Articles Posted in Declaratory Judgments

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Indianapolis, Indiana – In conjunction with co-counsel from Washington, D.C., 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 atrial-fibrillation-s3-photo-of-heart-rhythm.jpgYamaguchi, Japan sued in the Southern District of Indiana alleging that First Time US Generics LLC of Broomall, Pennsylvania infringed Effient® products, Patent Nos. 8,404,703 and 8,569,325 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 First Time US Generics LLC (“FTUG”) 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. Plaintiffs assert that Lilly 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.

FTUG has submitted an Abbreviated New Drug Application (the “FTUG 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 “FTUG Products”) in the United States.

Plaintiffs assert that FTUG will knowingly include with the FTUG Products instructions for use that substantially copy the instructions for Effient® products, including instructions for administering the FTUG Products with aspirin as claimed in the ‘703 and ‘325 patents. Moreover, Plaintiffs contend that FTUG knows that the instructions that will accompany the FTUG Products will induce and/or contribute to others using the FTUG Products in the manner set forth in the instructions. Plaintiffs also contend that FTUG specifically intends that health care providers, and/or patients will use the FTUG Products in accordance with the instructions provided by FTUG to directly infringe one or more claims of the ‘703 and ‘325 patents. FTUG 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 FTUG has infringed or will infringe, after the FTUG ANDA is approved, one or more claims of the ‘703 patent;
B. That FTUG has infringed or will infringe, after the FTUG ANDA is approved, one or more claims of the ‘325 patent;
C. That, pursuant to 35 U.S.C. § 271(e)(4)(B), FTUG and its agents be permanently enjoined from making, using, selling or offering to sell either or both of the FTUG Products within the United States, or importing either or both of the FTUG 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 FTUG 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. If FTUG commercially makes, uses, sells or offers to sell either or both of the FTUG Products within the United States, or imports either or both of the FTUG 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;
F. That this case be deemed exceptional under 35 U.S.C. § 285
G. Declaring that the ‘703 patent remains valid and enforceable;
H. Declaring that the ‘325 patent remains valid and enforceable; and
I. That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

Practice Tip:

In March 2014, Lilly et al. filed a 101-page complaint making similar accusations against more than thirty defendants: 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; 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.

FTUG is the latest of addition to Lilly’s list of defendants in the Effient litigation. In contrast to the March complaint against 30-plus mostly unrelated defendants, FTUG, as well as the other subsequent unrelated defendants, have been added via separate complaints alleging patent infringement.

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Indianapolis, Indiana – An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd of Tokyo, Japan; Daiichi Sankyo, Inc. of Parsippany, New Jersey; and Ube Industries, Ltd. of Yamaguchi, Japan sued in the Southern District of Indiana alleging that HEC Pharm Co., Ltd. of China and HEC Pharm USA Inc. of Princeton, New Jersey (collectively, “HEC Pharm”) infringed Lilly’s patented Effient® product, Patent No. 8,404,703, which has been issued by the United States Patent Office.

This lawsuit adds another defendant, HEC Pharm, to Lilly’s Indiana patent litigation regarding Effient. In these Effient patent-defense lawsuits, Lilly et al. allege infringement of certain patents related to the pharmaceutical Effient. At issue in the litigation against HEC Pharm is only one of the Effient-related patents, 8,404,703 “Medicinal Compositions Containing Aspirin,” (the “‘703 patent”).

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

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

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

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

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

The complaint, filed by an Indiana patent lawyer, lists two counts:

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

Plaintiffs ask the court for judgment:

• That HEC Pharm has infringed the ‘703 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of one or more claims of the ‘703 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(B), HEC Pharm be permanently enjoined from making, using, selling or offering to sell any of its accused products within the United States, or, where applicable, importing accused products into the United States prior to the expiration of the ‘703 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the HEC Pharm ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the later of the expiration dates of the ‘703 patent, including any extensions;
• If HEC Pharm commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of either of the ‘703 patent, including any extensions, that Plaintiffs be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
• That the case be deemed exceptional under 35 U.S.C. § 285;
• That the ‘703 patent remains valid and enforceable;
• That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

Practice Tip #1: The Effient litigation also involves Patent No. 5,288,726, “Tetrahydrothienopyridine Derivatives, Furo and Pyrrolo Analogs Thereof and Their Preparation and Uses for Inhibiting Blood Platelet Aggregation,” and Patent No. 8,569,325, “Method of Treatment with Coadministration of Aspirin and Prasugrel.”

