Pharmaceuticals

August 6, 2015

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

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.

July 22, 2015

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

By Overhauser Law Offices, LLC

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®.

July 7, 2015

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

By Overhauser Law Offices, LLC

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

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.

June 18, 2015

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

By Overhauser Law Offices, LLC

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.

May 26, 2015

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

By Overhauser Law Offices, LLC

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.

April 29, 2015

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

By Overhauser Law Offices, LLC

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.

April 23, 2015

USPTO Announces Patents for Humanity Winners

By Overhauser Law Offices, LLC

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.

February 25, 2015

Indiana University to Host BioPharma/Tech Law Symposium

By Overhauser Law Offices, LLC

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

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.

February 2, 2015

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

By Overhauser Law Offices, LLC

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.

January 15, 2015

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

By Overhauser Law Offices, LLC

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.