Indiana Intellectual Property Law News

February 13, 2014

Alcon Sues Cipla for Patent Infringement of Pataday™

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.

February 10, 2014

Swag Merchandising and Musical Group Devo Sue for Trademark Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana trademark attorney for Swag Merchandising, Inc. and Devo Inc., both of California, sued in Hamilton Superior Court alleging that Your Fantasy Warehouse, Inc. d/b/a T.V. Store Online and Fred Hajjar, both of Commerce Township, Michigan, infringed Devo’s Trademarks, Registration Nos. 3161662 and 3167516, which have been registered by the U.S. Trademark Office. The case has been removed from Indiana state court to the Southern District of Indiana.

Swag claims that it owns the exclusive right to license the various trademarks, copyrights and individual and collective rights of publicity of the musical group Devo. The group is best known for the song “Whip It,” which hit number 14 on the Billboard chart in 1980. Swag indicates that it licenses the Devo intellectual property to third parties around the globe.

T.V. Store Online is in the business of manufacturing, marketing and distributing apparel and memorabilia featuring classic and current television programming, movies and/or music. T.V. Store Online and Hajjar have been accused of manufacturing, producing, marketing, advertising and/or retailing a product known as “Energy Dome Hats.” Plaintiffs assert that these Energy Dome Hats are commonly associated with Devo but have not been licensed by Plaintiffs to Defendants. Plaintiffs further claim that consumers coming into contact with Defendants’ product would “immediately recognize the same as being associated with, sponsored by and/or endorsed by” the ’80s group.

In the complaint, filed by an Indiana trademark attorney, Plaintiffs assert the following:

• I: Violation of 15 U.S.C. §1125(a) of the Lanham Act
• II: Trademark Infringement – 15 U.S.C. §1114 and Common Law
• III: Counterfeiting
• IV: Dilution – 15 U.S.C. §1125(c) and New York General Business Law §360-1
• V: Common Law Unfair Competition
• VI: Statutory Right of Publicity [NB: under Indiana law]
• VII: Right of Publicity Infringement Under California Civil Code §3344
• VIII: Common Law Right of Publicity
• IX: Conversion [NB: under Indiana law]
• X: Deception [NB: under Indiana law]
• XI: Indiana Crime Victims Act

Plaintiffs ask for an injunction; the surrender of infringing materials; damages, including treble damages; costs and fees. An Indiana intellectual property lawyer for Defendants removed the case to federal court, although he noted that the removal was not a concession that the Southern District of Indiana was the proper venue for the California Plaintiffs or the Michigan Defendants.

Practice Tip:

This is at least the third case filed by Theodore Minch about which we have blogged. In at least two prior cases, LeeWay Media Group, LLC v. Laurence Joachim et al. and Leon Isaac Kennedy v. GoDaddy et al., Mr. Minch has filed in an Indiana court despite none of the parties having any connection to Indiana.

It can be surmised that perhaps the choice of Indiana as a forum might have been driven by an attempt to increase damages. I.C. §§ 35-43-4-3 and 35-43-5-3(a)(6) are criminal statutes, claimed in the complaint in conjunction with an attempt to parlay the accusation into an award for damages, costs and attorneys’ fees. The Indiana Court of Appeals has discussed “theft” and “conversion” as they pertain to takings of intellectual property in several recent cases (see, for example, here and here) and has made it clear that criminal statutes often apply differently to an unlawful taking of intellectual property.

February 7, 2014

Licensor of “Tiki Tan” Mark Alleges Infringing Use by Solarium and Solarium Bittersweet

By Overhauser Law Offices, LLC

South Bend, Indiana – An Indiana trademark attorney for Al Reasonover of Elkhart, Indiana sued in the Northern District of Indiana alleging that Solarium LLC of South Bend, Indiana (“Solarium”) and Solarium Bittersweet LLC of Elkhart, Indiana (“Solarium Bittersweet”) committed trademark infringement of “Tiki Tan”, Trademark Reg. No. 2602388, which has been registered by the U.S. Patent and Trademark Office.

