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Differentiating stem cell patents Laurence MacPhie* & Noel Courage Stem cells are defined by their capability for both self-renewal through cell division and for producing a lineage capable of differentiating into one or more specialized cell types. Stem cells are found both in adult tissues and in the developing embryo. While embryonic stem cells are able to differentiate into each and every cell type, adult stem cells are generally only able to form the cell types of the organ from which they originate. Stem cells are essential for the renewal and repair of human tissues and have been at the centre of research into regenerative medicine. They have also emerged as a valuable tool for drug discovery and development. Strong patent protection is a crucial driver of investment into new stem cell technologies. However, their special nature has created a number of uncertainties. In particular, the biological potential of embryonic stem cells to create new human life raised ethical concerns and caused boundaries to be set on the scope of patentability. The bar has been set at different places in the USA, Europe and Canada. Careful assessment of the options for protection in these jurisdictions is necessary in order to manage risk and maximize rewards. This article provides an overview of the patentability of stem cells with a focus on recent developments regarding embryonic, adult and induced pluripotent stem cells. The promise of regenerative medicine in the 21st century

The transition from regenerative medicine discoveries to successful clinical treatments using stem cells has been slow and difficult. However, there is still commercial optimism as the use of stem cells becomes more established and therapeutic applications of stem cells begin to enter the market. For example, Hemacord™, a cord blood hematopoietic progenitor cell therapy, was recently the first stem cell product approved by the US FDA [201] . Advanced Cell Technology, Inc. recently published a Phase I/II clinical trial demonstrating the safety of retinal pigment epithelium cells derived from human embryonic stem (ES) cells in two patients and also reported measureable improvements in vision [1] . Prochymal®, a formulation of mesenchymal stem cells, is currently in Phase III clinical trials for several indications and recently received regulatory approval in Canada to treat children suffering from acute graft versus host disease. While stem cells are usually considered as the basis for potential therapeutic treatments, the identification of cancer stem cells has opened up another area of research that targets cells in order to treat cancer. There have been commercialization setbacks. In November of 2011, a pioneering company terminated its ES cell research program as well as a small, early-stage clinical trial that involved the use of oligodendrocyte progenitor cells derived from human ES cells designed to treat severe spinal cord injuries. The termination was stated to be for financial reasons (i.e., high cost of the R&D program), not scientific difficulties and the company refocused on cancer drug development [2] . Nevertheless, the overall outlook remains positive and there has been a dramatic increase in the number of clinical trials that involve stem cells [3] . Stem cells have also emerged as an accepted tool for drug screening [4] . Obtaining effective patent protection for inventions related to stem cells is vital as the practical commercial and clinical applications of stem cells begin to come of age.

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Pharm. Pat. Analyst (2012) 1(4), 407–413

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Key terms

Criteria for patentability

Any invention must meet Embryonic stem cells: Cells certain key criteria for pattypically derived from a entability in the USA, Eudeveloping embryo and rope and Canada. It must be characterized by their ability to replicate indefinitely and to patentable subject matter, differentiate into all the cell types meaning that it must be a in an adult body (pluripotency). type of invention that is eligible for patenting. Patent Patentable subject matter: Subject matter that is eligible for laws in the USA and Canada patent protection provided it also provide enumerated catmeets the remaining criteria for egories of patentable subject patentability such as novelty and matter. For example, title 35 inventiveness. of the US Code, Section 101 (35 U.S.C. 101) provides that whoever “ invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor” [5] . In contrast, the European Patent Convention (EPC) states that patents “shall be granted for any inventions, in all fields of technology” and then provides a list of exceptions defining types of inventions for which European patents shall not be granted; for example, abstract ideas or scientific theories are not patentable. Methods of surgery are patentable in the USA, but not in Europe and Canada, however, med­ ical use claims are permitted and can often provide suitable protection. The boundaries of what is considered patentable subject matter differ in each patent office. An eligible invention must also be new, useful and inventive compared with previously known information (called ‘prior art’). For stem cells, there can be difficult issues in drafting patent claims, since they are a complex, living system, unlike pharmaceuticals, proteins or nucleic acid molecules that have a readily describable chemical structure. Proving to patent offices that an isolated stem cell is new and inventive compared with previously known cells, and therefore patentable, can be a challenge. The new stem cell may produce different cell lineages with variable expression patterns of biological markers depending on the culture conditions. Prior art stem cells are also dynamic and even the same cell type will have some inherent differences if taken from a genetically different tissue source. It can be difficult to compare and reconcile each researcher’s limited data set and make direct comparisons to show that a new cell is a patentably unique stem cell. Inventors should be prepared to provide detailed evidence to patent offices. Normally the patent office has the onus to prove a prima facie case showing the similarity of the claimed subject matter and the prior art. However, this onus can be reversed in some circumstances where it is difficult for

