Patent Infringement

March 11, 2015

Indiana Intellectual Property Law: Patent Infringement Allegations of Pro Se Plaintiff Dismissed

Indianapolis, Indiana – Judge Sarah Evans Barker of the Southern District of Indiana dismissed the patent infringement claims asserted in the amended complaint of pro se Plaintiff Dennis Lee Maxberry against ITT Technical Institute (“ITT”). Also included in Maxberry’s amended complaint were claims for copyright infringement, deprivation of disabled veterans’ benefits, sabotage of Maxberry’s bachelor’s degree, stalking, sabotage of Maxberry’s employment opportunities, RICO liability against ITT and the State of Wisconsin, malicious prosecution of intellectual property actions against Maxberry, violations of various executive orders relating to Maxberry’s service in the military, violations of the Higher Education Act, and violations of a number of Maxberry’s constitutional rights.

The parties in this patent infringement litigation are Defendant ITT, an Indiana-based for-profit higher education company, and Maxberry of West Allis, Wisconsin, who had previously been enrolled in an M.B.A. graduate course at ITT. In April 2014, Maxberry, acting as his own patent attorney, sued Defendant ITT alleging multiple harms, which the court summarized as follows:

It appears that Plaintiff accuses Defendant of stealing his federal student loan money, failing to award him grades for the classes that he completed, and applying money from his educational loans towards tuition payments even after he withdrew from school. Plaintiff also accuses Defendant of “being unconscious to the plaintiff by arbitrating the contract,” searching his person or property “without a warrant and without probable cause,” using excessive force upon him, failing to provide him with “needed medical care,” “false credit testimony, mayhem on property, defamation, false imcriminalization [sic], malicious prosecution, conspiracy, and/or any other claim that may be supported by the allegations of this complaint.” Plaintiff’s Complaint makes reference to 28 U.S.C. § 1983, 1985, and 1986, “Title IX, and Section 504 of the 1973 Rehabilitation Act,” the “False claim act,” and avers that “[t]he criminal proceeding by the defendants … [is] still pending,” but that Plaintiff “was innocent.”

The court dismissed Maxberry’s initial complaint on two grounds. First, Judge Barker noted that the Plaintiff was asking the Southern District of Indiana, a federal court, to review the rulings of a Wisconsin state court. Such a review, which would in effect place the Indiana federal court in the position of acting as a Wisconsin appellate court, was impermissible under the Rooker-Feldman doctrine. The court further found that the assertions in the complaint were “cast in such an incoherent and confusing manner that they must be dismissed under [Federal Rule of Civil Procedure 8(a)] based on Plaintiff’s failure to give Defendant (as well as the Court) fair notice of what they actually are.”

The court allowed Maxberry to file an amended complaint, which ITT moved to dismiss. In this complaint, Maxberry again made multiple claims, including five claims involving patent 8,632,592, for an “expandable vertebral body replacement device and method.” Maxberry asserted that this patent encompassed a cure for cancer, an automotive window-locking device, as well as a type of computer display equipment.

The court dismissed these “facially implausible” patent infringement claims with prejudice. Judge Barker noted that, not only was it wildly improbable that a single patent covered all of the asserted functions, but the records of the U.S. Patent and Trademark Office showed that the patent-in-suit was not registered to Maxberry.

The court also dismissed Maxberry’s other claims but granted him leave to reformulate those claims in a more understandable form and resubmit them.

March 4, 2015

Indiana Patent Litigation: TreeStuff Sued for Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana patent attorney for Sherrill, Inc. of Greensboro, North Carolina (“Sherrill”) filed a patent infringement complaint in the Southern District of Indiana alleging that TreeStuff, Inc. of Indianapolis, Indiana infringed Patent No. 5,887,577 entitled “Apparatus for Propelling a Projectile,” which has been registered by the U.S. Patent Office.

Plaintiff Sherrill asserts ownership by assignment to United States Patent No. 5,887,577 (“the ‘577 Patent”), which was issued to William T. Sherrill in 1999. It claims that TreeStuff manufactures, uses, offers for sale, and/or sells a product that infringes upon that patent, namely TreeStuff’s Stein Tekichu Throw Weight Launcher.

In November 2014, Sherrill sent a cease-and-desist letter to TreeStuff. In that letter, it identified the ‘577 Patent, stated that the Stein Tekichu Throw Weight Launcher infringed upon certain claims of the ‘577 Patent and demanded that TreeStuff cease all infringing activities.

