According to at least two commentators, the United States Patent and Trademark Office (USPTO) has already “issued more than 1,000 patents directed to stem cell technologies.” Spalding, T. N. and Simkin, M. M., “How Will Patents Impact the Commercialization of Stem Cell Therapeutics?” Intellectual Property & Technology Law Journal 19, no. 1 (2007): 7–11, at 7.Google Scholar

Gulbrandsen, C. E., “Bayh-Dole: Wisconsin Roots and Inspired Public Policy,” Wisconsin Law Review 2007, no. 6 (2007): 1149–1163, at 1156 (describing WARF's history and its assumption of title to inventions produced through federally funded activity).Google Scholar

See Korobkin, R., Stem Cell Century: Law and Policy for a Breakthrough Technology (New Haven: Yale University Press, 2007): at 11–12 (describing success with primate cell lines); University of Wisconsin Stem Cell & Regenerative Medicine Center, The Thomson Laboratory, Faculty Website, available at <http://www.stemcells.wisc.edu/faculty/thomson> (last visited August 20, 2009).Google Scholar

Balanced Budget Downpayment Act, I, Pub. L. No. 104–99, § 128, 110 Stat. 26, 34 (1996); see also Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, § 511, Pub. L. No. 105–277, 112 Stat. 2681, 2681–386 (1998) (same); Departments of Labor, Health and Human Services, Education and Related Agencies Appropriations Act, 1998, Pub. L. No. 105–78, § 513, 111 Stat. 1467, 1517 (1997) (same); Omnibus Consolidated Appropriations Act, 1997, Pub. L. No. 104–208, § 512, 110 Stat. 3009, 3009–270 (1996) (same).Google Scholar

See Miller, J., Comment, , “A Call to Legal Arms: Bringing Embryonic Stem Cell Therapies to Market,” Albany Law Journal of Science & Technology 13, no. 2 (2003): 555–592, at 562 (describing Geron's attainment of exclusive and nonexclusive rights in exchange for providing “approximately one million dollars”); see Korobkin, , Stem Cell Century, supra note 3, at 97 (“Geron demanded certain rights to any successes that might arise from the work.”).Google Scholar

See, e.g., Miller, , supra note 5, at 556 (arguing that “the breadth of [WARF's] patent on embryonic stem cells is antithetical to the goal of fostering commercial development of stem cell products”).Google Scholar

See id., at 563 (observing that a number of researchers “have criticized [WARF's approach to licensing] and refused to agree to its terms”).Google Scholar

In re Wis. Alumni Res. Found., No. G0002/06, slip op. at ¶ 22, at 23–24 (Enlarged Pat. Off. Bd. of App. Nov. 25, 2008), available at <http://legal.european-patent-office.org/dg3/bib-lio/g060002ex1.htm> (last visited April 22, 2010).+(last+visited+April+22,+2010).>Google Scholar

See O'Connor, S., “The Use of MTAs to Control Commercialization of Stem Cell Diagnostics and Therapeutics,” Berkeley Technology Law Journal 21, no. 3 (2006): 1017–1054, at 1027 (describing Thomson as having “achieved an amazing break-through… when he cultured immortal human embryonic stem cells”); Gearhart, J., “New Potential for Human Embryonic Stem Cells,” Science 282, no. 5391 (1998): 1061–1062, at 1061 (“This report of the derivation of [embryonic stem] cells from human blastocysts represents a major technical achievement with great importance for human biology.”); cf. Thomson, J. A. et al., “Embryonic Stem Cell Lines Derived from Human Blastocysts,” Science 282, no. 5391 (1998): 1145–1147, at 1145 (reporting the Thomson group's success in generating long-lasting pluripotent hESCs in one of the world's leading peer-reviewed scientific journals).Google Scholar

Request for Ex Parte Reexamination at 9, In re Reexamination Control No. 90/008,102 (July 17, 2006) (contending that “[t]he only difference between [certain prior art references] and the claims of the '780 patent is that [those prior art references] isolate mouse ES cells while the '780 patent claims primate ES cells”); Request for Ex Parte Reexamination at 10, In re Reexamination Control No. 90/008,139 (July 17, 2006) (making similar arguments with respect to the '806 patent's claims); Request for Inter Partes Reexamination at 5, In re Reexamination Control No. 95/000,154 (July 17, 2006) (making similar arguments with respect to the '913 patent's claims).Google Scholar

See U.S. Patent No. 5,843,780 (issued December 1, 1998) (hereinafter '780 Patent) (listing a filing date of January 18, 1996, for an application that was a continuation-in-part of an application filed on January 20, 1995); U.S. Patent No. 6,200,806 (issued March 13, 2001) (hereinafter '806 Patent) (showing the patent to have resulted from a divisional application based on the application leading to the '780 patent); U.S. Patent No. 7,029,913 (issued April 18, 2006) (hereinafter '913 Patent) (showing the patent to have resulted from a series of continuations of the application leading to the '806 patent).Google Scholar

See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1320 (Fed. Cir. 2003) (per curiam) (stating that the written description must contain “sufficient information… to show [an ordinary artisan] that the inventor possessed the invention at the time of the original filing”). The United States Court of Appeals for the Federal Circuit has recently granted a petition for en banc review of the validity and scope of this “demonstration of possession” requirement. See Ariad Pharms., Inc. v. Eli Lilly & Co., No. 2008–1248, slip op. at 2 (Fed. Cir. August 21, 2009) (en banc) (per curiam) (listing “issues raised in the petition”).Google Scholar

35 U.S.C. § 112, ¶ 1 (requiring that a patent “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same”).Google Scholar

See, e.g., Golden, J. M., “Construing Patent Claims According to Their ‘Interpretive Community’: A Call for an Attorney-Plus-Artisan Perspective,” Harvard Journal of Law & Technology 21, no. 2 (2008): 321–386, at 322 (2008) (“Claims—numbered clauses at the end of a patent—are meant to provide notice of what a patent covers… .”).Google Scholar

35 U.S.C. § 154(a)(1) (“Every patent shall contain… a grant… of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States… .”).Google Scholar

In the stem cell context, a “pluripotent” cell is one “[a]ble to give rise to differentiated cells of all three germ layers.” Lanza, R. et al., Essentials of Stem Cell Biology (Burlington: Academic Press, 2005): at 527. Such pluripotency is distinct from “totipotency,” “an ability to generate a whole animal autonomously”; “multipotency,” “an ability to give multiple cell types that belong to particular germ layers, not all three”; and “unipotency,” “an ability to give a single differentiation cell type.” Id.Google Scholar

The term “karyotype” “refers to the number and morphology of chromosomes and is characteristic for each species.” Gartner, L. P., Hiatt, J. L., and Strum, J. M., Cell Biology and Histology, 5th ed. (Baltimore: Lippincott Williams & Wilkins, 2007): at 18 (emphasis omitted). For example, a “normal human female karyotype would have each of the 22 pairs of autosomes (non-sex chromosomes[)] arranged in numerical order together with the two X-chromosomes.” See Lanza, et al., supra note 16, at 525.Google Scholar

The endoderm, mesoderm, and ectoderm are “three layers of cells” that form early in the development of an embryo and “from which different body tissues develop.” Barry, J. M., Molecular Embryology: How Molecules Give Birth to Animals (Taylor & Francis, 2002): at 153 (defining “gastrulation”); see also id., at 14 (describing gastrulation in the embryonic development of a fruit fly); id., at 152 (defining “ectoderm, endoderm, and mesoderm” (emphasis omitted)).Google Scholar

“Fibroblasts” are “connective tissue cells that secrete collagen and other molecules of the extracellular matrix” and “are the easiest vertebrate cells to grow in culture.” Id., at 153; see also Gartner, , Hiatt, , and Strum, , supra note 17, at 78 (describing fibroblasts as “the predominant cells in connective tissue proper”).Google Scholar

Ex Parte Reexamination Certificate, U.S. Patent No. 5,843,780, col. 1, ll. 25–37 (issued June 17, 2008) (hereinafter '780 Reexamination Certificate). A “feeder layer” is a “layer of cells that are growth-arrested, providing nutrients, growth factors, and matrix components to a second cell population.” See Lanza et al., supra note 16, at 523.Google Scholar

