“Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.
On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.
The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.
Of the 17 biosimilar products litigated under BPCIA to date, in most cases (about 70 percent), the applicants engaged in and completed the patent dance before the lawsuits (setting aside allegations of noncompliance with the disclosure requirements). So far, in three instances, the biosimilar applicants have declined to dance outright.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted in March 2010, provides for an elaborate process of information exchange — known as the “patent dance” — between a biosimilar applicant and a reference product sponsor (RPS) intended to resolve potential patent disputes in an orderly and expeditious fashion.
If the trend continues, inventions directed to methods of treatment (especially for follow-on indications), or even compositions and formulations, are susceptible to Section 101 challenges, whereas those directed to delivery systems or manufacturing processes appear to be still safely within the “patent eligible” subject matters.
In the Amgen v. Hospira decision, issued on Aug. 10, 2017, the U.S. Court of Appeals for the Federal Circuit gave a little more ammunition back to the biologics manufacturers (though on its face, it was a loss for Amgen), opining that the “could reasonably be asserted” language in the statute allows a biologics sponsor to initially include in the list any patent that it believes in good faith “could” reasonably be asserted, even if the belief is mistaken.
