A successful appeal against a remediation notice has highlighted the difficulties faced by local authorities when trying to secure the remediation of contaminated land. The appeal is only the second appeal to the Secretary of State for Environment, Food and Rural Affairs (SoS) since the contaminated land regime in Part 2A of the Environmental Protection Act 1990 was implemented in 2000 ...
While the Ukrainian Parliament continues heated debates over the open market for agricultural land, one thing remains clear - the lifting of the moratorium on sale of agricultural land is an inevitable process, which is largely driven by globalization and the expansion of influence of major world corporate groups in Ukraine. However, for the land market and agribusiness to become transparent and efficient, the relevant risk management systems have to be implemented ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
Geographical indication of origin, this very peculiar form of industrial property protection, has undergone a revival phase over the past few years, thus becoming more omnipresent not only within the circles of interest, but also amongst the Serbian public at large. Although, up to this day, there are only a few dozen geographical indications of origin registered before the Serbian Intellectual Property office, for a country of little over 7 million spread over 80 ...
Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...
The Corps Struggles to Balance Competing Constitutional and Statutory Duties Federal agencies must often balance competing policy concerns and legal requirements. This process may be difficult and fraught with intense public feedback, and frequently results in litigation. The U.S. Army Corps of Engineers (the Corps) has found itself in the hot seat over how it manages the nation’s rivers, pitting its obligations under the Endangered Species Act (ESA) against private property rights ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
As the Trump administration is pushing forward on its deregulatory agenda and, in particular, its efforts to improve the Endangered Species Act (ESA) and its implementation by the US Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (together, the Services), the Supreme Court is poised to hear a landmark case on designation of critical habitat under the ESA that could provide some guideposts for the Services’ new regulations ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
The Court of Justice of the European Union (CoJ) handed down an important judgment last week on the protection of geographical indications of spirit drinks in a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (Scotch Whisky Association (SWA) v Michael Klotz (Case C-44/17)). Facts: Mr Klotz markets a whisky under the designation ‘Glen Buchenbach’, which is produced by a distillery located in Berglen in the Buchenbach valley in Germany ...
The international trading market is currently quite favorable to commodity-producing countries such as Brazil. In recent months, the Bloomberg Commodity Index, which tracks daily the performance of main commodities, closed at US$89.49, 1.5% higher than it was at lhe end of 2017 and 6.73% higher than it was 12 months ago ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
The Danish government has now published its life science growth plan, which aims at making Denmark a leading life science nation in Europe. The growth plan is based on the recommendations submitted by the Growth Team for Life Science. Plesner has previously reported on the topic.1 The growth plan contains 36 initiatives in 6 key areas. One of the many initiatives is a pilot scheme for risk sharing in the drug reimbursement system ...
Not-for-profit Reforesting Scotland’s "Thousand Huts" campaign has spearheaded the regrowth of the hutting community, previously almost entirely eradicated by increasingly strict building regulations. The new Building (Miscellaneous Amendments) (Scotland) Regulations 2017 sets out the framework for ecologically sustainable hut development. What is a Hut? A hut must be a single storey building used as recreational accommodation ...
Scotland is currently home to one of the largest life science clusters in Europe, with more than 700 organisations based here employing some 37,000 people. With 15 universities producing highly skilled graduates; the NHS as a massive single source of patient data; and world leading research centres in life sciences, Scotland attracts some of the brightest international scientists and life science businesses ...
In Scots law, it is possible to acquire certain rights to land – access, for instance – simply by the passage of time. This process is known as “prescription” and is outlined in the Prescription and Limitation (Scotland) Act 1973. There are two forms of prescription: positive and negative. Negative prescription extinguishes certain rights after a period of time ...
With investors such as the Scottish Investment Bank, the soon-to-be-launched Scottish National Investment Bank and the Epidarex Life Sciences Fund all increasingly paying attention to the life sciences sector against the backdrop of an increasingly competitive life sciences market in Scotland, now is a great time to consider whether your business is ready for investment, and how it could be standing out in order to attract investors ...
To coincide with its 250th anniversary, Shepherd and Wedderburn commissioned the University of Strathclyde’s Fraser of Allander Institute to consider the future challenges and, more importantly, opportunities for Scotland’s economy ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities 1. Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
