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August 10, 2015

Indiana Patent Litigation: Lilly Files New Lawsuit Alleging Patent Infringement of Alimta

Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company of Indianapolis, 

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Indiana, in conjunction with Washington, D.C. co-counsel, sued for patent infringement in the Southern District of Indiana. Lilly claims that Emcure Pharmaceuticals Ltd. of Pune, India; Heritage Pharma Labs, Inc. of East Brunswick, New Jersey; and Heritage Pharmaceuticals, Inc. of Eatontown, New Jersey, will infringe and/or have infringed Lilly's patented "Novel Antifolate Combination Therapies," U.S. Patent Number 7,772,209 (the "'209 patent"), which has been issued by the U.S. Patent Office.

Plaintiff Lilly is in the business of, among other things, the manufacture and sale of various pharmaceuticals. Emcure Pharmaceuticals Ltd. is a generic pharmaceutical company engaged in developing, manufacturing and marketing a broad range of pharmaceutical products. Heritage Labs is believed to perform functions relating to Emcure's active pharmaceutical ingredient as well as formulation research and development. Heritage Pharmaceuticals is thought to be engaged in the acquisition, licensing, development, marketing, sale, and distribution of generic pharmaceutical products for the U.S. prescription drug market on behalf of Emcure.

Alimta®, which is licensed to Lilly, is a chemotherapy agent used for the treatment of various types of cancer. The drug 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 is also indicated as a single-agent treatment for patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy. Additionally, Alimta is used 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 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 lawsuit for patent infringement, submitted to the court by an Indiana patent lawyer, was triggered by the filing by defendant Emcure Pharmaceuticals of an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration. In that ANDA, Emcure Pharmaceuticals seeks approval to manufacture and sell its pemetrexed for injection, 500 mg/vial product prior to the expiration of the '209 patent.

This patent litigation asserts a single count: infringement of U.S. Patent No. 7,772,209. Lilly asks for a judgment that Emcure 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 that use of the intellectual property currently covered by the '209 patent shall be protected until its expiration date; injunctive relief; attorneys' fees and expenses; as well as other relief.

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August 6, 2015

Indiana Patent Litigation: Lilly Asks Indiana Court to Rule That It Has Not Infringed Patent

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Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana filed a patent-related lawsuit against Uropep Biotech GbR of Garbsen, Germany in the Southern District of Indiana.

Plaintiff Lilly is in the business of, among other things, the manufacture and sale of various pharmaceuticals including a drug trademarked as Cialis®. At issue in this intellectual property lawsuit is U.S. Patent No. 8,791,124, entitled "Use of Phosphordiesterase Inhibitors in the Treatment of Prostatic Diseases" ("the '124 patent"), which has been issued by the U.S. Patent Office.

Lilly states that the '124 patent was issued to Defendant Uropep Biotech. Lilly further states in this Indiana lawsuit that an entity related to Uropep Biotech, Erfindergemeinschaft UroPep GbR, sued Lilly last month in the Eastern District of Texas asserting that Lilly had infringed the '124 patent by manufacturing and selling Cialis.

Lilly contends that Erfindergemeinschaft does not own the patent-in-suit and that, consequently, the Texas lawsuit was improper. It further asserts that the Texas lawsuit provides evidence of an actual and justiciable controversy between Lilly and Uropep Biotech sufficient to warrant this instant Indiana lawsuit wherein the Indiana patent lawyer for Lilly asks the court for declaratory relief adjudging that it has not infringed the '124 patent. Lilly also asks the court for a declaration that the '124 patent is invalid as well as attorney's fees and costs.

Continue reading "Indiana Patent Litigation: Lilly Asks Indiana Court to Rule That It Has Not Infringed Patent" »

July 22, 2015

Indiana Patent Litigation: Lilly Adds Mylan to List of Defendants Accused of Infringing Alimta

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Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana sued in the Southern District of Indiana alleging that Mylan Laboratories Limited of Hyderabad, India; Mylan Pharmaceuticals Inc. of Morgantown, West Virginia; and Mylan Inc. of Canonsburg, Pennsylvania (collectively, "Mylan") infringed Patent No. 7,772,209 ("the 209 patent"), which covers the pharmaceutical product Alimta®.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceuticals worldwide. Alimta, which is 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.

The drug is also 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 used 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 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 Defendants 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. Defendants included as a part their ANDA filing 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 Defendants' ANDA products.

In its patent infringement complaint, filed by an Indiana patent lawyer, Lilly states that Defendants intends to engage in the manufacture, use, offer for sale and/or sale of Defendants' ANDA Products and the proposed labeling therefor immediately and imminently upon approval their ANDA filing, i.e., prior to the expiration of the '209 patent. Lilly asserts that Defendants' 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 lists a single count in this lawsuit - infringement of U.S. Patent No. 7,772,209 - and asks the court for:

a) A judgment that Mylan has infringed the '209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the '209 patent;
b) A judgment ordering that the effective date of any FDA approval for Mylan to make, use, offer for sale, sell, market, distribute, or import Mylan's ANDA Product, 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;
c) A preliminary and permanent injunction enjoining Mylan, and all persons acting in concert with Mylan, from making, using, selling, offering for sale, marketing, distributing, or importing Mylan's ANDA Product, 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;
d) A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Mylan's ANDA Product, 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 other of the '209 patent; and

e) A declaration that this is an exceptional case and an award of attorneys' fees pursuant to 35 U.S.C. § 285.

Practice Tip: Lilly has also sued all Mylan Defendants for patent infringement of Effient®. It has also won a lawsuit, which was heard by the Federal Circuit, against Mylan Pharmaceuticals Inc. for infringing the patented Strattera®.


