Patent Infringement

April 11, 2014

Indiana Patent Litigation: Cor-A-Vent Sues Alleging Patent Infringement by DCI Products

South Bend, Indiana – Indiana patent attorneys for Cor-A-Vent Inc. of Mishawaka, Indiana filed a lawsuit in the Northern District of Indiana alleging that Designer Cabinets Inc. d/b/a DCI Products of Clifton Heights, Pennsylvania (“DCI”) infringed the patented “Moisture Resistant Roof Vent,” Patent No. 5,704,834, which has been issued by the U.S. Patent Office.

Cor-A-Vent is a designer and manufacturer of roof vent and other venting products. In 1998, United States Patent No. 5,704,834 (the “‘834 Patent”) was issued for a moisture-resistant roof vent. Cor-A-Vent asserts that it owns this patent.

DCI is accused of infringing the ‘834 Patent – either directly, by inducement, and/or contributorily – by making, using, selling, offering for sale, importing or supplying infringing roof vent products, including DCI’s SmartRidge® II product, in violation of 35 U.S.C. § 271 et seq. Cor-A-Vent contends that DCI has profited, and Cor-A-Vent has suffered damages, as a result of this alleged patent infringement.

Cor-A-Vent also asserts that DCI has been aware of the ‘834 Patent since 2010 or earlier. As a result, Cor-A-Vent contends that the patent infringement committed by DCI has been willful. Further, Cor-A-Vent contends that this is an exceptional case, which would support an award of reasonable attorneys’ fees pursuant to 35 U.S.C. § 285.

In its complaint, filed by Indiana patent attorneys in Indiana federal court, Cor-A-Vent lists a single count: Infringement of United States Patent No. 5,704,834. It requests the following:

• A judgment that DCI has infringed the ‘834 Patent in violation of 35 U.S.C. § 271;
• Preliminary and permanent injunctive relief prohibiting DCI and its agents from infringing the ‘834 Patent pursuant to 35 U.S.C. § 283;
• An award to Cor-A-Vent of its damages for patent infringement,
• An award of pre-judgment and post-judgment interest and costs against DCI pursuant to 35 U.S.C. § 284;
• A judgment that DCI’s infringement of the ‘834 Patent has been deliberate and willful;
• A judgment that DCI’s infringement of the ‘834 Patent has been exceptional under 35 U.S.C. § 285;
• Treble damage under 35 U.S.C. § 284; and
• An award to Cor-A-Vent of its reasonable attorneys’ fees under 35 U.S.C. § 285.

Practice Tip:

A court may award increased damages for willful infringement. These punitive damages, up to and including a trebling of damages, are appropriate when an infringer has acted in wanton disregard of the patentee’s intellectual property rights. In determining whether the infringing behavior supports increased damages, the court will consider the “totality of the circumstances.”

Potential exposure for increased damages may be reduced by seeking – and acting on – timely advice from a competent patent lawyer. In contrast, the failure to seek and heed such advice may increase the chance of a finding of willfulness.

March 27, 2014

Indiana Patent Litigation: Orthopaedic Hospital Seeks Injunction and Damages for Patent Infringement

By Overhauser Law Offices, LLC

Fort Wayne, Indiana – Patent attorneys for Orthopaedic Hospital of Los Angeles, California (the “Hospital”) filed a lawsuit in the Central District of California alleging that DePuy Orthopaedics, Inc. of Warsaw, Indiana (“DePuy”) infringed Oxidation-Resistant and Wear-Resistant Polyethylenes for Human Joint Replacements and Methods for Making Them, Patent No. 8,658,710, which has been issued by the U.S. Patent Office. The lawsuit was transferred to the Northern District of Indiana pursuant to a joint stipulation by the parties.

The Hospital, located in Los Angeles, is an independent nonprofit charitable organization that treats children with musculoskeletal disorders and conducts scientific research aimed at improving orthopaedic materials, implants, surgical instrumentation, and surgical techniques.

At issue in this Indiana patent lawsuit is United States Patent No. 8,658,710 (the “‘710 patent”), which was issued on February 25, 2014. The Hospital asserts that it is the owner of the ‘710 patent, and that it possesses the exclusive right to bring suit for infringement of the patent.

