Pharmaceuticals

February 13, 2014

Alcon Sues Cipla for Patent Infringement of Pataday™

Indianapolis, Indiana – Indiana patent lawyers for Alcon Research, LTD of Fort Worth, Texas and Alcon Pharmaceuticals Ltd of Fribourg, Switzerland (collectively, “Alcon”) sued in the Southern District of Indiana alleging that Cipla Limited of Mumbai Central, Mumbai and Cipla USA Inc. of Miami, Florida (collectively, “Cipla”) infringed Olopatadine Formulations for Topical Administration, Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”), which have been issued by the U.S. Patent Office.

According to the complaint, the Cipla entities are engaged in the generic-pharmaceutical business. Alcon asserts that one or more of the entities develops, manufactures, imports, markets, offers to sell and/or sells generic drugs throughout the United States.

Cipla filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of Pataday™ ophthalmic solution, a drug product containing olopatadine hydrochloride. The two patents-in-suit, which Alcon claims to own, are asserted to cover Pataday™. Alcon contends that Cipla’s submission of this ANDA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of Cipla’s ANDA product before the expiration of the patents-in-suit is an act of infringement under 35 U.S.C. § 271(e)(2)(A).

Alcon states that it believes that the Cipla entities are part of a vertically integrated and unified organization and that they will act in concert to introduce the generic version of Pataday™ to the United States market prior to the expiration of Alcon’s patents.

In the complaint, intellectual property attorneys for Alcon list the following claims:

• Count I: Infringement of the ‘186 Patent
• Count II: Infringement of the ‘609 Patent
• Count III: Declaratory Judgment of Infringement of the ‘186 Patent
• Count IV: Declaratory Judgment of Infringement of the ‘609 Patent

Alcon asks for a judgment that the ‘186 and ‘609 patents are valid and enforceable and have been infringed; a judgment providing that the effective date of any FDA approval of commercial manufacture, use or sale of Cipla’s ANDA product be not earlier than the latest of the expiration date of the patents-in-suit, inclusive of any extension(s) and additional periods of exclusivity; preliminary and permanent injunctions protecting products covered by the ‘186 patent prior to its expiration; preliminary and permanent injunctions protecting products covered by the ‘609 patent prior to its expiration; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Cipla’s ANDA product, or any other drug product covered by the ‘186 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Cipla’s ANDA product, or any other drug product covered by the ‘609 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a declaration that this is an exceptional case and an award of attorneys’ fees; and costs and expenses.

Practice Tip:

India is the world’s leading exporter of generic drugs. Some Indian manufacturers are aggressively seeking to have their generic versions approved by the FDA well before a brand-name drug’s patent(s) expire. This has led to a substantial amount of patent litigation against Indian companies, as the difference in market price between brand-name drugs and their generic counterparts can be enormous.

In addition to Indian companies being subject to litigation in the United States, Indian courts are also actively engaged in the ongoing dispute over intellectual property rights. Those courts, as well as the Indian government, have in several notable instances found in favor of Indian generic-drug manufacturers and against intellectual property holders in the United States. For example, in 2012, a decision by India’s Controller General of Patents, Designs and Trademarks granted a “compulsory license” of the patented cancer drug Nexavar.

According to this decision, Bayer must license Nexavar to Natco Pharma, an Indian company, in exchange for a 6% royalty on Natco’s net sales. The generic drug will be sold in India for $176 per month instead of the $5,600 per month that Bayer had been charging in that market.

While a provision exists within the World Trade Organization‘s Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) Agreement that allows for compulsory licensing of pharmaceuticals, it has been used only infrequently, usually for drugs that treat AIDS. This was the first time such compulsory licensing was granted in India. India is only the second country, after Thailand, to grant a compulsory license to a cancer drug.

January 30, 2014

Lilly Sues Glenmark Generics for Over Proposed Manufacture and Sale of Generic Version of ALIMTA®

By Overhauser Law Offices, LLC

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.

