Two panels (at least) mentioned it explicitly: the panels on Openness and on Innovation and Access for Medical Technologies. I’ll try to summarize what was notable:

Openness: Tim Hubbard of the Wellcome Trust:

• Some funders are starting to require that their grantees develop data access policies.
• There is an effort to develop a “PubMed Commons”, building on top of PubMed Central, adding e.g. features for comments and tags.
• Recommendation: Policies for OA to publications and data should become standard for research funders.
• There are some problems remaining:
  • OA to publications: name control (e.g. recognizing that “Doe J Q” is the same person as “John Q. Doe”), permission problems (e.g. barriers to data mining)
  • OA to data: cultural attitudes (e.g. how to give credit/attribution, adjusting to new competitive environment — people interpreting your data before you can), practical problems (e.g. format standardization)
• The focus of the presentation was on the conflict between openness (e.g. OA to genetic data) and privacy. Even supposedlu de-identified data can be re-identified, posing a challenge to OA to data on human subjects. He suggested a solution where researchers could have free access to the complete data (with full granularity), but without handing it out in raw form: researchers could load programs onto a trusted broker’s computer, which would execute the algorithm and provide anonymized results. This would not be a perfect protection of privacy — there is still the possibility of leaks and ways to game the system — but it would make it easy enough for legitimate researchers and hard enough for malicious uses so as to discourage most of them.

Comments:

• How many funders actually have open data requirements for their grantees? This seems like a good topic for the Open Access Directory: collecting information on funder policies, as well as on projects and institutions with open data policies for their intramural researchers. This is such a nascent space that there’s a big role for sharing best practices here.
• I hadn’t previously heard of PubMed Commons — I’d certainly like to hear more about it.
• It was striking how much he presented OA to publications as a done deal — even the problems he mentioned had to do with leveraging OA for extra value, rather than the problem of getting OA to begin with. (This is especially striking since Wellcome’s own mandate after 8 months still had less than 30% compliance. I haven’t seen more recent numbers, but Wellcome announced they would start audits to increase the compliance rate.)
• Privacy is an important question when it comes to sharing data on human subjects. Unfortunately, human subjects is one of the areas where data is most critical to share, e.g. to better understand epidemics and more quickly develop responses. Hubbard’s proposal is an interesting one, and it’ll be interesting to see if anyone pilots such a model. At the same time, I think a dedicated person probably could still game such a system where motivation is high, e.g. seeking private data of a celebrity or public figure. Aside from the general damage of such breaches, they set back the research enterprise itself because people are less willing to share data with researchers. So I think there’s room for an additional layer of security, where researchers have to apply for access (which can be revoked if the system is misused). This will better give the public a sense that their data isn’t just “out there”, but there are legitimate filters to keep out bad actors. Inevitably there still will be breaches and leaks, but it’ll seem like more is being done to prevent them. There will also need to be legal and cultural elements to this too (as Hubbard also suggested), such as an effective framework for redress when private data is abused. It’s also important that the authorization system not evolve into something exclusionary: any legitimate research by a trustworthy investigator should be promptly granted access. Unfortunately, the structure is then already in place for charging subscriptions; particularly where databases are expensive to generate and maintain, there may be a temptation to do so.

Openness: Heather Joseph of SPARC:

• There is a growing but limited awareness among policymakers of the benefits of openness. We need policies to remove both access and permission barriers to research. So far most uptake of OA policies has been in the biomedical arena. There’s pushback from opponents even there.
• There’s a recognition that data is valuable and needs to be appropriately managed. But we need to move from mere “data management policies” toward open access to data.
• So far, the signs from the Obama administration are promising. The administration espouses openness (in general) and some key appointments are strong.
• Recommendation: Make OA policies throughout the government, e.g. through executive order or regulation, but not as part of IP policymaking.

Comments:

• I think this is the first time I’ve heard the suggestion that the U.S. adopt OA policies for its publicly-funded research via executive order or regulation. There’s some sense to this, I think: it has to do with the internal management of the government and doesn’t run afoul of any legislation. I see two challenges, though. First, other funding agencies don’t have the pre-existing cyberinfrastructure into which grantees could deposit their articles; funding for that has to come from somewhere (e.g. through the appropriations process). Second, as we saw with the “Fair Copyright in Research Works Act”, there’s some opposition to these policies in Congress: some members might take issue with executive policymaking — but I think that’s a fight we could win, especially with the administration on our side.

Openness: Questions:

• Bruce Perens: What about other IP on publicly-funded research, e.g. Bayh-Dole? Joseph: We need to draw a distinction — we’re focusing on access to the literature and data.
• Jamie Love: If there was an access to knowledge treaty, what specific issues would you want to include? Hubbard: OA data and literature; mandated protection of private data; greater openness to economic data; standards for government data. Joseph: OA literature and data.
• Jonathan Band: Some countries hold copyright on government works (Crown copyright — unlike the U.S.) — this needs to change.

Comments:

• There’s a little surge of discussion lately about patents (and the management thereof) on publicly-funded research, e.g. owing to developments in India and South Africa. It’s an issue I’ve been involved with before, and I’m sympathetic toward efforts to improve the current system. There are some common principles, but they’re also very different questions. Specificity, so we can understand well what we’re discussing, is important in policy, and especially in these areas, which are often so challenging to understand. So: OA can advance without affecting the Bayh-Dole system; the Bayh-Dole system doesn’t necessarily do harm to OA.

Innovation and Access for Medical Technologies: Anthony So of Duke University:

• Recommendation: Public access to full clinical trial protocols and regulatory submissions.

