1 The Protection of New Genomic Techniques (NGTs)

Plant biotechnology research for new traits and thus the development of new varieties is risky and costly. Plant innovation needs a return on investment to encourage private research and public-private partnerships [1]. Intellectual Property (IP) is a tool used to: (i) disseminate knowledge and innovation to speed-up innovation cycles, (ii) encourage collaboration and open innovation, (iii) build a sustainably growing knowledge and innovation pool, (iv) enable fair access and benefit sharing, and (v) prevent creation misappropriation and, when owned or licensed, allows for so-called freedom-to-operate (FTO). An FTO analysis (or clearance/infringement search) clarifies if a product or its potential commercialization infringes on other existing IP rights. It is an expensive undertaking. It begins by searching for issued or pending patents and thereafter, involves analysing the claimed scope of protection to get a legal opinion as to whether the product, process, or service potentially infringes on any patents owned by others. It establishes a list of potential patent holders, with whom the future (prospective) licensee must then contact and successfully negotiate a license for each patent. The negotiation process involves costs for both the licensee and the patent holders. On 29 April 2021, the European Commission (EC) published a study on the status of new genomic techniques (NGTs) that defined NGTs as “techniques capable of modifying the genetic material of an organism that have emerged or been developed since 2001”, i.e. after the existing EU legislation on genetically modified organism (GMO) was adopted in 2001 (Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC). NGTs include (i) CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), TALEN (Transcription Activator-Like Effector Nucleases), zinc-finger nucleases, meganuclease techniques, and prime editing; (ii) mutagenesis techniques, such as oligonucleotide directed mutagenesis; and (iii) epigenome-editing techniques, such as RNA-dependent DNA methylation.

With regard to IP and the patent protection of biotechnological inventions (under Directive 98/44/EC54), this EU study acknowledged the benefits of patents and licensing in promoting innovation and the development of NGTs and their products. The licensing landscape is developing rapidly with licensing agreements, some exclusive, some non-exclusive, on a diverse range of CRISPR technologies and application fields, from agriculture to therapeutics. More than 11,000 CRISPR-related patent applications have already been filed worldwide, with the majority being filed in USA and China [2] leading to some concerns about the complex patent landscape for NGTs with multiple players holding patents, and uncertainty surrounding the IP situation. IPStudies, a company based in Switzerland, has compiled a list of more than 100 variants of CRISPR enzymes beyond the best-known discovery of Cas9 in 2012, with some commercial players attempting to claim them exhaustively to ensure as much IP exclusivity as possible (dCas, dCas9, Cas12a, Cas13a…).

Prime editing, using a modified Cas9 protein that makes a single-stranded cut substantially expands the scope and capabilities of genome editing, a versatile and precise method that directly writes new genetic information into a specified DNA site (see Chap. 3). Prime editing shows higher or similar efficiency and fewer by-products than homology-directed repair, has complementary strengths and weaknesses compared to base editing, and induces much lower off-target editing than Cas9 nuclease at known Cas9 off-target sites. CRISPR-Cas-based techniques are still evolving and the list of NGTs is expected to expand further in the coming years (e.g. base editing). New CRISPR-associated enzymes have been engineered, such as base editors that are better able to make specific edits.

However, optimized tissue culture and transformation protocols should be in place to make genome editing a routine tool for plant breeding. More than 370,000 higher plant species exist in natura. But scientists can only make transformation (transgenesis and genome editing) successful in a few dozens of these.

1.1 Patents Characteristics

The protection conferred by a patent to biological material possessing specific characteristics that result from an invention [1]. (i) Patents usually have a term of protection for 20 years (starting from the filing of the application). As with all IP rights (IPRs), patent protection is also territorial, meaning that it provides protection only on a given territory. The scope of a patent on an invention is determined by the so-called patent claims. (ii) The protection conferred by a patent to biological material possessing specific characteristics that result from an invention, shall extend to any biological material which has derived from the original biological material through propagation or multiplication and possessing those same properties. Noting that in the case of a self-replicating biological material, the right of exhaustion does not apply at the first sale. (iii) A patented biotechnological invention incorporated into a variety remains protected in this variety but by no means is the variety itself patented, as this would be contrary to EU legislation prohibiting the patenting of varieties. Thus, the genome of this variety, when it no longer contains the patented biotechnological invention, is completely free of patent rights.