January 27, 2014

Eli Lilly Sues Par Pharmaceutical Asserting Patent Infringement of Effient®

By Overhauser Law Offices, LLC

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.

November 27, 2013

Eli Lilly Sues Actavis for Infringement of Patents Related to Axiron

By Overhauser Law Offices, LLC

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).

September 25, 2013

Alcon Sues Wockhardt for Patent Infringement of Pataday™

By Overhauser Law Offices, LLC

Indianapolis, Indiana — Alcon Research, Ltd. of Fort Worth, Texas, and Alcon Pharmaceuticals Ltd. of Fribourg, Switzerland (collectively, “Alcon”) have filed a patent infringement lawsuit in the Southern District of Indiana alleging that Wockhardt Limited of Mumbai, Maharashta, India; Wockhardt Bio AG of Zug, Switzerland; Wockhardt Bio Ltd. of Zug, Switzerland; and Wockhardt USA, LLC of Parsippany, New Jersey (collectively, “Wockhardt”) infringed Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”), both for Olopatadine Formulations For Topical Administration, which have been issued by the U.S. Patent Office.

According to the complaint, the Wockhardt entities are engaged in the generic-pharmaceutical business. Alcon asserts that one or more of the entities manufacture, import, market, offer to sell and/or sell generic drugs throughout the United States.

Wockhardt filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of Pataday™ ophthalmic solution, a drug product containing olopatadine hydrochloride. The two patents-in-suit, which Alcon claims to own, are asserted to cover Pataday™. Alcon contends that Wockhardt’s submission of this ANDA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of Wockhardt’s ANDA product before the expiration of the patents-in-suit is an act of infringement under 35 U.S.C. § 271(e)(2)(A).

Plaintiff Alcon states that it believes that the Wockhardt entities are part of a vertically integrated and unified organization and that they will act in concert to introduce the generic version of Pataday™ to the United States market prior to the expiration of Alcon’s patents.

In the complaint, intellectual property attorneys for Alcon list the following claims:

· Count I: Infringement of the ‘186 Patent

· Count II: Infringement of the ‘609 Patent

· Count III: Declaratory Judgment of Infringement of the ‘186 Patent

· Count IV: Declaratory Judgment of Infringement of the ‘609 Patent

Alcon asks for a judgment that the ‘186 and ‘609 patents are valid and enforceable and have been infringed; a judgment providing that the effective date of any FDA approval of commercial manufacture, use or sale of Wockhardt’s ANDA product be not earlier than the latest of the expiration date of the patents-in-suit, inclusive of any extension(s) and additional periods of exclusivity; preliminary and permanent injunctions protecting products covered by the ‘186 patent prior to its expiration; preliminary and permanent injunctions protecting products covered by the ‘609 patent prior to its expiration; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Wockhardt’s ANDA product, or any other drug product covered by the ‘186 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Wockhardt’s ANDA product, or any other drug product covered by the ‘609 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a declaration that this is an exceptional case and an award of attorneys’ fees; and costs and expenses.

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.

August 26, 2013

Eli Lilly Defending Method-of-Use Patent for Blockbuster Drug

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Patent lawyers for Eli Lilly and Company (“Lilly”) of Indianapolis, Indiana are in trial again this week in the Southern District of Indiana pursuing patent-infringement allegations against five generic-drug challengers, including AAP Pharmaceuticals of Schaumberg, Illinois and Pliva Hrvatksa of Croatia. At issue is Lilly’s patent on the use of Alimta in conjunction with specific vitamins; patents for the two Alimta treatments, both with and without the supplemental therapy, have been issued by the U.S. Patent Office.

Lilly sells the drug Alimta to treat various types of lung cancer, including mesothelioma. However, certain side effects were troublesome, including treatment-related hematologic and gastrointestinal toxicity. Deaths among some patients were attributed to treatment with Alimta. In response to this concern, Lilly took the unusual step of mandating supplementation of the Alimta protocol with two vitamins, folic acid and vitamin B12. The patentability of that idea is the focus of a patent challenge by five makers of generic drugs.

