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• Venable’s BiologicsHQ Monthly Injection - October 2024

  Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024

• 5 Key Takeaways - State Sales Tax in 2024: What Every Retailer Needs to Know

  Kilpatrick’s David Hughes and Kylan Memminger recently led a session at the firm's Retail & Consumer Goods Summit. The presentation, “State Sales Tax in 2024: What Every Retailer Needs to Know,” highlighted current sales tax issues and topics impacting retailers and consumer goods manufacturers and suppliers in the marketplace. The session provided an overview of multistate sales tax considerations and issues in the retailer space, ranging from exempt sales and selling on a marketplace to qui tam and class action lawsuits. The discussion also covered additional taxes to be aware of, including locally imposed taxes and fees specific to retailers.

• Spotlight On: Biosimilar Litigations - November 2024

  Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as litigations between two biosimilar applicants/manufacturers are included. Litigations relating to disputes between two reference product sponsors, or non-practicing entities/universities and reference product sponsors are not included. Litigations related solely to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent Nos. 6,331,415, 7,923,221, and 4,816,567 (“Cabilly Patents”)) also are not included.

• Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) / Hadlima™ (adalimumab-bwwd) / Abrilada™ (adalimumab-afzb) / Hulio® (adalimumab-fkjp) / Yusimry™ (adalimumab-aqvh) / Idacio® (adalimumab-aacf) / Yuflyma® (adalimumab-aaty) / Simlandi® (adalimumab-ryvk) - November 2024

  Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are counted more than once. Within each litigation a claim is counted only once. Within each IPR, claims are counted only once, whether they are challenged under § 102, § 103, or both. IPR2017-00826 and -01008 are counted as one IPR, IPR2017-00827 and -01009 are counted as one IPR. Claims in litigations are determined based on claims alleged infringed in Complaints.

• SEC Enforcement Heats up on Key Public Company Topics: Cyber Disclosure, Director Independence and Regulation FD

  The U.S. Securities and Exchange Commission's ("SEC") Division of Enforcement has recently brought a spate of enforcement actions relating to key topics for public companies. These include enforcement actions related to cybersecurity incident disclosure, director independence and Regulation Fair Disclosure ("Reg FD") violations, which are described below, and actions based on Section 13 and 16 beneficial ownership filings, as discussed in our prior alert. Cyber Disclosure Enforcement Actions - On October 22, 2024, the SEC announced charges against four companies for making materially misleading disclosures regarding cybersecurity. One company was also charged with disclosure controls and procedures violations. These actions all arose from the SEC's investigation of public companies that were potentially impacted by the compromise of SolarWinds Corp.'s' Orion software. The companies agreed to pay civil penalties ranging from $990,000 to $4 million.

• Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin glargine) / Rezvoglar™ (insulin glargine-aglr) - November 2024

  Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are counted more than once. Within each litigation a claim is counted only once. Within each IPR, claims are counted only once, whether they are challenged under § 102, § 103, or both. Claims in litigations are determined based on claims alleged infringed in Complaints.

• Have A Small Plan Or Forced To Offer One? Consider Joining A 401(k) PEP

  Having a small plan like a SEP a SIMPLE or a Solo 401(k) Plan may make sense from a financial standpoint. The problem is like I felt when I was an associate attorney at some “fak- akta” (my favorite Yiddish word) Long Is- land law firm: you’re left to die. That’s why I suggest plan sponsors with small plans consider joining a Pooled Employer Plan (PEP). This is what this article is all about.

• Dental/DSO Intelligence Monthly Report: September/October 2024

  Dentologie shares thoughts on growth by building on its unique brand identity - While other DSOs have focused on growth through acquisitions, Dentologie instead builds on its unique culture, modern aesthetic, and consumer demographic in key markets, focusing on experience education. Rob Brenneise, Chief Growth Officer & Bruce Tuck, Director of DSO Sales & Strategic Marketing of Glidewell and Dr. Oussama Founas, Founder of Dentologie shared their thoughts on Dentologie’s adoption of technology, including the integration of advanced solutions like Fastmill.io, a chairside milling unit, that streamlines the creation of dental restorations, to enhance patient care. This example underscores the importance of clinical education, which ensures that dental professionals remain adept at the latest techniques and technologies. Incorporating digital dentistry requires a strategic approach, that is focused on improving patient outcomes and practice efficiency through digital workflows and tools. The holistic integration of technology and education in dental practices promotes operational efficiency, and also elevates the standard of patient care.

