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Improving Orange Book Listing Eligibility for Drug Delivery Device Patents

Several products approved for marketing as drugs in the US are administered using a device (a drug-device combination product). Companies that own such products often file at least one U.S. patent to protect the device.  In addition to obtaining patent protection for the device, a company may also wish to list the device patent in the U.S. Food and Drug Administration’s (FDA) “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book).  Listing a patent in the Orange Book patent provides certain benefits to the owner of a drug product. Although the eligibility of drug delivery device patents for listing in the Orange Book for drug products is unclear, this blog provides some suggestions to strengthen eligibility for listing.

Prosecution, Drug Delivery Device Patents, Orange Book Listing, Hatch-Waxman
Author: Heidi L. Kraus

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CRISPR – Sometimes you win, sometimes you lose

On January 18, 2018, the European Patent Office (EPO) revoked European Patent No. 2,771,468 (“the ‘468 patent”), one of the original CRISPR patents.  The ‘468 patent was ultimately revoked by the European Patent Office because the Broad Institute could not establish a right of priority to their earliest U.S. Applications.

European Patent Prosecution, CRISPR
Author: Melissa J. Pytel

 

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