Patent Infringement

July 7, 2015

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

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

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

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

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

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

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

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

• Count XX for Declaratory Judgment: Infringement of U.S. Patent No. 8,993,520

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

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

g) Plaintiffs are entitled to any further appropriate relief under 35 U.S.C.§ 271(e)(4).

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

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

June 9, 2015

Indiana Patent Litigation: Donaldson Co. Sues Action Filtration Alleging Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Donaldson Company, Inc. of Bloomington, Minnesota, (“Donaldson”) commenced an intellectual property lawsuit in the Southern District of Indiana alleging that Action Filtration, Inc. of Hope, Indiana infringed Patent No. 6,488,746, “Air Filter Assembly Having Non-Cylindrical Filter Elements for Filtering Air With Particulate Matter”; Patent No. D499,177, “Filter Element Having Oval Shape”; and Patent No. 7,264,656, “Air Filter Assembly Having Non-Cylindrical Filter Elements for Filtering Air With Particulate Matter,” which have been issued by the U.S. Patent Office.

Plaintiff Donaldson, established in 1915, is a worldwide provider of filtration systems and replacement parts. Defendant Action Filtration designs and manufactures replacement filters for dust collection and liquid filtration.

At issue in this Indiana patent lawsuit are three patents, to which Donaldson claims ownership: United States Patent No. 6,488,746 (“the ‘746 patent”), United States Design Patent No. D499,177 (“the ‘177 patent”) and United States Patent No. 7,264,656 (“the ‘656 patent”).

In this Indiana complaint, filed by patent lawyers for Donaldson, the following is alleged:

• Count I: Infringement of the ‘746 Patent
• Count II: Infringement of the ‘177 Patent

• Count III: Infringement of the ‘656 Patent

Donaldson asks the court for injunctive relief; compensatory damages; an award of Action Filtration’s total profits derived from infringement of the ‘177 Patent; and a declaration that the case is exceptional, to include an award to Donaldson of its attorneys’ fees, expenses, and costs associated with this patent lawsuit pursuant to such a declaration.

June 5, 2015

Indiana Trademark and Patent Litigation: Simpson Sues Two Indiana Individuals Alleging Patent Infringement and Counterfeiting

By Overhauser Law Offices, LLC

Hammond, Indiana – Trademark and patent attorneys for Simpson Performance Products, Inc. of Mooresville, North Carolina (“Simpson”) and SFI Foundation, Inc. of Poway, California (“SFI”) commenced trademark litigation in the Western District of North Carolina alleging that Robert Wagoner of North Judson, Indiana and Derek Randall Cathcart of Valparaiso, Indiana infringed the SIMPSON® family of trademarks, some of which have been registered by the U.S. Trademark Office. The case was transferred to the Northern District of Indiana. Among the trademarks at issue are U.S. Trademark Registration Nos. 4,117,821; 1,243,427; 3,026,333; 3,026,334; and 3,050,920. Also at issue are U.S. Patent Nos. 6,931,669 and 8,272,074.

Plaintiff Simpson is a manufacturer of automotive and motorsports specialty/performance products, including head and neck restraints for competitive racing. The Simpson brand of automotive and motorsports products has existed 1959. Plaintiff SFI was established to develop and administer minimum performance standards for the automotive aftermarket and motorsports industries, including standards for specialty/performance racing equipment.

Simpson offers for sale the SIMPSON® Hybrid PRO Rage™ head and neck restraint. Simpson indicates that this product is one of the few such devices to be certified under a special classification, SFI SPEC 38.1, for use in NASCAR competitions.

Defendants Wagoner and Carthcart have been accused of engaging in the business of providing specialty/performance racing equipment, including head and neck restraints that are counterfeit versions of Simpson products. Plaintiffs contend that Wagoner is offering counterfeit head and neck restraints through ebay.com. Plaintiffs allege that Cathcart offers counterfeit head and neck restraints via the website racingjunk.com.

These restraints, Plaintiffs contend, bear trademarks owned by Simpson, including the SIMPSON® federally registered trademark as well as the HUTCHENS Hybrid PRO™ and Hybrid PRO™ common law trademarks.

The accused products also allegedly bear a label that falsely states, “This product designed & manufactured by Safety Solutions, Inc. PATENT NO.: 6931669; other patents pending.” According to Plaintiffs, the alleged counterfeiting activities of Defendants also constitute patent infringement.