Under the European Patent Convention which has been amended by the decisions of the Administrative Council since the publication of the 17th edition (November 2020), patents are granted only for inventions that are new, involve an inventive step and are industrially applicable. An invention meets these requirements if it: (i) was not known to the public in any form, (ii) is not obvious to a person skilled in the art, and (iii) can be manufactured or used industrially. They are valid in individual countries, for a specified period. New plant varieties in the EU are completely excluded from patentability. Plant variety rights are regulated under Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights. In Europe, transgenic or edited plants carrying a patented event (transgenic or edited trait) fall within the scope of the patent because this element is not limited to a single variety and at the same time a transgenic or edited variety can also be individually protected by a Plant Variety Protection (PVP) certificate.

1.2 The CRISPR Patent Dispute and Legal Uncertainty

Biotechnology in agriculture is a lucrative industry and its growth is going to continue. Universities hold most of the key patents using the CRISPR technology needed to deploy this technology [3]. Thus, the role of the public sector in fundamental research and surrogate companies such as the University of California, Berkeley, the Broad Institute of MIT, and Harvard, USA, are very relevant in holding fundamental/key patents of CRISPR technology. Key patents have no economically viable substitutes; a party needs a license to utilize the Intellectual Property Right (IPR) [4].

There has been extensive interest in IP issues surrounding CRISPR, including a patent dispute between two of the technology’s inventors, Jennifer Doudna (the University of California, Berkeley, USA) and Emmanuelle Charpentier (currently in Max-Planck Institute, Germany) on one side, and Feng Zhang (the Broad Institute of MIT and Harvard, USA) on the other over who first invented the gene-editing system and who should benefit from key patents [2]. This CRISPR-Cas9 dispute, which began in 2016, is still ongoing.

Companies now also have the option of avoiding these key patents (UC Berkeley, the Broad Institute and Harvard) altogether by using different CRISPR systems. Such systems occur naturally in many bacteria and Achaea and can have various properties. Relatively few of these use CRISPR–Cas9; instead, they use alternative enzymes such as Cas12a, Cas13a or Cas14, the latter being remarkably small and easy to transport into human cells. Labs have also engineered new CRISPR-associated enzymes, such as base editors, that are better able to make specific edits.

The IP around CRISPR is becoming increasingly complex. Commercial deployments are complicated by the legal uncertainty associated with the lack of patent clarity on CRISPR. Indeed, in the context of the dispute, patent offices in the USA and the EU have issued different decisions on the validity of CRISPR patents. The United States Patent and Trademark Office (USPTO) has repeatedly ruled in favour of the Broad Institute and, on February 28, 2022, determined that it was the first inventor. The decisions are on who is entitled to receive patent protection [5]. In the EU, since the main CRISPR-Cas9 patents in the Broad Institute’s portfolio were rejected due to lack of documentation, UC Berkeley is considered first by the European Patent Office (EPO) (“EP2800811” (November 10, 2020)). There is a need for greater clarity in patent rights in order to make researchers feel secure in developing further technological innovations using the CRISPR system.

Despite this legal uncertainty as to the final determination of ownership and patentability, the licensing landscape is developing rapidly with licensing agreements, some exclusive, some non-exclusive, on a diverse range of CRISPR technologies and application fields, from agriculture to therapeutics.

2 Alternative Models: Licensing Platforms and IP Clearing Houses

The current CRISPR patent landscape presents a variety of barriers to research, innovation and profit. In order to overcome the difficulties created by the overall presence of patents, academics and breeders of the private sector are debating alternative licensing models. Patent pools and clearing houses are the two models attracting most interest.

2.1 Concerns

Patent Profusion

With a steady increase of more than 200 patent families published each month IP studies shows the emergence of several new trends concerning both the enabling technology itself, and application developments. There are so many property rights in the hands of various owners—with whom parties must reach agreements to enable them to aggregate the rights they need in order to legally perform their activities—that it will prove difficult to negotiate licences for patented inventions successfully. High transaction costs may stand in the way of an agreement. If a high number of agreements with rights holders is required, transaction costs may lead parties to decide that the bargaining process is not worthwhile. Hence, a socially optimum level of consumption of the resource may not be achieved, resulting in “under-utilization” of the property which will have a blocking effect on further innovation. Moreover, the fact that licensees have to acquire many licences in order to avoid patent infringements, may lead to elevated royalty fees, caused by royalty stacking. Because the licensee will usually pass on the cost of these fees to the final consumer, the final development and manufacture of products may be obstructed [6].

