Articles Posted in Pharmaceuticals

Indianapolis, Indiana – Indiana patent attorneys for Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed a lawsuit in the Southern District of Indiana alleging that Glenmark Generics, Inc., USA of Mahwah, New Jersey (“Glenmark”) infringed Antifolate Combination Therapies, Patent No. 7,772,209, which has been issued by the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products worldwide. Glenmark is in the business of distributing, selling, and offering to sell drug products throughout the United States.

ALIMTA®, which is allegedly licensed to Lilly, is a chemotherapy agent used for the treatment of various types of cancer. ALIMTA® is composed of the pharmaceutical chemical pemetrexed disodium. It is indicated, in combination with cisplatin, (a) for the treatment of patients with malignant pleural mesothelioma, or (b) for the initial treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer. ALIMTA® also is indicated as a single agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy. Additionally, ALIMTA® is indicated for maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. One or more claims of U.S. Patent No. 7,772,209 (“the ‘209 patent”) cover a method of administering pemetrexed disodium to a patient in need thereof that also involves administration of folic acid and vitamin B12.

This Indiana patent infringement lawsuit arises out of the filing by Defendant Glenmark of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of ALIMTA® prior to the expiration of the ‘209 patent. Glenmark filed as a part of ANDA No. 205526 a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 55(j)(2)(A)(vii)(IV), with respect to the ‘209 patent, asserting that the claims of the ‘209 patent are invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of Glenmark’s ANDA products.

In its complaint, filed by an Indiana patent lawyer, Lilly states that Glenmark intends to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Glenmark’s ANDA Products and the proposed labeling therefor immediately and imminently upon approval of ANDA No. 205526, i.e., prior to the expiration of the ‘209 patent. Lilly asserts that Glenmark’s actions constitute 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 asks for:

• A judgment that Glenmark has infringed the ‘209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the ‘209 patent;
• A judgment ordering that the effective date of any FDA approval for Glenmark to make, use, offer for sale, sell, market, distribute, or import Glenmark’s ANDA Products, or any product the use of which infringes the ‘209 patent, be not earlier than the expiration date of the ‘209 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
• A preliminary and permanent injunction enjoining Glenmark, and all persons acting in concert with Glenmark, from making, using, selling, offering for sale, marketing, distributing, or importing Glenmark’s ANDA Products, or any product the use of which infringes the ‘209 patent, or the inducement of or contribution to any of the foregoing, prior to the expiration date of the ‘209 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
• A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Glenmark’s ANDA Products, or any product the use of which infringes the ‘209 patent, prior to the expiration date of the ‘209 patent, infringes, will infringe, will actively induce infringement of, and/or will contribute to the infringement by others of the ‘209 patent;
• A declaration that this is an exceptional case and an award of attorneys’ fees pursuant to 35 U.S.C. § 285; and
• An award of Lilly’s costs and expenses in this action.

Practice Tip: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing. Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process. The statute that created the abbreviated process, however, had also created some interesting issues with respect to the period of exclusivity. For a look at some of these issues, see here.

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Indianapolis, Indiana – An Indiana patent attorney sued in the Southern District of Indiana on behalf of Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd. of Tokyo, Japan (“Daiichi Sankyo”); Daiichi Sankyo, Inc. of Parsippany, New Jersey (“DSI”); and Ube Industries, Ltd. of Yamaguchi, Japan alleging that Par Pharmaceutical Companies, Inc. (“Par Pharmaceutical Companies”) and Par Pharmaceutical, Inc. (“Par”), both of Woodcliff Lake, New Jersey, (collectively “Par Pharmaceutical”) infringed Medicinal Compositions Containing Aspirin, Patent No. 8,404,703 (the “‘703 patent”) and Method of Treatment and Coadministration of Aspirin and Prasugrel, Patent No. 8,569,325 (the “‘325 patent”), which have been issued by the U.S. Patent Office.

This is a civil action for patent infringement. It arises out of the filing by Defendant Par of an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of two of Lilly’s pharmaceutical products, Effient® 5mg and Effient® 10mg tablets, prior to the expiration of Daiichi Sankyo’s and Ube’s U.S. patents, which purportedly cover methods of using Effient® products. Lilly asserts that it holds an exclusive license to these products. DSI currently co-promotes Effient® products in the United States with Lilly.

Effient® products were approved by the FDA for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI, or angioplasty). The instructions accompanying Effient® products state that patients taking Effient® products should also take aspirin. The use of Effient® products in combination with aspirin for the reduction of thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is covered by the claims of the ‘703 and ‘325 patents.

