Munger, Tolles & Olson’s Rohit Singla Quoted in Pharmaceutical Technology Article Discussing Sham Patents Filed by Pharma Companies in the Orange Book
Munger, Tolles & Olson partner Rohit Singla was quoted in Pharmaceutical Technology’s article titled “How Sham Patents Are Hurting the Pharma Industry.” The article discusses the Federal Trade Commission’s (FTC) crackdown on pharmaceutical companies filing sham patents in the Orange Book, which hinders or delays generics competition and does not protect genuine innovations.
The Orange Book’s role is to list approved drug products and their patents. “The purpose of the Orange Book process,” explains Mr. Singla, “including the triggering of patent litigation and a temporary stay of FDA approval, is to give generic drug companies patent certainty before coming to market.” He also says that generic companies can challenge patents without facing any damages if they lose, because they are not yet taking sales from the patent holder.
In September 2023, the FTC issued a policy statement that scrutinizes improper patent listings in the Orange Book as potential unfair methods of competition. The FTC claims that such listings have distorted pharmaceutical markets for decades and blocked competition.
Addressing sham patents requires a balance between protecting legitimate innovations and preventing the abuse of the patent system. Following this stance, restricting the patents in the Orange Book may seem like a good course of action. On the other hand, Mr. Singla argues this may discourage generic companies from challenging patents.
“The FTC wants to restrict the patents in the Orange Book to avoid the delay that comes from pre-market patent litigation and the associated stay of FDA approval,” he explains. “But that will come at a cost that the FTC may not be considering sufficiently. For drugs covered by a patent the FTC has excluded from the Orange Book, generics may be discouraged by the prospect of having to come to market and face damages exposure to challenge the patent.”