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 ...
Embezzlement and fraud within nonprofit organizations has reached epidemic proportions. According to the Association of Certified Fraud Examiner’s (2020) Global Study which contains an analysis of 2,504 cases of occupational fraud that were investigated between January 2018 and September 2019, 70 percent of frauds occurred in nonprofit organizations ...
The last installment of our three-part series explains U.S. tax considerations of a divided interest strategy for the bare owner who is a U.S. person. In most situations involving global families, it is the bare owner, rather than the holder of the usufruct, who is a U.S. person. The usufruct holder is often a nonresident alien who puts in place the property division for foreign estate planning purposes. In many instances, one or more members of the younger generation move to the United States ...
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 ...
Since the enactment of the statutory donor-advised fund (“DAF”) rules under the Pension Protection Act of 2006, sponsoring organizations that manage DAF programs have relied on the Internal Revenue Code (“IRC” or the “Code”) and certain limited administrative guidance to structure and operate DAFs ...
Last week, a trial court in Buffalo ruled that a group of personal injury plaintiffs’ strict liability claims against a who’s-who of social media companies, arising out of the tragic 2022 Tops Friendly Markets mass shooting, could proceed to discovery, rejecting the argument that Section 230 of the Communications Decency Act barred such claims from the get-go. Patterson, Diona Et Al v. Meta Platforms, Et Al, 0805896/2023 (NYSCEF Doc No. 409) ...
Recent bills in the U.S. House of Representatives and Senate demonstrate legislators’ concerns about several issues related to nonprofits, including: (1) admissions practices at institutions of higher education; (2) cross-border grantmaking by U.S ...
On May 30, 2023, National Labor Relations Board (“NLRB”) General Counsel Jennifer Abruzzo took yet another step to ban restrictive covenants in the employment context. In a memo issued to all regional offices, she set forth her view that nearly all non-compete provisions, with very limited exceptions, violate the National Labor Relations Act (“NLRA”) ...
On January 10, 2024, the Wage and Hour Division of the United States Department of Labor (“DOL”) published a final rule (the “Final Rule”), which became effective on March 11, 2024, modifying the DOL’s guidance on how to analyze who qualifies as an employee or an independent contractor under the Fair Labor Standards Act (“FLSA”) ...
Over the last three years, the U.S. Department of Justice has pursued its first-ever criminal antitrust cases targeting alleged deals between companies to avoid poaching each other's employees and to fix wages. In total, the DOJ has brought six cases. Four resulted in acquittals, while just one case yielded guilty pleas. Last month, the DOJ voluntarily dismissed its sixth and last case without explanation. A number of lessons can be drawn from this wave of labor-market prosecutions ...
The court’s decision in Mallory could have profound implications for larger-sized companies that operate in multiple states throughout the country. And nowhere is this truer than in New York, where the state’s status as a global hotspot for foreign investment has attracted myriad out-of-state companies to register to do business within its borders. For over half a century, the U.S ...
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 ...
In November 2021, the New York City Council passed a bill requiring that artificial intelligence (“AI”) tools used by employers to make or assist in hiring decisions or internal promotions undergo bias audits to screen for discriminatory effects. Under the City Charter, the bill became law a month later after it was returned unsigned to the Council by then-mayor Bill DeBlasio ...
On December 4, 2023, New York City Mayor Eric Adams signed into law the New York City Council’s bill, Int 0569-2022 (the “City Law”). The bill, known as the “Workers’ Bill of Rights,” will require New York City employers to abide by certain notice and distribution requirements by July 1, 2024. The notice and distribution requirements will inform employees and independent contractors of their rights under federal, state, and local law ...
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 ...
New York State Lifts Restrictions. On June 7, 2021, New York Governor Andrew Cuomo declared that the State would lift most remaining COVID-19 restrictions when 70% of adult New Yorkers had received their first dose of a COVID-19 vaccine. On June 15, 2021, Governor Cuomo held a press conference to announce that New York had reached the 70% first-dose threshold ...
The New York State Education Department (“SED”) has proposed an amendment to Title 8, Section 3.59 of the Rules of the Board of Regents that would clarify how a New York State institution of higher education (an “IHE”) might enter into certain corporate relationships with a “highly qualified out-of-state institution ...
Cybersecurity is one of the most critical challenges facing our nation and our economy. U.S. regulators on both the state and federal level are working to keep pace with the challenges and risks posed by cybercrime. On March 1, 2017, the New York State Department of Financial Services (DFS) issued a new cybersecurity regulation designed to protect financial institutions, their information technology systems, and their customers from cybercrime1 ...
With the public comment period closing in a few days, the New York Department of Financial Services (DFS) “first in the nation” cybersecurity regulation is one step closer to becoming law ...
On Tuesday September 12, Patterson Belknap Partner Bill Cavanaugh delivered the opening statement on behalf of a coalition of the Attorney Generals from 38 states and other jurisdictions in the trial of a historic monopoly antitrust lawsuit against Google involving its search engine. Bill was appointed by the Attorney Generals of Colorado and Nebraska, the lead plaintiffs in the states' case, to serve as lead trial counsel ...
Patterson Belknap has once again been included on The American Lawyer’s “A-List” of 20 leading law firms in the United States. The 2023 A-List is based on five criteria: pro bono performance, associate satisfaction, diversity of lawyers, percentage of women equity partners, and financial performance ...
