carlson, Human Embryology and Developmental Biology 3 (1994).

21 Forsythe, supra note 15, at 475-76 (citing Carlson, supra note 16, at 31).

22 Erich Blechschmidt, The Beginnings of Human Life 17 (1977).

23 The Inhuman Use of Human Beings: A Statement on Embryo Research, First Things (1995).

24 35 U.S.C. §§ 1-2 (2000).

25 Ibid.

26 Robert L. Harmon, Patents and the Federal Circuit 41 (4th ed. 1998).

27 Iver P. Cooper, Biotechnology and the Law § 2:3 (2002)

28 Ibid. § 2:4.

29 Application of Bergy, 563 F.2d 1031 (C.C.P.A. 1977).

30 Aaron Zitner, Patently Provoking a Debate, L.A. TIMES, May 12, 2002

31 See Ibid. at 116

32 Ibid. (emphasis added).

33 Belz, supra note 104, at 121 (stating that “virtually everyone in 1865 understood slavery as chattelism”).

34 Hoemann, supra note 98, at 39.

35 Akhil Reed Amar, Remember the Thirteenth, 10 Const. Comment. 403, 405 (1993)

36 Janet Farrell Brodie, Contraception and Abortion in Nineteenth Century America (1994).

37 Mary Krane Derr, Introduction to “Man's Inhumanity to Woman, Makes Countless Infants Die”: The Early Feminist Case Against Abortion ii (Mary Krane Derr ed., 1991).

38 MANUAL OF PATENT EXAMINING PROCEDURE § 2106 (2015).

39 Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

40447 U.S. 303 (1980).

41 Ibid. at 308.

42 Ibid. at 312-13.

43 Ibid. at 308-09.

44 Paul Hanna, Note, Recognizing the Need for Uniform International Regulation of Developing Biotechnology: A Focus on Genetic Experimentation, (2002).

45 May Mon Post, Note, Human Cloning: New Hope, New Implications, New Challenges, (2001).

46 Kevin D. DeBré, Note, Patents on People and the U.S. Constitution (1989).

47 U.S. Patent & Trademark Office, PTO Policy on Patenting of Animals (1987)

48 Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

49 Ibid.

50 Ibid.

51 Ibid.

52 Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

53 Dan Burk, Patenting Transgenic Human Embryos: A Nonuse Cost Perspective, (1993).

54 Stevan M. Pepa, Note, International Trade and Emerging Genetic Regulatory Regimes, (1998).

55 Johnson v. Eisentrager, 339 U.S. 763, 783-85 (1950).

56 The Dictionary Act, 1 U.S.C. § 1 (2000).”

57 Ibid.

58 Roe, 410 U.S. at 129.

59 Ibid.

60 See McDonald, supra note 17, at 1376–81.

61 Ibid.

62 Mayo Collaborative Services v. Prometheus Labs., 132 S. Ct. 1289, 1304 (2012).

63 In re Bergstrom 427 F.2d 1394 (C.C.P.A. 1970).

64 Myriad Genetics, 133 S. Ct. at 2120; Prometheus Labs., 132 S. Ct. 1289 (2012).

65 In re Roslin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014).

66 Ibid.

67 Ibid.

68 Ibid.

69 Ibid.

70 157 CONG. REC. E1179 (daily ed. Jun. 23, 2011).