Innovation and Access for Medical Technologies: Judit Rius of Knowledge Ecology International:

• Recommendation: Innovation inducement prizes should include an “open source dividend” to encourage open sharing of knowledge, data, material, and technology
• Recommendation: Governments should support the World Health Organization’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (as adopted in World Health Assembly resolution 61.21), including open access to scientific articles and data from publicly-funded research

Comments:

• The FDA Amendments Act requires the registration of clinical trials and reporting of some basic results on the OA site ClinicalTrials.gov. But the “basic results” really are pretty basic — there’s room for broader disclosure (and OA) here.
• KEI’s “open source dividend” idea is an interesting one — which may have application outside the area of inducement prizes — and one I’d like to hear more about.
• OA advocates shouldn’t forget about the WHO’s Global Strategy, which includes very favorable language toward OA. It’s worth mentioning when speaking with funders, policymakers, researchers, etc. Unfortunately, the language as adopted in WHA 61.21 only said that states should “strongly encourage” publicly-funded researchers to make their manuscripts OA, retreating from earlier language that states should “require” it. Still, as we saw with the NIH policy — maligned as the earlier voluntary policy was (and rightly so), it laid the groundwork for a mandatory policy (establishing a repository, starting to educate researchers, gathering evidence on the policy’s impact and effectiveness, building a constituency in favor of OA, etc.). We have a document representing global consensus that governments should support OA: we should remind people of that more often.

• Setting the Stage
• Openness
• Patents and Innovation
• Copyright Policy
• Patent Reform
• Innovation Inducement Prizes
• Enforcement of Intellectual Property Rights
• Innovation, Creativity and Access to Knowledge: Software and The Internet
• Innovation and Access for Medical Technologies

I’m not sure if the audio, video, or slides will be posted online — if they are, I’ll link them from here at a later date. Also send me links to other blog or press coverage of the event.

There were good and less-good aspects of the conference, but I’m too exhausted to say much other than this:

When Lawrence Lessig announced he was shifting focus away from information policy, some people were concerned it might leave a vacuum of leadership in the field. With all the luminaries and young leaders at this conference, from across Europe and North America, doing remarkably varied work, it’s clear there’s no lack of leaders or good ideas.

The only question is whether policymakers will listen. After this conference, I’m hopeful.

in most circumstances, prizes don’t replace patents
circumstances appropriate for prizes are limited
can be complex to administer with non-trivial administrative costs
as we consider & implement public prizes, we need to build in a system to evaluate effectiveness

prizes for achievements after the fact — don’t necessarily help

prizes ex ante — do induce effort/attention direction at specified goals

discrete prizes: designed for a particular objective; many of these, long history
series of prizes: Innocentive, X Prizes
program of prizes: Royal Society of Agriculture
system of prizes: 1 proposed

Royal Society of Agriculture: 100 years, awarded prizes & metals for innovative farm machinery
both monetary and honorific
each year, society targeted areas and announced in advanced

system: Medical Prize Innovation Act
awards based on improvements in public health
designed to produce open competition in production and distribution — patents unenforceable after award of prize

effectiveness of prizes:
purposes: achieve technical objective
encourage participation, e.g. of non-traditional participants [participatory science]
encourage unorthodox approaches (cf. limits of peer-review system)
often designed to encourage collaboration and team-building
often designed to educate & inspire non-participants [participatory science]

little scholarly evaluation of prizes
Lerner re: royal society: investments of winners 3x monetary prize; medals more attractive than monetary prizes

many rules to be decided
have to promote existence of prize to spur participation

what topics work?
ones where the market isn’t serving
but doesn’t work well for basic science

judging and establishing rules is tricky

there is a larger role for prizes than are currently used, but it’s not unlimited
don’t underestimate the complexity and cost of organizing prize contests

Next is Jamie Love of Knowledge Ecology International.

recommendations:
de-link R&D incentives from prizes
create sustainable institutions to increase the supply of global public goods

deficits in current funding system
only 10% of new drug approvals in 2007 were priority drugs

Next is Michelle Childs of Médecins Sans Frontières:

there is an absence of needs-driven research
lack of drugs, diagnostics, vaccines
antiquated or ill-adapted tools

e.g. diagnostic technology for TB as used not changed since 1800s; 50% failure rate

WHO IP report: patents not relevant or effective for needs without a market

WHA 60.30: needs-driven R&D; address link b/w costs of R&D and price of medicines, etc.

[link b/w science-innovation-entrepreneurship -- attracting participation in general, but especially to needed areas]

recommendations:
need targeted funds
support WHO proposal by Bolivia and Barbados
need new models for i+a
de-link R&D costs from prizes

change 1: created central patent court — had been significant divergence of results among different circuit courts
so central court fell in love with patents

change 2: patent office went from cost center to profit center
led to pressure to increase patent grants — also increased litigation

truth 1: there will always be mistakes
unrealistic to expect no “bad” patents

truth 2: there will always be more chaff than wheat
most innovations are worth little

truth 3: incentives matter
lower examination standards -> more applications -> fewer examiners/patent -> poorer examinations

truth 4: information flow is critical
examiners will always have limited information

needed reform: getting more information
opportunity to challenge before costly court system
current system is stacked against opposition

needed reform: address litigation
address issues with jury trials

currently:
congress: IT wants one thing, pharma wants another
USPTO: some progress, but limits to self-policing
courts: eBay, KSR, Bilski

why should you care: patents still relevant

Next is Dan Ravicher of the Public Patent Foundation.

