Duchesnay Sues Actavis, Charging Patent Violations

Case Summary:

Canada-based pharmaceutical company Duchesnay filed a suit against Dublin headquartered generic maker, Actavis on July 11, 2014, in the New Jersey District seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of Duchesnay’s patent US6340695 entitled ‘Rapid onset formulation’. This action formally initiates the patent challenge process under the Hatch-Waxman Act, which grants a 30-month stay to drug companies that file suit against generic manufactures challenging their patents.

The patent was issued by USPTO to inventor Eric Gervais on Jan 22, 2002 and expires[i] by Jun 21, 2021. Duchesnay is the current assignee[ii] of the ‘695 patent (source: MaxVal’s Assignment Database).

Actavis filed an Abbreviated New Drug Application (ANDA) no. 205811 with the FDA seeking approval to market doxylamines and pyridoxine hydrochloride delayed-release tablets, 10 mg/10 mg. The complaint futher added that Actavis’s generic product labeled the same indications and dosage as the drug, Diclegis.

Duchesnay is the current holder[iii] of Diclegis (source: Patent Marker) with NDA no. 021876, approved by FDA on Apr 08, 2013. The active ingredients of the drug include: doxylamine succinate and pyridoxine hydrochloride.

Duchesnay alleged that Actavis' ANDA product is a generic version of Duchesnay‘s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

See 2:14-cv-04384 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[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.

[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

Valeant, Dow, Actavis Settle Patent Challenge over Antibiotic Acanya®

Case Filed: Oct 24, 2013

Case Closed: Jun 09, 2014

Judge: Stanley R. Chesler

Court: New Jersey District Court

Case Summary:

Dow Pharmaceutical Sciences, Inc. (Dow) and Valeant Pharmaceuticals North America LLC (Valeant) together filed a patent infringement suit against Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.) and Andrx Corporation (Andrx), a wholly owned subsidiary of Actavis for filing abbreviated new drug application (ANDA) seeking FDA approval to market generic clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, for topical use gel.

Patent-in-Suit:

The patent in question was US8288434 entitled ‘Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent,’ issued on Oct 16, 2012 and set to expire[i] by Jun 03, 2029. Goldman Sachs Lending Partners is the current assignee[ii] of the ‘434 patent (source: MaxVal’s Assignment Database).

The ’434 patent claims formulations of benzoyl peroxide and clindamycin and methods of treating acne with such formulations.

As in Complaint:

The complaint was filed soon after the ‘434 patent was granted and after FDA’s approval of the drug.  Plaintiffs alleged that defendants have infringed the ’434 patent by submitting ANDA to the FDA, seeking approval for the commercial marketing of generic clindamycin phosphate and benzoyl peroxide gel before the expiration date of the ’434 patent. Counterclaims were filed by defendants for declaratory judgment of non-infringement and invalidity of one or more claims of the ‘434 patent.

NDA Holder:

Dow is the current holder[iii] of new drug application (NDA) no. 050819 for Acanya, which the FDA approved on Oct 23, 2008 (source: Patent Marker) and the ’434 patent is listed in the FDA’s approved drug products.

Acanya®:

According to Valeant, Acanya is the only FDA-approved fixed combination antibiotic and benzoyl peroxide (BPO) medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne. Acanya was developed by Arcutis, now a part of Coria Laboratories, a division of Valeant Pharmaceuticals. The formulation is protected by two U.S. patents and has pending patent applications. For the 12 months ending July 2013, Acanya had total U.S. sales of approximately $62 million and approximately $121 million ending Feb 2014, according to IMS Health data.

District Court Judgment:

A stipulated consent judgment was released by the court stating that unlicensed manufacture and sale of Acanya generics would infringe the ‘434 patent.  The parties are enjoined from marketing Acanya generics until the expiration of the patent or unless expressly licensed by the plaintiffs. Each party will bear their own costs and fees.

Settlement Agreement by the parties:

Under the terms of the agreement, Valeant will grant Actavis a license to market its generic Acanya beginning July 2018 or earlier under certain circumstances. Other details of the settlement were not disclosed.

See 2:13-cv-06401 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.

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[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.

[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

Lupin, Teva and Others Win Judgment over Anti-Inflammatory Drug

Case Filed: May 05, 2013

Case Closed: May 08, 2014

Court: Virginia Eastern District Court

Judge: Arenda L. Wright Allen

Case Summary:

G.D. Searle and Pfizer jointly filed a suit alleging patent infringement of U.S RES44048 by defendants Lupin, Teva, Mylan, Watson and Apotex. The lawsuit concerned filing of abbreviated new drug applications (ANDAs) with the U.S Food and Drug Administration (FDA) seeking approvals to market generic versions of Pfizer's Celebrex® drug product to treat rheumatoid arthritis and osteoarthritis, prior to expiration of the '048 patent and related period of exclusivity.