See '780 Patent, , supra note 11, at col. 3, 11. 51–56.Google Scholar

See id., at col. 16, ll. 23–48 (describing success in culturing macaque embryonic stem cells on various fibroblast layers, and hypothesizing “that similar culture conditions will support human [embryonic stem] cells”).Google Scholar

“Language in a preamble limits a claim where it breathes life and meaning into the claim, but not where it merely recites a purpose or intended use of the invention.” Innova/Pure Water v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1118 (Fed. Cir. 2004) (internal citation omitted); see also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“If… the body of the claim fully and intrinsically sets forth the complete invention, including all of its limitations, and the preamble offers no distinct definition of any of the claimed invention's limitations, but rather merely states, for example, the purpose or intended use of the invention, then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation.”). The preamble of claim 1 appears to “breath[e] life and meaning into” the remainder of the claim, given that the phrase “the stem cells” appearing immediately after “wherein” seems necessarily to refer to the “pluripotent primate embryonic stem cells” of the preamble.Google Scholar

See Loring, J. F. and Campbell, C., “Intellectual Property and Human Embryonic Stem Cell Research,” Science 311, no. 5768 (2006): 1716–1717, at 1716 (describing WARF's '780 patent as “effectively cover[ing] all [primate embryonic stem] cell lines regardless of who makes them or how they are generated”).CrossRefGoogle Scholar

A “blastocysts” is a “[v]ery early animal embryo consisting of a spherical outer epithelial layer of cells known as the trophectoderm …, a clump of cells attached to the trophectoderm known as the inner-cell mass (from which stem cells are derived), and a fluid-filled cavity, the blastocoels.” See Lanza, et al., supra note 16, at 522.Google Scholar

A cell's nucleus is a membrane-bounded portion of a eukaryotic cell that contains the basic genetic material – deoxyribonucleic acid or DNA – of the cell. Starr, C., Basic Concepts in Biology (Belmont, Cal.: Wadsworth Publishing Co., 1997): at 50 (describing a cell nucleus).Google Scholar

A cell's cytoplasm encompasses cellular material outside the nucleus. See Geller, E. et al., eds., McGraw-Hill Dictionary of Bioscience, 2d ed. (New York: McGraw-Hill Cos., 2003): at 161 (defining the cytoplasm as “[t]he protoplasm of an animal or plant cell external to the nucleus”).Google Scholar

A nucleolus is “a globular mass of material within the nucleus” of a eukaryotic cell where portions of ribosomes, structures that help to build proteins(see Starr, , supra note 26, at 46 [describing the function of ribosomes]), are constructed. Id., at 50 (describing nucleoli).Google Scholar

See '780 Reexamination Certificate, supra note 20, col. 1, l. 47, to col. 2, l. 18.Google Scholar

Compare id., cols. 1–2 (reciting 14 claims for primate embryonic stem cells and methods of producing them), with Ex Parte Reexamination Certificate, U.S. Patent No. 6,200,806, col. 1, ll. 25–37 (issued June 17, 2008) (hereinafter '806 Reexamination Certificate) (reciting 14 similar claims for hESCs and methods of producing them).Google Scholar

See '913 Patent, supra note 11, cols. 21–22 (reciting three claims for hESC cultures).Google Scholar

See Golden, J. M., “Principles for Patent Remedies,” Texas Law Review 88, no. 3 (2010): 505–592, at 515 (“[P]atent rights can encompass embodiments of the invention that one might otherwise view as differing significantly from what a patenting inventor specifically created or described.”).Google Scholar

See Holbrook, T. R., “Possession in Patent Law,” SMU Law Review 59, no. 1 (2006): 123–176, at 147 (“[D]emonstrating the possession of an intangible idea is difficult.”); Lefstin, J. A., “The Formal Structure of Patent Law and the Limits of Enablement,” Berkeley Technology Law Journal 23, no. 4 (2008): 1141–1225, at 1181 (arguing that patent law's “enablement doctrine faces fundamental difficulties as a coherent and complete doctrine of patent scope”); cf. Kelly, K. T., “Fragging the Patent Frags: Restricting Expressed Sequence Tag Patenting Using the Enablement-Commensurate-in-Scope-with-the-Claims Requirement,” Texas Intellectual Property Law Journal 17, no. 1 (2008): 49–79, at 77 (arguing that “the enablement requirement… employs several different factors… and can be used to shape strikingly the law governing [certain genetic sequence] patents”).Google Scholar

See infra text accompanying notes 39–46.Google Scholar

In a 2003 set of office actions rejecting claims for a “chimera” organism composed of a mixture of human and nonhuman cells, a USPTO examiner invoked an oft neglected and somewhat hoary doctrine of beneficial utility – the United States' best historical analog for Europe's morality requirement – as one justification for understanding patentable subject matter to be restricted in a way that excludes inventions “covering a human being,” Office Action, In re Application No. 08/993,564, at 24 (Jan. 29, 2003) (hereinafter '564 Office Action); see also Office Action, In re Application No. 10/308,135, at 18–19 (March 5, 2003) (hereinafter '135 Office Action) (similarly determining that claims were “directed to non-statutory subject matter” because, under their “broadest reasonable interpretation,” “they include[d] a human”). After asserting that both the doctrine of constitutional avoidance and the “ordinary common meaning” of the statutory “terms ‘manufacture’ and ‘composition of matter’” supported this exclusion, '135 Office Action, supra, at 20–21; '564 Office Action, supra, at 26–27, the examiner stated that “[w]hen Congress included the term ‘useful’ in the statute, the requirement that an invention not be frivolous, or injurious to well-being, good policy, or good morals of society was incorporated with it.” '135 Office Action, supra, at 22; '564 Office Action, supra, at 28. From this, the examiner concluded that “[c]oncerns for deference to the powers of other institutions of government weigh in favor of considering the patenting of humans as the kind of invention that would not be considered ‘useful’ under the [beneficial utility] doctrine.” '135 Office Action, supra, at 22; '564 Office Action, supra, at 28. See generally Holbrook, T. R., “The Expressive Impact of Patents,” Washington University Law Review 84, no. 3 (2006): 573–622, at 607 (finding that the examiner's reasoning “suggests that use of morality may yet resurface at the [USPTO]”). Although the examiner did not repeat this invocation of the doctrine of beneficial utility in later office actions, those office actions did incorporate such invocations by reference, again in the context of justifying rejections for lack of statutory subject matter. See Office Action, In re Application No. 10/308,135, at 20 (August 11, 2004) (“[T]he claimed invention is directed to non-statutory subject matter for the reasons of record.”); Office Action, In re Application No. 08/993,564, at 21 (August 2, 2004) (“For reasons already stated on the record, the Office does not agree that humans are patentable subject matter.”); Office Action, In re Application No. 10/308,135, at 16 (October 7, 2003) (“The prior Office Action set out the reasoning for considering that a human being is not patent eligible subject matter.”); Office Action, In re Application No. 08/993,564, at 17 (October 7, 2003) (“The prior Office actions set out the reasoning for considering that a human being at any stage of development is not patent eligible subject matter.”).Google Scholar

See Bagley, M. A., “Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” William and Mary Law Review 45, no. 2 (2003): 469–547, at 477 (concluding that, under United States patent law, “no explicit basis exists for denying patent protection to otherwise patentable, morally controversial subject matter”).Google Scholar

See infra text accompanying note 61.Google Scholar

See European Patent Office (EPO), Extract from the Register of European Patents: WO9622362, EPO Register Plus Website, available through <http://register.epoline.org/espacenet/regviewer> (last visited April 22, 2010) (showing that WARF requested examination of its application on November 15, 1996, but that this examination remained pending as of March 27, 2009).+(last+visited+April+22,+2010)+(showing+that+WARF+requested+examination+of+its+application+on+November+15,+1996,+but+that+this+examination+remained+pending+as+of+March+27,+2009).>Google Scholar

