Patent pools, their needs & trends in biotechnologyAccording to WIPO (World Intellectual Property Organization), a patent pool is defined as “anagreement between two or more patent owners to license one or more of their patents to oneanother or to third parties”. Main objective behind pooling multiple patents is to promotetechnological innovation & competition which requires innovators access to multiple patentsinstead of one. A competitive market which develops products using this approach benefits societyin terms of efficacy and cost-effectiveness of these products.In terms of downside to this approach, it could also impede licensing technologies to certaincompetitors leading to collusion. In the field of biotechnology, an idea of patent pool seemsmeritorious considering the challenges that are faced by institution or companies regardingdeveloping complex technologies that directly affect societal health. Traditionally, patent poolshave been used successfully in industrial & electronic fields such as in aviation, radio, multimedia(MPEG), agricultural, etc.
(Serafino 2007). In-licensing of these types of intellectual properties isrelatively easier when compared to licensing a patent that involves life sciences or biotechnologyrelated technology.In most cases, the life science related research is carried out at the university level, and majorityof the patents are held by these universities. For a biotechnology industry to innovate andcommercialize a new product, they require access to such multiple patents at once. “Patentthickets” is the term generally used when such patents are distributed among numerous ownersinstead of one. According to Shapiro C. (2001), “a patent thicket refers to a dense web ofoverlapping intellectual property rights that a company must hack its way through to actuallycommercialize its technology.”3Inability to gain access to these patents overall, leads biotechnology firms to divert their focusfrom essential technologies to products that can be comparatively easily licensed andcommercialized (Heller & Eisenberg, 1998).
The same authors elucidate principles of”anticommas”; wherein the competition among patent holders underlying a single technologyeventually leads to communication breakdown, stifling or striving society from reaping benefitsby not allowing access to these patents to each other. Hence, patent pools are essential inbiotechnology industry or even academia to conduct basic research and then commercialize it tobenefit society.III. USPTO white paper on patent poolingDue to such high potential of patent pools, and concerns related to access and utilization of them,United states Patents & Trademarks office released a white paper in 2001, underlying need forwide access of biotechnology related products and processes (Uspto.
gov, 2017). The paperhighlights concern regarding patents relating to genomics inventions and time & cost associatedwith licensing them from multiple owners. It suggests patent pool as “one-stop shop” for industriesinterested in employing these patents to commercialize their inventions.It also furthered implementation of ‘anti-trust law’ to grow fair competition among the patenteesto research and develop for consumer benefits (Uspto.gov, 2017). The guidelines released byDepartment of Justice and Federal Trade Commission for ‘anti-trust’ in 1995, iterate criteria forestablishing a patent pool when such arrangement integrates complementary technology, avoidsinfringement litigation, clears blocking patents, reduces transaction costs, and spreads thetechnology (Justice.
gov, 2017). 4IV. Crispr patents landscape and applicationsAccording to IPStudies, there have been 200 patents granted worldwide for Crispr technology(Landscape, 2017). Most of these patents are held by institutions in United states accounting foralmost 80 patents with Crispr claims. Broad institute of MIT, Harvard and its collaborators areleading in terms of having multiple patents for Crispr.The technology itself has numerous potential applications in human therapeutics, germline editing(Cai et al. 2016).
It can be used to develop cells and animal models to test the efficiency of multipledrug targets or mechanisms of different modulators (Ruiz & Perales, 2017). Gene mediated therapyusing Crispr has opened new avenues for treatment of hereditary movement disorder such asataxia, dystonia, Huntington’s disease, Parkinson’s disease (Im, Moon & Kim, 2016). The strategycan also be employed for treatment of neurological disorders. Recent experiments conducted usingchimeric antigen receptor T cells (CAR T) mediated immunotherapy may potentially treat severediseases such as HIV (Ren & Zhao, 2017).V. Need for Crispr patent poolAlthough, new inventions are innovated almost on daily basis using Crispr technology, they willnot benefit society unless these technologies are commercialized. One of the main blockade to thisis the fact that majority of the Crispr patents granted are riddled with overlapping claims for itsapplications i.e.
‘Patent thickets’ (Gray & Spruill, 2017). The authors discuss about how themechanism underlying the Crispr technology is manipulated or engineered to fit various claims.If the patents are granted accruing such broader claims, it eventually impedes other innovators orresearchers to conduct independent research underlying the same technology due to infringement 5claims. It is even difficult and costly for a biotechnology industry to claim licenses for multiplepatents. Traditionally, patent pool is not fully rooted in biotechnology sector, but foreseeing thetremendous application of Crispr technology it has never been needed more.VI. MPEG LA Crispr patent poolIn April 2017, MPEG LA LLC; a company based out of USA has called forth a patent pool forCrispr technology (Mpegla.
com, 2017). MPEG LA is an administrative body that was establishedearlier in 1997 when the patent pool for technology related to MPEG-2 was being formed (Levang2003). Mpeg-2 technology which was successfully implanted by forming a patent pool is used toreduce transmission time and conserving data space. The administrative body was responsible foradministrative tasks, collecting royalties, and negotiating licensing agreements.