The Hospital contends that DePuy is infringing and has infringed the ‘710 patent by making, selling, offering for sale, and using infringing products, including but not limited to DePuy’s AOX Antioxidant Polyethylene for Sigma and LCS Rotating Platform Systems. It is also claimed that DePuy’s infringement of the ‘710 patent has been and continues to be willful, deliberate, and/or objectively reckless.

The Hospital further asserts that DePuy has known of the ‘710 patent since at least February 25, 2014, when the patent issued. It also states that DePuy had constructive notice of the ‘710 patent by operation of law, as the Hospital and any of its predecessors-in-interest have complied with all marking requirements of 35 U.S.C. § 287.

A single-count complaint asserting patent infringement was filed by California patent lawyers for the Hospital. The Hospital asks that the court:

• Adjudge that DePuy has infringed and is infringing the ‘710 patent;
• Preliminarily and/or permanently enjoin DePuy and its affiliates and agents from further infringement, including inducement and contributory infringement, of the ‘710 patent;
• Award damages for willful infringement of three times the damages so determined, as provided by 35 U.S.C. § 284, together with interest;
• Order an accounting of all accrued damages;
• Award any supplemental damages to the Hospital;
• Award the Hospital their costs and, where appropriate, reasonable attorneys’ fees under 35 U.S.C. § 285; and
• Award compensatory damages to the Hospital, together with interest.

Practice Tip:

The question of willfulness in the context of patent infringement consists of two elements: (1) an objective element that is often, but not always, a question of law, and (2) a subjective element that is inherently a question of fact, to be decided by the jury.

Under the first prong, if an “accused infringer’s position is susceptible to a reasonable conclusion of no infringement,” the infringer’s conduct cannot be objectively unreasonable. Conversely, an action is objectively unreasonable if the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.

When considering the second prong — the element of subjective willfulness — fact-finders should consider: (1) whether the infringer copied the patentee’s commercial products; (2) whether the infringer presented evidence that it obtained legal opinions of patent counsel to justify its infringing actions; (3) whether the infringer attempted to avoid infringement by designing around the patents; and (4) whether the infringer acted in accordance with the standards of commerce.

March 24, 2014

Indiana Patent Litigation: Headsight Sues John Deere for Patent Infringement

By Overhauser Law Offices, LLC

Fort Wayne, Indiana – Patent lawyers for Richard Gramm and Headsight, Inc., both of Indiana, sued in the Northern District of Indiana alleging that Deere and Company of Moline, Illinois (also known as “John Deere”) infringed the patented “Combine Header Height Control“, Patent No. 6,202,395, which has been issued by the U.S. Patent Office.

Gramm, the founder and President of Plaintiff Headsight, claims to own all right, title and interest to Patent No. 6,202,395 (the “395 patent”). In its complaint, Plaintiffs allege that Deere makes, uses, sells and/or offers for sale products that infringe at least claim 27 of the ‘395 patent, including at least the header height sensor kit, for the Deere 600C Series corn headers (the “Deere Height Sensor”).

Plaintiffs contend that Deere has had actual knowledge of the ‘395 patent since at least as early as 2002 and that Deere has been and now is directly infringing, actively inducing others to infringe and/or contributing to the infringement of the ‘395 patent by making, using, selling, offering for sale and/or importing in the United States products, including at least the Deere Height Sensor, in violation of 35 U.S.C. § 271.

Plaintiffs assert one claim in their complaint, filed by Indiana patent attorneys: “Count I: Patent Infringement of U.S. Patent No. 6,202,395.” Gramm and Headsight ask the court for:

• a declaration that Deere has infringed one or more claims of the ‘395 patent in violation of 35 U.S.C. § 271;
• equitable relief under 35 U.S.C. § 283, including, but not limited to, permanently enjoining Deere and its agents from infringing, contributing to, and/or inducing infringement of the ‘395 patent;
• an award of damages adequate to compensate Plaintiffs for Deere’s infringement of the ‘395 patent, together with prejudgment and post-judgment interest under 35 U.S.C. § 284;
• a declaration that Deere’s infringement is willful and/or an order increasing damages up to and including three times the amount found or assessed consistent with 35 U.S.C. § 284; and
• a declaration that this case is “exceptional” under 35 U.S.C. § 285 and awarding Plaintiffs their reasonable attorney fees, costs, and expenses.

