AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim ...
On 12 May 2021, Prime Minister Boris Johnson committed to holding a Public Inquiry into COVID-19 that will place "the state's actions under the microscope". Demonstrating that it is independent, objective and fair is fundamental to an Inquiry’s purpose. We take a look at the extent to which the State can effectively examine itself in a Public Inquiry when it has ultimate responsibility for determining the remit, and therefore inevitably the scope of any conclusions ...
On 24 November 2021 Shoosmiths hosted a webinar exploring recent developments and forthcoming changes in environmental regulation – the COP26 climate change conference, the Environment Act 2021 and trends in sentencing for environmental offences. COP26 David Symons, director of sustainability at WSP UK outlined the three main messages from the COP26 conference: The 1 ...
On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals ...
Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range. In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges. Below, we discuss two of those cases in our “Also This Week” section ...
Tennessee healthcare providers now have a very different certificate of need (CON) law to consider when they plan new facilities or expand services. Tennessee's legislature and governor recently enacted the Health Services and Planning Act of 2021 (Public Chapter 557 or "the Act"), which became fully effective Oct. 1, 2021. The Act changes the substantive requirements for CON approval, as well as the application process to obtain a CON ...
The UK Government’s consultation on mandatory climate-related disclosures As the old saying goes – ‘knowledge is power’, and businesses caught in the net of proposed mandatory climate-related disclosures will need to empower themselves quickly in order to get up to speed by the proposed April 2022 rollout ...
Given the growing need for new sources of water for human and industrial consumption, in order to unify criteria in the evaluation of desalination projects, the General Directorate of the Maritime Territory and Merchant Marine (“DIRECTEMAR”) has published the following 3 guides with basic technical guidelines: Guide for the Environmental Assessment of Industrial Desalination Projects in Jurisdiction of the Maritime Authority The purpose of this guide is to update the minimu
The EU strives to become carbon neutral by 2050. This objective has been formally regulated through the EU Climate Law[i] and is enshrined in the European Green Deal[ii], being also in line with the EU’s commitment to global climate action according to the Paris Agreement[iii] and Glasgow Climate Pact[iv] ...
Milton Keynes, the New Town famous for its grid system, roundabouts and concrete cows is every bit the planner’s dream. Fifty-five years after its foundation and bidding for city status in the Queen’s platinum jubilee year, Milton Keynes has come of age ...
On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC) ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...
The Ministry of Interior issued a new Prakas No. 2644 PK dated 19 October 2021 on the Establishment and Management of Mandatory and Voluntary Taskforces for Fire Prevention and Firefighting (“Prakas 2644”) ...
