Articles Posted in Inducement

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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.

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South Bend, Indiana – Indiana patent lawyers for Lippert Components Manufacturing, Inc. of Elkhart Indiana sued in the Northern District of Indiana alleging that MOR/ryde International Inc. and MOR/ryde Inc., both of which are also from Elkhart Indiana, infringed “Equalizer for Suspension System,” Patent Nos. 7,918,478 and 7,296,821, which have been issued by the U.S. Patent Office.

At issue in this litigation are U.S. Patent Nos. 7,918,478 (“the ‘478 Patent”) and 7,296,821 (“the ‘821 Patent”). These inventions pertain to “equalizers” that dampen vibrations for recreational vehicle trailers. Plaintiff Lippert contends that Defendants MOR/ryde International Inc. and MOR/ryde Inc. (collectively, “MOR/ryde”) have infringed, and continue to infringe, these patents. The accused products include MOR/ryde’s CRE/3000 and SRE/4000 equalizer products.

Lippert states that MOR/ryde knew of Lippert’s intellectual property rights in the ‘478 Patent and that, despite this knowledge, MOR/ryde infringed at least claim 1 of that patent. Lippert also asserts that MOR/ryde induced infringement by others as well as contributed to others’ infringement of at least claim 15 of the ‘478 Patent.

Lippert makes similar allegations regarding its ‘821 Patent, stating that MOR/ryde knew of Lippert’s patents rights in that patent and that MOR/ryde nonetheless infringed at least claim 1. Finally, Lippert contends that MOR/ryde induced infringement by others and contributed to others’ infringement of at least claim 14 of the ‘821 Patent.

In this Indiana patent infringement lawsuit, the following claims are asserted:

• Count I: ‘478 Patent Infringement

• Count II: ‘821 Patent Infringement

Lippert asserts that Defendants’ acts have been willful and contend that those actions render this an “exceptional case” as that term is defined in 35 U.S.C. §285.

Lippert asks, via its Indiana patent counsel, that the court:

• Preliminarily and permanently enjoin both MOR/ryde entities and their agents from infringing, or from contributing to or inducing others to infringe, Lippert’s ‘478 Patent and ‘821 Patent;

• Award Lippert monetary damages adequate to compensate Lippert for past infringement consistent with 35 U.S.C. § 284, up to and including treble the amount of actual damages assessed, together with costs and prejudgment interest;

• Award Lippert its reasonable attorneys’ fees and costs pursuant to 35 U.S.C. §285; and

• Order MOR/ryde to provide notice to their customers of the infringing systems and of MOR/ryde’s unlawful acts.

Practice Tip #1:  A court may award increased damages for willful infringement. These extra damages are known as punitive damages. An award of punitive damages, up to and including a trebling of damages, is appropriate when an infringer has acted in wanton disregard of the patentee’s intellectual property rights. In determining whether the infringing behavior supports increased damages, the court will consider the “totality of the circumstances.”

Potential exposure for increased damages may be reduced by seeking – and acting on – timely advice from a competent patent lawyer. In contrast, the failure to seek and heed such advice may increase the probability that the court will find that the defendants have acted willfully.

Practice Tip #2: Lippert is not new to patent litigation. In fact, it has sued various competitors for patent infringement in 2003, 2008, 2012 and again in 2013. Lippert dropped the first three lawsuits. While the 2003 litigation lasted about a year and a half, the infringement actions filed in 2008 and 2012 were dropped only two months after the complaints were filed. The 2013 patent infringement lawsuit is ongoing.

Practice Tip #3: Under U.S. patent law, a trial court may award attorneys’ fees in cases of patent infringement litigation that it deems “exceptional.” Two recent U.S. Supreme Court rulings revisited how “exceptional” is defined. In part as a result of these rulings, plaintiffs filing questionable patent infringement lawsuits must exercise greater caution, as trial judges will now have greater latitude to award attorneys’ fees – including awarding fees to prevailing defendants – in those cases in which they determine that the conduct of the losing party “stands out from others.”

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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.

