The California Institute for Regenerative Medicine (CIRM) has devoted considerable effort to the development of its intellectual property policies, repeatedly drafting and revising the policies in response to wide-ranging feedback from different stakeholders.
Intellectual property is a policy tool for motivating investments in innovation. Patents and trade secrecy are two forms of legal protection for intellectual property. A patent provides a legal right to exclude competitors from the market for a new invention, thereby allowing an innovator to capture higher profits during the patent term before the invention enters the public domain (and competitors become free to use it). Without such a head-start advantage, innovators who anticipate prompt competition from free-riders in the market for a successful product might be reluctant to take on the costs and risks of new product development. Trade secrecy provides legally enforceable rights to confidential treatment of information that is not generally known to competitors, another way of protecting head-start advantage for innovators. Patents require public disclosure, which may make them less valuable than trade secrecy in some fields. In other fields, when secrecy is not possible or practical, innovators and policy makers may prefer patents. Empirical evidence suggests that patents are especially important in motivating biopharmaceutical research and development (R&D) (Cohen et al., 2000).
The argument for intellectual property rights is a bit different in the case of inventions developed with public funds. When the public bears the cost and risk of the R&D that yields an invention, it is arguable whether the public should not have to pay again for the same invention through
higher prices as a result of the exclusionary rights conferred by patents. Often, however, substantial further private investment is necessary to pick up where government funding leaves off, especially when the recipient of government funding is a research institution that is not itself in the business of translating new scientific discoveries into commercial products. Private firms might hesitate to make the very substantial further investment necessary to translate a new scientific finding into a commercial product without some protection from competition. That has been the working assumption for federally sponsored R&D at least since 1980, when Congress passed the first of a series of legislative acts allowing patenting and retention of ownership by grant recipients of inventions developed in the course of research funded by the United States.1
The Bayh-Dole Act of 1980 has been particularly influential in setting the ground rules for patenting of inventions by universities. In that framework, universities retain ownership of patents and license those patents to private firms for commercial development, while the government retains a license to use the invention for government purposes, as well as a “march-in” right to grant additional licenses if necessary to achieve practical utilization of the invention.2 The influence of these rules is not simply a function of familiarity. The pervasive reach of federal funding for academic biomedical research means that even when other funds are used for a particular research project, federal funding has often played a role as well. The difficulty of disentangling federal funding from other funding sources makes it prudent for institutions that receive federal research funding to comply with the terms of the Bayh-Dole Act whenever there is any question about the source of funding for a particular invention so as to avoid potential liability to the federal government.
CIRM’s intellectual property policies follow the broad contours of the Bayh-Dole regime by allowing grantees to retain ownership of inventions and by giving them considerable discretion in deciding when to pursue,
1The Bayh-Dole Act of 1980 allows grantees to retain ownership of patents on government-sponsored inventions in certain circumstances, while the Stevenson-Wydler Act of 1980 promotes patenting by government agencies of inventions arising in intramural research. In both cases, the goal is to facilitate technology transfer to the private sector for commercial development. Prior to 1980, some federal agencies required assignment to the government of any patents arising from government-sponsored research, but typically the government did not grant exclusive licenses or otherwise use its patent rights to promote commercial development. For a fuller account, see Eisenberg (1996).
retain, transfer, and license their rights. CIRM also follows the Bayh-Dole approach in obligating grantees to make reasonable efforts to achieve practical application of their inventions through either commercialization or licensing, and in fortifying this obligation by retaining march-in rights that allow CIRM to grant licenses if necessary. However, CIRM’s intellectual property policies also depart from the familiar Bayh-Dole framework in certain notable respects. These departures are sanctioned and required by the text of Proposition 71 and subsequent legislation3 and set forth in regulations that have the force of law.
First, California law calls for CIRM to use intellectual property not only to motivate firms to pursue commercial development of CIRM-funded technology but also to generate revenue to the state of California’s budget. This goal is stated in Section 3 of Proposition 71, which announces an intent to: “Protect and benefit the California budget … by funding scientific and medical research that will significantly reduce state health care costs in the future; and by providing an opportunity for the state to benefit from royalties, patents, and licensing fees that result from the research.”
Federal law has no comparable provision for revenue sharing or recoupment of federal grant funding; such proposals have repeatedly been rejected as conflicting with the primary goal of promoting further investment in commercial development by licensees. Although federal agencies collect royalties on patents they own on the inventions of their employees, they generally do not attempt to share in the revenues earned by grantees on their patents.4
Second, CIRM’s approach to intellectual property departs from the federal model in its requirements for (1) access plans to make drugs emerging from CIRM funding affordable for Californians who would not otherwise have access to these products, and (2) the provision of such drugs to eligible Californians and to those purchasing the drugs in California with public funds at prices established in the California Discount Prescription Drug Program.5 These requirements originated in CIRM regulations rather than in the text of Proposition 71 as approved by the voters, but a requirement
3California Legislature (Sen. Bill No. 1064), approved by Governor September 30, 2010. Filed with Secretary of State on September 30, 2010.
4The committee is aware of at least one exception to this generalization. The National Medical Test Bed at Loma Linda University Medical Center (NMTB), funded by congressional appropriation pursuant to a cooperative agreement with the Department of Defense, funded a series of research projects between 1992 and 2006 to develop new medical technologies. The cooperative agreement required NMTB to capture royalties from the commercialization of any and all research sponsored under the cooperative agreement, and to use such proceeds to endow a revolving fund to be administered by NMTB in conducting further research (LLUMC, 2012).