Practice Tip #2: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing. Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process.

The statute that created the abbreviated process, however, had also created some interesting jurisdictional issues with respect to declaratory judgments. For an interesting look at some of the issues, see here
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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, NewEffient-pill.jpg Jersey; and Ube Industries, Ltd. of Yamaguchi, Japan sued in the Southern District of Indiana alleging that Panacea Biotec, Ltd. of New Delhi, India (“Panacea”) infringed Effient® products, Patent Nos. 8,404,703 and 8,569,325, which have been issued by the United States Patent Office.

This lawsuit adds another defendant, Panacea, to Lilly’s Indiana patent litigation. In these “Effient” patent-defense lawsuits, Lilly et al. assert allegations of infringement of Effient. At issue in the Panacea 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 Panacea 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.

Panacea 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 Panacea’s products with aspirin as claimed in the ‘703 and ‘325 patents.

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

The complaint, filed by an Indiana patent lawyer, 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 Panacea 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 Panacea 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), Panacea 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 Panacea 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 Panacea 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.

Practice Tip: In March 2014, Lilly et al. filed a 101-page complaint making similar accusations against more than thirty defendants: 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; 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.

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Fort Waynpackaging.pnge, Indiana – Magistrate Judge Roger Cosbey of the Northern District of Indiana denied the motion for transfer filed by patent attorneys for Anchor Packaging, Inc. of St. Louis, Missouri (“Anchor”). Anchor sought a transfer of the declaratory judgment action filed by Mullinix Packages, Inc. of Fort Wayne, Indiana (“Mullinix”) to the Eastern District of Missouri where Anchor has a related, but later-filed infringement suit pending against Mullinix. Both patent infringement lawsuits pertain to the alleged infringement by Mullinix of Patent Nos. D679,587; D675,919 and D570,681, which were issued by the U.S. Patent Office.

Anchor and Mullinix are competitors in the commercial packaging industry. Prior to 2010, Anchor had been the primary supplier of mashed potato containers to Bob Evans Farms, Inc., a position now assumed by Mullinix. According to Mullinix, mashed potato container sales peak dramatically during the fourth quarter of the year and Mullinix’s ability to meet Bob Evans’s demand for containers during this period is critical to maintaining a successful relationship. It was around this time that patent lawyers for Anchor demanded that Mullinix cease and desist selling a tray that Anchor asserted was of a substantially similar design as trays claimed in three of Anchor’s patents.

While the cease-and-desist letter sent by Anchor’s patent counsel indicated that Anchor’s “interest is a resolution of this matter and not litigation,” Mullinix filed a complaint for declaratory judgment in the Northern District of Indiana shortly thereafter. Several weeks later, Anchor responded by filing a complaint for patent infringement in the Eastern District of Missouri.

In this opinion, Magistrate Judge Roger Cosbey, writing for the Northern District of Indiana, addresses Anchor’s motion to transfer Mullinix’s Indiana complaint for declaratory judgment for patent non-infringement to Missouri.

Anchor argued that the case should be transferred because (1) Mullinix filed its declaratory judgment action in anticipation of Anchor’s infringement suit, (2) a critical non-party witness is outside this Court’s subpoena power, but within the range of the Eastern District of Missouri, and (3) the Eastern District of Missouri is a more convenient forum.

The court evaluated Anchor’s request for transfer under § 1404(a) under precedent set by the Seventh Circuit. Under § 1404(a), a court may transfer a case if the moving party shows that: (1) venue was proper in the transferor district, (2) venue and jurisdiction would be proper in the transferee district, and (3) the transfer will serve in the convenience of the parties and the witnesses as well as the interests of justice.

As neither party disputed that both the Indiana and Missouri courts have jurisdiction and are proper venues, the court focused its analysis on the third factor. As the party requesting transfer, Anchor has the burden to show that the Eastern District of Missouri would be “clearly more convenient” than the Northern District of Indiana. In evaluating convenience, the factors to consider are: “(1) the plaintiff’s choice of forum, (2) the situs of the material events, (3) the relative ease of access to sources of proof, (4) the convenience of the parties, and (5) the convenience of the witnesses.”

The first factor, the plaintiff’s choice of forum, was held to be neutral. In general, a plaintiff’s choice of forum is entitled to substantial deference, particularly where the chosen forum is the plaintiff’s home forum. However, the court found that this factor did not weigh in either direction. In this case, there are two plaintiffs in two different fora. As a result, one of them will necessarily be disturbed.