See id. (listing renewal payments).Google Scholar

In re Wisconsin Alumni Research Foundation, No. G0002/06, slip op. ¶ 15, at 19 (hereinafter WARF), available at <http://legal.european-patent-office.org/dg3/biblio/g060002ex1.htm> (last visited April 22, 2010).+(last+visited+April+22,+2010).>Google Scholar

Id., at ¶ 22, at 23–24 (“Since in the case referred to the Enlarged Board the only teaching of how to perform the invention to make human embryonic stem cell cultures is the use (involving their destruction) of human embryos, this invention falls under the prohibition of Rule 28(c)… .”).Google Scholar

Convention on the Grant of European Patents, October 5, 1973, art. 53(a) (convention revise6d December 17, 1991, and November 29, 2000), in European Patent Office, European Patent Convention (2007) (hereinafter European Patent Convention): at 80, available at <http://www.epo.org/patents/law/legal-texts/epc.html> (last visited April 22, 2010).+(last+visited+April+22,+2010).>Google Scholar

Implementing Regulations to the Convention on the Grant of European Patents of October 1973, as Adopted by Decision of the Administrative Council of the European Patent Organisation of 7 December 2006, in European Patent Convention, supra note 42, at 256–258.Google Scholar

WARF, slip op. ¶ 25, at 25. The Enlarged Board's broad view of “industrial or commercial purposes” in construing a restriction on patentability resonates with the United States Court of Appeals for the Federal Circuit's broad view of non-experimental activities potentially liable for infringement. See Madey v. Duke Univ., 307 F.3d 1351, 1362 (Fed. Cir. 2002) (finding that “research projects with arguably no commercial application” nonetheless “further [a research university's] legitimate business objectives,” and that, “so long as [an] act is in furtherance of the alleged infringer's legitimate business…, the act does not qualify for the very narrow and strictly limited experimental use defense”).Google Scholar

WARF, slip op. ¶ 22, at 23.Google Scholar

Id., 22, at 23–24. According to the Enlarged Board, without such a broad view of the term “inventions,” “avoidance of the patenting prohibition [of Rule 28 would become] merely a matter of clever and skillful drafting of [a patent] claim.” Id., ¶ 22, at 24.Google Scholar

Id., ¶ 22, at 24.Google Scholar

See id., ¶ 25, at 25 (“On the facts which this Board must assume in answering the referred question …, making the claimed product involves the destruction of human embryos.”).Google Scholar

Cf. supra text accompanying note 36.Google Scholar

Science, State, Justice, Commerce, and Related Agencies Appropriations Act, 2006, Pub. L. 109–108, § 623, 119 Stat. 2290, 2342 (2005); Consolidated Appropriations Act, 2005, Pub. L. No. 108–447, § 626, 118 Stat. 2809, 2920 (2004); Consolidated Appropriations Act, 2004, Pub. L. No. 108–199, § 634, 118 Stat. 3, 101; see also Munzer, S. R., “Human-Nonhuman Chimeras in Embryonic Stem Cell Research,” Harvard Journal of Law & Technology 21, no. 1 (2007): 123–178, at 173 (“As part of omnibus appropriations bills in 2004, 2005, and 2006, Congress enacted the Weldon Amendment, which bans the use of federal funds ‘to issue patents on claims directed to or encompassing a human organism.’”).Google Scholar

The USPTO's Manual of Patent Examining Procedure (MPEP), a several-hundred-page set of guidelines for USPTO examiners, appears to have first included a prohibition of patent claims “encompass[ing] a human being” in 1996. Compare USPTO, Manual of Patent Examining Procedure, rev. 6th ed. (1995): § 2105, at 2100–4 (reporting the Commissioner's 1987 announcement that the USPTO “would now consider non-naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter”), with USPTO, Manual of Patent Examining Procedure, rev. 6th ed. (1996): § 2105, at 2100–4 (further stating that, “[i]f 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”). This prohibition remains in the MPEP today. USPTO, Manual of Patent Examining Procedure, rev. 8th ed. (2008): § 2105, at 2100–5 (using the same language as the 1996 revised edition of the MPEP).Google Scholar

See '780 Patent, supra note 11 (listing on the cover page an issuance date of December 1, 1998).CrossRefGoogle Scholar

See '806 Patent, supra note 11 (listing on the cover page an issuance date of March 13, 2001).Google Scholar

See '913 Patent, supra note 11 (listing on the cover page an issuance date of April 18, 2006).Google Scholar

WARF's patents only describe embryonic stem cells as pluripotent, rather than totipotent. Although pluripotent stem cells can give rise to a variety of types of cells of an adult organism, only totipotent cells have the capacity “to generate a whole animal autonomously.” See Lanza, et al., supra note 16, at 527 (defining pluripotency). If WARF's patent claims are understood to be directed only to pluripotent stem cells that are not also totipotent, this restriction might be grounds for feeling particularly safe in viewing such claims as allowable despite any PTO ban on allowing patent claims that encompass a human being.Google Scholar

See infra text accompanying note 60.Google Scholar

See American Bar Association, Report of the Special Committee on the Weldon Amendment to H.R. 2799, the Appropriation Bill for the Departments of Commerce, Justice, State and the Judiciary (2004) (hereinafter ABA Report): at 4 (expressing concern that the language of the Weldon Amendment “could be interpreted as broadening the current USPTO prohibition to pr[o]scribe also the patenting of human cells or human cell lines, such as embryonic stem cell lines”).Google Scholar

35 U.S.C. § 301 (“Any person at any time may cite to the Office in writing prior art consisting of patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent.”); see also id., § 302 (“Any person at any time may file a request for reexamination by the Office of any claim of a patent on the basis of any prior art cited under the provisions of section 301 of this title.”); id., § 311(a) (“Any third-party requester at any time may file a request for inter partes reexamination by the Office of a patent on the basis of any prior art cited under the provisions of section 301.”).Google Scholar

But cf. Merges, R. P. and Duffy, J. F., Patent Law and Policy: Cases and Materials, 4th ed. (Newark: Matthew Bender & Co., 2007): at 218 (noting that, in a case involving a different technology, a party accused of infringement “argu[ed] that it should be free to use [the patented invention] because the [invention was] so deceptive” and therefore unpatentable (emphasis omitted)).Google Scholar

149 Cong. Rec. H7274 (daily ed. July 22, 2003) (statement of Rep. Weldon).Google Scholar

See Request for Ex Parte Reexamination of U.S. Patent No. 5, 843,780, at 1 (July 17, 2006) (making a request for reexamination “[o]n behalf of the Foundation for Taxpayer and Consumer Rights”); Request for Ex Parte Reexamination of U.S. Patent No. 6,200,806, at 1 (July 17, 2006) (same); Request for Inter Partes Reexamination of U.S. Patent No. 7,029,913, at 1 (July 17, 2006) (same). “Consumer Watchdog” is the current name of the group formerly known as the Foundation for Taxpayer and Consumer Rights. Consumer Watchdog, About Consumer Watchdog, Consumer Watchdog Website, available at <http://www.consumerwatchdog.org/about/> (last visited April 26, 2010).+(last+visited+April+26,+2010).>Google Scholar

See '780 Ex Parte Reexamination Certificate, supra note 20 (issued on June 17, 2008); '806 Ex Parte Reexamination Certificate, supra note 30 (issued on June 17, 2008); Action Closing Prosecution in the Inter Partes Reexamination of U.S. Patent No. 7,029,913, at 78–79 (Feb. 25, 2008) (concluding that the '913 patent's claims were not anticipated by “prior art of record” and there was “no prima facie case of obviousness” of the '913 patent's claims); see also infra text accompanying notes 106–108. Consumer Watchdog, the third-party requester for the inter partes reexamination of the '913 patent, has appealed to the USPTO's Board of Patent Appeals and Interferences the examiner's reaffirmation of the '913 patent's claims. Notice of Appeal from the Examiner to the Board of Patent Appeals and Interferences at 2, In re Application of J. Thomson, Reexamination Control No. 95/000,154 (July 18, 2008) (“Consumer Watchdog appeals from the findings of patentability of claims 1–3 made by the Examiner… .”).Google Scholar