5CIRM’s intellectual property policy makes no mention of stem cell–based therapies.
for access plans was subsequently codified by the California Legislature, subject to certain qualifications.6
Third, CIRM’s intellectual property policies call for sharing of biomedical research materials within California after publication.7 Although sharing of such materials is consistent with aspirational norms of the scientific community that NIH attempts to facilitate through guidance documents, it is not required by federal law (NIH, 2003).
Finally, to monitor and enforce compliance with its intellectual property policies, CIRM has established reporting requirements that allow it to keep track of CIRM-funded inventions and related patents, patent applications, licenses, commercialization efforts, and revenues.8 As noted, CIRM also has march-in rights that allow it to grant licenses to use CIRM-funded inventions in certain circumstances, including if a grantee, collaborator, or exclusive licensee has not made reasonable efforts to achieve practical application of an invention or has failed to provide or comply with an access plan.9 To the extent that these march-in rights allow CIRM to enforce obligations with no counterpart in federal law (such as the access plan requirement), they go beyond the scope of march-in rights under the Bayh-Dole Act.
Each of these features of CIRM’s intellectual property policies has been a source of controversy, as reflected in public comments submitted to the Institute on drafts of those policies. These comments reveal the complex landscape of competing concerns that CIRM has had to reconcile in establishing its intellectual property policies. Constituencies that made their views known include the California legislature, universities, scientists, and the business community. Their comments, submitted at an early stage before any actual intellectual property was on the table, were necessarily conjectures about the future impact of proposed policies that had not yet taken effect for activities that had scarcely begun.
Although CIRM’s intellectual property policies are now in effect, there is still little track record with which to evaluate their actual performance. CIRM reports a total of 90 invention disclosures, 69 patents, and 2 license agreements as of January 2012. At this stage, concerns about the impact of CIRM’s intellectual property policies remain largely confined to the realm of speculation. But it is in the realm of speculation that patents do their work, motivating new investments by offering an expectation of future monopoly profits on products that do not yet exist. If concerns at this
6California Health and Safety Code § 125290.80.
717 California Code of Regulations § 100604.
817 California Code of Regulations § 100602.
917 California Code of Regulations § 100610.
stage are negatively influencing investment decisions, they could become self-fulfilling prophecies.
The discussion that follows begins with a review of the legal sources of CIRM’s intellectual property policies. The subsequent sections review the main criticisms of those policies that have emerged in public comments and in the committee’s investigation, with a focus on the distinctive features noted above. The final section offers the committee’s conclusions and recommendations with respect to CIRM’s intellectual property policies.
Consistent with the approach of the Bayh-Dole Act,10 Proposition 71 appears to assign a significant role to contracts as a mechanism for implementing CIRM’s intellectual property policies by binding grantees to its terms.11 In practice, however, CIRM has instead used regulations to govern intellectual property for CIRM-funded research results. By their terms, these regulations bind not only CIRM grantees and loan recipients but also their collaborators and licensees, and even third parties who subsequently acquire rights from them.12 Some flexibility is built into the regulations, but this very flexibility also creates uncertainty as to how the regulations will be applied in the future.
CIRM initially drafted separate intellectual property regulations for nonprofit organizations (17 California Code of Regulations §§ 100300-100306) and for-profit organizations (17 California Code of Regulations §§ 100400-100410). These two sets of regulations were subsequently replaced with a single set of rules applicable to both nonprofit and for-profit organizations for grants executed on or after December 17, 2009.13 These regulations, with certain exceptions (including an exemption from revenue-sharing obligations), were extended to loan recipients in 2011.14 CIRM recently revised its intellectual property guidelines to comply with
1035 U.S.C. § 202(c).
11Proposition 71 divides responsibility for CIRM’s intellectual property policies among the Independent Citizens Oversight Committee (ICOC), which is assigned to “establish policies regarding intellectual property rights arising from research funded by the institute”; the chair, whose responsibilities include “to lead negotiations for intellectual property agreements, policies, and contract terms”; and the president, whose responsibilities include “to manage and execute all intellectual property agreements and any other contracts pertaining to the institute or research it funds.” Codified at California Health and Safety Code § 125290.40.
12California Health and Safety Code § 125290.40(j); interview with Scott Tocher and Elona Baum, January 24, 2012.
1317 California Code of Regulations § 100600-100610.
1417 California Code of Regulations § 100801.
legislative changes15 that, among other matters, codified requirements for revenue sharing with the state16 and for submission of access plans by grantees and exclusive licensees to make commercial products emerging from CIRM funding affordable for low-income Californians.17 Further proposed modifications currently pending before the Independent Citizens Oversight Committee ICOC would require grantees to provide CIRM with copies of license agreements and would fortify the revenue-sharing obligations of third-party licensees (Tocher, 2012).
CIRM’s intellectual property policies apply to a broader range of research outcomes than the Bayh-Dole Act. For example, the revenue-sharing provisions apply to “CIRM-funded inventions,” “CIRM-funded technology,” and “results of CIRM-funded research.” These terms are broadly defined to capture any intellectual property that arises directly or indirectly from CIRM funding. For example, the term “CIRM-funded invention” includes any invention, whether patentable or not, that is either “(1) reduced to practice by a Grantee, Grantee Personnel and/or its Collaborator(s) during a CIRM-Funded Project or Activity; or (2) conceived during a CIRM-Funded Project or Activity and reduced to practice by a Grantee, Grantee Personnel and/or its Collaborator(s) during a CIRM-Funded Project or Activity or within 12 months of the close of the Grant.” By contrast, the Bayh-Dole Act defines “invention” more narrowly as “any invention or discovery which is or may be patentable or otherwise protectable under [the Patent Act]” and defines “subject invention” as “any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement.”18 The definition of “CIRM-funded technology,” which has no counterpart in the Bayh-Dole Act, is even broader, covering “data, materials, research results or know-how whether patentable or not, that is (1) generated or conceived in the Project Period of a Grant, and is paid for in whole or in part with CIRM-funds.” “CIRM-funded project or activity” and “CIRM-funded research” are also defined to include activities that are funded only partially by CIRM. The relatively broad scope of these definitions presents a risk that the rights of the State of California may come as a surprise to innovators if and when they are asserted, perhaps leading to late-stage conflict and litigation that delays product development. This risk is aggravated by the use of binding regulations to establish the rights of the state in intellectual
15SB 1064 (2010), available at http://ca.opengovernment.org/documents/1016634-20090sb106493chp, codified at California Health and Safety Codes § 125290.20-125290.80.
