Friday, June 19, 2015

Open Therapeutics

(This is a short form paper from a longer piece currently is work in progress. To request a copy of the long form, please contact jin.kong@microbialrobotics.com)


Open Therapeutics – All scientific knowledge and data should be openly accessible and readily exploitable through common rights licensing.

“Open source is not magic pixie dust.” - CatB[1]
By Jin Kong (CC BY)


Open is a state of mind. It is a choice by the free-market participants towards fairness and collaboration. The choice gets us out of the zero-sum game. To the pharmaceutical industry, this is especially important.

Currently, the industry is in a crisis. There are large number of industry patents expiring. This can put more than $200 billion in annual drug sales at risk for the industry.[2] Experts estimate large-cap pharmaceutical companies themselves will only be able to replace 26 cents for every dollar lost to the patent expirations by 2012.[3] Everyone in the industry agrees that without increasing R&D productivity dramatically, the industry cannot sustain itself economically. There are other problems in the industry. The patent-driven “closed” system helps proliferate patent trolls who do not promote innovation.[4] The closed model also promotes inefficiencies: each step of the therapeutic development requires specialized knowledge and a different set of expertise; front end R&D work requires scientific expertise, clinical trials require regulatory and medical expertise, productions and product monetization are even more complex and cost intensive requiring a range of manufacturing, promotion and sales entities. These critical steps in the development of a single therapeutic make vertical integration likely the only true efficient way to deliver products to market in an closed commercialization model. But vertical integration concentrates risks for the few large-cap players. The success rate for bringing products to market is about seven or eight percent.[5] Given the concentrated risks and low success rate, large-cap players is unlikely to increase R&D following the strict close-model. It is no wonder new therapeutic options are slow to meet the demand.

There are also public policy and ethical issues specific to synthetic biology. New therapeutic options based in synthetic biology are rooted in the public domain (the Human Genome Project (HGP)). The individual development power for a synthetic biology-based therapeutics is seriously outmatched by the amount of genetic information present. Due to the complexity and rapid maturity of the science itself and the need for the public accountability, it makes good policy to collaborate, copyleft[6], and share knowledge to ensure ongoing product quality, safety, and continued public benefits from the HGP.[7]

Industry players are already dabbling in Open Therapeutics: Novartis, Eli Lilly, Pfizer, AstraZeneca, Sanofi, for example. NGOs, consortia, and other loosely formed organizations are working hard moving forward Open Therapeutics (e.g., tranSMART, Structural Genomic Consortium, BioBricks Foundation and the Asian Cancer Research Group). A number of academics[8] and professional experts[9] have also joined the Open Therapeutics conversation. Yet these efforts are dispersed. The industry as a whole have yet to come to grip with the economics of Open Therapeutics. For example, Deloitte's recent 2015 article is an excellent analysis of the problems and path forward in Open Therapeutics, but it referenced the economic shift as “Open Innovation” rightly to focus on the front end work-in-progress that is lacking in the industry product pipeline. But the Deloitte article also discussed network characteristics, rights and talent management, as well as general governance issues. These are critical elements of open commercialization which co-exists with open innovation by necessity. These are means by which one can manage the open commercialization of therapeutics. The end goal is not about feeding industry R&D pipelines, however; the end goal is to lower cost, shorten development time, and put more life saving drugs into the under-served. This requires a broader sense of open commercialization than the industry currently acknowledges. This will require other tangible efforts to (1) building a productive conversation around, and the understanding of, our vast new dimensions of synthetic biology-based scientific options; (2) set standards and expectations, and open peer-reviews for open publications; (3) support annotation, analysis, and algorithm automation to make future developments more efficient; (4) involve all stakeholders to innovate and participate in downstream commercialization, and (5) provide ongoing community-driven, product support environment to ensure product safety and quality improvements. To achieve these goals, some fundamentals must be cataloged.

First, there are two important economic theories in an discussion of open commercialization: (1) Coase theorem (cost-benefit analysis) and (2) strategic complements and substitutes (Nash equilibrium) in game theory. Coase theorem generally states that a firm will expand until the costs of organizing an extra transaction within the firm becomes equal to the costs of carrying out the same transaction on the open market. So long as the transaction cost internally is lower, the firm will decide to keep that cost internal to extract value. Once the cost of executing a particular operation internally exceeds the cost of doing the same externally, the firm will consider outsourcing to extract value. Information cost is a large part of the overall transactional cost that drives the Coase type considerations. There are three types of costs of information: search cost, contracting cost, and coordination cost.[10] Strategic complements and substitutes are categories of market competition. Generally speaking, every product in the marketplace has substitutes and complements. A complement is something that is purchased together with the product itself. A substitute is another product that a consumer may buy when the first product is too expensive or otherwise unattainable. Usually the demand for a product is inversely correlated with the prices of its complements. When one strategic complement market participant changes its direction, the other player usually follow in the same direction. Strategic substitutes, works differently: when on firm sets a quantity below market equilibrium, the best responding firm will set the quantity of substitutes above the equilibrium.[11] These two economic and game theories helps us understand how players make their choices on the “spectrum of openness” given the market reality. These are theoretical frameworks as a starting point. The process of open commercialization in the social/legal context must also be carefully analyzed.

