Andrea Weiss Jeffries

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.

Feb 1, 2024 | mondaq.com | Jennifer J. Chheda |Sarah A. Geers |Andrea Weiss Jeffries

The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date after the addition of patent term adjustment ("PTA"). In the Order issued on January 19, 2024, the Federal Circuit denied Cellect's petition for rehearing en banc of the Federal Circuit decision regarding PTA and ODP.