Patent-infringement litigation between brand-name manufacturers and generic-drug makers is common. In a typical lawsuit, a company which wishes to sell a generic version of a brand-name drug, usually a widely used drug, will try to invalidate the patent on the drug, in the hopes that it could then offer the same drug in generic form.

This litigation is different from traditional patent litigation. The original patent on Alimta, administered as a stand-alone treatment, protects only Alimta’s active ingredient. That patent will expire in 2017. However, the focus of the current litigation is on the combination treatment which involves both Alimta and the vitamin regimen. The patent on the method of administration, if upheld, would expire in 2022.

The generic challengers contend in part that the patent on the combined therapy is invalid, arguing that someone knowledgeable about both nutrition and medicine could have easily concluded that supplementation with B12 and folate might alleviate certain side effects of Alimta.

Lilly, in contrast, argues that the vitamin regimen was not only counterintuitive when it was proposed, it was called “crazy” a leading cancer doctor before testing showed its benefits.

The case, which is before Judge Tanya Walton Pratt, began last Monday and is expected to continue another week.

Practice Tip:

Lilly 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 current top-selling drug, the antidepressant Cymbalta, will lose patent protection this year. The patent on blockbuster Evista, a breast cancer drug, will expire in early 2014.

Alimta is currently Lilly’s second-best-selling drug. It generated $2.6 billion in sales last year, or about 11 percent of total Lilly’s revenue. Since it was launched in 2004, Alimta has generated $12 billion in total sales for Lilly through 2012.

Under patent law, a court can deem a patent invalid if its claims are “obvious” and anticipated by previous research. In this case, the court will weigh the merits of the separate “method-of-use” patent on the administration of Alimta with B12 and folic acid.

If successful in defending this patent, intellectual-property law will grant market exclusivity to Lilly until 2022, allowing it to exclude generic manufacturers and, thus, to charge the higher brand-name price for Alimta therapy. If the patent is not upheld in this litigation, Lilly will lose the five additional years of exclusivity that the second patent would have afforded.

June 12, 2013

Eli Lilly Sues Perrigo for Patent Infringement of Axiron

By Overhauser Law Offices, LLC

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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February 28, 2013

Eli Lilly Sues Accord Healthcare Again for Infringement of Patented ALIMTA

By Overhauser Law Offices, LLC

Indianapolis, IN – Eli Lilly and Company of Indianapolis, Indiana filed an additional patent infringement suit in the Southern District of Indiana alleging that Accord Healthcare, Inc., USA of Durham, North Carolina will infringe U.S. Patent No. 7,772,209 (the “‘209 patent”) which has been issued by the U.S. Patent Office if relief is not afforded by the court.

In a complaint that was almost identical to a previous complaint filed in January 2012, patent attorneys for Eli Lilly and Company (“Lilly”) initiated an additional lawsuit against Accord Healthcare, Inc., USA (“Accord”) for attempting to gain FDA approval to manufacture and sell a generic version of Lilly’s ALIMTA, a drug that is used in the treatment in certain types of lung cancer. ALIMTA is protected by the ‘209 patent.

This is the second suit by Lilly against Accord involving the ‘209 patent. This suit was initiated after Accord filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a product that competes with Lilly’s ALIMTA, which is an “Antifolate Combination Therapies” product. The complaint from 2012 alleged intent to infringe by, among other activities, the production and sale of Accord’s “Pemetrexed Disodium for Injection,” a generic version of ALIMTA, in 100 mg/vial and 500 mg/vial products. The current complaint alleged intent to infringe with a “Pemetrexed Disodium for Injection” product in a 1000 mg/vial strength. As part of its ANDA filing, Accord alleged that the claims of the ‘209 patent are invalid and/or not infringed by Accord’s product.