16California Health and Safety Code § 125290.30(j). The legislation also codifies an exclusion in the guidelines from the revenue-sharing obligation for loan recipients and facilities grant recipients. California Health and Safety Code § 125290.30(j)(2).
17California Health and Safety Code § 125290.80.
1835 U.S.C. § 201(d), (e).
property as a matter of law, binding on parties that may never have known about them, in contrast to the approach of the Bayh-Dole Act, which sets forth federal rights in contracts that bind only those institutions that agree to them.
Each of CIRM’s current intellectual property provisions has antecedents in proposed CIRM regulations that provoked considerable public comment. Those comments provide a window on the distinct interests and values of the various commentators, as well as their perceptions of the practical impact of the proposed regulations.
CIRM’s intellectual property regulations call for revenue sharing with provisions that distinguish between inventions that are licensed by a grantee and those that are “self-commercialized.” In this manner, they effectively distinguish in many cases between the intellectual property of academic institutions (which ordinarily do not commercialize inventions and must license them to firms to earn revenue from them) and that of commercial firms that more typically commercialize inventions (although in some cases a commercial firm may license an invention).
For licensed inventions, grantees (and their collaborators) must remit to the state general fund 25 percent of licensing revenue in excess of $500,000, adjusted annually to account for inflation.19 If other funding sources contributed to the development of the CIRM-funded invention, the amount due is reduced proportionately.20
In the case of a product that is self-commercialized by grantees and collaborators rather than licensed, the amount due is calculated as a 3 percent royalty on “net commercial revenue” from sales of the product up to a total of three times the amount of CIRM grants that led to the product.21 Additional payments of three times the amount of grant funding are due for blockbuster products when annual sales exceed $250 million22 and $500 million.23 In addition, if CIRM funding exceeded $5 million, a royalty of 1
19California Health and Safety Code § 125290.30(j)(2)(A)(i); 17 California Code of Regulations 100608(a)(1).
20California Health and Safety Code § 125290.30(j)(2)(A)(ii); 17 California Code of Regulations 100608(a)(2).
21California Health and Safety Code § 125290.30(j)(2)(B)(i); 17 California Code of Regulations 100608(b)(1).
22California Health and Safety Code § 125290.30(j)(2)(B)(ii); 17 California Code of Regulations 100608(b)(2).
23California Health and Safety Code § 125290.30(j)(2)(B)(iii); 17 California Code of Regulations 100608(b)(2).
percent of commercial revenue in excess of $500 million is due for the life of any patent covering the CIRM-funded invention.24
These provisions stand in contrast to federal law, which has repeatedly rejected proposals that would require licensees to share revenues with federal research sponsors in the face of opposition from industry (Schacht, 2011a). The Bayh-Dole Act does not call for universities to share licensing revenues with the government, although it does require that they share royalties with inventors and that the balance of funds be used to support scientific research or education.25 The CIRM regulations avoid conflict with the utilization constraints of the Bayh-Dole Act in cases of combined CIRM and federal funding by specifying that the share of revenues paid to the state is “to be used by the State of California in a manner consistent with Title 35 United States Code, Section 202, subdivision (c)(7).”26
CIRM is not the only state science funding program that seeks to return financial benefits to the state. The Connecticut stem cell program requires grantees to pay to the state annually 5 percent of revenues derived from licensing or commercializing inventions that result from its grants. In contrast to the CIRM provisions, these revenue-sharing requirements do not phase in at a particular threshold. Moreover, Connecticut’s revenue-sharing requirement applies to any inventions resulting at least in part from Connecticut funding, with no reduction for inventions that result from work funded by multiple agencies. The Cancer Prevention Research Institute of Texas (CPRIT) also makes its grants subject to revenue-sharing requirements. Specifically, Texas law makes all CPRIT grants subject to an intellectual property agreement that allows the state to collect royalties, income, and other benefits realized as a result of CPRIT-funded projects. Typical terms for research projects at academic institutions include a requirement that 10 percent of the revenue received by the recipient institution be returned to the state, with the possibility for adjustments when research is funded by multiple entities. CPRIT’s investments in early-stage companies can take the form of royalties, milestone payments, equity shares, or other benefits.
On the other hand, the state stem cell programs in New York and Maryland do not impose revenue-sharing obligations on their grantees. Instead, grant recipients in these programs are free to pursue and com-
24California Health and Safety Code § 125290.30(j)(2)(B)(iv); 17 California Code of Regulations 100608(b)(3). As originally drafted in the CIRM regulations, the 1 percent royalty obligation extended to CIRM-funded technology regardless of whether it was patented. The California legislature limited this obligation to patented inventions, requiring conforming amendments to the language of the regulation.
2535 U.S.C. § 202(c)(7)(B), (C).
2617 California Code of Regulations § 100608(a)(1). In other words, the state will use the funds for the support of scientific research or education.
mercialize intellectual property associated with their state-funded research in accordance with pre-existing institutional policies. This choice avoids dampening incentives for commercialization while reducing the administrative burden associated with grants and has been perceived as a benefit by scientists and university administrators.