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Indianapolis, Indiana – Indiana patent attorneys for Polymer Technology Systems, Inc. (“PTS”) of Indianapolis, Indiana filed an intellectual property lawsuit in the Southern District of Indiana alleging that Jant Pharmacal Corporation of Encino, California (“Jant”) Infopia America LLC of Titusville, Florida (“Infopia USA”) and Infopia Co., Ltd. of Kyunggi, Korea (“Infopia

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Korea”) infringed “Method for determining HDL concentration from whole blood or plasma,” Patent No. 7,087,397, which was issued by the U.S. Patent Office. PTS has also accused Defendants of federal unfair competition under the Lanham Act.

PTS develops, manufactures and sells point-of-care diagnostic products for the human healthcare market. At issue in this Indiana litigation is PTS’s “CardioChek® Multi-Analyte Strip,” a hand-held, point-of-care testing system that can test for total cholesterol, high-density lipoproteins (HDL) and triglycerides with a single drop of blood. In August 2006, Patent No. 7,087,397 (“the ‘397 Patent”) was issued to PTS. PTS indicates that this patent includes a significant portion of the technology embodied in this Indiana invention.

Defendant Infopia Korea has also developed a test strip that tests for total cholesterol, high-density lipoproteins and triglycerides. This system is branded as the LipidPlus Lipid Profile Test Strip. PTS contends that Infopia Korea imports the LipidPlus testing strip into the United States and that Defendants Infopia USA and Jant offer and sell the LipidPlus product in the U.S. market.

PTS alleges that much of the technology incorporated into the LipidPlus testing strip is copied from PTS’s CardioChek product. It contends that the copied aspects include the concept of the testing strip itself, the analytes selected for analysis, the structure of the strip and the chemistries used. PTS also contends that Defendants have copied the trade dress of PTS’s CardioChek testing strip. PTS further accuses Defendants of offering the LipidPlus testing strip at a price that is both extremely low and below cost.

In its complaint, filed by Indiana trade-dress and patent lawyers, PTS alleges the following:

• Count I: Patent Infringement of the ‘397 Patent

• Count II: Violation of the Lanham Act, 15 U.S.C. 1125(a)

PTS asks the court:

• for a judgment that the ‘397 Patent is valid and enforceable;

• for a judgment of direct or indirect infringement, or inducement to infringe, by Defendants;

• to declare that Defendants have unfairly competed with PTS by infringing and misappropriating PTS’s trade dress;

• for an award to PTS of lost profits and a reasonable royalty for Defendants’ acts of patent infringement and trade-dress infringement;

• to treble the award of damages pursuant to a finding of willful, intentional and deliberate infringement;

• for an injunction prohibiting Defendants from engaging in acts of infringement or unfair competition; and

• for a declaration that the case is exceptional and an award of attorneys’ fees.

Practice Tip: The United States Supreme Court addressed the elements required for trade dress to be protected in Two Pesos, Inc. v. Taco Cabana, Inc., 505 U.S. 763 (1992). In Two Pesos, the Court held that, to establish a cause of action for trade dress infringement, a plaintiff must establish that (a) the design is non-functional; (b) the design is inherently distinctive or distinctive by virtue of having acquired secondary meaning; and (c) there is a likelihood of confusion.

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Indianapolis, Indiana – In conjunction with co-counsel from Washington, D.C., 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 atrial-fibrillation-s3-photo-of-heart-rhythm.jpgYamaguchi, Japan sued in the Southern District of Indiana alleging that First Time US Generics LLC of Broomall, Pennsylvania infringed Effient® products, Patent Nos. 8,404,703 and 8,569,325 which have been issued by the U.S. Patent Office.

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

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

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

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

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

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

Plaintiffs ask the court for judgment:

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

Practice Tip:

In March 2014, Lilly et al. filed a 101-page complaint making similar accusations against more than thirty defendants: Accord Healthcare, Inc. USA; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.; Aurobindo Pharma Limited; Aurobindo Pharma USA Inc.; Dr. Reddy’s Laboratories, Ltd; Dr. Reddy’s Laboratories, Inc.; Glenmark Generics Inc., USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.; Hetero USA Inc.; Hetero Labs Limited; Hetero Labs Limited Unit V; Hetero Drugs Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Limited; Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.; Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun Pharma Global Inc.; Sun Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis plc; Actavis, Inc.; Actavis Pharma, Inc.; Zydus Pharmaceuticals USA, Inc.; and Cadila Healthcare Ltd. d/b/a Zydus Cadila.