See supra note 9 (citing articles). But cf. Declaration of Douglas A. Melton, Ph.D., in Third Party Requester's Comments on Inter Partes Reexamination Communications in the Matter of Reexamination Control No. 95/000,154, at 5–6, ¶ 14 (June 29, 2007) (declaring a strong belief “that Dr. Thomson deserves the scientific and public recognition he has received,” but attributing Thomson's success to his ability to gather certain resources, not inventiveness); Declaration of Dr.Cowan, Chad, Ph.D., in Third Party Requester's Comments on Inter Partes Reexamination Communications in the Matter of Reexamination Control No. 95/000,154, at 5–6, ¶ 14 (June 29, 2007) (declaring that “Dr. Thomson deserved the acclaim bestowed upon him” for “the time and energy he spent getting fresh human embryos… and enough financial support …, not because he invented anything or made a non-obvious discovery”).Google Scholar

See Miller, , supra note 5, at 561.Google Scholar

See Korobkin, R., “Recent Developments in the ‘Stem Cell Century’: Implications for Embryo Research, Egg Donor Compensation, and Stem Cell Patents,” Jurimetrics 49, no. 1 (2008): 51–71, at 70–71 (stating a belief that, although WARF's patent claims “satisfy the Patent Act's nonobviousness requirement,” they should be found invalid as involving unpatentable “‘product[s] of nature’” and as inadequately supported under patent law's enablement requirement); Spalding, and Simkin, , supra note 1, at 9 (observing that “early stem cell patents” might be especially vulnerable to challenges for failure to fulfill patent law's written description and enablement requirements). Compare Miller, , supra note 5, at 586–587 (finding unconvincing a potential argument “that the process for deriving primate stem cells was obvious in light of the procedures used to isolate and purify stem cells from mice, sheep, hamsters, and rabbits”), with id., at 592 (concluding that, in light of patent law's enablement requirement, a court should hold that WARF's '806 patent cannot claim “all human embryonic stem cells, regardless of how they were produced”).Google Scholar

Cf. WARF, Wisconsin Alumni Research Foundation Changes Stem Cell Policies to Encourage Greater Academic, Industry Collaboration, Press Release, January 23, 2007 (quoting WARF's managing director as stating that a liberalization of WARF's policies “‘reflect[s] an ongoing dialog with researchers and university administrators across the country’”), available at <http://www.warf.org/news/news.jsp?news_id=209> (last visited April 26, 2010).+(last+visited+April+26,+2010).>Google Scholar

WiCell Research Institute, “About WiCellTM” (2008): at 2 (“WiCell is a nonprofit subsidiary of the Wisconsin Alumni Research Foundation (WARF), the private nonprofit technology transfer organization that supports research at the University of Wisconsin-Madison.”), available at <http://www.wicell.org/index.php?option=com_content&task=blogsection&id=11&Itemid=148> (last visited April 26, 2010).+(last+visited+April+26,+2010).>Google Scholar

See WiCell Research Institute, Press Release, WiCell to Establish National Stem Cell Bank (October 3, 2005) (hereinafter Stem Cell Bank Press Release) (reporting an assertion by the president of Wicell's board of directors that the National Stem Cell Bank would make stem cell lines available to researchers at lower cost and with improved support and training), available at <http://www.wicell.org/index.php?option=com_content&task=view&id=74&Itemid=170> (last visited April 26, 2010). (last visited April 26, 2010).' href=https://scholar.google.com/scholar?q=See+WiCell+Research+Institute,+Press+Release,+WiCell+to+Establish+National+Stem+Cell+Bank+(October+3,+2005)+(hereinafter+Stem+Cell+Bank+Press+Release)+(reporting+an+assertion+by+the+president+of+Wicell's+board+of+directors+that+the+National+Stem+Cell+Bank+would+make+stem+cell+lines+available+to+researchers+at+lower+cost+and+with+improved+support+and+training),+available+at++(last+visited+April+26,+2010).>Google Scholar

WARF, “About Us: Our History,” WARF Website, available at <http://www.warf.org/about/index.jsp?cid=26> (last visited April 26, 2010).+(last+visited+April+26,+2010).>Google Scholar

Cf. Scotchmer, Suzanne, Innovation and Incentives (Cambridge: MIT Press, 2004): at 24 (observing that, in contrast to the Research Corporation, WARF “tried to bridge the gap between academic and commercial mores through socially responsible investing that balanced dissemination against ‘reasonable royalties,’” and that WARF “managed to avoid cartels and other offensive tactics”).Google Scholar

WARF, “Licensing Process,” WARF Website, available at <http://www.warf.org/industry/index.jsp?cid=1> (last visited April 26, 2010). See generally (describing WARF's “first fulltime director” as characterizing WARF's).+(last+visited+April+26,+2010).+See+generally+(describing+WARF's+“first+fulltime+director”+as+characterizing+WARF's).>Google Scholar

Apple, R. D., “Patenting University Research: Harry Steenbock and the Wisconsin Alumni Research Foundation,” Isis 80, no. 3 (1989): 374–394, at 377, 383 n.25, 390.Google Scholar

See Marshall, E., “The Business of Stem Cells,” Science 287, no. 5457 (2000): 1419–1421, at 1420 (observing that Geron “has less control over Thomson's cells” than over the human germ cells developed at Johns Hopkins).CrossRefGoogle Scholar

See Kaiser, J. et al., “Stem Cell Fight,” Science 293, no. 5539 (2001): 2369, at 2369 (describing WARF's filing of suit against Geron to prevent its cells from being “tied up by Geron and unavailable to other researchers,” and to establish that Geron “has no exclusive rights to ‘research products’ of the stem cells, such as cell-based screening assays”).Google Scholar

Korobkin, Compare, Stem Cell Century, supra note 3, at 97 (“The current agreement between [Geron and WARF] gives Geron worldwide exclusive rights to develop diagnostic and therapeutic products from three types of specialized cells derived from the use of hESC technology.”); Abate, T., “Stem-Cell Suit Could Help Research: Geron Gives Up Some Rights in Deal with University,” San Francisco Chronicle, January 10, 2002, at B1 (“In the settlement announced yesterday, WARF greatly narrowed Geron's exclusive control to three types of tissues – heart, nerve and pancreatic islet cells… .”), with “WARF: Stem Cell Developer Lacking,” Capital Times, October 31, 2001, at 6D (reporting that in 2001 Geron held “exclusive rights to six cell types,” and that WARF had already “rejected Geron's attempt to exercise its option to 11 additional types of cells that could be developed from the five stem cell lines”).Google Scholar

See Marshall, , supra note 73, at 1420 (“[Thomson's] institution… insisted on retaining the right to distribute [human embryonic stem] cells to academics.”). The extent to which the publication policies of journal's such as Science helped to cause WARF to insist on such academic access to stem cell technology appears unclear. See Murray, Fiona, “The Stem-Cell Market – Patents and the Pursuit of Scientific Progress,” New England Journal of Medicine 356, no. 23 (2007): 2341–2343, at 2342 (observing that publication of research results by Thomson and co-workers in Science in 1998 mean that they were “subject to the journal's requirements to make their materials available”).Google Scholar

Id. (describing terms on which WiCell would authorize use of hESCs).Google Scholar

In 2005, WARF's managing director explained that rules against sharing WARF-derived stem cells were necessary “so WARF [could] honour promises made to the donors from whose leftover embryos the cells were generated” by requiring researchers to agree “not to do experiments to implant [such cells] in an embryo, generate an embryo, or implant an embryo in a uterus.” Wadman, M., “Licensing Fees Slow Advance of Stem Cells,” Nature 435, no. 7040 (2005): 272–73, at 272–273.Google Scholar

Strieffer, R., “Informed Consent and Federal Funding for Stem Cell Research,” Hastings Center Report 38, no. 3 (2008): 40–47, at 43.Google Scholar

