AstraZeneca Settles Litigation Over CRESTOR Patent

By: Pharma News | Views: 1537 | Date: 17-Apr-2013

AstraZeneca today announced that it has entered into a settlement agreement in its US patent infringement litigation against Watson Laboratories, Inc., Actavis, Inc. (formerly known as Watson Pharmaceuticals, Inc.), and EGIS Pharmaceuticals regarding Watson's proposed rosuvastatin zinc product. Watson, a successor of Cobalt, also agreed not to further appeal a decision by the U.S. Court of Appeals for the Federal Circuit that upheld the validity and enforceability of the CRESTOR® (rosuvastatin calcium) subs

AstraZeneca settles litigation over CRESTOR patent

AstraZeneca today announced that it has entered into a settlement agreement in its US patent infringement litigation against Watson Laboratories, Inc., Actavis, Inc. (formerly known as Watson Pharmaceuticals, Inc.), and EGIS Pharmaceuticals regarding Watson's proposed rosuvastatin zinc product. Watson, a successor of Cobalt, also agreed not to further appeal a decision by the U.S. Court of Appeals for the Federal Circuit that upheld the validity and enforceability of the CRESTOR® (rosuvastatin calcium) substance patent. Shionogi is also a party to the settlement agreement.

Under the agreement, Watson and EGIS concede that the CRESTOR substance patent is valid, enforceable and would be infringed by Watson's rosuvastatin zinc product and its rosuvastatin calcium product.

 

The settlement agreement permits Watson to begin selling its generic version of CRESTOR and its rosuvastatin zinc product beginning May 2, 2016, at a fee to AstraZeneca of 39% of net sales of Watson's products until the end of pediatric exclusivity on July 8, 2016. The entry date could be earlier and the fees eliminated in certain circumstances.

 

All claims and counterclaims will be dismissed in a consent judgment entered by the United States District Court for the District of Delaware. All other terms remain confidential.

 

The substance patent protecting CRESTOR expires on 8 January 2016, and the pediatric exclusivity period expires 8 July 2016.

In compliance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, AstraZeneca will file the settlement agreement with the United States Federal Trade Commission and United States Department of Justice.

 

About the trial
AstraZeneca brought suit against Watson and EGIS in the United States District Court for the District of Delaware, alleging that Watson's rosuvastatin zinc NDA infringed AstraZeneca's substance patent covering CRESTOR. Watson and EGIS filed counterclaims seeking declaratory judgment of non-infringement and invalidity of the substance patent. The trial took place between 12 and 19 December 2012.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.


 

Previous Page Next Page

People Searching On This Page:
  • shionogi and india and patent and rosuva
  • the lower court decision in rosuvastatin
  • AstraZeneca
  • torrent pharma settles
  • astrazeneca 'crestor' related litigation in us
  • patent litigation pharma news april 2013

Related Pages


AstraZeneca signs $350m Kidney deal

AstraZeneca signs $350m Kidney deal

News | Pharma Companies
Date:
20-Aug-2013  Views: 1425

AstraZeneca has signed a deal with private biotech company FibroGen to develop a novel compound aimed at treating anaemia associated with chronic kidn ...
Viagra patent expiry opens up market

Viagra patent expiry opens up market

News | Pharmaceutical Drugs
Date:
22-Jul-2013  Views: 5535

Pfizer lost its UK patent rights to its erectile dysfunction drug Viagra over the weekend, leading to an influx of cheaper generics into the market.In ...
US Firm Slaps Patent Suit on Dr Reddy’s

US Firm Slaps Patent Suit on Dr Reddy’s

News | Pharma Companies
Date:
29-Jun-2013  Views: 1129

US-based AbbVie Inc has slapped patent infringement suit against Dr Reddy’s Laboratories Limited alleging that the city-based drug maker had infringed ...
AstraZeneca New global R&D centre & Corporate Headquarters

AstraZeneca New global R&D centre & Corporate Headquarters

News | Pharma Companies
Date:
21-Jun-2013  Views: 1410

AstraZeneca announced that its new UK-based global research and development centre and corporate headquarters will be located at the Cambridge Biomedi ...
Recently Filed Direct Compression Patents

Recently Filed Direct Compression Patents

Articles | Pharmaceutics | Tablet
Date:
14-May-2011  Views: 2547

Direct Compressible Excipients, which can be used universally with any of the APIs, can lead to a revolution in tablet manufacturing techniques by way ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

82  + 4 =     
Comments
People Searched About:
Shionogi And India And Patent And Rosuva   |   The Lower Court Decision In Rosuvastatin   |   Astrazeneca   |   Torrent Pharma Settles   |   Astrazeneca 'Crestor' Related Litigation In Us   |   Patent Litigation Pharma News April 2013   |  
Google : 200 times | Yahoo : 15 times | Bing : 26 times |