Continue reading "Indiana Patent Litigation: Lilly Adds Mylan to List of Defendants Accused of Infringing Alimta" »

July 7, 2015

Indiana Patent Litigation: Lilly and Lupin in Federal Court Anew, Patent Infringement of Axiron Now Alleged

Indianapolis, Indiana - In conjunction with non-Indiana co-counsel, an Indiana patent attorney for Eli Lilly and Company, Eli Lilly Export S.A. (collectively, "Lilly") and Acrux DDS Pty Ltd., sued in the Southern District of Indiana alleging that Lupin Ltd. of Mubai, India and Lupin Pharmaceuticals, Inc. of Baltimore, Maryland infringed on various of Plaintiffs' patents, including U.S. Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520. These patents have been issued by the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of 

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pharmaceutical products worldwide. Acrux is engaged in the development and commercialization of pharmaceutical products. They sell their products worldwide. The Lupin Defendants are generic pharmaceutical companies that develop, manufacture, market, and distribute generic pharmaceutical products for sale.

At issue in this patent litigation are U.S. Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520. These patents are alleged to cover a testosterone metered transdermal solution used to treat males for conditions associated with a deficiency or absence of endogenous testosterone. This pharmaceutical product, trademarked as Axiron®, is marketed and sold by Lilly.

Plaintiffs contend that the Abbreviated New Drug Application No. 208061 submitted in the name of Lupin Ltd. to the U.S. Food and Drug Administration for approval to market a generic version of Lilly's Axiron product constitutes patent infringement.

In its complaint, filed by an Indiana patent lawyer, Lilly alleges the following counts:

• Count I for Patent Infringement: Direct Infringement of U.S. Patent No. 8,419,307
• Count II for Patent Infringement: Inducement To Infringe U.S. Patent No. 8,419,307
• Count III for Patent Infringement: Contributory Infringement of U.S. Patent No. 8,419,307
• Count IV for Patent Infringement: Direct Infringement of U.S. Patent No. 8,177,449
• Count V for Patent Infringement: Inducement To Infringe U.S. Patent No. 8,177,449
• Count VI for Patent Infringement: Contributory Infringement of U.S. Patent No. 8,177,449
• Count VII for Patent Infringement: Direct Infringement of U.S. Patent No. 8,435,944
• Count VIII for Patent Infringement: Inducement To Infringe U.S. Patent No. 8,435,944
• Count IX for Patent Infringement: Contributory Infringement of U.S. Patent No. 8,435,944
• Count X for Patent Infringement: Direct Infringement of U.S. Patent No. 8,807,861
• Count XI for Patent Infringement: Inducement To Infringe U.S. Patent No. 8,807,861
• Count XII for Patent Infringement: Contributory Infringement of U.S. Patent No. 8,807,861
• Count XIII for Patent Infringement: Direct Infringement of U.S. Patent No. 8,993,520
• Count XIV for Patent Infringement: Inducement To Infringe U.S. Patent No. 8,993,520
• Count XV for Patent Infringement: Contributory Infringement of U.S. Patent No. 8,993,520
• Count XVI for Declaratory Judgment: Infringement of U.S. Patent No. 8,419,307
• Count XVII for Declaratory Judgment: Infringement of U.S. Patent No. 8,177,449
• Count XVIII for Declaratory Judgment: Infringement of U.S. Patent No. 8,435,944
• Count XIX for Declaratory Judgment: Infringement of U.S. Patent No. 8,807,861
• Count XX for Declaratory Judgment: Infringement of U.S. Patent No. 8,993,520


Plaintiffs ask the court for judgment in their favor as follows:


a) United States Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520 are valid and enforceable;
b) Under 35 U.S.C. § 271(e)(2)(A), Defendants infringed United States Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520 by submitting ANDA No. 208061 to the FDA to obtain approval to commercially manufacture, use, offer for sale, sell, or import into the United States Lupin's Generic Product prior to expiration of said patents;
c) Defendants' threatened acts of commercial manufacture, use, offer for sale, or sale in, or importation into, the United States of Lupin's Generic Product prior to the expiration of United States Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520 would constitute infringement of said patents;
d) The effective date of any FDA approval of Lupin's Generic Product shall be no earlier than the latest of the expiration date of United States Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520 and any additional periods of exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(A)
e) Defendants, and all persons acting in concert with Defendants, shall be enjoined from commercially manufacturing, using, offering for sale, or selling Lupin's Generic Product within the United States, or importing Lupin's Generic Product into the United States, until the expiration of United States Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; and 8,993,520 in accordance with 35 U.S.C. §§ 271(e)(4)(B) and 283;) This is an exceptional case and Plaintiffs should be awarded their costs, expenses, and disbursements in this action, including reasonable attorney fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4); and
g) Plaintiffs are entitled to any further appropriate relief under 35 U.S.C.§ 271(e)(4).


The case was assigned to Judge Sarah Evans Barker and Magistrate Judge Debra McVicker Lynch in the Southern District of Indiana and assigned Case No. 1:15-cv-01047-SEB-DML.


Practice Tip: Information on Lilly's lawsuit against the Lupin Defendants, which asserts patent infringement relating to the drug Effient, can be found here.

Continue reading "Indiana Patent Litigation: Lilly and Lupin in Federal Court Anew, Patent Infringement of Axiron Now Alleged" »

June 18, 2015

Indiana Trademark Litigation: Imprimis Sues Hook's Apothecary for Trademark Infringement

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Indianapolis, Indiana - Trademark lawyers for Imprimis Pharmaceuticals, Inc. of California filed an intellectual property lawsuit in the Southern District of Indiana alleging that Hook's Apothecary, Inc. of Indiana, as well as unidentified Doe Defendants 1 through 20, infringed the following Imprimis Pharmaceuticals, Inc. trademarks: GO DROPLESS! (U.S. Serial No. 96143543), GO DROPLESS! - Logo (U.S. Serial No. 86143553), LESSDROPS (U.S. Serial No. 86497791), DROPLESS CATARACT THERAPY (U.S. Serial No. 86497090 ), and DROPLESS THERAPY (U.S. Serial No. 86497100), which have been registered by the U.S. Patent and Trademark Office.