MPEG LA has termed the platform as ‘One-stop shop’ for plethora of Crispr patents availableunder a single license to help promote technological and commercial innovation. The jointlicensing platform has put forward a Crispr-cas9 reference model in order for prospectiveinstitutions or patentees to be a part of the patent pool. According to Larry Horn; MPEG LAPresident & CEO, “”Pooling the foundational CRISPR patent rights under a single nonexclusive,cost-effective, transparent license will allow the market to focus on the creation of new productsand therapies that accelerate and expand CRISPR’s deployment” (2. Mpegla.
com, 2017). He hasalso drawn comparison of this pool with earlier successes in patent pool formation for digital videoand electronic industry. The goal in forming this pool is to create new therapies and products onthe market along with efficient deployment of Crispr technology.6The platform has promised royalties to foundational and other participant patent owners dependingon the licensing deals it proposes to make. The submission of the patents to same is voluntary andis based on willingness of patent holders to participate in such an agreement.
Only issued patentsare allowed to be part of this model.The reference model has put forth following criteria to submit a patent related to Crispr(3.Mpegla.com. (2017):”The CRISPR?Cas9 System (as defined below) or any of its elements;• A composition of matter containing the CRISPR?Cas9 System or any of its elements;• A composition of matter derived from use of the CRISPR?Cas9 System or any of itselements; or• A method of use, or a method of manufacture, pertaining to any of the foregoing.”VII. Broad Institutes ParticipationIn June 2017, Broad institute and its collaborators have decided to be a part of this patent pool andhave submitted an application to MPEG LA, LLC (Broadinstitute.
org, 2017). Currently, there are22 patents held by Broad and its collaborators such as Harvard university, and Rockefelleruniversity in 10 patent families of Crispr.Broad institute holds majority of the key patents relating to Crispr technology and already licensesits patents non-exclusively to all applications except human therapeutics. The non-exclusivelicenses are being applied for innovations in agricultural industry and commercial research.7For patents exclusivity of areas concerning human therapeutics, Broad institute implements “OpenInnovation” model, wherein, a licensee gets 2 years exclusivity for the patents then the patents areagain opened to license to other participants.
Being a majority key holder, there have been claimsraised whether the institute is trying to corral other patent holders to join the pool.VIII. Legal challenges associated with Crispr patent pool• First challenge associated with the patent pool is its eligibility criteria. The reference modelgiven by MPEG LA does not specifically draws out point to differentiate patents withinthe pool. Broad criteria are put forward which might lead to more confusion and reluctancefor patentees to participate.• The terms are not yet put forward with respect to share of royalties that will be distributedamongst the patent holders. The key participant may ask for higher share of royalties ascompared to other participants in the patent pool, which might lead to competition betweenparties within.
• The patent dispute for key patent issuing seems interminable. The university of Californiaat Berkeley has filed for a patent interference claim in July 2017 (Affairs, 2017). If theBroad institutions participation is successful in the patent pool, and in future, the courtgrants the key patents to University of California at Berkeley, it might negatively affect allthe licensors which are part of the patent pool.• The Crispr patenting landscape itself is complex. Majority of the patent holders in USAhave exclusive licensing agreements with “Spin-out” companies which act as a mediatorbetween the institutions and licensing industries. Editas Medicine (MIT & Harvard), 8Caribou Biosciences & Intellia Therapeutics (UC Berkeley, Vienna), ERS genomics(Emmanuelle Charpentier) are some of the spin-off companies that are used by institutionsto license their patents (Allenovery.
com, 2017).• These spin-off companies are formed by these institutions with one of their own principalinvestigator. According to Sherkow & Contreras (2017), “Exclusive licences granted to forhuman therapeutics might rapidly bottleneck the use of technology”. The authors highlightthat although, non-exclusive licenses are granted for non-commercial research. This meansthat even if a research institute or innovator comes up with an invention, they can notmarket or sell the product.• If the exclusive licenses granted to spin-off companies for human therapeutics applicationsare to be licensed to other participants in the patent pool, the institution will not be able todo so without the permission from the spin-off companies (Sherkow & Contreras, 2017).This creates another conundrum in terms of patent pool licensing, where licensor will haveto litigate with the spin-off companies.
• If an unlicensed company has necessary resources to innovate and come up with the newinventions, they can not do it so with the current patenting landscape and using the”surrogate” model of the universities.9IX. “Surrogate licensing and scientific discovery” – Ethical challengesSherkow & Contreras (2017) have critically assessed the current scenario involving Crispr patentsand licensing strategies of patent holders in terms of commercializing them. They have termed thespin-off companies as “surrogates” which have exclusive licenses granted to them by theuniversities.
