We would like to inform you that on December 27, 2018, the President of the Russian Federation signed the Federal Law No. 549-FZ “On Making Amendments to the Part Four of the Civil Code of the Russian Federation” (previously known as the Bill No. 428309-7) that provides for temporary legal protection to industrial designs during the stage of substantive examination of applications (URL: http://sozd.duma.gov.ru/bill/428309-7) (“Law”) ...
In case C-323/17 People Over Wind and Peter Sweetman v Coillte, the Court of Justice of the European Union (CJEU) ruled that mitigation measures could not be taken into account at the screening stage of an appropriate assessment. Facts This case focused on proposed works that were necessary to lay a cable connecting a wind farm to the electricity grid and the potential effects that this would have on two special areas of conservation ...
Fossil fuels are under attack in the legislative, regulatory, and judicial arenas, and in the market place—driven by environmental concerns, especially global warming and associated climate change. The Sierra Club, for example, has launched a “Beyond Dirty Fuels Initiative,” seeking to “push back against the construction of dirty fossil fuel infrastructure that would lock America into decades more of climate-polluting oil and gas production ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
In December of 2018, the U.S. Environmental Protection Agency (EPA) and Army Corps of Engineers (Corps) released their much-anticipated draft proposed rule to re-write the definition of “waters of the United States” (WOTUS) (“2018 Rule”). The definition of WOTUS establishes the scope of agency jurisdiction over waters and wetlands under the Clean Water Act (CWA) ...
In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners. In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
The Supreme Court has handed down one of the most anticipated Endangered Species Act (ESA) rulings in recent years. In Weyerhaeuser Co. v. U.S. Fish and Wildlife Serv., the Supreme Court unanimously overruled the Fifth Circuit Court of Appeals, holding that the Fish and Wildlife Service can only designate property that is “habitat” as critical habitat under the ESA ...
On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
From ground-breaking discoveries such as penicillin and insulin, to the development of the MRI body scanner and the creation of Dolly the sheep, the first mammal to be cloned from an adult cell ...
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 ...
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 ...
The High Court judgment in Friends of the Irish Environment v. An Bord Pleanála (delivered in 2018 by Meenan J) decided that if a Section 5 referral is made by a third party, then the owners and occupiers of the lands must be identified and served with notice of the referral, and given an opportunity to make submissions in accordance with basic fair procedures ...
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 ...
The UKCS is the largest decommissioning market in the North Sea. There are around 475 fixed facilities, over 10,000 kilometres of pipeline and approximately 5,000 wells. These will all need to be decommissioned over the next 30 years, when they reach the end of their economic life, at an estimated cost of £59.7 billion ...
In Australia, we're seeing enormous opportunities and some policy challenges in renewable energy ...
Feeling the heat: the draft Climate Change Bill, 2018 Earlier this year, the South African Minister of Environmental Affairs (the “Minister”) published the draft Climate Change Bill, 2018 for public comment. Since then, the Department of Environmental Affairs (“DEA”) has undertaken a road show across the country to solicit comments to the Bill and held further bilateral meetings with stakeholders earlier this year ...
On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0.5% m/m. 2020 is rapidly approaching, but is the shipping industry really prepared? In this article, we provide an overview of the regulations and the main alternatives for compliance that shipowners and operators are faced with. Introduction On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0 ...
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 ...
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 ...
