Inducement

March 17, 2014

Indiana Patent Infringement Litigation: Eli Lilly Sues Numerous Defendants

Indianapolis, Indiana – An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed a lawsuit in the Southern District of Indiana against multiple defendants asserting infringement of Patent Nos. 5,288,726, “Tetrahydrothienopyridine Derivatives, Furo and Pyrrolo Analogs Thereof and Their Preparation and Uses for Inhibiting Blood Platelet Aggregation,” 8,569,325, “Method of Treatment with Coadministration of Aspirin and Prasugrel” and 8,404,703, “Medicinal Compositions Containing Aspirin,” which have been issued by the U.S. Patent Office.

In a 101-page complaint, Indiana patent counsel for Plaintiffs Lilly; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; and Ube Industries, Ltd. sued alleging patent infringement by more than thirty Defendants. The Defendants are: 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 (these three companies are, collectively, “Mylan”); 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). Defendants hail from various areas of the world, including India, the United Arab Emirates, the British Virgin Islands, Israel, Ireland and the United States.

This complaint asserts patent infringement arising out of the filing by Defendants of Abbreviated New Drug Applications (“ANDA”s) 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 (pictured above) – prior to the expiration of United States Patent Nos. 5,288,726 (the “‘726 patent”), 8,404,703 (the “‘703 patent”) and 8,569,325 (the “‘325 patent”), which cover the 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.

Defendants are, in general, accused of infringing the patents-in-suit by including with their products instructions for use that substantially copy the instructions for Effient® products, including instructions for administering the Defendants’ products with aspirin as claimed in the ‘703 and ‘325 patents. Moreover, Plaintiffs contend that Defendants know that the instructions that will accompany the Defendants’ Products will induce and/or contribute to others using the Defendants’ Products in the manner set forth in the instructions.

Plaintiffs also contend that Defendants specifically intend that health care providers, and/or patients will use the Defendants’ Products in accordance with the instructions provided by Defendants to directly infringe one or more claims of the ‘703 and ‘325 patents. In doing so, state Plaintiffs, Defendants will actively induce and/or contribute to infringement of the ‘703 and ‘325 patents.

The complaint, filed by an Indiana patent attorney, lists a total of fifty counts. All Defendants are accused of infringement of the ‘703 and ‘325 patents. Declaratory judgment of infringement of these patents is sought against all Defendants. Additionally, claims of infringement of, and a request for declaratory judgment regarding, the ‘726 patent are made against Mylan.

Plaintiffs ask the court for judgment:

• That all Defendants, either individually or collectively, have infringed or will infringe one or more claims of the ‘703 patent;
• That all Defendants, either individually or collectively, have infringed or will infringe one or more claims of the ‘325 patent;
• That Mylan, either individually or collectively, has infringed or will infringe one or more claims of the ‘726 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(B), Defendants be permanently enjoined from making, using, selling or offering to sell any of the Defendants’ 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 any ANDAs 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;
• That the ‘703 patent remains valid and enforceable;
• That the ‘325 patent remains valid and enforceable;
• That the ‘726 patent remains valid and enforceable;
• If any Defendant 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;
• If Mylan 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 the ‘726 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; and
• That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

Practice Tip: Lilly is not an infrequent litigant. This may be in part due to the fact that the company is facing a significant patent cliff. Its patent for a former top product, the antipsychotic Zyprexa – which once generated $5 billion in annual revenues – expired in 2011. Its top-selling drug of 2013, the antidepressant Cymbalta, lost patent protection last year. The patent on blockbuster Evista, a drug for breast cancer and osteoporosis, expires this month.

February 13, 2014

Alcon Sues Cipla for Patent Infringement of Pataday™

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent lawyers for Alcon Research, LTD of Fort Worth, Texas and Alcon Pharmaceuticals Ltd of Fribourg, Switzerland (collectively, “Alcon”) sued in the Southern District of Indiana alleging that Cipla Limited of Mumbai Central, Mumbai and Cipla USA Inc. of Miami, Florida (collectively, “Cipla”) infringed Olopatadine Formulations for Topical Administration, Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”), which have been issued by the U.S. Patent Office.