A growing cause for concern in the CRISPR sphere is the so-called “tragedy of the anticommons.” There are two reasons why anti-commons could affect the CRISPR patent pool; a thicket of patents, and the current licensing model being implemented. (i) There is a potential “thicket” of patents in the CRISPR sphere with some fragmentation of IPRs because the technology tends to be patented and licensed on a gene-by-gene basis. (ii) The surrogate licensing model currently in use raises concerns about research bottlenecks [7]. A research bottleneck could occur because the exclusive licensing to surrogates has limited the availability of CRISPR technology as a global platform, and traditional protections against the overly broad surrogate licenses will not work.

Concentration of Players

The concentration of players in the seed market has led to high seed prices, reduced seed variety choices, and great dependence on farmers. Transgenesis technology has led to an increased concentration of ownership and power in agri-food systems through patents, contracts and licence agreements. Patent rights and the way they are granted and exercised contribute to a decrease in the diversity of breeding companies and threaten innovation in plant breeding. It is argued that the position of patents, combined with technological developments, has led to substantial consolidation of breeding companies in recent decades.

Farmers and producers fear that their freedom of choice will be threatened and that no varieties specifically meeting their needs will be developed for certain crops (orphan or underutilized crops). Genome editing holds great promise for increasing crop productivity, and there is particular interest in advancing the breeding of orphan crops, which are often burdened by undesirable characteristics resembling wild relatives. In order to diversify cropping systems, orphan or underutilized crops are better adapted to local or marginalized environments [8].

Access for Small and Medium-Sized Enterprises (SMEs) to Patents

The high cost of patenting innovations and high patent licence fees can be a barrier to market entry for SMEs (together with high business concentration) due to; (i) the complexity of patenting and the resulting monopolization, (ii) the licensing of patented products and the respective transaction costs, and (iii) the lack of transparency and FTO analyses, e.g. due to the complex patent landscape of the CRISPR technology. These same aspects may limit access to NGTs as mentioned in the EC study on the status of new genomic techniques in 2021.

2.2 Some Solutions of Collaborative Licensing Models: The Patent Pools

Alternative collaborative licensing models such as patent pools and IP clearing houses may play a significant role in facilitating access to patents and untangling a potential patent “thicket”.

A patent pool for the purpose of joint package licensing is an agreement between two or more patent owners to license one or more of their patents as a package either to one another or to third parties willing to pay the associated royalties [9]. The package is managed either directly by patentees to licensees, or indirectly through a new entity specifically established to administer the pool. The first licensing pool was established in 1856 among members of the sewing machine industry. More recently some pools are being established in biotechnology, such as the Golden Rice pool or the SARS-1 (severe acute respiratory syndrome) pool.

This package of IPRs is then licensed on a non-exclusive basis, providing licensees with affordability and FTO, while giving licensors adequate royalty returns [10]. A patent pool can provide competitive advantages by integrating complementary technologies, reducing transaction costs, clearing blocking positions, and avoiding costly infringement litigation. By promoting the dissemination of technology, patent pools can be pro-competition.

Classically, the creation of a patent pool involves four major characteristics. (1) It is built around the voluntary inclusion of key and specific IPR holders. (i) “Key” patents are those that have no economically viable substitute; a party needs a license to use the IPR. Key patents are those for which the application is general, such as a technique that applies to all genomes. (ii) “Specific” patents are those for which the application is specific (such as a modification of a genetic sequence for a given trait in a given species). (2) It relies on a model. A model is an attempt to encapsulate the details and patents necessary to enable uniformity of practice across a diverse range of implementations. (3) It requires pool administrators to conduct an in-depth and continual search of the patent landscape. Thus, a patent pool must be open to all IPR holders, but each patent must be analysed individually to determine if it is needed before possible inclusion; independent high-level scientists and lawyers analyse both the patent landscape and the potential key patents. (4) It can be subject to anti-competition laws. Any issues regarding anti-competition laws and patent pools have largely been resolved following the decision of the Department of Justice to grant MPEG LA pro-competitive clearance in 1997. The starting point for an anti-trust analysis of any patent pool is an investigation of the validity of the patents and their relationship with each other.

