Medical

July 14, 2014

Indiana Patent Litigation: HEC Pharm Added to Effient Patent Infringement Litigation

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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July 10, 2014

Indiana Patent Litigation: CeraMedic Sues Zimmer for Patent Infringement

By Overhauser Law Offices, LLC

South Bend, Indiana – Indiana patent lawyers for CeraMedic LLC of Plano, Texas sued for biolox picture.jpg patent infringement in the Northern District of Indiana alleging that Zimmer Holdings, Inc. and Zimmer, Inc., both of Warsaw, Indiana (collectively “Zimmer”), infringed “Sintered Al₂O₃ Material, Process for Its Production and Use of the Material,” Patent No. 6,066,584, which has been issued by the United States Patent Office.

Patent No. 6,066,584 (the “‘584 patent”) relates to the field of ceramics and concerns sintered Al₂O₃ compositions and methods for the use of such material as medical implants or tool material. Similar litigation was also recently commenced against Biomet by Indiana patent attorneys for CeraMedic.

The ‘584 patent was issued in May 2000 to Fraunhofer-Gesellschaft zur Förderung der Angewandten Forschung e.V., Germany (“Fraunhofer”), Europe’s largest application-oriented research organization. CeraMedic states that Fraunhofer, the assignee of over 1,500 U.S. patents, assigned ownership of the ‘584 patent to CeraMedic in early 2014.

CeraMedic indicates that non-party CeramTec GmbH (“CeramTec”) developed and manufactures Biolox delta, (pictured) an aluminum oxide matrix composite ceramic consisting of approximately 82% alumina (Al₂O₃), 17% zirconia (ZrO₂), and other trace elements.

The allegations Defendant Zimmer include that it “designs, develops, manufactures, offers for sale, sells, uses, distributes, and markets hip implants, many of which include” CeramTec’s Biolox product and that such actions constitute infringement of the ‘584 patent. Zimmer is accused of infringing the ‘584 patent directly, literally, and/or by equivalents.

The complaint, filed by Indiana patent counsel, lists a single count: infringement of the ‘584 patent. CeraMedic asks the court for a judgment against Zimmer determining that Zimmer has infringed and continues to infringe one or more claims of the ‘584 patent; enjoining Zimmer and its agents from further infringing the ‘584 patent; ordering Zimmer to account for and pay to CeraMedic all damages suffered by CeraMedic as a consequence of Zimmer’s alleged infringement of the ‘584 patent, together with interest and costs; trebling or otherwise increasing CeraMedic’s damages under 35 U.S.C. § 284 upon a finding that the asserted infringement by Zimmer of the ‘584 patent was deliberate and willful; and declaring that this case is exceptional and awarding to CeraMedic its costs and attorneys’ fees in accordance with 35 U.S.C. § 285.

Practice Tip:

Zimmer has been sued for patent infringement before. One patent lawsuit, Stryker v. Zimmer, is illustrative of the potential cost of willful infringement. In that litigation, the jury found that Zimmer had committed patent infringement and awarded $70 million in damages. The jury also held that Zimmer’s infringement had been willful. Plaintiff Stryker asked the court for, inter alia, attorneys’ fees and enhanced damages.

Under 35 U.S.C. § 285, if the prevailing party establishes by clear and convincing evidence that the case is “exceptional,” the court may exercise its discretion to award attorneys’ fees. The court in this case cited various factors that could be used in determining whether a case was exceptional, for example: “willful infringement, fraud or inequitable conduct in procuring the patent, misconduct during litigation, vexatious or unjustified litigation, [or] conduct that violates Federal Rule of Civil Procedure 11.” The court awarded Stryker’s attorneys’ fees, holding that that the jury’s finding of willful infringement weighed heavily in favor of such an award (“indeed, when a trial court denies attorney fees in spite of a finding of willful infringement, the court must explain why the case is not ‘exceptional’ within the meaning of the statute.”)

The court also evaluated whether an award of enhanced damages was warranted. Under 35 U.S.C. § 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 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 court found that all nine Read factors favored substantial enhancement and trebled the jury’s award of damages. The court stated, “Zimmer chose a high-risk/high-reward strategy of competing immediately and aggressively in the pulsed lavage market and opted to worry about the potential legal consequences later.” In total, Zimmer was ordered to pay Stryker over $228 million.

July 3, 2014

Indiana Patent Litigation: CeraMedic Sues Biomet for Patent Infringement

By Overhauser Law Offices, LLC

South Bend, Indiana – Indiana patent attorneys for CeraMedic LLC of Plano, Texas filed an intellectual property lawsuit in the Northern District of Indiana alleging that Biomet, Inc. of Warsaw, Indiana infringed “Sintered Al₂O₃ Material, Process for Its Production and Use of the Material“, Patent No. 6,066,584, which has been issued by the United States Patent Office.

This Indiana patent litigation concerns Patent No. 6,066,584 (the “‘584 patent”), which relates to the field of ceramics and concerns sintered Al₂O₃ compositions and methods for the use of such material as medical implants or tool material.

