“This paper is focused on openness movement and the principles that said movement declared regarding the use of works set under copyright protection to enable for open access works. The three-step-test legal edifice is deeply rooted in international copyright law; its meaning and application is of vital importance for any consideration of amending copyright law with the aim to include provisions for openness. Unless a provision for openness passes the three-step-test there can be no sustainable amendment of copyright law in favour of openness.”
“Rickover railed against the proposed policy changes. “Government contractors should not be given title to inventions developed at government expense,” he said. “These inventions are paid for by the public and therefore should be available for any citizen to use or not as he sees fit.”
This seemed self-evident to Rickover. After all, he noted, “companies generally claim title to the inventions of their employees on the basis that the company pays their wages.” It befuddled and angered him that the U.S. government would consider giving up its own shop rights to industries that would never do the same. …
In the summer of 1979, the latest such bill was entering its sixth month of hearings on the merits of pulling the Kennedy policy inside-out. Sponsored by Sen. Bob Dole, R-Kan., and Sen. Birch Bayh, D-Ind., it would shift the burden onto government to prove that its ownership of a patent better served the public than a private monopoly, rather than the other way around. The bill was considered a long shot to get past the dens of liberal lions in the Senate and President Jimmy Carter, but it was gaining traction among Democrats.
As the bill’s chances of passage grew, Rickover stepped up his warnings to lawmakers not to fall for “the age-old arguments of the patent lobby” and pass legislation that “promotes greater concentration of economic power [and] impedes the development and dissemination of technology.” …”
“California Gov. Gavin Newsom has signed into law a budget measure that provides millions of dollars to support the creation of openly licensed academic resources at the college level, in one of the most striking examples of a state throwing its weight behind the free, revisable materials.
The Democratic governor last week approved a higher education budget proposal that devotes $115 million toward reducing textbook costs and the development of open educational resources.
While the measure is aimed at the state’s postsecondary system, backers of open educational materials have told EdWeek Market Brief that it could benefit pre-college students in part by making those materials more freely accessible to high school students who are pursuing advanced content….”
“The math police told Nutt to keep his answers to himself. If he offers testimony that requires “engineering knowledge,” the state will bust him like a math outlaw because he lacks a professional engineering license — something he never needed during his career. Engineers at manufacturing firms such as DuPont have an exemption to the requirement….”
California Governor Gavin Newsom signed into law an unprecedented $115 million investment in the expansion of Zero Textbook Cost degrees and open educational resources at the state’s community colleges. Building on a successful pilot that concluded in 2019, the funding will support the development of degree and certificate pathways that students can complete without spending a single dollar on textbooks. The program will be administered through the California Community College Chancellor’s Office and marks the single largest state investment in open educational resources to date.
Abstract: Objectives To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.
Design Cross-sectional descriptive analysis.
Setting and participants Novel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.
Main outcome measures Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.
Results 26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88–100) vs 57% (0–100), p=0.01) and better data sharing (median of 100% (IQR 80–100) vs 20% (IQR 20–40), p<0.01). No significant differences were observed by company location or product type.
Conclusions It was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.
“A team of American researchers examined 62 products by 42 pharma companies that gained FDA approval in 2016 and 2017. Collectively, these drugs and biologics were approved based on 1,017 clinical trials involving more than 187,000 participants….
Around a quarter of these trials were subject to the FDA Amendments Act, a transparency law that requires drug makers to register applicable trials on a public registry within 21 days of their start date, and to make their results public on the registry within 30 days of initial FDA approval of a product.
The study team found that 55 of the 62 FDA approvals included at least one clinical trial that was subject to the transparency law. However, in the case of 13 products, these trials did not consistently meet legal registration or reporting requirements.
Large pharma companies were far more likely to comply with the law. For example, Merck Sharp & Dohme was legally responsible for registering and reporting 27 trials, and fully complied in every single case. However, several other major players – Gilead, Johnson & Johnson / Janssen, Novo Nordisk, Sanofi, and Shire – fell short of legal requirements.
Nonetheless, the study – which also covered companies’ data sharing policies – found that overall, there had been “sustained improvement” in pharma industry disclosure practices compared to previous years….”