everyone can agree that patent systems can be made better
i don’t care about the outcomes, as long as the processes are fair
who are the stakeholders: patent holders, patent attorneys, patent officials, public
we should always treat opponents with respect

reforms:
have a fair process

make quality job #1
not quantity
remove the examiner quota system
reform the continuation system
introduce more points where patents can be challenged (could go to pure registration system, with no assumption of validity upon suit [but wouldn't this create a massive amount of uncertainty?])

create fair use for patents
start negotiating point: remove injunctions as a remedy to infringement (just set a fair price for compulsory license — if infringer can’t pay, de facto injunction)
research: no research should be precluded
civil liberties

Next is Philippe Aigrain of Sopinspace.

standards of patentability

what won’t work: patentability reform just be first job
standard response: we don’t need to reform patentability standards
why this doesn’t work
USPTO adopted more extensive examination rituals — first year, sw patent grants dropped; but went up after that — because we can generate sw patent applications at will
Europe: 6-10 year backlog for category including sw patents
it’s in the interest of every innovator to understand standards of patentability

so how can we get generally understable standards of patentability?
Europe: some type of entities can’t be patented
US: history of software: committee during Carter admin was divided b/w copyright and no protection for software — but case law decided that subject matter restrictions were out

simplest approach to patent reform is to codify standard that information/processing can’t be patented — goes back to Jefferson’s stand that ideas can’t be patented

plan B: new examination ritual that leads to reject all patents on software, gene sequences, algorithms, data
already happening: US: Bilski; Europe: patent directive

Q&A

lerner: fair use is an interesting idea
compelling economic case for research exemption
less comfortable with human rights exemption — it’s amorphous

aigrain: sympathetic to fair use, but has to be carefully constructed
Europe has research exemption

ravicher: designing a fair use would be a deliberative process
if we have constitutional rights, we have to protect them
as long as the process is fair, it’ll be OK

questions:

Q: mentioned getting info into the patent system. often there’s a lot of information, but it’s of dubious quality.
lerner: it’s a needle in the haystack — examiner doesn’t know where to find the right pieces of information.
rules limit ability to bring up facts mentioned during patent examination during litigation — disinclines people to raise the info earlier.

ravicher: removing the quota system would also encourage people to raise the info, knowing that it might be considered.

love: alternatives to monopoly — in a system of liabilities rules, how to compensate for non-voluntary use?
ravicher: there are various arbitration systems, ways to compensate for loss, etc.
lerner: it may seem easy now, but later it may get more complicated.

karachelios: 1: society assumes that a system can set it owns boundaries. but it’s not that easy. 2: in case of doubt, grant or review? cultural context: if it’s profit center, grant it. if you think patent=innovation, then grant it. [systematic undervaluing of public domain, underestimating the costs of uncertainty, etc.]
ravicher: could create financial incentive for patentholders for bad patents — right to refund if your patent is held invalid.
aigrain: it’s not about old vs. new technologies, it’s about the nature of certain technologies.

Q: different purposes of patent system
ravicher: purpose is to enhance the state of technology available to the public. if the purpose is to incentivize innovation, system sucks. otherwise patents would be stronger.
lerner: sequential innovation — stronger patents != more innovation.
ravicher: sequential innovation depends on access. perspective should be on public access to technology, not the private right to control inventions.
aigrain: software copyright has enabled competition of approaches (proprietary vs. open) — patent gives only monopolies. orphan drugs aren’t just small or neglected diseases, but diseases where medicine is unpatentable.

Q: administrative reform: is patent examiner union a problem?
lerner: both labor & management have been incompetent.
ravicher: i have no solution.

rashmi rangnath: 1: what was bad about the patent bill from 110th congress? 2: what about peer to patent project?
lerner: damage calculation reform — opening pandora’s box of complexity and ambiguity. rather focus on patent quality.
ravicher: peer to patent is interesting, helpful to empower public to participate as early as possible. problem: even if we give examiners better info, if there’s other issues (e.g. not enough time), it won’t be helpful.

perens: people who’ve seen patent applications can’t participate in other projects — introduces issue of treble damages (for looking).
ravicher: the doctrine has changed somewhat but still has problems.

The next panel is on openness. First up is Konstantinos Karachalios of the European Patent Office.

• Civility is important. The field is very polarized. Our publication contains others’ vision.
• The definition of patents is openness — see its etymology. The opposite is secrecy (latent). But the patent system has come to mean its opposite in public perception. How can a system survive meaning its opposite?
• Openness and transparency are major components of social trust. Patents are a pivotal element of the knowledge economy. Patent offices offer a framework of global governance — you may criticize TRIPS, but at least there’s something there to criticize. Patent offices have been assigned to focus on innovation
• Backlogs are a serious problem. It’s a latent patent thicket.
• Transparency and availability of information about patents is a serious issue.
• How much is an ICT standard worth? If there are patents in it, it’s a goldmine. Proposal: coordinate competition authorities and patent offices, and link it with standardization bodies.
• Technology transfer to developing countries: if this fails, other Millennium Development Goals will fail. Climate change: can’t progress until people know how much it will cost.
• Patent system must look outside its narrow, legal/technical field and engage more broadly with social dialogue.

Next is Tim Hubbard of the Wellcome Trust. Genome informatics. Title: “Openness and privacy: can you have your cake and eat it?”

