Personalized medicine - a growing market

In March, I wrote about how personalized medicine is becoming an increasingly important concept in the biotechonomy worldwide. This development is now becoming more apparent and actors seem to be moving in this direction. One of the driving actors pushing this development certainly is insurance companies. Against this background, it is interesting to reflect upon how the U.S. health reform that President Obama signed into law last month. This is certainly one of the most comprehensive legislations concerning healthcare provisions in U.S. history. Obviously the health reform will have a tremendous impact on innovation for its many stakeholders, although some may feel more that they will reap more benefits than others will.

Health reform impact on new biotech business

April's edition of Nature Biotech (Vol 28 No 4) reports that "In return for supporting the bill and stumping up $90 billion in fees and discounts on Medicaid and Medicare pricing, the drug industry receives tax breaks, a biosimilars pathway and a massively expanded drug market." A key question for the Biotechnology Industry Organization (BIO) has been the exclusivity term for biosimilars, which in the reform was left intact at 12-years exclusivity. Another advantageous factor for pharmaceutical companies was that the industry managed to avoid suggested restrictions on drug price and drug importation. It is easy to conclude that all these factors will provide economic drivers for private biotech innovation. Much of the health reform, however, targets - a widely discussed subject in the U.S. - which is health insurance.

By enfranchisement of the many U.S. citizens previously uninsured, not only does the health reform provide societal benefits by progressing towards universality of healthcare access - but it simultaneously expands the U.S. healthcare market with more than 30 million people. For biotech and pharmaceutical companies such a market expansion is very good news and The RPM Report industry newsletter estimates that it could result in $115 billion in new business over 10 years.

How the bill drives the demand for life science innovation

Business models of health insurers in the U.S. have - ironically - been the most profitable when these actors successfully have circumvented the difficult and expensive burden of dealing with sick people. But the new bill prevents insurance companies from excluding coverage to children with pre-existing disorders and it forbids insurance to be dropped when a person becomes ill. I don't think it is far-fetched to say that this is somewhat of a game changer for these actors since their business models now will have to bear more of the financial risk and burden of the sick and vulnerable. This - at least to me - is very interesting from a business model building perspective but perhaps more interesting is the new demand that these actors will create for reducing costs associated with life science innovation.

From an insurer's point-of-view, a number of demands are likely to result;

• Innovations to diagnose patients at an early-stage
• Innovations to effectively prevent patients falling ill in the first place
• Innovations to reverse disease
• Innovations to effectively select patients that are likely to benefit from treatment at all
• Innovations to effectively select which patients that are the most likely to benefit from which drug

To me, the bullet point list above shortly translates into some of the most common biotech products such as diagnostic tools, screening methods, drugs, and vaccinations. But it is interesting that more or less all of these have a personalized medicine touch to them and it doesn't seem unlikely that this will be of the major effects of the new health reform. Naturally this will stimulate creation of new biotech assets such as biomarkers, drug targets and candidate inhibitors/activator molecules, which in turn will lead to new life science innovation (six of the 26 FDA approved drugs during 2009 are personalized medicines).

New development towards personalized medicine in the U.S.

Against this background, Medco Health Solutions provides an interesting business model to learn from. In February, it acquired the San Francisco-based genomic medicine company DNA Direct to strengthen its commitment to personalized medicine. The acquisition has similarities to the strategic partnership that was signed between CVS Caremark of Woonsocket and Generation Health, at the end of last year. Medco's aim is to help physicians and payors better match individuals to therapeutics and improve clinical outcome while saving money, by becoming a one-stop health service shop. Nature Biotech reports that several trends help draw pharmacy-benefit companies into personalized medicine. Firstly, there has been an explosion in the number of genetic tests. Medco estimates there to be a 1000 genetic tests, which in many cases the full benefits are not extracted due to inappropriate interpretation and lack of knowledge. A second factor - closely connected to the discussion above - is a growing interest from payors. CVS Caremark states that "To our clients, the insurance companies and self-insured employers, being able to provide tests that target drugs to individuals is of great interest". Thirdly, the main driver is cost reduction. The need to cut healthcare costs is most likely behind the surge in personalized medicine. PricewaterhouseCooper estimates that the core market for personalized medicine - diagnostics and therapeutics - is already worth $24 billion and expected to grow 10% annually, reaching $42 billion by 2015.

What will big pharma say?

What I find particularly interesting in all this is the predicament that this new focus on personalized medicine creates for pharmaceutical companies. Personalized medicine will transfer the control position for how and when drugs are used, something that used to be controlled by drug-label indications and physicians (in consultation with big pharma). Will big pharma remain on the sidelines or will they enter the arena?

