Stem Cell Research: Effects of the Patenting Landscape

Ever since stem cell research began in the late 1900’s, the field has been fraught with a variety of issues including bioethics, funding, and general skepticism. The debate on stem cells has been unrelenting, and policies on the field are usually contentious topics during political campaigns. Apart from bone marrow transplantation [1], all other potential stem cell treatments are either experimental or in trial phases under the stringent oversight of various regulating bodies [2]. Today, however, it is a different issue that is shaping this field of research. While politicians and the public debate about ethics and funding, the leading researchers in the field are turning their focus on the issue of intellectual property [3]. The subject of patents, who issues them to whom, and what they cover is gradually shaping approaches to research and affecting progress by stifling cooperation.

Prior to President Obama’s elimination of restrictions on federal funding for embryonic stem cell research in 2009 [4], private resources provided most of the funding and often reserved broad rights over the research. James Thomson, a scientist at the University of Wisconsin who was responsible for developing and maintaining the first human embryonic stem cell (hESC) line, received funding from the Geron Corporation in exchange for rights on consequent patents [3]. Patents on his work were also secured for the Wisconsin Alumni Research Foundation (WARF), a group in charge of patents from scientists at the university. Over the years, access to and licensing of these patents have become a source of controversy and has led to legal battles between public interest groups, the Geron Corporation, and WARF. Challenges from groups such as Consumer Watchdog and other advocates of stem cell research have criticized the extensive breadth and restrictions of the WARF patents. Even though WARF and the Geron Corporation later came to an agreement on patent sharing, they had disagreements on the licensing of the patent to other researchers. While none of the suits against WARF were successful in revoking the patents, they did lead to a substantial relaxation on the restrictions on licensing [3].

The controversy surrounding the patenting of stem cells is not limited to the United States, nor is it limited to the relatively restrictive terms of patents. In Europe, the European Patent Office (EPO) issued a directive in regards to the patenting of hESCs under the European Patent Convention (EPC) that includes a morality clause stating that no patent would be issued to an invention whose commercial use was contrary to the public order or morality [5]. It seems that in Europe the main opposition to patents on embryonic stem cells is tied to the ethical questions of morality and human dignity. A couple of patents have been contested as a result. The controversial “Edinburgh” patent that was issued for a method developed to isolate stem cells in Europe was successfully challenged and later restricted to exclude hESCs [6]. WARF, which had to deal with opposition to the restrictive nature of their patents in the United States, was denied a European patent, in 2004, because of the morality clause of the EPC [5]. A later appeal to the EPO’s Enlarged Board of Appeal (EBoA) in 2008 also turned out to be futile [5]. The acquisition of patents in Europe is further complicated by the fragmented legal landscape of the continent. A patent granted by the EPO to Oliver Bruestle, a German scientist on neuroprogenitor stem cells, was rendered partially invalid by the German Federal Patent Court [7]. An appeal by Bruestle was referred to the European Court of Justice (ECJ) leading to additional questions on the roles of supranational institutions such as the EPO and ECJ in the issuance of patents [7].

Stem cell technologies have advanced since the initial work of James Thomson. With the development of induced pluripotent stem cells (iPSCs) [8], one has to wonder how this new innovation and any other future advancement will affect patents on stem cells. Even though scientists working with iPSCs are less likely to be subjected to the same level of ethical controversy as their colleagues working with hESCs, they will probably be expected to follow policies and regulations formed as a result of the disagreements surrounding embryonic stem cells [8]. Following the reexamination of Thomson’s initial patents in 2007, the United States Patent and Trademark Office (USPTO) was able to provide a framework for determining the patentability of pluripotent stem cells by claiming that “the lack of stage-specific embryonic antigen-1 (SSEA-1) cell surface markers is a characteristic only of pluripotent hESCs, but not of other pluripotent kinds of human stem cells” [9]. While human iPSCs are not derived from embryos, they are very much like human embryonic stem cells in terms of “morphology, proliferation, surface antigens, gene expression, epigenetic status of pluripotent cell–specific genes and telomerase activity”. However, almost all lack SSEA-1 cell surface markers [9]. This important distinction may mean that the patentability of iPSCs and other future innovations in the field may be judged not by their function but by their physical characteristics [9].

In light of all the controversy and issues related to stem cell research, it has become imperative that scientists and relevant interest groups work together to advance the field. Support for stem cell research is usually justified with promises of its economic potential [10], and considering the fact that the most important patents in the field are held equally between public and private sectors [11], it is necessary that these two branches cooperate to ensure future success. The conflict between WARF and the Geron Corporation regarding Thomson’s work was not only representative of the friction between the private and public sectors, but also indicative of how private financing can fund groundbreaking research that would have been impossible otherwise due to limitations on public funding [3]. Besides the fact that most patent offices around the world seem to lack the needed infrastructure to keep up with the fast paced advancement in the field, there is also the issue of inaccessibility of a patent database and newly published information [7].