These types of licenses grant them the monopoly to exploit such arrangement in termsof deciding which companies to license the patents, seeking specific partners.Extensive share of royalties generated from these licensing deals are kept by these companies. Anindividual investigator or researcher having large share of these companies profits substantially.Hence, many universities, investigators prefer this surrogate model (Pressman et al. 2006).Although, non-exclusive rights are given in terms of academic research, agricultural applicationsand tool development, exclusivity of human therapeutics directly affects application of usefulproducts to public good. Simultaneously, it raises the ethical question whether these universitieshave abandoned their public focus.The universities funded using public funding have moral implication to disseminate its innovationas widely as possible prioritizing society first.
A patent pool should consider all these challengesand implement its licensing model in a way that commercialized essential technologies are widelyavailable throughout scientific community as well as within public.The anti-trust laws as mentioned earlier, necessitates the platform of patent pool to provide all theterms to its applicants in a ‘fair, reasonable, and non-discriminatory (FRAND)’ way (Contrerasand Sherkow, 2017).10X. Medicines Patent Pool (MPP)The medicines patent pool (MPP) is a recent example of successful execution of a patent pool inpharmaceutical industry. It was established in 2010 to allow access generic versions of patentedanti retroviral (ART) drugs to middle to low income countries, wherein, patients could not affordthe patented drugs (Juneja et al.
2017). UNITAID organization which helped foster this idea andimplemented successfully has helped over 18.2 million people to gain access to these generic drugsby 2016 (Unaids.org, 2017). MPP works with World Health Organization (WHO) to negotiatedeals with patent holding pharmaceutical companies which grant non-exclusive licenses to genericcompanies. The result of this strategy is increased competitiveness between local genericcompanies which has lowered down the cost of these life-savings treatment for millions of peoplearound the world.
This type of strategy of non-exclusivity of licenses which has helpedeconomically striving regions maybe far from implementing in current Crispr patent pool, butthese are the ethical concerns it will eventually have to face in near future.XI. Pros/Benefits of adapting Crispr patent pool• The idea of ‘one-stop shop’ for Crispr patents seem lucrative enough in terms of gainingeasy access to the technology.
• Crispr patent pool if implemented correctly, will ultimately increase the efficiency of thelicensing aspects for licensors in terms of having to go through regulatory framework ofan individual licensing deal.• The licensors will have access to all patents under a single license, which means it willhave access to multiple technologies underlying developing a single high priority product.11• The issues regarding ‘patent thickets’ are mitigated under a single pool, licensors will avoidhaving to go through infringement litigations.
• A successful patent pool fosters FRAND environment & promotes heathy competitionbetween competitors which will eventually lead to commercialization of Crisprcomponents and its tools for benefits of the society.• This type of model is beneficial economically as well. The licenses that are allowed onnon-exclusive basis for commercial research will aid academic and independent reseachentities to further innovation and its applications.XII. Personal Views and Probable solutions to challengesCrispr technology has shown promising signs of potentially curing many diseases especiallygenetic diseases. If the technology advances and implemented effectively it could be one of thebreakthrough technique in human history. The ethical and moral concerns related to technologyare valid and need to be addressed as the technology is progressing. The regulatory and ethicalframework needs build up eventually to catch up with the emerging methods.
Promulgation anddiscussion of Crispr technology needs to be done beyond scientific community.Open public platforms need to be organized which involve international representatives and theirperspectives to build a robust ethical network.As far as the patent pools are concerned, the disputes between institutions for key patent issuingneeds to be resolved primarily in order to have clear framework for the platform to be built upon. 12Sherkow & Contreras (2017) suggest limiting exclusive rights to specific genes within the patentpool. This will help in rapid development of potential effective commercialization of useful humantherapeutic products. The argument put forward by Sherkow & Contreras seems legitimate withrespect to use of “Spin-off” companies as surrogates in licensing deals. Termination or dilution ofsuch organization may serve greater purpose in terms of access of technology widely, forestallingthe exploitation that can be a result of such an arrangement.
An “independent patent pool” suggested by Caulfield et al. (2006) if structured correctly mightusher industries or innovators to prioritize public good over ‘profit’ as a sole goal. Such patent willalso involve public insight and scrutiny along with other governing bodies. Public involvementwill also address involvement of industries development, interest of researchers and discuss ethicaland moral issues at the same time.
In conclusion, the idea of patent pool over Crispr inventions in rational and necessary. In order toinnovate and advance the technology further in terms of benefitting society commercializingtechnologies is requisite. The challenges and concerns associated with current patent landscapeoutweigh its merits. An idea of independent patent pool as suggested by Caulfield et al., Sherkow& Contreras suggestions may effectuate a better path forward.