In this edition of the Mintz Life Sciences Newsletter, we share an interview with Arcturus CEO Joseph Payne, an invitation to the upcoming Barracuda Bowl competition, insights from the FDA's AI/Machine Learning Med Dev Workshop, and data on 3rd quarter deal and patent activity. We also provide an overview of recent Mintz life sciences transactions and highlight deals completed for our clients Cardurion Pharmaceuticals and Glycosyn, a biotech innovator.
C-Suite Interview
Welcome to the first C-suite interview to be featured in the Mintz Life Sciences Newsletter. We posed a series of questions to Joseph E. Payne, CEO of Mintz client Arcturus, an innovator in next generation mRNA vaccines and therapeutics. He shared his thoughts about the company, the industry, and the near future. We appreciate Joe's sharing his insights with us - and all of you!
// Interview with Arcturus CEO, Joseph E. Payne
What are the company's core areas of focus?
Arcturus is a clinical stage messenger RNA (mRNA) vaccines and therapeutics company. We currently have multiple SARS-COV-2 vaccines in later stage clinical trials.
While most people are familiar with mRNA due to the COVID-19 vaccines, what people may not yet be as familiar with are other uses for the technology. Arcturus is working on multiple applications for mRNA with different delivery platforms: vaccines using intramuscular delivery; liver disease therapies delivered intravenously; and lung disease therapies delivered by inhalation.
Click here to read the full interview.
Upcoming Event - Join Us for Barracuda Bowl!
Join Mintz and M2D2 for Barracuda Bowl 2021. We're still virtual, so you can join us from anywhere! Applicants for the competition have come from Europe, Asia, and across the US. Join us for the competition on November 16 to hear about "what's next" in med tech and biotech - and to glean insights from leading investors and advisors from J&J, GE Healthcare, Golden Seeds, Cap W Global Advisory, and Mission BioCapital. Click here or on the logo to the right to register.
FDA's AI/Machine Learning Med Dev Workshop
On October 14, the FDA hosted a Virtual Public Workshop titled, "Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices." The Mintz Health Law team was there and we provide insights into the program - and the FDA's past efforts at regulating medical device software and digital health - in a short series of blog posts. Providers, health plans, manufacturers, and patients expressed opinions and ideas at the workshop, resulting in a comprehensive discussion across all stakeholders on topics ranging from the need for transparency to data quality, bias and equity, proprietary versus open source code, data protection, and more. Read the series here.
Industry Activity
Each quarter, the Mintz transactions team reviews activity across several deal types in the US life sciences sector and presents that data and our thoughts through this newsletter. Overall, transaction volume was lower in the 3rd quarter, as compared to the 2nd, but was more in line with historical figures following what was a particularly strong 2nd quarter. IPOs had a very strong July and volume dropped into August and September. M&A experienced a similar reduction in transaction volume, as did VC, secondary offerings, and PIPES. Overall, however, the Mintz team views deal activity as robust in general. For more information on 2021 deals and to access our 2020 data and assessment, click here or on the title above.
// Industry Patent Issuance Data
In this edition, we continue the quarterly review of patent grants in the USPTO's Art Unit 1600. This art unit includes most biological and chemical innovations, and we use it here as an imperfect corollary for patent activity in the life sciences industry. Our review is a year-over-year comparison of patents granted by month each year between 2018 and 2021. The data is presented in charts by quarter for ease of review. Click here or on the title above to view the 2021 data and assessment and to access the 2020 data and assessment.
Mintz Team Highlights
// Quarterly Mintz Life Sciences Transactions
Last quarter, our Life Sciences team handled $3.3+ billion in client transactions, including public offerings, mergers & acquisitions, and private financings. We worked on high-end de-SPAC transactions for companies like Vicarious Surgical and Hyperfine, Inc., IPOs for Sera Prognostics and Nyxoah S.A., a crossover financing led by Mintz client PFM Health Sciences, and public offerings for clients such as Synlogic and Inhibrx. Click here to view all 3rd quarter Mintz deals in the Life Sciences sector.
// Cardurion Closes Large Private Investment from Bain
Mintz advised Cardurion Pharmaceuticals, a clinical-stage biotechnology company, in its recent private financing of up to $300 million from Bain Capital Life Sciences and Bain Capital Private Equity. We are proud to have served as legal counsel to Cardurion since the company's inception, advising on numerous complex contractual and strategic matters. Click here for full details.
// Appellate Victory at CAFC for Glycosyn, Biotech Innovator
On September 17, the US Court of Appeals for the Federal Circuit affirmed an International Trade Commission ruling from May 2020 finding that Jennewein Biotechnologie GmbH, a German biotechnology company, infringed Glycosyn's patent for the biosynthesis of human milk oligosaccharides in engineered bacteria, that the patent was neither invalid nor unenforceable, and issuance of a Limited Exclusion Order against Jennewein. Mintz represented Glycosyn at the CAFC, in the ITC case, and in the related Patent Trial & Appeal Board actions. Click here for more details.
The Mintz IP team authored the USA chapter of the International Comparative Legal Guide's "Patent Laws and Regulations 2022." The guide covers a wide range of topics, including patent enforcement, patent prosecution, amendments, the intersection with antitrust law, current developments in the law - and more. Click here to access the chapter.
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