In this lawsuit, filed by patent and trademark lawyers for Plaintiffs, the following causes of action are listed:

• Trademark Infringement
• Unfair Competition under 15 U.S.C. § 1125(a); False Designation of Origin; False or Misleading Advertising
• Unfair and Deceptive Trade Practices under N.C. [North Carolina] Gen. Stat. § 75-1.1
• Patent Infringment [sic]

• Common Law Fraud

Plaintiffs ask for a finding in their favor on each of the counts alleged, including a finding that the conduct was knowing and willful, and entry against each Defendant jointly and severally. Plaintiffs seek costs, attorneys’ fees and damages, including enhanced damages, as well as injunctive relief.

This federal trademark complaint was initially filed in the Western District of North Carolina in February 2015. In May 2015, District Judge Richard Voorhees ordered it to be transferred to the Northern District of Indiana, finding that the North Carolina court lacked personal jurisdiction over Defendants.

June 3, 2015

Indiana Patent Litigation: Lippert Components Sued on Allegations of Patent Infringement

By Overhauser Law Offices, LLC

Elkhart, Indiana – Indiana patent lawyers for LTI Holdings, Inc. of Modesto, California (“LTI”) filed a patent-infringement complaint in the Northern District of Indiana alleging that Lippert Components, Inc. of Elkhart, Indiana (“Lippert”) infringed Patent Nos. 6,966,590 for a “Two-Part Seal for a Slide-Out Room,” 7,614,676 for a “Resilient Seal for Mobile Living Quarters,” and 7,614,677 for a “Seal Assembly for Mobile Living Quarters.” These patents have been issued by the U.S. Patent and Trademark Office.

Indiana-based Lippert, a subsidiary of Drew Industries, is a large supplier serving the recreational vehicle, manufactured housing, trailer, and bus industries. It offers a line of products dedicated to improving the mobile lifestyle.

Three patents – Patent Nos. 6,966,590 (“the ‘590 patent”), 7,614,676 (“the ‘676 patent”) and 7,614,677 (“the ‘677 patent”) – are at issue in this federal intellectual property lawsuit. Defendant Lippert has been accused of making, offering for sale and/or selling products that infringe upon one or more of these patents. Some of these activities purportedly occurred on two or more recreational vehicles manufactured by facilities in Indiana.

The first accused product is a two-part seal that allegedly infringes one or more claims of the ‘590 patent. The second and third accused products, both “Slide Armor” seals, purportedly infringe as many as all of the patents-in-suit.

A cease-and-desist letter was sent to Jason Lippert, the CEO of Defendant, in March 2015. Plaintiff contends that, despite this letter and the communications that followed, Defendant’s manufacture, offer for sale, and sale of each of the accused products has continued.

In this Indiana complaint, patent attorneys for LTI assert the following claims:

• Count 1: Direct Infringement of the ‘590 Patent
• Count 2: Direct Infringement of the ‘676 Patent
• Count 3: Direct Infringement of the ‘677 Patent
• Count 4: Induced Infringement of the ‘590 Patent

• Count 5: Contributory Infringement of the ‘590 Patent

Plaintiff asks the court to enter a judgment:

a) declaring the ‘590 patent is directly infringed by Defendant;
b) declaring the Defendant induced infringement of the ‘590 patent;
c) declaring the Defendant has contributorily infringed the ‘590 patent;
d) declaring Defendant’s infringement of the ‘590 patent has been willful;
e) declaring Defendant be preliminarily and permanently enjoined from manufacturing, using, selling, and offering to sell the infringing products in the United States prior to the expiration of the ‘590 patent;
f) awarding damages adequate to compensate Plaintiff for Defendant’s infringement of the ‘590 patent including lost profits, but in an amount no less than a reasonable royalty, and that such damages be trebled according to 35 U.S.C. § 284;
g) declaring the ‘676 patent is directly infringed by Defendant;
h) declaring Defendant’s infringement of the ‘676 patent has been willful;
i) declaring Defendant be preliminarily and permanently enjoined from manufacturing, using, selling and offering to sell the infringing products in the United States prior to the expiration of the ‘676 patent;
j) awarding damages adequate to compensate Plaintiff for Defendant’s infringement of the ‘676 patent including lost profits, but in an amount no less than a reasonable royalty, and that such damages be trebled according to 35 U.S.C. § 284;
k) declaring the ‘677 patent is directly infringed by Defendant;
l) declaring Defendant’s infringement of the ‘677 patent has been willful;
m) declaring Defendant be preliminarily and permanently enjoined from manufacturing, using, selling, and offering to sell the infringing products in the United States prior to the expiration of the ‘677 patent;
n) awarding damages adequate to compensate Plaintiff for Defendant’s infringement of the ‘677 patent including lost profits, but in an amount no less than a reasonable royalty, and that such damages be trebled according to 35 U.S.C. § 284; and

o) awarding all costs and expenses of this action, including reasonable attorneys’ fees.

