Showing all posts written by Nima Zargari
Nima received his J.D. from Loyola Law School, Los Angeles, where he worked in the Ninth Circuit Appellate Clinic, and successfully briefed a withholding of removal immigration case to the U.S. Court of Appeals for the Ninth Circuit. He also served as the editor-in-chief of Volume 40 of the Loyola of Los Angeles Entertainment Law Review.
Before attending law school, Nima earned his Ph.D. in chemistry from the University of Southern California. His graduate work focused on small molecule synthesis via palladium(II) catalysis.
Nima worked as a summer associate with the firm in 2019 and joined the firm in 2021.
FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products
On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials, titled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft guidance describes the FDA’s current position regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices involving children. The guidance explains the fundamental concepts for the ethical framework that institutional review boards (IRBs), sponsors, and the industry should consider when reviewing or conducting clinical trials involving children.
Of note, the guidance outlines additional considerations and recommendations IRBs should assess when enrolling children in clinical investigations of medical products. The guidance explains that, in principal, the risk of the clinical investigations must be balanced by the prospect of direct and potential benefits and must at least be as favorable as any available accepted alternative treatment. Accordingly, the guidance suggests medical product developers need to use a dose or treatment level expected to be effective for the child which should also have a positive impact on the child’s life.
The FDA’s Office of Pediatric Therapeutics noted that “the best way to provide children with safe and effective treatment options is by including them in clinical research.” The Office of Pediatric Therapeutics further noted that children are afforded additional safeguards when participating in a clinical investigation since they are a vulnerable class who cannot provide informed consent for themselves. The FDA’s guideline comes at an important time. By way of example, although 48.2% to 72.6% of parents are willing to vaccinate their children against the COVID-19 virus, a lower rate of parents allow their children to participate in clinical trials.
The FDA’s draft guidance is available here, and is available for comments until December 27, 2022.
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft guidance covers a wide range of issues, including cybersecurity device design, labeling, and documentation. The guidance is intended to provide medical device makers a road map on how to satisfy the FDA’s quality system and patient safety regulations and how to address cybersecurity considerations within their premarket submissions.
The FDA’s draft guidance was released shortly before a report underlining the cybersecurity security practice deficiencies of various medical device makers. On April 20, 2022, Cybellum – a company specializing in assessing product security – reported the results of its 2022 medical device cybersecurity survey in an article titled Medical Device Cybersecurity: Trends and Predictions. The survey found that, although 83% of the medical device companies surveyed saw device security as a competitive edge, 75% of respondents noted that they do not have a dedicated senior management who takes responsibility for device cybersecurity.
The Cybellum survey also revealed that only about a quarter of the medical device companies surveyed (27%) generate and maintain a Software Bill-of-Materials (SBoM) for their products. An SBoM is a formal record containing the details and supply chain relationships of various components used in building software. President Joe Biden previously highlighted the importance of an SBoM in his Executive Order on Improving the Nation’s Cybersecurity from May 2021. Moreover, the National Telecommunications and Information Administration published The Minimum Elements for an SBoM on July 21, 2021, in an effort to bring “transparency to the components and connections within and across supply chains.”
The FDA’s draft cybersecurity guidance document is available here and is available for stakeholder comments until July 7, 2022.
Federal Circuit Reverses District Court’s Decision Based on On-Sale Bar (Junker v. Medical Components, Inc.)
On February 10, 2022, in Junker v. Medical Components, Inc., the U.S. Court of Appeals for the Federal Circuit reversed the Eastern District of Pennsylvania’s grant of summary judgment of no invalidity under the “on-sale bar” of 35 U.S.C. § 102(b) (pre-AIA). Mr. Junker’s lawsuit alleged that Medical Components, Inc. and Martech Medical Products, Inc. (collectively, “MedComp”) infringed the claimed design of U.S. Design Patent No. D450,839 (the “D’839 patent”), entitled “Handle for Introducer Sheath.”
Under 35 U.S.C. § 102(b) (pre-AIA), a patent claim is invalid if “the invention was . . . on sale in this country, more than one year prior to the date of the application for patent in the United States.” Section 102(b)’s on-sale bar is triggered if, more than one year before the United States patent application filing date (i.e., before the “critical date”), the claimed invention was both (1) the subject of a commercial offer for sale and (2) ready for patenting. Mr. Junker filed the application that led to the D’839 patent on February 7, 2000; as such, the critical date for analyzing the applicability of the on-sale bar is February 7, 1999. The parties did not dispute that the claimed design was ready for patenting, but disagreed whether a January 8, 1999 letter was a commercial offer for sale of the claimed design or merely a quotation of the parties’ preliminary negotiations.
Applying traditional contract law principles, the Federal Circuit held that the January 8, 1999 letter was a commercial offer for sale. First, the Federal Circuit noted that the letter was directly responding to a “request for quotation.” In addition, the letter also contained a number of necessary terms typical for a commercial contract such as “shipment in bulk, non-sterile,” “FOB Athens, Texas,” and a “net 30-day basis” payment term. The Court further highlighted that the letter specified multiple different purchase options for the patented products. Accordingly, the Court determined based on the “overall language of the letter” that the specificity and completeness of the commercial terms therein outweighed three references to “quotation” and mention of possible future discussions. The Federal Circuit thus found that the letter triggered the on-sale bar and invalidated the D’839 patent, and therefore reversed the district court’s summary judgment of no invalidity.
The Federal Circuit’s decision is available here.
Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).
In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.” The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve. The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed. Therefore, the PTAB found that the prior art anticipated the claims.
The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.” The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.” The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.
The Federal Circuit’s decision is available here.
Nephros is a water technology company, providing filtration and pathogen detection solutions to the medical and commercial markets. Nephros acquired substantially all of GenArraytion’s assets, namely, GenArraytion’s proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other microorganisms using Polymerase Chain Reaction (PCR) technology. GenArraytion has developed infectious disease diagnostics for hospital-acquired infections and other water safety targets
GenArraytion currently produces MultiFLEX® Bioassays. These bioassays are customizable for detection of “clinical pathogens, tick- and mosquito-borne pathogens, food- and water-borne pathogens and biothreat agents” according to GenArraytion’s website.
The acquisition enhances Nephros’ capabilities for measuring and monitoring waterborne pathogens utilizing PCR testing, and propels Nephros’ abilities to detect and mitigate the spread of infectious disease in premise plumbing.
Waterborne pathogens are a major worldwide public health concern. In addition to developing organisms and new strains from already known pathogens, high prevention and treatment costs present concrete challenges to the public health sectors. The acquisition will allow Nephros to provide on-site testing and data for premise water management.
Nephros issued 123,981 shares of its common stock to GenArraytion, for an aggregate purchase price of $1.2 million. Half of the shares are subject to a risk of forfeiture, which will lapse upon the satisfactory completion of certain intellectual property transition services. Nephros will also make royalty payments to GenArraytion based on net sales of GenArraytion products over the next five years.