In the absence of a patent pool, users (licensees) have to enter into negotiations with all relevant patent holders, which is a time-consuming and expensive process. In the presence of a patent pool, licensees turn to the patent pool for the rights as one package, which results in simplification and a significant reduction of transaction costs.

Example: MPEG LA

The platform MPEG LA, an independent licensing agent based in Denver (USA), aims to pool CRISPR-Cas9 patents into a one-stop licensing point (accessibility to a multi-user market will maximize CRISPR’s life-enhancing potential) [11]. Its model offers fair, reasonable, and non-discriminatory access to essential IP from multiple patent holders under a single license as an alternative to separate licenses.

By assisting users with the implementation of their technology choices, MPEG LA offers licensing solutions that provide access to fundamental IP, freedom to operate (FTO), reduced risk of litigation, and predictability in the business planning process. In turn, this enables inventors, research institutions, and other owners to monetize and accelerate market adoption of their assets in the global market while also substantially reducing the cost of licensing.

The CRISPR-Cas9 Reference Model is authored by MPEG LA for MPEG LA’s use in the formation of a CRISPR-Cas9 Joint Licensing Platform which aims to provide one-stop, worldwide licenses to CRISPR-Cas9 patent rights as a convenient alternative to negotiating separate licenses with individual patent owners, and pursues the broader purpose of fostering innovation in genome engineering and accelerating the development and deployment of CRISPR-based products, therapies, and services. The Reference Model is intended only to support the efficiency of a single licensing transaction that allows access to as many specific patents as possible for the benefit of the market and is consistent with applicable legal requirements. Inclusion requires that at least one claim is directed to the CRISPR-Cas9 System. MPEG LA’s CRISPR Cas-9 Joint Licensing Platform will give technology owners the opportunity to share in mass-market royalties from their CRISPR technology while also enjoying, with other developers, broad access to other important CRISPR technologies. As a voluntary, market-based business solution to the problems relating to patent access, designed to balance and resolve competing market and public interests, an independently managed patent pool represents the greatest opportunity to unleash CRISPR’s full potential for the benefit of humanity.

To ensure that no single party has control over the licensing of the package, the organisation works with all the included patent holders to create a single set of licensing terms and conditions, upon which all included patent holders must agree. The patent holders also hold most of the enforcement powers. While MPEG LA can enforce contractual provisions, it does not file patent enforcement lawsuits on its own; instead, it must notify the patentees that they may want to file an enforcement suit.

MPEG LA develops its “CRISPR-Cas9 Reference Model”, which describes how to patent essentiality will be determined with respect to the CRISPR platform (the CRISPR-Cas9 System is defined). This outline of essentiality in MPEG LA’s Reference Model is meant to encompass all patents key and specific to the underlying CRISPR platform. If a patent meets the established criteria, it will be eligible for inclusion in the pool. To collect these platform patents, MPEG LA is seeking “target-agnostic” patents that do not require a specific genome. The Reference Model discloses the criteria for pool inclusion. MPEG LA’s initiative was to provide a worldwide non-exclusive license to multiple patents held by multiple entities in a single transaction.

2.3 Some Solutions of Collaborative Licensing Models: The Clearing House Models

An alternative mechanism supporting licensing negotiations is the clearing house model. The term clearing house is derived from banking institutions and refers to the mechanism by which cheques and bills are exchanged among member banks in order to transfer only the net balances in cash. The platform may provide information on patented technologies, bring together potential providers (licensors) and users (licensees) of patented technologies, and may provide additional services, e.g. negotiating licensing conditions, and collecting and distributing royalties. An IP clearing house was analysed for agricultural biotechnology [12].

They are five models of clearing houses: (1) The information clearing house, (2) The technology exchange clearing house, (3) The open access clearing house, (4) The standardized licenses clearing house and (5) The royalty collection clearing house (RCCH). The RCCH model could be useful in providing access to and use of patented inventions in NGTs and novel traits.

