News | Pharmaceuticals | November 24, 2015

Federal Circuit Overturns District Court Decision on Bivalirudin Patents

Court grants The Medicines Company’s request for rehearing of appeal

November 24, 2015 —The U.S. Court of Appeals has overturned a federal circuit court’s decision in The Medicines Company v. Hospira Inc., supporting the patents claims for bivalirudin (Angiomax). This vacates the court’s earlier decision invalidating the Orange Book patents covering bivalirudin that expire in 2028 (pediatric exclusivity expiring in 2029). 

The court requested briefing concerning the commercial on-sale bar issue. It has requested the views of the United States Department of Justice, and will also allow other amicus curiae to submit their views. An amicus curiae is someone who is not a party to a case and offers information that bears on the case, but who has not been solicited by any of the parties to assist a court.

“We are extremely pleased that the invalidity decision has been vacated, and that the entire Appeals Court will now review the issue anew,” said Clive Meanwell, M.D., Ph.D., chief executive officer, The Medicines Company. “We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan and other generics.”

For more information: themedco.com

Related Content

FDA Approves Portola Pharmaceuticals' Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process
News | Antiplatelet and Anticoagulation Therapies | January 02, 2019
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for...
Daily Aspirin Use May Do More Harm Than Good for Healthy People
News | Antiplatelet and Anticoagulation Therapies | December 17, 2018
Among otherwise healthy people, a daily dose of aspirin does not save lives and causes additional bleeding, a new...
Experimental Vaccine May Reduce Post-Stroke Blood Clot Risk
News | Antiplatelet and Anticoagulation Therapies | November 01, 2018
A vaccine may one day be able to replace oral blood thinners to reduce the risk of secondary strokes caused by blood...
Thrombolytic Science Initiates Phase 2 Trial of Novel Ischemic Stroke Treatment Regimen
News | Antiplatelet and Anticoagulation Therapies | September 07, 2018
A new Phase 2 clinical trial looks to confirm the efficacy and safety of Thrombolytic Science LLC’s (TSI) sequential...
Bleeds and Benefit With Aspirin Balanced in Diabetes Patients
News | Antiplatelet and Anticoagulation Therapies | September 05, 2018
Aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease,...
Extended Post-Hospital Oral Anticoagulant Use Reduces Non-Fatal Blood Clots
News | Antiplatelet and Anticoagulation Therapies | August 31, 2018
Use of an oral anticoagulant in medically ill patients for 45 days following hospital discharge reduces the rate of non...
AFib Patients Want More Information About Anticoagulation Reversal
News | Antiplatelet and Anticoagulation Therapies | June 27, 2018
Results from a 902-person, five-country survey of people living with atrial fibrillation (AF) reinforce the importance...
Lower Oral DOAC Anticoagulant Use Associated With More Thromboembolic Events Than Warfarin. #HRS 2018
News | Antiplatelet and Anticoagulation Therapies | May 18, 2018
May 18, 2018 — Nearly half of patients prescribed warfarin and just under one third of those using newer direct oral
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

 

Feature | Antiplatelet and Anticoagulation Therapies | May 07, 2018
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first antidote indicated...
Overlay Init