Skinny Labelling on Generic Drugs Does Not Avoid Induced Infringement of Patents Covering Non-Indicated Uses
Before Prost, Newman, and Moore. Appeal from the U.S. District Court for the District of Delaware
Summary: Evidence of inducement for a method of administering a drug is not limited to the indications of use on a generic drug label. Promoting a generic drug as equivalent to branded drug may be sufficient to induce infringement of a method covering use for which the generic drug is not indicated.
GSK sued Teva for inducing patent infringement based on its sale of a generic for carvedilol sold under GSK’s brand Coreg®. GSK’s patent for the compound expired in 2007. Here GSK accused Teva of inducing infringement of GSK’s patent covering the method of using carvedilol to treat congestive heart failure. Teva sold its generic version with a “skinny label,” that was indicated for some but not all the indications for which the branded drug is approved. Teva’s skinny label indicated use for hypertension, but specially carved out and did not reference congestive heart failure. A jury found Teva willfully infringed and assessed damages. The district court granted Teva’s JMOL motion of no inducement based on a lack of evidence that Teva actually caused physicians to directly infringe a patent directed to the method of treating congestive heart failure.
The Federal Circuit reinstated the induced infringement verdict and damages award. The court rejected Teva’s argument that it did not cause cardiologists to directly infringe because the doctors already knew of carvedilol and its uses before Teva’s generic sales. The court found that Teva’s promotional materials, press releases, product catalogs, FDA labels, and witness testimony all stating that Teva’s generic was equivalent to Coreg®, were substantial evidence of inducement. The Court stated that “when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.”
Judge Prost dissented. She noted that Congress specifically recognized the practice of skinny labelling for exactly these circumstances.
Editor: Paul Stewart