The RCCH comprises all the features of the previous models (1, 2 and 4), but also collects license fees from users on behalf of the patent holder in return for the use of certain technologies or services. For the user, RCCH organizations would simplify licensing negotiations and, therefore, facilitate access to and use of patented inventions. For the patent holder, increased visibility of their patent rights and the streamlining of royalty collection and monitoring may lead to a rise in licensing and thus, licensing revenue. At the same time, awareness and respect for IPRs may grow among researchers and their public and private institutions, leading to decreased enforcement costs through fewer infringements. Hence, a reasonable price for licensees (royalties, transaction costs) and licensors (royalties, transaction costs, and enforcement costs) may be achieved. The patent holder is reimbursed by the clearing house pursuant to a set allocation formula. In addition, a RCCH may offer other services such as the monitoring of patents transferred to the clearing house or an independent dispute resolution mechanism.

However, the RCCH may have some drawbacks. (i) Patent holders may be reluctant to voluntarily participate in it. They would have to grant a licence to the clearing house which would then issue licences to all applicants without discrimination and on a non-exclusive basis in accordance with competition law. As a consequence, patent holders would lose some control over their business licensing strategy. (ii) Unless the RCCH represents a high proportion of all relevant patented inventions, it might not be a viable and effective alternative, nor could it prevent the emergence of an anti-commons effect. (iii) RCCH might be more complicated and costly to set up in comparison with the other clearing house models. Experts (high-level scientists and lawyers) will have to be hired to evaluate the often very complex patents, to match licensees with the patented inventions, to develop standardized licence agreements, and for monitoring and dispute resolution purposes. (iv) The standardized licences might not allow for measures highly appreciated in commercial licensing practices, such as the setting of milestones, due diligence, and the maintenance of long-term business relationships. (v) The exchange of relevant technical know-how is often fundamental for the smooth application and further development of a patented invention. Know-how is generally protected as a trade secret, but the clearing house will probably not be able to guarantee the preservation of secrecy when know-how is exchanged. Thus, with respect to complex technologies, direct negotiations between the licensor and the licensee on the issue of know-how may still be required, which may diminish some of the advantages of the royalty collection clearing house. This drawback might be a reason to advocate for the establishment of an RCCH that is limited to inventions that do not require the exchange of technical know-how, such as patented DNA sequences and mutations.

In the absence of a clearing house, licensees must enter into negotiations with all patent holders. In the presence of a clearing house, licensees turn to the patent pool for the acquisition of required rights.

Example: Agricultural Crop Licensing Platform (ACLP)

The ACLP, located in Brussels (Belgium), is open to all private or public sector organizations involved in plant breeding or trait research and development, and having employees and tangible assets in the ‘territory’ (the geographical scope of the ACLP is 38 member states of the EPO along with Russia and Ukraine). The initiative is currently driven by 10 European plant breeding companies and trait developers representing a wide range of agricultural crops and includes small, medium-sized, and large companies. The ACLP is financed by membership fees. Small members enjoy free membership during the five first years of the existence of the ACLP. The scope is all patented traits present in commercial varieties that are sold on the open market in the ‘territory’ (“Trait”) and all agricultural crops as defined by CPVO (The Community Plant Variety Office is the EU agency responsible for protecting plant variety rights (PVR) in the EU). The ACLP provides an innovative, simple legal framework for all breeders to use and enables transparent access to patented traits including genome edited traits.

This initiative provides breeding and guaranteed marketing rights for commercial traits which in turn fosters the transfer of technology. Transparent information on all commercial varieties that contain patented traits within the territory is shared via PINTO (Patent Information and Transparency On-line). PINTO was established with the aim of improving transparency regarding plant varieties that might fall under the scope of patents or patent applications and is updated continuously by Euroseeds.

The entitlement of members to a commercial variety containing a patented trait is established as soon as it is sold by a member on the open market in the Territory. Member’s rights are; (i) to obtain a non-assertion agreement from the patent holder for breeding in the Territory with the patented trait(s) including using its specific markers, (ii) to obtain a commercial license from the patent holder for the production and sale of the varieties, bred under the non-assertion agreement and containing the patented trait(s), within in the Territory.