The evaluation of the situs of the material events weighed against transfer. In patent infringement actions “the situs of the injury is the location, or locations, at which the infringing activity directly impacts on the interests of the patentee.” Mullinix is headquartered in Fort Wayne, Indiana, which is in the Northern District of Indiana, and keeps its documents pertaining to the accused infringing products in Fort Wayne. Additionally, two of the individuals who worked on the accused infringing products work and reside within the district.

For similar reasons, the court held the third factor, relative ease of access to sources of proof, to weigh against transfer.

The court briefly addressed the fourth factor, the convenience of the parties, noting that there was no way to avoid inconveniencing either one party or the other. In such a circumstance, the court held that “when the inconvenience of the alternative venues is comparable there is no[] basis for a change of venue; the tie is awarded to the plaintiff[.]”

Finally, the court addressed the fifth factor, the convenience of non-party witnesses, noting that this element was “often considered the most important factor in the transfer analysis.” The court noted with some displeasure that the parties had perhaps been disingenuous in arguing this factor. After a discussion of the evidence that had been submitted, it concluded that the parties had failed to provide it with much enlightenment on the subject and, as a result, the court was largely left to speculate about the convenience of non-party witnesses. The court thus held that this analysis-of-transfer factor was neutral.

In sum, it was found that the convenience factors did not support transfer.

The court also evaluated the interests-of-justice inquiry. On the whole, these factors – the speed to trial, familiarity with the applicable law, desirability of resolving controversies and relation of each community to the controversy – also weighed against transfer.

Finally, the court addressed the first-filed analysis under Federal Circuit precedent, which governs declaratory judgment actions in patent cases. Given that no “sound reason” for transfer had been found in the earlier analysis, court dismissed the first-filed analysis as “ancillary” and largely non-dispositive.

Practice Tip #1: The first-to-file rule is a doctrine of federal comity that generally favors pursuing only the first-filed action when multiple lawsuits involving the same claims are filed in different jurisdictions. It was designed to avoid conflicting decisions and promote judicial efficiency. Finding an exception to the first-to-file rule requires a “sound reason that would make it unjust or inefficient to continue the first-filed action.”

Practice Tip #2: A court may also consider the extent to which a declaratory judgment action is anticipatory and motivated by forum shopping. However, the Federal Circuit has repeatedly held that a finding that a filing was anticipatory does not in itself constitute sufficient legal reason to transfer or dismiss the first-filed case.

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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 Effient-picture.jpgAggregation,” 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.

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Washington, D.C. – An issue in the patent infringement dispute between medical-device giant Medtronic, Inc. and Mirowski Family Ventures, LLC (“Mirowski”) was heard by the United USSCPicture.jpgStates Supreme Court. In question was the placement of the burden of proof in patent infringement litigation that seeks a declaratory judgment. The Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit, holding that the burden of proof of infringement rests with the patent holder even if the lawsuit is filed under the Declaratory Judgment Act.

After hearing arguments by patent attorneys for each side, the district court had held that Mirowski, the party asserting infringement, had the burden of proving patent infringement; it found that Mirowski had not met that burden.

The Federal Circuit reversed. It concluded that, when a patentee (Mirowski) is a declaratory judgment defendant and is also prevented from asserting an infringement counterclaim by the existence of a license between the parties – as Mirowski was – the party seeking the declaratory judgment (Medtronic) bears the burden of proving that it had not infringed the patent.

The Supreme Court granted certiorari. The question before the Court was “whether the burden of proof shifts when the patentee is a defendant in a declaratory judgment action, and the plaintiff (the potential infringer) seeks a judgment that he does not infringe the patent.”

Mirowski argued that it would be unfair to place a burden of proof on the party that was not seeking relief. The Intellectual Property Owners Association supported Mirowski’s position, contending that a failure to shift the burden of proof in such cases would lead to abuse of declaratory judgment actions, as the risks and burdens of patent infringement litigation would be placed entirely on the patent owner.

In contrast, Medtronic argued that placing the burden on a licensee would create an unacceptable choice between finality and fairness, as it would require the judicial system to permit a party to relitigate issues that had been previously decided under a different burden of proof.

The Supreme Court reversed the shifted burden of proof imposed by the Federal Circuit. The Court declared that it saw “no convincing reason why burden of proof law should favor the patentee” simply because it was filed under the Declaratory Judgment Act.