The ‘584 patent was issued in May 2000 to Fraunhofer-Gesellschaft zur Förderung der Angewandten Forschung e.V., Germany (“Fraunhofer”), Europe’s largest application-oriented research organization. CeraMedic states that Fraunhofer, the assignee of over 1,500 U.S. patents, assigned ownership of the ‘584 patent to CeraMedic in early 2014.

CeraMedic indicates that non-party CeramTec GmbH (“CeramTec”) developed and manufactures BIOLOX delta, an aluminum oxide matrix composite ceramic consisting of approximately 82% alumina (Al₂O₃), 17% zirconia (ZrO₂), and other trace elements.

CeraMedic then states that Defendant Biomet “designs, develops, manufactures, offers for sale, sells, uses, distributes, and markets hip implants, many of which include” CeramTec’s BIOLOX delta and that such actions constitute infringement of the ‘584 patent. Biomet is accused of infringing the ‘584 patent directly, literally, and/or by equivalents.

The complaint, filed by Indiana patent lawyers, lists a single count: infringement of the ‘584 patent. CeraMedic asks the court for a judgment against Biomet determining that Biomet has infringed and continues to infringe one or more claims of the ‘584 patent; enjoining Biomet and its agents from further infringing the ‘584 patent; ordering Biomet to account for and pay to CeraMedic all damages suffered by CeraMedic as a consequence of Biomet’s alleged infringement of the ‘584 patent, together with interest and costs; trebling or otherwise increasing CeraMedic’s damages under 35 U.S.C. § 284 upon a finding that the asserted infringement by Biomet of the ‘584 patent was deliberate and willful; and declaring that this case is exceptional and awarding to CeraMedic its costs and attorneys’ fees in accordance with 35 U.S.C. § 285.

Practice Tip:

The Federal Circuit has somewhat tempered the threat of a finding of willfulness in patent infringement in recent years. In 2007, sitting en banc, it established a heightened standard for willfulness that included an inquiry into whether a defendant’s actions were “objectively reckless” in In re Seagate Technology LLC.

In 2012, in Bard Peripheral Vascular Inc. v. W.L. Gore & Associates Inc., the Federal Circuit removed the threat of findings of willfulness by “runaway juries,” including the uncertainties inherent in the fact that such jury findings would be delayed for many years as patent litigation made its way to trial and finally to a jury verdict. In that case, the Federal Court held that the threshold determination for willful infringement is a question of law and, as such, is to be decided by the trial court.

Nonetheless, compensatory damages in patent infringement litigation can reach seven, eight or even nine figures. Given that a finding of willfulness can treble those damages, patent infringement defendants must not take assertions of willfulness lightly.

April 25, 2014

Indiana Patent Litigation – Bonutti Research and Joint Active Systems Sue Lantz Medical for Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Patent attorneys for Bonutti Research, Inc. (“Bonutti”) and Joint Active Systems, Inc. (“JAS”), both of Effingham, Illinois, filed an intellectual property lawsuit in the Southern District of Indiana alleging that Lantz Medical, Inc. of Indianapolis, Indiana (“Lantz”) infringed multiple patents: “Orthosis,” Patent No. 5,848,979; “Elbow Orthosis,” Patent No. 7,955,286; “Finger Orthosis,” Patent No. 7,404,804; and “Orthosis,” Patent No. 7,112,179, which have been issued by the U.S. Patent Office.

Bonutti claims ownership by assignment of four patents. The patents at issue are:

• Patent No. 5,848,979 (“the ‘979 patent”), titled “Orthosis,” which generally covers apparatuses for use in effecting relative movement between bones in an arm of a patient, was issued in 1998.
• Patent No. 7,112,179 (“the ‘179 patent”), titled “Orthosis,” which generally covers apparatuses for stretching tissue around a joint of a patient between first and second relatively pivotable body portions, was issued in 2006.
• Patent No. 7,404,804 (“the ‘804 patent”), titled “Finger Orthosis,” which generally covers apparatuses for positioning a joint in a finger on a hand of a patient, was issued in 2008.
• Patent No. 7,955,286 (“the ‘286 patent”), titled “Elbow Orthosis,” which generally covers apparatuses for stretching tissue around a joint of a patient between first and second relatively pivotable body portions, was issued in 2011.

The ‘979, ‘179, ‘286, and ‘804 patents are licensed exclusively to JAS. Among the products that JAS develops and markets are products covered by the patents-in-suit, including the JAS Pro/Sup, JAS EZ Pro/Sup, JAS EZ Elbow, JAS EZ Wrist, and JAS EZ Finger products.

Defendant Lantz manufactures and sells, among other products, the Stat-A-Dyne® ESP, Stat-A-Dyne® Pro/Sup, Stat-A-Dyne® Elbow, and Stat-A-Dyne® WHFO products. Bonutti and JAS contend that these products infringe their patented inventions and are sold in direct competition with products offered for sale by JAS.

