On November 23, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that the United States Patent and Trademark Office (USPTO) issued a Patent Term Extension Certificate for U.S. Patent No. 7,399,865, extending the patent term five (5) years (Press release, Puma Biotechnology, NOV 23, 2021, View Source [SID1234595994]). The patent includes composition of matter claims for NERLYNX and will now expire on December 29, 2030. The patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, also referred to as the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are very pleased to have the patent term for NERLYNX extended to 2030. This will allow us to invest further in the drug to look at additional ways that the drug can continue to help cancer patients," said Alan H. Auerbach, Chief Executive Officer and President of Puma.
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.