Practice Tip #1: It is settled law that, in patent infringement litigation, a patentee normally bears the burden of proof. Because 1) the operation of the Declaratory Judgment Act is only procedural and leaves substantive rights unchanged and 2) the burden of proof is a substantive aspect of a claim, this holding by the Supreme Court is not unanticipated.

Practice Tip #2: When drafting the terms of a license, patent owners should consider adding provisions to deter potential challenges by licensees.

Practice Tip #3: We have also blogged recently about another declaratory judgment case involving Mirowski, which is being heard in the Southern District of Indiana.

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Terre Haute, Indiana – Copyright attorneys for Union Hospital, Inc. of Terre Haute, Indiana filed an Indiana copyright lawsuit against Attachmate Corporation of Seattle, Washington in the Southern District of Indiana asking the court to declare that Union Hospital had not unionhospitalpicture.jpginfringed either of two Attachmate software works titled “EXTRA!” and “Reflection”, Copyright Registration Nos. TX0005717997 and TX0007351951, which were issued by the U.S. Copyright Office.

Union Hospital, a not-for-profit regional hospital, provides healthcare to residents of the Wabash Valley community, regardless of their ability to pay. Attachmate is one of the largest software companies in the world, with 40 offices doing business in 145 countries.

Union Hospital states that, since at least 1997, it has been licensed to use Attachmate software for which it paid tens of thousands of dollars. In 2013, Attachmate conducted an audit of Union Hospital’s use of Attachmate software products. According to the complaint, as a result of this audit, Attachmate determined that Union Hospital had used the software beyond the terms of the licenses and demanded that Union Hospital pay Attachmate over $2,000,000 in license fees, interest and other charges. Union Hospital indicates Attachmate subsequently threatened to initiate copyright infringement litigation against Union Hospital.

The claims of liability which Attachmate apparently made have been attacked by Union Hospital on several grounds. Union Hospital states that the claim of over-deployment of certain software was based not upon the actual usage of Attachmate’s product, but upon the potential total number of users who could have used Attachmate software on Union Hospital’s server regardless of whether the user ever accessed or used the product. Union Hospital further asserts “estoppel, waiver, laches, and/or acquiescence” in its defense.

This Indiana litigation, filed under the Declaratory Judgment Act, was filed by Indiana copyright lawyers for Union Hospital. The complaint lists three causes of action:

1. Declaratory Judgment on Copyright Infringement Claims
2. Declaratory Judgment on Copyright Infringement Claims for Unregistered Copyrights
3. Declaratory Judgment on Breach of Contract Claims

Union Hospital asks the court to:
a. Declare that one or more of Attachmate’s breach of contract claims are preempted by the Copyright Act;
b. Declare that Attachmate’s asserted license agreements are invalid and unenforceable;
c. Declare that Union Hospital is not liable to Attachmate for copyright infringement, as Union Hospital’s use of Attachmate’s software was licensed;
d. Declare that Attachmate’s copyright infringement and/or breach of contract claims are barred by estoppel, waiver, laches, and/or acquiescence;
e. Declare that Attachmate’s copyright infringement and/or breach of contract claims are barred by the applicable statute(s) of limitations;
f. Declare that, if Attachmate’s claims are allowed to proceed, any damages for Attachmate’s copyright and/or breach of contract claims be substantially reduced due to Attachmate’s failure to mitigate its damages;
g. Declare that Attachmate’s alleged copyrights were not timely registered and therefore Attachmate is barred from seeking statutory damages and attorneys’ fees for its copyright infringement claims;
h. Declare that Attachmate’s copyright infringement claims based on unregistered copyrights are barred; and
i. Alternatively, declare that Attachmate’s is only entitled to de minimis damages because Union Hospital’s uses did not exceed the total number of uses that it contracted for with Attachmate.

Practice Tip:

The use of the compound conjunction “and/or” in this complaint raises some interesting possibilities. As one basis for federal jurisdiction, Plaintiff alleges that “Attachmate’s representatives have expressly or impliedly threatened litigation for breach of contract and/or copyright infringement….” Such an assertion may not be sufficient to invoke federal-question jurisdiction, as it claims that the threat of litigation exists for one of three possible circumstances: breach of contract only, copyright infringement only, or both breach of contract and copyright infringement. Under the first scenario – breach of contract only – no federal jurisdiction would lie. This potential problem may be remedied by other allegations in the complaint, including a separate assertion of diversity jurisdiction.