Imprimis offers slow-releasing ophthalmic compositions containing triamcinolone acetate, moxifloxacin hydrochloride, triamcinolone acetate, and vancomycin. It offers these products for use in the treatment of acute infections of the eye and for use via intraocular injection. These products are sold under the trademarks at issue in this Indiana lawsuit. The products are also claimed to be the subject of patent applications numbers 14/361,242 and 14/227,819, which have been filed with the USPTO.

Hook's has been accused of infringing all, or some subset, of these intellectual property rights. Imprimis claims that Hook's has been manufacturing, marketing, and selling "copycat" "Dropless" formulations, the administration of which has been reported to have caused a high incidence of endophthalmitis and other related problems in patients recovering from cataract surgery. This, Imprimis contends, has created confusion, harmed the reputation of Imprimis' inventions, and caused some physicians to cease ordering from Imprimis.

In this complaint, filed by trademark attorneys for Imprimis in Indiana federal court, the following counts are alleged:

• Infringement of Trademarks (Against All Defendants)
• Common Law Unfair Competition (Against All Defendants)
• Common Law Trademark and Trade Name Infringement (Against All Defendants)
• For Declaratory Relief under 28 U.S.C. § 2201 (Against All Defendants)
• For Injunctive Relief (Against All Defendants)

Imprimis asks for general and special damages, as well as a trebling of those amounts "because of the willful nature of said infringements"; for a judgment that Hook's has violated §§ 1114 and 1125(a) of the Lanham Act; for a judgment that Hook's has engaged in unfair competition under the common law; for injunctive relief; and for an award of the costs of litigation, including attorneys' fees.


Continue reading "Indiana Trademark Litigation: Imprimis Sues Hook's Apothecary for Trademark Infringement" »

May 26, 2015

Indiana Patent Litigation: Lilly Files a New Complaint Against HEC Pharm for Infringement of Effient Patents

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Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd. of Tokyo, Japan; Daiichi Sankyo, Inc. of Parsippany, New Jersey; and Ube Industries, Ltd of Yamaguchi, Japan filed a federal lawsuit in the Southern District of Indiana alleging that HEC Pharm USA, Inc. of Princeton, New Jersey and HEC Pharm Co. Ltd. of Yichang, China, infringed Patent Nos. 8,404,703 and 8,569,325, which cover the patented pharmaceutical Effient (pictured left). These patents have been issued by the U.S. Patent Office.

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). Effient products contain prasugrel hydrochloride, which is also known as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride.

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 allegedly covered by the claims of the '703 and '325 patents.

In July 2014, Plaintiffs sued Defendants asserting infringement of the '703 patent. That complaint asserted patent infringement arising out of the filing by HEC Pharm of an Abbreviated New Drug Applications ("ANDA") with the United States Food and Drug Administration ("FDA") seeking approval to manufacture and sell generic versions of two pharmaceutical products - Effient 5mg and Effient 10mg tablets - prior to the expiration of the '703 patent. This patent covers a method of using Effient products for which Lilly claims an exclusively license. Specifically, HEC Pharm was accused of planning to infringe the patent-in-suit by including with its products instructions for use that substantially copied the instructions for Effient products, including instructions for administering HEC Pharm's products with aspirin as claimed in the '703 patent.

Plaintiffs contended in this earlier lawsuit that HEC Pharm knew that the instructions that HEC Pharm intended to include with its products would induce and/or contribute to others using those products in the allegedly infringing manner set forth in the instructions. Moreover, Lilly et al. also contended that HEC Pharm specifically intended for health care providers, and/or patients to use HEC Pharm's products in accordance with the instructions provided by HEC Pharm and that such use would directly infringe one or more claims of the '703 patent. Thus, stated Plaintiffs, HEC Pharm's actions would actively induce and/or contribute to infringement of the '703 patent.

This prior complaint, also filed by the Indiana patent lawyer who filed this lawsuit, listed two 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

That patent infringement lawsuit was dismissed without prejudice shortly thereafter. It has in effect been replaced with this current complaint, which includes the prior counts and adds the following:

• 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: a judgment of infringement; injunctive relief; a judgment regarding the effective date of Defendants' ANDA; monetary damages; the case to be deemed exceptional; a judgment that the patents-in-suit remain valid and enforceable; and Plaintiffs to be awarded reasonable attorney's fees, costs and expenses.

Continue reading "Indiana Patent Litigation: Lilly Files a New Complaint Against HEC Pharm for Infringement of Effient Patents" »

April 29, 2015

Indiana Patent Litigation: Eli Lilly Again in Federal Court Asserting Patent Infringement

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Indianapolis, Indiana - An Indiana patent lawyer for Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd. of Tokyo, Japan; Daiichi Sankyo, Inc. of Parsippany, New Jersey; and Ube Industries, Ltd of Yamaguchi, Japan (collectively "Lilly") sued in the Southern District of Indiana alleging that Lupin Ltd. of Mumbai, India and Lupin Pharmaceuticals, Inc. of Baltimore, Maryland infringed Patent Nos. 8,569,325, titled Method of Treatment with Coadministration of Aspirin and Prasugrel and 8,404,703, titled Medicinal Compositions Containing Aspirin, which have been issued by the U.S. Patent Office.

