Posts Tagged: "orphan drug act"

Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with TRND’s help. The therapy demonstrated enough potential that it was licensed by a small company which took it through Phase I and II trials. Both showed very promising results. Ron choked up describing how he felt after such a long struggle to help his child and finally seeing a real glimpse of hope. Everyone in the room shared the lump in his throat. A day like that reminds you why tech transfer and intellectual property are so important. When used correctly they improve and protect lives all around the world.

Mouse Model of Parkinson’s Disease Shows Improved Brain Function — DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ — Actavis Files ANDA for Generic Suboxone® Sublingual Film — AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz — Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer — Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant — NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals — Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation — Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation — Therapeutic Vaccine for Hepatitis C Enters Phase I — Urine Test for Cancer Monitoring — Popular Prenatal Vitamin Patent Upheld in District Court — Clinical Trials on Brain Technology to Assist ALS Patients — Teva Gets Favorable Ruling on COPAXONE in the Netherlands — BVGH Recruits Dr. Linda Venczel as New Program Director — Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott

Mark Lemley’s Firm Files DJ Against Myriad in Northern California —– Promise Not to Infringe Insufficient in ANDA Litigation —– Licensing Deals Stall in Pharmaceutical Sector in First Half of 2013 —– Mylan Settles with FTC over Agila Acquisition from Strides —– Amgen and ShanghaiTech University Announce China R&D Center —– Forest Laboratories sues over SAVELLA® generics —– Teva Pharmaceutical scores patent cictory over Mylan on AZILECT® —– Patent Awarded to New Hepatitis C Treatment —– Orphan drug designation for treatment of Acute Radiation Syndrome —– Avanir settles ANDA litigation with Actavis over NUEDEXTA

Those who are opposed to exclusive rights because it prevents innovation and provides no benefit to the public really should do their homework. They run about throwing this study from an agenda driven economist or that study from a disgruntled economist as if these fictitious mental exercises that ignore reality are evidence of some kind. At the same time they ridicule and pick apart the Studies that reach a contrary conclusion, and simply ignore facts. In this space we really don’t need to be doing any Studies. We just need to observe history. The numbers simply do not lie. Granting exclusive rights has resulted in 13 times the number of drugs to treat rare disease.