Practice Tip:

A court may award increased damages for willful infringement. These punitive damages, up to and including a trebling of damages, are appropriate when an infringer has acted in wanton disregard of the patentee’s intellectual property rights. In determining whether the infringing behavior supports increased damages, the court will consider the “totality of the circumstances.”

Potential exposure for increased damages may be reduced by seeking – and acting on – timely advice from a competent patent lawyer. In contrast, the failure to seek and heed such advice may increase the chance of a finding of willfulness.

March 17, 2014

Indiana Patent Infringement Litigation: Eli Lilly Sues Numerous Defendants

By Overhauser Law Offices, LLC

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

In a 101-page complaint, Indiana patent counsel for Plaintiffs Lilly; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; and Ube Industries, Ltd. sued alleging patent infringement by more than thirty Defendants. The Defendants are: Accord Healthcare, Inc. USA; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.; Aurobindo Pharma Limited; Aurobindo Pharma USA Inc.; Dr. Reddy’s Laboratories, Ltd; Dr. Reddy’s Laboratories, Inc.; Glenmark Generics Inc., USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.; Hetero USA Inc.; Hetero Labs Limited; Hetero Labs Limited Unit V; Hetero Drugs Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Limited (these three companies are, collectively, “Mylan”); Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.; Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun Pharma Global Inc.; Sun Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis plc; Actavis, Inc.; Actavis Pharma, Inc.; Zydus Pharmaceuticals USA, Inc.; and Cadila Healthcare Ltd. (d/b/a Zydus Cadila). Defendants hail from various areas of the world, including India, the United Arab Emirates, the British Virgin Islands, Israel, Ireland and the United States.

This complaint asserts patent infringement arising out of the filing by Defendants of Abbreviated New Drug Applications (“ANDA”s) with the United States Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of two pharmaceutical products – Effient® 5mg and Effient® 10mg tablets (pictured above) – prior to the expiration of United States Patent Nos. 5,288,726 (the “‘726 patent”), 8,404,703 (the “‘703 patent”) and 8,569,325 (the “‘325 patent”), which cover the two Effient® products and/or methods of using Effient® products and for which Lilly claims an exclusively license.

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

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

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

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

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

Plaintiffs ask the court for judgment:

• That all Defendants, either individually or collectively, have infringed or will infringe one or more claims of the ‘703 patent;
• That all Defendants, either individually or collectively, have infringed or will infringe one or more claims of the ‘325 patent;
• That Mylan, either individually or collectively, has infringed or will infringe one or more claims of the ‘726 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(B), Defendants be permanently enjoined from making, using, selling or offering to sell any of the Defendants’ accused products within the United States, or, where applicable, importing accused products into the United States prior to the expiration of the ‘703 and ‘325 patents;
• That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of any ANDAs under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the later of the expiration dates of the ‘703 and ‘325 patents, including any extensions;
• That the ‘703 patent remains valid and enforceable;
• That the ‘325 patent remains valid and enforceable;
• That the ‘726 patent remains valid and enforceable;
• If any Defendant commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of either of the ‘703 and ‘325 patents, including any extensions, that Plaintiffs be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
• If Mylan commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of the ‘726 patent, including any extensions, that Plaintiffs be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
• That the case be deemed exceptional under 35 U.S.C. § 285; and
• That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.

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

March 12, 2014

Supreme Court Reverses Federal Circuit on Burden of Proof in Patent Infringement Litigation Brought Under the Declaratory Judgment Act

By Overhauser Law Offices, LLC

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 States 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.

March 7, 2014

Supreme Court Grants Review for Four Intellectual Property Lawsuits

By Overhauser Law Offices, LLC

Washington, D.C. – The Supreme Court of the United States agreed to review the judgments of several Courts of Appeals in four intellectual property disputes. The cases included two patent cases (regarding joint-infringement liability and indefiniteness invalidity), a copyright case (concerning public performances), and a case which may have implications under trademark law (whether a Lanham Act claim is barred by the Food Drug and Cosmetic Act).

