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For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA Litigation
Patterson Belknap Webb & Tyler LLP, November 2020

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...

SECURE Act Update: Nondiscrimination Testing Relief and Changes to Permissible In-Service Distribution Ages for Defined Benefit and Money Purchase Plans
Patterson Belknap Webb & Tyler LLP, November 2020

As part of our series of continuing updates1 on different aspects of The Setting Every Community Up For Retirement Enhancement Act of 2019 (the “SECURE Act”) and related legislation that may impact (or provide opportunities for) employers that sponsor retirement plans, this alert provides an overview of changes to rules related to nondiscrimination testing where defined benefit plans have been frozen or closed to new participants under the SECURE Act, and a reduction in the m

SECURE ACT Update: Lifetime Income Illustrations
Patterson Belknap Webb & Tyler LLP, November 2020

The Setting Every Community Up For Retirement Enhancement Act of 2019 (the “SECURE Act”), made sweeping changes to retirement plan rules...

Data Security Law Blog
Patterson Belknap Webb & Tyler LLP, September 2020

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...

FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines
Patterson Belknap Webb & Tyler LLP, July 2020

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 U.S. Senate Passes the Holding Foreign Companies Accountable Act
Patterson Belknap Webb & Tyler LLP, June 2020

The United States Senate passed S. 945, the “Holding Foreign Companies Accountable Act” (the HFCAA), by unanimous consent on May 20, 2020. The HFCAA was first introduced in the Senate on March 28, 2019 by Senator John Kennedy (R-LA) and co-sponsored by Senator Chris Van Hollen (D-MD)...

COVID-19 Update: IRS and DOL Extend COBRA and Other Benefit Plan Deadlines During the Pandemic Outbreak Period
Patterson Belknap Webb & Tyler LLP, May 2020

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”)...

Cross-Border Tax-Related COVID-19 Relief
Patterson Belknap Webb & Tyler LLP, May 2020

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...

EEOC Issues Guidance on the Permissibility of Mandatory COVID-19 Testing in the Workplace
Patterson Belknap Webb & Tyler LLP, May 2020

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...

Coronavirus (COVID-19) Resource Center
Patterson Belknap Webb & Tyler LLP, March 2020

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...

New York Employer Tips for Responding to the Coronavirus
Patterson Belknap Webb & Tyler LLP, March 2020

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...

Perspective and Planning During Uncertainty
Patterson Belknap Webb & Tyler LLP, March 2020

Recent market volatility and the public health implications of the spread of coronavirus (COVID-19) have been unsettling.  It can be stabilizing in turbulent times to take a deep breath, focus on long-term planning strategies and goals, and assess whether there might be new opportunities to enhance your estate plan...

COVID-19’s Effect on New York Commercial Division
Patterson Belknap Webb & Tyler LLP, March 2020

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...

The FDA Regulatory Landscape for COVID-19 Treatments and Vaccines
Patterson Belknap Webb & Tyler LLP, March 2020

As the United States and countries all over the world continue to grapple with the Covid-19 pandemic, the race is on for Covid-19 treatments and vaccines.  There is currently no FDA-approved therapy or vaccine for Covid-19.  Given the profound urgency, life sciences companies and other researchers are prioritizing research and development of potential therapies and vaccines...

Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira
Patterson Belknap Webb & Tyler LLP, December 2019

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...

Assessing Potential Risk: Due Diligence for Acquisition of Product Manufacturers
Patterson Belknap Webb & Tyler LLP, December 2019

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...

Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco
Patterson Belknap Webb & Tyler LLP, December 2018

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...

Daesang V. NutraSweet Reaffirms NY's Pro-Arbitration Attitude
Patterson Belknap Webb & Tyler LLP, October 2018

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...

Seventh Circuit Issues Strong Endorsement of Learned Intermediary Doctrine in Medical-Device MDL
Patterson Belknap Webb & Tyler LLP, April 2018

The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician...

Fed. Circ. Case May Change Biosimilar IPR Strategy
Patterson Belknap Webb & Tyler LLP, April 2018

 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...

Mixed Results as IPR Petitions for Biosimilars Soar
Patterson Belknap Webb & Tyler LLP, December 2017

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...

Patterson Belknap Publishes New York Commercial Division Practice Guide
Patterson Belknap Webb & Tyler LLP, November 2017

Patterson Belknap Webb & Tyler LLP announced today the publication of its New York Commercial Division Practice Guide.  This new publication is part of Bloomberg BNA’s Litigation Practice Portfolio Series, and an excerpt is available to download at: http://on.bna.com/H1KM30gCY7v...

A Lawyer's Struggle to Overcome Barriers and Live by Ideals in the Practice of Law
Patterson Belknap Webb & Tyler LLP, August 2017

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...

Puerto Rico Files for Bankruptcy: New York Judge to Hear Case
Patterson Belknap Webb & Tyler LLP, May 2017

The Financial Oversight and Management Board for Puerto Rico recently filed a voluntary petition for relief on behalf of Puerto Rico in federal court there.  The filing required the Chief Justice of the United States to designate a district court judge to conduct the case.  In recent months Chief Justice Roberts appointed District Judge Laura Taylor Swain of the Southern District of New York...

New York's Cybersecurity Regulations for Financial Institutions & Health Care
Patterson Belknap Webb & Tyler LLP, April 2017

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...

 

 

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