Industry criticisms of CIRM’s revenue-sharing provisions have been muted (ARI, 2007; CHI, 2006a, 2007a,b; Invitrogen, 2007),27 as has criticism from universities (UCOTT, 2006).28 Comments in support of revenue sharing have been far more numerous, sometimes calling for larger payments to the state (Consolidated non-profit public comments on CIRM’s IP policy, 2012; The Foundation for Taxpayer and Consumer Rights, 2006; Kuehl et al., 2007; Sholes, 2006).29 Perhaps more important, the revenue-sharing provisions enjoyed the support of California legislators (Kuehl et al., 2007), who subsequently mustered the supermajority necessary to codify these provisions in the California Health and Safety Code, where they can no longer be modified by CIRM through changes in the regulations.
Perhaps the lack of significant controversy over the revenue-sharing provisions reflects recognition that Proposition 71 explicitly requires revenue sharing, or perhaps the revenue-sharing obligations seemed remote and speculative at the time these public comments were submitted. (Indeed, any payment obligations that may arise from these provisions must await successful commercialization of CIRM-funded technology, which may not occur for years.) But the same could be said of the provisions for access plans (see below), which drew far more opposition from both commercial firms and academic institutions. Academic institutions also spoke out more forcefully in opposition to provisions in the intellectual property regulations
27See, e.g., letters dated June 15, 2006, October 5, 2007, and November 21, 2007, from the California Healthcare Institute expressing concern that the calculation of “net commercial revenues” may underestimate the expenses of drug development and noting that “direct revenue sharing and royalty provisions may actually reduce the public benefit of Prop 71 funded research” and “could create unnecessary obstacles for commercial enterprises working with the government”; a letter dated April 30, 2007, from the Alliance for Research Innovation (on behalf of a group of life sciences companies) noting concern that regulations should guard against the potential for royalty stacking in the case of a compound product involving multiple proprietary inputs; and a letter dated December 11, 2007, from Invitrogen noting “a few minor, but critical changes that should be made.”
28See, e.g., a letter dated June 16, 2006, from the University of California Office of Technology Transfer noting concern that “the revenue sharing and other requirements will have the effect of making CIRM funding less attractive to researchers than other funds, and may perhaps even put California at a disadvantage as compared to other states and other countries.”
29See, e.g., a letter dated June 6, 2006, from the Foundation for Taxpayer and Consumer Rights urging that the threshold for triggering a recoupment obligation on licensing revenue be lowered from $500,000 to $100,000. Approximately 30 individuals submitted comments to the same effect by e-mail in the same time period. See also an e-mail dated June 15, 2006, from Elizabeth Sholes on behalf of the California Church IMPACT to the same effect.
that define “CIRM-funded inventions” broadly to include inventions conceived prior to the grant period or reduced to practice in the year following the grant period (BIMR, 2009; Goldstein, 2009; SRI, 2009; Stanford University Office of Technology Licensing, 2009; UCOTT, 2009a,b) and to cover unpatented and unpatentable inventions (UCOTT, 2009c).30
Although it may be premature to assess whether the revenue-sharing provisions will ultimately dampen incentives for commercialization of CIRM-funded inventions, at this point they do not appear to rank high among the concerns of potential grantees and licensees.
Perhaps the most controversial aspect of CIRM’s intellectual property provisions is the requirement that grantees and their exclusive licensees submit to CIRM access plans that will afford access to any drug resulting from CIRM-funded research to “Californians who have no other means to purchase the drug.”31 The term “drug” is broadly defined to include “blood, blood products, and cells,” but does not include medical services.32 Proposition 71 does not explicitly call for access plans, but CIRM introduced the requirement in its intellectual property regulations,33 and
30See, e.g., a letter dated July 31, 2009, from the University of California Office of Technology Transfer. The California Legislature ultimately limited the 1 percent royalty on net commercial revenue in excess of $500 million annually to apply only when CIRM funding exceeded $5 million and generated patented inventions that contributed to the creation of the product, and only during the life of the patent. California Health and Safety Code § 125290.30(j)(2)(B)(iii).
31California Health and Safety Code § 125290.80; 17 California Code of Regulations § 100607.