Tobias Thornblad

(Contact via Twitter)

The digital economy is all about the content

Yesterday I and about 100 other people attended a seminar here in London, jointly arranged by Queen Mary Intellectual Property Research Institute (QMIPRI) and the Institute of Computer and Communications Law. The focus was the Digital Economy bill which is trying to address the ever-present issue of rights holders’ rights and possibilities for enforcement on internet.

However, the discussion yesterday circled much around if and how internet users could be cut off or suspended from their internet connection because they had been involved in illegal file sharing. The issue is an important one and I have trouble seeing the proportionality in restricting access to internet for what in many cases are small amounts of direct loss in sales revenue, which apparently is one of the suggestions in the bill. Jim Killock from the Open Rights Group, did also point out that downloading was more like trespassing than theft. This is true, but it is still illegal in the system that we have today. The discussion about changing the copyright system is partly a different and much bigger one.

I do however believe that the discussion we are having today about illegal file sharing and how to enforce it will pass over as a result of technical development and new ways of consuming content.

Carrot and stick
The industry representative, Richard Mollet of British Phonographic Industry (BPI), did go about quite hard on why enforcement was important. It was an expected point of view and he had a fair point in that enforcement is part of a system where that is the stick in one end and legal services, such as Spotify, are the carrot in the other end. Both sides need to exist.

Richard Mollet’s argument continued in the lines of that the rights holders were to scared to put out content in this uncertain environment without strong enforcement measures. This is where I do not agree.

Business model innovation
One of the first portable MP3 players was released some 12 years ago. Steve Jobs presented the first iPod in 2001. This is of course all known and the discussion about the rights holders not understanding the potential in the technology and that the old business model of selling content on physical carriers was and is outdated, that discussion is not new. What still surprises me however is the total lack of innovation in new business models and product offerings when it comes to rights intense industries such as publishing, film and music.

Intellectual property in the form of copyright is one of the most easily distributed forms of property. It lacks the need to be bundled with physical carriers, it can be packaged in various forms and the legal wrapping can be crafted in just any way.

To be fair, there are several services and platforms offering copyrighted material digitally and with consent from the rights holders. Spotify and Hulu are two examples of this.

I do however believe that there is much more that could be done, if just the interest was there. The technology is there, the consumers are there. The content is not nearly there.

The legal dimension
The issue has of course also a legal dimension, something the third speaker, Graham Smith of Bird & Bird, pointed out. It is far from certain from a legal perspective what is actually legal and what is not and how to enforce it. It is even harder from a consumer’s perspective to do this distinction. It is can be argued that this becomes the result if you let the development happen by itself and not being part of crafting the norms in the marketplace.

As I pointed out earlier, IP in general and copyright in particular are well suited to be developed in to new contractual models. The content can without any particular problem be packaged in just about any way. To look at the problem from the perspective of enforcement of content that has been distributed and copied by norms created by the users themselves, will probably almost always be messy. Especially when the behavior of consumers has been more or less accepted for over 10 years.

If the rights holders on the other hand are the directors on the distribution end and take advantage of the versatility of the content and distribution methods that could be used, I believe that the need for enforcement would be radically less and the revenues would be greater. It just takes someone to be brave enough to let go of the known models and revenue streams and focus on how to embrace the technology and meet the consumer need in a legal way.

Johan Orneblad
Follow me on Twitter

Business models and open IP platforms in personalized medicine

Personalized Medicine is a frequently discussed concept in healthcare thought to hold great value for the future. Since I am currently involved in a project where the technology could provide utilities for personalized medicine while at the same time co-authoring a paper on open IP platforms, I thought that a blog post that combines the two worlds could be interesting to write - so here it goes.

What is personalized medicine and why does it matter?

Medical practice relies on evidence-based medicine - the development of standards of care based on epidemiologic studies of large cohorts - a practice that has been around more than 50 years. The rationale is that a statistical approach to large cohort studies enables reduction of background noise, i.e. ignoring individual differences in the data points. Traditionally, individual care by a medical practitioner is built on the patient's family history, social circumstances, environment and behaviors - meaning that the doctor's personal observations, skills and intuition have been crucial factors.

Personalized medicine seeks to provide an objective basis for consideration of individual differences by the systematic use of genetic information about each individual patient to select or optimize the patient's preventative and therapeutic care. A simple example would be to be recommended to take a genetic test before being prescribed a certain drug to shows whether you have a genetic profile that makes you more responsive to drug A or drug B (used for the same disease). Obviously tremendous health-economic gains could also be expected where one example is hypersensitivity to gluten (for which Phadia is developing diagnostic technology) that currently takes an average time of eleven years to diagnose in the US according to Phadia.