May 29, 2015

Indiana Patent Litigation: Starmark Funeral Products Sues Matthews International Alleging Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Vandor Corporation d/b/a Starmark Funeral Products of Richmond, Indiana filed a patent-infringement complaint in the Southern District of Indiana alleging that Matthews International Corporation of Pittsburgh, Pennsylvania and Matthews International – Cremation Division of Apopka, Florida (collectively, “Matthews”) infringed Patent No. 8,104,151, entitled “Lightweight Casket Having Foldable Features,” which has been issued by the U.S. Patent and Trademark Office.

Plaintiff Vandor claims ownership of United States Patent No. 8,104,151 (“the ‘151 Patent”). Vandor indicates in this intellectual property complaint that it has sold a cremation-insert product that embodies claims of the ‘151 Patent since at least 2009.

Defendants are accused of the manufacture, use, offer for sale, and/or sale of the “Matthews Cremation Fold-Down Rental Insert,” which Vandor contends directly infringes at least claim 1 of the ‘151 Patent under 35 U.S.C. § 271(a) literally and/or under the doctrine of equivalents.

Plaintiff also claims that Matthews intended to induce patent infringement by others as well as has contributorily infringed the ‘151 Patent under 35 U.S.C. § 271(c) literally and/or under the doctrine of equivalents. Finally, Vandor contends that Matthews been aware that it has been infringing since approximately January 2015. Consequently, Matthews’ alleged infringement has been labeled as “willful and deliberate” by Plaintiff.

The Indiana patent lawyers for Plaintiff ask the Southern District of Indiana to:

• Declare that United States Letters Patent 8,104,151 was duly and legally issued, is valid and is enforceable;
• Enter judgment that Defendants have infringed at least claim 1 of the ‘151 Patent;
• Enter judgment that Defendants have induced infringement of at least claim 1 of the ‘151 Patent;
• Enter judgment that Defendants have contributed to infringement of at least claim 1 of the ‘151 Patent;
• Enter a preliminary and permanent injunction enjoining Defendants and their agents, from any further sales or use of their infringing products and any other infringement of claims of the ‘151 Patent, whether direct or indirect, pursuant to 35 U.S.C. § 283;
• Award damages to compensate Vandor for Defendants’ infringement of the claims of the ‘151 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 Vandor in accordance with 35 U.S.C. § 284; and

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

May 26, 2015

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

By Overhauser Law Offices, LLC

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

Effient products were approved by the FDA for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI, or angioplasty). Effient products contain prasugrel hydrochloride, which is also known as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride.

The instructions accompanying Effient products state that patients taking Effient products should also take aspirin. The use of Effient products in combination with aspirin for the reduction of thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is allegedly covered by the claims of the ‘703 and ‘325 patents.

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

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

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

• Count I: Infringement of U.S. Patent No. 8,404,703

• Count II: Declaratory Judgment of Infringement of U.S. Patent No. 8,404,703

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

• Count III: Infringement of U.S. Patent No. 8,569,325

• Count IV: Declaratory Judgment of Infringement of U.S. Patent No. 8,569,325

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

May 21, 2015

Committee Approves TROL Act to Squash Patent Trolls

By Overhauser Law Offices, LLC

WASHINGTON DC – The House Energy and Commerce Committee recently voted to approve H.R. 2045, the Targeting Rogue and Opaque Letters (TROL) Act, by a vote of 30 to 22. Authored by Commerce, Manufacturing, and Trade Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), the TROL Act was designed to help stop the practice of abusive patent demand letters while protecting the rights of legitimate patent holders to protect their intellectual property.

The TROL Act increases transparency and accountability in patent demand letters so businesses can weed out deceptive letters. The Act also establishes a national standard for the enforcement of abusive patent demand letters and allows the Federal Trade Commission (FTC) and state attorneys general to levy fines on bad actors.

“This legislation takes on a costly scam that, by many accounts, continues to worsen,” said Burgess. “The very real problem of abusive patent demand letters compels us to find a solution expressly designed to enable enforcement that’s free of constitutional setbacks.” To learn more about the TROL Act, click here.

