Novartis, Apotex Resolve Suit over Lotrel Patent

Case Filed: Sep 06, 2012

Case Closed: Oct 10, 2013

Court: New Jersey District Court

Judge: Jose L. Linares

Case Summary:

Apotex resolved a suit brought in by Novartis accusing the generic manufacturer for infringing its patent related to treating cardiovascular disease. Judge granted the stipulation filed by the parties and dismissed the case without prejudice, ending the litigation that alleged Apotex’s abbreviated new drug application for a generic version of Lotrel infringed the ‘802 patent covering the medication.

Novartis filed a complaint to protect its ‘802 patent after Apotex submitted an ANDA no. 91431 to the U.S. Food and Drug Administration (FDA) for amlodipine and benazepril hydrochloride combination capsules (generic version of Lotrel), in 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg dosage strengths. With its suit, Novartis sought the court to declare a permanent enjoinment of Apotex from marketing and selling its generic version of Lotrel, as well as a court order that any approval of Apotex's ANDA would not be effective until after expiration of the ‘802 patent.

The patent in suit US6162802 entitled ‘Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor’, was legally issued to Joseph Papa and Marc M. J. Henis on Dec 19, 2000 and expires[i] by Dec 19, 2017. The patent is currently assigned[ii] to Novartis (source: MaxVal’s Assignment Database).

As pointed out in complaint, the ’802 patent is directed to compositions consisting of specified amounts of benazepril and amlodipine as well as a method of treating hypertension in humans, consisting of administering a daily dose of specified amounts of benazepril and amlodipine.

Novartis’s Lotrel is used to treat high blood pressure (hypertension). It works by relaxing blood vessels, causing them to widen. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Novartis currently holds[iii] the new drug application no. 020364 for amlodipine and benazepril hydrochloride combination capsules in various dosage strengths, which it sells under the brand name Lotrel® (source: MaxVal’s Patent Marker) and approved by FDA on Mar 3, 1995.

See case 2:12-cv-05574 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.

MSD, Sandoz Settle Suit over Zetia Generic

Case Filed: Sep 27, 2012

Case Closed: Sep 09, 2013

Court: New Jersey District Court

Judge: Jose L. Linares

Case Summary:

A patent infringement suit was filed by MSD against Sandoz as a result of the latter filing an abbreviated new drug application (ANDA) with FDA concerning their intent to market a generic version of Zetia, used to treat high cholesterol. The patents involved in suit are:

•         RE37721 entitled Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents issued on May 28, 2002 and expires* by Sep 21, 2013
•         US5846966 entitled Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors issued on Dec 08, 1998 and expires* by Sep 21, 2013
•         US7612058 entitled Methods for inhibiting sterol absorption issued on Nov 03, 2009 and expires* by Sep 21, 2013
•         RE42461 entitled Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents issued on Jun 14, 2011and expires* by Jun 14, 2028
•         US7030106 entitled Sterol absorption inhibitor compositions issued on Apr 18, 2006 and expires* by Jan 25, 2022

The patents are currently assigned+ to MSD (source: MaxVal’s Assignment Database). MSD alleged that Sandoz’s abbreviated new drug application no. 203-931 to manufacture a generic version of Zetia, filed with FDA had the infringed the above mentioned patents, all of which cover the composition of the drug.

MSD currently holds± the new drug application (NDA) no. 21-445 (source: MaxVal’s Patent Marker), approved by FDA for 10 mg ezetimibe tablets on October 25, 2002, which is sold under the trade name Zetia. It is used to treat high cholesterol, along with a low-fat, low-cholesterol diet. It is sometimes given with other cholesterol-lowering medications. It is also used to treat high blood sitosterol and campesterol along with diet therapy. Plaintiffs wanted judgment that defendant has infringed the patents and an injunction barring their products until expiration of the patents, along with costs and expenses.

The Court rendered its final verdict pursuant to the parties agreeing upon a consent judgment. The Judge ordered:

•        Claims, counterclaims are dismissed without prejudice
•        Defendant is enjoined from manufacturing/ marketing a generic version of Zetia until April 25, 2017
•        Parties to bear their own costs and expense

See 2:12-cv-06077 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.

