Justia Patents Opinion Summaries

Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of prior art; the combination is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. The district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms. On remand, following the Supreme Court decision, Teva Pharmaceuticals v. Sandoz (2015), the Federal Circuit again reversed the district court’s constructions of the disputed claim terms and subsequent findings of infringement, and remanded. View "Shire Dev., LLC v. Watson Pharma., Inc." on Justia Law

Commil, holder of a patent for a method of implementing short-range wireless networks, sued, claiming that Cisco Systems, a maker and seller of wireless networking equipment, had directly infringed Commil’s patent in its networking equipment and had induced others to infringe the patent by selling the infringing equipment for use. After two trials, Cisco was found liable for both direct and induced infringement. Cisco had raised the defense that it had a good-faith belief that Commil’s patent was invalid, but the court found Cisco’s supporting evidence inadmissible. The Federal Circuit held that the trial court erred in excluding evidence of a good-faith belief that Commil’s patent was invalid. The Supreme Court vacated and remanded. A defendant’s belief regarding patent validity is not a defense to an induced infringement claim. The Court noted the long held presumption that a patent is valid; 35 U.S.C. 282(a) establishes a high bar, the clear and convincing standard, to rebut the presumption. If a patent is actually shown to be invalid, there is no patent to be infringed. Orderly administration of the patent system requires courts to interpret and implement the statutory framework to determine the procedures and sequences that the parties must follow to prove the act of wrongful inducement and any related issues of patent validity. Accused inducers who believe a patent is invalid have other, proper ways to obtain a ruling to that effect, including seeking ex parte reexamination. View "Commil USA, LLC v. Cisco Systems, Inc." on Justia Law

A jury found that Samsung smartphones infringed and diluted Apple’s patents and trade dresses amd awarded Apple $290,456,793. The Federal Circuit affirmed the verdict on the design patent infringements, the validity of two utility patent claims, and the damages awarded for the design and utility patent infringements, but reversed findings that the asserted trade dresses are protectable. Apple claimed elements from its iPhone 3G and 3GS products to define an asserted unregistered trade dress: a rectangular product with four evenly rounded corners; a flat, clear surface covering the front of the product; a display screen under the clear surface; substantial black borders above and below the display screen and narrower black borders on either side of the screen; and when the device is on, a row of small dots on the display screen, a matrix of colorful square icons with evenly rounded corners within the display screen, and an unchanging bottom dock of colorful square icons with evenly rounded corners set off from the display’s other icons. The registered trade dress claims the design details in each of the 16 icons on the iPhone’s home screen framed by the iPhone’s rounded-rectangular shape with silver edges and a black background. View "Apple, Inc. v. Samsung Elecs. Co., Inc." on Justia Law

Elan marketed metaxalone, a muscle relaxant, under the brand-name Skelaxin. Years after Skelaxin’s approval, Elan learned that another company conducted in vivo bioequivalence fasting studies and in vitro dissolution tests on metaxalone and that, based on the results, the FDA proposed to change the designation of metaxalone from “non bioproblem” to “bioproblem.” Elan initiated a study and observed a significant effect of food on bioavailability. Elan petitioned the FDA to require both fed and fasting data for any abbreviated new drug application for a generic version of Skelaxin and to revise its product label. The FDA granted both. Elan obtained patents based on its bioavailability data, which were later invalidated in light of prior art. Classen’s 472 patent is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and commercializing that new use. Classen alleged that Elan infringed that patent when it studied the effect of food on Skelaxin’s bioavailability, used the data to identify a new use, and commercialized that use. The court entered summary judgment of noninfringement, finding Elan protected by the safe harbor provision of 35 U.S.C. 271(e)(1), for activities “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. During ex parte reexamination of the 472 patent, the PTO cancelled 107 of the 137 originally issued claims. The Federal Circuit affirmed with respect to the 271(e)(1) exemption, but remanded an allegation that activities that occurred after the FDA submissions infringed the 472 patent and were not exempt. View "Classen Immunotherapies, Inc. v. Elan Pharma., Inc." on Justia Law

The 703 patent concerns a method of delivering internet content. A jury found that Limelight practices every step of the methods disclosed in the patent’s four claims except the “tagging” step, which is performed by Limelight’s customers. Customers must tag the content to be hosted and delivered by Limelight’s content delivery network. Limelight instructs its customers how to tag, and employees are on call if customers require additional assistance. In a 2014 decision, the Federal Circuit held that because Limelight did not perform all of the steps of the asserted method claims and because there was no basis on which to impose liability on Limelight for the actions of its customers who carried out the other steps Limelight did not directly infringed the patent under 35 U.S.C. 271(a). After remand by the Supreme Court, the Federal Circuit again found no infringement, stating that the statutory framework “does not admit to the sweeping notions of common-law tort liability argued in this case.” The court noted that the case involved neither agency nor contract nor joint enterprise. Encouraging or instructing others to perform an act is not the same as performing the act oneself and does not result in direct infringement. View "Akamai Techs., Inc. v. Limelight Networks, Inc.." on Justia Law