This lawsuit adds another two new Defendants, Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively "Lupin"), to Lilly's Indiana patent litigation efforts. In these "Effient" patent-infringement lawsuits, the Lilly group of Plaintiffs alleges infringement of its pharmaceutical product Effient. The patents at issue in the Lupin litigation are Effient-related patents 8,404,703 "Medicinal Compositions Containing Aspirin," (the "'703 patent") and 8,569,325 "Method of Treatment with Coadministration of Aspirin and Prasugrel" (the "'325 patent").

This complaint asserts patent infringement arising out of the filing by Lupin of an Abbreviated New Drug Applications ("ANDA") with the United States Food and Drug Administration ("FDA") seeking approval to manufacture and sell generic versions of two pharmaceutical products - Effient 5mg and Effient 10mg tablets - prior to the expiration of the '703 patent and the '325 patent. These patents cover two Effient products and/or methods of using Effient products and for which Lilly claims an exclusively license.

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). Effient products contain prasugrel hydrochloride, which is also known as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride or 2-acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzy1)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride, and is covered by the '726 patent.

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 allegedly covered by the claims of the '703 and '325 patents.

Lupin is accused of planning to infringe the patents-in-suit by including with its products instructions for use that substantially copy the instructions for Effient products, including instructions for administering Lupin's products with aspirin as claimed in the '703 and '325 patents.

Plaintiffs contend that Lupin knows that the instructions that Lupin intends to include with its products will induce and/or contribute to others using those products in the allegedly infringing manner set forth in the instructions. Moreover, the Lilly Plaintiffs also contend that Lupin specifically intends for health care providers, and/or patients to use Lupin's products in accordance with the instructions provided by Lupin and that such use will directly infringe one or more claims of the '703 and '325 patents. Thus, state Plaintiffs, Lupin's actions will actively induce and/or contribute to infringement of the '703 and '325 patents.

The complaint, filed by an Indiana patent attorney, lists four 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:

• That Lupin has infringed the '703 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of one or more claims of the '703 patent;

• That Lupin has infringed the '325 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of one or more claims of the '325 patent;

• That, pursuant to 35 U.S.C. § 271(e)(4)(B), Lupin be permanently enjoined from making, using, selling or offering to sell any of its accused products within the United States, or, where applicable, importing accused products into the United States prior to the expiration of the '703 and '325 patents;

• That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the Lupin ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the later of the expiration dates of the '703 and '325 patents, including any extensions;

• If Lupin commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of either of the '703 and '325 patents, including any extensions, that Plaintiffs 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;

• That the case be deemed exceptional under 35 U.S.C. § 285;

• That the '703 patent remains valid and enforceable;

• That the '325 patent remains valid and enforceable; and

• That Plaintiffs be awarded reasonable attorney's fees, costs and expenses.

Continue reading "Indiana Patent Litigation: Eli Lilly Again in Federal Court Asserting Patent Infringement" »

April 23, 2015

USPTO Announces Patents for Humanity Winners

Washington, D.C. - The U.S. Commerce Department's United States Patent and Trademark Office ("USPTO") recently announced the latest winners of the Patents for Humanity program. The Patents for Humanity program was launched by the USPTO in February 2012 as part of an Obama administration initiative promoting game-changing innovations to solve long-standing development challenges.

"As innovation and economic progress have made the world increasingly connected, more and more industries are realizing that their technologies can improve lives everywhere," said Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office Michelle K. Lee. "The experiences of businesses across industries have shown that helping the less fortunate can go hand in hand with developing commercial markets, and that humanitarian entrepreneurship provides new opportunities for those with vision to pursue them."

The Patents for Humanity Award is the top award for applicants best representing the Patents for Humanity principles. Award recipients will receive public recognition at an award ceremony sponsored by the USPTO. They will also receive a certificate to accelerate certain matters before the USPTO: a patent application, ex parte reexam, or an ex parte appeal to the Patent Trial and Appeal Board. Inter partes matters and other post-grant proceedings may not currently be accelerated. Honorable mentions will receive accelerated examination of one patent application and a featured write-up on the USPTO website. A portion of honorable mentions may be awarded for the best up-and-coming technologies.

Entrants competed in five categories: medicine, nutrition, sanitation, household energy and living standards. Applications to the pilot were accepted through October 31, 2014.

Following is a list of the 2015 Patents for Humanity winners:

Sanofi
Artemisinin is an important antimalarial drug derived from the sweet wormwood plant in Asia and Africa. Growing cycles, crop yields, and weather cause supply volatility of artemisinin, making it difficult to obtain at times. To address this problem, a public-private partnership to create synthetic artemisinin was formed in 2004 by PATH, the University of California Berkeley (a 2013 Patents for Humanity award winner), and Amyris, Inc., with support from the Bill & Melinda Gates Foundation. In 2007, Sanofi joined the project as the manufacturing partner for their chemical expertise and industrial capacity, taking this project from laboratory experiments to factory production. Sanofi is now supplying large quantities of artemisinin anti-malarial compounds on a no-profit-no-loss basis for use in developing countries.

Novartis
Tuberculosis kills more adults worldwide than any infectious disease except HIV/AIDS. One of the biggest challenges facing tuberculosis researchers has been how to combat multidrug-resistant tuberculosis, which is caused by an organism that is resistant to the most potent tuberculosis drugs. Novartis has discovered a class of compounds called indolcarboxamides that are active against drug-sensitive and multidrug-resistant strains of tuberculosis. In an arrangement requiring no upfront or milestone payments, Novartis has provided their entire tuberculosis R&D program, including these compounds, to the TB Alliance, a non-profit product-development partnership that seeks to find new and improved tuberculosis treatment regimens. The agreement allows the TB Alliance to develop these compounds further into potential tuberculosis treatments and potentially conduct clinical trials. Early toxicology, safety, and therapeutic studies have been promising.