3217 California Code of Regulations § 100600(i).
3317 California Code of Regulations § 100306(d) (Regulations applicable to nonprofit organizations governing grants prior to December 17, 2009, permit grantee organizations to grant exclusive licenses “only to persons that agree to have a plan in place at the time of commercialization to provide access to resultant therapies and diagnostics for uninsured California patients. In addition, such licensees will agree to provide drugs at prices negotiated pursuant to the California Discount Prescription Drug Program … to eligible Californians under that program.”); § 100407 (Regulations applicable to for-profit organizations for grants prior to December 17, 2009, require that a grantee or its exclusive licensee “must submit a plan to afford uninsured Californians access to a Drug … the development of which was in whole or in part the result of CIRM-funded Research … no fewer than 90 days prior to the time the Drug is commercialized … the access plan must be consistent with industry standards at the time of commercialization, accounting for the size of the market for the Drug and the resources of the Grantee or its exclusive licensee…. A Grantee (or its exclusive licensee) must provide a Drug, the development of which was in whole or in part the result of CIRM-funded Research, at a price as provided in the California Discount Prescription Drug Program … to eligible Californians under this program.”); and 17 California Code of Regulations § 100607 (similar). Pending amendments to § 100607 make changes to conform to Senate Bill 1064,
the California legislature has now codified it in the California Health and Safety Code.34 The access plan, which must be submitted within 10-30 days of Food and Drug Administration (FDA) approval of a drug, “must be consistent with industry standards at the time of commercialization in California, accounting for the size of the market for the drug, and the resources of the grantee or exclusive licensee.” The plan is subject to ICOC approval following a public hearing. The ICOC may also waive the requirement following a public hearing if it determines “that in the absence of the waiver, development and broad delivery of the drug will be unreasonably hindered or that the waiver will provide significant benefits that equal or exceed the benefits that would otherwise flow to the state.”35 CIRM regulations further require that the grantee, collaborator, or exclusive licensee provide the drug to eligible Californians and to those purchasing the drug in California with public funds at a price provided in the California Discount Prescription Drug Program.36
Federal law and other state-funded stem cell programs have no comparable provisions. The closest parallel in recent memory is the policy of the National Institutes of Health (NIH) in the 1990s, ultimately abandoned in the face of persistent industry opposition, to commit industry partners to a “reasonable pricing clause” in the terms of cooperative research and development agreements (Gavaghan, 1995).37
CIRM’s access plan provisions are much less far-reaching than the abandoned NIH reasonable pricing clause. For one thing, the CIRM provisions apply only to sales in California. Even within California, they do not lower prices to all customers, but only to those who otherwise could not afford to pay the higher price or who are purchasing the drug in California with public funds. Drug companies often have their own programs for providing low-cost access to expensive drugs for uninsured patients who
including changing the phrase “uninsured Californians” to “Californians who have no other means of purchasing the drug”; changing the time period for submission of access plans from “no fewer than 90 days prior to the time the Drug is commercialized in California, unless CIRM agrees to a shortened time” to “within 10 business days following final approval of the drug by the Food and Drug Administration unless, within that time period, the Grantee, Collaborator, or Exclusive Licensee seeks an extension from CIRM”; and authorizing the Independent Citizens Oversight Committee (ICOC) to waive access plan requirements if certain requirements are met.
34SB 1064, codified at California Health and Safety Code § 12590.80.
35California Health and Safety Code § 12590.80(c).
3617 California Code of Regulations § 100607(f) in pending version (December 29, 2011).
37The story is recounted in Schacht, 2011b.
would otherwise be unable to pay for the drugs—hence the reference in the statute and regulations to “industry standards.”38
Public comments on the access plan requirement include opposition from industry (BIOCOM, 2007a; CHI, 2007a; StemCells, 2007a,b)39 and academic institutions,40 as well as support from consumer advocates (CNA, 2007; Consumer Watchdog, 2009a,b).41 Industry representatives have argued that the requirement will make industry and investors less interested in licensing CIRM-funded inventions (CHI, 2006b,c),42 while legislators have argued that the access provisions are “too weak and vague” to ensure “meaningful access for the uninsured” (Kuehl et al., 2007).
Uncertainty about how the system will work could make industry cautious about licensing and investing in CIRM-funded inventions, especially if they have the option of turning to other sponsors that do not impose
38On the other hand, firms that are willing to provide a drug at a reduced price as a matter of private charity might oppose regulations that would bind them to that price as a matter of law. Moreover, reduced prices that are formalized in state regulations could become benchmarks in negotiating with other payers, just as private insurers look to Medicare prices as a benchmark in negotiating with providers.
39See letters dated October 5, 2007, and November 21, 2007, from StemCells (criticizing the requirement as “overly burdensome, unclear, unworkable and risky as well as beyond the statutory mandate of Proposition 71”); a letter dated November 21, 2007, from BIOCOM (noting that pricing under the California Discount Prescription Drug Program enjoys statutory protection under California law as confidential and corporate proprietary information and would not be made available to CIRM to use as a benchmark); and a letter dated October 5, 2007, from the California Healthcare Institute (noting that without clarification of these provisions, “it would be difficult to attract private investment to develop CIRM-funded technology,” that “there is no evidence that an industry standard exists” for access plans, and that the references to prices under the California Discount Prescription Drug Program are forms of price control that “will create a substantial disincentive to commercial interest in licensing CIRM-funded inventions from for-profit grantees”).
40See, e.g., a letter dated August 18, 2009, from the Stanford University Office of Technology Licensing (suggesting that the access plan requirement may be why Stanford has been unable to find licensees for any of its 13 CIRM-funded patents and asking for a mechanism to allow case-by-case exceptions).
41See, e.g., letters dated August 18, 2009, and September 11, 2009, from Consumer Watchdog (first criticizing CIRM for watering down access provisions through definitions that exclude sublicensees from access requirements, then applauding a change in definitions that restored broader application of the requirements); and a letter dated November 20, 2007, from the California Nurses Association (arguing for use of the Medicaid fee schedule rather than the California Discount Prescription Drug Program as a benchmark because the former is more predictable and measurable).
42See, e.g., letters dated August 22, 2006, and October 4, 2006, from the California Healthcare Institute noting that access plan provisions “would discourage commercial collaboration, technology transfer and licensing by (a) increasing the administrative complexity of licensing agreements involving CIRM-funded technologies in comparison to the mainstream of academic-industry transactions, which derive from federally-funded research, and (b) increasing investors’ financial risk by imposing state price regulation on downstream products.”
similar requirements. Perhaps this uncertainty is undermining commercial interest in licensing CIRM-funded inventions, or perhaps the limited licensing activity to date reflects nothing more than continuing uncertainty about the technological viability and commercial value of stem cell therapies.