Two examples of business models personalized medicine could enable in the future

1. Insurance model: Let's say that you consider buying a life insurance. Obviously, it is in your best interest as well as in your insurance company's best interest that you live a long and healthy life. With the latest advances in genomics your insurance company provides you with a voucher to get your genome sequenced and get access to a web portal where you can see your genetic profile - without the insurance company having any access to your data! This means that you can make dietary and lifestyle changes to improve your chances against your genetic predisposition toward obesity, diabetes, high blood pressure, dyslipidemia, etc. while lowering the risk for your insurance company. A win-win situation!

2. Diet model: Your latest cholesterol checkup suggests that you should reconsider your diet. At the dietist's office, your current diet is matched with your genetic predisposition to absorb nutrition. The results show that the diet is not the issue, it is your body that does not handle some of your daily intake very well. Consequently, your dietist recommends you to ask your doctor for drug X to enhance your nutrition absorption.

Personal Genome Project (PGP) - an Open IP Platform

The Human Genome Project provided the first drafts of nearly complete human genome sequences in 2001. This "generic" human genome sequence is now being used to advance medicine, human biology and knowledge of human origins. The available information, however, is not enough to determine individuals' risk profiles for disease. PGP - led by George M. Church, Professor of Genetics at Harvard Medical School - was launched to create a platform to do just that.

The cost to extract all the information during the human genome project was close to US$ 3 billion, which has decreased all the way down to US$ 1500 per genome by now (although most sequencing companies charge US$ 30-50k to sequence a genome). PGP aims - as its first milestone - to collect genomic information from 100 000 people together with their trait information (i.e. phenotypic data such as diseases). Sample collection is entirely built on samples contributed by volunteers all agreeing on their personal information being open for access to the public, mainly providing two utilities;

• Profiles of patients getting their genomes sequenced can compare their genetic profiles to the genotypes of risk profiles
• Statistical correlation of the data can provide novel gene-trait associations leading to new drug targets

The platform is open in multiple layers and several IP transactions take place in an open innovation fashion. Core R&D data making up the platform is - as mentioned - donated by volunteers by collecting cells that are then cultured in cell line libraries for future reference pooled together with written trait data collected via a virtual interface. Genomic data is available for download and cell lines are available to order. Analysis of the data is conducted through open source software to ensure that users can help develop the tools in case something seems to be missing. Sequencing technology and tools are inlicensed from commercial sequencing companies. PGP is conducted at nominal cost and most of the financing is raised through donations.

So what about IP ownership? The Material Transfer Agreement states that: " i) the Provider retains ownership and title to the Materials (including any Materials contained in any Modifications) and ii) the Recipient retains ownership and title to the Modifications (except that the Provider retains ownership and title to any Materials contained in any Modifications). The Recipient is free to file patent application(s) claiming inventions made by, or on behalf of, the Recipient through the use of the Materials, but agrees not to file any patent application containing a composition of matter claim on the original Materials or an Unmodified Product.".

To me, the PGP initiative exemplifies an extremely interesting example of an open IP platform with the potential to create value for both society and knowledge based companies leveraging diagnostic tools, drugs and preventative medicine and I may come back to do a deeper analysis in an upcoming blog post.

Tobias Thornblad

(Contact via Twitter)

Literary sampling creates German bestseller

A quite interesting story about plagiarism versus sampling in literature has unveiled itself in Germany over the last few weeks. My German might not be as good as it should but the journalists at the New York Times has helped me (and perhaps you) with the key elements of the story. Helene Hegemann a 17 year old writer and cultural wunderkind has obviously borrowed a bit too much from an earlier published book and forgot to tell anyone about it.

The publication last month of her novel about a 16-year-old exploring Berlin’s drug and club scene after the death of her mother, called “Axolotl Roadkill,” was heralded far and wide in German newspapers and magazines as a tremendous debut, particularly for such a young author. /…/

That is, until a blogger last week uncovered material in the novel taken from the less-well-known novel “Strobo,” by an author writing under the nom de plume Airen. In one case, an entire page was lifted with few changes.
From the New York Times.

Sampling and litterature
This could of course have been the end for this otherwise talented and promising German writer. Even though sampling by now more or less has been accepted in music industry, to use material from other writers has previously not been taken lightly.

The quite recent case with the Swedish writer Fredrik Colting using the character Holden Caulfield from J. D. Salingers’ book Catcher in the Rye is an illustrative example of how serious copyright and plagiarism is taken in the publishing business.

Mr. Salinger, who has not published any new work since 1965, has sued several times to protect his writing, including successful efforts to stop publication of some of his personal letters in a biography and to halt a staging of “Catcher” by a college theater company in San Francisco.
From the New York Times.