Socially speaking, voluntary standardization is a powerful tool to lower transaction costs and promote market efficiency. Standardization can also become a market inhibitor and can corrupt market integrity if left in the hands of oligarchies. The concept of open standards have been around in the U.S. and Euorpean legal/social context for some time now.[12] Global standard setting organizations (SSOs) have long adopted the “fair, reasonable, and non-discriminatory” (F/RAND) commitment requirements for their members to facilitate open collaboration and control anti-competitive behaviors.[13] Generally, SSOs and participants follow a set of principles to efficiently move forward with the market. These principles include: open meetings, consensus building, due process rights for members, open intellectual property rights (sharing), global standardization, open change, open documentation, open interface, open access, and community support.[14] A more recent phenomenon of legal standardization directly aimed at open innovation is Creative Commons. Creative Commons is a legal copyleft licensing structure designed for the public to facilitate sharing of documents and content. Creative Commons is GNU inspired, Creative Commons today makes available “flexible, customizable intellectual-property licenses that artists, writers, programmers and others can obtain free of charge to legally define what constitutes acceptable uses of their work.”[15] Creative Commons supports two categories of legal rights models: (1) public domain notices (or no rights reserved), and (2) licenses (some rights reserved). The licenses are divided into six types randing from “Attribution” only (allowing for commercial exploits and derivative works) to “Attribution-NonCommercial-NoDeriv licenses offering the most restrictive legal mechanism on the copyleft open spectrum.

Finally, an important aspect of open commercialization is the conceptual paradigm that it is an open spectrum[16] and the market participants have their own rational choices to make. Assuming Nash equilibrium[17] holds, rational players recognizing the industry pressure from expiring patents, the increased risks, cost, and development time for therapeutics, and assuming the Internet will continue to lower transaction cost enabling better cost-benefit analysis, participants will make more rational decisions based on Coase theorem, and the courts will refine its enforcement of the F/RAND terms: the synthetic biology-based therapeutics development will accelerate the cascade towards open commercialization.

Once critical mass is achieved, Open Therapeutics becomes a culture of new economics of therapeutics: all scientific knowledge and data are openly accessible and readily exploitable through common rights licensing enabling better treatments and better patients.

“Adoption at the most open end is still infrequent and slow, mainly due to concerns about intellectual property (IP) rights, adopting new [Open Innovation] OI-based R&D models, and cultural and management style issues. Nontheless, for biopharma companies, OI seems to be the way forward, as it appears to be a more cost- and time-effective way to bring drugs to market. In fact, several key trends will likely continue to drive the adoption of OI, especially at the most open end of the spectrum.”[18]

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Footnotes:

1. Eric S. Raymond, The Cathedral and the Bazaar: Musing on Linux and Open Source by an Accidental Revolutionary (referred to as “CatB”), available at http://www.catb.org/esr/writings/cathedral-bazaar (first presented in 1997 at the Linux Kongress). 

2. Paul, S. M. et al. How to Improve R&D Productivity: the pharmaceutical industry’s grand challenge, Nature Rev. Drug Discov. (2010) available at http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html

3. Goodman, M. Market watch: Pharma industry performance metrics: 2007–2012E. Nature Rev. Drug Discov. 7, 795, (2008) available at http://www.nature.com/nrd/journal/v7/n10/full/nrd2730.html

4 . R. Feldman & M. A. Lemley, Does Patent Licensing Mean Innovation? Stanford Working Paper Series, Paper No. 473 (2015) available at http://ssrn.com/abstract=2565292 (stating “patent licensing seems to be an activity almost entirely divorced from innovation, a fact that has troubling implications for the patent system as a whole.”). 

5 . Tufts Center for the Study of Drug Development, Cost to Develop and Win Marketing Approval for a New Drug is $2.6 Billion, (November 18, 2014), available at http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study); see also Nature Reviews, Drug Discovery, How to Improve R&D Productivity: the pharmaceutical industry’s grand challenge, http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html (2010). 

6. Copyleft is a play on the word “copyright”. It is designated to mean the right to freely distribute, copy, and modify versions of a work with the stipulation that the same rights be preserved in the derivative works. See GNU Operating System, What is Copyleft? https://www.gnu.org/copyleft (Last visited May 20, 2015). 

7 . The U.S. Patent and Trademark Office (USPTO) called for a “patent pool” approach in 2000. United States Patent and Trademark Office, Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? (Dec 5, 2000) available at http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf (“No single company or organization, however, has the resources to develop any significant fraction of the genetic information present in an organism. If proprietary information is not freely available or licensed in an affordable manner, researchers will be precluded from using these protected nucleic acids to develop new therapeutics and diagnostics. It would be, however, shortsighted for a patent holder to demand such a prohibitively expensive licensing agreement that would preclude anyone else from utilizing a patented invention. . . . By minimizing licensing fees and extending non-exclusive licenses, potential infringers were inclined to obtain licenses and the technology was therefore broadly distributed. . . .). 

