On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug Administration (FDA) approval. The Notice relates to certain duties owed to the USPTO with regard to statements and documents submitted to the FDA and other government agencies. The duties include a duty to disclose certain information and a duty of reasonable inquiry.
REALTIME ADAPTIVE STREAMING LLC v. NETFLIX INC.
Before: Newman, Reyna, and Chen. Appeal from the Central District of California.
Summary: Courts may use their inherent equitable powers to award attorneys’ fees for bad faith conduct.
The 3M Company announced on July 26th that it will spin off its health care business into a separate, publicly-traded company. The health care business will focus on wound care, oral care, healthcare IT, and biopharma filtration. The current health care business lines include bandages, skin adhesives, oral aligners, air purifiers, optical lenses, and the Bair Hugger™ surgical warming system that is currently the subject of nearly 6,000 lawsuits.
AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology. AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention if it has been for sale for over one year prior to the patent filing.
CAREDX, INC. V. NATERA, INC.
Before Lourie, Bryson, and Hughes
Summary: Expert testimony that steps of challenged patent claims were unconventional failed to preclude summary judgment of ineligibility where specification admitted the steps were conventional.
LG ELECTRONICS INC. v. IMMERVISION INC.
Before Stoll, Cunningham, and Newman, Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.
Summary: Where a reference contains an “obvious” error in a disclosure, even if not immediately apparent on the face of the disclosure, the erroneous information may not support a finding of obviousness.
On July 1, 2022, Acutus Medical (”Acutus”), an arrhythmia-based medical device company, reported that it completed the first of its two closings in its left-heart access portfolio sale to Medtronic. Acutus, the maker of the AcQCross™ line of sheath-compatible septal crossing devices and systems, first announced this deal in late April 2022, and it includes an upfront $50 million cash payment to Acutus Medical upon the initial closing of the transaction.
On June 15, 2022, Boston Scientific entered into a definitive agreement to purchase a majority stake in M.I.Tech Co., Ltd, a publicly traded Korean medical device company in the field of endoscopic and urological procedures. The agreement includes a purchase price of approximately $230 million. According to the announcement, M.I.Tech is the creator of the HANAROSTENT® technology, a family of conformable, non-vascular, self-expanding metal stents. Non-vascular stents can be used in gastrointestinal applications and in airways to clear obstructions or constrictions in areas such as the biliary tree, pancreatic duct, esophagus, colon, and duodenum.
MEENAXI ENTERPRISE, INC. v. THE COCA-COLA COMPANY
Before Dyk, Reyna, and Stoll. Appeal from the Trademark Trial and Appeal Board.
Summary: To maintain a statutory cause of action under the Lanham Act for activities solely conducted outside the United States, the claimant must provide concrete evidence of reputational injury or lost sales.
