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There are few things more important today than lawyers willing to serve their communities - whether its people of color or immigrants or anyone pursuing freedom of speech, religion or from oppression. We’re living in extraordinary times. The ability to earn a legal education and serve a greater good has rarely been more important than it is today. My law school''s library and classrooms were my home away from home ...

Recently, the International Organization for Standardization (ISO) adopted a new set of voluntary standards, designated as ISO 37001, to assist organizations in their ongoing fight against bribery. As a result of recent increases in the enforcement of the U.S. Foreign Corrupt Practices Act of 1977 (FCPA) and, notwithstanding the guidance provided by the U.S. Department of Justice’s (DOJ) Resource Guide to the U.S ...

On March 11, 2021, President Biden signed into law the American Rescue Plan Act of 2021 (“ARPA”) which is another coronavirus stimulus package aimed at speeding up the United States’ recovery from the economic and health effects of the COVID-19 pandemic ...

The American Rescue Plan Act (“ARPA”) became law in March of this year. One of the many relief provisions included in ARPA is a temporary subsidy of COBRA continuation premiums for certain individuals, summarized in our prior alert, found here ...

With an increase in recent years of mass tort litigations and runaway jury verdicts, the scope and complexity of product liability and mass torts litigation continues to expand. The result:  product manufacturers face ever-growing potential risk and exposure. While in the past, manufacturers may have viewed products liability litigation as an inherent risk of doing business, the current legal climate has resulted in products liability litigation being far from business as usual ...

At Patterson Belknap we continue to diligently monitor the outbreak of the COVID-19 coronavirus and assess the potential legal and business issues that may arise relating to the virus.  The situation is fluid, and best practices and guidelines are evolving in real time.  We are closely monitoring the situation as it unfolds, and share our latest perspectives on the legal issues relating to COVID-19 below ...

On April 28, 2020, the Employee Benefits Security Administration, the Department of Labor, the Internal Revenue Service, and the Department of the Treasury (the “Agencies”) signed a joint notification of relief, which was published in the Federal Register on May 4, 2020 (the “Notice”) ...

Over the last few days, Judge Lawrence K. Marks, the Chief Administrative Judge of the New York State Unified Court System, issued two memoranda bearing on COVID-19’s effect on the Commercial Division. First, by memorandum dated March 13, 2020, Judge Marks announced that he and Chief Judge Janet DiFiore have implemented a number of measures to prevent the spread of COVID-19 and protect the well-being of court personnel ...

On April 21, 2020, the IRS released a much-awaited package of guidance in the cross-border tax space that provides relief to those impacted by the COVID-19 pandemic. The guidance relates to (1) day-counting for both tax residency purposes and certain treaty positions, (2) the ability of taxpayers to claim the foreign-earned income exclusion, and (3) carrying on a U.S. trade or business ...

Earlier this year, in a widely followed arbitration case, a unanimous panel of the New York Supreme Court Appellate Division, First Department, concluded that the New York County, Commercial Division, erred when it partially vacated an arbitration award on the ground that the arbitrators manifestly disregarded the law. As a result, the Appellate Division confirmed the arbitration award ...

DataSecurityLaw.com is the firm’s resource for the latest news, analysis, and thought leadership in the critical area of privacy and cybersecurity law. Patterson Belknap’s Privacy and Data Security practice provides public and private enterprises, their leadership teams and boards with comprehensive services in this critical area ...

In an effort to keep our readers up-to-date on the latest developments in cybersecurity law and regulation, we are pleased to share an overview of our team’s recent blog posts. We periodically send updates compiling links to our most recent blog posts and news. If you do not wish to receive email updates, please email Marketing to be removed from the distribution list ...

On April 23, 2020, the U.S. Equal Employment Opportunity Commission (“EEOC”) issued new guidance clarifying that employers may conduct mandatory testing of employees for COVID-19 before they enter the workplace so long as the testing is “job related and consistent with business necessity ...

The Equal Employment Opportunity Commission (“EEOC”) recently updated its Compliance Manual Section on Religious Discrimination, seeking to clarify how Title VII of the Civil Rights Act of 1964 (“Title VII”) protects individuals from religious discrimination in the workplace. The enforcement guidance also discusses the legal protections available to religious employers, which have been bolstered in recent years ...

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...

 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 ...

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 ...

Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia ...

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3 ...

On February 18, 2021, the IRS issued Notice 2021-15, which provides guidance with regard to a number of provisions of the temporary changes to the rules related to the operation of health and dependent care flexible spending accounts that were included as part of the Consolidated Appropriations Act, 2021 (the “New Law”), and also provides for an additional exception from the standard rules regarding Section 125 plan (often referred to as cafeteria plans or flexible benefits p

On March 26, 2021, the Internal Revenue Service (“IRS”) published Announcement 2021-7, which notifies taxpayers that certain amounts paid for personal protective equipment (such as masks, hand sanitizer, and sanitizing wipes) for the primary purpose of preventing the spread of COVID-19 (“COVID-19 PPE”) may be an eligible expense that can be reimbursed from certain health care account based plans ...

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 ...

OSHA Adopts CDC Vaccine Guidance. On May 17, 2021, the federal Occupational Health and Safety Administration (“OSHA”) updated its online COVID-19 portal to announce that OSHA is revising its employer materials to reflect recent interim guidance from the Centers for Disease Control and Prevention (“CDC”). In the meantime, OSHA recommends that employers “refer to the CDC guidance for information on measures appropriate to protect fully vaccinated workers ...

New law provides up to four hours of paid leave for vaccination: On March 12, 2021, New York Governor Andrew Cuomo signed legislation entitling New York employees to up to four hours of paid leave to receive COVID-19 vaccinations, effective immediately ...

The recent outbreak of 2019-nCOV, a flu-like respiratory illness better known as the Coronavirus, is causing employers to ready themselves for a variety of responses to the spread of the virus.  Human Resources professionals are seeking guidance on how to promote a safe and healthy working environment without violating the rights of ill or potentially ill employees.  We have some tips to help strike the right balance ...

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