The interesting twist to the German story is that the author, Helene Hegemann, seems to come out on top after the initial discussion has settled. But it also raises interesting questions about copying and sources of inspiration as well as attribution; because the lack of attribution to her sources is one of the key discussions afterwards.

“I myself don’t feel it is stealing, because I put all the material into a completely different and unique context and from the outset consistently promoted the fact that none of that is actually by me,” Hegemann told the daily Berliner Morgenpost.
From The Local.

The future
I think we in the future will see more and more of mixing and borrowing inspiration from different sources. Not only because “everything is already written” but also because the technology makes it possible in a totally different way than for instance in the 1980’s.

This might seem as a cliché, but I also believe that it is important that we really think through how we should face this new era of easy access. Technology is developing and that is something we cannot hinder. I am quite convinced that we should not hinder the development either. It is therefore important to be prepared for the changes that are coming, both in our own mindset but also legislatively. I have no solution just yet, but I am quite convinced that we have much more to gain by adapting to the changing society that to try to keep some parts in a pre-computer-era state of mind.

Techdirt writes an interesting piece about the phenomenon and concludes:

In the same way that remixes and mashups often drive people to buy the original music, it seems like remixed/mashedup books can do the same. It may be a big cultural leap for those who think there is "a way things must be done," but it seems that the younger generation has other ideas.

But, and this might be where I eventually will end up personally, the fact that information is readily available and collaboration in the creative space can be both with and without the consent of all involved parties does not mean that it should be without rules to follow.

A first step in this is definitely to fully credit the sources used. Something which Helene Hegemann has had trouble with.

"I think there are good ethical grounds for giving sources for a book - and the fact that I neglected to do so reflects my thoughtlessness and my narcissism," Hegemann said in an interview with Die Welt, adding, "But for me personally, it doesn’t matter at all where people get their material - what matters is what they do with it.”
From Deutsche Welle.

Johan Orneblad
Follow me on Twitter

[Via Svante Weyler in “Godmorgon, Världen!" Sveriges Radio P1.]

Too much ownership creates gridlock

The Columbia Law School professor Michael Heller is perhaps best known for his book The Gridlock Economy from 2008. A book which popularizes the concept of "tragedy of the anticommons". He summarizes the thesis in a speech at Google 2008 as "When too many people own pieces of the same thing, no one can use it".

Gridlock Economy
His works on the Gridlock Economy comes from the time when he was working for the World Bank on post socialist property in the aftermath of the fall of the Soviet Union. The state had little experience in private property and ended up in many cases dividing the property in too small and conflicting pieces for anyone to be able to use it.

He published his experiences in the 1997 article "The Tragedy of the Anticommons: Property in the Transiton from Marx to Markets". From this came 2008 the book The Gridlock Economy. Heller writes in the abstract to the 1997 article:

"When there are too many owners holding rights of exclusion, the resource is prone to underuse -- a tragedy of the anticommons. Anticommons property may appear whenever new property rights are being defined. For example in Moscow, multiple owners have been endowed initially with competing rights in each storefront, so no owner holds a useable bundle of rights and the store remains empty. Once an anticommons has emerged, collecting rights into private property bundles can be brutal and slow. This article explores the dynamics of anticommons property in transition economies, formalizes the empirical material in a property theory framework, and then shows how the idea of anticommons property can be a useful new tool for understanding a range of property puzzles."

Modern gridlock
To understand the concept of the tragedy of the anticommons one can think of a piece of land divided in to so small pieces that in order for any one person to farm one acre he would need permission from hundreds of property owners. The cost and effort needed to gather all of those property owners and negotiate agreements with each would take more time and cost more than what it would be worth farming the land. In the terms of Heller this would be the opposite of the tragedy of the commons where for instance a pond is fished dry of fish since there is no owner managing the fishing in the pond.

The effects of the gridlock can rarely be seen even though they might be most significant. The New Yorker puts it as that

...the effects of underuse created by too much ownership are often invisible. They’re mainly things that don’t happen: inventions that don’t get made, useful drugs that never get to market.

One of the clearest examples of tragedy of the anticommons today is patent gridlock. The fact that there is in a specific are so many patents that you can not in any meaningful way use the technology without infringing on potentially hundreds or thousands of patents. This could be the way with for instance mobile phones which might be covered by some 5000 patents or new drugs which could have similar patent thickets laid out.

A similar situation is present when it comes to the documentary series "Eyes on the prize" from the late 80s. Heller talks about that the series which portraits the African-American Civil Rights Movement to a large extent is built on archival footage and contemporary songs, met problems when it was to be broadcast again and also released on DVD since it was too costly to track down each rights holder to get permission for the new release. Further on this can be read here.

