Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

NuVasive’s patent generally relates to “[a] system and method for spinal fusion comprising a spinal fusion implant of non-bone construction releasably coupled to an insertion instrument dimensioned to introduce the spinal fusion implant into any of a variety of spinal target sites.” On inter partes review, the Patent Trial and Appeal Board found certain claims invalid as obvious. The Federal Circuit vacated. The Board did not adequately explain how a claim would have been obvious over prior art, 35 U.S.C. 103(a) and did not articulate a motivation to combine prior art references. View "In re: Nuvasive, Inc." on Justia Law

The Alfred E. Mann Foundation owns two patents that cover implantable cochlear stimulators and formed Advanced Bionics to manufacture implants. The patents are directed to an ear implant with telemetry functionality for testing purposes, and generally describe a two-part system comprising an external wearable system with a wearable processor (WP) and headpiece, and an internal implantable cochlear stimulator (ICS). Sound is transmitted from the headpiece to the WP, which processes the transmissions before sending them to the ICS. The ICS processes the sound to stimulate the cochlea––the organ that converts sound to nerve impulses––via implanted electrodes, thereby allowing the user to hear. The system allows testers, usually physicians, to measure and adjust various parameters of the implant to assess whether the device is functioning properly. The Foundation sued Cochlear Corporation for infringement. The court found certain claims invalid for indefiniteness, entered judgment as a matter of law of no willful infringement, and granted a new trial on damages. The Federal Circuit affirmed in part, upholding the infringement determination with respect to some claims, but vacated and remanded with respect to willfulness in light of the Supreme Court’s 2016 decision, Halo Electronics, Inc. v. Pulse Electronics, Inc. View "Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp." on Justia Law

NuVasive’s patent describes and claims implants for spinal fusion surgery. On inter partes review, the Patent Trial and Appeal Board cancelled all but one challenged claim under 35 U.S.C. 103, finding in one prior-art reference (Michelson), a spinal fusion implant that meets two of the claim requirements of the NuVasive patent—having a length both greater than 40 mm and at least 2.5 times its width. NuVasive argued that it did not receive adequate notice of or opportunity to address that reading of Michelson and its consequences for the overall obviousness analysis. The Federal Circuit vacated in part and remanded Medtronic’s petition put NuVasive on notice that Medtronic was relying on particular portions of Michelson to teach the NuVasive patent’s claimed long-and-narrow implants. Medtronic’s petition did not, however, notify NuVasive of the assertions about the pertinent portions of Michelson that later became critical; the Board’s ultimate reliance on that material, together with its refusal to allow NuVasive to respond fully once that material was called out, violated NuVasive’s rights under the Administrative Procedure Act. View "In re: NuVasive, Inc.." on Justia Law

The 141 application relates to methods of treating or preventing influenza by administering the drug zanamivir by oral inhalation. The examiner rejected the pending claims as obvious over Australian Patent No. AU-A1-27242/92 (Von Itzstein I), in view of WIPO Publication WO 91/16320 (Von Itzstein II) and other references. The Patent Trial and Appeal Board agreed, finding that Von Itzstein II’s disclosure of “inhalation” for treating influenza with its compounds “is reasonably understood to disclose inhalation by either the nose alone, mouth alone, or both” and concluded that Von Itzstein II ,in view of Von Itzstein I’s disclosure of zanamivir, rendered the claims obvious. The Board also considered the applicant’s evidence of secondary considerations—namely of unexpected results—but found it to be unpersuasive. The Federal Circuit affirmed the rejection as supported by substantial evidence. View "In re: Efthymiopoulos" on Justia Law

Massachusetts Institute of Technology sued Shire Pharmaceuticals, for infringement of patents that are directed to three-dimensional scaffolding for growing cells in vitro to produce organ tissue in vivo. Following the district court’s construction of the terms “vascularized organ tissue” and “cells derived from a vascularized tissue” and its determination that the term “three-dimensional scaffold” was not indefinite, the parties stipulated to a final judgment of validity and infringement. The Federal Circuit affirmed, finding no error in the district court’s claim construction. View "Mass. Inst. of Tech. v. Shire Pharma., Inc." on Justia Law

