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Genetically Modified Purple Tomatoes

By Brian D. Keppler, Ph.D.

Purple tomatoes developed by Norfolk Plant Sciences in the UK may be coming to grocery stores in the not too distant future. Last month, USDA APHIS announced that, from a plant pest risk perspective, the purple tomato may be safely grown and used in breeding in the US. The purple color of the tomato is […]

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Radar-Based Sleep Trackers: Sweet Dreams or Privacy Nightmare?

By Sarah M.D. Luth

It’s no secret that more people than ever are sleeping poorly.  A recent study by the American Academy of Sleep Medicine found that more than half of all Americans have had problems sleeping since the onset of the COVID-19 pandemic. Even independent of the pandemic, an estimated 70 million Americans are believed to suffer from […]

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COVID-19 Prioritized Examination Pilot Program Extended

By Brian D. Keppler, Ph.D.

The USPTO recently announced on March 25, 2022 that the COVID-19 Prioritized Examination Pilot Program has been extended for a third time. Requests for prioritized examination filed in qualifying patent applications will now be accepted until midnight on June 30, 2022. The pilot program began accepting requests on July 13, 2020 and was initially limited […]

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Proposed rulemaking to implement WIPO Standard ST.26

By Brian D. Keppler, Ph.D.

Patent applications containing nucleic acid or protein sequences will be required to submit a sequence listing in compliance with the new WIPO Standard ST.26 beginning on January 1, 2022. With the implementation of the new standard coming soon, the USPTO has issued a notice of proposed rulemaking to revise the rules of practice for submitting […]

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COVID-19 VACCINE IP WAIVERS AND PLATFORM PATENTS

By Charles P. Romano, Ph.D.

The recent announcement by US Trade Representative Katherine Tai that the “US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic” has led to concern over the potential scope and effect of such waivers. Forced disclosure of trade secrets related to vaccine manufacturing processes has generated the most concern since […]

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Inherent anticipation – Is the phenotype exhibited by a transgenic plant an inherent feature?

By Brian D. Keppler, Ph.D.

A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference. If a prior art reference expressly sets forth each of the elements of a claim, then there is typically little question of whether or not the […]

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Antibody Claim Strategies After the Amgen v. Sanofi Decisions

By Charles P. Romano, Ph.D.

Monoclonal antibodies (“mAb”) which specifically bind therapeutic targets dominate the biopharmaceutical market with global sales revenues estimated at nearly US$163 billion in 2019. Prior to the 2017, mAb were often protected in the US by broad claims which described the therapeutic target (i.e., the “antigen”) that the mAb could bind since such mAb could be […]

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Deposit of biological material and the differing national laws

By Brian D. Keppler, Ph.D.

For patent applications in the biotechnology area, a biological material is sometimes essential for carrying out the invention. The biological material can be any material capable of reproducing itself or being reproduced in a biological system, including bacteria, fungi, algae, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, and plant seeds. If the biological material cannot […]

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Has the Federal Circuit Made It Nearly Impossible to Maintain Genus Claims?

By Blog Staff

A recent denial by the Supreme Court of the United States (SCOTUS) to hear an appeal by Merck’s Idenix Pharmaceuticals LLC (Idenix), leaves unanswered questions regarding the overall validity of genus claims, particularly within the biopharma field. The SCOTUS denied a petition for writ of certiorari to clarify certain Section 112 requirements with respect to […]

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Breakthrough in Protein Structure Prediction

By Brian D. Keppler, Ph.D.

Knowing the three-dimensional structure of a particular protein is critical in determining its function and has implications for everything from treating human disease to herbicide resistant plants. Researchers currently use experimental techniques such as x-ray crystallography, nuclear magnetic resonance, or cryo-electron microscopy to establish the structure. However, these techniques are time consuming and can take […]

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