8 . E.g., W H Lee, Oxford University, Open Access Target Validation Is a More Efficient Way to Accelerate Drug Discovery, PLOS Biology, (CC BY), http://www.plosbiology.org/article/fetchObject.action?uri=info:doi/10.1371/journal.pbio.1002164&representation=PDF (June 4, 2015) (“What was clear at the outset was that adhering to open access principles allowed cross-leveraging of public and private funds to explore novel areas of human biology in an organized way, thus reducing duplication and sharing the risks and costs that no single institution could bear alone.”); Deloitte, Executing an open innovation model: Cooperation is key to competition for biopharmaceutical companies, (2015) http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-open-innovation.pdf

9 . .g., Deloitte, Executing an open innovation model: Cooperation is key to competition for biopharmaceutical companies, (2015) http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-open-innovation.pdf

10 . D. Tapscott, A. Williams, WIKINOMICS, (Portfolio, 2006). 

11 . J. Potters & S Suetens, Cooperation in Experimental Games of Strategic Complements and Substitutes, The Review of Economic Studies, available at http://www.researchgate.net/publication/4867103_Cooperation_in_experimental_games_of_strategic_complements_and_substitutes, (Sep 2008) (“A straightforward but important implication of strategic complementarity is that a change in one player’s choice gives the other player an incentive to move in the same direction, whereas with strategic substitutability the incentive for the other player is to move in the opposite direction.”). 

12 . There have been many cases in recent years focused directly on SSO members’ FRAND commitments. Within the United States, Broadcom alleged that Qualcomm’s patent licensing policies violated its FRAND commitment to the European Telecommunications Standards Institute (ETSI). See Broadcom Corp. v. Qualcomm, Inc., No. 05-3350 (D. N.J. Aug 31, 2006). Nokia also filed suit alleging similar grounds and enforceable contractual obligations claiming that Qualcomm breached its contract by offering licensing terms that are not fair, reasonable, and non-discriminatory. See Nokia Corp. v. Qualcomm, Inc., No. 06-509 (D. Del Aug. 16, 2006). 

13 . A. Layne-Farrar et al., CEMFI Working Paper No. 0702, Pricing Patents for Licensing in Standard Setting Organizations: Making Sense of FRAND Commitments, (Jan 2007) available at ftp://ftp.cemfi.es/wp/07/0702.pdf

14 . K. Krechmer, Open Standards Requirements, (Feb 2005, originally published Nov. 1998), available at http://www.csrstds.com/openstds.pdf. See also OpenStand, Principles, https://open-stand.org/about-us/principles (Last visited May 18, 2015) (The OpenStan Principles are jointly affirmed on August 12, 2012, by the Institute for Electrical and Electronics Engineers (IEEE), the Internet Society (ISOC), World Wide Web Consortium (W3C), the Internet Engineering Task Force (IETF), and the Internet Architecture Board (IAB). The joint affirmation contributed to exponential growth of the internet and related technologies.); ITU-T, Definition of “Open Standards”, http://www.itu.int/en/ITU-T/ipr/Pages/open.aspx (Last visited, May 18, 2015). 


15 . H. Plotkin, All Hail Creative Commons / Stanford professor and author Lawrence Lessig plans a legal insurrection, http://www.sfgate.com/news/article/All-Hail-Creative-Commons-Stanford-professor-2874018.php (Feb 11, 2002, 4 AM, Special to SF Gate). 

16. See Deloitte, Executing an open innovation model: Cooperation is key to competition for biopharmaceutical companies, (2015) http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-open-innovation.pdf (referring to the “open spectrum”). 

17. Mathematician John Nash originated a theory proving the likely occurrence of several players making decisions at the same time cascading towards an equilibrium of rational decisions – if each player has chosen a strategy and no player can benefit by changing strategies while the others do not, then the current set of strategic choices are said to have reached a Nash Equilibrium. J. Nash, Equilibrium points in n-person games, Proceedings of the National Academy of Sciences, 36(1): 48-49, available at http://www.sscnet.ucla.edu/polisci/faculty/chwe/austen/nash1950.pdf; see also J. Nash, Non-cooperative Games, The Annals of Mathematics, Second Series, Volume 54, Issue 2 (1951), available at http://www.cs.upc.edu/~ia/nash51.pdf

18. Deloitte, Executing an open innovation model: Cooperation is key to competition for biopharmaceutical companies, (2015) http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-open-innovation.pdf.

Friday, May 29, 2015

Global Open Standards

The core of open communities is the freedom to copy, modify and commercialize. The methods and organizations are many. However, dispersed open communities can do very little on their own if their methods and organizational models are not connected. Collaboration and standardization are keys to their success. For example, a Linux software developer needs to work with hardware makers and customers to design its products. The parts manufacturer that depends on the automotive patent-pool will have to work with other parts manufacturers and suppliers to standardize production and assembly process. Therefore, one important facet of the open commercialization uniformity is “open standardization”. Conceptually, much of our attention so far has been on the definitions of “open”—what it is and who are the players. What about the process and ecosystem interoperability? In scientific terms: what about reproducibility confirming scientific progress? Compatibility standards are therefore crucial to the interactions between idea and science; between software and hardware; between supply chain and widget makers, between services, products and consumers; between components, companies and ecosystem. In other words, there has to be some level of shared language to enable communication and action.[1] In commercialization, this is economics; in pure science, it is the language of mathematics and logic.

