Legal

The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.
Panelists at the 2020 Specialty Therapies and Biosimilars Congress discussed the strategies needed to get biosimilars to market and overcome obstacles by originator product manufacturers.
It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.
In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.
The Center for Biosimilars® recaps the top stories for the week of January 6.
 
The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.
In the past decade of experience with the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation. 
Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.
This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.
 
The Federal Circuit, in Arthrex, Inc v Smith & Nephew, Inc, ruled that the appointment of Administrative Patent Judges (APJs) at the Patent Trial and Appeal Board (PTAB) violated the Appointments Clause of the US Constitution, and held that APJs could be removed from office without cause. Absent a dramatic ideological shift in the PTAB, however, this decision likely will have little impact on how follow-on biologics developers use inter partes review (IPR).

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