FTUG is the latest of addition to Lilly’s list of defendants in the Effient litigation. In contrast to the March complaint against 30-plus mostly unrelated defendants, FTUG, as well as the other subsequent unrelated defendants, have been added via separate complaints alleging patent infringement.

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Hammond, Indiana – An Indiana patent attorney for Stopinc Aktiengesellschaft of Stopinc-Patent-Picture2.jpgHünenberg, Switzerland sued in the Northern District of Indiana alleging that J. W. Hicks Inc. of Merrillville, Indiana infringed “Slide Gate for a Container Containing Molten Metal,” Patent No. 6,422,435, which has been issued by the U.S. Patent Office.

Plaintiff Stopinc Aktiengesellschaft (“Stopinc AG”) asserts that it is the owner by assignment of Patent No. 6,422,435 (the “‘435 patent”). It charges Defendant J. W. Hicks Inc. with infringing upon the patent by, inter alia, importing into the United States and selling its product, known both as the OMEGA Slidegate Systems and also as the TITAN Slidegate, that infringes at least claims 1, 8, 11 and 12 of the ‘435 patent. Stopinc AG also asserts that J. W. Hicks Inc. has induced and contributed to the infringement of the patent by others. Finally, Stopinc AG contends that Defendant’s acts of infringement and inducement to infringe are willful, knowing and deliberate.

A single count – patent infringement – is listed in Stopinc AG’s complaint, which was filed by an Indiana patent lawyer. The Indiana court is asked for the following relief:

• An injunction prohibiting Defendant and its agents from marketing, importing, offering for sale, selling, advertising or promoting or distributing in the United States any products that infringe the ‘435 patent;
• An Order that all infringing products, as well as all means for producing, advertising or promoting those products, be destroyed;
• An Order that all infringing products already distributed be recalled;
• Damages, including Defendant’s profits, as well as for Plaintiff’s lost sales, attorney’s fees, and interest; and
• That damages be trebled.

Practice Tip: Patent infringement can be demonstrated under two general theories: literal infringement and infringement under the doctrine of equivalents. An assertion of “literal infringement” will require a showing that every element recited in a claim has identical counterpart in the accused device or method. A claim may also be infringed under the “doctrine of equivalents” if some other element of the accused device or method performs substantially the same function, in substantially the same manner, to achieve substantially the same result.

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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 sued in the Southern District of Indiana alleging that HEC Pharm Co., Ltd. of China and HEC Pharm USA Inc. of Princeton, New Jersey (collectively, “HEC Pharm”) infringed Lilly’s patented Effient® product, Patent No. 8,404,703, which has been issued by the United States Patent Office.

This lawsuit adds another defendant, HEC Pharm, to Lilly’s Indiana patent litigation regarding Effient. In these Effient patent-defense lawsuits, Lilly et al. allege infringement of certain patents related to the pharmaceutical Effient. At issue in the litigation against HEC Pharm is only one of the Effient-related patents, 8,404,703 “Medicinal Compositions Containing Aspirin,” (the “‘703 patent”).

This complaint asserts 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. These patents cover a method of using Effient products 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.

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 patent.

HEC Pharm 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 HEC Pharm’s products with aspirin as claimed in the ‘703 patent.

Plaintiffs contend that HEC Pharm knows that the instructions that HEC Pharm 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, Lilly et al. also contend that HEC Pharm specifically intends 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 will directly infringe one or more claims of the ‘703 patent. Thus, state Plaintiffs, HEC Pharm’s actions will actively induce and/or contribute to infringement of the ‘703 patent.