American Standard Brands
American Standard's "SaTo" (Safe Toilet) Technology was created for people worldwide who do not have access to safe, basic sanitation. The SaTo Technology includes specially designed latrine pans and collectors with a counterweighted trapdoor-like flapper that can be flushed by pouring a small amount of water onto it. Upon closure, the flapper door creates an air-tight seal that reduces odors and prevents insects from entering and exiting the pit, eliminating a primary route of disease transmission. American Standard has partnered with BRAC, UNICEF, Save the Children, and other non-governmental organizations to distribute SaTo pans and collectors throughout the developing world. Over 700,000 SaTo pans have been distributed in Bangladesh, Uganda, Haiti, Malawi, and the Philippines.

SunPower Corp.
Nearly 18 percent of the world's population is energy impoverished. Traditional forms of lighting are combustion-based (firewood, charcoal, kerosene and dung), contributing to an estimated 3.5 million deaths a year from health impacts and house fires. For these communities, SunPower has outfitted a standard shipping container with solar panels on top and equipment inside to power hundreds of safe, rechargeable lanterns. Locals rent these lanterns for a small fee which is then reinvested to expand and improve the program. SunPower donates the container and supplies to partner organizations, along with ongoing technical support.

Nutriset
According to UNICEF, as many as 67 million children suffer from acute malnutrition every year. Children suffering from prolonged malnutrition often develop digestive problems that interfere with eating more food, causing further health problems and death. Nutriset developed nutritional products made from peanuts and other ingredients that helps malnourished children quickly and safely regain weight and digestive function. In addition to delivering their Plumpy'Nut branded products throughout the world with partners like UNICEF and USAID, Nutriset also offers open licensing to producers in the developing world so communities can work toward self-sufficiency. Their PlumpyField® network assembles entrepreneurs in participating countries to manufacture the Plumpy range of products for local needs.

Golden Rice
Despite current interventions, vitamin A deficiency is the leading killer of children globally (2 - 3 million annually) and also is the leading cause of childhood blindness (500,000 cases annually). Most cases occur in Asia where the staple food white rice, eaten by 3.5 billion people daily, lacks vitamin A sources typically found in animal products and leafy vegetables. These deaths and blindness are preventable. Golden Rice was genetically enhanced to provide a source of vitamin A for people subsisting mainly on rice, making it one of the first biofortified foods. Professors Potrykus and Beyer invented the technology after a decade of research, and have worked with Dr. Dubock since 2000 to donate it to the resource poor in developing countries. Local Golden Rice varieties are currently being developed by public sector institutions in Bangladesh, China, India, Indonesia, the Philippines, and Vietnam. Through licenses with national governments, farmers are free to plant, grow, harvest, locally sell, and replant seed - there are no licenses for farmers and no fees for use.

Global Research Innovation & Technology ("GRIT")
An estimated 65 million people in the developing world require wheelchairs. However, conventional wheelchairs don't function well on the rough and uneven terrain commonly found in developing regions. GRIT was created by engineering graduates of the Massachusetts Institute of Technology ("MIT") to increase mobility for the disabled around the world. Their three-wheel Leveraged Freedom Chair uses a push-lever drivetrain to help people move over broken pavement, dirt roads, fields, hills, rocky terrain and more. It's built from standard bicycle parts to enable local repairs with available materials. After graduating, the MIT students founded GRIT to bring the product to market, and MIT assisted by transferring the patent rights to GRIT for further development. The chair has been distributed in partnership with the World Bank, Red Cross, and others in India, Brazil, Guatemala, Guinea, Kenya, Haiti, Easter Island, Nepal, and Tanzania. A new version of the Leveraged Freedom Chair, known simply as the Freedom Chair, is now available in the United States for recreational use, helping Americans move beyond the pavement.

For more information on Patents for Humanity, including expanded descriptions of the winning patents and selection criteria, visit www.uspto.gov/patents/init_events/patents_for_humanity.jsp.

February 25, 2015

Indiana University to Host BioPharma/Tech Law Symposium

Indianapolis, Indiana - The Center for Intellectual Property Law and Innovation of the 

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Indiana University Robert H. McKinney School of Law will be hosting its Annual BioPharma/Tech Law Symposium on Thursday, March 12, 2015. CLE credit of 7.0 hours is pending approval.

Time: 8:00 a.m. - 5:30 p.m.

Location: 

Wynne Courtroom and Atrium
Inlow Hall
530 West New York Street
Indianapolis, Indiana

Contact: Kristin Brockett, kbrocket@iupui.edu, 317-278-9160

Registration:

Online Registration for Outside Attendees

• $75 Attorney, with 7.0 CLE Credit hours (pending approval)

• $50 General Admission

Online Registration for IU McKinney Students, Faculty and Staff ONLY

Agenda:

8:00 - 8:30 a.m. Registration
8:30 a.m. Welcome Remarks: Dean Andrew Klein
8:35 a.m. Conference Organizer: Professor Xuan-Thao Nguyen, Gerald L. Bepko Chair in Law; Director, Center for Intellectual Property Law and Innovation
8:40 a.m. Opening Address: Professor Emily Michiko Morris, IU McKinney School of Law, The Changing Landscape in Biopharmaceuticals

9:00 - 10:15 Panel One: University Tech Transfers in BioPharma

Chad Pittman, Vice President, Purdue Research Foundation
James Myers, JD, PhD, Eli Lilly
Professor Greg Dolin, University of Baltimore School of Law
Moderator: Constance Lindman, Partner, SmithAmundsen

