Warner Chilcott Appeals District Court’s Judgment Favoring Lupin

Case Filed: Jul 02, 2014

Origin Case: 3:11-cv-07228

Case Summary:

Puerto Rico-based pharmaceutical company, Warner Chilcott, now a subsidiary of Actavis, filed a complaint against India-based generic drug maker, Lupin as a result of the latter filing ANDA seeking approval to market a generic version of Generess^TM Fe, before expiration of  US patent covering use of the drug. The suit was originally filed in New Jersey District Court in Dec 2011. The case is currently open in Appeal court concerning the district court’s judgment against Warner Chilcott.

Patent-in-Suit:

The patent in suit is: US6667050 entitled ‘Chewable oral contraceptive,’ issued on Dec 23, 2003 and expires[i] by Jun 12, 2021. Warner Chilcott is the current assignee[ii] of the patent (source: MaxVal’s Assignment Database). The ‘050 patent relates to an oral contraceptive delivery system involving alternate dosages to improve compliance.

As in Complaint:

Warner Chilcott alleged that Lupin submitted to the FDA an abbreviated new drug application (ANDA) no. 20-3448 to obtain approval to engage in the commercial manufacture, use, or sale of a generic version of Generess^TM Fe. Lupin have notified FDA and Warner Chilcott that the ‘050 patent is purportedly invalid, unenforceable and/or will not be infringed by the manufacture of the ANDA product.

NDA Holder:

Watson, another subsidiary of Actavis, is the holder of New Drug Application (NDA) no. 22-573 for Generess^TM Fe, which contains the active ingredients, norethindrone and ethinyl estradiol. The drug was approved by the FDA in Dec 2010 and is indicated for the prevention of pregnancy in women.

Generess™ Fe:

Generess^TM Fe is sold as a 28-day oral contraceptive regimen that includes 24 chewable tablets comprising 0.8 mg norethindrone and 0.025 mg ethinyl estradiol and 4 chewable ferrous fumarate tablets (placebo).

District Court Judgment:

A bench trial was held in Jan as well as in Feb 2014 and as a result, judgment was entered in Apr favoring defendant’s counterclaims of non-infringement. Additionally, the ‘050 patent was declared invalid as obvious.

See 2014-1582 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

Max-Insight enables you to access all of our patent tools such as Patent Term Estimator, Patent Family Tree, Has This Patent Been Litigated, etc. in one location. Max-Insight is available in 4 different subscriptions: Free, Bronze, Silver and Gold with varying usage levels. To learn more about Max-Insight, click here.

---

[i] 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.

[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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.

Max-Insight enables you to access all of our patent tools such as Patent Term Estimator, Patent Family Tree, Has This Patent Been Litigated, etc. in one location. Max-Insight is available in 4 different subscriptions: Free, Bronze, Silver and Gold with varying usage levels. To learn more about Max-Insight, click here.

---

* 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.

Court Issues Judgment Favoring Warner Chilcott against Watson in Patent Dispute

Case Filed: May 16, 2012

Case Closed: Jan 17, 2014

Court: New Jersey District Court

Judge: Joel A. Pisano

Case Summary:

Warner Chilcott sued Watson and Amneal for patent infringement to prevent them from selling a generic version of its oral contraceptive Lo Loestrin Fe. The cause of the suit was Watson’s filing of an Abbreviated New Drug Application (ANDA) no. 202982 with FDA for a pharmaceutical equivalent of Lo Loestrin® Fe before the expiration of plaintiffs' 2 patents covering the medication and its use. The patents involved in suit were:

•      US5552394 entitled “Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy,” issued on Sep 03, 1996 and expiring* by Jul 22, 2014
•         US7704984 entitled “Extended estrogen dosing contraceptive regimen,” issued on Apr 27, 2010 and expiring* by Apr 22, 2025

The ‘394 and ‘984 patent are currently assigned+ to Warner Chilcott (source: MaxVal’s Assignment Database).

Warner Chilcott is the current holder± of New Drug Application (NDA) No. 22-501, for Lo Loestrin® Fe (source: MaxVal Patent Marker), which contains the active ingredients norethindrone acetate and ethinyl estradiol and was approved by the FDA on October 21, 2010. It is indicated for the prevention of pregnancy in women who elect to use it as a method of contraception. Warner Chilcott said the Watson version would infringe the 2 patents and sought a Court order to prevent sales until the patents expire.

In February 2013, the '394 patent was dismissed from the case. The case is now concluded as the Court rendered its final verdict on Jan 17, 2014 ordering a judgment in favor of plaintiff against defendant as follows:

• the 984 patent is not invalid
• defendants infringe the ‘984 patent
• the  effective date of any approval by the FDA of defendants’ ANDA should not be earlier than the expiration of the ’984 patent

See 3:12-cv-02928 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

* Expected expiration date using Patent Term Estimator, use our free tool or download our free Android app on Google Play Store. 

---

* 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.