One way to get around these problems with too fragmented rights can be to pool the rights. This is commonly used for patents, where it for many products would be an impossible task to evaluate each patent and track down it's potential rights holder. Collection societies such as ASCAP and BMI can provide the same function for copyrighted works, for instance music played on the radio.

But as Michael Heller concludes in a Newsweek article we still have a big challenge in the gridlock economy.

A survey sponsored by the National Academy of Sciences found that scientists now routinely respond to gridlock by becoming patent pirates, just like students who illegally download music. Commercial drug developers, of course, cannot risk disregarding competitors' patents. Many of the world's leading drugmakers simply redirect investment toward less challenging areas and innovation quietly slips away. The dearth of new blockbuster drugs should prod Big Pharma off its longstanding position that the existing patent regime must be defended no matter what.

Commons and Anticommons
The ideas of commons and anticommons are not new and Michael Heller does not claim to have come up with the concepts, though he has coined the term "tragedy of the anticommons". It is in this rich idea tradition the newly published anthology "Commons and Anticommons" edited by Heller, takes an in depth approach trying to understand the relation between overuse and underuse of property.

Heller has collected 35 articles over a total of 1,192 pages in two volumes. Contributors ranging from Aristotle and Carl Shapiro to the 2009 Nobel laureate Elinor Ostrom and Michael Heller himself.

To me, the book's contribution lays in that it collects most of the relevant research on the tragedy of the commons and anticommons in one place and thus challenges the reader to understand the broader picture as well as the specifics of for instance spectrum allocation and the fishing industry.


Johan Orneblad
Follow me on Twitter


Further resources

Audio and video
Authors@Google: Michael Heller on YouTube
Heller on Gridlock and the Tragedy of the Anticommons on Econtalk
Tragedies of the Gridlock Economy, an Economy Information Project conference on the Gridlock Economy hosted by George Mason University School of Law, with a discussion by Michael Heller and Richard Epstein. The conference is discussed here and some of the papers from the book Commons and Anticommons can also be found on the conference website.
Hearsay Culture interview with Michael Heller
Are patents and copyrights making innovation impossible? Out-Law Radio interview with Michael Heller

Books
Gridlock Economy on Amazon.com and Amazon.co.uk
Commons and Anticommons on Amazon.com and Amazon.co.uk

TEDxGöteborg

On Saturday, I was one of 200 selected applicants to attend the first TEDxGöteborg event, which is one of several locally organized TED talk events that the famous TED organization endorses (but does not organize). The event was a well-organized gathering of people from different backgrounds watching a number of live talks by inspiring thought leaders combined with a number of selected talks streamed from the TED website.

This was a full day event, which included the following list of speakers and performances;

• Ramnath Narayanswami
• Kajsa Sperling
• Julian Treasure
• Jesper Larsson
• Olof Kolte

-- Group discussion --

• Remmy Shawa
• Aimee Mullins
• Magnus Larsson
• Karolina Nätterlund

-- Visualization of audio: performance by Sönderbyggd --

-- Group discussion --

• Caren Steel
• Jacob Lagerqrantz

-- Musical performance: Göteborgs Indiekör

It was an interesting and varied discussion covering subjects such as biomimicry for solving technological challenges, new uses for bacteria, gender-based violence in Africa, creative destruction of industries through disruptive innovation, how to prevent desertification, how the perception has changed on disability, sustainability in transportation and food distribution. I think that the organizers had done an excellent job in creating an innovative atmosphere and the schedule was set with a number of coffee breaks for group discussion and debriefing of the covered topics.

There were several highlights but I want to mention two that were particularly interesting. Jesper Larsson talked about how he had redefined the concept of accommodation when being away from home. He has, together with sponsors and colleagues, started something that he refers to as a creator's-inn. Basically this is a way of providing free accommodation for artists when they perform their creative work away from their home city. Jesper and his crew have, among a number of examples he presented, built hotel rooms that should feel like "home". In these rooms there are clothes in the drawers for those who wishes to use them, music records to listen to, a wallpaper with a city map where visitors can recommend good restaurants to each other using post-its and even an online directory with suggested people to hang out with. These things are all possible through the collaborative effort of a number of altruistic soles that likes helping others. The beauty of this is that creates a "win-win-win-win situation" since the idea benefits creators (staying for free), local creative organizers (can offer guests accommodation), culture of the city (makes the city attractive to go to for creators), creative exchanges (more creators may be able to travel and perform at other places) and sponsors (e.g. IKEA that seemed to have contributed with some of the furniture).