Limelight Networks, Inc. v. Akamai Technologies, Inc., Docket No. 12-786, is a patent case involving technology for managing web images and video. Appellate attorneys for Limelight Networks brought the case to the Court after the U.S. Court of Appeals for the Federal Circuit held that, in the case of method patents, multiple parties could be found to jointly infringe on a patent. The Federal Circuit, sitting en banc, held by a 6-5 vote that “all the steps of a claimed method must be performed in order to find induced infringement, but that it is not necessary to prove that all the steps were committed by a single entity.”

The question raised for review by the Supreme Court is whether a defendant may be liable for inducing patent infringement under 35 U.S.C. § 271(b) even if none has committed direct infringement under § 271(a). Patent attorneys for technology companies including Google Inc., Cisco Systems, Inc., Oracle Corporation, Red Hat, Inc., and SAP America, Inc. filed a brief in support of Limelight.

February 28, 2014

PC Ruehl Engineering Sues AM General for Patent Infringement of Humvee Frame Rail Assembly

By Overhauser Law Offices, LLC

South Bend, Indiana – Indiana and Wisconsin patent attorneys for Phillip C. Ruehl of Wauwatosa, Wisconsin (“Ruehl”) and PC Ruehl Engineering, Inc. of Wisconsin (“PC Ruehl”) filed patent infringement litigation in the Northern District of Indiana alleging that AM General LLC of South Bend, Indiana infringed Boxed Frame Member and Method for Manufacture, Patent No. 8,484,930 B2 (the “‘930 Patent”), which has been issued by the U.S. Patent Office.

From 1969 to 2001, Ruehl was employed as an automotive frame chassis engineer. In his various positions, including as a manager of product design, Ruehl’s responsibilities included contributing to the designs of many light truck and sport utility vehicle frames.

Since the early 1980s, AM General has manufactured for the United States military, and eventually for the militaries of many other countries around the world, a High Mobility Multi-Purpose Wheeled Vehicle (or HMMWV, also known as the Humvee).

In November 2004, an employee of AM General allegedly contacted Ruehl to inquire if Ruehl was interested in consulting on a project to upgrade the frame rails for AM General’s Humvee line of trucks. The employee described the frame rail project objectives to Ruehl and sent drawings to Ruehl showing the current side rail design.

From December 2004 through February 2005, Ruehl indicates that he studied the drawings and began to consider ways to meet AM General’s objectives so that he could add value if and when AM General decided it wanted to retain him as a consultant. He contends that he was neither under contract with AM General nor was he being paid or otherwise compensated by AM General during this time.

Ruehl states in his complaint that he began to consider several potential solutions which he believed to be the most efficient means of solving the stated challenges. He sketched up many of these potential solutions so that he would remember each and be able to explain how he would proceed with each idea if he were asked. One of the new solutions Ruehl conceived of and sketched was a design that solved many of the unique dimensional and quality problems that AM General was experiencing with its current frame rail design (the “Invention”).

AM General allegedly was never invoiced and never paid Ruehl for the work he did during this preparation period. Instead, Ruehl states that AM General specifically told him that the rail design program itself was tentative, and that if it did go forward, he would not be “on board” and under contract until he had met with representatives of AM General and signed additional documents at AM General’s Michigan facility.

In February 2005, having allegedly already conceived of the Invention, PC Ruehl received from AM General a purchase order dated February 24, 2005 for “engineering support for HMMWV frame rail feasibility study.” Under this purchase order, AM General asked Ruehl to provide engineering support for a feasibility study and stated that PC Ruehl would be paid $150 per hour for Ruehl’s efforts. Ruehl signed the purchase order on behalf of PC Ruehl.

In March 2005, Ruehl drew a more detailed, presentable, and buildable sketch illustrating the Invention in its preferred embodiment, and had the owner of a Milwaukee-area prototype shop confirm its manufacturability, witness it, and agree to build a small “proof-of-concept” sample. Ruehl states that he did not bill, and was not paid by, AM General for this work.

Ruehl then brought the Invention to a meeting with AM General. Before beginning the substance of the meeting, Ruehl states that he (on behalf of PC Ruehl) and AM General signed a Mutual Confidentiality Agreement. This agreement provided that all confidential information disclosed by Ruehl to AM General and by AM General to Ruehl would “remain the property of [the] Disclosing Party[.]” “Confidential Information” was defined in the agreement as “[a]ny information that has value to the Disclosing Party and is not generally known to its competitors,” and specifically included “ideas, concepts, plans,…drawings,…products, processes[.]” Moreover, the agreement stated, “Nothing contained in this Agreement shall be construed as granting or conferring to Receiving Party any patent rights or licenses from Disclosing Party either expressly or by implication[.]”