10:30 - 11:45 Panel Two: Legal Issues in Clinical Trials (US and Asia)

Professor Rebecca S. Eisenberg, Robert and Barbara Luciano Professor of Law, University of Michigan School of Law
Hsin Hsieh, Counsel, PRAHEALTHSCIENCES, Taiwan
Moderator: Professor David Orentlicher, Samuel R. Rosen Professor of Law; Co-director of the William S. and Christine S. Hall Center for Law and Health, IU McKinney School of Law

Noon - 1:15 p.m. Keynote Address

Janet Gongola, Senior Advisor in the Office of the Under Secretary of Commerce and Director of the U.S. Patent and Trademark Office (USPTO)
Introduction: Professor Xuan-Thao Nguyen, Gerald L. Bepko Chair; Director, Center for Intellectual Property Law and Innovation

1:15 p.m. - 2:30 p.m. Panel Three: Latest Litigation Issues in BioPharma

Sarah Spires, Skiermont Puckett LLP
Professor Yaniv Heled, Georgia State University School of Law
Dr. J. Patrick Elsevier, Jones Day

2:45 p.m. - 4:00 p.m. Panel Four: Patent Prosecution of Biologics

Ken Gandy, Woodard, Emhardt, Moriarty, McNett & Henry
Professor Nicholson Price, University of New Hampshire School of Law
Jay Sanders, Faegre Baker Daniels
Moderator: Michael Bartol, Bose McKinney & Evans

4:15 p.m. - 5:30 p.m. Panel Five: Generic Drugs and Quality Challenges

Professor Cynthia Ho, DePaul University School of Law
Ann McGeehan, General Counsel, HR Pharmaceuticals, Inc. and Adjunct Professor, Georgetown University School of Law
Greg Laker, Cohen & Malad
Moderator: Professor Diana Winters, IU McKinney School of Law

Closing Remarks: Professor Emily Morris, IU McKinney School of Law

Parking:

Parking is available for a nominal fee at the campus Gateway Garage at 525 Blackford Street, which is located on the corner of Michigan and California Streets.

Parking is also available for a nominal fee at the Natatorium Garage two blocks west of the law school.

Special Accommodations:

Individuals with disabilities who need special assistance should call 317-278-9160 no later than one week prior to the event. Special arrangements can be made to accommodate most needs.

February 2, 2015

Indiana Patent Litigation: Lilly in Court Again Asserting Infringement of Alimta

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Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company ("Lilly") of Indianapolis, Indiana filed an intellectual property lawsuit in the Southern District of Indiana alleging that Fresenius Kabi USA, LLC ("Fresenius") of Lake Zurich, Illinois infringed the patented product ALIMTA®, Patent No. 7,772,209, which has been registered by the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products worldwide. Fresenius is in the business of manufacturing, marketing, and selling generic drug products.

ALIMTA, which is 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. The drug is also 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 used 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 Fresenius 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. Fresenius included as a part its ANDA filing 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 Fresenius' ANDA products.

In its patent infringement complaint, filed by an Indiana patent lawyer, Lilly states that Fresenius intends to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Fresenius' ANDA Products and the proposed labeling therefor immediately and imminently upon approval its ANDA filing, i.e., prior to the expiration of the '209 patent. Lilly asserts that Fresenius' 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 asserts that, in a prior case, 10-cv-1376-TWP-DKL, the court rejected Fresenius' challenges to the validity of certain claims of the '209 patent. Accordingly, states Lilly, Fresenius should be estopped from challenging the validity of those claims of the '209 patent in the instant litigation.

Lilly lists a single count in this lawsuit - Infringement of U.S. Patent No. 7,772,209 - and asks the court for:

a) A judgment that Fresenius has infringed the '209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the '209 patent;

b) A judgment ordering that the effective date of any FDA approval for Fresenius to make, use, offer for sale, sell, market, distribute, or import Fresenius' ANDA Product, 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;

c) A preliminary and permanent injunction enjoining Fresenius, and all persons acting in concert with Fresenius, from making, using, selling, offering for sale, marketing, distributing, or importing Fresenius' ANDA Product, 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;

d) A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Fresenius' ANDA Product, 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 other of the '209 patent;

e) A declaration that this is an exceptional case and an award of attorneys' fees pursuant to 35 U.S.C. § 285; and

f) An award of Lilly's costs and expenses in this litigation.

Continue reading "Indiana Patent Litigation: Lilly in Court Again Asserting Infringement of Alimta" »

January 15, 2015

Indiana Trade Secret Law: Federal Prosecutors Drop All Charges Against Scientists Accused of Theft of Lilly Trade Secrets

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Indianapolis, Indiana - All federal criminal charges against Guoqing Cao and Shuyu Li, who were formerly employed by Eli Lilly and Company ("Lilly"), were recently dropped by federal prosecutors, who stated that "additional information" had been received that altered "the investigative facts initially relied upon by the government" in its case against Cao and Li.

This federal indictment was brought in 2013 in the Southern District of Indiana. Defendants Cao and Li, two doctoral-level scientists, were charged with multiple counts of theft. At issue was intellectual property belonging to Indiana-based Lilly valued at $55 million. Counts one through three of the indictment, as well as counts five through ten, were listed as theft of trade secrets and aiding and abetting. Count four alleged conspiracy to commit theft of trade secrets.

In the initial proceedings, the United States maintained that Defendants were traitors who had conveyed "American trade secrets" - specifically, "crown jewels" in the form of many millions worth of intellectual property belonging to Lilly - to Jiangsu Hengrui Medicine Co., Ltd., a company located in Shanghai, China.

