Justia Patents Opinion Summaries

The Biologics Price Competition and Innovation Act, concerning FDA approval of a drug that is biosimilar to an already-licensed biological “reference product,” 42 U.S.C. 262(k), treats submission of a biosimilar application as an “artificial” patent infringement. An applicant must provide its biosimilar application and manufacturing information to the reference product’s sponsor. The parties collaborate to identify patents for immediate litigation. Second phase litigation is triggered when the applicant gives the sponsor notice at least 180 days before commercially marketing the biosimilar. Amgen claims patents on methods of manufacturing and using filgrastim. Sandoz sought FDA approval to market a biosimilar, Zarxio, and notified Amgen that it had submitted an application, that it intended to market Zarxio immediately upon receiving FDA approval, and that it did not intend to provide application and manufacturing information. Amgen sued for patent infringement and asserted that Sandoz engaged in “unlawful” conduct under California law by failure to provide its application and manufacturing information and by notification of commercial marketing before obtaining FDA licensure. The FDA licensed Zarxio. Sandoz provided Amgen another notice of commercial marketing. The Supreme Court unanimously held that section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit should determine whether a state-law injunction is available. Submitting an application constitutes artificial infringement; failing to disclose the application and manufacturing information does not. Section 262(l)(9)(C) provides a remedy for failure to turn over the application and manufacturing information, authorizing the sponsor, but not the applicant, to bring an immediate declaratory-judgment action, thus vesting in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. An applicant may provide notice under section 262(l)(8)(A) before obtaining FDA licensure. View "Sandoz Inc. v. Amgen Inc." on Justia Law

One-E-Way filed a complaint with the International Trade Commission, alleging infringement of its patents, which disclose a wireless digital audio system designed to let people use wireless headphones privately, without interference, even when multiple people are using wireless headphones in the same space. The specification explains that previous wireless digital audio systems did not provide “private listening without interference where multiple users occupying the same space are operating wireless transmission devices.” The Commission found the claim term “virtually free from interference” indefinite and invalidated the asserted claims of One-E-Way’s patents. The Federal Circuit reversed, finding that the term “virtually free from interference,” as properly interpreted in light of the specification and prosecution history, would inform a person of ordinary skill in the art about the scope of the invention with reasonable certainty. View "One-E-Way, Inc. v. International Trade Commission" on Justia Law

CAC’s patent includes both system and method claims directed to “provid[ing] financing for allowing a customer to purchase a product selected from an inventory of products maintained by a dealer.” In one embodiment, the products are vehicles for sale at a car dealership. The invention involves “maintaining a database of the dealer’s inventory,” gathering financing information from the customer, and “presenting a financing package to the dealer for each individual product in the dealer’s inventory.” Westlake petitioned for Covered Business Method (CBM) review, asserting that all claims were ineligible for patenting under 35 U.S.C. 101. Three months after the Board instituted review of some claims, the Supreme Court vacated precedent on which the Board had relied. In view of the developments in section 101 jurisprudence, Westlake filed a second petition, challenging the remaining claims. In its decision to institute review, the Board rejected CAC’s argument that the existence of the first CBM proceeding estopped Westlake from challenging claims the remaining claims under 35 U.S.C. 325(e)(1). The Board’s determination was based on the fact that the first proceeding had not yet resulted in a final written decision. The Federal Circuit agreed that estoppel did not apply and that the challenged claims were unpatentable. View "Credit Acceptance Corp. v. Westlake Services" on Justia Law

The District Court for the Northern District of Texas dismissed, for lack of personal jurisdiction, New World’s declaratory judgment complaint against FGTL, a wholly owned subsidiary of the automaker Ford Motor Company. FGTL had previously filed an infringement suit against New World in the Eastern District of Michigan. The Federal Circuit affirmed the dismissal of the declaratory judgment action. Both FGTL and the Ford Motor Company are incorporated in Delaware and headquartered in Michigan. FGTL does no business in Texas and neither maintains an office nor has any employees in Texas. FGTL does not make or sell automobiles or automotive products; it owns, manages, and licenses intellectual property for Ford. FTGL’s pertinent contacts with Texas are limited to the cease and desist letters. While those letters may be sufficient to constitute minimum contacts with the forum, they are not sufficient to satisfy the fairness part of the test for specific personal jurisdiction. View "New World International, Inc. v. Ford Global Technologies, LLC" on Justia Law

Skky’s patent describes a method for delivering audio and/or visual files to a wireless device, stating that existing devices required music or video clips to be either factory-installed, or downloaded through a direct Internet interface. The patent allows users to “browse, download, and listen to or watch sound or image files without the need for hand wired plug-in devices or a computer connection to the Internet.” The patent states that “a software system may be integrated with the existing hardware chip of a conventional cellular phone without the need for additional hardware.” In other embodiments, a separate accessory unit attached to the wireless device provides this functionality. On inter partes review, the Patent Board concluded that challenged claims would have been obvious in view of publications entitled “MP3: The Definitive Guide” and “OFDM/FM Frame Synchronization for Mobile Radio Data Communication.” The Board determined that “wireless device means” was not a means-plus-function term. Even assuming that the term was in means-plus-function format, however, the Board rejected Skky’s argument that the term requires multiple processors, wherein one is a specialized processor. The Federal Circuit affirmed, upholding the claim construction and the conclusion that the challenged claims are unpatentable as obvious. View "Skky, Inc. v. MindGeek, S.A.R.L." on Justia Law