Sherrill claims that TreeStuff did not respond to this letter but instead continued to use, offer to sell, and/or sell the accused product. Sherrill contends that, by engaging in these activities, TreeStuff has directly infringed, and will continue to directly infringe, at least claim 8 of the ‘577 Patent under 35 U.S.C. § 271(a) literally and/or under the doctrine of equivalents. Sherrill also suggests in its complaint that it is “reasonable to infer” that TreeStuff also intended to induce infringement. TreeStuff has also been accused of contributory infringement. Sherrill asserts that TreeStuff’s infringement has been and continues to be willful and deliberate.

In its complaint, filed by an Indiana patent attorney, Sherrill asks that the court:

• Declare that the ‘577 Patent was duly and legally issued, is valid and is enforceable;

• Enter judgment that defendant TreeStuff has infringed at least claim 8 of the ‘577 Patent;

• Enter judgment that defendant TreeStuff has induced infringement of at least claim 8 of the ‘577 Patent;

• Enter judgment that defendant TreeStuff has contributed to infringement of at least claim 8 of the ‘577 Patent;

• Enter a preliminary and permanent injunction enjoining defendant TreeStuff and its agents from any further sales or use of their infringing products and any other infringement of claims of the ‘577 Patent, whether direct or indirect, pursuant to 35 U.S.C. § 283;

• Award damages to compensate Sherrill for defendant TreeStuff’s infringement of the claims of the ‘577 Patent pursuant to 35 U.S.C. § 284;

• Award enhanced damages pursuant to 35 U.S.C. § 284;

• Award pre-judgment and post-judgment interest and costs to plaintiff Sherrill in accordance with 35 U.S.C. § 284; and

• Deem the case to be “exceptional” within the meaning of 35 U.S.C. § 285, entitling plaintiff Sherrill to an award of its reasonable attorney fees, expenses and costs in this action.

February 11, 2015

Indiana Patent Litigation: Four Mile Bay Asserts Patent Infringement Claims Against Zimmer

By Overhauser Law Offices, LLC

Hammond, Indiana – Patent attorneys for Four Mile Bay LLC (“FMB”) of Wadsworth, Ohio instituted intellectual property litigation in the Northern District of Indiana alleging that Zimmer Holdings, Inc. (“Zimmer”) of Warsaw, Indiana infringed its patented “Hip Implant With Porous Body,” Patent Nos. 8,821,582 and 8,506,642, which have been registered by the U.S. Patent Office.

Zimmer is a manufacturer and marketer of reconstructive orthopedic implants, including hip implants. At issue in this Indiana patent lawsuit are United States Patent Nos. 8,821,582 (the “‘582 patent”) and 8,506,642 (the “‘642 patent”). Zimmer is accused of having infringed and continuing to infringe the ‘582 and ‘642 patents by making, selling, and using hip implants, including a Trabecular Metal Primary Hip Prosthesis, that embody the patented invention.

Ownership of the ‘582 patent, issued for an invention in a method of machining, fabricating, and attaching components of a hip implant with a porous body, is claimed by FMB. FMB also asserts ownership of the ‘642 patent.

In this Indiana litigation, patent lawyers for FMB ask the court for the following:

Judgment that Zimmer has directly infringed claims of the ‘582 patent and the ‘642 patent;

For a reasonable royalty; and

For pre-judgment interest and post-judgment interest at the maximum rate allowed by law.

The case was assigned to Chief Judge Philip P. Simon and Magistrate Judge Christopher A. Nuechterlein in the Northern District of Indiana and assigned Case No. 3:15-cv-00063-PPS-CAN.

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 29, 2015

Indiana Patent Litigation: Knauf Alleges Infringement of Three Patents

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Knauf Insulation, LLC of Shelbyville, Indiana; Knauf Insulation GmbH of Iphofen, Germany; and Knauf Insulation SPRL of Visé, Belgium filed a patent infringement lawsuit in the Southern District of Indiana alleging that Johns Manville Corporation and Johns Manville, Inc., both of Denver, Colorado, infringed Patent Nos. 8,114,210 and 8,940,089, both for “Binders,” and D631,670 for “Insulation Material.”

Plaintiffs Knauf Insulation GmbH, Knauf Insulation SPRL, and Knauf Insulation, LLC are affiliated companies (collectively, “Knauf Insulation”). They produce and sell building materials including fiberglass insulation and related products. Defendants Johns Manville Corporation and Johns Manville, Inc., which are wholly owned subsidiaries of Berkshire Hathaway Inc., are stated to be direct competitors of Knauf Insulation GmbH and Knauf Insulation, LLC in the U.S. for fiberglass insulation products.

