Infignos Media -- buyersUSA Consulting
NOW PLAYING
15 Radio Streams
Click Here
Tangible Investment Group
Advertise Here

From Government, Legal and Policy - Legal Issues

Brought to you by TCBY Yogurt

The country's best yogurt. Softserve, hand scooped, smoothies, cakes, pies, and specialty items. There's nothing like a specialty ice cream cake for your next special occasion! Visit or Anniston location at 1903 Quintard Avenue. 256-238-8229.

Commitment

CRESTOR US Patent Upheld by Court of Appeals for the Federal Circuit

Mon, 17 Dec 2012 10:47:29 EST

AstraZeneca announced today that the Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the US substance patent protecting CRESTOR (rosuvastatin calcium) (RE37,314 – the '314 patent) is valid and enforceable. The defendants may seek a rehearing and/or review by the U.S. Supreme Court. Absent a reversal of this decision, none of the Abbreviated New Drug Applications (ANDAs) filed by Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent may be approved by the FDA prior to expiration of the '314 patent. The '314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR.

The Federal Circuit also held that Apotex Corp. was liable as a submitter and is therefore bound by the District Court's decision.

NOTES TO EDITORS

About the Trial

Beginning in 2007, nine generic drug manufacturers filed ANDAs along with Paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the CRESTOR '314 substance patent. AstraZeneca and Shionogi (the owner of the '314 patent) filed patent infringement suits against eight manufacturers (various parent or subsidiary entities of Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the '314 substance patent. These suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the U.S. District Court, District of Delaware. Trial commenced on February 22, 2010 before Judge Farnan and ended on March 3, 2010.

In June 2010, the US District Court for the District of Delaware found the '314 patent valid and enforceable and infringed by the eight generic defendants.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.


Source: WebWire



From Our Blogs

Three Simple Ways to Trim Monthly Expenses

You can devote more toward the things you want, as well as save more for the future.

Time and Money-Saving Holiday Gift Ideas

The savings experts at Dollar General have a few gift ideas that are easy and fun to get you in the

Delight the Five Senses this Holiday Season

Turn your gifts, celebrations and home décor into a festive feast for the five senses.

Super Simple Tips to Manage and Help Prevent Diabetes

It’s no surprise that diabetes is a leading cause of death in the United States.


Sign up for our weekly newsletter.

Our Website Sponsors

TransformationSolutions.com

Stop smoking, lose weight, and even improve your golf score. For our free consultation call 256-237.8049 or visit us on the web at transformationsolutions.com

Buyer's Edge Realty

Annie Brunson, Buyer’s Edge Realty: A long record of successfully guiding buyers and sellers through all aspects of real estate.

Oxford Carpets Coldwater

A new depth of 1st quality luxury for your family at frugal prices! Always 50% less than our local competitors! Call Oxford Carpets Coldwater at 256-835-2155

LaMar's Donuts

Our donuts are the ultimate indulgence. Visit us at our 1781 Hamric Drive E. location in Oxford. Call 256-832-4353.

TCBY Yogurt

The country's best yogurt. Softserve, hand scooped, smoothies, cakes, pies, and specialty items. There's nothing like a specialty ice cream cake for your next special occasion! Visit or Anniston location at 1903 Quintard Avenue. 256-238-8229.