See, e.g., Vogel, Gretchen, “Bush Squeezes between the Lines on Stem Cells,” Science 293, no. 5533 (2001): 1242–1245, at 1245 (“Several scientists… chafed at the requirements of an earlier [materials transfer agreement] from WiCell… .”).CrossRefGoogle Scholar

See Wadman, , supra note 78, at 272.Google Scholar

See Seelye, K. Q., “The President's Decision: The Overview: Bush Gives His Backing for Limited Research on Existing Stem Cells,” New York Times, August 10, 2001, at A1 (reporting President Bush's decision to “allow federal taxpayer money to be used for research” using already existing cell lines).Google Scholar

See Loring, and Campbell, , supra note 24, at 1717 (“The NIH took steps to engage WARF's cooperation shortly after [a] presidential announcement [regarding federal funding for hESC research in August 2001].”).Google Scholar

Holden, C. and Vogel, G., “‘Show Us the Cells,’ U.S. Researchers Say,” Science 297, no. 5583 (2002): 923–925, at 923, 925.CrossRefGoogle Scholar

See Loring, and Campbell, , supra note 24, at 1717 (reporting that, in the memorandum of understanding with NIH, WARF “agreed that it would not impose more restrictive terms for any other not-for-profit institutions”); Holden, and Vogel, , supra note 84, at 925 (reporting WARF's position that it would not object to the acquisition of cells for research “as long as the [associated MTA was] ‘substantially similar’ to the agreement between WiCell and NIH”).Google Scholar

See Wadman, , supra note 78, at 272 (reporting a statement by WARF's managing director that WARF had “lost $1.3 million by distributing the cell lines through the WiCell Research Institute”); cf. Holden, and Vogel, , supra note 84, at 923 (observing that even WiCell's original $5,000 rate for academic distribution was “modest” and perhaps insufficient in itself to provide significant “incentive to supply cells to competing [research] groups,” as opposed to collaborators).Google Scholar

See Wadman, , supra note 78, at 272 (“Academic scientists are also griping about WARF's charges for access to the five stem-cell lines that it owns.”).Google Scholar

Id. (reporting complaints from commercial and academic actors).Google Scholar

Id., at 272–273 (discussing WARF's typical fees for a commercial license and the inability of Arcos BioScience, a biotechnology startup, to pay an upfront fee of $100,000); see also Rohrbaugh, M. L., “Intellectual Property of Human Pluripotent Stem Cells,” in National Institutes of Health (NIH), Regenerative Medicine (2009): at 54 (describing the upfront fee as a potentially “high hurdle for small companies that have limited funds and for large companies that do not have a strong interest in the field”), available at <http://stemcells.nih.gov/info/scireport/2006report> (last visited April 26, 2010).Google Scholar

See Rohrbaugh, , supra note 89, at 54 (“While many scientists have achieved hESCs for non-profit research, fewer have been able to reach agreements with providers for collaborative research that directly benefits the commercial sector… .”).Google Scholar

See Loring, and Campbell, , supra note 24, at 1717.Google Scholar

Beardsley, D., “A Two-Front Assault on the Stem Cell Patents,” John Marshall Review of Intellectual Property Law 6, no. 3 (2007): 501–524, at 507 & n.47 (reporting that an NIH subsidy helped to support WiCell's price reduction); cf. Stem Cell Bank Press Release, supra note 68 (reporting that NIH's choice of WiCell as host of the bank brought with it a $16 million grant from NIH).Google Scholar

See Loring, and Campbell, , supra note 24, at 1717 (describing typical terms for commercial licensees).Google Scholar

Id.Google Scholar

See Kintisch, E., “Groups Challenge Key Stem Cell Patents,” Science 313, no. 5785 (2006): 281, at 281 (2006) (quoting criticism of WARF's “licensing terms” by Professor Douglas Melton of Harvard University).CrossRefGoogle Scholar

Hall, Z. W., “Stem Cell Research in California: The Intersection of Science, Politics, Culture, and Law,” Minnesota Journal of Law, Science & Technology 10, no. 1 (2009): 1–17, at 1 (discussing Proposition 71).Google Scholar

Id., at 12 (describing the California Institute for Regenerative Medicine (CIRM) as “responsible for administering the grants” pursuant to California's Proposition 71).Google Scholar

Wahlberg, D., “Wisconsin, California in a Stem-Cell Skirmish: Outcome of Dispute Involving Money and Patents Could Have Global Effect,” Wisconsin State Journal, June 18, 2006, at A1 (“In February, CIRM said universities and nonprofits that receive the grants must give back to the state 25 percent of royalties on discoveries that yield more than $500,000.”).Google Scholar

Id. (reporting a WARF attorney's statement that “the CIRM demand amounted to a commercialization of the research,” and that WARF might “seek license fees and payments from the commercial partners of [CIRM] grantees”); see also Check, E., “Patenting the Obvious?” Nature 447, no. 7140 (2007): 16–17, at 16 (reporting that, in March 2006, “a WARF official told a conference of biotechnology entrepreneurs that WARF expected the CIRM to pay it licence fees and royalties”).Google Scholar

Holden, C., “… And Sought,” Science 314, no. 5796 (2006): 35, at 35. WARF's public pursuit of licensing fees from a California government agency was peculiarly ill-timed given that news of the WARF-California standoff came at about the same time that the Supreme Court's hearing of oral arguments in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), was focusing much attention, fairly or unfairly, on the presumptively scurrilous behavior of “patent trolls” – a term often conceived as encompassing any patent holder who does not itself work to produce commercial embodiments of its invention, but instead seeks to exploit its patent rights through licensing. See Golden, J. M., “‘Patent Trolls’ and Patent Remedies,” Texas Law Review 85, no. 7 (2007): 2111–2161, at 2112 (describing one definition of “patent trolls”). As an entity separate from the University of Wisconsin, WARF could not claim to be anything but an entity formed to manage, to own, and to enforce intellectual property rights. It was thus particularly liable to be stamped with the stigmatizing “troll” label, an undesirable position to be in at a time when a plurality of Supreme Court justices was being moved to respond to an alleged plague of patent licensing companies. See eBay, 547 U.S. at 396 (Kennedy, J., concurring) (expressing concern about the development of an industry “in which firms use patents not as a basis for producing and selling goods but, instead, primarily for obtaining licensing fees”). WARF's bargaining position with prospective licensees was presumably further weakened by the relatively swift move of district courts, in the wake of the Supreme Court's decision in eBay, toward a position of consistently denying injunctions against infringement when patent holders do not compete in product or service markets with the adjudged infringer. See Golden, , “‘Patent Trolls,’” supra, at 2113 (describing post-eBay district courts as “hav[ing] consistently denied permanent injunctions in cases where… the infringer and patent holder were not competitors”). But cf. Commonwealth Sci. & Indus. Research Organisation v. Buffalo Tech. Inc., 492 F. Supp. 2d 600, 601 (E.D. Tex. 2007) (subsequently granting a permanent injunction that had been requested by “the principal scientific research organization of the Australian Federal Government”), vacated on other grounds, 542 F.3d 1363 (Fed. Cir. 2008).CrossRefGoogle Scholar

See Check, , supra note 99, at 16 (reporting that Jeanne Loring, a California-based biologist, had “joined forces with two pressure groups, the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation in New York, to ask the patent office to re-examine the patents”); see also Request for Ex Parte Reexamination of U.S. Patent No. 5,843,780 (July 17, 2006); Request for Ex Parte Reexamination of U.S. Patent No. 6,200,806 (July 17, 2006); Request for Inter Partes Reexamination of U.S. Patent No. 7,029,913 (July 17, 2006).Google Scholar

See Order Granting Request for Ex Parte Reexamination of U.S. Patent No. 5,843,780, at 1 (September 29, 2006); Order Granting Request for Ex Parte Reexamination of U.S. Patent No. 6,200,806, at 1 (September 29, 2006); Order Granting Request for Inter Partes Reexamination of U.S. Patent No. 7,029,913, at 1 (September 29, 2006).Google Scholar

