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 ...
Dear valued clients, colleagues and friends, Our Arbitration and Mediation partners Rabindra S. Nathan, Rodney Gomez and K. Shanti Mogan have co-authored the Malaysian chapter of The Legal 500 Country Comparative Guides: International Arbitration 2021. The Arbitration Act 2005 (“AA 2005”) applies to arbitration in Malaysia ...
Dear valued clients, colleagues and friends, Our Dispute Resolution partners, Dhinesh Bhaskaran, Datin Jeyanthini Kannaperan, Rabindra S. Nathan and K. Shanti Mogan, have co-authored the Malaysian Law and Practice and Trends and Developments chapters in the Chambers Global Practice Guide: Litigation 2022 ...
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 ...
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 ...
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 ...
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 ...
phttps://www.huntonak.com/en/insights/medical-timeshares-require-more-than-what-you-learned-in-kindergarten-american-health-law-association ...
What is your outlook for Chinese businesses and investment as we approach the end of 2021? China is, and will continue to be, the strongest market for offshore law firms in Asia. China's outbound investment activity has been subdued since 2016, due to domestic constraints on outbound capital flows and tighter scrutiny of Chinese investments abroad ...
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 Process Migration is the process which allows an overseas company to be registered as a Guernsey company in accordance with the provisions of The Companies (Guernsey) Law, 2008 (as amended) (the "Law") ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
We are seeing renewed interest in these types of structures – particularly from fund managers who have not previously targeted Shariah investors - as (i) sovereign wealth funds, pension funds and HNW individuals from the Middle East and South East Asia diversify into alternative assets like private equity (PE), and (ii) traditional or "western" managers look to expand into the Shariah market by establishing bespoke feeder or parallel funds in Guernsey which offer a Shariah complian
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
The Federal Trade Commission (FTC) has made several recent announcements signaling its intention to increase antitrust merger enforcement under the leadership of Chairperson Lina Kahn, appointed by President Biden. Some relate to the Hart-Scott-Rodino (HSR) pre-merger notification requirements, which apply regardless of whether a transaction is substantively reviewed by the FTC or the Department of Justice (DOJ) ...
In association with Macmillan Davies and led by Employment Partner, Emma Morgan and Associate, Lauren Bholé, this webinar focused on the menopause in the workplace. With World Menopause Day having just passed (18 October 2021) and a parliamentary debate on the menopause having entered the House of Commons in September 2021, the menopause has been a focal point for media coverage ...
On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...
In February 2012, the FATF published the revised FATF Recommendations (also known as the Standards). The Standards continue to develop to detect and prevent new money laundering and terrorist-financing techniques impacting the international financial system, such as misuse of virtual assets and COVID-19 related threats ...
OSHA’s long-anticipated (as we have previously discussed) COVID-19 Emergency Temporary Standard ("ETS") is out and, as promised, it will require companies with at least 100 employees – across all facilities – to either institute a vaccine mandate or compel unvaccinated employees to submit to weekly testing and workplace masking for at least the next six months ...
