The suitability of DEAE-Cl active groups on customized poly(GMA-co-EDMA) continuous stationary phase for fast enzyme-free isolation of plasmid DNA

The creation of a commercially viable and a large-scale purification process for plasmid DNA (pDNA) production requires a whole-systems continuous or semi-continuous purification strategy employing optimised stationary adsorption phase(s) without the use of expensive and toxic chemicals, avian/bovine-derived enzymes and several built-in unit processes, thus affecting overall plasmid recovery, processing time and economics. Continuous stationary phases are known to offer fast separation due to their large pore diameter making large molecule pDNA easily accessible with limited mass transfer resistance even at high flow rates. A monolithic stationary sorbent was synthesised via free radical liquid porogenic polymerisation of ethylene glycol dimethacrylate (EDMA) and glycidyl methacrylate (GMA) with surface and pore characteristics tailored specifically for plasmid binding, retention and elution. The polymer was functionalised with an amine active group for anion-exchange purification of pDNA from cleared lysate obtained from E. coli DH5α-pUC19 pellets in RNase/protease-free process. Characterization of the resin showed a unique porous material with 70% of the pores sizes above 300 nm. The final product isolated from anion-exchange purification in only 5 min was pure and homogenous supercoiled pDNA with no gDNA, RNA and protein contamination as confirmed with DNA electrophoresis, restriction analysis and SDS page. The resin showed a maximum binding capacity of 15.2 mg/mL and this capacity persisted after several applications of the resin. This technique is cGMP compatible and commercially viable for rapid isolation of pDNA.

A phase II trial of brivanib in recurrent or persistent endometrial cancer: An NRG oncology/gynecologic oncology group study

PURPOSE Brivanib, an oral, multi-targeted tyrosine kinase inhibitor with activity against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR) was investigated as a single agent in a phase II trial to assess the activity and tolerability in recurrent or persistent endometrial cancer (EMC). PATIENTS AND METHODS Eligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and performance status of ≤2. Treatment consisted of brivanib 800 mg orally every day until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) at six months and objective tumor response. Expression of multiple angiogenic proteins and FGFR2 mutation status was assessed. RESULTS Forty-five patients were enrolled. Forty-three patients were eligible and evaluable. Median age was 64 years. Twenty-four patients (55.8%) received prior radiation. Median number of cycles was two (range 1-24). No GI perforations but one rectal fistula were seen. Nine patients had grade 3 hypertension, with one experiencing grade 4 confusion. Eight patients (18.6%; 90% CI 9.6%-31.7%) had responses (one CR and seven PRs), and 13 patients (30.2%; 90% CI 18.9%-43.9%) were PFS at six months. Median PFS and overall survival (OS) were 3.3 and 10.7 months, respectively. When modeled jointly, VEGF and angiopoietin-2 expression may diametrically predict PFS. Estrogen receptor-α (ER) expression was positively correlated with OS. CONCLUSION Brivanib is reasonably well tolerated and worthy of further investigation based on PFS at six months in recurrent or persistent EMC.

Free Sherlock: The copyright battle of Baker Street

Sherlock Holmes faces his greatest challenge – since his fight to the death with Professor James Moriarty at Reichenbach Falls. Who owns Sherlock Holmes, the world’s greatest detective? Is it the estate of Sir Arthur Conan Doyle? Or the mysterious socialite Andrea Plunket? Or does Sherlock Holmes belong to the public? This is the question currently being debated in copyright litigation in the United States courts, raising larger questions about copyright law and the public domain, the ownership of literary characters, and the role of sequels, adaptations, and mash-ups.

Fossil free Stanford: Universities, climate ethics, and fossil fuel divestment

There has been an international movement led by 350.org, Bill McKibben, and student groups to encourage schools, universities, and educational institutions to divest their endowments of fossil fuel stocks. The decision of Stanford University on coal divestment should an inspiration for elite universities around the world.

