Scott Bass

My Foley colleagues discuss the latest report by the USPTO and FDA that examines the time from approval of a New Drug Application to the first generic launch for 25 drug products. Click below to read more. #Pharmaceuticals #FDA #Patents

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My Foley colleagues discuss the latest report by the USPTO and FDA that examines the time from approval of a New Drug Application to the first generic launch for 25 drug products. Click below to read more. #Pharmaceuticals #FDA #Patents

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Read key takeaways from FDA's long-awaited Draft Guidance on its platform technology designation program in our latest Goodwin Life Sciences Regulatory & Compliance team client alert below!

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I’m confused by business antipathy for regulation. Good rules provide predictability and can help avoid liability. Regulations may sometimes go too far, but that doesn’t make the solution no more rulemaking. Business interests may see the end of the Chevron Doctrine as a rainbow leading to higher profits. That may be true, but maybe not so much for businesses as for lawyers: plaintiff lawyers seeking damages awards for worksite injuries, pollution, and other torts, and public interest lawyers suing businesses under subjective interpretation of laws previosusly clarified by administrative experts. And since this Court has clearly gutted the concept of stare decisis in American law, no reason that any loss should discourage any future lawsuit. The absence of an expert administrative function will generate chaos, legal sclerosis, and workers who are less productive from unsafe conditions and injuries. This seems like a careful what you wish for decision.

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In a recent victory, Frier Levitt attorneys Dae Y. Lee, Pharm.D, Esq., CPBS and Adam Farkas successfully aided a NJ pharmacy overturn more than 91% of the alleged discrepancies issued by a major PBM. The alleged discrepancy types included missing proof of delivery, drug invoice shortages, and missing pharmacy licenses. To learn more about how Frier Levitt can assist your pharmacy with adverse PBM actions, read the article here: https://lnkd.in/eRETCK53 #FrierLevitt #PBMaudits #PharmacyLaw #LegalVictory

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Don’t miss the opportunity to attend the NYSBA Antitrust Section’s upcoming panel, “Trial & Error: Winning Strategies for Trying Antitrust Cases” on Wednesday May 1, 2024 from 6-8 pm.   This program will provide insights about effective trial strategies and courtroom advocacy from a judge who recently presided over a merger enforcement action and experienced practitioners who have tried civil and criminal cases as enforcers, plaintiffs’ counsel, and defense counsel. Topics of discussion will include effective techniques for opening and closing arguments, presenting complex legal and economic principles, cross-examining expert and hostile witnesses, and developing themes that will resonate with a judge or jury.   Sign-up here: https://lnkd.in/eXP-XTrM

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Sponsored genetic testing involves a third party, such as a biopharmaceutical company, covering the costs for a patient to undergo genetic testing. This Law360 article does a great job explaining why DOJ and OIG’s legal theories about sponsored genetic testing are incorrect. Sponsored genetic tests play a critical role in helping patients and families receive accurate and timely diagnoses of their rare disorders. They are not kickbacks. The federal government’s position will make diagnoses for these patients even harder and will discourage companies from sponsoring these important diagnostic tools in the first place. We have the tools to help these patients, and we must do better. Proper diagnosis is not a privilege; it is a right.   #DOJ, #Ultragenyx, #genetictesting

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Interesting analysis that my colleagues (Ryan Murr, Karen Alexandra Spindler, Marina Szteinbok, and Artin Au-Yeung) and I drafted of the Delaware Chancery Court’s recent decision on whether a buyer, in the context of a pharmaceutical earnout, used “commercially reasonable efforts” (“CRE”) to achieve certain milestones, and the implications for drafting CRE definitions in the context of license agreements, royalty financings, and merger agreements. #CRE #CommerciallyReasonableEfforts #Earnout #M&A #Licensing #RoyaltyFinance #Royalty #MileStones

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ADCs are a promising class of cancer treatments with an accelerating number of FDA approvals and a rapidly growing market size. This article discusses issues relating to deals and licensing for ADCs/Antibody therapeutics. #technology

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Read our Goodwin Life Sciences Regulatory & Compliance team's LDT update below!

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My Foley colleagues discuss the latest report by the USPTO and FDA that examines the time from approval of a New Drug Application to the first generic launch for 25 drug products. Click below to read more. #Pharmaceuticals #FDA #Patents

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Are you prepared for the upcoming changes to NYC labor laws? Find out about the new NYC Workers' Bill of Rights notice requirement and the DOL overtime final rule taking effect on July 1, 2024 in Lowenstein Sandler LLP's latest Employment client alert. #employmentlaw #newyorkcity #workersrights #employers #lawyers

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Check out this great summary of the new FDA guidance on “platform” technologies from Goodwin partners Julie Tibbets, Susan Lee and Steven Tjoe.

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On April 29, FDA announced its final rule and policy aimed at phasing out enforcement discretion for laboratory-developed tests over four years. The official Federal Register notice publication is scheduled for May 6, 2024 with an effective date of 60 days thereafter. How the final rule and policy ultimately will play out is not completely clear, but they represent significant new FDA medical device regulatory obligations for clinical laboratories making their own in vitro diagnostic tests. Below is a link to the FDA announcement. Have questions? We can help. #LDTs #FDA #medicaldevices https://lnkd.in/gkfPFP96

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For many years, the FDA has failed to respond substantively to requests from drug makers for clarity regarding which types of patents that cover drug-device combination products should be listed in the Orange Book. Recently, the FTC filed an amicus brief advocating a narrow view of the Orange Book listing rules. Read Jones Day's Commentary, which analyzes the FTC's stance on the Orange Book listing of drug-device patents. #FDA #pharmaceuticals #patentlaw https://ow.ly/AKLc50REMg5

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Did you know that the U.S. Congress is currently considering legislation to prevent the governments of certain foreign adversaries from siphoning data and information from U.S. companies in order to advance their own capabilities in the biotechnology field? Read on for more interesting details from my OGC life sciences partner Elizabeth Dana Smith.

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