Another highlight of the day was a talk given by Karolina Nätterlund who talked about how knowledge from biology may be used to solve everyday technological problems by imitating nature. Karolina who is a former student from the engineering design program at Chalmers has also started the company Equidesign, where she focuses on bringing in biologists to brainstorming sessions about solving commercial problems. There must be countless interesting features in nature (just think about spider webs or different forms of venoms) that could be used as an interdisciplinary problem solving (Biomimicry) approach to everyday problems.

Tobias Thornblad

(Contact via Twitter)

Ford and Geely closer to agree on Volvo IPR

The talks between the Chinese car manufacturer Geely and Ford seems to have gotten a step closer to actually closing the deal on Volvo Cars. According to a press release on November 27 the key issue about how and in what form the technology is to be part of the transfer has been solved.

For acquired Volvo Cars from the Swedish automotive company Volvo some 10 years ago. Volvo AB still manufactures trucks and heavy vehicles under the same brand name.

Ford has for some time had negotiations with the Chinese car manufacturer Geely about selling Volvo, a deal estimated to be worth some USD 2 billion. Even though the brand itself probably adds up to a great deal of that price the actual technology to build up the cars have been one of the key issues in the negotiations. For one, Volvo has been tightly integrated in to Ford and as such most likely shared technology, and IP, across both companies. This has been an issue in the negotiations, since Chinese companies are not as highly regarded when it comes to respecting IP. The current integration in to Ford has therefore created some issues, now when it is assumed Volvo will operate independently as an own entity.

The press release yesterday stated that a solution might be close at hand.

"Volvo will retain ownership over key technologies and IP that it has developed and will retain access to all Ford IP that Volvo plans to use to implement its business plan," and that by owning Volvo Geely would get "access to a significant suite of IP, including Volvo's safety and environmental IP."According to Reuters.

I think this is interesting for two reasons.

1) The automotive industry is to a large extent driven by innovations and the IP portfolios and teams of engineers are key assets that Chinese companies have had a hard time keeping up with. By acquiring Volvo Geely will get access to many interesting technologies, possibly both to be deployed in vehicles with the Volvo brand but also in other brands.

2) That the IP owned bu Volvo will come with the purchase might not come as a total surprise and will possibly be quite easy to handle in the long run. The issue which to me is a bit less clear is that Volvo will get access to IP for the planned implementation of the business plan. What is included, for how long and to what extent. They will possibly/hopefully define it in a better way in the final contract, though one can not be too sure.

I recollect the now settled dispute between eBay and Joltid around the fundamental technology for Skype. It turned out that it was not included in the purchase of the company. I might not see as fundamental technology retention in this case, but there might be some core IP kept in Ford's control to surface in a couple of years time when the cars not planned in the business plan are a reality. Perhaps impeding Volvo and it's owner in efforts challenging established US companies (read Ford).

Johan Örneblad
Follow me on Twitter.

Access to plant genetic resources in the public domain

I had an interesting discussion a few days ago with prof. Carl-Gustaf Thornström ( Division of legal affairs, finances and H&R and dept. for Plant Biology and Forest Genetics), executive director of the Sida sponsored programme: Genetic Resources and Intellectual Property Rights (GRIP) and member of the CGIAR Genetic Resources Policy Committee. The discussion was centralized around how intellectual asset management (IAM) in the public sphere differs from IAM in a private- or academic setting, where prof Thornström has close to 30 years of experience in the former. One of the main differences resides in the fact that asset portfolios of plant genetic material are intended to be held and managed in the public sphere as a benefit for society without any dependencies, biases or promoting any self-interests. Beneficiaries in this public domain constitute a multi-stakeholder consortium with actors from everything between private multinational corporations, non-profit organizations to individual farmers in third world countries.

Who's responsibility should it be to maintain these portfolios of gene diversity?

This question easily slips into a philosophical discussion about power positions between state versus private capital. However, my intention is not to go into a political discourse but rather explain why management of these portfolios are in the interest of more stakeholders than just the private sector. Prof Thornström uses Sweden as an illustrative example (in the Swedish University of Agricultural Sciences' blog: Forskarbloggen) for the purpose of showing the importance of maintaining plant breeding in a sustainable way. The Swedish state co-financed national plant breeding until the end of the 90's when it left this responsibility with the only Swedish plant breeding company - Weibull-Svalöf. In 2006, due to fiercer international competition the company had to discontinue its breeding of a number important annual crops, e.g. rye, malt barley and potatoes, which severely weakens Swedish agriculture for these crops. This is because of the high environmental dependence (e.g. hours of sun light, soil, weather, temperature, etc.) of each crop that makes a plant variety bred in south of Italy unsuitable for the conditions in Germany, which even applies between varieties bred in the south of Sweden and the mid-north. In the long-term, this could mean that traditionally grown crops such as rye would have to be imported from countries where plant breeding is still being carried out since domestic yields wouldn't be price competitive compared to international equivalents.