To this end, some of the major global standard setting organizations (SSOs) have long adopted the “fair, reasonable, and non-discriminatory” (“FRAND”) commitment requirement for their members. U.S. based FRAND membership commitments drops the “fair” requirement in the commitment (“RAND”) to implicate legal commitment to offer intellectual property openly.[2] The basic concept behind FRAND/RAND is that a patent that applies to standards must be adopted on “fair, reasonable and non-discriminatory terms” to enhance pro-competitive character of the industry. It is, in essence, an anti-trust tool. Other than the SSO commitments, there are also a number of smaller industries or technology specific groups forming consortia and adopting their own standardization process. On the other end of the spectrum, we see relatively lose information standards developing communities including the open source software movement.[3] These SSOs, consortia, and loosely connected open development ecosystems struggle with the tension between design standards and emergence of technology. Commonly referred to as “standard wars” (e.g., VHS vs. Betamax), the tension is much of the recent debate and case studies.[4] In light of the standard wars, it is important here to pause and consider the conceptual overlaps and exclusivity between open innovation and open standards. This is because there is no clear indication that close standards is uniformly bad or that open standards works best with open innovation. The cost determination is a complex study on its own. We merely present the introduction to the problem here for future inquiries by more capable theorists.

Open standards and open innovation both refer to a process involving sharing or exchange of technology across firm boundaries.[5] Open standard promotes the adoption of a common standard while open innovation’s objective is to profit from the commercialization efforts. Therefore, it is conceivable to think open innovation take place in a regime of close standards. Notably, open standards usually produce more value by promoting more competition between implementations, which cuts down prices and improves product quality.[6] Open standardization also reduces risk by coordinate failures and reduces implementation costs. However, a close standardization model is incentivized by the seemingly larger pie. Additionally, the cost of close-standard approach is higher for companies that specialize in developing input technologies and licensing them to downstream implementation companies. On the other hand, vertically integrated companies that can burden the cost on the front end can establish market dominance by the closed-standardization option. The effect of this business bet is depended on a number of factors including the quality of their product and brand recognition. The key to standardization is that value is not created by the standardization artifacts themselves. Rather, value is created in the implementation process, a process which is conditionally necessary. Therefore, the choice is ultimately the determining factor. Choice aside, there is also much controversy in the enforceability of FRAND/RAND.[7]

Leaving the choice of standardization (open or closed) and the difficulty in interpreting the public commitments (FRAND/RAND), we turn to the common characteristics of open standards. According to the Open Stand, the paradigm of open standards is shaped by adherence to five (5) principles[8]:

1. Cooperation and respect for autonomy, integrity, processes, and intellectual property rules of the others;
2. Compliance with:
  • Due process, 
  • Consensus, 
  • Transparency, 
  • Balance (fairness), 
  • Openness; 
3. Collective empowerment through:
  • Technical merit peer-judged, 
  • Global interoperability, scalability, stability, and resiliency, 
  • Enabled global competition, d. Contribution to global community 
4. Accessibility and availability of standards based on and derivatives of FRAND/RAND; and 5. Voluntary adoption.

The United Nations special agency, International Telecommunications Union, has its own standards development organization called ITU-T. The ITU-T’s definition of open standard adopts similar principles but added two additional requirements: (1) quality and level of detail, and (2) ongoing support. Quality and level of detail requirement stipulates the sufficiency for development of variety of competing implementations and of interoperability. Ongoing support is required to sustain long term operability.[9] There are also various country specific laws regarding “open standard”. For example, the Indian government’s policy states mandatory characteristics to include: free or nominal fee limits for standardization documents, royalty free basis for patented standards, universal access and non-profit hosting entities, and localization.[10] Similar laws exist in a number of other countries (e.g., Italy, France, New Zealand, etc.,).

Another influential publication on open standards is written Ken Krechmere, Fellow of the International Center for Standards Research, University of Colorado. Krechmere enumerated ten (10) requirements that enable open standards:[11]

1. Open meetings,
2. Consensus,
3. Due Process,
4. Open Intellectual Property Rights
5. One World-Wide Standard
6. Open Change
7. Open Documentation
8. Open Interface
9. Open Access
10. Ongoing support.

The importance of open standards cannot be over looked. The Internet itself, in fact, is an open global model tuned to may open collaborations (e.g., the Polymath Project) enabled by open standards. Open standards are critical to communication and implementation of processes or plans. Without standards, we would not be able to execute joint global efforts in disaster relief, outbreak response, security cooperation, fight climate change, and conduct other important global initiatives. But open standards are only half of the tale. The other half is in open licensing terms. We shall see in the next subsection, there are already adopted models (e.g., Creative Commons). But on the spectrum of SSOs to loosely organized ecosystem platforms such as Linux, there are many ways of imposing contractual obligations to help the open ecosystem self-organize. The limiting agent here is simply the cost of initial legal services, but for that one can always turn to legal clinics at law schools or passionate pro bono attorneys.

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[1] T Simcoe, Open Innovation: Researching a New Paradigm, Chapter 8 (TBD), available at http://www-2.rotman.utoronto.ca/timothy.simcoe/papers/OpenStandards_IPR.pdf.