The principal means of mitigating the effects of the access plan requirement is the provision for the ICOC to waive the requirement. But this provision is unlikely to reassure firms about the impact of the requirement on the future profitability of products that may not come to market for many years. Even if firms had confidence that the ICOC itself would forbear from enforcing the access plan requirement so as not to undermine the profitability of future products, they might worry that the ICOC will no longer exist at the point of successful commercialization, and that the rights of the state will instead be exercised by another agency that is more concerned with containing health care costs than with promoting the development of new products. With little experience to guide future implementation, the access plan provisions introduce considerable risk and uncertainty for product-developing firms.
CIRM holds march-in rights that allow it to enter into license agreements on behalf of a grantee or its exclusive licensee with respect to a CIRM-funded invention under three circumstances: (1) the grantee, collaborator, or exclusive licensee is failing to exercise reasonable efforts to achieve practical application of the invention; (2) the grantee, collaborator, or exclusive licensee has failed to submit or comply with an access plan; or (3) the grantee, collaborator, or exclusive licensee has unreasonably failed to use a CIRM-funded invention to alleviate a public health emergency declared by the governor.43 The first and third of these circumstances correspond to march-in rights retained by federal research sponsors under the Bayh-Dole Act,44 but the second—failure to submit or comply with an access plan—has no counterpart in the federal system, leading to some uncertainty about how CIRM will exercise its march-in rights (CHI, 2007a,b).45
Many comments in opposition to the CIRM march-in provisions stressed the uncertainty that march-in rights create for potential licensees
4317 California Code of Regulations § 100610(b).
4435 U.S.C. § 203(a)(1) and (2).
45See, e.g., letters dated October 5, 2007, and November 21, 2007, from the California Healthcare Initiative (stating that inclusion of failure to adhere to pricing and access plans as triggering events for march-in rights distinguishes CIRM provisions from those of the Bayh-Dole Act, increases the risk of litigation, and adds another layer of risk and uncertainty to commercial transactions).
(BIOCOM, 2007a,b; Geron, 2007; StemCells 2007a,b),46 which could make it difficult for universities to license their inventions.47 Similar arguments have been made in opposition to the statutory march-in rights retained by the federal government under the Bayh-Dole Act, although the federal government can now point to a track record of declining to exercise these rights. The University of California’s Office of Technology Transfer observed that CIRM does not have the same track record of decades of forbearing from the exercise of march-in rights and concluded, “We believe there is a legitimate concern that CIRM will be much more likely to exercise its march-in rights than the federal government has been” (O’Connor, 2006; UCOTT, 2006).48
Other comments from public interest groups favored strong march-in rights. Comments from the Center for Genetics and Society, echoed by individual e-mails, urged CIRM to empower the California attorney general to enforce march-in rights (Consumer Watchdog, 2008; Reynolds, 2006),49 while comments from the Berkeley Center for Law & Technology commended CIRM for improving on the Bayh-Dole Act by making march-in rights less cumbersome to exercise (Samuelson et al., 2006).
Concerns about march-in rights reflect a combination of unhappiness with the underlying rights they enforce (such as access plans) and uncertainty about how CIRM will exercise its discretion. Perhaps over time, CIRM can reassure licensees that it will use its march-in rights as sparingly as NIH has done, but CIRM may run out of time before commercialization begins. It is also possible that in the future, CIRM (or another enforcer of
46See, e.g., letters dated April 30, 2007, and November 21, 2007, from BIOCOM (noting that the march-in provisions are “so overly broad and all-encompassing that [they] would present an unacceptable level of risk to most companies” and would be better left to the federal government to avoid conflict between state and federal requirements); letters dated October 5, 2007, and November 21, 2007, from StemCells (arguing that the march-in rights, “especially those tied to public access and public health, are overly burdensome, unclear, unworkable, and risky as well as beyond the statutory mandate of Proposition 71”); and a letter dated April 30, 2007, from Geron (noting differences between CIRM and Bayh-Dole march-in provisions that create uncertainty for firms contemplating commercialization).
47See a letter dated August 1, 2009, from Burnham Institute for Medical Research (stating that march-in provisions “will have a chilling effect on the ability to license results” because they “invite legal challenges to every licensee’s efforts to commercialize licensed technology”).
48See a letter dated June 16, 2006, from the University of California Office of Technology Transfer. See also a letter dated June 19, 2006, from Sean O’Conner, Center for Advanced Study and Research on Intellectual Property, noting the potential for conflict if the federal government and CIRM chose to exercise march-in rights on the same invention in inconsistent ways.
49See an e-mail dated June 19, 2006, from Jesse Reynolds on behalf of the Center for Genetics and Society. See also a letter dated June 25, 2008, from Consumer Watchdog (urging a provision giving the attorney general the right to intervene in cases of unreasonable pricing of CIRM-funded projects).
march-in rights) will face considerable political pressure to exercise those rights more aggressively in order, for example, to address rising health care costs. Like the requirement for access plans, the march-in rights provisions thus raise considerable uncertainty about the future implementation of rights that may outlive CIRM itself.
Another distinctive feature of CIRM’s intellectual property policies is the requirement for distribution of publication-related biomedical materials,50 a term that is broadly defined to include “tangible research material of biomedical relevance first produced in the course of CIRM-Funded Research including but not limited to unique research resources (such as synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data), as described in a published scientific paper.”51 Grantees must share publication-related biomedical materials “for bona fide purposes of research in California” for free or at cost within 60 days of receiving a request unless CIRM determines that doing so is unduly burdensome52 or approves an alternative method of dissemination (such as making the materials broadly commercially available).53 A grantee may also comply by providing requesters with the information necessary to reconstruct or obtain identical material.54 Transfers of materials may be made subject to a “university standard or industry standard Materials Transfer Agreement.”55 Compliance with this requirement is fortified by the further requirement that grantees submit abstracts of publications to CIRM for disclosure to the general public, and that such abstracts include “the URL of a website where a Materials Transfer Agreement (or similar document) can be accessed to facilitate requests for Publication-related Biomedical Materials.”56
The Bayh-Dole Act does not address the dissemination of unpatented materials. However, NIH requires grant applicants to address plans for dissemination of research results in grant applications seeking more than
5017 California Code of Regulations § 100604. Proposed versions of the regulations had included a broader “research use exemption” that would have allowed researchers in California to use patented inventions covered by the regulations without liability, but CIRM retreated from this proposal in the face of objections from commercial firms.