Plaintiffs Knauf Insulation SPRL and Knauf Insulation, LLC are each owners of one-half undivided interests of United States Patent Nos. 8,114,210 (“the ‘210 Patent”), 8,940,089 (“the ‘089 Patent”) and D631,670 (“the ‘670 Patent”; collectively, the patents-in-suit), which have been registered by the U.S. Patent Office.

Defendants offer for sale various bio-based binder insulation products, including “Formaldehyde Free” “Bio-based binder” insulation products. These products are marketed as “EasyFit,” “RANGE-GLAS EQ,” “SPIN-GLAS WH EQ,” “Flex-Glass EQ,” “Microlite EQ,” “Microlite L,” “ComfortTherm,” and “PEBS Blanket” insulation. Plaintiffs claim that the manufacture of these products infringes upon the patents-in-suit.

Specifically, Knauf Insulation contends that Defendants have infringed – directly, contributory and/or by inducement – various method claims of the patents-in-suit. That infringement, they claim, was willful and done with knowledge by Defendants with respect to the ‘210 and ‘670 patents. No claim of knowing or willful infringement was made with respect to the ‘089 patent, which issued on January 27, 2015, the date on which the complaint was filed. Knauf Insulation states that the patent infringement includes, in part, the manufacture of Johns Manville’s bio-based binder insulation.

In this lawsuit, Indiana patent lawyers for Knauf Insulation list three counts against the Johns Manville Defendants:

• Count I – Infringement of U.S. Patent 8,114,210

• Count II – Infringement of U.S. Patent 8,940,089

• Count III – Infringement of U.S. Patent D631,670

Knauf Insulation asks the court for a judgment of infringement of the patents-in-suit; an injunction; damages, including treble damages; an award of Defendants’ total profits, as well as other remedies under 35 U.S.C. §289 for the infringement of the ‘670 Patent; and an award of interest, fees and costs.

The case was assigned to Judge William T. Lawrence and Magistrate Judge Mark J. Dinsmore in the Southern District of Indiana and assigned Case No. 1:15-cv-00111-WTL-MJD.

January 26, 2015

Indiana Patent Litigation: Agri-Labs Asserts Infringement of Patented GPS-Enabled Soil-Analysis System

By Overhauser Law Offices, LLC

Fort Wayne, Indiana – An Indiana patent attorney for Agri-Labs Holdings LLC of Auburn, Indiana filed a patent infringement lawsuit in the Northern District of Indiana alleging that TapLogic, LLC of Murray, Kentucky infringed its patented “Soil Sample Tracking System and Method.”

At issue in this Indiana patent litigation is U.S. Patent No. 8,286,857 (the “`857 Patent” or the “Patent-in-Suit”), to which Agri-Labs claims ownership. The patent-in-suit, which was issued based upon an application filed by inventor Tony Wayne Covely, has been registered by the U.S. Patent Office. The `857 Patent generally relates to a system and method for performing soil analysis that uses smart phones, applications for smart phones, soil containers having unique identifiers, and global positioning (“GPS”).

TapLogic is accused of selling and offering for sale in the United States its “Ag PhD Soil Test,” which Agri-Labs contends infringes the patent-in-suit. To implement its soil-testing system, TapLogic provides its customers with soil containers. Customers are instructed to manually pull soil samples from a field and place them in separate containers, each of which includes a unique identifier. TapLogic’s Ag PhD test obtains a GPS coordinate reading associated with a location in the field from where the soil sample is taken and associates the GPS coordinate reading with the soil container having the customer scan the barcode contained on the soil container.

In December 2014, Agri-Labs sent a letter to TapLogic “attempting to amicably resolve this matter.” Agri-Labs indicates that it received no meaningful reply from TapLogic in response to the letter.

In this Indiana patent infringement complaint, the patent lawyer for Agri-Labs asserts a single count: Infringement of the ‘857 Patent by TapLogic. Agri-Labs asks the court to adjudge that the ‘857 Patent has been infringed and to enjoin TapLogic and its agents from directly and/or indirectly infringing the patent. Agri-Labs also asks for an award of compensatory damages pursuant to 35 U.S.C. § 284, as well as enhanced damages under 35 U.S.C. § 285, and for an award of its costs.

January 13, 2015

Indiana Patent Litigation: Federal Circuit Overturns Trial Court’s Award of Enhanced Damages for Patent Infringement

By Overhauser Law Offices, LLC

Washington, D.C. – The U.S. Court of Appeals for the Federal Circuit ruled on the patent infringement litigation between Zimmer of Warsaw, Indiana and Stryker of Kalamazoo, Michigan. The Federal Circuit upheld the jury’s finding that Zimmer had infringed three of Stryker’s patents but overturned the decision of the Western District of Michigan to triple the damage award, reducing the award from $228 million to $70 million, and vacated the district court’s award of attorneys’ fees.