ArcelorMittal alleged infringement of the 805 patent, directed toward a steel sheet with “a very high mechanical resistance” after thermal treatment. The court construed the phrase “very high mechanical resistance” as limited to steel with a tensile strength greater than 1500 MPa. The Federal Circuit affirmed the construction, but remanded on other grounds. While the appeal was pending, ArcelorMittal sought reissue to correct the construction. The application issued as the RE153 patent, adding dependent claims, including: claim 23, which recites “[t]he coated steel sheet of claim 1, wherein said mechanical resistance is in excess of 1000 MPa”; claim 24, which confines claim 1 to the construction affirmed by the Federal Circuit by claiming “[t]he coated steel sheet of claim 1, wherein said mechanical resistance is in excess of 1500 MPa”; and claim 25, which depends on and further limits claim 24. ArcelorMittal amended its complaint. The district court granted summary judgment on remand, finding claims 1 through 23 of the RE153 patent invalid as impermissibly broadened in the reissue proceedings (35 U.S.C. 251.1). The Federal Circuit reversed in part, finding that newly added claims 24 and 25 were not broadened during reissue. The court was bound by its construction of the original claims; the reissue claims broadened that construction. View "Arcelormittal France v. AK Steel Corp." on Justia Law

Standard markets kinesiotherapy devices, including models that practice claims of its 605 Patent. In 2009, Standard formed a subsidiary to distribute products in the U.S. Neither Standard nor Standard U.S. manufactures in the U.S.; Standard sources components from suppliers in the U.S. and other countries. It contracts Chinese manufacturers to assemble devices from those components for export to more than 50 countries, including the U.S. The U.S. International Trade Commission (ITC) addressed four components in its domestic industry analysis: a backbone material, a rubber, microcontrollers, and a pigment. The backbone material, rubber, pigment, and wafers used in the microcontrollers are manufactured in the U.S. Lelo, a California corporation with a Swedish majority shareholder, imports kinesiotherapy devices. Standard filed a 19 U.S.C. 1337 complaint alleging that Lelo imported kinesiotherapy devices and components that infringed its 605 Patent. The ITC concluded that statutory domestic industry requirements were satisfied upon a showing of a “significant investment in plant or equipment” and a “significant employment of labor or capital.” The Eighth Circuit reversed, holding that qualitative factors alone are insufficient. The purchase of so-called “crucial” components from third-party U.S. suppliers was insufficient to satisfy the “significant investment” or “significant employment of labor or capital” criteria absent evidence that connects the cost of the components to an increase of U.S. investment or employment. View "LELO Inc. v. Int'l Trade Comm'n" on Justia Law

Beginning in 1983, interferences were declared between Fiers and Sugano generally relating to claims to DNA sequences that encode the precursor and/or mature forms of human fibroblast interferon proteins, which promote viral resistance in human tissue, and in the case of the most recent interference, to claims for the proteins themselves. All of Fiers’ applications claimed priority to a United Kingdom Patent Application filed in April 1980, while Sugano’s applications and patents claimed priority to a Japanese Patent Application, filed in March 1980. In the first and second interferences, the Board of Patent Appeals and Interferences awarded priority to Sugano. In 2013, in response to a third interference the Board declared that Fiers was estopped from proceeding, given that Fiers lost the prior interferences and the subject matter was the same as in the prior interferences. The district court held that it lacked subject matter jurisdiction because the Leahy-Smith America Invents Act, 125 Stat. 284, eliminated district court jurisdiction under 35 U.S.C. 146 with respect to interferences commenced after September 15, 2012. The district court transferred the case to the Federal Circuit, which concluded that the district court correctly decided that it lacked jurisdiction and that the Board’s decision was not erroneous. View "Biogen Ma, Inc. v. Japanese Found. for Cancer Research" on Justia Law

EON’s patent, issued in 1997, is directed to software embodied in a “local subscriber data processing station” that operates to interconnect various interactive features of a television. The software allows “impulse purchase transactions with immediate payment,” audience participation voting, and sorting television programs by theme. EON alleges that “the modern iteration of the 757 Patent’s local subscriber data processing station is a smartphone with certain capabilities,” and, in 2010, sued smartphone manufacturers, cellular network providers, and smartphone content providers (FLO TV case). In 2011, EON filed a separate action (AT&T case). The cases were consolidated. The 757 patent went through two reexaminations. All claims, as amended, were confirmed in the second reexamination. The district court granted summary judgment to the FLO TV defendants, finding all of the means-plus-function claims in the patent invalid as indefinite. The parties in the AT&T case stipulated to final judgment of invalidity. The Federal Circuit affirmed. View "EON Corp., IP Holdings LLC v. AT&T Mobility LLC" on Justia Law

Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an New Drug Application under the Hatch Waxman Act, 21 U.S.C. 355(b)(2). In 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule. Hikma launched Mitigare, and Takeda filed suit, asserting induced infringement under 35 U.S.C. 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare in October 2014. The district court granted Takeda’s request for a temporary restraining order, but later denied a preliminary injunction. The Federal Circuit affirmed. Takeda acknowledged that evidence of mere knowledge of infringing uses is not sufficient and did not establish a probability of success on the issue of infringement. View "Takeda Pharma., U.S.A. v. Hikma Am., Inc." on Justia Law