According to the complaint, the Cipla entities are engaged in the generic-pharmaceutical business. Alcon asserts that one or more of the entities develops, manufactures, imports, markets, offers to sell and/or sells generic drugs throughout the United States.

Cipla filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of Pataday™ ophthalmic solution, a drug product containing olopatadine hydrochloride. The two patents-in-suit, which Alcon claims to own, are asserted to cover Pataday™. Alcon contends that Cipla’s submission of this ANDA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of Cipla’s ANDA product before the expiration of the patents-in-suit is an act of infringement under 35 U.S.C. § 271(e)(2)(A).

Alcon states that it believes that the Cipla entities are part of a vertically integrated and unified organization and that they will act in concert to introduce the generic version of Pataday™ to the United States market prior to the expiration of Alcon’s patents.

In the complaint, intellectual property attorneys for Alcon list the following claims:

• Count I: Infringement of the ‘186 Patent
• Count II: Infringement of the ‘609 Patent
• Count III: Declaratory Judgment of Infringement of the ‘186 Patent
• Count IV: Declaratory Judgment of Infringement of the ‘609 Patent

Alcon asks for a judgment that the ‘186 and ‘609 patents are valid and enforceable and have been infringed; a judgment providing that the effective date of any FDA approval of commercial manufacture, use or sale of Cipla’s ANDA product be not earlier than the latest of the expiration date of the patents-in-suit, inclusive of any extension(s) and additional periods of exclusivity; preliminary and permanent injunctions protecting products covered by the ‘186 patent prior to its expiration; preliminary and permanent injunctions protecting products covered by the ‘609 patent prior to its expiration; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Cipla’s ANDA product, or any other drug product covered by the ‘186 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Cipla’s ANDA product, or any other drug product covered by the ‘609 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a declaration that this is an exceptional case and an award of attorneys’ fees; and costs and expenses.

Practice Tip:

India is the world’s leading exporter of generic drugs. Some Indian manufacturers are aggressively seeking to have their generic versions approved by the FDA well before a brand-name drug’s patent(s) expire. This has led to a substantial amount of patent litigation against Indian companies, as the difference in market price between brand-name drugs and their generic counterparts can be enormous.

In addition to Indian companies being subject to litigation in the United States, Indian courts are also actively engaged in the ongoing dispute over intellectual property rights. Those courts, as well as the Indian government, have in several notable instances found in favor of Indian generic-drug manufacturers and against intellectual property holders in the United States. For example, in 2012, a decision by India’s Controller General of Patents, Designs and Trademarks granted a “compulsory license” of the patented cancer drug Nexavar.

According to this decision, Bayer must license Nexavar to Natco Pharma, an Indian company, in exchange for a 6% royalty on Natco’s net sales. The generic drug will be sold in India for $176 per month instead of the $5,600 per month that Bayer had been charging in that market.

While a provision exists within the World Trade Organization‘s Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) Agreement that allows for compulsory licensing of pharmaceuticals, it has been used only infrequently, usually for drugs that treat AIDS. This was the first time such compulsory licensing was granted in India. India is only the second country, after Thailand, to grant a compulsory license to a cancer drug.

February 12, 2014

Sprint Weighs in with Civil Suit Against Defendants in Criminal Phone-Trafficking Scheme

By Overhauser Law Offices, LLC

Indianapolis, Indiana – In a 42-page complaint for damages and injunctive relief, trademark attorneys for Sprint Solutions, Inc. of Reston, Virginia; Sprint Communications Company L.P. and Boost Worldwide, Inc., the latter two of Overland Park, Kansas (collectively, “Sprint”), sued in the Southern District of Indiana alleging that Reginald Aldridge and Arrice Aldridge, both of Park Forest, Illinois, and Damion Transou of Humboldt, Tennessee infringed certain Sprint trademarks. These trademarks include the following Sprint marks: Registration Nos. 1,104,943, 1,573,863, 1,712,259, 1,839,302, 2,833,134, 2,836,616, and 3,046,207. They have been registered with the U.S. Trademark Office.