The complaint, filed by an Indiana patent lawyer, lists 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

Plaintiffs ask the court for judgment:

• That HEC Pharm 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, pursuant to 35 U.S.C. § 271(e)(4)(B), HEC Pharm 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 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the HEC Pharm 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 patent, including any extensions;
• If HEC Pharm 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 patent, 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 Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

Practice Tip #1: The Effient litigation also involves Patent No. 5,288,726, “Tetrahydrothienopyridine Derivatives, Furo and Pyrrolo Analogs Thereof and Their Preparation and Uses for Inhibiting Blood Platelet Aggregation,” and Patent No. 8,569,325, “Method of Treatment with Coadministration of Aspirin and Prasugrel.”

Practice Tip #2: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing. Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process.

The statute that created the abbreviated process, however, had also created some interesting jurisdictional issues with respect to declaratory judgments. For an interesting look at some of the issues, see here
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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, NewEffient-pill.jpg Jersey; and Ube Industries, Ltd. of Yamaguchi, Japan sued in the Southern District of Indiana alleging that Panacea Biotec, Ltd. of New Delhi, India (“Panacea”) infringed Effient® products, Patent Nos. 8,404,703 and 8,569,325, which have been issued by the United States Patent Office.

This lawsuit adds another defendant, Panacea, to Lilly’s Indiana patent litigation. In these “Effient” patent-defense lawsuits, Lilly et al. assert allegations of infringement of Effient. At issue in the Panacea 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 Panacea 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.

Panacea 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 Panacea’s products with aspirin as claimed in the ‘703 and ‘325 patents.

Plaintiffs contend that Panacea knows that the instructions that Panacea 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, Lilly et al. also contend that Panacea specifically intends for health care providers, and/or patients to use Panacea’s products in accordance with the instructions provided by Panacea and that such use will directly infringe one or more claims of the ‘703 and ‘325 patents. Thus, state Plaintiffs, Panacea’s actions will actively induce and/or contribute to infringement of the ‘703 and ‘325 patents.

The complaint, filed by an Indiana patent lawyer, 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 Panacea 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 Panacea 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), Panacea 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 Panacea 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 Panacea 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.

Practice Tip: In March 2014, Lilly et al. filed a 101-page complaint making similar accusations against more than thirty defendants: Accord Healthcare, Inc. USA; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.; Aurobindo Pharma Limited; Aurobindo Pharma USA Inc.; Dr. Reddy’s Laboratories, Ltd; Dr. Reddy’s Laboratories, Inc.; Glenmark Generics Inc., USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.; Hetero USA Inc.; Hetero Labs Limited; Hetero Labs Limited Unit V; Hetero Drugs Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Limited; Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.; Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun Pharma Global Inc.; Sun Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis plc; Actavis, Inc.; Actavis Pharma, Inc.; Zydus Pharmaceuticals USA, Inc.; and Cadila Healthcare Ltd. d/b/a Zydus Cadila.

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South Bend, Indiana – Indiana patent attorneys for Cor-A-Vent Inc. of Mishawaka, Indiana CoraventPicture.jpgfiled a lawsuit in the Northern District of Indiana alleging that Designer Cabinets Inc. d/b/a DCI Products of Clifton Heights, Pennsylvania (“DCI”) infringed the patented “Moisture Resistant Roof Vent,” Patent No. 5,704,834, which has been issued by the U.S. Patent Office.

Cor-A-Vent is a designer and manufacturer of roof vent and other venting products. In 1998, United States Patent No. 5,704,834 (the “‘834 Patent”) was issued for a moisture-resistant roof vent. Cor-A-Vent asserts that it owns this patent.

DCI is accused of infringing the ‘834 Patent – either directly, by inducement, and/or contributorily – by making, using, selling, offering for sale, importing or supplying infringing roof vent products, including DCI’s SmartRidge® II product, in violation of 35 U.S.C. § 271 et seq. Cor-A-Vent contends that DCI has profited, and Cor-A-Vent has suffered damages, as a result of this alleged patent infringement.

Cor-A-Vent also asserts that DCI has been aware of the ‘834 Patent since 2010 or earlier. As a result, Cor-A-Vent contends that the patent infringement committed by DCI has been willful. Further, Cor-A-Vent contends that this is an exceptional case, which would support an award of reasonable attorneys’ fees pursuant to 35 U.S.C. § 285.

