Since the induced infringement finding in GSK v. Teva, the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead?). This is because, at a minimum, if a skinny-labeled generic is the basis for induced infringement liability, generic manufacturers will certainly think twice about using the skinny label process and still calling themselves AB-rated, which ultimately would lead to less reliance on the skinny label, leaving the statutory skinny label provision to do very little. Enter Congress.
Senators John Hickenlooper, Tom Cotton, Peter Welch, and Susan Collins recently introduced the bipartisan Skinny Labels, Big Savings Act, which would amend federal patent infringement law so that generic drug manufacturers can:
- Submit or seek approval of a skinny label for a generic or biosimilar pharmaceutical product;
- Include labeling, promotional materials, or commercial marketing, consistent with the Federal Food, Drug, and Cosmetic Act regulations, for a drug with skinny labeling approved by the FDA;
- Describe, consistent with the Federal Food, Drug, and Cosmetic Act, a drug approved via skinny label as a generic of or therapeutic equivalent to the branded drug. .
The sponsors describe it as a "safe harbor" in a one-page explainer on the bill available here.
More specifically, the bill states that these activities "shall not be acts of direct, induced, or contributory infringement of a method of use claim in a patent" listed in the Orange Book. The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent. And though induced infringement through skinny label has not yet been an issue with biosimilars and interchangeable biosimilars, the bill seeks to stop any more trouble before it starts. It applies the same limitation on induced infringement to applications under 351(k) of the Public Health Service Act. Importantly, the bill applies to conduct that occurs "before, on, of after" enactment of the Act.
This bill would go a long way to alleviating the concerns of the generic industry (AAM has applauded it), but it will clearly have objections from the brand side. It has a long way to go through the machine that is Congress, but we'll be watching to see if the skinny label will, in fact, be safe.
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