In this complaint for trademark infringement and unfair competition, Plaintiff Reasonover states that he operates tanning salons under the Tiki Tan Mark and that he also develops tanning salons operated by others to whom he licenses the use of the Mark for a fee. Among these licensees, claims Plaintiff, is Solarium.

Reasonover asserts that, instead of displaying the Tiki Tan Mark as licensed, Solarium displays a service mark at its website reading “Tiki Tan by Solarium”. Reasonover also claims that, while he and Solarium entered into a licensing agreement that permitted Solarium to use the Mark only within a five mile territory around 4542 Elkhart Road, Elkhart, Indiana, Defendants Solarium and/or Solarium Bittersweet are operating additional tanning salons under the name “Tiki Tan” at 306 N. Bittersweet Road, Mishawaka, Indiana; 1290 E. Ireland Road, South Bend, Indiana and 215 E. University Drive, Granger, Indiana.

Plaintiff indicates that the licensing agreement neither permits Solarium to alter the Mark nor to use the Mark outside of the five mile territory around 4542 Elkhart Road, Elkhart, Indiana. He also claims that Solarium’s modification of the Mark to include its own name in connection with the promotion, sale and distribution of tanning salon services infringes on Plaintiff’s rights in his federally registered trademark, in violation of 15 U.S.C. Sec. 1114. Reasonover further alleges that Defendants’ actions are intended to cause, have caused, and are likely to continue to cause, confusion, mistake, deception among consumers, the public, and the industry as to whether Defendants’ services originate from, are affiliated with, sponsored by or endorsed by Plaintiff.

Finally, Defendants are accused of infringing the Mark intentionally, deliberately and willfully. The complaint, filed by an Indiana trademark lawyer, lists the following counts:

• Count I – Trademark Infringement – Injunctive Relief
• Count II – Trademark Infringement – Damages
• Count III – Common Law Trademark Infringement
• Count IV – Common Law Unfair Competition

Reasonover asks the court for:

• a finding that Defendants have violated 15 U.S.C. Sec. 1114; that Defendants have engaged in trademark infringement and unfair competition under the common law of Indiana; and that such conduct has damaged Plaintiff monetarily and in ways not adequately remedied by monetary damages alone;
• an injunction, preliminarily and permanently restraining Defendants from altering the registered Mark, “Tiki Tan,” in any way including but not limited to including the words “by Solarium” with the Mark; operating tanning salons at 306 N. Bittersweet Road, Mishawaka, Indiana; 1290 E. Ireland Road, South Bend, Indiana; or 215 E. University Drive, Granger, Indiana under the name “Tiki Tan”; engaging in any other activity constituting unfair competition with Plaintiff; and engaging in any other activity constituting trademark infringement or which deceives consumers or the public about the origin of services associated with Plaintiff;
• an order for corrective advertising;
• statutory damages or, alternatively, the disgorgement of all profits realized as a result of Defendants’ wrongful acts and also awarding Plaintiff its actual damages;
• a trebling of damages under 15 U.S.C. Sec. 1117;
• Plaintiff’s costs, attorney fees, investigatory fees, and expenses under 15 U.S.C. Sec. 1117; and
• pre-judgment interest on any monetary award.

Practice Tip: A trademark license may be granted by a licensor to a licensee to permit the licensee to use a trademark in a way that would otherwise infringe upon the licensor’s intellectual property rights. A license to use a trademark typically includes various restrictions. Those restrictions may include, among other things, limits on territory, term and manner of use.