Eli Lilly has sued alleging infringement of the patented ALIMTA before:

· Eli Lilly Sues Apotex Inc. for Patent Infringement of ALIMTA

· Eli Lilly and Company Sues Accord Healthcare for Patent Infringement of Lung Cancer Drug ALIMTA

· Lilly Wins Patent Infringement Suit Regarding Chemotherapy Drug

· Eli Lilly Company Sues APP Pharmaceuticals LLC for Patent Infringement of Chemotherapy Drug

Lilly seeks a judgment that Accord has infringed and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the ‘209 patent; a judgment ordering that Accord delay virtually all activities pertaining to its ANDA product until after the ‘209 patent has expired; a preliminary and permanent injunction against activity that infringes upon the ‘209 patent; a declaratory judgment of infringement; a declaration that the case is exceptional and an award of attorneys’ fees pursuant to such a declaration; and Lilly’s costs and expenses.

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 jurisdictional issues with respect to declaratory judgments. For an interesting look at some of the issues, see here.

February 28, 2013

Lilly Sues Genentech to Invalidate Cabilly Patents

By Overhauser Law Offices, LLC

San Jose, CA – Lilly of Indianapolis, Indiana filed a declaratory judgment suit against Genentech asking the U.S. District Court, Northern District of California to invalidate Genentech’s recombinant-antibody patents.

This suit, filed by patent attorneys for Eli Lilly & Company (“Lilly”) and its subsidiary ImClone Systems LLC, of Delaware, included as defendants both Genentech, Inc. (“Genentech”) and City of Hope National Medical Center (“City of Hope”).

Genentech, also known as “Genetic Engineering Technology, Inc.” is a wholly owned subsidiary of F. Hoffmann-La Roche Holding AG engaged in biotechnology research.

It has won numerous awards as an employer and corporate citizen, including earning the number-one spot on Fortune Magazine’s “100 Best Companies To Work For” in 2006.

City of Hope is a private, not-for-profit clinical research center, hospital and graduate medical school located in Duarte, California.

The suit involves two patents held by Genentech: 6,331,415: “Methods of producing immunoglobulins, vectors and transformed host cells for use therein” (“Cabilly II”) and 7,923,221: “Methods of making antibody heavy and light chains having specificity for a desired antigen,” (“Cabilly III”), together known as the “Cabilly patents” after one of the inventors. They have been issued by the U.S. Patent Office.

At issue is the drug Erbitux (cetuximab), made by Lilly’s ImClone unit. Genentech claims that the drug, approved in the U.S. to treat colon cancer and tumors of the head and neck, infringes the Cabilly patents through the unlicensed use of a patented process and various patented starting materials.

Despite that Lilly already has a non-exclusive license to the Cabilly patents, it filed a declaratory judgment action. It asserts that it has no obligation to pay royalties on the sale of Erbitux, arguing that the Cabilly patents are invalid and unenforceable, and, further, not infringed by Lilly. It alleges that Cabilly patents are invalid for, among other reasons, lack of inventorship, inequitable conduct and violation of 35 U.S.C. § 135(c) (which relates to the filing of settlement agreements with the PTO in interference actions). Lilly also alleges that Genentech deceived the U.S. Patent Office into issuing the Cabilly patents.

Lilly seeks a declaratory judgment that the Cabilly patents are invalid and unenforceable, and are not implicated in the manufacture of Erbitux.

Practice Tip: The Cabilly patents have a potentially broad scope and could confront any manufacturer of recombinant antibodies. Genentech has been quoted as stating that the patents broadly cover the co-expression of immunoglobulin heavy and light genes in a single host cell, and are not limited by the type of antibody or host cell. Genentech has also been quoted as stating that the Cabilly II patent is “the backbone of recombinant antibody production in the biotech industry.” Given Genentech’s history of actively litigating this family of patents (see, e.g., MedImmune, Inc. v. Genentech, Inc, et al., which was litigated to the U.S. Supreme Court), and the purported broad scope of the Cabilly patents, it seems that litigation regarding these patents may continue for quite some time.

April 23, 2012

Eli Lilly Sues Apotex Inc. for Patent Infringement of ALIMTA

By Overhauser Law Offices, LLC

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