For small molecule drugs the legal issues surrounding generics are if not straight forward at least well practiced, with numerous examples of case law playing out since the Drug Price Competition and Patent Term Restoration Act – known as the Hatch-Waxman Act – came into force in 1984.
Under Hatch-Waxman, generic firms are protected from being sued by the proprietary drug maker when filing their copycat drugs to the US Food and Drug Administration (FDA) as patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations - commonly known as the Orange Book – pertain solely to the drug'a API.
Patents referring to the manufacturing process can be attested following submission and, under the ruling, if the branded owner sues the FDA cannot approve the drug for a 30 month period.
However, for biopharmaceuticals there is no Orange Book and the branded biologic company “is allowed to sue [a biosimilar maker] for infringement of manufacturing, processes, intermediates patents, etc, right at the get go,” Stacie Ropka, an associate at law firm Axinn, Veltrop & Harkrider, told Biopharma-Reporter.com.
This theoretically allows the branded drug owner to deal with all patents in one go though this may also benefit biosimilar developers she said, despite the “many moving parts” of the legal procedure, she said.
The procedure is relatively untested, and Ropka said those looking to file a biosimilar should be well-prepared with a patent list ready before filing a submission, whilst the reference product sponsor too should ensure they know their own patents.
“There is a universe of patents out there and no Orange Book for reference,” she said. “There are likely to be many risks (on both sides) but no one knows how this is going to work out yet.”
The Patent Dance
Sandoz recently announced its biosimilar filing to Amgen’s anti-infective Neupogen had been accepted by the FDA, and a lengthy series of correspondence and ‘good faith negotiations’ – beginning to be known as ‘the patent dance’ - has now kicked off between the two firms concerning possible patent infringements.
This stemmed from a separate court case between Sandoz and Enbrel which led to an amendment last November to the Biologics Price Competition and Innovation Act (BPCIA) of 2009, after Sandoz challenged Amgen over the patent validity of Enbrel (etanercept).
US District Court Judge Maxine Chesney noted: “Neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information.”
Commenting on the November ruling, Sandoz spokesman Chris Lewis told this publication: “We do have some concerns about the dossier submission component of the, which we believe could lead to unnecessary litigation.”
“However, we support the flexibility of the overall FDA approach and look forward to a timely processing of our submission.”
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...