February 6, 2014

173 Trademark Registrations Issued to Indiana Companies in January 2014

By Overhauser Law Offices, LLC

The U.S. Trademark Office issued the following 173 trademark registrations

to Indiana persons and businesses in Indiana in January 2014 based on

applications filed by Indiana trademark attorneys:

Reg. Number	Word Mark	Click to View
4475395	HEALTHY LIFE	View
4475322	BANKERS UNIVERSITY	View
4468104	POWER DRIVE	View
4472854	REAL HEALTH PROFILE	View
4472841	4PETS HEALTH	View
4466639	SONIC	View
4466631	HEALTHY LIFE BREAD	View
4474927	MEDI-SPAN	View
4475100	ONEC1TY	View
4475098	ARRAYSTAT	View
4474971	THE WAY TO GO!	View
4474879	TECHNOLOGY BREAKS. WE FIX IT.	View
4474858	NIAAA	View
4474695	SEAL THE DEAL	View
4474693	MANZANITA AUDIO SOLUTIONS, INC.	View
4474651	WICKED SUGA	View
4474568	GREEDY GLUTTON SOFTWARE	View
4474390	SPREE CONNECT	View

February 5, 2014

Patent Office Issues 111 Patents To Indiana Citizens in January 2014

By Overhauser Law Offices, LLC

The U.S. Patent Office issued the following 111 patent registrations to persons and businesses in Indiana in January 2014, based on applications filed by Indiana patent attorneys:

Pat No.		Title
D698,459		Container
D698,294		Motorcycle license plate
D698,220		Tubular lever
D698,175		Side chair
8,639,547		Method for statistical comparison of occupations by skill sets and other relevant attributes
8,639,403		Modularized hybrid power train control
8,637,740		Omega-9 quality Brassica juncea
8,637,684		Tautomycetin and tautomycetin analog biosynthesis
8,637,533		Inhibitors of human phosphatidylinositol 3-kinase delta
8,637,265		Cathepsin E as a marker of colon cancer
8,637,183		Expanders for lead-acid batteries

February 3, 2014

Indiana Court of Appeals Rules in Favor of Resident’s Daughter in Nursing Facility Dispute

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Alexis Hutchison (“Hutchison”) (pictured right) appealed a small claims court (“trial court”) judgment in favor of Trilogy Health Services, LLC, d/b/a Springhurst Health Campus (“Springhurst”), on Springhurst’s claim against Hutchison and her now-deceased mother, Martha Farber (“Farber”), for payment of services provided to Farber while she was a resident at Springhurst. The Indiana Court of Appeals reversed.

For a number of years, Farber was ill with cancer, requiring various trips to, and stays at, hospitals. After one of her hospital visits, and finding that she was in need of constant care, she became a resident at Springhurst, a skilled nursing facility.

When Farber was admitted to Springhurst, Hutchison signed Springhurst’s Move-In Agreement (“Agreement”) as a “Responsible Party/Agent.” This Agreement stated that, to the extent that Hutchison was authorized to “control[] or access[]” her mother’s assets, she agreed to direct her mother’s income and resources towards any financial obligations which Farber had to Springhurst. Springhurst later contended that Farber and Hutchison, as Farber’s Responsible Party/Agent, owed $1,716.90 for services rendered to Farber. Farber disputed all but a small portion of the charges and Springhurst filed suit against Farber and Hutchinson.

A trial was held. During the trial, Hutchison testified that she was not Farber’s power of attorney and that she had “no authority to use [her] mother’s income for anything.” Hutchison indicated that the only thing she could have done was point out to her mother that a bill was owed. When Hutchison cross examined Dionne Fields (“Fields”), Springhurst’s business office manager, Fields admitted that Springhurst had no documents indicating that Hutchison had any authority over her mother’s financial affairs.

Hutchison also called as a witness her husband, David Hutchison (“David”), who was present when Hutchison signed the Agreement. David testified that Hutchison had asked if signing the Agreement would make her personally financially responsible for her mother’s stay at the nursing facility. The Springhurst representative, he said, had answered with “an emphatic no.”

The trial court found the evidence – including the language of the contract, the assurances of Springhurst that Hutchison would not be held personally liable and the uncontroverted testimony that Hutchison had no power of attorney over her mother – to be unpersuasive. It rendered a general judgment in favor of Springhurst stating that “the court found the plaintiff proved the defendant liable pursuant to contract and Indiana case law for the sum of $2,610.87” but declined to specify further facts or law in support of the judgment.