Par has submitted an Abbreviated New Drug Application (the “Par ANDA”) to the FDA pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic version of Lilly’s product for oral administration (the “Par Products”) in the United States.

Plaintiffs assert that Par will knowingly include with the Par Products instructions for use that substantially copy the instructions for Effient® products, including instructions for administering the Par Products with aspirin as claimed in the ‘703 and ‘325 patents. Moreover, Plaintiffs contend that Par knows that the instructions that will accompany the Par Products will induce and/or contribute to others using the Par Products in the manner set forth in the instructions. Plaintiffs also contend that Par specifically intends that health care providers, and/or patients will use the Par Products in accordance with the instructions provided by Par to directly infringe one or more claims of the ‘703 and ‘325 patents. Par therefore will actively induce and/or contribute to infringement of the ‘703 and ‘325 patents, state Plaintiffs.

In the complaint, the Indiana patent lawyer for Plaintiffs listed the following counts:

• Count I: Infringement of U.S. Patent No. 8,404,703
• Count II: Declaratory Judgment of Infringement of U.S. Patent No. 8,404,703
• Count III: Infringement of U.S. Patent No. 8,569,325
• Count IV: Declaratory Judgment of Infringement of U.S. Patent No. 8,569,325

Plaintiffs ask the court for judgment:

A. That Defendants, either individually or collectively, have infringed or will infringe, after the Par ANDA is approved, one or more claims of the ‘703 patent;
B. That Defendants, either individually or collectively, have infringed or will infringe, after the Par ANDA is approved, one or more claims of the ‘325 patent;
C. That, pursuant to 35 U.S.C. § 271(e)(4)(B), Par and Par Pharmaceutical Companies be permanently enjoined from making, using, selling or offering to sell either or both of the Par Products within the United States, or importing either or both of the Par Products into the United States prior to the expiration of the ‘703 and ‘325 patents;
D. That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the Par ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the latest of the expiration dates of the ‘703 and ‘325 patents, including any extensions;
E. A judgment declaring that the ‘703 patent remains valid and enforceable;
F. A judgment declaring that the ‘325 patent remains valid and enforceable;
G. If either Par or Par Pharmaceutical Companies commercially makes, uses, sells or offers to sell either or both of the Par Products within the United States, or imports either or both of the Par Products into the United States, prior to the expiration of either of the ‘703 and ‘325 patents, including any extensions, that Plaintiffs will be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
H. That this case be deemed exceptional under 35 U.S.C. § 285; and
I. That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

Practice Tip: Lilly is not an infrequent litigant. This may be in part due to the fact that the company is facing a significant patent cliff. Its patent for a former top product, the antipsychotic Zyprexa – which once generated $5 billion in annual revenues – expired in 2011. Its top-selling drug of 2013, the antidepressant Cymbalta, lost patent protection last year. The patent on blockbuster Evista, a drug for breast cancer and osteoporosis, will expire this March.

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Indianapolis, Indiana – Eli Lilly and Company of Indianapolis, Indiana; Eli Lilly Export S.A. of Geneva, Switzerland (collectively, “Lilly”); and Acrux DDS Pty Ltd. of West Melbourne, Australia have filed a patent infringement lawsuit in the Southern District of Indiana alleging that Actavis, Inc. and Actavis Pharma, Inc., both of Parsippany, New Jersey, and Watson Laboratories, Inc. of Corona, California infringed Patent Nos. 6,299,900 – Dermal Penetration Enhancers and Drug Delivery Systems Involving Same; 6,818,226 – Dermal Penetration Enhancers and Drug Delivery Systems Involving Same; 6,923,983 – Transdermal Delivery of Hormones; 8,071,075 – Dermal Penetration Enhancers and Drug Delivery Systems Involving Same; 8,419,307 – Spreading Implement; and 8,435,944 – Method and Composition for Transdermal Drug Delivery (collectively, the “patents-in-suit”) which have been issued by the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products. Acrux is engaged in the development and commercialization of pharmaceutical products. Both sell their products worldwide.

Actavis, Inc., along with its wholly owned subsidiaries Actavis Pharma and Watson Laboratories, (collectively, “Actavis”) are pharmaceutical companies that develop, manufacture, market and distribute generic pharmaceutical products for sale in the United States.