In a complaint filed by patent attorneys for Plaintiffs, the following claims are made:

• Count I: Infringement of U.S. Patent No. 5,848,979
• Count II: Infringement of U.S. Patent No. 7,955,286
• Count III: Infringement of U.S. Patent No. 7,404,804
• Count IV: Infringement of U.S. Patent No. 7,112,179

Plaintiffs Bonutti and JAS seek injunctive relief, damages, pre- and post-judgment interest, costs and attorneys’ fees.

Practice Tip: Since September 2012, Bonutti Skeletal Innovations LLC, an entity believed to be related to Bonutti Research, Inc., has initiated a series of patent-infringement lawsuits against medical-device manufacturers, including Depuy, Inc.; Zimmer, Inc.; Smith & Nephew, Inc.; Wright Medical Group, Inc.; ConforMIS, Inc.; Arthrex, Inc.; Linvatec Corporation; ConMed Corporation and Biomet, Inc. We blogged about the Biomet lawsuit, in which Biomet sought declaratory judgment of non-infringement and invalidity the Bonutti patents, here.

April 16, 2014

Indiana Trademark Litigation: Roche Diagnostics Sues Polymer Technology Systems for Trademark Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana trademark attorney for Roche Diagnostics GmbH of Roche Picture.jpg Germany and Roche Diagnostics Operations, Inc. of Indianapolis, Indiana (collectively “Roche Diagnostics”) filed a trademark infringement lawsuit in the Southern District of Indiana alleging that Polymer Technology Systems, Inc. d/b/a CHEK Diagnostics of Indianapolis, Indiana (“PTS”) infringed the trademarked “ACCU-CHEK“, Registration Nos. 1,277,867; 2,403,536; 2,628,696; 2,651,417; 2,681,644; 2,703,048; 2,732,629; 3,071,846; 3,076,905; 3,127,170; 3,194,287; 3,199,675; 3,202,402; 3,256,740; 3,411,797; 3,481,185; 3,595,149; 3,602,825; 3,609,052; 3,676,782; 3,703,434; 3,991,903; 3,749,950; 4,214,217; 4,230,563; and 4,226,844, which have been issued by the U.S. Trademark Office.

The Roche Diagnostics entities are global providers of medical products that help healthcare providers and consumers to prevent, diagnose, treat and manage diseases and other medical conditions. Included in the Roche Diagnostics offerings are products and services relating to diabetes care, including blood-glucose testing, monitoring and analysis. In connection with these products and services, Roche Diagnostics owns and uses numerous registrations for the federally registered trademark Accu-Chek and related marks.

Defendant PTS is a manufacturer of point-of-care diagnostic products headquartered in Indianapolis, Indiana. PTS designs, manufactures, and markets products for distribution in over 120 countries around the world and has sales offices in Europe, Latin America, and the Pacific Rim, and manufacturing facilities in Indianapolis, Indiana and Sunnyvale, California.

For several years prior to this trademark infringement complaint by Roche Diagnostics, PTS had sold a product under the name CardioChek, a medical device that measures blood cholesterol. Roche Diagnostics states that it did not assert its trademark rights to oppose the sale of CardioChek when it was marketed under the business name “Polymer Technology Systems.”

In March 2014, PTS announced that it was making two changes. According to a press release, it would be changing its business name to “CHEK Diagnostics” and would begin offering a line of diabetes-care products, the AICNow® family of products, which PTS had purchased from Bayer Diabetes Care. This new line of products would be offered under the CHEK Diagnostics business name. Roche Diagnostics contends the expansion into this new market, in conjunction with Defendants’ changed business name, violates its trademark rights and is likely to cause confusion, mistake and/or deception as to the source of PTS’s diabetes-care goods.

In its complaint, filed by an Indiana trademark lawyer, Roche Diagnostics asserts trademark infringement of its Accu-Chek trademarks under 15 U.S.C. § 1114(1) and § 1125 (a) of the Lanham Act, as well as trademark infringement and unfair competition in violation of the common law of the State of Indiana.

Roche Diagnostics requests that the court enjoin PTS from using “CHEK Diagnostics” as a company name or in a manner in any way related to the promotion or sale of diabetes-care products. It asks that the court direct PTS to immediately recall any materials bearing the “CHEK” business name and to order PTS to cancel or modify any pending trademark registrations that include the CHEK name.

Roche Diagnostics also seeks monetary damages as well as a declaration by the court that the use of “CHEK Diagnostics” as a company name, or in a manner in any way related to the sale or promotion of diabetes-care products, would constitute trademark infringement and unfair competition under both federal and Indiana-state law.

Practice Tip: The protection afforded to a registered trademark is not exhaustive in scope. Among the limits to its applicability are restrictions based on the type of business and product to which the trademark pertains. In this case, while Roche may have declined to object to PTS’s use of “CHEK” in conjunction with the sale of a non-diabetes-related product (here, a cholesterol-measuring product), that failure to object is unlikely to waive its right to assert infringement later if the word “CHEK” is used to market a product that is allegedly related to the product for which Roche Diagnostics owns a trademark (here, the purportedly similar line of diabetes products to be offered by PTS).