35 U.S.C. § 304 (providing that, when the USPTO Director, either in response to a request for ex parte reexamination or “[o]n his own initiative,” 35 U.S.C. § 303(a), “finds that a substantial new question of patentability affecting any claim of a patent is raised, [this] determination will include an order for reexamination”); id., § 312 (providing that, when the USPTO Director, in response to a request for inter partes reexamination, “finds that a substantial new question of patentability affecting a claim of a patent is raised, [this] determination shall include an order for inter partes reexamination”).Google Scholar

WARF denied that the reexaminations inspired the adoption of new policies, asserting instead that the changes resulted from a review, done in consultation with NIH scientists, that had begun several months beforehand. Wahlberg, David, “Certain Fees for Stem Cells Waived: WARF Won't Charge for Non-Commercial Research,” Wisconsin State Journal, January 23, 2007, at A1 (reporting statements by Andy Cohn of WARF).Google Scholar

Gulbrandsen, C., Letter to the Editor, “WARF's Licensing Policy for ES Cell Lines,” Nature Biotechnology 25, no. 4 (2007): 387–388, at 387 (describing WARF's policy changes and clarifications); WARF, Wisconsin Alumni Research Foundation Changes Stem Cell Policies to Encourage Greater Academic, Industry Collaboration, Press Release, January 23, 2007 (hereinafter WARF 2007 Press Release) (same), available at <http://www.warf.org/news/news.jsp?news_id=209> (last visited April 27, 2010); see also Wahlberg, , “Certain Fees,” supra note 104, at A1 (same); Somers, Terri, “Stem Cell Scientists Shout Out Hallelujah: Rule Changes Expected to Improve Research,” San Diego Union-Tribune, January 23, 2007, at C1 (same). WARF continued to assert “that companies that wish to develop marketable products with any hESCs must negotiate a license from WARF.” See Korobkin, , supra note 3, at 98. Further, WARF still required that researcher-to-researcher transfers of cells from the University of Wisconsin's cell lines be accompanied by an MTA “wherein the recipient acknowledges that he or she will not conduct experiments that donors of the embryos were promised would not be done.” See Gulbrandsen, , Letter, supra, at 387.CrossRefGoogle Scholar

Consumer Watchdog has appealed the USPTO's decision to end reexamination of the '913 patent in WARF's favor. See Notice of Appeal to the Board of Patent Appeals and Interferences by Third Party Requester in Inter Partes Reexamination, Inter Partes Reexamination of U.S. Patent No. 7,029,913 (July 18, 2008). Consumer Watchdog could not appeal the USPTO's final determinations with respect to the other two reexamined patents because these were subjected to ex parte reexaminations for which Consumer Watchdog, although an instigator, was not a legal party.Google Scholar

See '780 Reexamination Certificate, supra note 20, col. 1, ll. 26–27; '806 Reexamination Certificate, supra note 30, col. 1, ll. 25–26; Third Supplemental Amendment, Inter Partes Reexamination of U.S. Patent No. 7,029,913, at 3 (Oct. 4, 2007) (listing amended claims).Google Scholar

See Holden, C., “Wisconsin Stem Cell Patents Upheld,” Science 319, no. 5870 (2008): 1602–1603, at 1602 (reporting on the narrowing of WARF's patent claims in reexamination).CrossRefGoogle Scholar

See id., at 1602 (“Scientists are still grumbling about the Wisconsin Alumni Research Foundation's grip on stem cell patents… .”); Holden, C., “Prominent Researchers Join the Attack on Stem Cell Patents,” Science 317, no. 5835 (2007): 187, at 187 (reporting in July 2007 that “it is difficult of find a stem cell researcher other than [Thomson himself and one other] who thinks WARF's patents are justified”).CrossRefGoogle Scholar

See Holden, , supra note 108, at 1602 (acknowledging “widespread feeling that challenges to WARF's patents and continuing public pressure have had a desirable effect”); WARF 2007 Press Release, supra note 105 (quoting Katharine Ku of Stanford University's Office of Technology Licensing as describing WARF's 2007 policy changes as constituting “a thoughtful responsible approach to licensing” [internal quotation marks omitted]).Google Scholar

WARF, United States Patent and Trademark Office Upholds Key WARF Stem Cell Patent, Press Release, February 28, 2008, available at <http://www.warf.org/news/news.jsp?news_id=224> (last visited April 27, 2010).+(last+visited+April+27,+2010).>Google Scholar

WARF, Cellartis and WARF Sign License Agreement for Human Embryonic Stem Cells, Press Release, January 15, 2009, available at <http://www.warf.org/news/news.jsp?news_id=240> (last visited April 27, 2010). In May 2009, WARF announced a further licensing agreement with biopharmaceutical giant Pfizer, Inc. WARF, Wisconsin Alumni Research Foundation (WARF) Signs License Agreement with Pfizer for Human Embryonic Stem Cells, Press Release, May 5, 2009, available at <http://www.warf.org/news/news.jsp?news_id=246> (last visited April 27, 2010).+(last+visited+April+27,+2010).+In+May+2009,+WARF+announced+a+further+licensing+agreement+with+biopharmaceutical+giant+Pfizer,+Inc.+WARF,+Wisconsin+Alumni+Research+Foundation+(WARF)+Signs+License+Agreement+with+Pfizer+for+Human+Embryonic+Stem+Cells,+Press+Release,+May+5,+2009,+available+at++(last+visited+April+27,+2010).>Google Scholar

See NIH, “NIH Budget,” NIH Website, available at <http://www.nih.gov/about/budget.htm> (last visited April 27, 2010) (“The NIH invests over $30.5 billion annually in medical research… .” [internal footnote omitted]).+(last+visited+April+27,+2010)+(“The+NIH+invests+over+$30.5+billion+annually+in+medical+research…+.”+[internal+footnote+omitted]).>Google Scholar

See Golden, J. M., “Biotechnology, Technology Policy, and Patentability: Natural Products and Invention in the American System,” Emory Law Journal 50, no. 1 (2001): 101–191, at 110 (asserting that “publicly funded research still plays a dominant role in fostering the basic scientific and technological advances that drive biotechnology forward”).Google Scholar

See supra note 63 (citing declarations of scientists filed during the reexamination of WARF's '913 patent).Google Scholar

Geron Corporation, “About Geron,” Geron Corporation Website, available at <http://www.geron.com/about/> (last visited April 27, 2010) (“Incorporated in the state of Delaware in 1990, Geron has been in business since 1992.”).+(last+visited+April+27,+2010)+(“Incorporated+in+the+state+of+Delaware+in+1990,+Geron+has+been+in+business+since+1992.”).>Google Scholar

See Gulbrandsen, , supra note 2, at 1162 (“[I]t is worth noting that the exclusive rights given to Geron, a small business at the time, have allowed Geron to raise venture capital sufficient to pay for research and development in the human-embryonic-stem-cell area.”); cf. Korobkin, , “Recent Developments,” supra note 65, at 69 (observing that, “[i]n the world that actually existed in the late 1990s (call this W1), Congress's Dickey Amendment, which prohibits federal funding of ‘research in which a human embryo or embryos are destroyed,’ rendered Thomson's research program ineligible for government support”).Google Scholar

See Korobkin, , supra note 3, at 99 (“In the case of hESCs, if no patent protection were available, a very valuable innovation might have been delayed for many years.”).Google Scholar

Cf. Golden, , supra note 32 (“In an area of high technological and economic contingency, there is an especially great likelihood that ['private parties or government actors who operate on a finer scale than a high-level policymaker'] will have a greater capacity, due to better knowledge or sheer force of numbers, to identify or to devise optimal or closer-to-optimal approaches to meting out shares of technological value.”).Google Scholar

Vogel, G., “Stem Cell Claims Face Legal Hurdles,” Science 305, no. 5692 (2004): 1887, at 1887.CrossRefGoogle Scholar

See Golden, , supra note 32 (arguing that “the value of patents as incentives for disclosure should not be lightly dismissed”); cf. Holbrook, , supra note 33, at 146 (arguing that courts “have grossly overstated” patents' “teaching function,” but also recognizing that patents can “encourage teachings via pre-patent disclosures and publications”).Google Scholar