[2] A. Layne-Farrar et al., CEMFI Working Paper No. 0702, Pricing Patents for Licensing in Standard Setting Organizations: Making Sense of FRAND Commitments, (Jan 2007) available at ftp://ftp.cemfi.es/wp/07/0702.pdf.

[3] Simcoe.

[4] Simcoe.

[5] Simcoe.

[6] Simcoe.

[7] There have been many cases in recent years focused directly on SSO members’ FRAND commitments. Within the United States, Broadcom alleged that Qualcomm’s patent licensing policies violated its FRAND commitment to the European Telecommunications Standards Institute (ETSI). See Broadcom Corp. v. Qualcomm, Inc., No. 05-3350 (D. N.J. Aug 31, 2006). Nokia also filed suit alleging similar grounds and enforceable contractual obligations claiming that Qualcomm breached its contract by offering licensing terms that are not fair, reasonable, and non-discriminatory. See Nokia Corp. v. Qualcomm, Inc., No. 06-509 (D. Del Aug. 16, 2006).

[8] OpenStand, Principles, https://open-stand.org/about-us/principles (Last visited May 18, 2015) (The OpenStan Principles are jointly affirmed on August 12, 2012, by the Institute for Electrical and Electronics Engineers (IEEE), the Internet Society (ISOC), World Wide Web Consortium (W3C), the Internet Engineering Task Force (IETF), and the Internet Architecture Board (IAB). The joint affirmation contributed to exponential growth of the internet and related technologies.).

[9] ITU-T, Definition of “Open Standards”, http://www.itu.int/en/ITU-T/ipr/Pages/open.aspx (Last visited, May 18, 2015).

[10] Government of India, Ministry of Communications & Information Technology, Department of Information Technology, Policy on Open Standards for e-Governance, (Nov. 2010), available at https://egovstandards.gov.in/sites/default/files/Published_Policy_Framework_Document/Policy%20on%20Open%20Standards%20for%20e-Governance.pdf.

[11] K. Krechmer, Open Standards Requirements, (Feb 2005, originally published Nov. 1998), available at http://www.csrstds.com/openstds.pdf.

Monday, May 25, 2015

Open Therapeutics - Intro

“Open source is not magic pixie dust.'' – CatB[1]

What is “open”? A survey of the Internet reveals no precise definition or word origin. Much of the axiomatic bits of the concept “open” depend on what one means by “closed” or “shut”; and the proliferation of using “open” in the English language openly, pun intended, began in the 1800s.[2] History aside, “open” is used in this article to clear the contours of therapeutics. To begin, we first clear the foundation of what open source is generally. This will help us understand its many mirages of a single “open” vision for better global participations. From there, we will see the potentials of Open Therapeutics.

Introduction - A Historical Perspective

Open source is not a new concept. For example, Chinese traditional medicine during its 5,000 years or so history was loosely based on an open source and collaborative approach with reserved private commercial rights protected as trade secrets by those who have mastered their domains.[3] There were no pro-active governmental policies to assign proprietary control over intellectual resources. Collaboration and social norms found in the more flexible systems of open publication governed under Confucius traditions. Trade secrets passed down from master to apprentice governed the private affairs of responsible business conducts. It was a social enterprise model of sort idealistic nonetheless with its own set of problems.

Turning to the modern times (1949 onward), the Chinese government actively participated in the further opening of traditional Chinese medicine industry and published knowledge for public consumption. It wasn’t until recent years of global growth that forced China to turn its intellectual property focus on a more western style private property protection model. Some scholars created the perception that the proprietary control over traditional Chinese medical knowledge was non-existence.[4] This supported a mistaken view that China’s early technological advancement fell into decline in modern times due to lack of private intellectual protection.[5] The fallacy is assuming China had no regulatory regime to intellectual property in the commercial sense during its long history. Or that it was not conducive to innovation and commerce. But a look at China’s success with innovation and commercialization in its long dynastic history reveals the core of those false beliefs and fallacies. Attributing modern China’s early technological failures to this lack of western sense of individual intellectual property rights is a jump of inferences, one that should not go well with those who indeed understands the value of China’s own ways. Indeed, as we discover here, the open source approach is nothing new to China or the world. It is intuitive. Open source requires a sense of entrepreneurial responsibility and encourages a distribution of wealth based on meritocracy and equal opportunity—not monopolies. This aligns with Confucian values and a traditional sense of responsible business conducts. There is something to be gained from understanding better China’s historical open source approach then, but that is not the aim here. That’s a topic requiring its own devotion of time and attention. This article focuses its attention here on moving forward with an open approach globally and leaves the details of China’s anthropology to others.

