Abstract
In some ways, patenting human stem cells represent the outer limits of patent-eligible subject matter. In addition to their existence as “products of nature,” these cells raise difficult and legitimate moral, religious, and ethical concerns. Many countries have decided, whether in the first instance or after legal challenge, that human stem cells are not eligible for patenting. The USA has notably not been one of the countries denying patent protection to human stem cells, consistent with the effects of Supreme Court precedent giving patent-eligible subject matter a broad interpretation. That status may be subject to change, however, if a recent Supreme Court precedent limiting this broad access to patent eligibility is extended to stem cells. Any such changes may become important, even as patents on stem cells begin to expire in the next 5 years. Even more important is whether any such changes negatively impact protection of, and investment in, new stem cell preparations and therapies.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
- 2.
35 U.S.C. §112, first paragraph.
- 3.
35 U.S.C. § 271(a).
- 4.
Because the 20 year term only came into effect in the U.S. after the adoption of the GATT/TRIPS agreement in 1995, there are some biotechnology patents having longer terms under the old regime of 17 years from grant date.
- 5.
596 F.2d 952 (C.C.P.A. 1979).
- 6.
The bacterium was not a recombinant organism, i.e., no novel recombinant genetic construct was introduced. Rather, using conventional transduction protocols Chakrabarty introduced three naturally occurring plasmids into the bacteria and selected a stable strain. These plasmids encoded members of a metabolic pathway that contributed to digestion of the crude oil components by the bacteria.
- 7.
- 8.
Claim 1. A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.
- 9.
For example, the Canadian Supreme Court overruled the Canadian Patent Office and lower courts and required cancelation of claims to the mouse itself, while in Europe the patent was ultimately revoked after extensive opposition proceedings by 17 separate opponents.
- 10.
- 11.
Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells” (March 9, 2009).
- 12.
See infra at “7.5.3 The Rest of the World: What’s the Situation in Europe?”
- 13.
The ex parte reexaminations against U.S. Patent No. 5,843,780 and 6,200,806 were assigned Control Nos. 90/008102 and 90/008139, respectively, and the inter partes reexamination against U.S. Patent No. 7,029,913 was assigned Control No. 95/000154. The complete file histories of these reexaminations can be viewed under the Public portion of the Patent Application Information Retrieval (PAIR) system at www.uspto.gov.
- 14.
The grounds of rejection asserted by the Patent Office in reexamination of “the ‘780 patent that the claims were unpatentable for lack of novelty under 35 U.S.C. § 102(b) or for being obvious under 35 U.S.C. § 103(a) over a variety of references that were published prior to the priority date of the Thomson patents.
- 15.
Supra note 13.
- 16.
The grounds asserted by the requestors in the inter partes reexamination were slightly different than in the ex parte reexaminations, due to the requestors’ ability to submit affidavit evidence inter partes. The grounds of unpatentability asserted were supported by declaration evidence and the prior art references cited in the parallel ex parte reexaminations. See supra note 13, supra.
- 17.
The Office expressly rejected the assertions in the declaration as the basis for its determination, stating that it expressed “opinion on the ultimate legal issue without providing sufficient underlying factual support.” Supra note 13.
- 18.
In its decision, the Board reinstated rejection for obviousness under 35 U.S.C. §103(a) on the following grounds: (1) that claims 1-3 were unpatentable over U.S. Patent No. 5,166,065 to Williams; (2) that claims 1-3 were unpatentable over the combination of the Robertson ‘83 reference, the Robertson ‘87 reference, the ‘065 patent, and the ‘926 patent; (3) that claims 1-3 were unpatentable over the combination of the Piedrahita reference, the ‘065 patent and the ‘926 patent; and (4) that claims 1-3 were unpatentable over the combination of the Robertson ‘83 reference, the Robertson ‘87 reference, the Piedrahita reference, the ‘065 patent, and the ‘926 patent.
- 19.
702 F. Supp.2d 181 (S.D.N.Y. 2010).
- 20.
National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009).
- 21.
The Guidelines also provide a shortened path for cells established before the Guidelines were promulgated, requiring that the cells were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and were donated by donor(s) who gave voluntary written consent for the human embryos to be used for research purposes.
- 22.
