GSK, other drug makers challenge patent office limits on continued applications
WASHINGTON New rules adopted by the United States Patent and Trademark Office discourage drug companies from taking risks that could lead to development of new drugs, GlaxoSmithKline and other drug makers have said in a lawsuit in a federal appeals court they have filed to reverse them.
The Patent and Trademark Office says the rules are meant to stop abuse of the patent system by limiting the number of continuations inventors can file. Continuations are used to amend applications or challenge rejections.
Drug inspectors receive Aleong National Patient Safety Award
FT. LAUDERDALE, Fla. Two drug inspectors in Florida have received the first annual Stephanie F. Aleong, J.D., National Patient Safety Award from Nova Southeastern University.
NSU announced that Brand Institute president and chief executive officer James Dettore and NSU dean Andres Malave presented the award last month to Gene Odin and Cesar Arias, two state drug inspectors who worked on a task force to investigate pharmaceutical drug abuse with Aleong, a prosecutor and NSU law professor who died in October.
The work of Aleong and the two inspectors resulted in counterfeiters of drugs for cancer, cholesterol, HIV and organ transplants being imprisoned, the university said.
Study results show Lipitor helps reduce rate of heart-health emergencies
NEW YORK Results of an observational study indicate that patients taking Pfizer’s Lipitor (atorvastatin calcium) had a 13 percent reduction in the relative risk of heart-related emergencies compared to Merck’s Zocor (simvastatin), drug maker Pfizer said Wednesday.
The study, published in the December issue of Mayo Clinic Proceedings, was based on the managed care claims of patients between 18 and 64. The patients had recently begun using the drugs, had not used statins before and did not have evident cardiovascular disease. The average doses in the study were 29 mg of Zocor and 17 mg of Lipitor. It did not find any significant difference among patients with the secondary endpoints of stroke, revascularization surgery or peripheral vascular disease.
“Observational data such as this, which reflect the use of medicines in real-world clinical practice rather than in a controlled trial setting, mayhelp healthcare providers and managed care companies improve clinical outcomes for patients,” Emory University medicine professor and director of the health promotion and disease prevention office at Grady Health Systems Terry Jacobson said in a statement.
The study analyzed claims for statin prescriptions filed between January 2003 and December 2005 by patients having their first inpatient or emergency room admission for heart disease, heart attack, chest pain, certain heart surgeries, peripheral vascular disease, swelling of the aorta, stroke and transient ischemic attack.