“The global pandemic has turned a spotlight on clinical trials, which test thousands of drugs and therapies each year. In Europe, however, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. A total of 3846 European trials—nearly 28% of 13,874 completed trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results on the register, according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018 to expose lax reporting. Public research hospitals and universities, not drugmakers, are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion….”
“Over the course of the past year, three state legislatures have introduced legislation that would impose limits on a publisher’s ability to sell e-books to libraries at a high cost. Under the current licensing model, libraries can pay as much as $60 per title for an e-book license, which often have very restrictive terms, whereas consumers can purchase an e-book license for the same title at a fraction of the cost. The first of these bills was passed in Maryland, and the New York state legislature has also recently approved the New York bill. A bill in Rhode Island is currently pending. Additionally, groups in Connecticut, Texas, Virginia, and Washington have reportedly begun advocating for similar legislation. …”
The Court of Justice of the European Union (CJEU) has held that operators of online platforms to which users post copyright-protected content are not liable for copyright infringement in such user-posted content if they meet certain conditions. First, they must not contribute to giving access to such content to the public in breach of copyright, beyond merely making those platforms available. Second, they must not play an active role that gives them knowledge of or control over the content posted.
GitHub is currently causing a lot of commotion in the Free Software scene with its release of Copilot. Copilot is an artificial intelligence trained on publicly available source code and texts. It produces code suggestions to programmers in real time. Since Copilot also uses the numerous GitHub repositories under copyleft licences such as the GPL as training material, some commentators accuse GitHub of copyright infringement, because Copilot itself is not released under a copyleft licence, but is to be offered as a paid service after a test phase. The controversy touches on several thorny copyright issues at once. What is astonishing about the current debate is that the calls for the broadest possible interpretation of copyright are now coming from within the Free Software community.
“IIPA [International Intellectual Property Alliance] attacked subsection 12D7(a) as a threat to “academic freedom” because it gives the author of a scientific article that is the result of a research activity primarily funded by the government the right to make the article available on an open access basis. This is a truly Orwellian argument. How does preserving a scientist’s right to make her research publicly available undermine her academic freedom? The statute doesn’t obligate her to provide open access, although the Government certainly has the authority to do so as a condition of its providing the research funding. Indeed, the United States government conditions it research grants on making the resulting articles available on an open access basis. So do the EU and many other research funders around the world.
“On behalf of the leaders of 125 major research libraries, the Association of Research Libraries (ARL) is pleased to see that the US House of Representatives included the following policies in the National Science Foundation (NSF) for the Future Act (H.R. 2225), which center researchers and create public value by promoting the availability of publicly funded research:
Criteria for trusted open repositories to be used by federally funded researchers sharing data, software, and code. According to the House bill, the criteria would be developed with input from the scientific community. Research libraries look forward to partnering with NSF and the scientific community to develop these criteria.
Data management plans to facilitate public access to NSF-funded research products, including data, software, and code….
We strongly support public access to publications resulting from NSF-funded research with zero embargo, and we are heartened to see language in the Senate-passed US Innovation and Competition Act (S. 1260) requiring the publication of federally funded research data within 12 months, “preferably sooner.” Making research outputs publicly available to the widest possible audience in the timeliest manner possible, and machine-accessible for computation, is critical for developing scientific insights and solutions for public health, climate, technological advancement, and more….”
“Maintaining the status quo for public libraries – to build collections, preserve and lend them – is now seen as a radical and frightening mission, according Ben White, PhD researcher at the Centre for Intellectual Property Policy & Management, Bournemouth University and co-founder of KnowledgeRights21. Here he speaks to Rob Mackinlay about why not challenging the methods used by publishers to protect their content will damage not only libraries, but also threatens research and innovation.
“Publishers can’t refuse to sell paper books to libraries, but they can and do refuse to sell them eBooks. And all we want to do is to be allowed to do what we’ve always done, to keep the status quo, to be allowed to build collections, preserve and lend, so it is strange that the solution sounds a bit frightening and radical,” says Ben White who has been immersed in the legal minutiae of intellectual property across Europe for decades….”
About two years ago, the Copyright in the Digital Single Market (CDSM) Directive was adopted, obliging European Union Member States to ‘bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 7 June 2021’. On this date, we take a look at the progress of Member States, and at some of the policy choices they have made.