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a patent examiner to distinguish between the prior art and the subject matter of the invention. Another important criteria for patentability is that the patent application must disclose the invention in sufficient detail to show a skilled person how to make and use the invention (called ‘enablement’ or ‘support’). A discussion of this requirement is beyond the scope of this article, however, briefly, it is usually readily satisfied for methods of isolating stem cells or using cells for drug screening. Enablement becomes a challenge for patent claims on medical applications of stem cells because stem cells are highly unpredictable and difficult to use successfully in treatment. Patents are also normally filed well in advance of any experimental use in humans. However, the necessary level of data to support a patent claim is generally significantly less than what may be required for regulatory approval for clinical treatment. Demonstrating a particular effect in vitro or in a model organism that provides a correlation to effects in humans can be sufficient to enable claims to therapeutic uses in humans. ES cells

ES cells are typically derived from the inner cell mass of a developing embryo and are characterized by their ability to differentiate into every �������������������������� cell type ���������� except extra embryonic tissue such as the placenta (i.e., pluripotency). While a number of human ES cell lines are now available, their creation, traditionally, required the destruction of a human embryo, which has generated substantial controversy. ■■ USA

In the USA, ES cells are considered patentable subject matter, as are methods for isolating or producing ES cells, even if the invention requires that a human embryo be destroyed. A well-known, early stem cell patent portfolio belongs to the Wisconsin Alumni Research Foundation (WARF) that was granted three related US patents based on pioneering work by Thomson [101–103] . For example, claim 1 of WARF patent [101] recites: “A purified preparation of pluripotent primate ES cells derived from a pre-implantation embryo wherein the stem cells (i) will proliferate in an in vitro culture for over one year in an undifferentiated state, (ii) maintain a karyotype in which all the chromosomes characteristic of the primate species are present and not noticeably altered through prolonged culture, (iii) maintain the potential to differentiate into derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) will not differentiate when cultured on a fibroblast feeder layer” [101] . The claims primarily focus on functional properties of the cells, rather than chemical properties, in order to

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Differentiating stem cell patents

establish novelty and inventiveness. Simpler claims are preferable, where possible in view of prior art [104,105] . Subsequently, WARF patented methods of isolating a pluripotent human ES cell line [102] and a replicating in vitro culture of human ES cells [103] . Protecting the isolated cells, methods of production and methods of use is a common strategy for building an effective patent portfolio. The claims in the WARF patents have come under third-party scrutiny, resulting in requests for reexamination of the patents at the US Patent Office. WARF’s first two patents [101] and [102] were upheld on re-examination with amendments. However, the Board of Patent Appeals and Interferences eventually invalidated WARF’s patent [103] on stem cell cultures as being obvious in light of prior art [6] . More recently, US patent [106] “Neural precursor cells, method for the production and use thereof in neural defect therapy” was issued to Brüstle on 28 June 2011 [106] . It has claims directed to methods for the generation of an isolated, non-tumorigenic cell composition that involve culturing mouse or human ES cells to produce neural precursor cells. This process is considered patentable even though it could result in the destruction of a human embryo. The opposite result occurred in Europe, as explained in the discussion of Europe below. ■■ USA: limits on patentability and the Mayo decision

No US patent may give rights in a human being or organ, which are considered nonpatentable subject matter. Section 33(a) of the Leahy–Smith America Invents Act signed into law on 16 September 2011 now states “Notwithstanding any other provision of law, no patent may be issued on a claim directed to or encompassing a human organism.” This reflects long-standing US Patent Office policy that human organisms are not patentable subject matter. Certain living matter, such as transgenic animals, that the result of human intervention can be patentable subject matter [107] . Isolated, naturally occurring biological material, such as isolated genes, proteins or stem cells, is also considered patentable [7] . The recent US Supreme Court decision in Mayo v. Prometheus ����������������������������������������� has rekindled the debate regarding whether certain types of inventions are patent eligible  [8] . Exceptions to patent eligibility include claims that are considered to be effectively directed to a ‘law of nature’, a ‘natural phenomenon’ or an ‘abstract idea’. The decision in Mayo concerned the patentability of method claims directed towards optimizing a suitable drug dosage for autoimmune disease therapy. The method involved measuring levels of the drug’s metabolites in a patient through the specific claimed steps of ‘admin­istration’ of the drug and ‘determining’ drug metabolite levels. Further guidance, particularly with