See Korobkin, , supra note 3, at 100 (“Without patent potential, Geron almost certainly would have demanded, at a minimum, that Thomson refrain from publishing his results or sharing his cell lines.”).Google Scholar

Required disclosures to the Food and Drug Administration (FDA) do not obviate the possibility of holding such disclosed data as trade secrets. The FDA has generally treated “data submitted to the FDA as proprietary information of the sponsor not subject to public disclosure.” Eisenberg, R. S., “The Role of the FDA in Innovation Policy,” Michigan Telecommunications and Technology Law Review 13, no. 2 (2007): 345–388, at 380 (“The pharmaceutical industry has long taken the position that data from clinical trials of drugs are a trade secret belonging to the submitting firm, and the FDA has consistently supported this position… .”); cf. Gitter, D. M., “Innovators and Imitators: An Analysis of Proposed Legislation Implementing an Abbreviated Approval Pathway for Follow-on Biologics in the United States,” Florida State University Law Review 35, no. 3 (2008): 555–625, at 580–581 (observing that FDA rules permit “indefinit[e]” extension of pharmaceutical companies' ability to keep “confidential business information,” such as manufacturing processes, as trade secrets). Under federal law, the FDA might be sued for “misappropriation of trade secrets and breach of a confidential relationship” if it discloses such information without the submitter's permission. Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1256 (D.C. Cir. 2005) (holding that a pharmaceutical company had “sufficiently allege[d]” such claims); cf. Diamond, E., “Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy Clinical Trial Data,” Food and Drug Law Journal 63, no. 1 (2008): 321–373, at 369 (“[A]s described by former Commissioner Kennedy, FDA's understanding of [21 U.S.C. § 331(j)] as precluding the release of safety and efficacy data is an ‘interpretation’ historically motivated by the ‘strong incentive’ of possible criminal liability under the Trade Secrets Act.”).Google Scholar

Cf. Wagner, R. P., “Information Wants to Be Free: Intellectual Property and the Mythologies of Control,” Columbia Law Review 103, no. 4 (2003): 995–1034, at 997 (contending that intellectual property “rights (even in strong forms) are likely to increase the content of the public domain rather than decrease it”).CrossRefGoogle Scholar

See Kumar, Sapna & Rai, Arti, “Synthetic Biology: The Intellectual Property Puzzle,” Texas Law Review 85, no. 7 (2007): 1745–1768, at 1753 (concluding that “historical evidence… suggests that the transaction costs associated with developing broad patents on foundational research can slow growth in the [relevant] industry”).Google Scholar

Merges, R. P. and Nelson, R. R., “On the Complex Economics of Patent Scope,” Columbia Law Review 90, no. 4 (1990): 839–916, at 907.CrossRefGoogle Scholar

Id.Google Scholar

See Golden, , supra note 32 (discussing how a high value for patent rights can generate a socially inefficient patent race).Google Scholar

See Golden, , supra note 114, at 144 (discussing the motivation to research provided by “public sector values—values that prize the advancement and wide dissemination of scientific and technical knowledge, and, less altruistically, support a ‘credit economy’ in which personal achievement is tied to status, reputation, and academic empire building”).Google Scholar

See Rai, A. K., “Regulating Scientific Research: Intellectual Property Rights and the Norms of Science,” Northwestern University Law Review 94, no. 1 (1999): 77–152, at 145 (contending that “various structural features of university research make it likely that research norms will be efficient”).Google Scholar

See Eisenberg, R. S., “Proprietary Rights and the Norms of Science in Biotechnology Research,” Yale Law Journal 97, no. 2 (1987): 177–231, at 207 (suggesting that “patent law may aggravate preexisting conflict between scientific norms and the reward structure of science”); cf. Barnett, J. M., “Property as Process: How Innovation Markets Select Innovation Regimes,” Yale Law Journal 119, no. 3 (2009): 384–456, at 414–420 (arguing that recent growth in patents relating to financial services might illustrate how defections from “a sharing regime” can lead parties into a “property trap”).CrossRefGoogle Scholar

See Gallagher, K., “Stem Cell Patent Fight Gets Personal: Challenge Is ‘Demeaning,’ Foundation Head Declares,” Milwaukee Journal Sentinel, September 2, 2007, at 1 (quoting WARF's managing director as saying: “On one hand, they say [Thompson] deserves all these accolades. On the other hand, they say anyone could have done it. That's demeaning to him—that's what really gets my dander up.” [internal quotation marks omitted]). See generally supra note 115 and accompanying text.Google Scholar

Rebecca Eisenberg and Arti Rai have noted how downside effects of the interplay between public sector and private sector research efforts might also run in the opposite direction because, for example, “aggressive versions of a public domain approach [to research or the development of inputs to research] may undermine the types of small firms that tend to provide specialized research inputs.” Eisenberg, R. S. and Rai, A.K., “Harnessing and Sharing the Benefits of State-Sponsored Research: Intellectual Property Rights and Data Sharing in California's Stem Cell Initiative,” Berkeley Technology Law Journal 21, no. 3 (2006): 1187–1213, at 1202. But given historical restrictions on public funding of stem cell research, such a phenomenon does not appear implicated in the story of WARF's basic stem cell patents.Google Scholar

See, e.g., Adelman, D. E., “A Fallacy of the Commons in Biotech Patent Policy,” Berkeley Technology Law Journal 20, no. 2 (2005): 985–1030, at 988 (noting that, “contrary to the fears of many legal commentators, there are few signs that biotech patenting has impeded biomedical innovation”); Eisenberg, R. S., “Noncompliance, Nonenforcement, Nonproblem? Rethinking the Anticommons in Biomedical Research,” Houston Law Review 45, no. 4 (2008): 1059–1099, at 1061 (“The results [of various empirical studies] suggest that, overall, intellectual property has presented fewer impediments to research than policymakers may have projected on the basis of early salient controversies.”); Shiu, C. J., “Of Mice and Men: Why an Anticommons Has Not Emerged in the Biotechnology Realm,” Texas Intellectual Property Law Journal 17, no. 3 (2009): 413–456, at 415 (observing that a “predicted biomedical anticommons problem has largely not come to pass”). But cf. Rai, A. K. and Eisenberg, R. S., “Bayh-Dole Reform and the Progress of Biomedicine,” Law and Contemporary Problems 66, nos. 1–2 (2003): 289–314, at 297 (“Concern about an anticommons, or ‘patent thicket,’ is quite pressing in contemporary biomedical research that draws upon many prior discoveries made by different scientists in universities and private firms.”).Google Scholar

Recent studies suggest that difficulties in accessing crucial data or research materials, such as hard-to-obtain hESCs as opposed to relatively easy-to-generate IPSCs, might be substantially more significant barriers to follow-on research than patent rights. See Eisenberg, , supra note 134, at 1082 (“In contrast to the perceived minimal impact of patents, scientists report that their work is interrupted with some regularity by the need to negotiate terms of access to proprietary materials or data.”); Strandburg, K. J., “User Innovator Community Norms: at the Boundary Between Academic and Industry Research,” Fordham Law Review 77, no. 5 (2009): 2237–2274, at 2250 (concluding that a rational-choice model predicts “more significant difficulties with sharing of research materials” that are difficult for other researchers to reproduce than with sharing of tools that other researchers can reproduce comparatively easily after public disclosure). Consistent with this suggestion, a number of complaints about WARF's restrictions on the use of hESCs might have been more properly associated with WARF's materials transfer agreements than WARF's patents themselves. See generally supra text accompanying notes 77–88.Google Scholar