The use of “and/or” is also found in the prayer for relief. There, Plaintiff asks for, inter alia, declarations “that Attachmate’s copyright infringement and/or breach of contract claims are barred by estoppel, waiver, laches, and/or acquiescence” and “that Attachmate’s copyright infringement and/or breach of contract claims are barred by the applicable statute(s) of limitations.” Again, this use of the compound conjunction leaves open the possibility that the court might interpret the prayer for relief as a request to bar the claims of breach of contract or copyright infringement, but not both.

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Indianapolis, Indiana – An Indiana trademark attorney for Chartreuse LLC of Indianapolis, candle-picture.jpgIndiana (“Chartreuse”) filed a lawsuit in the Southern District of Indiana seeking a declaration that the trademark Chartreuse, Trademark Registration No. 2,997,572, would not be infringed when used in association with handmade soy candles. The trademark, which has been issued by the U.S. Patent and Trademark Office, belongs to Chartreuse Fragrances LLC of Fort Lee, New Jersey (“Chartreuse Fragrances”).

Chartreuse states that it has been selling handmade soy candles bearing a “Chartreuse” trademark since January of 2013. Chartreuse Fragrances indicates, via its trademark application, that it has used the “Chartreuse” trademark in commerce since 2002. The trademark is registered to Chartreuse Fragrances for use on candles.

Chartreuse states in its complaint that, on January 7, 2014, Chartreuse Fragrances asserted that Chartreuse’s use of the “Chartreuse” mark constituted trademark infringement and demanded that Chartreuse cease and desist all use of the trademark. Plaintiff Chartreuse also states that Chartreuse Fragrances contended that Chartreuse’s use of the trademark in connection with the candles was likely to cause consumer confusion.

In this complaint, Chartreuse requests a declaration that its use of “Chartreuse” in connection with handmade soy candles has not infringed the intellectual property rights of Chartreuse Fragrances in the “Chartreuse” trademark. Chartreuse also seeks a declaration that any trademark rights asserted by Chartreuse Fragrances are invalid and unenforceable. Chartreuse supports this assertion in part by contending that Chartreuse Fragrances’ trademark is descriptive of Defendant’s candles and therefore not entitled to registration, as the term Chartreuse is descriptive of a greenish-yellow color.

Chartreuse makes several additional claims in its complaint: that Chartreuse Fragrances misstated the first-use-in-commerce date that it provided to the U.S. Patent and Trademark Office (“USPTO”); that Chartreuse Fragrances asserted falsely to the USPTO that it was using the trademark at the time it applied for a federal registration with the USPTO; that Chartreuse Fragrances is not currently using the trademark in interstate commerce in connection with the candles; and that any use by Chartreuse Fragrances of the trademark on or in connection with candles has been discontinued for at least three consecutive years and, thus, the trademark has been abandoned pursuant to § 1127 of the Lanham Act.

Chartreuse’s complaint, filed by an Indiana trademark lawyer, makes two claims for relief: 1) Unenforceability and Invalidity of Defendant’s Mark and 2) Non-Infringement of Trademark. It asks that Chartreuse Fragrances’ trademark be declared to be not entitled to registration; that the trademark be canceled; for a declaration that Chartreuse is not infringing, has not infringed, and is not liable for infringing the trademark; and for attorneys’ fees, costs, and expenses.

Practice Tip:

At first glance, this complaint has a number of potential areas of weakness. While this is a suit for declaratory judgment, it seems as if it may not be yet justiciable for lack of ripeness. In MedImmune v. Genentech, 549 U.S. 118 (2007), the U.S. Supreme Court revised the Federal Circuit’s test for ripeness under the Declaratory Judgment Act, which had required a reasonable apprehension of a lawsuit in order to establish jurisdiction. The Court broadened the scope of declaratory judgment jurisdiction, holding that the totality of the circumstances should be evaluated in determining the existence of “a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant relief.”

In this case, where the only allegation of controversy is that a single assertion of infringement was purportedly made, it is unclear whether the complaint adequately alleges, under the totality of the circumstances, a controversy of sufficient immediacy to warrant jurisdiction under the Declaratory Judgment Act.

Additionally, Plaintiff asserted that “Defendant’s Mark is descriptive of the Covered Goods and therefore not entitled to registration, as the term CHARTREUSE is descriptive of a greenish-yellow color.” However, it was not alleged in the complaint that Chartreuse Fragrances’ product was, in fact, greenish-yellow in color.