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respect to the patentability of product claims (such as isolated genes or cells), is expected in the Myriad Genetics [9] case. It will now be reconsidered by the lower courts in light of the Mayo decision. In Myriad Genetics, the Court of Appeals for the Federal Circuit previously decided that an ‘isolated’ biological product, such as an isolated DNA sequence, is a patentable, distinct chemical entity compared with the gene in its natural state. If the Court again decides to uphold the product claims, this will most likely be the basis put forward. This outcome would also support validity of isolated stem cell patents. In the initial decision, the Court rejected arguments that the product claims were invalid because DNA is a natural phenomenon and ‘isolation’ of DNA is a routine, non-patentable activity for scientists. The Court will have to consider this argument again in view of the reasoning set out by the Supreme Court in the Mayo decision. It remains to be seen whether these decisions will have a significant impact on the long-standing practice of the US Patent Office to grant patents on biological material, such as DNA or cells that are isolated or purified from nature and are otherwise deemed patentable. ■■ Europe

In Europe, a number of overlapping legal frameworks serve to govern the grant and enforcement of patent rights. The EPC provides a unitary framework instituted through the EPO, which allows a single application to result in the grant of a patent that can be registered in individual countries. Many, but not all, countries who are signatories of the EPC are also part of the EU, whose system of laws is binding on member countries. Variations in national laws between individual countries also serve to differentiate the landscape with respect to medical research and the availability of patent protection for inventions in biotechnology [10] . Concerns over the interpretation of the EPC and the need for greater clarity regarding the boundaries of patent protection led to the adoption of the European Biotechnology Directive (the Directive) by the EU [11] . Many of the provisions in the Directive were subsequently incorporated into the EPC in an effort to harmonize the framework for inventions related to biotechnology. For example, under the EPC, inventions related to biotechnology are considered patentable subject matter but must not fall into one of a number of exceptions including: methods of medical treatment; diagnostic methods practiced on the body; plant and animal varieties; and essentially biological processes for the production of plants and animals. Inventions relating to individual human, animal or plant genes and proteins are considered patentable subject matter as long

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as the remaining criteria for patentability are fulfilled. Biological maAdult stem cells: Also known as terial such as cells that are isolated somatic stem cells, these are cells from their natural environment or that are found in the body after otherwise produced by a technidevelopment characterized by their ability to replicate cal process may also be considered indefinitely and to differentiate patentable even if they previously into a limited number of cell types. occurred in nature. Article 53 of the EPC prohibInduced pluripotent stem cells: Type of stem cell similar to an its the patenting of any invention embryonic stem cell but whose commercial exploitation artificially derived from a would be contrary to ‘ordre public’ non-pluripotent cell such as by or morality. Similarly, Article 6 of inducing the expression of the Directive states that inventions specific genes. shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality. The Directive and the EPC both specifically prohibit patents that concern the use of human embryos for ‘industrial or commercial purposes’ [12] . These prohibitions have resulted in a much more restrictive landscape for ES cell patenting in Europe than in the USA or Canada. For example, after a lengthy prosecution before the European Patent Office, WARF’s European patent application no. 96903521 directed to primate ES cells was rejected by the Enlarged Board of Appeal. The Board held that a patent cannot be granted for a product that could only be prepared by a method necessarily involving the destruction of human embryos, which was seen as a commercial exploitation of an embryo and against ordre public or morality [13] . The Enlarged Board of Appeal also noted that it was not relevant in this context that after the filing date the products could be obtained without necessarily involving the destruction of human embryos, such as by the use of human embryonic cell lines. More recently, in October of 2011, the Court of Justice of the European Union (CJEU) released its decision in the Brüstle case that effectively excludes from patentability a number of inventions related to human ES cells [14] . The patent in Brüstle was directed to methods for deriving neuronal cells from mammalian ES cells. The decision has been criticized for its perceived negative impact on investment into stem cells as well as basic research for regenerative medicine involving ES cells [15] . The Brüstle decision broadly prohibited the patentability of inventions that use human embryos as a base material, and not just those inventions wherein a human embryo is destroyed. In Brüstle, ����������������������������� t������������������� he CJEU broadly defined the term ‘human embryo’ within the context of the Directive to include cells that are capable of commencing the process of development into a human being. Key terms