5117 California Code of Regulations § 100602dd.
5217 California Code of Regulations § 100604(c)(1).
5317 California Code of Regulations § 100604(e).
5417 California Code of Regulations § 100604(d).
5517 California Code of Regulations § 100604(f).
5617 California Code of Regulations § 100603.
$500,000 in direct costs (NIH, 2003). NIH and the Association of University Technology Managers encourage universities to retain the right to share “research tools” for noncommercial purposes (AUTM, 2007).57
The provision on sharing biomedical materials for research purposes is the sole remaining vestige of an earlier proposal in draft intellectual property regulations for a broader research exemption for the use of all CIRM-funded intellectual property for research purposes. Many comments criticized this earlier proposal, arguing that it would undermine the commercial dissemination of research tools (ARI, 2007; CHI, 2007b; Invitrogen, 2007). CIRM responded with revisions that allow it to approve alternatives to the sharing requirement when the requirement is onerous and that allow grantees to discharge their sharing obligations by disclosing how to reconstruct the materials or by making them “broadly commercially available.”58
Texas has a broader research exemption within the CPRIT program, requiring that patented inventions resulting from CPRIT funding be shared on reasonable terms with other CPRIT award recipients for noncommercial purposes. The comparable provisions of the Connecticut stem cell program are more similar to those of CIRM, setting an expectation that grant recipients and their institutions, hospitals, and companies will share reagents, data, and protocols developed as part of state-funded stem cell research. The Connecticut program specifies in its requests for proposals that such resources shall be made freely available to other Connecticut-based researchers. Similar to California and Connecticut, New York stipulates that resources, materials, and methods created through its sponsorship should be made easily available at reasonable cost to the research community. Maryland also requires grantees to share research results, including new cell lines as well as other materials developed with state funding, with qualified researchers. Grant recipients are permitted to request reasonable compensation for these materials.
More recently, CIRM has proposed Interim Regulations for the iPSC Banking Initiative to facilitate worldwide dissemination of a comprehensive collection of disease-specific human induced pluripotent stem (iPS) cell samples. These interim regulations would exempt grantees from the usual intellectual property and revenue-sharing regulations and provide for CIRM to own human iPS cell lines in the CIRM human iPS cell bank. The repository could charge a reasonable fee for the lines so that it could become self-sustaining, and CIRM could receive a share of revenues generated by the repository under the terms of a licensing agreement with the grantee (Baum, 2012).
5764 Fed. Reg. 72090 (1999).
5817 California Code of Regulations § 100607(c), (d), (e).
CIRM’s intellectual property policies reflect a reasonable effort to balance conflicting interests of different constituencies that each have a legitimate stake in these policies. The actual impact of the policies may not be clear for many years, but the concerns of stakeholders are already apparent. Some of the more contested provisions attempt to address competing views by leaving CIRM with discretion over implementation, but this flexibility cuts two ways: it provides for adaptation to particular circumstances, but it also creates uncertainty and risk for potential developers of commercial products.
Reliance on CIRM’s discretion to mediate competing interests is problematic for two reasons. First, CIRM itself is a new institution with no track record to reassure stakeholders about how it is likely to exercise its discretion. Second, CIRM’s future is uncertain given the time limits of its authorization and funding, yet its policies create obligations for the benefit of the State of California extending years into the future. It is not clear who will be responsible for overseeing these obligations on behalf of the state at the point of commercial product development, but it appears entirely possible that a future enforcer may be more concerned with revenue and access and less concerned with the interests of grantees and licensees than CIRM has been. This uncertainty may make commercial development of CIRM-funded inventions unattractive to grantees and licensees, especially if they have alternative opportunities that are not burdened with these risks and uncertainties.
CIRM might reduce some of the uncertainty arising from the unfamiliarity of its policies by modifying those policies to conform more closely to the more familiar Bayh-Dole approach. CIRM may have had more latitude to depart from this familiar approach in its early years when alternative sources of funding were unavailable. Departures from the Bayh-Dole approach may put CIRM-funded inventions at a growing disadvantage in the future as funding from other states and the federal government yield competing candidates for commercial development that are available for licensing on more favorable terms. The most significant departures from that approach from the perspective of grantees and licensees—those pertaining to revenue-sharing and access plans—are required by California law and evidently popular with the California legislature, posing a considerable political challenge if CIRM seeks to modify them at this point. Other departures from the Bayh-Dole approach, such as the broad definition of “CIRM-funded invention,” may be less politically salient and easier to modify.
CIRM can and should address the uncertainty as to the future enforcement of its intellectual property policies by considering this issue as part of the sustainability platform recommended in Chapter 2. Innovators with a
long time horizon for product development are entitled to greater guidance on the allocation of institutional stewardship over the retained rights of the state in CIRM-funded intellectual property if and when CIRM itself ceases to exist. The notice and comment model used by CIRM to develop and revise its current intellectual property policies would be a good approach to provide useful feedback as the Institute thinks through this issue. Stakeholders would thereby have an opportunity to identify and explain their specific concerns about the long-term implications of rights created in the course of a time-limited research funding initiative. Perhaps stakeholders would have good ideas about how to minimize the resulting uncertainty for investors. In particular, the ICOC should reconsider whether, given the globalized nature of research and development in regenerative medicine there might be some advantage to California’s long term interests to bring CIRM’s IP policies into closer harmonization with the principles that are incorporated in Bayh-Dole. At this stage, however, it appears more likely that the limitations of the science and technology, rather than CIRM’s intellectual property policies, are delaying the development of commercial products. It may be difficult to assess the impact of these policies until commercial prospects appear more realistic and imminent to product-developing firms.
