Glycerol phenylbutyrate – USA

Glycerol phenylbutyrate – USA

IPR decision (Jul 26, 2018):

AIA Review
Filing Date
Institution Date
Petitioner
Patent No.
Final Written Decision
IPR2017-01159
03/27/2017
09/28/2017
Lupin Ltd.
9,254,278
Terminated-Settled
IPR2017-01160
03/27/2017
09/28/2017
Lupin Ltd.
9,326,966
Terminated-Settled

On US’278 patent, Par Pharma filed IPR (IPR2017-01767) on 07/13/2017, which was instituted on 01/30/2018.
On US’966 patent, Par Pharma filed IPR (IPR2017-01769) on 07/13/2017, which was instituted on 01/30/2018.

US 9,254,278 & US 9,326,966 patents owned by Horizon Therapeutics are expiring on 03/09/2032. These patents claim method of treating & method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate in urea cycle disorder.
Previously, on June 27, Horizon Pharma entered into a Settlement and License Agreement with Lupin Pharmaceuticals relating to RAVICTI Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains to on-going patent infringement litigation against Lupin in the U.S. District Court for the District of New Jersey. The Settlement Agreement also includes the pending IPRs. Under the Settlement Agreement, the License Effective Date is July 1, 2026; however, Lupin may be able to enter the market earlier in certain circumstances.

Leave a Reply

Leave a Reply

Your email address will not be published.

Disclaimer
All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2022 Pharma IP Circle. All Rights Reserved