For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution.  Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product.  This allows for a generic to go to market under a so called “little viii statement” in lieu of a patent certification or being blocked from marketing by a 3-year period of market exclusivity by saying they do not intend to seek approval for the protected indication or information.  Big Pharma has attacked this provision of the Drug Price Competition and Patent Term Restoration (Hatch-Waxman) ever since the first ANDA application was approved with a little viii statement.

The little viii statement is included in the original Hatch-Waxman Act which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products.  The use of the “skinny label” has been a touchstone of that balance.  We have written extensively about this issue. (Rather than repeat a lot of what was in my November 2020 post that captures the relevance of the so called “little viii” statement that can lead to a skinny label, I will just refer you to that post (here).  For other posts on the perilous fight to protect the skinny label just go to the Lachman Blog (here) and search by the term “Skinny label.”

U.S. Senators John Hickenlooper, Tom Cotton, Peter Welch, and Susan Collins reintroduced the bipartisan Skinny Labels, Big Savings Act, a bill designed to lower drug prices by accelerating the roll-out of generic drugs and creating legal barriers to endless lawsuits for generic drug manufacturers who obtain “skinny label” FDA approvals.  The Senators previously introduced the legislation in the 118th Congress” (see here) and now it looks like help may be on the way to finally put the skinny label debate to bed.

A one-page document describing the provisions of the proposed legislation, including the benefits to both generic drugs and biosimilars outlines the solution to this ongoing battle.  The document (here) reads in part:

“The Skinny Labels, Big Savings Act would create a safe harbor for generic manufacturers from liability in patent infringement cases if they seek or obtain FDA approval for skinny label indications. This bill’s text stipulates that this safe harbor is only applicable to the approved indications included in the skinny label application, as determined by the FDA.  The bill states that the following actions are not considered violations of a method of use patent under the Federal Food, Drug, and Cosmetic Act (FFDCA):

  • Submitting or seeking approval of a skinny label for a generic or biosimilar pharmaceutical product;
  • Labeling, promoting, or commercially marketing a drug with skinny labeling approved by the FDA;
  • Describing, consistent with FFDCA, a drug approved via skinny label as a generic of or therapeutically equivalent to the branded drug.”

AAM strongly supports the passage of this legislation and acknowledges its importance in continuing to sustain the important balance that was intended in the Hatch-Waxman Act.  Will this legislation pass, or will there be additional litigation on the matter?  After 40 years of debate, that is the question we are all waiting to see answered!