• Open data, releasing it as you collect it, is a recent idea. Human Genome Project drove this model. Has been adopted as a requirement of many funders — must include data access policy in grant requests.
• Value of open data: maximize investment, enable competition/collaboration
• Openness has risen in other fields: OA literature, open source software
• 2003 report by Wellcome Trust did the economic analysis which lead to its OA policy. Others have followed. Remaining problems: name control, permission problems (e.g. data mining)
• Pubmed Commons: Comments, tags
• Recommendation: Success of open data and OA literature hasn’t yet lead to mandates everywhere — should become a standard.
• Data sharing: Cultural attitudes are a problem (credit/attribution, adjusting to new competitive environment — people interpreting your data before you can). Other practical problems (e.g. standardization).
• Privacy: genome sequences and genotypes are anonymized, but potentially re-identifiable. Individual data will be limited to bona fide researchers, but summaries will be publicly available — but we’ve shown that these can be re-identified too. But will your registered researchers share it with unauthorized third parties?
• In the future, the whole of the UK NHS will have DNA data attached. Plans for connecting this to research. People like to contribute to health research, but don’t want their data leaked or misplaced. UK: significant lack of trust about this.
• Hard for data to be anonymous and useful. Need to be able to do research with fine granularity of data.
• Potential solutions: Make it fuzzy (but hard); change in social values; do everything behind closed doors (literally) — but slows research; or run researchers’ code on the mainframe system, but the results are only released as summary data
• Latter: Can’t make it perfectly leak-proof, but if you make it “good enough”, most legitimate researchers will use it; make it hard and illegal to discourage bypassing
• Is this a model of a generic implementation for openness + privacy? [But everyone has to trust the honest broker]
• But conflict with profit motive, even in public sector
• Recommendation: establish principles regarding private data
• Recommendation: standards for data formats and implementation

Next: Heather Joseph of SPARC.

• Need for openness in scholarly arena. Raising awareness of lawmakers of benefits of openness, but need to see it more in policy. Keeping policymakers convinced of benefits, even for biomedical research (other fields worse), is tenuous. But initial recognition that communicating results is an essential part of research. And growing view among public that openness in research is good, and an essential component of investment in research.
• Need for policy framework to remove access and permission barriers to maximize investment. But uptake so far mostly limited to biomedical research. And there’s pushback from opponents.
• Time to move from =”data management plans” to greater push for OA to data.
• Incoming administration does seem to value communication of science. Key posts filled to date have been filled to some extent with scientists who demonstrate this.
• OA policies should be made throughout administration — whether through executive order or regulation — and not as part of IP policymaking.
• OA policies are low overhead, aren’t punitive, and take advantage of the Internet to maximize existing public investment in research, fueling innovation and economic growth

Q&A:

• Perens: (1) Patent system is seen as opaque because IP policymaking is undemocratic (WIPO). (2) To protect personal data, give it IP protection and require users (e.g. companies) to get my permissions or face class action suit. (3) Are we talking about just OA to research literature or about overturning Bayh-Dole? A: (1) Patent offices must be advocates for transparent. (2) IP protection probably won’t help much when a junior official loses a laptop of private data on the train. (3) Have to draw distinction between OA literature and patents — many Congressional offices ask about relation to Bayh-Dole.
• Love: If there was an access to knowledge treaty, what specific issues would you want to include? Hubbard: OA data and literature; mandated protection of private data, to make it useful for research; greater openness to economic data; standards for government data. Joseph: OA literature and data — need to repeat the value of this to any innovation, competitiveness, A2K agenda. Karachalios: Define a technology commons. See climate change: can’t continue with private thinking in the face of public challenges. Hubbard: Everybody seems to think they’ll make a fortune from tech transfer, but it causes a significant disruption to other activities. Another prisoner’s dilemma.
• Jonathan Band: Crown copyright — having U.S. government works in the public domain creates a lot of value. But other countries hold copyright on government-created works. We should advocate for a change to this.

• Perfect storm in pharma industry: lower productivity of R&D pipeline, increased generic competition, VC funding drying up
• Clinical trials as a public good: non-transparent trial results (selective disclosure); avoidance of clinical trials that might reveal unfavorable outcomes (head-to-head effectiveness not compared); data exclusivity; shelved products
• Public funding for trials = less need to recoup costs with high prices
• Opportunity: Call for comparative effectiveness clinical trials; call for economic recovery package
• Implementation issues: Start with revenue-neutral strategy with targets of opportunity (e.g. comparative effectiveness trials); strategic support for alternative business models for neglected diseases; must not have conflicts of interest
• Recommendations: Public access to full clinical trial protocols and regulatory submissions; establish an independent entity to conduct clinical trials in the public interest; offer funding incentives for alternative business models to lower the costs of drug development

Questions:
[I asked about the FDA Amendments Act and clinicaltrials.gov, as well as the U.S. withdrawing support for the Declaration of Helsinki.]

Jamie Love asked a question but I was too busy Googling the above to pay attention.

Q: Is there a standard model for drug development that takes these concerns into account?
There are common elements: royalty-free access to developing countries, establishing the conditions up front from funding.

Next is Sophie Bloemen of Health Action International.

• Recommendation: Apply competition policy more strictly in the area of pharmaceuticals.
• Recommendation: Move regulatory authority from the European Commission’s Directorate General of Enterprise and Industry to DG of Health and Consumers.
• Recommendation: Re-assess IP policy toward developing countries. No correlation between EU position at WHO IGWG and in bilateral trade agreements.