From Kafka to KAFTA: Intellectual property, and the Korea-Australia free trade agreement

This paper provides a critical examination of the intellectual property sections of the Korea-Australia Free Trade Agreement 2014. Chapter 13 of the Korea-Australia Free Trade Agreement 2014 deals with the subject of intellectual property law. The Chapter covers such topics as the purposes and objectives of intellectual property law; copyright law; trade mark law; patent law; and intellectual property enforcement. The Joint Standing Committee on Treaties in the Australian Parliament highlighted the controversy surrounding this chapter of the agreement: The intellectual property rights chapter of KAFTA has drawn considerable attention from academics and stakeholders regarding the proposed need for changes to Australian intellectual property law and the inclusion of intellectual property in the definition of investment with regard to the investor-state dispute mechanism. Other concerns raised with the Committee include the prescriptive nature of the chapter, the lack of recognition of the broader public interests of intellectual property rights, and possible changes to fair use provisions. Article 13.1.1 of the Korea-Australia Free Trade Agreement 2014 provides that: ‘Each Party recognises the importance of adequate and effective protection of intellectual property rights, while ensuring that measures to enforce those rights do not themselves become barriers to legitimate trade.’ This is an unsatisfactory description of the objectives and purposes of intellectual property law in both Australia and Korea. There is a failure to properly consider the range of public purposes served by intellectual property law – such as providing for access to knowledge, promoting competition and innovation, protecting consumer rights, and allowing for the protection of public health, food security, and the environment. Such a statement of principles and objectives detracts from the declaration in the TRIPS Agreement 1994 of the public interest objectives to be served by intellectual property. Chapter 11 of the Korea-Australia Free Trade Agreement 2014 is an investment chapter, with an investor-state dispute settlement regime. This chapter is highly controversial – given the international debate over investor-state dispute settlement; the Australian context for the debate; and the text of the Korea-Australia Free Trade Agreement 2014. In April 2014, the United Nations Conference on Trade and Development (UNCTAD) released a report on Recent Developments in Investor-State Dispute Settlement. The overall figures are staggering. UNCTAD reports a significant growth in investment-state dispute settlement, across a wide array of different fields of public regulation. Given the broad definition of investment, intellectual property owners will be able to use the investor-state dispute settlement regime in the Korea-Australia Free Trade Agreement 2014. This will have significant implications for all the various disciplines of intellectual property – including copyright law, trade mark law, and patent law.

Robbery under arms: Copyright law and the Australia-United States free trade agreement

TThis article considers the radical, sweeping changes to Australian copyright law wrought by the Australia–United States Free Trade Agreement 2004 (AUSFTA). It contends that the agreement will result in a “piracy of the public domain”. Under this new regime, copyright owners will be able to obtain greater monopoly profits at the expense of Australian consumers, libraries and research institutions, as well as intermediaries, such as Internet service providers. Part One observes that the copyright term extension in Australia to life of the author plus 70 years for works will have a negative economic and cultural impact — with Australia’s net royalty payments estimated to be up to $88 million higher per year. Part Two argues that the adoption of stronger protection of technological protection measures modelled upon the Digital Millennium Copyright Act 1998 (U.S.) will override domestic policy–making processes, such as the Phillips Fox Digital Agenda Review, and judicial pronouncements such as the Stevens v Sony litigation. Part Three questions whether the new safe harbours protection for Internet service providers will adversely affect the sale of Telstra. This article concludes that there is a need for judicial restraint in interpreting the AUSFTA. There is an urgent call for the Federal Government to pass ameliorating reforms — such as an open–ended defence of fair use and a mechanism for orphan works. There is a need for caution in negotiating future bilateral trade agreements — lest the multinational system for the protection of copyright law be undermined.

Free Mickey! The copyright term and the public domain

In a victory for corporate control of cultural heritage, the Supreme Court of the United States has rejected a constitutional challenge to the Sonny Bono Copyright Term Extension Act 1998 (US) by a majority of seven to two.