See Kieff, F. S., “Coordination, Property, and Intellectual Property: An Unconventional Approach to Anticompetitive Effects and Downstream Access,” Emory Law Journal 56, no. 2 (2006): 327–438, at 424 (concluding that “recent empirical work… did not find transaction costs problems associated with patents in basic science, essentially because potential infringers engaging in low value uses were simply being allowed to infringe with approval, albeit tacit, from patentees”); Ramirez, H. H., Comment, “Defending the Privatization of Research Tools: An Examination of the ‘Tragedy of the Anticommons’ in Biotechnology Research and Development,” Emory Law Journal 53, no. 1 (2004): 359–389, at 379 (“Due to the relatively small size of the biotechnology community, informal norms have evolved, and will continue to evolve, to manage problems that arise with regard to the dissemination of research tools.”); cf. Miller, , supra note 5, at 569–570 (observing that WARF “distributes the [hESCs] to academic and government scientists for the costs of production, and it does not demand ownership rights of any discoveries produced using the cells”). See generally Merges, R. P., “IP Rights and Technological Platforms,” Manuscript (2008): 1–30, at 12 (observing that, commonly with respect to platform technologies, “owners waive their rights on a massive scale”), available at <http://ssrn.com/abstract=1315522> (last visited April 27, 2010). In some cases, public or private actors have acted to prevent assertion of rights by others by preemptively putting material or information in the public domain. See, e.g., Merges, R. P., “A New Dynamism in the Public Domain,” University of Chicago Law Review 71, no. 1 (2004): 183–203, at 188–190 (describing work by Merck Pharmaceuticals and a Single Nucleotide Polymorphism Consortium to put various biotechnological materials in the public domain); Shiu, , supra note 134, at 435 (describing an NIH practice of “consciously engag[ing] in projects that claim most of an area of upstream research, thereby rendering attempts to exploit that area commercially unviable”).Google Scholar

See, e.g., Golden, , supra note 114, at 175–76 (describing how NIH and scientist opposition “led DuPont to allow non-profit researchers free use (for noncommercial purposes) of its Onco-Mouse®, as well as its Crelox gene removal technique”); Lee, P., “Contracting to Preserve Open Science: Consideration-Based Regulation in Patent Law,” Emory Law Journal 58, no. 4 (2009): 889–975, at 893 (discussing how public actors like NIH and CIRM “are building, through contract-like quid pro quos, a research commons for biomedicine”); Munzer, S. R., “Commons, Anticommons, and Community in Biotechnological Assets,” Theoretical Inquiries in Law 10, no. 1 (2009): 271–298, at 284 (describing how opposition of research scientists and legal scholars to patents on relatively short strips of DNA called expressed sequence tags “turned around the NIH and pushed the USPTO to come up with more stringent utility guidelines, effectively limiting the number of EST patents to a very few”).Google Scholar

See, e.g., Adelman, , supra note 134, at 1030 (concluding that “the standard finite commons model is not representative of the essentially unbounded opportunities in biotech research”); Shiu, , supra note 134, at 416 (arguing that “there is no anticommons problem [in biomedical technology], in part, because far less of the biomedical research domain has been fenced in than previously supposed”).Google Scholar

See Cyranoski, D., “Japan Ramps Up Patent Effort to Keep iPS Lead,” Nature 453, no. 7198 (2008): 962–963, at 962 (observing that induced pluripotent stem cells [IPSCs] are “easier to produce than [embryonic stem] cells,” might similarly possess “the potential to develop into any of the body's cell types, and are expected to have tremendous value in drug screening and for therapeutic purposes”); Holden, C. and Vogel, G., “A Seismic Shift for Stem Cell Research,” Science 319, no. 5863 (2008): 560–563, at 561 (describing IPSCs as having great potential at least “for studying disease mechanisms” and “for testing the efficacy of new drugs,” and potentially for discovering “better ways to coax pluripotent cells to differentiate into desired cell types”).CrossRefGoogle Scholar

Human IPSCs might ultimately be found to be less effective in producing the full range of human cell types, or they might prove to be therapeutically unusable because of their incorporation, for example, of potentially cancer-causing retroviruses used to make the cells pluripotent. See Holden, and Vogel, , supra note 139, at 561 (noting that then-existing IPSCs might be therapeutically unusable because they were developed using retroviruses that, if injected into a patient, might also “interfere with important genes and lead to cancer”).Google Scholar

See Holden, and Vogel, , supra note 139, at 560 (2008) (“Research teams around the world are now adding [induced pluripotent stem] cells to their repertoire.”); Korobkin, , supra note 65, at 55 (“The California Institute for Regenerative Medicine, charged with distributing 3 billion dollars in state taxpayer funding of stem cell research, is currently funding both research paths.”).Google Scholar

See Eisenberg, , supra note 134, at 1062.Google Scholar

Walsh, J. P., Cho, C., and Cohen, W. M., “View from the Bench: Patents and Material Transfers,” Science 309, no. 5743 (2005): 2002–2003, at 2002 (concluding that “few academic bench scientists currently pay much attention to others' patents”). See generally id., at 2003 (finding “little empirical basis for claims that restricted access to IP is currently impeding biomedical research,” but reporting stronger evidence of harm from restricted “access to material research inputs”).CrossRefGoogle Scholar

See Holden, , supra note 108, at 1603 (“[Embryonic stem] cells are still needed to validate [induced pluripotent stem] cells, and even if [induced pluripotent stem] cells prove viable substitutes for [embryonic stem] cells in research, some scientists believe they will never be suitable for cell therapy.”).Google Scholar

Cf. Rai, , supra note 130, at 132 (contending that “the historical record makes it clear that collective exchange norms with respect to patents emerge only with difficulty”).Google Scholar

See generally Simon, B., “How to Get a Fair Share: IP Policies for Publicly Supported Biobanks,” Stanford Journal of Law, Science & Policy (forthcoming) (discussing instances and uses of biobanks), available at <http://ssrn.com/abstract=1413951>..>Google Scholar

See Lee, J. A., Comment, “The Ownership and Patenting of Inventions Resulting from Stem Cell Research,” Santa Clara Law Review 43, no. 2 (2003): 597–630, at 627 (predicting that WARF's basic stem cell patents will have only limited effects on therapeutic applications of stem cell technology because “progress is slow”); Spalding, and Simkin, , supra note 1, at 9 (“Conservative commentators believe that significant discoveries necessary for stem cell therapeutics still are 10 years away, which would be followed by a five- to eight-year regulatory approval period.”). Only in January of 2009 did Geron Corporation obtain Food and Drug Administration “clearance to begin the first human clinical trial of cells derived from human embryonic stem cells.” NIH, “Stem Cell Information: Frequently Asked Questions (FAQs),” NIH Website, available at <http://stemcells.nih.gov/info/faqs.asp> (last visited April 27, 2010).Google Scholar

Cf. Hayden, E. C., “Stem-Cell Patents Confirmed,” Nature News, March 17, 2008, available at <http://www.nature.com/news/2008/080317/full/452265b.html> (last visited April 27, 2010) (reporting that “Ken Taymor, head of the University of California's Berkeley Center for Law, Business and the Economy, says the re-examination has been a boon for WARF, in part because it has diverted attention from WARF's attempts to bolster its patent positions” with “downstream” patents).Google Scholar

Cf. Dreyfuss, R., “Protecting the Public Domain of Science: Has the Time for an Experimental Use Defense Arrived?” Arizona Law Review 46, no. 3 (2004): 457–472, at 472 (concluding that a combination of changes to legal, technological, and scientific environments mean that “it is time to put some serious thought into protecting the vitality of the public domain of science”); Herder, M., “Two Models of Commercializing Stem Cell Science: Creating Conditions for Collaboration,” Manuscript, July 22, 2009 (calling for greater forethought in setting terms for MTAs and “a practice of not patenting ‘fundamental discoveries’”), available at <http://ssrn.com/abstract=1437690> (last visited April 27, 2010); Munzer, , supra note 137, at 295 (observing the existence of “open-access resources and IP-protected resources” in synthetic biology, and hoping for “a symbiotic relationship between” them [emphasis omitted]); Wynickoff, D. E., Saha, K., and Graff, G. D., “Opening Stem Cell Research and Development: A Policy Proposal for the Management of Data, Intellectual Property, and Ethics,” Yale Journal of Health Policy, Law, and Ethics 9, no. 1 (2009): 52–127, at 108 (proposing a collaborative institution “for the collection, standardization, and organization of non-confidential information,” and for the analysis and mitigation of research-and-development bottlenecks).Google Scholar