Lexmark holds patents on the components of toner cartridges that it manufactures and sells. Lexmark allows consumers to buy a cartridge at full price, with no restrictions, or to buy a cartridge at a discount through Lexmark’s “Return Program,” by signing a contract agreeing to use the cartridge only once and to refrain from transferring the cartridge to anyone but Lexmark. Remanufacturers acquire empty Lexmark cartridges—including Return Program cartridges—from purchasers in the U.S. and overseas, refill them, and resell them in the U.S. Lexmark sued remanufacturers with respect to Return Program cartridges that Lexmark had sold within the U.S. and cartridges that Lexmark had sold abroad and that remanufacturers imported into the country. The Federal Circuit ruled for Lexmark with respect to both. The Supreme Court reversed. Lexmark exhausted its patent rights (35 U.S.C. 271(a)) in all of the cartridges. A patentee’s decision to sell a product exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose. If a patentee negotiates a contract restricting the purchaser’s right to use or resell an item, it may be able to enforce that restriction as a matter of contract law, but may not do so through a patent infringement lawsuit. The exhaustion doctrine is not a presumption about the authority that comes along with a sale; it is a limit on the scope of the patentee’s rights. The Patent Act just ensures that the patentee receives one reward—of whatever it considers satisfactory compensation—for every item that passes outside the scope of its patent monopoly. View "Impression Products, Inc. v. Lexmark International, Inc." on Justia Law

A jury found that Pulse directly infringed Halo’s patents with products that it shipped into the U.S. and induced others to infringe those patents with products delivered outside the U.S. that ultimately were imported into the U.S. in finished products; it was highly probable that Pulse’s infringement was willful; and the Halo patents were not invalid. The jury awarded Halo $1.5 million in royalty damages. The court held that Pulse had not willfully infringed and taxed costs. Halo did not seek interest. The Federal Circuit affirmed that Pulse’s infringement was not willful. In June 2015, in the district court, Halo sought an accounting for supplemental damages and awards of interest. The Supreme Court subsequently held that the enhanced damages test applied by the Federal Circuit was inconsistent with 35 U.S.C. 284. On remand, the Federal Circuit vacated the unenhanced damages award with respect to products delivered in the U.S. and remanded. In the meantime, the district court awarded Halo prejudgment and post-judgment interest and supplemental damages for direct infringement. In November 2016, the court entered a stipulation of satisfaction of judgment for the $1.5 million damages award, including costs, supplemental damages, and post-judgment interest, expressly excluding prejudgment interest, enhanced damages, and attorney fees. The Federal Circuit dismissed an appeal for lack of jurisdiction. There is no final decision because the district court has not specified the means for determining the amount of prejudgment interest. View "Halo Eelectronics, Inc. v. Pulse Electronics, Inc." on Justia Law

The 320 patent describes single-brew coffee machines, such as the Keurig® system, and purports to address the incompatibility between pod-based and cartridge-based systems. The invention “more particularly relates to an adaptor assembly configured to effect operative compatibility between a single serve beverage brewer and beverage pods.” None of the claims as issued included any reference to a “pod,” “pod adaptor assembly,” or “brewing chamber for a beverage pod.” Instead, the relevant claims call for “a container . . . adapted to hold brewing material.” In 2014, Rivera filed a complaint with the International Trade Commission, alleging that Solofill was importing beverage capsules that infringed the patent, in violation of 19 U.S.C. 1337. Solofill’s K2 and K3 beverage capsules are made to fit into a Keurig® brewer, and include an integrated mesh filter surrounding a space designed to accept loose coffee grounds. An ALJ found no violation of section 337, The Commission affirmed, finding asserted claims invalid for lack of written description, and others invalid as anticipated. The Federal Circuit affirmed, agreeing that the claims were invalid for lack of written description. View "Rivera v. International Trade Commission" on Justia Law

Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law

In 2010, ArcelorMittal sued (050 case), alleging infringement of the 805 patent. A jury found that Defendants did not infringe and that the asserted claims were invalid as anticipated and obvious. The Federal Circuit reversed the court’s claim construction and concluded that, as a matter of law, the claims were not anticipated. In 2013, the Patent Office reissued the 805 patent as the RE153 patent. ArcelorMittal filed the 685 and 686 infringement suits based on events occurring after the reissuance and moved to amend its 050 complaint to substitute allegations of infringement of the RE153 patent. The court entered summary judgment, finding that claims 1–23 had been improperly broadened, and denied the motion to amend as moot. The Federal Circuit affirmed the invalidity of RE 153 claims 1–23, but reversed as to claims 24 and 25. On remand, the court granted defendants summary judgment of invalidity on RE 153 claims 24 and 25, denied ArcelorMittal’s motion to dismiss the 050 case for lack of subject matter jurisdiction, and granted ArcelorMittal’s motion to amend its 685 complaint. The Federal Circuit affirmed. The district court possessed subject matter jurisdiction to grant summary judgment, properly followed the mandate on remand, and properly exercised its discretion to deny ArcelorMittal’s request for new discovery. View "Arcelormittal v. AK Steel Corp." on Justia Law