A second indictment was later filed by the United States modifying the initial charges. Under the new indictment, Defendants faced no counts of trade-secret theft. Instead, they were charged with one count each of wire fraud, aiding and abetting, and conspiracy to commit wire fraud. As a result of this change, the court ordered that the Defendants be released from lockdown, noting that the earlier allegation - that Lilly's "crown jewel" trade secrets had been stolen and provided to China - had been a critical factor in justifying the Defendants' incarceration.

The nature of this new "additional information" recently received by the U.S. Department of Justice that prompted prosecutors to drop all charges is not entirely clear. Contentions by defense attorney Alain Leibman include that "Lilly provided bad information to the government," and that "information originally alleged to be confidential and proprietary was actually not confidential and proprietary." David Hensel, also serving as a criminal defense attorney in the case, added that Lilly's handling of computer data may have amounted to "spoliation of evidence material to the defense."

January 2, 2015

Indiana Patent Litigation: Eli Lilly Sues Sandoz Inc. Alleging Infringement of Patented ALIMTA

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Indianapolis, Indiana - In conjunction with co-counsel, an Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana sued in the Southern District of Indiana alleging infringement by Sandoz Inc. of Princeton, New Jersey of ALIMTA®, Patent No. 7,772,209, which was issued by the U.S. Patent Office.

ALIMTA, which is 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 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 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. Defendant filed as a part of that ANDA 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 patent-in-suit, asserting that the claims of the patent-in-suit are invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of Defendant's ANDA products.

In its complaint, filed by an Indiana patent lawyer, Lilly states that Defendant intends to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Defendant's ANDA products and the proposed labeling therefor immediately and imminently upon approval of the ANDA i.e., prior to the expiration of the patent-in-suit. Lilly asserts that Defendant's actions constitute and/or will constitute infringement of the patent-in-suit, active inducement of infringement of the patent-in-suit, and contribution to the infringement by others of the patent-in-suit.

The complaint lists a single claim: Infringement of U.S. Patent No. 7,772,209. Lilly asks the court for the following relief:

(a) A judgment that Sandoz has infringed the '209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the '209 patent;

(b) A judgment ordering that the effective date of any FDA approval for Sandoz to make, use, offer for sale, sell, market, distribute, or import Sandoz'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;

(c) A preliminary and permanent injunction enjoining Sandoz, and all persons acting in concert with Sandoz, from making, using, selling, offering for sale, marketing, distributing, or importing Sandoz'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;

(d) A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Sandoz'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 other of the '209 patent;

(e) A declaration that this is an exceptional case and an award of attorneys' fees pursuant to 35 U.S.C. § 285; and

(f) An award of Lilly's costs and expenses in this action.

Continue reading "Indiana Patent Litigation: Eli Lilly Sues Sandoz Inc. Alleging Infringement of Patented ALIMTA" »

December 23, 2014

Indiana Patent Litigation: Lilly Sues Amneal on Allegations of Patent Infringement of Axiron

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Indianapolis, Indiana - In conjunction with co-counsel, an Indiana patent attorney for 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 sued for patent infringement in the Southern District of Indiana alleging that Amneal Pharmaceuticals LLC of Bridgewater, New Jersey, infringed its patented product Axiron®, for which Plaintiffs claim patent protection under Patent Nos. 8,435,944; 8,419,307; 8,177,449 and 8,807,861, 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. They sell their products worldwide. Amneal is a pharmaceutical company that develops, manufactures, markets and distributes 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") submitted by Amneal to the U.S. Food and Drug Administration ("FDA") for approval to market a generic version of Lilly's Axiron product. Defendant certified to the FDA that, in its 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.

Plaintiffs contend that the submission of the ANDA to the FDA constitutes infringement by Defendant of the patents-in-suit. In the complaint, patent lawyers for Lilly and Acrux assert sixteen separate counts related to patent infringement. Among the allegations listed for the patents-in-suit are counts of "Direct Infringement," "Inducement to Infringe," "Contributory Infringement" and for declaratory judgment.

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

Continue reading "Indiana Patent Litigation: Lilly Sues Amneal on Allegations of Patent Infringement of Axiron " »

October 23, 2014

Indiana Patent Litigation: Lilly Sues Alleging Infringement of ALIMTA

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Indianapolis, Indiana - An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana ("Lilly") and The Trustees of Princeton University of Princeton, New Jersey ("Princeton") filed a patent infringement complaint in the Southern District of Indiana alleging that Nang Kuang Pharmaceutical Co., Ltd. of Tainan City, Taiwan and CANDA NK-2, LLC of Waco, Texas infringed and/or will infringe ALIMTA®, U.S. Patent Nos. 5,344,932 ("the '932 patent") and 7,772,209 ("the '209 patent"; collectively, "the patents-in-suit"), which have been issued by the U.S. Patent Office.

ALIMTA, which is 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 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. The '932 patent, titled "N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," along with the '209 patent, have been listed in connection with ALIMTA in the FDA's publication Approved Drug Products with Therapeutic Equivalence Evaluations.

This Indiana patent infringement lawsuit arises out of the filing by Defendant Nang Kuang 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 '932 and '209 patents. Nang Kuang filed as a part of that ANDA 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 patents-in-suit, asserting that the claims of the patents-in-suit are invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of Defendants' ANDA products.

In their complaint, filed by an Indiana patent lawyer, Lilly and Princeton state that Defendants intend to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Defendants' ANDA products and the proposed labeling therefor immediately and imminently upon approval of the ANDA i.e., prior to the expiration of the patents-in-suit. Plaintiffs asserts that Defendants' actions constitute and/or will constitute infringement of the patents-in-suit, active inducement of infringement of the patents-in-suit, and contribution to the infringement by others of the patents-in-suit.