Open Source Generally 

To begin then: open source communities today generally promote public access to products’ designs or blueprints (e.g., the Linux ecosystem). Additionally, they also promote universal redistribution of those designs or blueprints including subsequent improvements and commercial exploitations, by anyone using consistent common rights license terms voluntarily chosen by the users (e.g., CreativeCommons.org). Open source approach is typically disruptive and pervasive. It is disruptive in that it decentralizes the process of innovation and production. And it is pervasive because of the decentralized and distributed network. But the open source approach in economic progress is not limited to promoting disruptive innovation. In the economic sense, “open” does not mean “free” and profit opportunities are just as diverse as the closed intellectual property system. In the software industry, for example, commercialization occurs for open sourced models in layers of proprietary products or services (e.g., RedHat and hardware manufacturers like System76). Open sourced commercial applications today include: software and hardware,[6] electronics, beverages, digital content, medicine, science and engineering, architecture, fashion and others. Open societies and cultures now encompass: government and municipalities, ethics, religion, media, education, innovation communities, and arts and recreation. Although the open source communities are decentralized, they are usually pretty well self-organized and self-regulated. For example, various open standard and licensing structures exist that can easily be adopted cross platform, across industry sectors.[7] These common licensing agreements often ensure simplicity and applicability of legal rights aligned with the right kind of market incentives.

Open Source Communities and Commercialization 

Sharing technology for commercial purposes is not new. China, for example, has historically followed a somewhat open sourced approach; or at least the government did not attempt to regulate intellectual property.[8] Open science and journal publishing for the common progress has also been around since the 1600s. Open source commercialization is also not foreign to the United State. Henry Ford built his empire on an open model.[9] The United States aviation industry was built on an open patent-pool platform. Another notable global open platform is the Human Genome Project.

With respect to biologics and therapeutics commercialization, the U.S. Patent and Trademark Office (USPTO) specifically noted the open (patent-pool) approach:

“No single company or organization, however, has the resources to develop any significant fraction of the genetic information present in an organism. If proprietary information is not freely available or licensed in an affordable manner, researchers will be precluded from using these protected nucleic acids to develop new therapeutics and diagnostics. It would be, however, shortsighted pf a patent holder to demand such a prohibitively expensive licensing agreement that would preclude anyone else from utilizing a patented invention. . . . By minimizing licensing fees and extending non-exclusive licenses, potential infringers were inclined to obtain licenses and the technology was therefore broadly distributed. . . .”[10]

The public fear of a “closed” biologic or synthetic biology-based therapeutic commercialization model was the removal of valuable research resources from the public domain. This allows private companies leverage publicly funded research to privately benefit and also preclude others from participating and improving on the Human Genome Project. Some level of open licensing approach to commercialization is beneficial as the USPTO noted.

Open source achieved cult commercial status alongside of the explosion of Internet usage. Linux, the open platform, is developer favorited due its stability and community support. Some industry folks estimate 97% of the world’s 500 fastest supercomputers run some variant of Linux.[11] Android, your familiar mobile phone platform, is Linux based and covers 79.3% of the phones sold worldwide.[12] Open sourced software are now widely used and commercialized. The open business participants include independent software vendors, value-added resellers, and hardware vendors. Opens sourced concept now applies in frameworks, modules, and libraries which can be housed in proprietary for-profit products or models. In terms of funding, open models like Kickstarters and Indigogos of the world supplement the now global commercialization process. Also worth mentioning is the “Free Beer” open commercialization platform. Free Beer was developed in collaboration between the IT-University and an artist collective Superflex, both located in Copenhagen. The Free Beer receipt is published under a Creative Commons (Attribution-ShareAlike 2.5) license. This means anyone can use the recipe and branding to modify, brew and commercialize.[13] The license requires users to post the same ShareAlike license to their products irrespective if they commercialize. To date, Free Beer has funded artistic production in New Zealand and has active commercial users in Australia, Germany and Taiwan.







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Footnotes:

[1] Eric S. Raymond, The Cathedral and the Bazaar: Musing on Linux and Open Source by an Accidental Revolutionary (referred to as “CatB”), available at http://www.catb.org/esr/writings/cathedral-bazaar/ (first presented in 1997 at the Linux Kongress).

[2] See Random House, Inc., open – Word Origin and History for open, Dictionary.com, http://dictionary.reference.com/browse/open (accessed: May 17, 2015) (“Of shops, etc., ‘available for business’ . . . dates from 1824. . . . Open door in reference to international trading policies is attested from 1856. . . . Open season is first recorded 1896, of game . . . . Open book . . . is from 1853. . . . Open house is first recorded 1824. . . . Open road (1817, American English) originally meant a public one; romanticized sense of ‘traveling as an expression of personal freedom’ first recorded in 1856, in Whitman.”).

[3] See Heath & Sanders, eds., New Frontiers of Intellectual Property Law: IP and Cultural Heritage, Bloomsbury Publishing (2005) (Chinese traditional medicine, like Chinese martial art known as kung-fu generally, is taught from master to apprentice mostly. Apprenticeship selection is in part based on the master’s belief of temperament alignment with the teaching. However, the anthropologic study of traditional Chinese medicine and its 5,000 years of intellectual property regime is only beginning.).

[4] Heath & Sanders, at 3.

[5] Alford, To Steal A Book is an Elegant Offense: Intellectual Property Law in Chinese Civilization, Stanford University Press (1995).

[6] E.g., software platform: Linux, Ubuntu; hardware platform: Sun Microsystems’s OpenSPARC T1 Multicore processor, Tinkerforge’s open source hardware platform of stackable microcontroller building blocks that can control different modules.

