Thursday, May 8, 2014

Warner Chilcott Challenges Lower Court Decision over Actonel Patents

Case Filed: Apr 29, 2014

Origin Case: 1:08-cv-00627

Case Summary:

Hoffmann-La Roche, Proctor & Gamble (P&G) and Warner Chilcott Company filed a patent infringement complaint in Sep 2008 against Teva in response to its filing an amended ANDA to market a generic version of P&G’s drug product, Actonel.

The patents involved in the suit are:
  •  US7192938 entitled ’Method of treatment using bisphosphonic acid,’ issued on Mar 20, 2007 and expiring* by May 10, 2022    
  •  US5583122 entitled ‘Pharmaceutical compositions containing geminal diphosphonates,’ issued on Dec 12, 1996 and expired* on Dec 10, 2013
  • US6165513 entitled ‘Film-coated tablet for improved upper gastrointestinal tract safety,’ issued on Dec 26, 2000 and expiring* by Jun 10, 2018
The ‘938 patent was originally issued to Hoffmann-La Roche and the ‘122 and ‘513 patents were originally issued to P&G.  Currently the patents are assigned+ to Warner Chilcott (source: MaxVal’s Assignment Database.)

Actonel is the commercial formulation of risedronate sodium developed and manufactured by P&G. The complaint stated that the drug product is covered by the claims of the patents-in-suit.  P&G is the current holder± of Actonel approved by FDA for 30, 5, 35, 75 and 150 mg (source: Patent Marker).

Actonel is used to prevent and treat certain types of bone loss (osteoporosis) in adults. This medication works by slowing bone loss to help maintain strong bones and reduces the risk of broken bones (fractures.)

According to the complaint, P&G received a notice letter from Teva regarding the amended ANDA filing for Actonel generics and will engage in manufacture after receiving approval from FDA. Teva also asserted that claims of the ‘938, ‘122 and ‘513 patents are invalid. Plaintiffs believed that the amended ANDA products have the same active ingredients, dosage forms and are bioequivalent to Actonel.

In each of the three counts of infringement brought against Teva, the complaint was common, stating Teva’s amended ANDA  (no. 79-215) submission intended to commercialize the generics that infringe the patents-in-suit, prior to expiration.

P&G requested   a court order enjoining Teva from manufacturing the accused product until after the expiration of the asserted patents and award them with reasonable costs.
A few other cases asserting the same patents were consolidated, and defendants included Apotex, Mylan and Sun. The case came to an end in Apr 2014 with judgment favoring defendants against plaintiffs. The Court considered the patents-in-suit invalid due to fact that prior art disclosed the efficacy and safety of high doses of risedronate, rendering the patents-in-suit obvious.

The judge granted a joint motion for summary judgment of invalidity filed by Teva, Apotex, Mylan and Sun, while denying the plaintiffs' motion for summary judgment of infringement.

Warner Chilcott filed an appeal challenging the district court’s decision of considering the patents obvious.

See 2014-1439 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents. 
+ MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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