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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Facebook recently won a landmark victory in the Ninth Circuit against a company that accessed Facebook’s computers to help users manage their social network accounts. Now the company, Power Ventures, Inc., says that the Ninth Circuit’s decision risks creating “widespread confusion” about when it is a crime to use a computer to access a website. The issue in Facebook, Inc. v. Power Ventures, Inc., No. 13-17102 (9th Cir ...