In its complaint, filed by Indiana patent attorneys in Indiana federal court, Cor-A-Vent lists a single count: Infringement of United States Patent No. 5,704,834. It requests the following:

• A judgment that DCI has infringed the ‘834 Patent in violation of 35 U.S.C. § 271;
• Preliminary and permanent injunctive relief prohibiting DCI and its agents from infringing the ‘834 Patent pursuant to 35 U.S.C. § 283;
• An award to Cor-A-Vent of its damages for patent infringement,
• An award of pre-judgment and post-judgment interest and costs against DCI pursuant to 35 U.S.C. § 284;
• A judgment that DCI’s infringement of the ‘834 Patent has been deliberate and willful;
• A judgment that DCI’s infringement of the ‘834 Patent has been exceptional under 35 U.S.C. § 285;
• Treble damage under 35 U.S.C. § 284; and
• An award to Cor-A-Vent of its reasonable attorneys’ fees under 35 U.S.C. § 285.

Practice Tip:

A court may award increased damages for willful infringement. These punitive damages, up to and including a trebling of damages, are appropriate when an infringer has acted in wanton disregard of the patentee’s intellectual property rights. In determining whether the infringing behavior supports increased damages, the court will consider the “totality of the circumstances.”

Potential exposure for increased damages may be reduced by seeking – and acting on – timely advice from a competent patent lawyer. In contrast, the failure to seek and heed such advice may increase the chance of a finding of willfulness.

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Fort Wayne, Indiana – Patent lawyers for Richard Gramm and Headsight, Inc., both of Indiana, sued in the Northern District of Indiana alleging that Deere and Company of Moline, jdcombinepicture.jpgIllinois (also known as “John Deere”) infringed the patented “Combine Header Height Control“, Patent No. 6,202,395, which has been issued by the U.S. Patent Office.

Gramm, the founder and President of Plaintiff Headsight, claims to own all right, title and interest to Patent No. 6,202,395 (the “395 patent”). In its complaint, Plaintiffs allege that Deere makes, uses, sells and/or offers for sale products that infringe at least claim 27 of the ‘395 patent, including at least the header height sensor kit, for the Deere 600C Series corn headers (the “Deere Height Sensor”).

Plaintiffs contend that Deere has had actual knowledge of the ‘395 patent since at least as early as 2002 and that Deere has been and now is directly infringing, actively inducing others to infringe and/or contributing to the infringement of the ‘395 patent by making, using, selling, offering for sale and/or importing in the United States products, including at least the Deere Height Sensor, in violation of 35 U.S.C. § 271.

Plaintiffs assert one claim in their complaint, filed by Indiana patent attorneys: “Count I: Patent Infringement of U.S. Patent No. 6,202,395.” Gramm and Headsight ask the court for:

• a declaration that Deere has infringed one or more claims of the ‘395 patent in violation of 35 U.S.C. § 271;
• equitable relief under 35 U.S.C. § 283, including, but not limited to, permanently enjoining Deere and its agents from infringing, contributing to, and/or inducing infringement of the ‘395 patent;
• an award of damages adequate to compensate Plaintiffs for Deere’s infringement of the ‘395 patent, together with prejudgment and post-judgment interest under 35 U.S.C. § 284;
• a declaration that Deere’s infringement is willful and/or an order increasing damages up to and including three times the amount found or assessed consistent with 35 U.S.C. § 284; and
• a declaration that this case is “exceptional” under 35 U.S.C. § 285 and awarding Plaintiffs their reasonable attorney fees, costs, and expenses.

Practice Tip:

A court may award increased damages for willful infringement. These punitive damages, up to and including a trebling of damages, are appropriate when an infringer has acted in wanton disregard of the patentee’s intellectual property rights. In determining whether the infringing behavior supports increased damages, the court will consider the “totality of the circumstances.”

Potential exposure for increased damages may be reduced by seeking – and acting on – timely advice from a competent patent lawyer. In contrast, the failure to seek and heed such advice may increase the chance of a finding of willfulness.

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Indiana Intellectual Property: IP Litigation, Patents, Trademarks, Copyrights
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Paul B. Overhauser
Overhauser Law Offices, LLC
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Greenfield, IN 46140
Phone: 317.467.9100
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