by Dennis Crouch
Most of the Orange Book patents do not cover a novel active ingredient or new drug. Rather, most are new methods of treatment or formulations. When a drug is covered only by method-of-treatment claims, that means that generic sales of the active ingredients does constitute patent infringement, unless the sales are somehow inducing folks to perform the method. This gets a bit complicated when a drug has multiple therapeutic uses, only some of which are patented. Obviously, generic versions should be permitted for the non-patented uses. But, we know that there is going to be a lot of substitution at the retail level because of the price differential between the brand & generic.
Skinny Label: Congress thought through this problem (a little bit). The basic approach is that the Brand (Patent Owner) must tell the FDA (under penalty of perjury) which of its labelled & approved uses are protected by patent. When approving a generic version, the FDA will respect the patent by carving-out the patented uses for the generic’s “skinny label.” Of course, doctors, pharmacists, and patients all know that the generic version is the same drug at a lower price and so go ahead and substitute the generic version even for the patented uses. In these cases we’re talking about many millions of dollars in sales. That means we have very sophisticated parties on all sides–everyone knows what is happening.
The statute does not create any express ‘safe harbor’ for the generic manufacturer against liability for patent infringement. Certainly, the manufacturer would be liable for inducement if it encouraged off-label infringing use of its product. But, does the manufacturer need to take a more active role in discouraging infringing use?
This situation was litigated most recently in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021), en banc denied at GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 25 F.4th 949 (Fed. Cir. 2022). GSK sells the beta blocker carvedilol labelled for three uses:
- treatment of congestive heart failure
- treatment of hypertension
- treatment of left ventricular dysfunction following myocardial infarction
All three uses were patented, but by 2007, patents covering the second and third uses had expired. At that point, Teva received approval for its generic version, but with a skinny label that carved-out the congestive heart failure usage. The procedural posture of the case is somewhat confusing, but the Federal Circuit eventually sided with the patentee–holding that Teva’s skinny-label along with other practices induced infringement (i.e., encouraged folks to use it for congestive heart failure).
In a recent filing, Teva’s attorney William Jay (Goodwin Proctor) indicated that Teva plans to petition the Supreme Court for writ of certiorari in the case. (Request for Extension). If Teva’s request for extension is granted, the petition will be due July 11, 2022 with any amicus in support due in early August. Teva’s failed en banc petition provides a guide for questions that it will likely ask in its petition:
(1) Can the generic manufacturer nonetheless be held liable for induced infringement based on evidence that would be available in every carve-out case—the skinny label itself and product materials that describe the generic drug product as the AB-rated generic equivalent of the brand product, but do not even mention the patented method?
(2) Even if the generic manufacturer were found to have encouraged infringement, can it be held liable for infringement that it did not cause—e.g., if the direct infringer undisputedly did not see the communication that supposedly encouraged infringement?