[7] E.g., CreativeCommons.Org, http://creativecommons.org/licenses, (offers a spectrum of licensing choices for copyrights); GNU General Public License, http://www.gnu.org/licenses/gpl.html, (ensures copyleft for software licensing).

[8] E.g., generally, Heath & Sanders. The open source approach is pervasive in Chinese history. A more in-depth exploration of that topic is explored elsewhere.

[9] The early years of automobile development was controlled by a patent originally filed by George B. Selden. Using the patent, a group of capital monopolists forced car manufacturers to adhere to their demands. Henry Ford won a challenge to the Selden patent in 1911. Ford’s success in challenging the patent opened the market to collaboration. The Motor Vehicle Manufacturers Association was formed. The newly formed association implemented a cross-licensing agreement among all United States auto makers. The open framework stipulated that each company is free to develop its patents, but the patents will be shared openly without the exchange of money. By the Second World War, Henry Ford had 92 open patents and the association had over 500 open patents for the patent pool. See James J. Flink (1977). The Car Culture. MIT Press. ISBN 0-262-56015-1.

[10] United States Patent and Trademark Office, Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? (Dec 5, 2000) available at http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf. The USPTO noted two of the most profitable in the biotechnology area are those of Cohen and Boyer, which are owned by Stanford University. Stanford minimized licensing fees and extended non-exclusive licenses. This discouraged would-be infringers since the cost of obtaining a license is low. Instead of encourage infringement and patent trolling, the ease of non-exclusive licenses meant broad distribution and spurred further innovation. See also National Research Council, Intellectual Property Rights and Research Tools in Molecular Biology (1996), available at http://www.nap.edu/readingroom/books/property/5.html.

[11] Top500.org, TOP500 Supercomputer Sites: Operating system Family / Linux, http://www.top500.org/statistics/details/osfam/1, (Last visited May 18, 2015).

[12] TechCrunch, Android Nears 80% Market Share In Global Smartphone Shipments, As iOS And BlackBerry Shares Slides, Per IDC, http://techcrunch.com/2013/08/07/android-nears-80-market-share-in-global-smartphone-shipments-as-ios-and-blackberry-share-slides-per-idc/ (reporting based on International Data Corporation (IDC) Worldwide Quarterly Mobile Phone Tracker).

[13] Free Beer, About, http://www.freebeer.org/blog/about (Last visited, May 18, 2015).

Tuesday, April 14, 2015

#OpenTherapeutics

Mortal Man

The caterpillar is a prisoner to the streets that conceived it
Its only job is to eat or consume everything around it, in order to protect itself from this mad city
While consuming its environment the caterpillar begins to notice ways to survive
One thing it noticed is how much the world shuns him, but praises the butterfly
The butterfly represents the talent, the thoughtfulness, and the beauty within the caterpillar 
But having a harsh outlook on life the caterpillar sees the butterfly as weak and figures out a way to pimp it to his own benefits
Already surrounded by this mad city the caterpillar goes to work on the cocoon which institutionalizes him
He can no longer see past his own thoughts
He’s trapped When trapped inside these walls certain ideas start to take roots, such as going home, and bringing back new concepts to this mad city

The result?

Wings begin to emerge, breaking the cycle of feeling stagnant
Art by: Jyoti Thomas

Finally free, the butterfly sheds light on situations that the caterpillar never considered, ending the eternal struggle Although the butterfly and caterpillar are completely different, they are one and the same.

Lyrics from Mortal Man (Kendrick Lamar, To Pimp a Butterfly) 



Social Capitalism in an Open Economy - the synthetic biology narrative.

Altruism – The very first question to ask about social capitalism is whether altruism (being self-disinterested) is a moot point in a market economy? Or can there be self-disinterest for a purpose greater than the economic good that will render possible the offer of compromise to escape the prisoner’s dilemma or the tragedy of commons?

The first question assumes market economy and altruism are mutually exclusive. I leave you to that debate. The latter I think is possible in therapeutics – the “broad idea of everything done to protect or improve someone else's health”; because therapeutics is by definition self-disinterested. Also because of its anthropomorphic nature, an awareness of impact on the global ecosystem also presents opportunity for the economy of therapeutics to move the entire economic model into a more balanced state – by definition sustainable.

Monday, April 13, 2015

Synthetic Biology - The Irony That Needs a Narrative

“To inhabit a nomos is to know how to live in it.” - Robert Cover, The Supreme Court, 1982 Term – Forward: Nomos and Narrative. 

We are beginning to understand our interrelated world from an anthropomorphic center. The “normative” – a universal concept of acceptance, is ever increasingly the law. We are more and more reliant on the operations of law (rule by the law) when in fact it is no different than slavery – a form of self-imposed mental slavery. But when the law protects the dissent and preserves the language of progress, we have the rule of law and we are in control and inhabit a nomos – a normative universe. Isn’t this the hope for how law plays a part in our lives?

In a normative world, the “law and narrative are inseparably related.”

Every prescription is insistent in its demand to be located in discourse – to be supplied with history and destiny, beginning and end, explanation and purpose.” Robert Cover. 