Sprint sells wireless handsets (“Phones”) under the brands Sprint, Boost Mobile, Virgin Mobile, payLo and Assurance Wireless for use on Sprint’s wireless network at prices significantly below the wholesale prices of the Phones so that they will be more widely accessible to consumers. Sprint states that it subsidizes the cost of the new Phones for the benefit of its “legitimate” customers. Sprint asserts that it spent more than $6.6 billion on handset subsidies in 2012.

Defendants, along with their alleged co-conspirators are accused of perpetrating an unlawful scheme of bulk handset theft and trafficking to profit from the illegal acquisition and resale of new Phones for their own profit and to the detriment of Sprint. As part of this purportedly fraudulent scheme, Sprint Phones are purchased and resold multiple times. During that process, the Phones are “unlocked” so that they may be used with any service provider, including non-Sprint providers. Sprint contends that, ultimately, these Phones end up in the hands of someone other than the Sprint customer whom Sprint intended to benefit. Sprint contends that the Phones often are sold overseas, where it does not provide service. As a result, Sprint states, Defendants are profiting from this scheme by appropriating the subsidies that Sprint provides to its customers.

Defendants are also accused of unlawfully accessing Sprint’s protected computer systems and wireless network, trafficking in Sprint’s protected and confidential computer passwords, and/or stealing legitimate customer upgrades. It is asserted that Defendants fraudulently placed at least 65 orders on more than 17 corporate accounts to which they had no legal right of access for the purpose of ordering more than 288 items valued at over $100,000.

Finally, Sprint contends that Defendants’ behavior violates the Terms and Conditions to which the sales of Phones are subject as well as willfully infringes Sprint’s trademark rights.

Defendants Arrice Aldridge and Damion Transou were indicted, in part for the activities described in the complaint.

In the complaint, filed by an Indiana trademark lawyer, in conjunction with trademark attorneys from Florida and Georgia, the following counts are asserted:

• Count I: Unfair Competition
• Count II: Tortious Interference with Business Relationships and Prospective Advantage
• Count III: Civil Conspiracy
• Count IV: Unjust Enrichment
• Count V: Conspiracy to Induce Breach of Contract
• Count VI: Common Law Fraud
• Count VII: Fraudulent Misrepresentation
• Count VIII: Trafficking in Computer Passwords – 18 U.S.C. §1030(a)(6)
• Count IX: Unauthorized Access – 18 U.S.C. §1030(a)(5)(C)
• Count X: Unauthorized Access with Intent to Defraud – 18 U.S.C. §1030(a)(4)
• Count XI: Federal Trademark Infringement – 15 U.S.C. §1114
• Count XII: Federal Common Law Trademark Infringement and False Advertising – 15 U.S.C. §1125(a)(1)(A)
• Count XIII: Contributory Trademark Infringement
• Count XIV: Conversion

Plaintiffs ask the court for damages, including exemplary damages; attorneys’ fees and costs; a permanent injunction prohibiting the practices described in the complaint; and the delivery to Plaintiffs of the Defendants’ inventory of accused Phones.

Practice Tip: Cases of cellular phone trafficking such as these, and there are more than a few of them, are an unusual combination of contract law, trademark law and criminal law. In at least one case similar to this one, 16 defendants were also convicted of terrorism charges when it was found that the proceeds from their phone trafficking and other illegal conduct was being funneled to the terrorist organization Hezbollah.

March 27, 2012

Digonex Technologies Sue QCUE Inc. for Patent Infringement of Ticket Pricing Software

By Overhauser Law Offices, LLC

Indianapolis, IN – Patent attorneys for Digonex Technologies, Inc. of Indianapolis, Indiana has filed a patent infringement suit in the Southern District of Indiana alleging that Qcue Inc., of Austin, Texas infringed patent numbers of the 8,095,424 and 8,112,303, which have been issued by the US Patent Office.

The plaintiff claims that the defendants sell dynamic pricing software products aimed at pricing tickets for events by a variety of names “Dynamic Pricing Dashboard,” “the Qcue Product,” and “software-based dynamic pricing solution” that infringe the patents held by Digonex. The technology is apparently marketed to sports teams and event promoters. The complaint alleges that Qcue has sold infringing products to Major League Baseball, Major League Soccer, National Basketball Association, National Hockey League and NASCAR. The complaint makes two claims of patent infringement and seeks a declaration of infringement, an injunction, damages, attorney fees and costs. The complaint also alleges that Qcue has the specific intent to induce others to infringe Digonex’s patents.