The Australia-Chile free trade agreement 2008: Intellectual property and development. A submission to the Joint Standing Committee on treaties

A submission to the Joint Standing Committee on treaties

Patenting free energy: The BlackLight litigation and the hydrogen economy

Legal Context In the wake of the Copenhagen Accord 2009 and the Cancun Agreements 2010, a number of patent offices have introduced fast-track mechanisms to encourage patent applications in relation to clean technologies - such as those pertaining to hydrogen. However, patent offices will be under increasing pressure to ensure that the granted patents satisfy the requisite patent thresholds, as well as to identify and reject cases of fraud, hoaxes, scams, and swindles. Key Points This article examines the BlackLight litigation in the United States, the United Kingdom, and the European Patent Office, and considers how patent offices and courts deal with patent applications in respect of clean energy and perpetual motion machines. Practical Significance The capacity of patent offices to grant sound and reliable patents is critical to the credibility of the patent system, particularly in the context of the current focus upon promoting clean technologies.

Free trade, Gangnam Style: The Korea-Australia free trade agreement

On the 5th December 2013, Australia and Korea announced that they had finalised a new free trade agreement. Is it a fair trade fairytale? Or is it a dirty deal done dirt cheap? It is hard to tell, because the respective governments have not yet published the text of the Korea-Australia Free Trade Agreement (KAFTA). There has been much debate in the Australian Parliament over the transparency of the trade agreement; the scope of market access provided under the deal; and the impact of the investment chapter, with an investor-state dispute settlement clause. KAFTA foreshadows the approach of the new Conservative Government in Australia to other trade deals – such as the Trans-Pacific Partnership.

A Submission to the Joint Standing Committee on Treaties on the Korea-Australia Free Trade Agreement (KAFTA)

Australia and South Korea have signed a new free trade agreement - the Korea-Australia Free Trade Agreement (KAFTA). Is it a fair trade fairytale? Or is it a dirty deal done dirt cheap? Or somewhere in between? It is hard to tell, given the initial secrecy of the negotiations, and the complexity of the texts of the agreement There has been much debate in Parliament over the transparency of the trade agreement; the scope of market access provided under the deal; the impact of the investment chapter, with its investor-state dispute settlement clause; the intellectual property chapter; the environment chapter; its impact upon public health; and the labor rights chapter. KAFTA provides an indication of the approach of the new Conservative Government in Australia to other trade deals – such as the Trans-Pacific Partnership.

Defining anthropometric cut-off levels related to metabolic risk in a group of Sri Lankan children

Background: Body mass index (BMI) is widely used as a measure of adiposity. However, currently used cut-off values are not sensitive in diagnosing obesity in South Asian populations. Aim: To define BMI and waist circumference (WC), cut-off values representing percentage fat mass (%FM) associated with adverse health outcomes. Subjects and methods: A cross-sectional descriptive study of 285 5–14 year old Sri Lankan children (56% boys) was carried out. Fat mass (FM) was assessed using the isotope (D2O) dilution technique based on 2C body composition model. BMI and WC cut-off values were defined based on %FM associated with adverse health outcomes. Results: Sri Lankan children had a low fat free mass index (FFMI) and a high fat mass index (FMI). Individuals with the same BMI had %FM distributed over a wide range. Lean body tissue grew very little with advancing age and weight gain was mainly due to increases in body fat. BMI corresponding to 25% in males and 35% in females at 18 years was 19.2 kg/m2 and 19.7 kg/m2, respectively. WC cut-off values for males and females were 68.4 cm and 70.4 cm, respectively. Conclusion: This chart analysis clearly confirms that Sri Lankan children have a high %FM from a young age. With age, more changes occur in FM than in fat free mass (FFM). Although the newly defined BMI and WC cut-off values appear to be quite low, they are comparable to some recent data obtained in similar populations.