The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation for treating atrial fibrillation.
MaxQ-AI (previously known as MedyMatch) recently filed for an $8 million IPO. According to Nasdaq, MaxQ-AI filed confidentially on February 13. The prosepectus filed with the SEC describes MaxQ-AI as “a clinical stage artificial intelligence, or AI, company specializing in improving diagnostic accuracy through deep learning technology.” MaxQ-AI is currently classified as an “emerging growth company” under the 2012 JOBS Act (meaning it had revenues of less than $1.07 billion last fiscal year). MaxQ-AI’s CEO is Gene Saragnese.
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed patents for Xyrem®.
Before Prost, Dyk, and O’Malley. Appeal from the Patent and Trial Appeal Board.
Summary: An IPR petitioner lacks standing to appeal an adverse decision by the Board if it sells no infringing products and there is no risk of future infringement or infringement allegations by the patentee.
Before Lourie, O’Malley, and Taranto. Appeal from the United States District Court for the Northern District of Texas.
Summary: Where remand of post-reexamination claims that issued during the pendency of an appeal would be futile, the Federal Circuit may address the claims as they emerge from reexamination.
In Cosmetic Warriors v. Pinkette Clothing, the Ninth Circuit addressed the availability of laches in trademark infringement and cancellation actions under the Lanham Act.
Cosmetic Warriors Limited (CWL) is a cosmetics retail company, which owns almost 1000 LUSH retail stores worldwide and has been operating in the U.S. since 2002. CWL owns multiple U.S. trademark registrations, including registrations of LUSH on perfumes and hair services.
Before Newman, Clevenger and Chen. Appeal from the United States District Court for the Central District of California.
Summary: Prosecution history estoppel does not bar enforcement of a patent when the accused product falls outside the scope of the purported surrender.
On July 20, 2018, SingHealth, a Singapore healthcare institution consisting of four public hospitals, five national specialty centers and a network of nine polyclinics, reported that it had been the target of a cyberattack resulting in the information of around 1.5 million individuals being compromised.
Before Newman, Lourie, and Reyna. Appeals from the Patent Trial and Appeal Board.
Summary: A party did not waive SAS-based relief in an IPR appeal when it requested remand for consideration of non-instituted claims shortly after issuance of SAS and requested remand for consideration of non-instituted grounds shortly after issuance of the Federal Circuit’s first orders recognizing that SAS also required consideration of all grounds raised in an IPR petition.
On July 18, 2018, the FDA released a Biosimilar Action Plan[1] that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish these goals:[2]