Next is Ellen ‘t Hoen, formerly of MSF and futurely of UNITAID:

• Use of Doha flexibilities is widespread
• But older (generic) ARVs are much cheaper than newer second-line ARVs
• UNITAID is a multilateral funding mechanism for AIDS, TB, and malaria drugs. Explicitly supports Doha principles and other innovative mechanisms.
• Patent pool [voluntary collective license]. Supported in WHO global strategy on IP, UNITAID commitment, NGO support, response from patented and generic manufacturers positive
• Recommendations: Support UNITAID initiative to set up a patent pool for LMI countries. Support i+a agenda: implement WHO IP global strategy, WHA resolution 60.30. Obama should tell WHO DG to release Bolivia/Barbados proposal.

Next is Judit Rius of Knowledge Ecology International:

• Recognize the Doha Declaration, honoring the public health flexibilities in IP rules. Countries have the right to do this, but US and Europe are threatening when they do so. Don’t negotiate for TRIPS+ provisions like data exclusivity.
• Mandate open licensing of public funded R&D to developing countries.
• Promote R&D incentives that separate innovation from market for the product, e.g. prize funds
• Inducements should include open source dividends to encourage open sharing of knowledge, data, material, and technology
• Support a biomedical R&D treaty (WHA 61.21) — sustainable financing for needs-based R&D, open access to scientific articles and data from publicly-funded research

Next is Rob Weissman of Essential Action

• Renegotiate bilateral FTAs: Eliminate TRIPS-plus measures (minimum: renegotiate to revise patent rules to match changes in Peru/Panama), abandon anti-counterfeiting agenda for medicines (including ACTA)
• Climate change technologies: no pressure on countries for using TRIPS flexibilities regarding climate change technologies; publicly funding technologies openly licensed to developing countries
• Biogenerics: biologics are much more expensive than conventional drugs; no process for generic approval. Issues:
  • Regulatory pathway
  • Data exclusivity (submitted regulatory data — generics point to data submitted previously; exclusivity means they can’t use that data and have to re-do the tests at high expense) — recommendation: no exclusivity (alternative: cost-sharing, generics pay a share of the disclosed costs of trials)
  • Patent-related issues: how do you figure out which patents apply to a drug (patents listed in Orange Book), how do you resolve patent disputes before a patent expires — recommendation: disclose patents as a condition of enforceability, no delay for when generics can challenge a patent (industry wants a delay), no requirement for generics to share confidential information with patent holder (industry wants to require disclosure so they can assess potential infringement).
• Consequences: could have massive savings with an efficient generic approval system. Affordability depends on an effective generic market

Questions:
Love: How does biogenerics track in Europe?
Weissman: I don’t know.
Sarah Rimmington of Essential Action: Europeans have higher data exclusivity than 5 years under Hatch-Waxman. Why shouldn’t we have higher levels like Europe? Well, Europeans have price controls.
Weissman: Should they be called biogenerics or biosimilars? Question is whether they’re substitutes or in the same class.

Love: If WHO begins discussion on an R&D treaty, what advice would you give negotiators on what to include?
Rohit Malpani of Oxfam: Have to clarify funding levels.
‘t Hoen: Principle is that everyone contributes to the R&D. Priority-setting is important: how do you identify needs.
Weissman: Still being able to have a patent system for drugs makes the R&D treaty more politically feasible.
Rius: Negotiation needs is start. Prioritization is important. How to fund it is important — not high prices. Who pays for it — must include middle-income and some low-income countries.

Aigrain: Do you plan a campaign to move authority to SANCO?
Bloemen: Yes, we are planning to campaign on it.

Q: Does the fact that citizens in Europe and U.S. will have crisis with access to medicines will change the way they see it? Do we have something to learn from developing countries?
Weissman: Reality is industry vs. consumers (governments, employers). Pricing fights: biogenerics, Medicare compensation for publicly-funded drugs, reimportation.
‘t Hoen: Pricing crisis will offer opportunity — more people will get involved, offer ideas.

Malpani: Advance market commitment, priority review voucher: Comments?
Rius: They’re good — consequence of IGWG. But implementations are just at the service of the current business model. But doesn’t de-link from monopoly rights. Need i+a.
‘t Hoen: Companies have scooped up extra subsidies through this. AMC goes to a pre-existing product and doesn’t change the IP. Priority review is difficult: speeding up health review is not in the interest of health consumers. But encouraging to have new proposals and to test them. But we need to assess them critically.

[end of conference. I'll post the notes from this morning later, as well as my missing-but-now-recovered post from yesterday.]

First is Anne-Catherine Lorrain of Trans Atlantic Consumer Dialogue.

• Interoperability should be a public principle.
• ISP liability: Pressure for filtering solutions (consumer surveillance).
• Government procurement should require open standards.

Richard Wilder of Microsoft.

• (I’m not speaking on behalf of Microsoft.) IP online is important; we need more enforcement. This is key to our continued R&D.
• Open source is an important part of the software sector. Our goal is to work together.
• We need to be clear about the role of government involvement in standards-setting.
• We recognize the role of IP in collaboration and competition online.
• We’re interested in patent quality.

Bruce Perens:

• Learning is a human right. There are threats under the heading of both “IP” and “security” to learning.
• Innovation in different areas has different models. But we have the same IP law. So in software we created open source.
• Government’s function is to create a level playing field for competition. IP is the main barrier to interoperability.
• Governments should make sure that file formats and communication protocols are freely available.

Nicole Allen of the Student PIRGs:

• The Internet provides the opportunity to access learning materials. It also creates the need for industries to change business models.
• Textbook prices have risen significantly and pose a significant burden to students.
• We need policies that increase the supply and demand of low-cost textbooks and help new companies enter the market.
• If textbooks take the lead in changing their business model, other industries will follow suit.

What should government do?

