Articles Posted in Pharmaceuticals

Lilly-1-300x132Indianapolis, IndianaEli Lilly and Company of Indianapolis, Indiana filed a federal lawsuit in the Southern District of Indiana alleging patent infringement. Defendants are Actavis LLC of Parsippany, New Jersey; Teva Pharmaceuticals USA, Inc. of North Wales, Pennsylvania; and Teva Pharmaceutical Industries, Ltd. of Petach Tikva, Israel.

At issue is a patent for Antifolate Combination TherapiesPatent No. 7,772,209 (“the ‘209 patent”) which has been issued by the U.S. Patent and Trademark Office.  This patent covers intellectual property embodied in Alimta®, a drug therapy used for the treatment of various types of cancer.

In a complaint filed by an Indiana patent litigator, Lilly states that Defendants filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell generic equivalents of ALIMTA® prior to the expiration of the ‘209 patent.  It asserts that this filing constitutes and/or will constitute infringement of the ‘209 patent, active inducement of infringement of the ‘209 patent, and contribution to the infringement by others of the ‘209 patent.

Lilly seeks, inter alia, injunctive relief, costs and attorneys’ fees.

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Lilly-300x132Indianapolis, IndianaEli Lilly and Company of Indianapolis, Indiana filed a patent infringement lawsuit in the Southern District of Indiana asserting infringement of U.S. Patent No. 7,772,209 (‘209 Patent).  Defendant is Amneal Pharmaceuticals LLC of Bridgewater, New Jersey.

Lilly states that Amneal filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell two “Pemetrexed for Injection” products prior to the expiration of the ‘209 patent.  Lilly contends that the ‘209 patent, which was issued by the U.S. Patent and Trademark Office, protects the Pemetrexed products.

In this patent litigation, filed by attorneys for Lilly, a single count is listed, “Infringement of U.S. Patent No. 7,772,209.”  Lilly seeks relief from the Indiana court including a judgment of infringement, injunctive relief, costs and attorneys’ fees.

Practice Tip: Lilly has had some success protecting its ‘209 patent, which relates to the cancer drug Alimta®, against generic manufacturers.  See, e.g., U.S. Court of Appeals Rules In Lilly’s Favor on Alimta Vitamin Regimen Patent.

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Figure-6_903-Patent-300x283Washington, D.C. — The Federal Circuit ruled on two patent infringement decisions, Los Angeles Biomedical Research Institute v. Eli Lilly & Co. and Eli Lilly & Co. v. Los Angeles Biomedical Research Institute, that involve Indianapolis-based Eli Lilly and Company.

These companion cases pertain to a pharmaceutical patent, U.S. Patent No. 8,133,903 (“the ’903 patent”), owned by Los Angeles Biomedical.  Also at issue is one prior art reference, International Patent Application No. WO 01/80860, published Nov. 1, 2001, common to both lawsuits.

Los Angeles Biomedical Research Institute v. Eli Lilly & Co. arose as an inter partes review of a decision by the Patent Trial and Appeal Board holding all claims of the ‘903 patent to be obvious.  The Federal Circuit reviewed claims in a provisional application relating to a study involving rats in combination with a method in an uncited reference to convert those results to apply to humans.  It held that the rat study and uncited conversion method did not support the claimed dosage for humans.  It further concluded that claims directed to an underlying condition should not be construed broadly to treat symptoms of that condition, holding that the Board had not adopted the broadest reasonable interpretation of the claims but instead had adopted an overbroad interpretation. The panel remanding, stating:

The question remains whether a person of skill in the art would have had a reason to combine [the three cited references relating to the medical condition] and would have had a reasonable expectation of success from doing so.  Because the Board’s obviousness analysis was based on an erroneous construction of the claim language and an overly broad interpretation of [one of the references], and because the Board did not address the record evidence summarized above, we remand for the Board to make new findings as to whether there was an apparent reason to combine the prior art references and whether that combination would have rendered [the treatment] obvious.

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Indianapolis, Indiana – The matter of Eli Lilly and Company, et al. v. Apotex Inc., et al. has been stayed pending a ruling by the U.S. Court of Appeals for the Federal Circuit.

This Indiana lawsuit was initiated by Lilly, an Indianapolis pharmaceutical company, in conjunction with other Plaintiffs.  Patent attorneys for Plaintiffs filed a lawsuit asserting patent infringement after Defendants filed an Abbreviated New Drug Application seeking approval to market a generic version of the drug Axiron® before various patents related to the drug expired.  Among Plaintiffs’ contentions were claims of patent infringement of seven patents pertaining to Axiron.861-Patent_Fig-2-300x219

In this motion, patent lawyers for Plaintiffs have asked the court to stay its proceedings pending a ruling in a similar case, Eli Lilly and Company, et al. v. Perrigo Company, et al.  The Perrigo case was filed in the Southern District of Indiana in 2013.  After a trial, the court issued findings including that one claim in one of the Axiron patents was invalid, while two claims pertaining to another Axiron patent were valid.  That ruling was appealed to the Federal Circuit; that appeal remains pending.

LillyHeadquarters-300x127Indianapolis, Indiana – A patent lawyer for Eli Lilly and Company of Indianapolis, Indiana, Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS, Pty Ltd. of West Melbourne, Australia filed an intellectual property lawsuit in the Southern District of Indiana.

Two Defendants are listed, TWi Pharmaceuticals, Inc. of Paramus, New Jersey and TWi Pharmaceuticals USA, Inc. of Taipei, Taiwan.  In a 28-count complaint, Defendants are accused of infringing seven patents by filing an Abbreviated New Drug Application with the U.S. Food and Drug Administration for approval of a generic version of the pharmaceutical product Axiron® before the expiration of the patents under which the drug is protected.  The patents at issue in this litigation are U.S. Patent Nos. 8,435,944; 8,993,520; 9,180,194; 8,419,307; 8,177,449; 8,807,861 and 9,289,586.