Hutchison, again acting as her own attorney, appealed this ruling and the Indiana Court of Appeals held in her favor. The appellate court first cited federal limitations that have been enacted regarding the notion of imposing upon one family member financial responsibility for another family member’s care. For example, under 42 U.S.C. §§1396r(c)(5)(A)(ii) and 1395i-3(c)(5)(A)(ii), a nursing home certified as eligible for Medicare or Medicaid reimbursement “must not require a third party guarantee of payment to the facility as a condition of admission . . . to, or continued stay in, the facility.” The Indiana Administrative Code provides a similar restriction in 410 Ind. Admin. Code 16.2-3.1-16.5.

The appellate court then acknowledged that resident rights activists echoed Hutchison’s argument that an agreement to assume the status of a “responsible party,” and the personal financial liability which might accompany that, might be inconsistent with federal law and inherently illegal. The court, however, declined to decide this issue, which was apparently one of first impression in Indiana courts.

The court also declined to address the testimony that Springhurst had assured Hutchison that she would not incur personal financial liability by signing the Agreement.

Instead, the court found the provisions of the Agreement itself, in conjunction with undisputed evidence, to be dispositive. The Agreement stated that Farber “may designate” a person to act on her behalf as a Responsible Party/Agent and that, if such a designation was to be made, “the Resident shall provide the Facility with a copy of a written agreement that authorizes such individual to manage, use, control or access the Resident’s income, financial account(s) or other resources” (emphasis added by the court). It was undisputed that neither Farber nor anyone else had provided Springhurst with any such document; indeed, the unrefuted evidence had been that Springhurst did not possess any such document.

The court noted that Hutchison’s responsibilities, then, were at most “to pay the Facility the full amount of the Resident’s income and resources that the Responsible Party/Agent controls or accesses” (emphasis added by the court). As it was undisputed that Hutchison possessed neither control nor access to Farber’s income and resources, the appellate court concluded that the trial court had clearly erred. It reversed and remanded the matter with instructions to the trial court to enter judgment in favor of Hutchison.

Practice Tip #1: Cases tried before the bench in small claims court are reviewed for clear error and appellate courts are particularly deferential to the trial court in small claims actions. The appellate court, when reviewing the case, will not reweigh the evidence or determine the credibility of witnesses but will consider only the evidence that supports the judgment and the reasonable inferences to be drawn therefrom. Moreover, when a trial court’s judgment is rendered as a “general judgment,” as was the case here, that judgment will be affirmed upon any legal theory consistent with the evidence. Thus, it is very important to put on one’s best possible case to the trial court, as substantial deference is given to the trial court’s findings.

Practice Tip #2: While this case was not an Indiana intellectual property case, we include it in the Indiana Intellectual Property Law Blog to congratulate Alexis Hutchison, a valued and talented member of the Overhauser Law Offices team, on her well-deserved success in litigating this matter.

January 30, 2014

Lilly Sues Glenmark Generics for Over Proposed Manufacture and Sale of Generic Version of ALIMTA®

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed a lawsuit in the Southern District of Indiana alleging that Glenmark Generics, Inc., USA of Mahwah, New Jersey (“Glenmark”) infringed Antifolate Combination Therapies, Patent No. 7,772,209, which has been issued by the U.S. Patent Office.

Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products worldwide. Glenmark is in the business of distributing, selling, and offering to sell drug products throughout the United States.

ALIMTA®, which is allegedly 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 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 Glenmark 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. Glenmark filed as a part of ANDA No. 205526 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 Glenmark’s ANDA products.