• Wilder: PLoS is an example of new business models made possible by the Internet. But there has to be a business plan that makes it [financially] sustainable. At PLoS, authors pay a fee to publish, which can be internalized in research funding. In software, several business models are possible, from providing services, advertising, sale and licensing, new models from software-as-a-service. IP has a role in each model.
• Perens: I don’t think it’s true in the case of scientific and technical journals today. It used to be true. We used to need the publisher for printing and distribution. There doesn’t have to be a business plan: the important players, the journals, have never been paid. They do it for the prestige, which is an economic motive, but it’s not direct remuneration. PLoS, by the way, isn’t the only such publisher. In a number of fields, we can cast aside IP because it’s no longer relevant. Apache is the most popular Web browser of the world, none of which has direct remuneration to develop Apache. They need Apache as infrastructure. There are two types of IP. One grants a substantial business differentiation, e.g. Amazon’s recommendation system — if Amazon let others use that system, they’d lose their business differentiation. But Amazon uses Linux and funds it as a cost center.
• Lorrain: The discussion on IP has been frozen, so we’re trapped talking about enforcement. Hugenholtz said we need to increase the consumer’s power in Europe. The Paris Accord, a TACD project, is about finding alternative means of remuneration for creative communities while facilitating broader access. Our goal is to build an A2K movement at the Europe.
• Allen: Business models are important, whether compensation comes from money or prestige. We need more government involvement in stimulating innovation in business models. [Marc Rotenberg: So we should spend on broadband infrastructure?] I don’t think it addresses the concern. Industry needs to evolve. We need to ensure access to affordable education.
• Wilder: I’m concerned about government intervention in standard-setting, government procurement policies using standards favoring one business model or another.
• Lorrain: Interoperability and standards are important for consumers but they must be adopted transparently.
• Perens: We need standards for standards — Danish have the best. We need transparent, open, equitable development of standards; and standards must be available to all and royalty-free. On education, formal education is not the only or best way that people learn. We’ve gotten rid of the means of private hands-on education in the name of law enforcement.

Questions:
Phillipe Aigrain: These recommendations are somewhat small. (1) We need a government that acts as a trustee for the information commons and should consider new regulation in light of its impact on the commons. (2) We need to recognize activities that occur outside markets. The IP economy is the bubble that has not exploded yet. We need a positive synergy between the economy and non-market activities.
Perens: We don’t make policy democratically, but rather by treaty.

Q: Deep packet inspection — copyright owners like this. How do we prevent copyright infringement online?
Q: (1) Interconnection directive in Europe — could we have an interoperability directive? (2) Are there open source models for textbook development?
Q: We need to keep all media of delivery in consideration. Books are expensive. We need ways to promote open source without a brand.
Q: Is government action necessary in these areas? Regulation is not necessary the answer to everything.
Q: Microsoft dominates the industry in Egypt. Is open source relevant to developing countries?

Allen: Open source knowledge and educational content exist. In the U.S., books need to be marketable to professors. Open textbooks have to replicate traditional textbooks. DRM is a big issue with textbooks. Publishers sell digitized versions of books, but it’s a subscription, so it expires. They’ll face piracy. The market is powerful, and using market forces as much as possible is important, but when there’s a market malfunction there’s a role for government to play — such as the textbook market.

Perens: The answer isn’t greater regulation, but existing regulation that is bad, such as the DMCA. It doesn’t work for music. The rhetoric of defending small businesses doesn’t hold up — small businesses can’t actually enforce patents against big business. Instead big businesses can use their IP to preclude disruptive technologies. Does open source have a role in developing countries — OLPC has been killed by big companies, Intel and Microsoft. I published open books with Prentice Hall, and people are using them in Egypt. Egypt should defend the right to learn internationally.

Wilder: We want to see access to technology. The right to learn sets up a conflict, similar to debates about the right to health — really infrastructure is the issue. On deep packet inspection, IP protection is important, but government should let business models evolve naturally.

Lorrain: (1) Governments should promote procurement of devices complying with open standards.
(2) Governments should develop alternative reward systems to compensate artists without requiring consumer surveillance.
(3) Governments should support robust work program on E&Ls at WIPO, including access for the blind, distance education, and others.

• Forum shifting/institution shifting.
• Enforcement agenda. ACTA — fear obfuscating details of policy making. Opaque negotiations.
• Customs and INTERPOL not trained to adjudicate complex legal issues. Can they judge fair use?
• Recommendations:
  • Moratorium. No enforcement detail until definitions are sorted out.
  • Evidence-based policymaking.
  • Reform the PTO.
  • Campaign finance reform (cf. Lessig). Cooling-off period from USTR to working in private sector.
  • Enforcement is not just about property rights — also about enforcing fair use, privacy, competition policy, etc.

Next is Christophe Geiger of the Centre d’Etudes Internationales de la Propriété Intellectuelle.

• Draft French enforcement bill (passed Sénat — not discussed in the Assemblée nationale). Even if passed, likely unconstitutional and violates European and international standards on human rights (e.g. right to fair trial, privacy, proportionality)
• Alternative: graduated response (cf. parking ticket)
• Good signs: progress on E&Ls in Europe, WIPO

Next is Paul Levy of Public Citizen.

