On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June. The updated guidance, which is being “implemented immediately” and “without prior public comment,” is intended “to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA . . . for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency."
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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about the perceived lack of predictability and clarity in determining subject matter eligibility under 35 U.S.C. § 101. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019). The guidance, which is intended for use by USPTO personnel in evaluating subject matter eligibility, “revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas).” Id. This new guidance represents an attempt by the USPTO to address “the legal uncertainty surrounding Section 101,” recognizing that “[m]any stakeholders, judges, inventors, and practitioners across the spectrum have argued that something needs to be done to increase clarity and consistency in how Section 101 is currently applied.” Id.
Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing denied, 890 F.3d 1369, address what qualifies as patent-eligible subject matter under 35 U.S.C. § 101 and how courts should resolve that question. These cases expose divisions within the court on § 101 issues, however, and leave uncertainty in their wake. Many stakeholders, including judges, are therefore calling for guidance from the Supreme Court as to how to resolve such issues or seeking the aid of Congress.