• 2024 Post-Election Outlook and Analysis

  President-elect Donald Trump declared victory overnight after convincing wins in Georgia, North Carolina and Pennsylvania; further electoral gains this morning could preview a true red wave this cycle, pending results in additional House races. Senate Republicans secured a clear majority, successfully defending incumbents and gaining at least three additional seats with victories in Montana, Ohio and West Virginia. Several key Senate races that will determine Republicans’ final margin of control in the chamber remain too close to call this morning.

• MHH Condo/Co-op Digest, Vol. XIII (November 2024)

  This newsletter explores the emerging legal topics and issues affecting the condominium and cooperative services industry. Thought-leading attorneys from Moritt Hock & Hamroff’s Condominium and Cooperative Services Practice Group share their legal insight, experience and best practices on this rapidly evolving area of law.

Featured documents

• Are Iowa statutes prohibiting referral sales programs constitutional?

  The Iowa Supreme Court held that the statutes prohibiting referral sales programs were constitutional. The legislature is free to enact statues that protect the public welfare and suppress fraud, and may constitutional regulate legitimate business that is detrimental to the public. The sales...

• Connecticut v. Bull Investment Group

  The Superior Court was asked to decide if the sales of a coupon book distributorship, which authorized the sale of similar distributorships to others, violated Connecticut statutes prohibiting the sale of rights or privileges with payment to the purchaser upon the procurement of additional...

• Is a scheme a "common enterprise" if the factor linking the fortunes of the parties is at the option of one of the parties?

  Golden State Home Loans (GSHL) was a broker and servicer of loans secured by deeds of trust on real property. The Wrights invested in GSHL's loans. GSHL had a policy of advancing payments to its investors if the mortgagee paid late, at GSHL's option. GSHL ran into financial difficulty, eventually...

• Is an airplane investment program gambling under Indiana law?

  The Court of Appeals affirmed the convictions of gambling under Indiana law because the essences of an airplane program is the investment of money with the payoff to come from conditions outside of the investors control. The initial investment consisted the initial payment on the chance that enough ...

• What is the proper definition of a security under New Mexico State law?

  The New Mexico Court of Appeals held that the definition of a security under New Mexico State law is the same a the definition of the Ninth Circuit in Glenn W. Turner, an investment of money with profits to come primarily from the efforts others. Using this definition of security, the Court held...

• Is willful intent necessary to violate the fraud provisions of the state securities act?

  The Nebraska Supreme Court held that it was necessary to prove willful intent to be found guilty under the state securities statutes, but willful intent was not the same as scienter, or an evil motive. Irons managed a pure pyramid program where participants gave "gifts" to those on the list above...

• FTC v. Trek Alliance, Inc. et al.

  Trek Alliance ran a multi-level marketing program selling water filters, cleaning products, nutritional supplements and beauty aids. Trek's rules included a "6 Receipt rule," requiring sales representatives to have six retail sales per month, a "70% rule," requiring representatives to have sold or...

• FTC and State of Maryland v. Jacobson (2005)

  The FTC alleged in its complaint that Sandra Jacobson, through her participation in the Trek Alliance pyramid program, made deceptive claims about employment opportunities, earnings potentials, and promoted a pyramid program in violation of federal law. The FTC had earlier found that Trek Alliance...

• Appraisal of Franchises Requires the Use of Unique Valuation Procedures

  Appraisers operate on the presumption that, however different the individual business is from all others, businesses within a specific industry nonetheless share certain characteristics that make it possible to compare one to another and thus derive a value. Franchise operations, however, are a...

• SEC Proposes New Anti-Fraud Rule & Changes to the Definition of "Accredited Investor" for Private Investment Vehicles

  The Securities and Exchange Commission (the “SEC”) recently released for public comment proposed new rules aimed at providing additional investor protections for investors in pooled investment vehicles. The proposed new rules would (i) prohibit advisers to pooled investment vehicles from making...