Collaborative creativity works the same way doesn’t it? Law on the large scale where we are passive participants, the context is uncertain. Law on the large scale where we are active participants and the narrative is the understood context, certainty comes from a sense of fluid development from crowd intelligence. In the synthetic biology context, where markup language (SBML for example) and open-sourced annotation are community driven, passive participation translates to risks of automation driving innovation that can do more harm and good. But on the other hand, where the community driven initiatives understand the automation as the syntax of a synthetic biology in a narrative of anthropic biology, we are in control of the history and destiny, beginning and end, explanation and purpose of biologic adaptation in the context of evolution.

So, if we are to have an open universal discourse about our biology and shape its future as we do with math and science and our atomic bombs through synthetic discourse, then let’s have a constructive one and build on the past mistakes we’ve made with math – the language of our physical universe. A normative system or language master frame must both ground predictable behavior and provide meaning for behavior that departs from the ordinary. If we are to tinker with the unknown, then we owe the world a diligent and constituted approach. The Chinese word for this is “su-zhi” (素质) – or in English I think “diathresis”.

Su-zhi, or diathresis, depends on three things from which it stands to the test of time: that it is always “open” (open sourced, open accessed, open platform); that it is always evolving (process based and controlled); and finally that it is always altruistic. The open, evolving and altruistic synthetic biology language master-frame is part and parcel of a complex normative world. The master frame includes not only axioms and elements, but also syntax and mythos – narratives in which the synthetic biology is located and can act upon it.




Tuesday, April 7, 2015

The Adventures of an Old Bossy Troll

"If a man is not ready to risk his life, where is his dignity?" André Malraux, La Condition Humaine (1933).

Three travelers walked into an inn and handed the keeper ten silvers each. “We are traveling fools and we need a place to stay; we are decent folks and we want no trouble.” The inn keeper took the thirty silvers and told the bellhop to show the travelers their rooms. "No trouble follows I hope" the bellhop mumbled.

Half through the night, the inn keeper saw a red cardinal land on his windowsill. In these bad lands of frequent toil, this rare bird was a sign of better times ahead, or so he thought. He hadn’t seen one since his father was still alive and that was decades ago.

“The gods must have smiled,” he said to the bellhop who was falling almost to sleep, “it seems our guests either had brought this luck upon us or they had followed their luck here to my inn. Regardless, we will honor this sign of grace. Take five silvers from my safe and return them to the travelers as a token of our goodwill.” The bellhop counted the five heavy silvers into his palm. The cold silvers were heavy and tugged strangely on his legs as he walked those old creaking stairs. Just atop of the second floor, the bellhop stopped to ponder as gravity took its full toll.

“I have five silvers and there are three guests, how am I to divide this equally?”

Seeing that the guests may never know just how much was in his pocket now, five heavy silvers, he would just give one to each guest and keep two silvers for himself. Tomorrow is his birthday and he deserves a pint of aged sour ale. Win and win for all.

He knocked on each of the three guests’ door, told the same tale of tale of the red bird and good fortune for all. He handed each guest a silver from his pocket. Each guest gave the same gawk and gladly accepted the silver back into their palms. The bellhop hopped away with two heavy silvers in his pocket and dreamed of pints of old aged sour ale.

The red cardinal flew from the inn’s windowsill to the city near and found the old bossy trolls. The red cardinal told the tale of the inn keeper, the bellhop, and the heavy silver for the aged ale. The troll smiled to himself and mumbled back to the red little bird, “yet another riddle plagues the world.”

_________________ 

The city had been gloomed in darkness for a while now. Trolls had been trolls for the last few centuries and no one can remember much beyond the age of trolls. Sometimes, a glimpse of light would escape the toxic clouds above, and the old ones would muster some nonsense tale of old earth and green trees, people standing tall under the sun, and birds of all colors flew the clear sky and fish flew the sea; air afresh and water pure. Trolls would laugh because no one believes the living could be any other color besides brown, black, gray and the occasional red from blood and death. Only machines and neon signs took on the shades of yellow, blue, green, pink, and it was only the toxicity of color that the trolls could see. Nature, as the trolls believes now, is incapable of being or anything else.

The city had been gloomed in darkness for a while now. Now one seems to know what had happened but darkness took over. Everything now is a shade of gray and the sun hadn't been seen in years. Living things are rare these days other than the different mutated trolls; at least rare from what the eyes could see. But then again, most trolls don't have very much of an eyesight to begin with as they have adapted to the gloom and city life. They live on the edge of polluted mesh of land and spillage. They are guided by blinking neons and pitched noises to tell when they should eat, sleep, and pass into the abyss. Most of them have never seen a red cardinal in the city before. The only birds that flew the roof tops above the neon signs are crows. Red-beady eyed crows with blood redder than the trolls own bleed. A red bird is rare as the impossibles: sunlight and fresh water, both of which are forgotten by a forgotten people. The little red bird is a sore sight for the grayish world of the bossy trolls but the little red bird flew to the edge of one old troll’s windowsill. From the inn to the city, from the keeper to the troll, two windows and two different memories of what led to this world. The keeper kept his window open for the hope of seeing the little bird but this one bossy old troll had forgotten to close his window – a rare occurrence indeed.

To be continued 
(Copyright - Jin Kong, all rights reserved) 


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