On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers.
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Federal Circuit Confirms Addition of Two Inventors of Groundbreaking Immunotherapies for Cancer
In Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co. Ltd, the Federal Circuit held that two scientists, Dr. Gordon Freeman and Dr. Clive Wood, should be included as joint inventors, along with Dr. Tasuku Honjo for patents related to immunotherapy for treating cancer. Identifying foundational discoveries underlying a patent claim could be considered a significant contribution that may rise to the level of inventorship even though the claims do not recite such discoveries. The decision clarifies inventorship rules in the context of pioneering therapeutic work, and suggests that no necessary contribution can be ignored in the inventorship analysis, even if the contribution was independently published before the application for patent.
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USPTO Provides Form for Claiming 30-Day COVID-19 Extensions
On March 31, 2020, the USPTO announced that it is permitting applicants, for delays that are based on the ongoing COVID-19 emergency in the United States, to request a 30-day extension of the time allowed to file certain documents and to pay certain fees. We provided an explanation of this announcement when it was published. Since then, the USPTO provided a form to be used for the “statement of delay” required in claiming a COVID-19-related filing extension. Extensions were originally applicable to due dates falling between March 27 and April 30. The USPTO, on April 28, 2020, extended the applicable period for due dates to June 1, 2020.
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Congress Gives Patent and Trademark Office Temporary Authorization to Move Deadlines in Light of COVID-19 Pandemic
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act into law. The CARES Act is a $2 trillion economic stimulus and rescue package designed to mitigate the economic impact of the COVID-19 global pandemic caused by the novel coronavirus, which has resulted in a level of societal and economic disruption that is unprecedented in living memory. Included in the bill is a temporary authorization to the Director of the United States Patent and Trademark Office (USPTO) during the pandemic to toll, waive, adjust, or modify any timing deadline under the patent or trademark laws. While the USPTO Director has not pointed to any specific change that will be made under the new authorization, it is possible that at least some timing deadlines will be modified to accommodate hardships faced by stakeholders during this crisis.
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Federal Circuit Weighs in on Patent Subject-Matter Eligibility of Dietary Supplements
The Federal Circuit weighed in on patent subject matter eligibility again last week, finding certain amino-acid containing dietary supplements, and related methods of use, to be patent eligible. In Natural Alternatives Int’l v. Creative Compounds, LLC, the Federal Circuit vacated the decision of the district court in the Southern District of California, which held that several sets of claims issued to Natural Alternatives International (“Natural”) were not directed to patentable subject matter under 35 USC § 101. The district court found the claims not patent eligible following a motion on the pleadings. Although the claims at issue included methods of treatment, composition, and process claims, this entry looks at the court’s decision with respect to methods. The decision could put some wind in the sails of developers of supplements and nutraceuticals.
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PTO Cancer Immunotherapy Fast Track
In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative:
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