Following this agreement, Ruehl worked with AM General to provide engineering support services for the frame rail feasibility study. Ruehl was paid for this work pursuant to the February 2005 purchase order. Ruehl also provided additional engineering support services to AM General under an April 2005 purchase order. Ruehl contends that AM General never paid him or PC Ruehl for the transfer of ownership of Ruehl’s Invention.

On November 1, 2005, Ruehl filed a patent application on the Invention, Provisional Patent Application No. 60/732,451. Ruehl followed that application with a non-provisional patent application, Patent Application Serial No. 11/279,321, on April 11, 2006.

AM General filed its own patent application on Ruehl’s Invention, filing Provisional Patent Application Serial No. 60/764,045 on February 1, 2006, and non-provisional patent application Serial No. 11/670,217, on February 1, 2007.

On November 1, 2005, the day that Ruehl filed the provisional patent application, he informed AM General of the filing and of his expectation of receiving royalties for the use of his Invention. Conversely, AM General has purportedly advised Ruehl that it is AM General’s position that Ruehl had an obligation to assign his rights in the Invention to AM General.

On July 16, 2013, the United States Patent and Trademark Office issued the ‘930 Patent to Ruehl. Ruehl now contends that AM General has incorporated Ruehl’s Invention into the frame rail assembly it is now using for its Humvee which it is manufacturing and selling to the United States Military and to others.

At issue in this Indiana patent litigation are the following:

• Count I: Infringement of the ‘930 Patent, and
• Count II: Breach of Contract.

Ruehl and PC Ruehl, via patent counsel, ask the court for a judgment that AM General has directly infringed and continues to infringe the ‘903 Patent; damages, including treble damages; a judgment that AM General’s infringement has been willful; an injunction enjoining AM General from infringing the ‘930 Patent; a declaration that this case is exceptional; costs and fees.

Practice Tip: The U.S. Patent and Trademark Office provides for the recordation of assignments of applications, patents, and registrations. The patent assignment abstract of title shows that an interest in this patent was assigned from Ruehl to AM General in 2008. In 2010, another assignment of this patent was executed from AM General to Ruehl. In 2011, an assignment from AM General to itself was filed to correct error. Finally, in 2013, a second assignment to correct error, this time to and from Ruehl, was executed.

February 26, 2014

One Number Sues Google in Indiana for Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent infringement litigation was commenced by a patent attorney for One Number Corporation of Anderson, Indiana. The lawsuit, filed in the Southern District of Indiana, alleges that Google, Inc., of Mountain View, California, infringed One Number’s Contact Number Encapsulation System, Patent No. 8,611,511 (the “‘511 patent”), which has been issued by the U.S. Patent Office.

At issue in this patent litigation are the respective intellectual property rights of One Number and Google in single-phone-number telephone services. Such services allow a phone call made to one number to be transferred to multiple other phone numbers.

One Number asserts that Google has infringed and is still willfully infringing the ‘511 patent by making, selling and using a system that embodies One Number’s patented invention. The service claimed to infringe upon the ‘511 patent is Defendant’s Google Voice technology. The patent-in-suit was issued on December 17, 2013 and has been assigned to One Number.

One Number asks for judgment in its favor against Google, a final injunction against the continuing infringement, an accounting for damages, interest, costs and attorneys’ fees.

Practice Tip: This is not the first Indiana patent litigation that One Number has instituted against Google relating to the Google Voice application. At least one similar complaint was filed in March 2010, although that complaint pertained to U.S. Patent Nos. 7,680,256 and 7,440,565. Google responded, among other ways, by seeking reexamination of One Number’s patents. This approach met with some success but was apparently insufficient to dissuade One Number from pursuing further patent litigation.

February 13, 2014

Alcon Sues Cipla for Patent Infringement of Pataday™

By Overhauser Law Offices, LLC

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

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

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

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

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

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

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

Practice Tip:

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

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

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

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

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.