The complaint, filed by an Indiana patent lawyer, lists the following claims:

  • Count I: Infringement of U.S. Patent No. 5,344,932
  • Count II: Infringement of U.S. Patent No. 7,772,209

Lilly and Princeton ask the court for:

(a) A judgment that Defendants have infringed the '932 patent and/or will infringe and/or actively induce infringement of the '932 patent;

(b) A judgment ordering that the effective date of any FDA approval for Defendants to make, use, offer for sale, sell, market, distribute, or import Defendants' ANDA Products, or any product the use of which infringes the '932 patent, be not earlier than the expiration date of the '932 patent, inclusive of any extension(s) and additional period(s) of exclusivity;

(c) A preliminary and permanent injunction enjoining Defendants, and all persons acting in concert with Defendants, from making, using, selling, offering for sale, marketing, distributing, or importing Defendants' ANDA Products, or any product the use of which infringes the '932 patent, or the inducement of any of the foregoing, prior to the expiration date of the '932 patent, inclusive of any extension(s) and additional period(s) of exclusivity;

(d) A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Defendants' ANDA Products, or any product the use of which infringes the '932 patent, prior to the expiration date of the '932 patent, infringes, will infringe and/or will actively induce infringement of the '932 patent;

(e) A judgment that Defendants have infringed the '209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the '209 patent;

(f) A judgment ordering that the effective date of any FDA approval for Defendants to make, use, offer for sale, sell, market, distribute, or import Defendants' 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;

(g) A preliminary and permanent injunction enjoining Defendants, and all persons acting in concert with Defendants, from making, using, selling, offering for sale, marketing, distributing, or importing Defendants' 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;

(h) A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Defendants' 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;

(i) A declaration that this is an exceptional case and an award of attorneys' fees pursuant to 35 U.S.C. § 285; and

(j) An award of Plaintiffs' costs and expenses in the action.

Practice Tip #1: This summer, Lilly succeeded in defending the '209 method-of-use patent in before District Judge Tanya Walton Pratt in the Southern District of Indiana. The court found, inter alia, that the patent did not fail for "obviousness."

Practice Tip #2: Obviousness is a legal conclusion based on underlying factual findings. Such findings include: 1) the scope and content of the prior art; 2) the differences between the claims and the prior art; 3) the level of ordinary skill in the art; and 4) objective considerations of non-obviousness such as commercial success and satisfaction of a long-felt need. Moreover, it is insufficient that prior art merely includes separate references to the subject matter of a subsequent patent claim. Instead, obviousness requires the additional showing that a person of ordinary skill in the art of the subject matter would have combined those elements of the prior art.

Continue reading "Indiana Patent Litigation: Lilly Sues Alleging Infringement of ALIMTA" »

July 30, 2014

Indiana Trade Secret Law: Removing Allegation of Theft of Trade Secrets Results in Defendants' Release from "Lockdown"

secret-300x237.jpgIndianapolis, Indiana - In 2013, a federal indictment including counts of theft of trade secrets belonging to Eli Lilly and Company ("Lilly") was presented to the Southern District of Indiana. On the basis of this indictment, the court ordered Defendants Guoqing Cao and Shuyu Li, formerly employed by Eli Lilly and Company, to be detained at housing provided by Volunteers of America - Indiana ("VOA"), pending their criminal trial. When the 2013 indictment was superseded by a second indictment that did not include counts for the theft of trade secrets, the court granted Defendants' request to be released to home detention.

On August 14, 2013, Defendants Cao and Li, two doctoral-level scientists formerly employed by Lilly, were charged with multiple counts of theft. At issue was intellectual property belonging to Lilly valued at $55 million. Counts one through three of the indictment, as well as counts five through ten, were listed as theft of trade secrets and aiding and abetting. Count four alleged conspiracy to commit theft of trade secrets.

In the initial proceedings, the United States maintained that the Defendants were traitors who had conveyed "American trade secrets" - specifically, "crown jewels" in the form of many millions worth of intellectual property belonging to Lilly - to Jiangsu Hengrui Medicine Co., Ltd., a company located in Shanghai, China. These arguments strongly impacted the court's decision to order "lockdown" detention at the VOA.

A second indictment was later filed by the United States. Under the new indictment, the Defendants faced no charges of trade-secret theft. Instead, they were charged with one count each of wire fraud, aiding and abetting, and conspiracy to commit wire fraud. Based on the absence of allegations relating to trade-secret theft in the subsequent indictment, the Defendants asked the court to modify the terms of their detention.

The court was persuaded that such a change was warranted. It noted that there was "a difference between allegations of 'theft of trade secrets' and disclosure of 'Lilly Property.'" It further stated that the earlier allegation - that Lilly's "crown jewel" secrets had been stolen and provided to China - had been a critical factor in justifying the Defendants' incarceration.

When the allegations of trade secret misappropriation were removed, the court found that those justifications were no longer applicable: "No longer are the Defendants accused of stealing 'trade secrets'--those words are found nowhere in the superseding indictment" and released the Defendants from lockdown to the less-restrictive conditions of home detention.

Practice Tip #1: Nine Lilly trade secrets pertaining to pharmaceuticals under development for cardiovascular disease, diabetes and cancer were at issue in this Indiana criminal prosecution for theft of intellectual property.

Practice Tip #2: Defendants' home detention restricts individuals to their residence at all times except for employment; education; religious services; medical, substance abuse, or mental health treatment; attorney visits; court appearances; court-ordered obligations; or other activities approved in advance by the pretrial services office or supervising officer. Defendants were also ordered not to access or use any internet-enabled device with the exception of utilizing email to communicate with counsel.

Continue reading "Indiana Trade Secret Law: Removing Allegation of Theft of Trade Secrets Results in Defendants' Release from "Lockdown"" »