Lilly is the holder of approved New Drug Application No. 022504 for the manufacture and sale of a transdermal testosterone solution made at a concentration of 30 mg/1.5L, which it markets under the trade name “Axiron®.” This drug is used to treat males for conditions associated with a deficiency or absence of endogenous testosterone.

This action relates to the Abbreviated New Drug Application (“ANDA”) No. 205328 submitted by Watson Laboratories to the U.S. Food and Drug Administration (“FDA”) for approval to market a generic version of Lilly’s Axiron product. Defendants certified to the FDA that, in their opinion, 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.

As part of its ANDA filing, Defendants sent to Lilly and Acrux an “Offer of Confidential Access” which would allow limited access to Actavis’ ANDA. Lilly and Acrux were unsatisfied with the offer, stating that the restrictions it contained would prohibit crucial decision makers from having access to the ANDA. Lilly and Acrux also contended that the restrictions were improper as they were not directed to the purpose of protecting trade secrets and other confidential business information. While attempts to reach an agreement regarding access to the ANDA were made, they were not successful.

Plaintiffs contend that the submission of the ANDA to the FDA constitutes infringement by Defendants of the patents-in-suit. In their complaint, patent lawyers for Lilly and Acrux assert twenty-four separate counts related to patent infringement. For each of the patents-in-suit, there is one count of “Direct Infringement,” one count of “Inducement to Infringe,” one count of “Contributory Infringement” and one count for declaratory judgment.

The complaint asks for an injunction to stop Defendants from producing the generic version of Axiron until the expiration of Lilly’s patents-in-suit. In addition, Lilly asks that the court declare the patents to be valid and enforceable; that Defendants infringed upon all of the patents-in-suit by, inter alia, submitting ANDA No. 205328 to obtain approval to commercially manufacture, use, offer for sale, sell or import its generic version of the drug into the United States; that Defendants’ threatened acts constitute infringement of the patents-in-suit; that FDA approval of Defendants’ generic drug be effective no sooner than the expiration date of the patent that expires last; and that this is an exceptional case. Plaintiffs also ask for costs and attorneys’ fees.

Practice Tip #1: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing. Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process. The statute that created the abbreviated process, however, had also created some interesting issues with respect to the period of exclusivity. For a look at some of these issues, see here.

Practice Tip #2: An offer of confidential access to an ANDA “shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information.” 21 USC § 355(c)(3)(D)(i).

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Indianapolis, Ind. — Patent lawyers for Eli Lilly & Co. of Indianapolis, Ind. (“Lilly”), Eli Lilly Export S.A., of Vernier/Geneva, Switzerland (a wholly owned subsidiary of Eli Lilly & Co.) and Acrux DDS Pty Ltd. of West Melbourne, Victoria, Australia (“Acrux”) filed a patent infringement suit alleging that Perrigo Company of Allegan, Mich. (“Perrigo Company”) and Perrigo Israel Pharmaceuticals Ltd. of Bnei Brak, Israel (“Perrigo Israel,” a wholly owned subsidiary of Perrigo Company), infringed Patent Nos. 8,435,944; 8,419,307; and 8,177,449, filed with the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products.  Acrux is engaged in the development and commercialization of pharmaceutical products for sale.  Both sell their products worldwide. 

Perrigo Company and Perrigo Israel (collectively, “Perrigo”) are pharmaceutical companies that develop, manufacture, market and distribute generic pharmaceutical products for sale throughout the United States.  These products include pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients.  Perrigo’s consumer-healthcare segment includes over 2,100 store-brand products which are marketed to major national chains such as Wal-Mart, CVS, Walgreens, Sam’s Club and Costco.  They also sell to major drug wholesalers.

Lilly is the holder of approved New Drug Application No. 022504 for the manufacture and sale of a transdermal testosterone solution made at a concentration of 30 mg/1.5L, which is marketed by Lilly under the trade name “Axiron.”  Axiron is a pharmaceutical drug which raises the amount of testosterone in a patient’s body.  Recent sales of Axiron are estimated to be $229 million annually, according to Symphony Health Solutions.  Axiron is subject to Patent Nos. 8,435,944, 8,419,307, 8,177,449 (the “‘944 patent,” the “‘307 patent,” and the “‘449” patent, respectively).  All three patents have been licensed to Lilly.

Perrigo announced on May 29, 2013 that it had filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) for approval of a generic version of Axiron.  Prior to filing the ANDA, No. 204255, Perrigo sent a letter to Lilly to inform Lilly that “in Perrigo’s opinion and to the best of its knowledge, the ‘449 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, or importation of the drug product described in Perrigo’s ANDA.”  Perrigo sent similar letters regarding the ‘307 and ‘944 patents.