Patents granted in 2011 and 2012 include U.S. Patent Nos. 7,932,084 and 8,119,398 issued on 2/21/2012 (adipose stem cells), 7,947,501 (recombination in human ES cells), 7,955,846 (female germline stem cells), 7,955,850 (dental pulp-derived stem cells), 7,964,402 (clonal populations of hESCs), 7,968,336 (fetal stem cells), 7,968,337 (neural stem cells), 7,972,767, 8,084,023, and 8,142,773 issued on 3/27/2012 (mesenchymal stem cells), 7,976,836 and 8,057,789 (placental stem cells), 7,994,144 and 8,017,393 (hematopoietic stem cells), 8,034,329 (umbilical cord stem cells), 8,110,399 issued on 2/7/2012 (islet of Langerhans stem cells), 8,153,359 issued on 4/10/2012 (toxicity studies in human ESCs) and 8,153,421 issued on 4/10/2012 (prostate stem cells).
- 23.
The Leahy Smith America Invents Act, Pub. L. No. 112-29. (September 16, 2011).
- 24.
See, for example, Consolidated Appropriations Act of (2010), Pub. L. NO. 111-117, 123 Stat. 3034, 3153.
- 25.
Speech of Hon Lamar Smith of Texas, 112 Cong. Rec. E1182-E1185 (June 22, 2011).
- 26.
See Manual of Patent Examining Procedure 8th Ed. § 2105 (Revised August 2012).
- 27.
“If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.” Id
- 28.
132 S.Ct. 1289 (2012).
- 29.
669 F.Supp. 2d 365 (S.D.N.Y. 2009), affirmed in part, reversed in part, 653 F.3d 1329 (Fed. Cir. 2011), certiorari granted, decision vacated and remanded, 2012 U.S. LEXIS 2356 (U.S. Mar. 26, 2012).
- 30.
See, for example, the Court’s decisions in KSR Int’l Co. v. Teleflex Inc 127 S.Ct. 1727 (2007). (expanding obviousness), eBay Inc. v. MercExchange LLC 547 U.S. 388 (2006) (reducing injunctions), Quanta Computer, Inc. v. LG Electronics, Inc 553 U.S. 617 (2008). (expanding scope of patent exhaustion), Merck KGAA v. Integra Lifesciences I, Ltd. 545 U.S. 193 (2005) (expanding scope of “safe harbor” for FDA submissions), Microsoft Corp. v. AT&T Corp. 550 U.S. 437 (2007) (reducing scope of extraterritorial reach of U.S. patent law), Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002) (reducing scope of doctrine of equivalents, i.e., the extent to which insignificant changes to a claimed invention will still invoke patent infringement liability), and Medimmune, Inc. v. Genentech, Inc. 549 U.S. 118 (2007) (expanding declaratory judgment jurisdiction for challenging patents).
- 31.
The Patent and Trademark Office did not join in this brief, and it is widely believed that the Office does not agree with the brief’s recommendations or conclusions.
- 32.
Whether alternative embodiments, such as pluripotent stem cells produced by specific treatments of ESCs, would fall within any such preclusive determination of patent eligibility is unclear.
- 33.
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
- 34.
Oliver Brüstle v. Greenpeace eV, European Court of Justice C-34/10, (Oct. 18, 2011).
- 35.
Opinion of the Advocate General, Case C-34/10, Brüstle v. Greenpeace, (March 10, 2011).
- 36.
Germany, Bundestag, Stem Cell Act of 2002 (Stammzellgesetz), Bundesgesetzblatt [Federal Law Gazette] 2002, Part I, no. 42, p. 2277, (June 29, 2002), §1-1.
- 37.
Article 27 reads as follows: “Members may exclude from patentability, inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law.” Agreement on Trade-related Aspects of Intellectual Property Rights, Part II, Section 5, Article 27. Individual countries can make their own decisions based on moral objections (or acceptance) of a technology; for example, Sweden granted a patent for human ES cells (SES536490) based on the argument that while producing human ES cells was required, the cells may have been isolated long before the invention was made (and hence embryos were not instrumentalized or did not require repeated use of embryos (an element in Swedish patent law). See Torremans (2010. p. 299) and Salter (2007).
- 38.
Oliver Brüstle v. Greenpeace eV, European Court of Justice C-34/10, para. 35 (Oct. 18, 2011).)
References
112 Cong. Rec. E1182 (June 22, 2011) (speech of Hon. Smith).
Bush, G. W. (2001). Presidential Address. August 9, 2001.
California Institute for Regenerative Medicine. (2009). CIRM stem cell grant regulations. Retrieved August 10, 2012, from http://www.cirm.ca.gov/cirm-operations/Regulations.
Cook-Deegan et al. (2009). The dangers of diagnostic monopolies. Nature, 458(7237), 405–406.
Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells” (March 9, 2009).
Heller, M. A., & Eisenberg, R. S. (1998). Can patents deter innovation? The anticommons in biomedical research. Science, 280, 698–701.
The Hinxton Group. (2008a). The science, ethics, and policy challenges of pluripotent stem cell-derived gametes. Retrieved August 8, 2012, from http://www.hinxtongroup.org/au_pscdg_cs.html.
The Hinxton Group. (2008b). Transnational cooperation in stem cell research. Retrieved August 8, 2012, from http://www.hinxtongroup.org/au_trans_cs.html.
Kass, L. R. (2002). Human cloning and human dignity: An ethical inquiry. Report of the President’s Council on Bioethics. New York: PublicAffairs.
Mooney, C. (2006). The republican war on science. New York: Basic Books.
Murugan, V. (2009). Embryonic stem cell research: A decade of debate from Bush to Obama. Yale Journal of Biology and Medicine, 82(3), 101–103.
National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009).
Nebraska prohibits state funding of hESC research absolutely: Neb. Rev. Stat. § 71-7606 (2007).
Salter, B. (2007). Patenting, morality and human embryonic stem cell science: Bioethics and cultural politics in Europe. Regenerative Medicine, 2(3), 301–311.
Secretary’s Advisory Committee on Genetics, Health, and Society. (2009). The integration of genetic technologies into health care and public health. http://oba.od.nih.gov/SACGHS/sacghs_documents.html.
Shulman, S. (2006). Undermining science: Suppression and distortion in the Bush Administration. Los Angeles: University of California Press.
Speech of Hon Lamar Smith of Texas, 112 Cong. Rec. E1182 (Jun. 23, 2011).
Stout, D., & Harris, G. (2009, March 6). Obama reversing stem cell limits Bush imposed (pp. 2). New York Times.
Torremans, P. L. (2010). Legal problems raised by patents on human stem cell—Based interventions. In K. Hug & G. Hermerén (Eds.), Translational stem cell research (pp. 287–307). New York: Springer.
Vrtovec, K. T., & Scott, C. T. (2008). Patenting pluripotence: The next battle for stem cell intellectual property. Nature Biotechnology, 26(4), 393–395.
Cases American Fruit Growers v. Brogdex Co., 283 U.S. 1 (1931).
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
In re Bergy, 596 F.2d 952 (C.C.P.A. 1979).
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
Association for Molecular Pathologists et al. v. U.S. Patent and Trademark Office et al., 702 F. Supp.2d 181 (S.D.N.Y. 2010), affirmed in part, reversed in part, 653 F.3d 1329 (Fed. Cir. 2011), certiorari granted, decision vacated and remanded, 2012 U.S. LEXIS 2356 (U.S. Mar. 26, 2012).
Opinion of the Advocate General, Case C-34/10, Brustle v. Greenpeace, 10 March 2011.
Oliver Brüstle v. Greenpeace eV, European Court of Justice C-34/10, OCTOBER 18, 2011
Sherley v. Sebelius, 644 F.3d 388 (2011).
Mayo Collaborative Services Inc. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).
Association for Molecular Pathologists et al. v. U.S. Patent and Trademark Office et al., 698 F.3d 1303 (Fed. Cir. 2012).
Statutes The Leahy Smith America Invents Act, Pub. Law 112–29, 125 STAT. 284. September 16, 2011
Consolidated Appropriations Act, 2010, Pub. Law 111–117, 123 Stat 3034
Germany, Bundestag, Stem Cell Act of 2002 (Stammzellgesetz), Bundesgesetzblatt [Federal Law Gazette] 2002, Part I, no. 42, p. 2277, June 29, 2002, §1-1.
35 U.S.C. §112, 1st paragraph (1952).
35 U.S.C. § 271(a) (1952).
Neb. Rev. Stat. § 71-7606 (2007).
Md. Code, Com. Law §10-434 (2008)
Mass. Gen. Laws ch. 111L, §12J (2008).
Euro Parliament and Council: Directive 98/44/EC “Directive on the legal protection of biotechnological invention. Brussels, Belgium, July 6, 1998.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media New York
About this chapter
Cite this chapter
Noonan, K.E. (2014). The Patenting Landscape for Human Embryonic Stem Cells. In: Hogle, L. (eds) Regenerative Medicine Ethics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9062-3_4
Download citation
DOI: https://doi.org/10.1007/978-1-4614-9062-3_4
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-9061-6
Online ISBN: 978-1-4614-9062-3
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)