The key expected outcomes of the ACLP are as follows; (i) novel patented plant traits, including those produced by new genomic technologies, are available among ACLP members on fair conditions, (ii) the sustainable development of novel varieties be enabled by information and rights shared amongst members, under the framework of the ACLP, (iii) the facilitation of technology transfer will make it easier for the ACLP members to further innovate.

Principal rights and obligations applicable to members of the ACLP Initiative are; (i) members are entitled to any commercial variety containing a patented trait, as soon as is sold by a member on the open market in the Territory; (ii) for members to obtain from the patent holder, a non-assertion agreement for the breeding of plants containing patented trait(s), including using its specific markers, within the Territory, (iii) for members to obtain from the patent holder, a commercial license for the production and sale of varieties, bred under the non-assertion agreement and containing the patented trait(s), within the Territory.

Licensing can take the form of the Standard License Agreement (SLA) of the ACLP in which case only royalties need to be agreed between the patented trait holder and the interested member. In circumstances where no agreement on royalties is reached within a prescribed period of time, a process known as “Baseball” Arbitration [13] begins.

The ACLP will foster bilateral agreements between members as the standard licensing agreement will not fit all specific factual situations best. The ACLP gives never less assurance that a commercial license will be available under the Standard License Agreement (SLA). For breeding activities, the ACLP acts as a technology exchange clearing house: all members get a non-assert for breeding activities which is not available in all states of the territory. The standardized licenses clearing house is also a component of the ACLP.

3 Success and Acceptability of Licensing Platforms and IP Clearing Houses

3.1 The Public Sector

The public sector plays an important role in fundamental research and represents a substantial source of IP in agricultural biotech. There are quantitative and qualitative distinctions between the public- and private-sector IP portfolios (1/3 of CRISPR patents are held by private companies) [2]. It is important to distinguish between ‘enabling’ technologies representing the research tools needed to create NGT varieties, and ‘trait’ technologies which provide the genetic basis for new functionalities. The public sector contributes more and more to the discovery of new trait technologies. The extent to which private and public-sector inventions can be used to assemble a platform of enabling technologies and gene-trait technologies sufficient to develop (new edited varieties) have been examined [12]. A major challenge facing the management of public-sector IP is the high degree of fragmentation of technology ownership across numerous institutions, especially in light of the need for multiple technology components to provide FTO in edited crops. Based in part on some of the economic principles of an ‘IP clearing-house,’ a model of public-sector collaboration, including data sharing and patent pooling, has recently been suggested as a solution that could directly address this issue. It seems that the technologies patented by the public sector might indeed be capable of providing a platform of technologies that could be sufficient to enable the development of new NGT varieties and cultivars. Such a strategy may be particularly important in the future for sharing access to key enabling technologies and enabling innovators to develop and deploy the trait technology projects with the public sector. Public funding for research emphasizes the discovery of a wide spectrum of previously unknown gene functions whereas private research focuses on application-driven research in a narrower range of established product lines.

3.2 Ethical Licensing

Ethical licensing is one way of thinking about the role of universities and other public institutions in the regulatory process, but there is a wealth of other initiatives promoting ethical licensing. IP pooling, clearing houses and open source initiatives are examples of private ordering mechanisms that differ from solutions aimed at changing or harmonizing the legislative framework in that they are generated by the users themselves. Thus, a voluntary pool or a clearing house model could promote commercialization and include provisions for royalty-free research use by public institutions, while addressing ethical concerns about particular CRISPR applications.

A successful patent pool could do more than solve licensing issues (fragmentation and downstream litigation, the patent thicket and licensor issues such as the surrogate licensing model). It could also mitigate ethical concerns. Point 9 in the Nine Points to Consider in Licensing University Technology (AUTM, Washington, DC, 2007) states: “Through thoughtful management and licensing of intellectual property, however, drugs, therapies, and agricultural technologies developed at universities can at least help to alleviate suffering from disease or hunger in historically marginalized population groups”.

License restrictions could be used, in theory, to require that R&D funds be used, in part, to ethically promote access to NGTs (access for SMEs or to research/biotech institutes in developing countries) and also to develop traits for orphan crops in developing countries.