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However, the CJEU noted that it was for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at a particular stage is capable of commencing the process of development of a human being. Claims to methods that resulted in the destruction of a human embryo were held not to be patentable subject matter, and the CJEU also excluded from patentability subject matter that “requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos”. The CJEU also held that “uses of human embryos for industrial or commercial purposes” includes the use of human embryos for scientific research leading to a patent application. It noted that the Directive does permit inventions for therapeutic and diagnostics purposes that are applied to an embryo and are useful to it. Previously, it was possible to obtain patents for pluripotent stem cells and related methods in Europe, as long as the inventions made use of pre-existing human ES cell lines. These inventions were patentable even if those pre-existing cell lines were originally created by a method that necessarily involved the destruction of human embryonic material. It remains to be seen whether the EPO will amend current practice in light of the Brüstle decision, which potentially prohibits the destruction or use of human embryos as a base material at any stage prior to the invention, such as by a third party generating a human ES cell line years prior to the invention at issue. Practically, it will be very difficult for inventors, let alone the EPO, to check for such any such violations in the development of an invention that under a strict interpretation of Brüstle would render an invention unpatentable. While the ����������������������������������������� Brüstle ��������������������������������� decision may appear very restrictive, recent technological advances may help overcome some of the moral and legal hurdles preventing the patentability of ES cell technologies in Europe. For example, new technologies have been developed that allow for the production of ES cells without destroying the embryo [16] . One patent that covers such technology has already been granted in the USA [108] , and a corresponding European patent is pending [109] . The continued prosecution of such patents should result in better guidelines and practices that reflect the law surrounding patentable subject matter while hopefully encouraging the development and patenting of stem cell technologies. ■■ Canada

In Canada, isolated biological material such as cells, nucleic acid molecules or proteins is patentable subject matter. Claims to ‘higher’ life forms including plants or

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transgenic mice are not considered patentable subject matter [17] . This is more restrictive than the USA and Europe. The Canadian Patent Office has issued a practice notice stating its position that fertilized eggs and totipotent cells, which have the potential to develop into an entire animal, are excluded from patent­ability [202] . Embryonic, multipotent and pluripotent stem cells that do not have the potential to develop into an entire animal are patentable subject matter. Processes or methods that involve ES cells or the harm or death of an embryo are not excluded from patentability. Canadian patent [110] is in the same family as WARF’s US patent [101] and was granted in Canada on 4 April 2010. The Canadian patent issued with claims to primate ES cells very similar to those found in the corresponding US patent [110] , reflecting a similarity of practices in the US and Canadian Patent Offices with respect to patentable subject matter for ES cells. Brüstle’s Canadian patent [111] directed to methods for turning ES cells into neurons was recently granted by the Canadian Patent Office. Adult stem cells & induced pluripotent stem cells Adult stem cells are found in most tissues and are char-

acterized by their ability for self renewal and for differentiating into specialized cell types. Patents directed towards adult stem cells have been less controversial than patents directed towards ES cells and accordingly have been greeted with less resistance. Recent advances in the molecular biology surrounding cellular re­ programming have led to the development of induced pluripotent stem cells (iPSCs). iPSCs are technically not adult stem cells, but rather cells that have been reprogrammed, typically using transcription factors, to generate pluripotent cells. Adult stem cells and iPSCs are patentable subject matter in the USA, Europe and Canada. Any claims to compositions or methods that involve adult stem cells or iPSCs must still meet the usual criteria for patentability such as novelty and inventiveness. Notably, distinguishing iPSCs from previously known stem cells that they may claim to emulate is a challenge that may block some claims to iPSCs from being patented. Such patent applications will have to focus on the methods of making the iPSCs, rather than the cells themselves. A number of research groups and companies working on iPSCs have each actively sought patent protection for their inventions. This has resulted in a varied landscape of patents owned by different companies on foundational technologies related to iPSCs. For example, in early 2010 iZumi Bio (now iPierian Inc.) was granted one of the first patents related to iPSCs in the UK [112] . Claim 1 of GB2450603 recites: “An in  vitro method of inducing human pluripotent