Thus, it appears somewhat more likely, without additional facts, that this trademark might properly be placed into the “arbitrary” category. A trademark is deemed to be “arbitrary” when the word used as a trademark does not suggest or describe a significant ingredient, quality, or characteristic of the goods or services but instead is used in an unexpected or uncommon way (e.g., using “Apple” for computers). Under trademark law, trademarks falling into the arbitrary category are accorded the highest level of protection, as they are deemed to be inherently distinctive.

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Indianapolis, Indiana — Alcon Research, Ltd. of Fort Worth, Texas, and Alcon Pharmaceuticals Ltd. of Fribourg, Switzerland (collectively, “Alcon”) have filed a patent infringement lawsuit in the Southern District of Indiana alleging that Wockhardt Limited of Mumbai, Maharashta, India; Wockhardt Bio AG of Zug, Switzerland; Wockhardt Bio Ltd. of Zug, Switzerland; and Wockhardt USA, LLC of Parsippany, New Jersey (collectively, “Wockhardt”) infringed Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”), both for Olopatadine Formulations For Topical Administration, which have been issued by the U.S. Patent Office. 

According to the complaint, the Wockhardt entities are engaged in the generic-pharmaceutical business.  Alcon asserts that one or more of the entities manufacture, import, market, offer to sell and/or sell generic drugs throughout the United States. 

Wockhardt 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 Wockhardt’s submission of this ANDA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of Wockhardt’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).

Plaintiff Alcon states that it believes that the Wockhardt 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 Wockhardt’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 Wockhardt’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 Wockhardt’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: 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 an interesting look at some of these issues, see here.

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South Bend, Indiana – NIBCO, Inc. of Elkhart, Indiana has sued Valvulas Arco, S.A. (“Arco”) of Valencia, Spain in the Northern District of Indiana asking for a declaratory judgment that it has not violated Arco’s patents, U.S. Design Patent Nos. 429,518; 429,519; 429,520; 438,595; and 479,307.

NIBCO-logo.jpgArco and NIBCO both manufacture shut-off valves.  From about 2002 to 2008, Arco manufactured and sold to NIBCO shut-off valves of the type involved in this dispute.  Around 2008, NIBCO discontinued purchasing valves from Arco.  Currently, NIBCO manufactures shut-off valves for its own use and for sale.

In letters dated April 22, 2013 and August 16, 2013, Arco purportedly asserted that NIBCO infringes the Arco valves (the “patents-in-suit”).  As a result of Arco’s claims of infringement in those letters, NIBCO asserts that there is now an actual controversy between it and Arco regarding the alleged infringement and validity of the patents-in-suit; NIBCO seeks a resolution under the Declaratory Judgment Act.

NIBCO states that Arco has never fixed upon its shut-off valves notice of, nor was there ever any mention of any of, any of the patents-in-suit.  It further claims that most, if not all, of the features shown in the claims are functional.  To the extent that any purely ornamental features do exist, it contends that those ornamental features of NIBCO’s products would not appear substantially similar to an ordinary observer.  Consequently, NIBCO asserts that its products do not infringe, either literally or under the doctrine of equivalents.  Finally, NIBCO denies inducing others to infringe any of the patents-in-suit.

NIBCO asks that this be found to be an exceptional case and asks that attorney’s fees be awarded pursuant to such a finding.  In its complaint, patent attorneys for NIBCO ask the court for:

  • Count I: Declaratory Judgment of Non-Infringement
  • Count II: Declaratory Judgment of Invalidity of the Patents-In-Suit

Practice Tip: In MedImmune v. Genentech, 549 U.S. 118 (2007), the U.S. Supreme Court revised the Federal Circuit’s test for ripeness under the Declaratory Judgment Act, which had required a reasonable apprehension of suit in order to establish jurisdiction.  The Court broadened the scope of declaratory judgment jurisdiction, holding that the totality of the circumstances should be evaluated in determining the existence of “a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant relief.” 

In this case, it is unclear whether the complaint adequately alleges, under the totality of the circumstances, a controversy of sufficient immediacy to warrant jurisdiction under the Declaratory Judgment Act. 

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Contact Information
Indiana Intellectual Property: IP Litigation, Patents, Trademarks, Copyrights
  • Seventh Circuit
  • Northern District of Indiana
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Paul B. Overhauser
Overhauser Law Offices, LLC
Greenfield
18 E Main St #202
Greenfield, IN 46140
Phone: 317.467.9100
Fax: 866.283.8549
Indianapolis
101 W Ohio St #2000
Indianapolis, IN 46204
Phone: 317.891.1500
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