In its complaint, filed by an Indiana patent lawyer, Lilly states that Glenmark intends to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Glenmark’s ANDA Products and the proposed labeling therefor immediately and imminently upon approval of ANDA No. 205526, i.e., prior to the expiration of the ‘209 patent. Lilly asserts that Glenmark’s 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 asks for:

• A judgment that Glenmark has infringed the ‘209 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of the ‘209 patent;
• A judgment ordering that the effective date of any FDA approval for Glenmark to make, use, offer for sale, sell, market, distribute, or import Glenmark’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;
• A preliminary and permanent injunction enjoining Glenmark, and all persons acting in concert with Glenmark, from making, using, selling, offering for sale, marketing, distributing, or importing Glenmark’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;
• A judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing of Glenmark’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 others of the ‘209 patent;
• A declaration that this is an exceptional case and an award of attorneys’ fees pursuant to 35 U.S.C. § 285; and
• An award of Lilly’s costs and expenses in this action.

Practice Tip: 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 issues with respect to the period of exclusivity. For a look at some of these issues, see here.

January 29, 2014

Sixteen Doe Defendants Alleged to Have Infringed “Charlie Countryman”

By Overhauser Law Offices, LLC

South Bend, Indiana – Michigan copyright attorney Paul Nicoletti, on behalf of Countryman Nevada, LLC (“Countryman”), sued in the Northern District of Indiana alleging that 16 unidentified John Does infringed the copyright of the motion picture “Charlie Countryman,” which has been registered by the U.S. Copyright Office. The movie stars Shia LaBeouf, Evan Rachel Wood and Mads Mikkelsen. It was directed by Fredrick Bond.

Countryman alleges that the infringing transfer and copying of this movie, which was released on DVD in January 2014, was accomplished by Defendants using BitTorrent, a peer-to-peer file-sharing protocol. Plaintiff states that the BitTorrent protocol makes even small computers with low bandwidth capable of participating in large data transfers for copying large files such as movies.

In this Indiana lawsuit, the Doe Defendants are accused of deliberately participating in a peer-to-peer “swarm” and illegally reproducing and/or distributing portions of the movie “Countryman” in digital form with other Defendants. Countryman indicates in its complaint that it used geolocation technology to determine that the Doe Defendants were located in Indiana.

The complaint lists a single count: copyright infringement. The copyright lawyer for Plaintiff Countryman asks the court for permanent injunctions prohibiting infringement of Plaintiff’s movie by all Doe Defendants; the destruction of all copies of infringing works in any Defendant’s control; judgment that Defendants have willfully infringed Plaintiff’s copyrighted work; judgment that Defendants have otherwise injured the business reputation and business of Plaintiffs; actual damages or statutory damages; an order impounding all infringing copies of Plaintiff’s movie; attorneys’ fees and litigation expenses.

Practice Tip: This is at least the second movie starring Shia LaBeouf which is the subject of copyright litigation in Indiana. In October 2013, a similar Indiana lawsuit regarding “The Company You Keep,” also starring LaBeouf, was filed in the Southern District of Indiana. That lawsuit was also filed by copyright lawyer Nicoletti. In addition to these lawsuits filed by the owners of the copyrighted movies, LaBeouf seems to have intellectual property concerns of his own, most recently having been served with another cease and desist letter for posts to his Twitter feed.

January 27, 2014

Eli Lilly Sues Par Pharmaceutical Asserting Patent Infringement of Effient®

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana patent attorney sued in the Southern District of Indiana on behalf of Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd. of Tokyo, Japan (“Daiichi Sankyo”); Daiichi Sankyo, Inc. of Parsippany, New Jersey (“DSI”); and Ube Industries, Ltd. of Yamaguchi, Japan alleging that Par Pharmaceutical Companies, Inc. (“Par Pharmaceutical Companies”) and Par Pharmaceutical, Inc. (“Par”), both of Woodcliff Lake, New Jersey, (collectively “Par Pharmaceutical”) infringed Medicinal Compositions Containing Aspirin, Patent No. 8,404,703 (the “‘703 patent”) and Method of Treatment and Coadministration of Aspirin and Prasugrel, Patent No. 8,569,325 (the “‘325 patent”), which have been issued by the U.S. Patent Office.

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

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

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

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

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

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

Plaintiffs ask the court for judgment:

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