Practice Tip: The complaint alleges that Qcue has referenced the two Digonex patents in a Qcue patent application pending before the US Patent Office. This, in part, is Digonex’s “evidence” of willful infringement. Also, Patent Office’s records reveal that in prosecuting the 8,095,424 patent it submitted an Information Disclsosure Statement on September 30, 2011, after the claims had been allowed. However, the Patent Office refused to consider the IDS becuase it did not comply with Patent Office regulations. Therefore, there may be some question regarding the validity of this patent.

March 8, 2012

Fostech Outdoors, LLC Sues Slide Fire Solutions, Inc. for Patent Infringement of Semi-Automatic Firearm Device

By Overhauser Law Offices, LLC

Indianapolis, IN- Patent attorneys for Fostech Outdoors, LLC of Paris Crossing, Indiana filed a patent infringement suit in the Southern District of Indiana alleging Slide Fire Solutions, Inc. of Moran, Texas infringed patent no. 6101918, METHOD AND APPARATUS FOR ACCELERATING THE CYCLIC FIRING RATE OF A SEMI-AUTOMATIC FIREARM, which has been issued by the US Patent Office.

The patented technology is described as “bump fire stocks” which are a device that, when attached to certain firearms, allows the firearm to rapidly fire multiple shots. The complaint alleges that Slide makes, imports, and/or sells a product called “SSAR-15 stock” that infringes the ‘918 patent “when used in conjunction with certain firearms assemblies.” The complaint alleges that Slide actively induces other to infringe the Fostech’s patent and that Slide should be liable for contributory infringement because it knows there are no non-infringing uses for its product. The complaint makes one claim of patent infringement and seeks an injunction, damages, costs and attorney fees.

Practice Tip: The plaintiff here has made a claim of contributory patent infringement, which governed by 35 U.S.C. § 271(b) and is defined as selling or importing a device “for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use”

Personal jurisdiction may be an issue in this case. The plaintiff alleges Slide regularly conducts business in Indiana and the events giving rise to the suit occurred in Indiana. However, none of the specific acts of infringement seem to have occurred in Indiana.
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May 31, 2011

U.S. Supreme Court Holds “Willful Blindness” Suffices for Induced Infringement Knowledge Requirement

By Overhauser Law Offices, LLC

Washington, D.C. – While unanimously agreeing that induced patent infringement liability requires knowledge that the induced acts will infringe one or more patents, the United States Supreme Court, in an 8-1 decision in the Global-Tech Appliances, Inc., v. SEB S.A. case, held that the knowledge requirement is met by “willful blindness.”

SEB S.A. is a French company specializing in home-cooking appliances. The inventor of a home-use deep fryer with external surfaces that remain cool during the frying process, SEB holds Patent No. 4,995,312, as issued by the U.S. Patent Office, for a Cooking Appliance with Electric Heating. Global-Tech Appliances, Inc. (now known as Global-Tech Advanced Innovations Inc.) is a British Virgin Islands corporation. Global-Tech subsidiary Pentalpha Enterprises, Ltd. supplied Sunbeam Products, Inc. (a U. S. competitor of SEB) with certain deep fryers having all but the cosmetic features of the patented SEB fryer. Shortly after agreeing to supply Sunbeam, Pentalpha retained an attorney to conduct a right-to-use analysis, but did not inform him that their product was based on the SEB product, and the attorney did not locate the ‘312 patent during prior art searching.

Previously in this case, a jury found that Pentalpha directly infringed the ‘312 patent and willfully induced others to infringe the patent. On an appellate challenge to the induced infringement judgment, the U.S. Court of Appeals for the Federal Circuit held that “deliberate indifference” of known risks is a form of actual knowledge and the evidence supported the conclusion that Pentalpha deliberately disregarded a known risk that SEB held a patent covering its deep fryer.
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