How open is this public domain?

Well, it depends on the perspective from which you are approaching this. It may be argued that assets in this domain are fully accessible and that this provides an open platform contingent upon that the accessing party accepts terms and conditions that this material may be attached to. However, contemplate the Convention of Biological Diversity (CBD), which was adopted in 1992 in Rio de Janeiro. The convention provides national sovereignty over genetic resources and access conditions for other sovereign parties. This means that there are different procedures and rules to access material in the many countries that are parties of the CBD. Can genetic material still be thought of as being openly available in a public domain? In 1996 in South America, the Andean Community founded a close to draconian legislation and access conditions for foreign scientists wishing to conduct research on genetic material in this region, which may severely inhibit valuable research. Other countries have bureaucratic procedures that takes more than 5 years from the time of application (compare this to Hernando de Soto's findings of how long some of developing countries' property systems take in the Mystery of Capital) which obviously risks leading to illegal material exchanges that could have dramatic repercussions for universities and others.

Other legislation in the genetic policy landscape to take into account include;

• TRIPS, adopted in Marrakesh in 1994, provides a minimum IP protection standard for biological matter such as plant varieties, microorganisms, and microbiological processes.

• ICGTK was set up in 2001 by WIPO to discuss IP issues relating to access to genetic resources and the protection of traditional knowledge, including disclosure requirements in patent applications.

• UPOV provides legal protection for plant varieties fulfilling the NDUS criteria (new, distinct, uniform, and stable), while including a breeder’s exemption and farmer’s privilege.

• The International Treaty on Plant Genetic Resources for Food and Agriculture, adopted in Rome in 2001, provides a multilateral system of access and benefit sharing under a revised material transfer agreement (MTA) in relation to some 35 defined crops.

• The Global Crop Diversity Trust, set up in 2002, is an attempt by the Food and Agriculture Organization (FAO) of the United Nations and the World Bank to establish a trust fund for global ex situ collections of germplasm of relevance for food and agriculture.

• The Cartagena protocol, adopted in Montreal in 2000, provides rules for the transfer of genetically modified living organisms across borders.

• In 2002, the CBD adopted the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization. A voluntary supplement to the CBD, the Bonn guidelines offer basic information about the rules on access and concrete procedures (or protocols) to follow.

(The list above - emphasis has been added- is borrowed from CG. Thornström's article Access and Benefit Sharing: Understanding the Rules for Collection and Use of Biological Materials, chapter 16.2 (or p.1462) in the IP Handbook)

Conclusions

As the legislative landscape is growing denser (alongside patent thickets), I think that there will be a need within the agribio sector for open platforms where stakeholders from all spheres can come together and form clearing house mechanisms together to ensure that agricultural biotech innovations/technology and valuable germplasm are available and accessible on a broader level. Not the least for economic development and welfare! One of the key challenges, among many, will be to ensure that this can be achieved at a high enough level since the CBD evidently will require national anchoring. This will take a long time if this is to happen solely from the wills of people in an administrative and governmental arena, and I therefore think that it will be crucial that there will be some sort of push from academic institutions and private entities to speed up this process. During CIP FORUM 2009 we spoke about how research utilization and company output will be increasingly dependent upon effective open & early innovation, and this is a case-in-point where the two come together. The future of genetic access is ours to shape!

Tobias Thornblad

(Contact via Twitter)

Monetizing R&D intangibles

In my job, I work quite a lot together with medical doctors and professors carrying out research projects where some form of commercialization potential has been identified. Often it is my role to come in as a business developer and by an initial intellectual asset due diligence process distinguish which of the R&D building blocks that are truly value creating and how these potential values may be extracted. As a part of this, I get to see quite a number of grant applications and discuss how these can be re-designed for effective communication of a project's value with a basis in their intellectual assets.

Tacit valuation model for early stage research

I think that it is interesting to think that a grant reviewer will (although probably to a large extent tacitly and indirectly) value the underlying potential of research activities and new technologies, and eventually determine whether the sought amount is a feasible investment. Certainly there are parallels with such an implicit valuation model to patent valuation where a challenge is to identify suitable metrics for estimation of the value of a technology.

So what are some of the soft metrics that could determine the value of a technology for a grant reviewer?

Value of scientific excellence

Most grant reviewers probably would like to say that their sharp eye spotted the Nobel Prize candidate long before its nomination and that it was that particular early-stage grant that enabled the discovery. However, in reality scientific brilliance may be difficult to determine. Especially so, if the grant reviewer's expertise happens to be in another area than what the application is describing. One way to "outsource" this determination is to rely on citations in scientific journals. A citation count corresponds to the number of times other research papers reference the results of a publication-of-interest. But it is not self-evident how to value citations solely based on the number. How would you distinguish between?