After receiving the letter, Lilly filed suit alleging infringement of the three patents.  It states in its complaint that the ‘944 patent claims, inter alia, methods of increasing the testosterone blood level of an adult male by applying a transdermal drug-delivery composition that contains testosterone.  The ‘307 patent includes in its claims a method of increasing the level of testosterone in the blood by applying a liquid pharmaceutical that contains testosterone.  The claims for the ‘449 patent include a method of transdermal administration of a physiologically active agent.  All three patents are used in connection with Axiron. 

Lilly’s complaint lists the following claims:

·         Count I for Patent Infringement (Direct Infringement of U.S. Patent No. 8,435,944)

·         Count II for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,435,944)

·         Count III for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,435,944)

·         Count IV for Patent Infringement (Direct Infringement of U.S. Patent No. 8,419,307)

·         Count V for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,419,307)

·         Count VI for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,419,307)

·         Count VII for Patent Infringement (Direct Infringement of U.S. Patent No. 8,177,449)

·         Count VIII for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,177,449)

·         Count IX for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,177,449)

·         Count X for Declaratory Judgment (Infringement of U.S. Patent No. 8,435,944)

·         Count XI for Declaratory Judgment (Infringement of U.S. Patent No. 8,419,307)

·         Count XII for Declaratory Judgment (Infringement of U.S. Patent No. 8,177,449)

Lilly’s lawsuit asks for an injunction to stop Perrigo from producing the generic version of Axiron until the expiration of Lilly’s three patents-in-suit.  In addition, Lilly asks that the court declare the three patents to be valid and enforceable; that Perrigo infringed upon all three by, inter alia, submitting ANDA No. 204255 to obtain approval to commercially manufacture, use, offer for sale, sell or import its generic version of the drug into the United States; that Perrigo’s threatened acts constitute infringement of the three patents; that FDA approval of Perrigo’s generic drug be effective no sooner than the expiration date of the patent that expires last; that this is an exceptional case; and for costs and attorneys’ fees.

Practice Tip: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing.  Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process.  The statute that created the abbreviated process, however, had also created some interesting issues with respect to the period of exclusivity.  For an interesting look at some of these issues, see here. 
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Indianapolis, IN – Patent attorneys for Eli Lilly of Indianapolis, Indiana filed a patent infringement suit in alleging Apotex of Toronto, Canada infringed patent no. 7772209, ALIMTA, which has been issued by the US Patent Office.

ALIMTA is a chemotherapy drug used to treat mesothelioma and other lung cancers. Lilly co-owns the patent with Princeton University. This lawsuit arises from Apotex’s filing of an Abbreviated New Drug Application in March 2012 with the Food and Drug Administration that utilizes the ALIMTA patent. Lilly alleges that Apotex seeks approval for ANDA and that the product infringes its patents. The complaint makes one claim of patent infringement and seeks a declaration of infringement, an injunction, attorney fees and costs.

Practice Tip: Lilly’s ALIMTA has been the subject of several patent infringement cases. Here are a few we have blogged about:

• Eli Lilly and Company Sues Accord Healthcare for Patent Infringement of Lung Cancer Drug ALIMTA
• Eli Lilly Company Sues APP Pharmaceuticals LLC for Patent Infringement of Chemotherapy Drug
• Lilly Wins Patent Infringement Suit Regarding Chemotherapy Drug

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Indianapolis, IN – Patent attorneys for Eli Lilly and Company of Indianapolis, Indiana filed a patent infringement suit in the Southern District of Indiana alleging that Accord Healthcare, Inc., USA of Durham, North Carolina infringed patent no. 7,772,209, Antifolate combination therapies, which has been issued by the US Patent Office.

The complaint states that in December Accord sent a letter notifying Lilly that Accord had submitted an Abbreviated New Drug Application (ADNA) to the Food and Drug Administration (FDA) for its generic version of Alimta. Lilly alleges that Accord’s proposed product and labeling will infringe its patents. Lilly seeks an injunction to prevent Accord from developing, manufacturing and selling the allegedly infringing product.

Practice Tip: Lilly has already won a patent infringement case over Alimta. As we blogged about last year, the District Court of Delaware affirmed the validity of Alimta patents. This lawsuit, however, is over a patent that was not the subject of the District Court of Delaware’s decision.
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