The counts against Defendants include “direct patent infringement,” “inducement to infringe” and “contributory infringement” as well as counts requesting declaratory judgment.  Lilly et al. are seeking declaratory relief, injunctive relief, costs and attorney fees.

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Indianapolis, Indiana – The U.S. Court of Appeals for the Federal Circuit has upheld the district court’s decision and ruled in favor of Eli Lilly regarding validity and infringement of the vitamin regimen patent U.S. Patent No. 7,772,209 for Alimta® (pemetrexed for injection).

In the case of Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al., the court affirmed the earlier district court’s rulings that the vitamin regimen patent is valid and would be infringed by the generic challengers’ proposed products. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force. The Alimta compound patent remLillyHeadquarters-300x127ains in force through January 24, 2017.

In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly’s favor regarding infringement of the vitamin regimen patent.

2016-12-29Indianapolis, IndianaEli Lilly and Company of Indianapolis, Indiana filed a lawsuit in the Southern District of Indiana alleging patent infringement.

Defendant is Hospira, Inc. of Lake Forest, Illinois.  It has been accused of infringing U.S. Patent No. 7,772,209 (the “‘209 patent”) by the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a pharmaceutical product, “Pemetrexed for Injection,” in various concentrations.  In its filing with the FDA, Hospira contended that the claims of Lilly’s patent are “invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of Hospira’s NDA Products.”

Lilly contends that this product will compete with Alimta®, which also consists of the pharmaceutical chemical pemetrexed disodium.  Alimta is used as a chemotherapy agent to treat certain types of cancer.

Indianapolis, IndianaAlcon Research, Ltd. of Fort Worth, Texas and Alcon Pharmaceuticals Ltd. of Fribourg, Switzerland filed an intellectual property lawsuit in the Southern District of Indiana.  They assert infringement of two patents covering Pataday®, an ophthalmic pharmaceutical.  Pataday is covered by U.S. Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”).

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Defendant Akorn, Inc., a generic drugmaker based in Lake Forest, Illinois, filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration seeking approval to manufacture and sell a generic version of Plaintiffs’ drug prior to the expiration of the two patents-in-suit.  Plaintiffs contend that the submission of this ANDA is an act of patent infringement.

In this Indiana complaint, patent lawyers for Alcon ask the court to adjudicate the following:

Indianapolis, Indiana – Patent attorneys for Plaintiff Eli Lilly and Company filed a lawsuit in the Southern District of Indiana alleging infringement.  Defendant is Fresenius Kabi USA, LLC of Lake Zurich, Illinois.

Lilly, an Indianapolis-based company, is a developer and seller of pharmaceutical drugs.  One of its drugs, ALIMTA®, is marketed as a chemotherapy agent used for the treatment of various types of cancer.

Fresenius, formerly known as APP Pharmaceuticals, LLC, manufactures and sells generic drugs.  Earlier this year, Fresenius amended its Abbreviated New Drug Application (“ANDA”), which was previously filed to seek U.S. Food and Drug Administration (“FDA”) approval to manufacture three different concentrations of ALIMTA.  Through its recent amendment, Fresenius now asks for approval to manufacture and sell a fourth generic version of ALIMTA.  Lilly filed this litigation in response.

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Indianapolis, Indiana – Patent lawyers for Plaintiffs Eli Lilly and Company of Indianapolis, Indiana, its subsidiary Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS Pty Ltd of West Melbourne, Australia filed a lawsuit alleging patent infringement. This federal lawsuit, commenced in the Southern District of Indiana, lists two Defendants, Cipla Limited of Mumbai, India and its wholly owned subsidiary Cipla USA, Inc. of Miami, Florida.

The parties in this litigation are engaged in the development and sale of pharmaceuticals. At issue is Plaintiffs’ transdermal testosterone solution, which is marketed under the trade name “Axiron®.” Lilly holds New Drug Application No. 022504 for this drug, which was approved by the U.S. Food and Drug Administration (“FDA”).

Defendants submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to market a generic version of Lilly’s Axiron product. In this ANDA, Defendants certified to the FDA that they believed that the patents-in-suit were invalid, unenforceable and/or would not be infringed by the commercial manufacture, use or sale of the generic version of Axiron described in the ANDA.

According to Plaintiffs, the filing of this ANDA by Defendants constitutes patent infringement. Plaintiffs also contend that other threatened activities, such as commercial manufacture, importation and sale of a generic version of Axiron, would also infringe Plaintiffs’ patents.

Plaintiffs list three disputed patents in this lawsuit: U.S. Patent Nos. 8,435,944; 8,993,520 and 9,180,194. These patents have been issued by the U.S. Patent and Trademark Office. Indiana attorneys for Plaintiffs ask the court for relief with respect to the following claims of patent infringement:

• Count I: Direct Infringement of U.S. Patent No. 8,435,944
• Count II: Inducement To Infringe U.S. Patent No. 8,435,944
• Count III: Contributory Infringement of U.S. Patent No. 8,435,944
• Count IV: Direct Infringement of U.S. Patent No. 8,993,520
• Count V: Inducement To Infringe U.S. Patent No. 8,993,520
• Count VI: Contributory Infringement of U.S. Patent No. 8,993,520
• Count IV [sic]: Direct Infringement of U.S. Patent No. 9,180,194
• Count V [sic]: Inducement To Infringe U.S. Patent No. 9,180,194

• Count VI [sic]: Contributory Infringement of U.S. Patent No. 9,180,194

The complaint also lists three counts seeking declaratory judgment.

Plaintiffs aver that this case is “exceptional” and ask the court for an award of their costs, including attorneys’ fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4).

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