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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
On September 29, 2023, the Equal Employment Opportunity Commission (“EEOC”) published new proposed enforcement guidance ("the Proposed Guidance”) on harassment in the workplace. This is the first proposed EEOC guidance on workplace harassment since the turn of the century ...
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 ...
As noted in our May 3, 2023 and August 14, 2023 client alerts, Congress enacted the Pregnant Workers Fairness Act (PWFA) in late 2022, expanding protections for pregnant workers. Pursuant to the Act, the Equal Employment Opportunity Commission (EEOC) was directed to make rules to implement the statute. On April 15, 2024, the EEOC issued its final rule and interpretive guidance, which will go into effect on June 18, 2024 ...
Pension-Linked Emergency Savings Accounts (“PLESAs”) are a special retirement plan feature created under SECURE ACT 2.0. PLESAs were first permitted to be made available to participants as of January 1, 2024. PLESAs, which provide a flexible savings opportunity for non-highly compensated employees, can be added to certain defined contribution plans. New guidance regarding this option has been released, which may be of interest to employers and plan sponsors ...
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 ...
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 ...
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 ...
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 ...
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 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”) ...
Published in Corporate Counsel Business Journal March 1, 2023 CCBJ: To start out, please share your background with our readers, including your involvement with the WSG–Legal 500 Survey of In-House Legal Technology. Herman Raspé: I am a partner at Patterson Belknap Webb & Tyler in the capital markets group with a focus principally on equity, but also cross-border debt transactions ...
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 ...
U.S. Bankruptcy Judge Jacqueline P. Cox recently found that three Illinois attorneys violated their ethical obligations by failing to return their client's phone calls. She ordered the attorneys to return roughly half of their already-court-approved, and paid, flat fee. In In re: Molnar in the U.S. Bankruptcy Court for the Northern District of Illinois in February, the debtor filed a petition under Chapter 13 ...
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 ...
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 ...
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 ...
It would be a surprise to many, but it has been common knowledge to criminal practitioners for years, that a criminal defendant’s sentence for a crime which they have been convicted can be increased based on consideration of conduct that the jury acquitted ...
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 ...
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 ...