MPEG LA and its prospective licensors could potentially solve said ethical dilemmas through ethical constraints in their licensing agreement (ethical limitations in their licensing agreements by granting licenses for only very specific applications). This is largely the case with Monsanto’s license from the Broad Institute covering the use of CRISPR-Cas9 for a variety of agricultural purposes in 2016. This non-exclusive license agreement will deliver a wide array of crop improvements to global agriculture. The Broad Institute’s license to Monsanto covering the use of CRISPR-Cas9 for a variety of agricultural purposes requires Monsanto to allow its farming customers to save and re-sew seed from one season to the next, in contrast to some of Monsanto’s past practices. Requiring this of Monsanto provides greater access to the outcomes of CRISPR technology to farmers, who would otherwise be required to purchase expensive new seeds each year from Monsanto. The Broad Institute has used ethical limitations in their licensing agreements by granting licenses for only very specific applications (discussing Broad’s non-exclusive licensing with Bayer for specific agricultural applications such as genetic modification of plant varieties). In October 2017 DuPont entered into a joint non-exclusive licensing agreement with the Broad Institute for use in commercial agricultural research and product development (except gene drive and tobacco for human use) on the CRISPR-Cas9 IP held by the Broad Institute and its collaborators.

Only genetic modification (mutation, allele replacement or gene insertion) by NGTs can be patented. Prohibiting patents on native sequence, crossover processes and random mutations is important in defending the principle that all the information contained in a plant genome belongs to the scientific heritage of humanity.

3.3 Open Licensing Systems (with CRISPR IP Research Tools Available)

Companies would benefit from a CRISPR patent pool that would provide a non-exclusive license to CRISPR as a research tool, and it would appear that many of the exclusive licenses already granted would permit this field of use to be included in a pool license.

In the context of CRISPR, this non-commercial use is done through a non-profit repository and licensor of patents on CRISPR technologies for academic organizations. AddGene, a company (a non-profit organization) based in the USA and UK, serves academic and non-profit institutions that provide access to CRISPR constructs and plasmids through a standardized Biological Material Transfer Agreement (BMTA). AddGene’s BMTAs contain patent licenses for the academic use of the underlying technology. For example, the University of California, the Broad Institute, and hundreds of other institutions have agreed to make many of their CRISPR IP research tools available for free or at a reduced cost through AddGene [14].

3.4 Patent Quality

The scope of patents should be clearly defined for two major reasons. (i) When the product (a trait in crops) is only vaguely defined and its essential character is difficult to determine, the utility of the pool may be diminished in upstream research, as it may be too narrow to be useful for product development. (ii) Biotech patents tend to be incomplete meaning that the innovation must be completed before the final product is incorporated and brought to market. Incompleteness and long development cycles can make it difficult to define specific patents. This can be a problem because, if a pool does not contain specific rights, the pool may no longer be a one-stop licensing point for potential licensees.

4 Conclusion

Although patent pooling (licensing platforms and IP clearing houses) is an attractive solution for the licensing of IPR in fragmented fields such as NGTs, there are many challenges that could hinder the formation of such a pool. Public perception of NGTs is critical to their adoption by the market. Understanding and awareness enable consumers to make informed choices, therefore it is necessary to provide consumers with information. With respect to IP and patent protection, alternative licensing models could overcome the difficulties caused by the complex patent landscape of CRISPR technology. Patent pools and clearing houses are a promising approach. When access and use to a certain technology are hindered by the existence of multiple patents, a patent pool could be a useful model to facilitate access and reduce potential litigation risk. The package of IPRs is licensed on a non-exclusive basis, allowing licensees to benefit from affordability and freedom to operate while providing licensors with adequate royalties. Non-exclusive licensing schemes could allow many companies to enter the market, creating a commercial ecosystem that has strengthened innovation and the economy. The ACLP, a clearing house, can be mentioned as a solution for products produced by the CRISPR technology for plant breeding in the agricultural sector in Europe. A CRISPR patent pool depends on the willingness of a sufficient number of IP owners to join the pool to ease licensing burdens and costs. The CRISPR platform will take off in a big way when a major company and all key players (major research institutions) announce that they will join the patent pool. The platform should be a low-complexity platform that lawyers and breeders are familiar and comfortable with.