Recommendation 5-1.59Incorporate Future Enforcement of Intellectual Property Policies in the Sustainability Platform. As part of the plan maximizing the continued impact of CIRM’s many achievements (see Recommendation 2-1), CIRM should propose regulations that specify who will have the power and authority to assert and enforce the future rights retained by the state in CIRM-funded intellectual property. CIRM should seek to clarify which state agencies and actors will be responsible for the exercise of discretion currently allocated to CIRM and the ICOC over future determinations on issues regarding march-in rights, access plans, and revenue-sharing rights that might arise years after CIRM’s initial funding period has passed. As it has done in the past, CIRM should provide ample opportunity for public comment on proposed changes to its intellectual property policies that pertain to transition planning.
Recommendation 5-2.60Consider Harmonizing Intellectual Property Policies with Policies of Bayh-Dole Act. As other sources of funding for stem cell research become available and as the field of regenerative medicine advances from the laboratory to the clinic, the ICOC should
59In the committee’s view, this recommendation can be carried out by CIRM without legislative action.
60CIRM may need to work with the state legislature in order to fully implement this recommendation.
reconsider whether its goal of developing cures would be better served by harmonizing CIRM’s IP policies wherever possible with the more familiar policies of the Bayh-Dole Act.
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AUTM (Association of University Technology Managers). 2007. In the public interest: Nine points to consider in licensing university technology. https://www.autm.net/Nine_Points_to_Consider.htm (accessed August 23, 2012).
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BIOCOM. 2007a.*Response to proposed IP and revenue sharing requirements for for-profit organizations. CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated November 21, 2007).
BIOCOM. 2007b.*Letter to members of the Independent Citizen’s Oversight Committee. CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated April 30, 2007).
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Eisenberg, R. S. 1996. Public research and private development: Patents and technology transfer in government-sponsored research. Virginia Law Review 82(8):1663-1727.
The Foundation for Taxpayer and Consumer Rights. 2006.*Comment on the CIRM IP policy for non-profit regulations. CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy (dated June 6, 2006).
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Geron. 2007.*Response to proposed regulations: Intellectual property and revenue sharing requirements for for-profit organizations. CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated April 30, 2007).
Goldstein, L. 2009.*Letter to Scott Tocher. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated July 31, 2009).
Invitrogen. 2007.*Response to proposed adoption of the CIRM intellectual property and revenue sharing requirements for for-profit organizations (compiled 4th public comment). CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated December 11, 2007).
Kuehl, S. J., M. Dymally, N. Mcleod, K. Bass, D. Steinberg, P. Berg, L. Yee, D. L. Torre, N. Evans, M. Hayashi, R. Hernandez, D. Jones, and S. Lieber. 2007.*CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy. California legislature letter to Robert Klein (dated December 10, 2007).
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O’Connor, S. 2006.*Email response to IPPNPO. CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy (dated June 19, 2006).
Reynolds, J. 2006.*Email to CIRM: Comment on intellectual property policy for non-profit organizations. CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy (dated June 19, 2006).
Samuelson, P., B. Robert, and A. Centivany. 2006.*Letter response to intellectual property policy for non-profit organizations. CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy (dated June 19, 2006).
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Sholes, E. 2006.*Proposed regulations on ownership and benefits of stem cell research. CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy (dated June 12, 2006).
SRI (Scripps Research Institute). 2009.*Comments on proposed adoption of revised IP regulations. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated July 31, 2009).
Stanford University Office of Technology Licensing. 2009.*Comments on proposed intellectual property and revenue sharing requirements for non-profits and for-profit grantees. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated August 18, 2009).
StemCells. 2007a.*Response to proposed CIRM regulations for intellectual property and revenue sharing by for-profit organizations. CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated October 5, 2007).
StemCells. 2007b.*Response to proposed CIRM regulations for intellectual property and revenue sharing by for-profit organizations. CIRM’s response to IOM’s data request: For-profit public comments on CIRM’s intellectual property policy (dated November 21, 2007).
Tocher, S. 2012. Response to the consideration of proposed amendments to the intellectual property regulations—Additional amendments to revenue sharing and reporting requirements. http://www.cirm.ca.gov/files/meetings/pdf/2012/072612_item_9_IP_Regs.pdf (accessed August 23, 2012).
UCOTT (University of California Office of Technology Transfer). 2006.*CIRM’s response to IOM’s data request: Non-profit public comments on CIRM’s intellectual property policy. Comment on proposed CIRM regulation entitled: Intellectual property policy for non-profit organizations (dated June 16, 2006).
UCOTT. 2009a.*Comments on proposed adoption of intellectual property regulations for non-profit and for profit grantees. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated February 2, 2009).
UCOTT. 2009b.*Comments on proposed intellectual property regulations for non-profit and for-profit grantees. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated October 13, 2009).
UCOTT. 2009c.*Comments on proposed intellectual property regulations for non-profit and for-profit grantees. CIRM’s response to IOM’s data request: Consolidated public comments on CIRM’s intellectual property policy (dated July 31, 2009).
References with an asterisk (*) are public access files. To access those documents, please contact The National Academies’ Public Access Records Office at (202)334-3543 or firstname.lastname@example.org.