• A higher number of citations due to a rather basic discovery
• A low number of citations in highly respected journals
• A high number of citations but none within the same research area
• A low number of citations

Value of personal brands

Another aspect that is often quoted as high perceived value in the eyes of grant reviewers is to have successful competences associated to a project. Metrics to measure the significance of human capital include;

• Curriculum Vitae (e.g. previous positions and experience)
• Academic titles
• Citations (e.g. H-index, citations per year, total citations)
• Publications (e.g. how many, in which journals, co-authors)
• Previously raised financing through grants and commercialization

Value of association to other trademarks

Association of research projects with other entities and initiatives can be interpreted as different identities and perceived values for projects. Here are some examples;

• Market closeness: Letter of intent from a collaborating company
• National/regional importance: Proof of participation in research platform (e.g. IMI, FP7)
• Societal value: Grant approval letter from major foundation (e.g. B&M Gates Foundation)

Value of legal clarity and technology transferability

For grant reviewers that are interested in seeing research results being utilized and commercialized, value metrics may include;

• Patents (e.g. number of patents, coverage, assignee/inventorship)
• Agreements (e.g. consortia agreements - ensuring that rights to results are governed)
• Freedom-to-operate evaluations

However, there are also newer metrics in the knowledge economy such as quotes on how many registered unique users one's database has. Other interesting metrics could for example be generated in open innovation projects such as Folding@Home (where a complex biological computation is distributed on 250 thousand CPUs of personal computers) where the project could claim to have access to 25 000 CPUs (assuming 10% usage of each CPU).

Will we see the numbers of "Digg it"-clicks, twitter hits and LinkedIn connections in future grant applications as metrics for societal interest and networks?

Tobias Thornblad

(Contact via Twitter)

Intangitopia Picks - Google books

Intangitopia has previously written about the Google Books project and its effort to digitize all books available. The full scale of the project is probably not seen yet, especially since Google still is in legal dispute around the digitization efforts. To me it seems quite inevitable that they will be able to digitize most books, at some point, the relevant question will then be who can get access to the information and on what terms.

The Economist has interviewed Paul Courant, librarian at University of Michigan, on the subject and the impact for research to have, at least, all orphan books digitized and searchable. One of the points he makes is that the book project gives different universities access to each other's libraries digitally, for the benefit of research. But as he also points out, Google is not doing this only to be nice, but rather to get more eyeballs to browse their webpages and adverts.



They have recently given On Demand Books access to their digital library to print books for customers. This posts interesting questions to how other actors in the digital/physical distribution of books should react. Even though the currest deal with On Demand Books only covers orphan book, books without rights holders, it is most likely that it at some point also will cover books with rights holders.

The role of the university - in the Future of Early Innovation

Ulf Petrusson opened up the second day of the Early Innovation and Knowledge City/Region track at CIP FORUM, on Tuesday afternoon. The theme of the talk was about how innovation and openness can be safeguarded in research platforms. The full panel included;

Arundeep Pradhan, President, AUTM and Oregon Health Sciences

Boo Edgar, Chairman, MedCoast Scandinavia and Director, GIBBS

Karen Hersey, fm Senior Counsel IP MIT and Professor, Franklin Pierce Law Center

Michael Cleare, Director TTO, University of Pennsylvania

Philippe Cupers, PhD, IMI European Union

Ulf Petrusson, Professor of Law, University of Gothenburg and Director, CIP

IP as discussion topic is often focused on the commercialization aspect on the underlying technologies but this was a discussion focused on the ability to use instruments such as IPRs, policies and technology transfer functions to stimulate research and knowledge dissemination. Universities face major challenges as increasing complexities of new technologies demands more extensive developments before research results can be readily utilized and provide societal benefits. In order for universities to not being risked to be blocked further down the line of the collaboration, there is an increasing need for intellectual asset management capabilities (e.g. for managing research processes, research collaborations, contract research, research funding, development processes, project selection, etc.).

A model was also presented where the role of the university was tracked over time from being a pure educational platform based on solely contributing to the public domain. Over time, this has also started to incorporate an increasing licensing and collaboration model where its responsibility has also started to include supporting the industry and society by transferring its research. As the importance of providing societal value has increased the university has also engaged in more entrepreneurial activity through a venture creation model. As all of the functions above have been incorporated, a new role for the university has emerged - the Intellectual Asset (IA) platform university.

Tobias Thornblad

(Contact via Twitter)