Patent-in-suit:

The patent involved in this suit is: RE44048 entitled ‘4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder,’ duly issued to G.D. Searle on May 05, 2013 and expired[i] on Nov 30, 2013. The patent describes a class of pyrazolyl benzenesulfonamide compounds, compositions and methods for treating inflammation and inflammation-associated disorders.

As in complaint:

Pfizer filed this suit on the day the patent office issued the '048 patent and has a pediatric exclusivity that expires by Dec 02, 2015. Defendants intend to market generic versions of Pfizer's Celebrex® drug product beginning on or about May 30, 2014, which is prior to the expiration of the '048 patent. One or more claims of the '048 patent cover use of the pyrazolyl benzenesulfonamide compounds disclosed to treat each of the indications in Pfizer's Celebrex® label.

Defendants’ notice letters referring to the ANDAs (nos. 202240, 76-898, 78-857, 200562 and 204197) stated the claims 1-17 of the patent-in-suit as invalid, unenforceable and/or will not be infringed by the commercial manufacture of their ANDA products.

The complaint stated that the act of infringement will cause plaintiffs to suffer irreparable harm (even in case of later judicial determination) and sought preliminary injunction to prevent irreparable and irreversible harm.

ANDA holder:

G.D. Searle currently holds[ii] an approved new drug application, no. 20-998, for celecoxib capsules, 50, 100, 200and 400mg dosage strengths, which it sells under the registered name Celebrex® (source: Patent Marker). As stated in Pfizer's FDA approved label for Celebrex®, the drug is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea.

Final Judgment:

The Court found that the '048 patent is invalid for obviousness-type double patenting. Accordingly, the Court granted in part the Joint Motion for Summary Judgment filed by defendants and denied plaintiffs' Motion for Summary Judgment. In line with court’s opinion and order, final judgment was entered in favor of defendants.

Appeal:

The case has now been appealed by G.D. Searle and Pfizer on May 09 challenging court’s decision favoring Lupin, Teva, Mylan, Watson and Apotex.

See 2:13-cv-00121 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.

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[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] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

Actavis, Novartis Resolve Patent Dispute over Iron-Control Drug Patents

Case Filed: Mar 21, 2012

Case Closed: Apr 29, 2014

Court: Delaware District Court

Judge: Richard G. Andrews

Case Summary:

Novartis, based in Basel, Switzerland sued generic-drug maker Actavis of Zug, Switzerland, alleging infringement of two U.S. patents, which Novartis listed as covering the iron-control drug, Exjade. The lawsuit concerned Actavis filing  an ANDA seeking approval to market a generic version of Exjade, deferasirox in tablet form.

The patents at issue were: US6465504 and US6596750 both reading ‘Substituted 3, 5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators’. The patents were issued on Oct 15, 2002 and July 22, 2003, respectively. The patents are set to expire[i] by Jun 25, 2016 and are currently assigned[ii] to Novartis (source: MaxVal’s Assignment Database).

The complaint alleged that Actavis Group acted collaboratively in the preparation and submission of ANDA No. 203560. By filing ANDA, Actavis has represented that its generics have the same active ingredient and are bioequivalent to Exjade®. In the notice letter, Actavis had told Novartis its patents “are invalid, unenforceable.”

Novartis is the current holder[iii] of New Drug Application (NDA) No. 21-882, which the FDA granted approval for marketing and sale of 125 mg, 250 mg and 500 mg strength deferasirox tablets, oral suspension (source: Patent Marker.) Novartis markets deferasirox tablets in the United States under the trade name Exjade®. It is used to treat patients with chronic anemia disorders who get blood transfusions that result in an excess of iron, which may cause damage to the heart, liver and other organs.

According to the complaint, the composition, formulation, dosing and method of administration for Exjade® are covered by certain claims of the ’504 and’750 patents.

Stipulation and order of dismissal was filed by Novartis in which it stated that both the parties stipulate and agree to dismiss all the claims and counterclaims, defenses, motions and petitions asserted in this action without prejudice and each party shall bear its own costs and attorneys' fees. Accordingly, Court granted the stipulation, thereby ending the dispute.

See 1:12-cv-00366 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.

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[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.