Abbott’s 915 patent discloses a protein, TBP-II, which binds to and neutralizes a protein called Tumor Necrosis Factor α (TNFα), which is associated with various immunological diseases. Following a 2008 remand by the district court, the Board of Patent Appeals rejected claims by Yeda that the patent was invalid as anticipated. In 2015, the district court affirmed. The issue of invalidity turned on whether the patent benefits from the filing dates from either of two German patent applications. If it did, then the field of prior art narrows to exclude the claimed anticipating reference. Whether the 915 patent was entitled to benefit from the German application’s filing date depends on whether the German application provided adequate written description support for the invention claimed in the 915 patent. The Federal Circuit affirmed the district court’s 2015 decision that Abbott’s 915 patent is supported by the written description of one of the German applications, rendering moot Yeda’s appeal concerning the 2008 decision. View "Yeda Research & Dev. Co., Ltd. v. Abbott GMBH & Co. KG" on Justia Law

LifeNet’s 200 patent claims plasticized soft tissue grafts suitable for transplantation into humans. The patent explains that tissue grafts are typically preserved and provided in a dehydrated state, such as through freeze-drying, then rehydrated before implantation. The freeze-drying process is not optimal: it can cause the tissue to become brittle with a tendency to fracture; it requires time in the operating room to rehydrate the tissue; and even after rehydration the tissue’s properties do not approximate that of normal tissue, and the graft can fail. The 200 patent’s “plasticized” tissue grafts avoid these problems. The tissue is preserved not by freeze-drying but by replacing the tissue’s water with biocompatible plasticizers, such as glycerol, that provide the hydrating functions of water. These plasticized grafts exhibit properties similar to that of normal tissue and avoid the rehydration process required for freeze-dried tissue. A jury found that the patent was not invalid and was infringed. The Federal Circuit affirmed, upholding the district court’s conclusion that construction of the entire term “not removed” was “unnecessary,” because that two-word phrase is easily understood by a person of ordinary skill in the art to have its plain meaning that no plasticizers are removed prior to transplantation.” View "LifeNet Health v. Lifecell Corp." on Justia Law

UCB sought a declaration that its Cimzia® brand antibody does not infringe Yeda’s 923 Patent and that the 923 Patent was invalid. Yeda counterclaimed for infringement. The district court granted summary judgment of non-infringement, holding that, based on the specification and prosecution history, the monoclonal antibodies claimed in the 923 patent are not infringed by the chimeric or humanized antibodies of the Cimzia® product. The Federal Circuit affirmed, finding that the district court correctly applied the law and that Yeda is estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed in the 923 Patent. View "UCB, Inc. v. Yeda Research & Dev. Co., Ltd." on Justia Law

The 997 patent relates to spinal surgery that “insert[s] an artificial implant between two adjacent vertebrae” from a patient’s side and discloses “instrumentation and methods of performing surgical procedures on the human thoracic and lumbar spine along the lateral aspect [(i.e., side)] of the spine” to correct “thoracic and lumbar disc disease and spinal deformities where concomitant fusion is desired.” The lateral approach to spinal surgery seeks to avoid complications that may arise when the surgery is performed from the patient’s front or back. Based on petitions filed by NuVasive, the Patent Trial and Appeal Board instituted inter partes review and found claims 1–8 and 17–23 obvious and therefore invalid. The Federal Circuit affirmed in part. Substantial evidence supported findings of obviousness in light of prior art and concerning motivation to combine prior art. The court vacated with respect to a limitation in one specific claim. View "In re: Warsaw Orthopedic, Inc." on Justia Law

TMC owns patents relating to bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and, from 1997 to 2006, purchased pharmaceutical batches from BV. In 2005, BV created batches of bivalirudin with levels of impurity above the FDA-approved maximum. TMC’s consultant discovered that certain methods of adding a pH-adjusting solution during compounding minimize the impurity. In 2008, TMC filed patent applications, describing this discovery. A year earlier, TMC had hired BV to prepare batches using the patented method. Each was released for commercial packaging. In 2010, TMC sued, alleging infringement by Hospira’s ANDA filings. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar (35 U.S.C. 102(b)), which applies when, before the critical date, the claimed invention was the subject of a commercial offer for sale and was ready for patenting. The court found that the claimed invention was ready for patenting but not commercially offered for sale. The Federal Circuit initially reversed, but affirmed on reconsideration. To be “on sale” a product must be the subject of a commercial sale or offer for sale; a commercial sale bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. No such invalidating commercial sale occurred in this case. View "Medicines Co. v. Hospira, Inc." on Justia Law