GSK, Apotex Patent Suit Administratively Closed

Case Filed: Aug 31, 2012

Case Closed: Sep 04, 2013

Court: Delaware District Court

Judge: Richard G. Andrews

Case Summary:

GlaxoSmithKline (GSK) filed a patent infringement suit against Apotex concerning its filing of abbreviated new drug application with FDA with its intent to commercialize a generic version of Avodart. The patent involved in suit was US5565467, entitled ‘Androstenone derivative’, issued on Oct 15, 1996 and expires[i] by Oct 15, 2013. Smithkline Beecham Corporation is the current assignee[ii] of the patent (source: MaxVal’s Assignment Database).  

GSK alleged that Apotex’s abbreviated new drug application (ANDA) no. 204292, to manufacture generic Avodart capsules, filed with the FDA had infringed the ‘467 patent covering the drug. GSK currently holds[iii] New Drug Application (NDA) no. 21-3199 (source: MaxVal’s Patent Marker), approved by FDA on Nov 2001 for dutasteride capsules, which it sells under the trade name Avodart ®. The capsules are used for the treatment of symptomatic benign prostatic hyperplasia (BPH)--essentially, enlargement of the prostate gland. GSK wanted judgment that Apotex has infringed the patent and an injunction barring Apotex’s products until expiration of the patent, along with costs and expenses.

Initially, the case was stayed as the parties requested a stay due to pending entry of judgment in another case 11-46-RGA, by Apotex Inc. against GlaxoSmithKline LLC. Later, the stay was removed as Judgment has been entered in 11-46-RGA. In Sep, GSK filed a stipulation and proposed order, considering which Court granted the same and ordered the case to be administratively closed.  

See 1:12-cv-01090 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts. 

Are you looking for a tool to calculate patent terms? Try Patent Term Estimator, our free tool or  download our free Android app on Google Play Store.

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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.

Court Dismisses Takeda Lawsuit against Mylan

Case Filed: May 02, 2011

Case Closed: Jun 12, 2013

Judge: Joel A. Pisano

Court: New Jersey District Court

Other Plaintiff: Ethypharm

Case Summary:

A patent infringement suit was filed by Takeda against Mylan as a result of an Abbreviated New Drug Application (ANDA) no. 202-396 filed by Mylan with the FDA concerning its intent to market lansoprazole delayed release orally disintegrating tablets.

The patents involved in the suit were:

US6328994, entitled Orally disintegrable tablets, issued on Dec 11, 2001 and expiring* by May 18, 2018

US5464632, entitled Rapidly disintegratable multiparticular tablet, issued on Feb 20, 2001 and expiring* by Feb 20, 2018.

The ‘632 patent is currently assigned⁺ to Ethypharm and ‘994 patent is assigned⁺ to Takeda (source: MaxVal’s Assignment Database). Takeda is the current holder^± of FDA approved New Drug Application (NDA) no. 21-428 for lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg (source: MaxVal’s Patent Marker), which is sold under the name Prevacid® SoluTab™. It is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers) and relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. 

The case is now closed as the parties have filed for dismissal. Pursuantly, the Court ordered the dismissal of this case. No further information is available on the terms of settlement at this time.

See 3:11-cv-02506 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

Patent Term Estimator, use our free tool or download our free Android app on Google Play Store.

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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.

Janssen Files Patent Infringement Lawsuit over Hetero Drugs

Plaintiffs: Janssen Products and Janssen R&D Ireland (formerly known as Tibotec Pharmaceuticals)

Defendants: Hetero Drugs and Invagen Pharmaceuticals

A patent infringement case 2:13-cv-01444 was filed on Mar 08, 2013 in the District Court of New Jersey. The patents involved in this suit are US7126015 (Method for the preparation of hexahydro-furo [2,3 b]furan 3 ol) and US7595408 (Methods for the preparation of (3R,3aS,6aR) hexahydro-furo [2,3 b]furan 3 ol). These patents are currently assigned[i] to Tibotec Pharmaceuticals (source: MaxVal’s Assignment Database). The '015 and '408 patents cover processes that are useful for the preparation of hexahydro-furo [2,3 b]furan 3 ol (bis THF) as present in Prezista®. 

