Matthew Hertko

Jul 31, 2024 | mondaq.com | Jennifer J. Chheda |Sarah A. Geers |Matthew Hertko |Daniel Sloan

In Short The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents that a sponsor of an originator biological product, or RPS, may assert in an infringement action against a biosimilar applicant. The Result: S.B. 150 has been sent to the United States House of Representatives.

Jul 9, 2024 | jdsupra.com | Sarah A. Geers |Matthew Hertko |Anthony Insogna

In ShortThe Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to avoid findings of infringement in standard Hatch-Waxman cases, but in post-marketing situations, the generic's "skinny label," coupled with its public statements, can be evidence of induced infringement even as to the carved-out, patented uses.

Jul 9, 2024 | mondaq.com | Anthony Insogna |Sarah A. Geers |Matthew Hertko |Andrea Weiss Jeffries

The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to avoid findings of infringement in standard Hatch-Waxman cases, but in post-marketing situations, the generic's "skinny label," coupled with its public statements, can be evidence of induced infringement even as to the carved-out, patented uses.

Jul 8, 2024 | lexology.com | Anthony Insogna |Sarah A. Geers |Matthew Hertko |Andrea Weiss Jeffries |Gasper LaRosa |John Normile

In ShortThe Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to avoid findings of infringement in standard Hatch-Waxman cases, but in post-marketing situations, the generic's "skinny label," coupled with its public statements, can be evidence of induced infringement even as to the carved out, patented uses.