Stryker and Zimmer are the two principal participants in the market for orthopedic pulsed lavage devices. A modern, orthopedic pulsed lavage device is a combination spray-gun and suction-tube, used by medical professionals to clean wounds and tissue during surgery.

In 2010, Stryker Corp, Stryker Puerto Rico, Ltd. and Stryker Sales Corp. (collectively, “Stryker”), sued Zimmer, Inc., Zimmer Surgical, Inc. and Zimmer Orthopaedic Surgical Products of Warsaw, Indiana (collectively, “Zimmer”) alleging that Zimmer’s line of Pulsavac Plus pulsed lavage devices infringed three of Stryker’s patents – U.S. Patent No. 6,022,329 (“the ‘329 patent”), U.S. Patent No. 7,144,383 (“the ‘383 patent”) and U.S. Patent No. 6,179,807 (“the ‘807 patent”). A jury awarded $70 million in damages and the district court increased that figure by approximately $2.4 million to reflect sales made by Zimmer during a time period that had not been considered by the jury.

Stryker also moved for enhanced damages under 35 U.S.C. § 284, alleging willful patent infringement by Zimmer. Under § 284, “the court may increase the damages up to three times the amount found or assessed” at trial. For this determination, the court referred to Read Corp. v. Portec, Inc.. In Read, the Federal Circuit had held that the “paramount determination in deciding to grant enhancement and the amount thereof is the egregiousness of the defendant’s conduct based on all the facts and circumstances.” In evaluating the egregiousness of the defendant’s conduct, courts typically rely on the nine Read factors, which are:

1. whether the infringer deliberately copied the patentee’s ideas or design;

2. whether the infringer investigated the scope of the patent and formed a good faith belief that it was invalid or not infringed;

3. the infringer’s conduct during litigation;

4. the infringer’s size and financial condition;

5. closeness of the case;

6. duration of the infringing conduct;

7. remedial actions, if any, taken by the infringer;

8. the infringer’s motivation for harm; and

9. whether the infringer attempted to conceal its misconduct.

The district court found that all nine Read factors favored substantial enhancement of the jury’s award and trebled both the jury’s award of $70 million and the court’s award of supplemental damages.

In the current opinion, the Federal Circuit affirmed the jury’s findings that Stryker’s patents were valid and had been infringed by Zimmer, as well as the jury’s award of damages to Stryker but reversed the district court’s judgment that Zimmer’s infringement was willful.

To establish willfulness, the patentee has the burden of showing “by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” If and only if the patentee establishes this “threshold objective standard” does the inquiry then proceed to the question of whether the objectively defined risk was either known or so obvious that it should have been known to a party accused of patent infringement.

The Federal Circuit noted that the district court had failed to undertake the required objective assessment of Zimmer’s specific defenses to Stryker’s claims. The Federal Circuit then considered the question of objective recklessness, which “will not be found where the accused infringer’s position is susceptible to a reasonable conclusion of no infringement.” The court held that the objective standard showed that Zimmer had presented reasonable defenses to all of the asserted claims of Stryker’s patents. Consequently, Zimmer was found not to have acted recklessly and the decision to award enhanced damages was reversed.

Because the appellate court reversed the trial court’s determination that the infringement of the patents had been willful – and because district court’s award of attorneys’ fees was based on that determination – the Federal Circuit vacated district court’s finding that the case was exceptional as well as the award of attorneys’ fees and remanded the issue to the trial court for further consideration.

January 9, 2015

High Court Will Decide Whether to Overrule Brulotte Doctrine

By Overhauser Law Offices, LLC

picture of gavel.png

Washington, D.C. – The U.S. Supreme Court granted certiorari in a case asking whether its decision in Brulotte v. Thys Co., 379 U.S. 29 (1964), that a licensee’s obligations are absolved after the expiration of a patent, should be overruled. Kimble v. Marvel Ent. Inc., U.S., No. 13-720.

Ninth Circuit Decision

In this case, Kimble held a patent on a glove that allows its wearer to shoot pressurized foam string from the palm, mimicking a gesture of the comic-book hero “Spider-Man.” (Patent No. 5,072,856). Kimble met with Marvel’s predecessor to discuss his glove invention, which was then covered by his pending patent application. When Marvel began manufacturing a similar toy called the “Web Blaster,” Kimble sued in 1997 for patent infringement and for breach of contract based on an alleged oral agreement to compensate him for any use of his ideas.

January 2, 2015

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

By Overhauser Law Offices, LLC

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.

December 23, 2014

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

By Overhauser Law Offices, LLC

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.