The complaint alleges that the defendants with Abbreviated New Drug Application (ANDA) no. 202-083 seek FDA approval for a generic version of Prezista® (darunavir) (400 mg and 600 mg) that infringes the above patents. Janssen Products with New Drug Application (NDA) no. 21-976 is the current holder of FDA approved Prezista® (source: Patent Marker). 

Prezista is a drug used to treat HIV infection. Developed by pharmaceutical company Tibotec, darunavir is named after Arun K. Ghosh, the chemist who discovered the molecule at the University of Illinois at Chicago. It was approved by the Food and Drug Administration (FDA) on June 23, 2006.

Other cases filed by plaintiffs 

2:12-cv-05358 and 2:12-cv-02840 for Lupin Limited

2:12-cv-03570 for Hetero Drugs, Ltd., Unit III

2:12-cv-03569 for Teva Pharmaceuticals USA

If you are interested in knowing more about the cases filed, please contact us. To get alerts on cases filed, subscribe to our Litigation Alerts. 

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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.

Pfizer Files Case against Generic Drug Makers

Plaintiffs: G.D Searle, Pfizer

Defendants: Lupin, Mylan, Teva, Watson, Apotex

Case Number: 2:13-cv-00121

Court: Virginia Eastern District Court

Date Filed: Mar 05, 2013

Patent-in-Suit: USRE44048

The patent involved in this suit is assigned to G.D Searle LLC as per face page. The patent entitled 4 [5 (4-methylphenyl) 3 (trifluoromethyl) 1H pyrazol 1 YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder was issued on March 05, 2013 and expires[i] by Mar 05, 2030.

The Parties:

G. D. Searle, LLC is a research-based pharmaceutical company that manufactures and markets prescription pharmaceuticals and other healthcare solutions worldwide. G.D Searle is a wholly owned subsidiary of Pfizer.

Pfizer is a research-based, global biopharmaceutical company. The company's diversified global healthcare portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products.

Mylan Pharmaceuticals is a manufacturer of generic prescription and specialty drugs with facilities for large scale manufacture of active pharmaceutical ingredient (API). Mylan's medicine cabinet holds generic versions of antibiotics, antidepressants, anti-inflammatories, and respiratory agents in a range of delivery forms.

Teva Pharmaceutical Industries develops, manufactures, markets, and distributes pharmaceutical products worldwide. It offers generic pharmaceutical products; and basic chemical entities, as well as specialized product families, such as sterile products, hormones, narcotics, high-potency drugs, and cytotoxic substances.

Lupin is a manufacturer of the anti-TB drugs based in Mumbai, Maharashtra, India. The company production lines include the cardiovascular (prils and statins), diabetology, asthma, pediatrics, CNS, GI domains, apart from anti-infectives and NSAIDs.

Apotex is a pharmaceutical company engaged in the research and development, manufacture, and distribution of generic pharmaceuticals. It offers products in various dosage forms, such as liquids, ophthalmics, nasal sprays, and injectables. Apotex Inc. operates as a subsidiary of Apotex Pharmaceutical Holdings Inc.

Watson Pharmaceutical is engaged in the development, manufacture, marketing and distribution of generic pharmaceuticals in a number of therapeutic categories and specialized branded pharmaceutical products. Watson also distributes generic and branded pharmaceuticals through Anda, Inc.

As in Complaint:

Defendants with the Abbreviated New Drug Application (ANDA) No. 202240 (Lupin), 76-898 (Teva), 78-857 (Mylan), 200562 (Watson) and 204197 (Apotex) seeks approval of FDA to market a generic version of Pfizer’s pharmaceutical product Celebrex®, which is covered by the patent-in-suit.

G.D Searle is the current holder[ii] of the New Drug Application (NDA) no. 20-998 for Pfizer’s Celebrex, (source: Patent Marker) (see Fig. 1) for 50mg, 100mg, 200mg, and 400 mg dosage strengths that is approved by FDA on Dec 31, 1998.  Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis and ankylosing spondylitis. It is also used in the treatment of hereditary polyps in the colon.

If you are interested in knowing about the other cases filed by plaintiffs, please contact us.To get alerts on cases filed, 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] Patent Marker provides an online environment where patentees can virtually mark products and search for patent-related information.