In a recent district court decision, a New Jersey federal judge granted summary judgment to an accused infringer of a patented design. Skull Shaver LLC. v. IdeaVillage Products Corp., No.18cv3836 (EP) (AME) (D.N.J. Dec. 28, 2022). In its complaint,
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The Current State of 340B and What to Expect in 2023
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration’s (HRSA) underlying enforcement authority, and changes to 340B-related laws on the state level.…
Design Patents are Heating Up at the Federal Circuit
Oral arguments were held on Thursday, January 12, 2023, in Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc. The parties faced off in a rematch at the Federal Circuit following an earlier bout involving the same design patent, U.S.…
Brenda Shafer, Michael French and Richard Davis Author Law360 Article on Questions Related to Section 340B Drug Pricing
Quarles Health & Life Sciences attorneys Brenda Shafer, Michael French and Richard Davis recently wrote an article for Law360 about questions surrounding the ability of the Health Resources and Services Administration’s ability to enforce key requirements related to the Section 340B drug…
Failure to Mark Patent Number on Products Results in Complete Loss of Pre-Suit Infringement Damages
As highlighted by a recent decision of the United States District Court for the Southern District of New York[1], a party’s failure to properly mark its products with its issued U.S. patent number(s) will very likely result in…
340B Program Changes on the Horizon? Start Planning Now for Potentially Seismic Impact of Upcoming Genesis Decision
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In the meantime, covered entities should begin planning and strategizing now…
Protecting the Product™: Typefaces and Fonts
While copyright law is at the center of a few recent disputes over intellectual property protection for typefaces and fonts, design patents are an often-overlooked mechanism for protecting these designs. Those who develop or license fonts will benefit from the following…
UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling
On June 15, 2022, after many years of ongoing litigation1, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain outpatient prescription drugs provided to Medicare patients for…
Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B Program?
Earlier today, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used to determine enhanced reimbursement rates depending on…
Recent Trends in Article of Manufacture of Design Patent Claims: GUIs Remain King
This article supplements our previous post with updated 2021 data.
U.S. design patents continue to grow in popularity. Although 2021 saw a slight downtick in the number of issued design patents compared to the previous two years—most likely caused by…