In an attempt to foster international cooperation, the Hinxton Group [12], a consortium of professionals with a vested interest in stem cells, proposes establishing databases for patents and currently used stem cell lines [13]. Their proposals include the creation of an international human tissue and stem cell bank and the provision of conditional funding to improve data sharing. They also suggest implementing patenting policies that will encourage easy access and cooperation [13]. While some of the recommendations proposed by the Hinxton Group do not currently seem feasible, they do represent a positive motion of stem cell supporters. Furthermore, the formation of groups such as the NIH Stem Cell Task Force [14] and their European counterparts, the European Stem Cell Group [15] with similar goals as the Hinxton Group reinforces the determination of the stem cell community to work together and show their commitment to reduce conflicts and promote advancements in the field.

Stem cells represent the potential future of medicine and the continual advancement of the field translates into future treatments and therapies for diseases and medical disorders we currently have no effective medication for. The nature of stem cell research and its funding however has resulted in disputes over patents on cell lines and experimental procedures. These patent wars and their accompanied lack of cooperation have threatened to stifle progress in the field.  However, the stem cell community is fighting back with renewed proposals for policies and forming groups that will allow for better cooperation among its members. With adequate funding and effective collaboration between stem cell researchers, we can be hopeful that a cure for cancer and other diseases is on the horizon.

References

  1. Ammann A. J, Meuwissen H. J, Good R. A and Hing R. Successful Bone Marrow Transplantation with Humoral and Cellular Immunity Deficiency. Clin. Exp. Immunol. 1970;7: 343-353.
  2. Magnus D. Translating Stem Cell Research: Challenges at the Research Frontier. J Law Med Ethics. 2010;38(2):267-76
  3. Golden, John M. WARF’s stem cell patents and tensions between public and private sector approaches to research. J Law Med Ethics. 2010; 38(2):314-31.
  4. Robertson JA. Embryo stem cell research: ten years of controversy. J Law Med Ethics. 2010;38(2):191-203
  5. Treichel P. Patenting of human embryonic stem cells in Europe. Biotechnol J. 2009; 4(4):462-4
  6. Times Higher Education. “Edinburgh” patent limited after European Patent Office opposition hearing [document on the Internet].Munich: 2002 [updated 2002 July 25; cited 2011 March 4]. Available from: http://www.timeshighereducation.co.uk/story.asp?storyCode=170621&sectioncode=26 .
  7. Aurora Plomer. Stem Cell Patents in a Global Economy: The Legal Challenges. Stanford Journal of Law, Science & Policy. 2010; 3: 5-15.
  8. Caulfield T, Scott C, Hyun I, Lovell-Badge R, Kato K, Zarzeczny A. Stem cell research policy and iPS cells. Nat Methods. 2010; 7(1):28-33.
  9. Vrtovec, Katja Triller & Scott, Christopher Thomas. Patenting pluripotence: the next battle for stem cell intellectual property. Nat Biotechnol. 2008; 26(4):393-5
  10. Caulfield Timothy. Stem cell research and economic promises. J Law Med Ethics. 2010; 38(2):303-13.
  11. Konski AF, Spielthenner DJ. Stem cell patents: a landscape analysis. Nat Biotechnol. 2009; 27(8):722-6.
  12. Hinxton Group. [internet site]. 2006. [cited 2011 March 4]. Available from http://www.hinxtongroup.org/
  13. Brice P. Will patents hinder equitable access to stem cell medicine? [document on the Internet]. The Phg Foundation; 2011. [updated 2011 January 30; cited 2011March 4]. Available from   http://www.phgfoundation.org/news/7458/.
  14. NIH Stem Cell Task Force. [internet site]. 2008. [updated 2008 November 13; cited 2011 March 4]. Available from http://stemcells.nih.gov/policy/taskforce/
  15. European Stem Cell Group. [internet site]. 2009. [cited 2011 March 4] Available from http://www.eurosystemproject.eu/news/european_group
  16. Benvenisty, N. [photograph] 2005. Available at: http://commons.wikimedia.org/wiki/File:Human_embryonic_stem_cells.png

Emmanuel Aryee is a fourth-year biology major at the University of Chicago. Please join The Triple Helix Online on Facebook. Follow The Triple Helix Online on Twitter.

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  • Axeline

    I happen to be reading Gawande’s ‘Checklist Manifesto’ and your article reminded me of his discussion about all of the people involved in a surgical operation: “…evidence suggests we need them to see their job not just as performing their isolated set of tasks well but also as helping the group get the best possible results. People don’t always get it–really feel the urgency of the patient’s condition.” My favorite part of your piece is in the very last paragraph, when after carefully laying out many of the details of this debate, you bring home the why. This matters because stem cells hold the possibilities for curing a good deal of very sick people, and that is urgent. It is unfortunate that patents, politics, and greed would deter scientists from this most important mission. This piece certainly offers hope, however, that the stem cell community can get it together and prevail. This is a thoughtful, well-written piece – thank you for sharing!