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stem cells having in  vitro long-term self-renewal ability and the pluripotency to differentiate into ectoderm, mesoderm and endoderm, comprising subjecting human postnatal tissue to forced expression of each of the genes Oct3/4, Sox2 and Klf4, but not c-Myc, and culturing in the presence of FGF-2” [112] . On 3 August 2011, a European patent [113] was granted to Kyoto University (Japan) for work conducted by Yamanaka related to nuclear reprogramming factors and uses thereof for producing iPSCs [113] . Similar patents have been granted in the USA [114–116] and are pending in Canada [117,118] . Kyoto University set up an affiliate named iPS Academia Japan, Inc. in order to manage patents and other IP developed by Yamanaka and his colleagues. Claim 1 of [113] patent recites: “A nuclear reprogramming factor for a somatic cell, which comprises: a) an Oct family gene or gene product; b) a Klf family gene or gene product; c) a Myc family gene or gene product, and/or a cytokine.” Technology related to iPSCs and nuclear reprogramming was also developed by Jaenish at the Massachusetts Institute of Technology and is being commercialized by Fate Therapeutics, Inc. [119,120] . Claim 1 of Jaenish’s US Patent [120] recites: “A composition comprising an isolated primary somatic cell that comprises an exogenously introduced nucleic acid encoding an Oct4 protein operably linked to at least one regulatory sequence.” The competitive landscape for IP rights for iPSCs has led to some interesting collaborations and licensing agreements. On 1 February 2011 Kyoto University, iPS Academia Japan Inc. and iPierian Inc. announced a series of IP agreements in which iPeirian assigned a number of its patents to Kyoto University, and iPS Academia Japan Inc. in turn granted iPierian Inc. non-exclusive rights to its combined patent estate. Fate Therapeutics, Inc. and Becton, Dickinson and Company have entered into a collaboration to jointly develop and commercialize iPSC tools and technologies for drug discovery and development. There is some debate whether iPSCs and adult stem cells will prove as useful as ES cells for use in regenerative medicine and drug screening [18] , but will likely figure prominently in newly developed stem cell technologies. Patent claims to methods and compositions for re-programming cells in order to produce iPSCs may prove to be more valuable than earlier patent claims to ES cells. Companies with a strong patent position will have a significant advantage when seeking collaborations or taking other steps towards commercialization of these technologies. Future perspective

Consistent strategies can be applied in the USA, Europe and Canada to patent inventions involving adult stem

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cells and iPSCs. Patents can typically cover the cells per se as well as their uses and methods of production. For ES cells, stronger patent protection should be available in the USA and Canada than in Europe. Certain types of ES cell inventions that harm or commercially exploit embryos are patentable subject matter in the USA and Canada but not in Europe. Companies must actively consider these regional differences when preparing patent applications and developing an effective patent strategy. Recent decisions by the US Supreme Court in Mayo and the CJEU in Brüstle have caused concerns about the scope of patentable subject matter. The full impact of these decisions on specific inventions currently under review by patent offices remains to be seen. In the next few years, the law should con-

tinue to evolve and further clarify the boundaries of patentability. Stem cell commercialization will be supported if these boundaries confirm the patentability of isolated products of nature in the USA and inventions that use pre-existing ES cell lines in Europe. Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert t­estimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

Executive summary ƒƒ Therapeutic applications of stem cells are central to regenerative medicine and are starting to be commercialized. ƒƒ Stem cells and particularly embryonic stem cells have raised legal and moral issues with respect to whether they are patentable subject matter. ƒƒ The legal landscape for patenting embryonic stem cells is evolving and varies across the USA, Canada and countries in Europe. Patent strategies can often be adapted to acquire protection in each jurisdiction. ƒƒ Technologies related to adult stem cells and induced pluripotent stem cells appear to face fewer barriers to patentability and have been the subject of increasing patent activity.

References

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Papers of special note have been highlighted as: of interest of considerable interest n

n n

1

Schwartz SD, Hubschman JP, Heilwel G et al. Embryonic stem cell trials for macular degeneration: a preliminary report. Lancet 379(9817), 713–720 (2012).

