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.

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.

AstraZeneca, Apotex Settle Suit over Crestor Patent

Case Filed: Apr 17, 2010

Case Closed: May 24, 2013

Judge: Donald M. Middlebrooks

Court: Florida Southern District Court

Other Plaintiffs: IPR Pharmaceuticals and Shionogi Seiyaku Kabushiki Kaisha

Case Summary:

AstraZeneca filed a patent infringement suit against Apotex as a result of an Abbreviated New Drug Application (ANDA) no. 79-145 filed by Apotex with the FDA concerning its intent to market a generic version of AstraZeneca’s Crestor. 

The patent involved in this suit was USRE37314 entitled ‘Pyrimidine derivatives’, which was issued on Aug 07, 2001 and expired[i] on Jul 01, 2011. As per face page, assignee of the patent is Shionogi Seiyaku Kabushiki Kaisha. IPR Pharma currently holds[ii] an FDA approved NDA no. 021366 for Crestor tablets in 5, 10, 20 and 40 mg dosages containing rosuvastatin calcium (source: Patent Marker). It is used to lower cholesterol and triglycerides (types of fat) in the blood.

The case is now closed as the parties have filed for dismissal. The Court ordered the claims and counterclaims be dismissed without prejudice and the parties to bear their own costs. However, no further information is available on the terms of settlement at this time.

See 1:10-cv-21389 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] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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.

Apotex, Watson, Sandoz and Hi-Tech Pharma Sued for Filing ANDA

Plaintiff: Allergan

Defendant: Apotex, Watson, Sandoz and Hi-Tech Pharma

Case Number: 1:13-cv-00016

Date Filed: January 08, 2013

Court: North Carolina Middle District Court

Patent-in-Suit: US8263054

The patent US8263054 involved in suit is currently assigned to Allergan (as per face page). The patent entitled Method of enhancing hair growth was issued on September 11, 2012 and expires[i] by January 15, 2023. The patent describes a method of increasing eyelash growth in a human including length, thickness and darkness of the eyelashes, the method comprising administering bimatoprost to an eyelid margin of the human.

About the Parties:

Allergan is a pharmaceutical company. Their product range includes ophthalmic pharmaceuticals, dermatology products, and neurological products. It also develops and commercializes prescription and non-prescription eye care products. 

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 pharmaceuticals is engaged in the development, manufacture, marketing and distribution of generic pharmaceuticals in a number of therapeutic categories and specialized branded pharmaceutical products that are focused on urology, women’s health and pain management. Watson also distributes generic and branded pharmaceuticals through Anda, Inc.

Sandoz a division of the Novartis is a generic pharmaceutical company with key product groups such as antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnologically active substances and anti-infectives. 

Hi-Tech Pharma develops, manufactures and markets products in three categories, generics, prescription brands and OTC brands. It produces a range of products for various disease states, including glaucoma, asthma, bronchial disorders, dermatological disorders, allergies, pain, stomach, oral care and other conditions. Its generic products are primarily prescription items and include oral solutions and suspensions, topical creams and ointments, as well as nasal sprays. 

As in Complaint:

Allergan is the current holder[ii] of New Drug Application (NDA) no. 22-369 for bimatoprost ophthalmic solution, 0.03%, sold under the Latisse® brand (source: Maxval’s Patent Marker) that is approved by FDA. Latisse (see Fig. 1) is a prescription treatment for hypotrichosis (inadequate lashes) to grow eyelashes longer, fuller, darker. Plaintiff alleges that defendants seeks FDA approval to market a generic version of Latisse with the Abbreviated New Drug Applications (ANDA) no. 201894 (Apotex), 202719 (Sandoz), 203051 (Hi-Tech) and 203749 (Watson) that infringe the above patent.

 

Other Cases Filed:

Plaintiff has recently filed cases against the below companies:

Defendant	Case Number	Date Filed	Status
Sandoz	2:12-cv-00500	08/23/2012	Closed
Hi-Tech	1:12-cv-00492	05/16/2012	Pending
Watson	1:12-cv-00321	03/30/2012	Pending
Apotex	1:12-cv-00247	03/13/2012	Pending

If you are interested in knowing more about the cases filed, please contact us. 

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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 for patentees to virtually mark products and search for patent related information.