[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

Patent Litigation Resolved between Medicis and Actavis

On August 2012, Medicis filed a complaint against Actavis for infringing the patent US8236816. The patent is entitled ‘2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod’. The patent was issued in Aug 2012 and expires[i] in Dec 2029. The patent is currently assigned[ii] to Medicis (source: MaxVal’s Assignment Database).

The case was filed against Actavis for filing Abbreviated New Drug Application (ANDA) no. 203-792 and 202-564 for Clindamycin and Tretinoin Gel and Imiquimod Cream, seeking FDA approval to manufacture generic versions of Zyclara® and Ziana®.

Zyclara cream is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp. Ziana is a gel used to treat severe nodular acne above 12 years.

Now Medicis (a subsidiary of Valeant) and Actavis have reached a settlement agreement. Under the terms of the agreement, Actavis may launch its generic versions of Zyclara® and Ziana® in July 2016 and Jan, 2019.

Actavis stated that Valeant will receive a share of the economics from the generic products sold under the agreements. No other information about the agreement is available at this time. The settlement agreement puts an end to the litigation between the parties.

For more details see 1:12-cv-01091. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[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.

Watson Sued Over Generic Version of Nexium

Plaintiffs: AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI-E and KBI

Defendants: Watson Laboratories, Watson Pharma, and Actavis

A patent infringement case (3:13-cv-01669) was filed on Mar 19 in the District Court of New Jersey. The case involves 5 patents that relate to medicinal preparations and their use in the manufacture of pharmaceuticals.

The patent information as follows:

Patent Number Current Assignee[1]	Issue Date	Expiry Date[2]	Title
US5714504 AstraZeneca	Feb 03, 1998	Feb 03, 2015	Compositions
US5877192 AstraZeneca	Mar 02, 1999	May 28, 2013	Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole
US6369085 AstraZeneca	Apr 09, 2002	May 30, 2017	Form of S-omeprazole
US6875872 AstraZeneca	Apr 05, 2005	May 28, 2013	Compounds
US7411070 AstraZeneca	Aug 12, 2008	May 30, 2017	Form of S-omeprazole

Source: MaxVal’s Assignment Database. 

KBI-E and KBI have the exclusive rights in the above patents. 

As per the complaint, defendants seek FDA to approve their proposed product Esomeprazole Magnesium Delayed Release Capsules, 40 mg, containing the active ingredient esomeprazole magnesium, prior to the expiration of the patents-in-suit, as a generic version of the Nexium® product. The ANDA no. filed for the approval is 204358. AstraZeneca currently holds[3] the NDA no. 021153 for Nexium which was approved by FDA on February 20, 2001 (source: Patent Marker).

Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. It is also used to promote healing of erosive esophagitis (damage to the esophagus caused by stomach acid).

It may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the excessive use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Another case is recently filed by AstraZeneca is 3:13-cv-00091 against Dr. Reddy`s Laboratories, which is pending. If you are interested in knowing more about the case(s) filed, please contact us.

 

To get alerts on cases filed, subscribe to our Litigation Alerts. 

Has this patent been litigated? Use our free tool or download our free Android app on Google Play.

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

[2] 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.

[3] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

Watson Sued by Depomed over Generic Drugs

Plaintiff: Depomed, Inc. 

Defendant: Watson Laboratories, Actavis and Watson Pharma

A patent infringement case 1:13-cv-00342 was filed on Feb 28 in the Delaware District Court. The case was filed by Depomed against Watson and Actavis. The patents-in-suit are US6340475 and US6635280 (Extending the duration of drug release within the stomach during the fed mode), US6488962 (Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms) and US6723340 (Optimal polymer mixtures for gastric retentive tablets). These patents are currently assigned[i] to Depomed (source: MaxVal’s Assignment Database). 

Plaintiff is the current holder[ii] of the New Drug Application (NDA) no. 021748 for Glumetza® (source: MaxVal’s Patent Marker) that was approved by FDA for metformin hydrochloride extended release tablets in 500 and 1000 mg dosage strengths. Plaintiff alleges that defendants (Watson is a wholly owned subsidiary of Actavis) with the Abbreviated New Drug Application (ANDA) no. 203755 is seeking FDA approval to market a generic version of Glumetza, which infringes the claims covered in the patents-in-suit.

Glumetza is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes.

Recently Depomed has filed a case against Purdue Pharma and the case involves the patents US6340475, US6635280 and US6723340. If you are interested in knowing more about the above case, please contact us. To get alerts on cases filed, subscribe to our Litigation Alerts.

Has this patent been litigated? Use our free tool or download our free apps on iTunes App Store and Google Play.

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

[ii] Patent Marker provides an online environment where patentees can virtually mark products and search for patent-related information.