2

Pollack A. Geron is shutting down its stem cell clinical trial. New York Times, 14th November (2011).

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Trounson A, Thakar RG, Lomax G, Gibbons D. Clinical trials for stem cell therapies. BMC Med. 10(9), 52 (2011).

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Ebert AD, Svendsen CN. Human stem cells and drug screening: opportunities and challenges. Nat. Rev. Drug Discov. 9(5), 367–372 (2010).

Association for Molecular Pathology v. US Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. 29 March 2010); reversed in part by the Court of Appeals for the Federal Circuit 2010–1406 (29 July 2011).

10 Donnelly SR. The patentability of human embryonic stem cells. Dalhousie J. Legal Stud. 20, 106–128. n

Includes a review of the patentability of human embryonic stem cells at the national level in Europe.

11 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. 12 Article 6 of Directive 98/44/EC and Rule 28(c) of the EPC.

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35 U.S.C §101.

13 Decision G 2/06 of the Enlarged Board of Appeal, 25 November 2008.

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US BPAI decision dated April 28, 2010. Control No. 95/000,154.

14 Oliver Brüstle v. Greenpeace e.V., Case C-34/10, 18 October 2011.

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Association for Molecular Pathology v. Myriad Genetics, Court of Appeals for the Federal Circuit 2010–1406 (29 July 2011) (now remanded by the US Supreme Court 26 March 2012 in view of Mayo).

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n n

Mayo Collaborative Servs. v. Prometheus Labs Inc., No. 10–1150 (US Mar. 20,314 2012) Slip Opinion. US Supreme Court decision regarding the scope of patentable subject matter and the patentability of diagnostic methods.

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n n

Court of Justice of the EU decision holding that methods involving the destruction of human embryos cannot be patented.

15 Nature. Error of judgment. Nature 480, 291–292 (2011). 16 Klimanskaya I, Chung Y, Becker S, Lu SJ, Lanza R. Human embryonic stem cell lines derived from singleblastomeres. Nature 444, 481–485 (2006). 17 Harvard College v. Canada (Commissioner of Patents) 4 S.C.R. 45, 2002SCC (2002).

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18 Robinton DA, Daley GQ. The promise of induced pluripotent stem cells inresearch and therapy. Nature 481(7381), 295–305 (2012).

■■ Patents 101 Wisconsin Alumni Research Foundation: US5843780 (1998). 102 Wisconsin Alumni Research Foundation: US6200806 (2001). 103 Wisconsin Alumni Research Foundation: US7029913 (2006). 104 HSC Research and Development Limited Partnership: US6117675 (2000). 105 Rhode Island Hospital, A Life Span Partner: US6129911 (2000). 106 Oliver Brüstle: US7968337 (2011). 107 President and Fellows of Harvard College: US4736866 (1984). 108 Advanced Cell Technology, Inc.: US7893315 (2011). 109 Advanced Cell Technology, Inc.: European Patent Application 07794602 (2012). n

Interesting patent family [108/9] directed to an in vitro method for producing human embryonic stem cells from a blastomere that does not require the destruction of the embryo.

110 Wisconsin Alumni Research Foundation: CA2190528 (2010). 111 Oliver Brüstle: CA2315538 (2012). 112 Izumi Bio Inc.: GB2450603 (2010).

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113 Kyoto University: EP1970446 (2011). 114 Kyoto University: US8048999 (2011). 115 Kyoto University: US8058065(2011). 116 Kyoto University: US8129187(2012). 117 Kyoto University: Canadian Patent Application 2632142. 118 Kyoto University: Canadian Patent Application 2660123.

120 Whitehead Institute for Biomedical Research:US8071369 (2011).

■■ Websites 201 US FDA. FDA approves first cord blood product. www.fda.gov/newsevents/newsroom/ pressannouncements/ucm279575.htm (Accessed 14 May 2012)

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202 Canadian Intellectual Property Office. Office practice regarding fertilized eggs, stem cells, organs and tissues. www.cipo.ic.gc.ca/eic/site/cipointernetinternetopic.nsf/eng/wr00295.html (Accessed 14 May 2012)

119 Whitehead Institute for Biomedical Research: US7682828 (2010).

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Differentiating stem cell patents.

Stem cells are defined by their capability for both self-renewal through cell division and for producing a lineage capable of differentiating into one...
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