Teva v. Eisai: what's the real "controversy"?

The current system of regulating the multi-billion-dollar pharmaceutical industry via market exclusivity comes from the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The statute creates the framework for controlling the entry of generic drugs by a notification and certification system that heavily relies on the "Approved Drug Products with Therapeutic Equivalence Evaluations," a publication commonly known as the "Orange Book." Ever since Congress passed the Hatch-Waxman Act and directed FDA to time generic drug entry based on patents, brand name and generic manufacturers alike have come up with innovative strategies to exploit the system.

Functional effects of novel anti-ClC-3 antibodies on native volume-sensitive osmolyte and anion channels in cardiac and smooth muscle cells.

Whether ClC-3 encodes volume-sensitive organic osmolyte and anion channels (VSOACs) remains controversial. We have shown previously that native VSOACs in some cardiac and vascular myocytes were blocked by a commercial anti-ClC-3 carboxy terminal antibody (Alm C592-661 antibody), although recent studies have raised questions related to the specificity of Alm C592-661 antibody. Therefore, we have developed three new anti-ClC-3 antibodies and investigated their functional effects on native VSOACs in freshly isolated canine pulmonary artery smooth muscle cells (PASMCs) and guinea pig cardiac myocytes.