• Problems of DMCA take-down procedure. OSPs have safe harbor if they comply with the requirements: take action against repeat infringers and take down sword allegations of infringement (with counter-notification).
• This isn’t so good for consumers who are engaging in fair use, e.g. criticism of copyright materials.
• ex: Both Obama and McCain received YouTube takedowns for videos with short excerpts of news. McCain complained about 10-day length of takedown. McCain asked for carve-out for political campaigns — hand review for postings by political campaigns.
• ProgressIllinois posted short excerpts of news; Fox objected. Fox said they should link to full segments instead (but not all videos were available on Fox site). 3 videos had been taken down — YouTube treated as repeat infringer, took down all its videos. Fox said it’d drop its complaints if they wouldn’t do it in the future (waive the right to fair use).
• Recommendation: No assumption that a complaint of infringement is valid; wait for take-down only if no counter-notice received within reasonable period of time.
• Recommendation: Allow the suit for a wrongful takedown to proceed without proof that takedown was willfully wrong. Statutory damages.
• Recommendation: Public notice of takedown [cf. Chilling Effects]

Next is Eddan Katz of EFF.

• History of ACTA: STOP!, EU-US strategy on enforcement, US IP czar predecessor in Commerce Dept.
• ACTA is important and we need to stop it
• In addition to forum-shifting, there’s meme-shifting. The treaty is named “counterfeiting”, but it’s about “piracy”. Need to disentangle them.
• Must address secrecy about ACTA. Opportunity with change of administration.
• Plurilateral agreement — doesn’t require consent of Congress. [Really?]
• Contents of ACTA: not sure — text not public. Three pillars: international cooperation, legal framework. Separate meeting on Internet issues.
• “Information customs”. Customs officers not known for nuance and sensitivity.
• Under WCO, was body for IP — abolished — expect something to replace it.
• Concern about ex officio authority given to customs officials.
• Recommendation: Electronic Device Privacy Act, meant to address border searches of laptops & etc. should be reintroduced and promoted.
• Criminal provisions of ACTA a significant concern. Willful non-commercial infringement.
• DMCA-like provisions may be under discussion (anticircumvention).
• This is a way to exclude the [WIPO] Development Agenda
• Recommendation: Need public access to the substantive language. New U.S. IP czar must work with consumers. Should pass anti-laptop search act. Should consider future economic concerns — think more about what drives innovation.

Questions:
[I asked a question and so was away from my computer.]
My question was on ACTA and the seeming contradiction with the EU’s move to create a fifth freedom for the free movement of knowledge within the internal market. But nobody answered it.

Yesterday, my post on the openness session… disappeared. I don’t know where it went. (Another reason to update the WordPress install on this blog.) So, apologies.

Update: The post on the openness session has been found.

First: You’ve been named special advisor on copyright to the U.S., E.U., or Canada. What are your top three recommendations?

Fred von Lohmann of EFF:

• Think less about enforcement and more about solutions. Infringement drives much innovation in the copyright market — e.g., Napster spurred iTunes. Pushing or even transgressing the boundaries encourages copyright industries to step up their game. Part of the goal of copyright law should be ensuring there’s room for disruptive innovation. 1906: Music industry asked for copyright owner control over music machines (player pianos), said they’d kill the industry — and they were right — but we got something better in return. We’ve done great things — the p2p “library” is huge — so let’s find ways to get rightsholders compensated without dismantling that. More enforcement won’t help that — more solutions would.

William Patry of Google:

• We need effective copyright laws, not “strong” or “weak” copyright laws. Current shape of copyright law is clearly not very effective. We’ve seriously distorted incentives, ergo we’ve distorted behaviors.
• So we need someone to have the guts to stand up and do something about it. We need to re-evaluate copyright from top to bottom, without concern for our existing international obligations. Start from scratch: figure out what we want to incent and then figure out how to do it.

Maria Pallante of the Copyright Office:

• (responding instead to what the Copyright Office’s work will focus on) Three legislative areas: performance rights in sound recordings — we have it for Webcasting but not for terrestrial broadcasting — would create parity with Internet radio. Orphan works. Section 108.

Bernt Hugenholtz of the University of Amsterdam:

• Repeal E.U. proposal to extend copyright term for musicians from 50 years to 95.
• Create a coordinating committee for copyright policy in the European Commission.
• Stop further harmonization projects. The E.U. still has 20+ national laws, which have some similarities but there are still significant differences. It’s time to start thinking about unification for the E.U. — one copyright law for the E.U. Imagine if we had different state copyright laws in the U.S. [We do have state para-copyright.]
• We could seize the opportunity to do some rebalancing, or make a fresh start.

Michael Geist of the University of Ottawa:

• Obama’s first foreign visit will be to Canada. Among many other issues, copyright and IP may be a topic of discussion. Canada’s PM should use the opportunity to tell the U.S. to stop bullying Canada over its copyright law.
• Tell the ACTA negotiating partners that either it’s open or we’re out — demand transparent. If there’s nothing to hide, why hide it?
• Do nothing for the next 12 months at least. Canada has twice failed to pass a “Canadian DMCA” and has suffered significant criticism. Don’t bring back the same bill — tell the lobbyists to lay off.

Next: How do we win on ACTA? How do we decouple IP from trade?

• von Lohmann: We’re concerned about ACTA and have sued to get information about ACTA. We should keep up the pressure for transparency.
• Hugenholtz: I did try to get the documents from the EC, but failed. The EU is not competent to enter into a treaty on criminal enforcement on IP without the backing of member states — which is why the member states accompany the EC negotiators.
• Patry: ACTA has been poorly executed and we should walk away from it. Any significant changes should be made democratically, starting domestically. If we don’t have something to hide, why hide it?
• Geist: Three groups of participants in ACTA: Some who will be unlikely to be moved at all (U.S., Japan, Korea, maybe E.U.). Some weak-link countries, who think it’s better to be in than out (Canada, Australia, New Zealand) — this is where to apply pressure. And groups that aren’t involved at all: need to express concern about this and put pressure to open it up.
• Pallante: I was not part of the Copyright Office delegation to this meeting. Our role is to provide technical advice upon request of the U.S. government. My predecessor was at the Paris ACTA meeting.

