The World Trade Organization is considering a proposal, advanced by India and South Africa in October 2020, to waive intellectual property rights related to the development of the vaccines against COVID-19 for the duration of the pandemic. The Biden administration has indicated its support.
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On April 22, 2021, the Supreme Court of the United States unanimously held that Section 13(b) of the Federal Trade Commission Act does not authorize the FTC to seek, or a court to award, equitable monetary relief. The decision is likely to have a significant impact on the FTC’s decision-making process in bringing future cases directly to federal district court, as opposed to going through the administrative process, and it will likely spur congressional debate and possibly lead to new legislation.
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On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day.
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The Supreme Court of the United States is to decide the fate of administrative patent judges of the Patent Trial and Appeal Board, namely whether the current appointment scheme violates the Appointments Clause of the U.S. Constitution. This case, which may have broad implications on post-grant proceeding process before the USPTO, is being watched by companies around the world.
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The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices. The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.
To read the full text of this post by Duane Morris attorney Sharon O’Reilly, please visit the Duane Morris Products Liability Blog.
Confidentiality agreements or nondisclosure agreements (NDAs) are generally one of the first documents that in-house counsel require teams to execute when exploring licensing and/or research opportunities with third parties. NDAs are meant to protect the confidential information of one or both parties while each party determines whether the collaboration is worth pursuing. However, in a recent case in the Southern District of New York, one party tried to invoke a forum selection clause of an NDA to prevent the other party from challenging patents using inter partes review at the USPTO’s Patent Trial and Appeal Board.
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In connection with a crackdown on CBD manufacturers pursuant to its “Operation CBDeceit,” the FTC announced today settlements with six CBD-infused product manufacturers who, according to the FTC, allegedly made a “wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.” Under the settlements of the respective complaints against them, each of the manufacturers will be required to pay a fine, and cease making “unsupported health claims” in connection with the marketing of their products.
To read the full text of this post by Duane Morris partner Seth Goldberg, please visit the Duane Morris Cannabis Industry Blog.
The U.S. Food and Drug Administration (FDA) recently published the draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, Guidance for Industry. Comments can be submitted to FDA by January 19, 2021.
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In Abbott Laboratories v. Grifols Diagnostic Solutions Inc., the U.S. District Court for the Northern District of Illinois opined as to patent-eligible subject matter in the context of a biological invention. The case presents another situation in which the law of nature and natural phenomenon judicial exceptions have come to the forefront in the analysis of patent-eligible subject matter.
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Pharmacy benefit managers (PBMs) play a significant role in U.S. drug pricing, yet their existence is little known to those outside of the pharmaceutical and insurance arenas. In an effort to modify one of the largest drivers in increasing drug costs―rebates paid to PBMs by drug manufacturers―the U.S. Department of Health and Human Services on November 20, 2020, published three final rules that, most notably, declared that these rebates are no longer protected by the safe harbors to the anti-kickback statute.
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