May 18, 2015

Indiana Patent Litigation: Klink Trucking Sues Seaboard Asphalt for Declaration of Non-Infringement

By Overhauser Law Offices, LLC

Fort Wayne, Indiana – Indiana patent attorneys for Klink Trucking Inc., K-Tech Specialty Coatings, Inc., BIT MAT Products of Indiana, Inc. and BIT MAT Products of Michigan, Inc. (collectively the “Klink Group”), all of Ashley, Indiana, initiated an intellectual property lawsuit in the Northern District of Indiana alleging that Seaboard Asphalt Products Company (“Seaboard Asphalt”) of Baltimore, Maryland wrongly accused Klink Group of infringing Seaboard Asphalt’s patented “Trackless Tack Coat,” Patent No. 8,764,340, which has been issued by the U.S. Patent Office.

Seaboard Asphalt claims ownership of U.S. Patent No. 8,764,340 for a “Trackless Tack Coat” (“the ‘340 patent”). This patent protects an “asphalt emulsion available for high performing, trackless tack coat applications. The tack coat can be used with hot mix asphalt, warm mix asphalt or cold mix asphalt to provide a tack coat on an existing bituminous or concrete pavement surface. The tack coat can also be used for repair of potholes, utility cuts, and general pavement patching areas.”

On April 28, 2015, Seaboard Asphalt contacted Klink Group. According to a document filed with the Indiana court, Seaboard Asphalt stated that it believed that Klink Group’s “AE-NT Trackless Tack Coat” infringed Seaboard Asphalt’s ‘340 patent and requested that Klink Group “discontinue production and distribution for sale of your AE-NT and all versions of Trackless Tack Coat which violate our Patent” until Klink Group and Seaboard Asphalt had entered into a licensing agreement.

This Indiana litigation arises from that assertion and request by Seaboard Asphalt. Klink Group asserts that it has no liability for infringement of the ‘340 patent because none of the Klink Group entities have infringed any valid and enforceable claim of the ‘340 patent. Plaintiffs have sued under the Declaratory Judgment Act. They ask the Indiana federal court for two declarations with respect to the patent-in-suit:

• Count I – Declaration of Non-Infringement

• Count II – Declaration of Invalidity

Plaintiffs also ask the court to declare this case to be exceptional under 35 U.S.C. § 285 and, pursuant to such a declaration, to award to Plaintiffs its reasonable attorneys’ fees, expenses and costs relating to this patent litigation.

May 1, 2015

Appellate Patent Law: Federal Circuit Affirms that Prior Art was Anticipatory

By Overhauser Law Offices, LLC

Washington, D.C. – The United States Court of Appeals for the Federal Circuit heard an appeal in the matter of Ineos USA LLC v. Berry Plastics Corporation. It affirmed the decision reached by the United States District Court for the Southern District of Texas, Case No. 3:13-cv-00017, regarding the infringement of Patent No. 6,846,863 (the “‘863 patent), which was issued by the U.S. Patent and Trademark Office.

Ineos holds the ‘863 patent, which was directed to polyethylene-based compositions which could be used to form shaped products, such as screw caps for bottles. In a patent lawsuit filed in Texas, Ineos accused Berry Plastics of infringing its ‘863 patent.

Berry Plastics moved for summary judgment that the asserted claims were anticipated independently by various prior art references, including U.S. Patent No. 5,948,846. Prior art incorporated a lubricant to allow the cap to glide better, which facilitated unscrewing the cap. However, in addition to increasing usability, the prior chemical formulations also imparted a bad odor and flavor to food products stored in contact with them. Ineos’ ‘863 patent claimed to have solved this problem by modifying the proportions of polyethylene, lubricants, and additives.

The district court ruled in Berry Plastic’s favor, holding that the ‘863 patent was invalid as anticipated by prior art under 35 U.S.C. § 102 (2006).

Ineos appealed from the district court’s ruling. The Federal Circuit affirmed, holding that Ineos had failed to show that the range claimed by the ‘863 patent was “critical to the operability of [Ineos’] invention.”

April 29, 2015

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

By Overhauser Law Offices, LLC

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

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

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

Effient products were approved by the FDA for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI, or angioplasty). Effient products contain prasugrel hydrochloride, which is also known as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride or 2-acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzy1)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride, and is covered by the ‘726 patent.

The instructions accompanying Effient products state that patients taking Effient products should also take aspirin. The use of Effient products in combination with aspirin for the reduction of thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is allegedly covered by the claims of the ‘703 and ‘325 patents.

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

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

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

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

• Count IV: Declaratory Judgment of Infringement of U.S. Patent No. 8,569,325

Plaintiffs ask the court for judgment:

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

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

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

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

• If Lupin commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of either of the ‘703 and ‘325 patents, including any extensions, that Plaintiffs be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;

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

• That the ‘703 patent remains valid and enforceable;

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

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