Next: WIPO: Do we need international E&Ls? Where is common ground to be found?

• Pallante: WBU proposal will be on the table at WIPO. Copyright Office will likely issue a RFC to see if there are issues about access for visually impaired, potentially followed by roundtables or hearings.
• Hugenholtz: It’s good to have WBU proposal on the agenda, but if we stop there, that’s bad. I would prefer a coherent instrument listing principles from which E&Ls derive. We wrote a study for OSI proposing this — not hard law, but a declaration of principles. Could serve as reference for bilateral negotiations as well. Some principles: free speech, development, science, competition. E&Ls should be an integral part of any copyright system.
• Patry: WBU treaty would be helpful but we shouldn’t carve it up. E&Ls by its name suggests protection by default.
• Geist: It’s less than ideal, so WBU proposal is a considerable step forward. But it’s only the first step.
• von Lohmann: The chief danger to E&Ls in domestic law is not whether or not this proposal passes — E&Ls everywhere are under assault.

What’s the verdict on the DMCA, WIPO Copyright Treaty, DRM?

• von Lohmann: DRM (TPMs) has been an abject failure is the goal was to prevent widespread infringement. There’s no sign that DRM or legal backing for it has stemmed widespread infringement online. Each year, there are more people engaged in unauthorized filesharing than the year before. But DRM hasn’t been effective, as was promised. Yet it’s continued to be popular. The DMCA/Copyright Treaty have failed at their stated goal — so what was their actual goal? It wasn’t about piracy. Apple removed DRM from music on iTunes, but Apple continues to use TPMs in many other parts of its business, such as locking iPod to iTunes, locking iPhones to selected carriers, locking iPhones to the Apple app store, locking their OS to their hardware… TPMs are principally used to prevent competition, not piracy. It’s competitors [innovators] whose behavior is chilled. We need to reform this area. We don’t have to repeal the Copyright Treaty — it doesn’t require a U.S.-style DMCA — but the anticircumvention provisions of the DMCA have to go, and Canada and others shouldn’t adopt them.
• Geist: [gave a history of proposals for and opposition to the Canadian DMCA]

Enforcement and damages

• Patry: Statutory damages have been used against start-up companies, to extract equity stakes in new companies, in RIAA’s copyright wars. Rep. John Conyers, chair of House Judiciary Committee suggested a full review of statutory damages — this would be good.
• Hugenholtz: No statutory damages in civil law countries. Not mentioned as a remedy in EU Enforcement Directive. I assume European common law jurisdictions have statutory damages. There are some de facto practices that resemble statutory damages. Punitive damages are taboo in Europe.
• Geist: We have statutory damages in Canada. It makes sense for commercial infringement but not for e.g. RIAA’s copyright wars. Proposal in Canada is to carve exemption for non-commercial infringement.
• Pallante: There’s a range of statutory damages in the U.S. — they can be quite low. I was involved with discussions in the last Congress but mostly through the perspective of orphan works. With group registration, e.g. 1 photo of 700, you haven’t registered it in a way that’s useful for someone to find it.
• von Lohmann: Copyright owners in the U.S. have a number of weapons at their disposal. The cost of litigation (attorney’s fees) is the most useful against e.g. individual downloaders. Biggest need for reform is in area of intermediaries. There was a bill by Rep. Boucher to eliminate statutory damages against secondary liability where there’s good faith.

Collective strategies:

• von Lohmann: Collective approaches aren’t a bad option. RIAA wants ubiquitous Internet surveillance — if it’s that or blanket licensing, the choice is clear.
• [Sohn: Some people wanted Google to fight to the death for fair use in the Google Books case.] Patry: No comment. The settlement hasn’t been approved yet.
• Hugenholtz: EFF should be applauded for suggesting collective licensing — we’re clearly moving in that direction. Authors can actually make money here. But oversight is important here — competition law isn’t sufficient — collective licensing bodies are somewhere between public and private.
• Pallante: Collective strategies are indispensable. Fear: Some uses that would be fair wouldn’t be if you could license it. But generally, collective strategies are important.
• Geist: Some courts have found that p2p is arguably legal due to the private copying levy. Songwriters have come out in favor of legalizing p2p. But transparency is key when it comes to distributing the money — who gets paid, how much overhead. Market distortions (levy on blank CD vs. blank DVD).

Lightning round:

We’ve been talking about bringing balance back to copyright for a decade in the U.S. What’s the most important thing to do to turn the tide?

Geist: We’ll win, but the question is how soon. Rightsholders recognize some criticisms are legit. Young people have a much different take on IP.

Hugenholtz: Everything will end up well at some point. Academics agree — someday politicians may.

Pallante: Rightsholders are more organized — we don’t see everybody. The more that people get organized and coordinated, it helps.

Patry: I have no faith in our ability to make any meaningful legal reform. Our hands have been deliberately tied by international obligations. Can’t impose formalities, can’t reduce copyright term, very hard to pass copyright reform (even orphan works is hard). My only hope is that market realities force copyright owners to change, and eventually we won’t care about copyright.

von Lohmann: I have no reason to believe that government action won’t make things any better. The pivot remains what it has been: fans/consumers. It’s the only force that can move businesses.

Q&A:
[I asked a question, which made it difficult to blog at the same time.]
[After that I kind of spaced out. It's been a long day. I've seen myself in the mirror: I look as bleary-eyed as I feel.]