Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. Court of Appeals for the Federal Circuit
Phigenix, Inc. v. Immunogen, Inc.
The 856 patent generally relates to “huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates.” The claimed methods of treatment purport to combat a variety of cancers. ImmunoGen provided Genentech with a “worldwide exclusive license,” which Genentech uses to produce the drug Kadcyla®TM. Phigenix, “a for-profit discovery stage biotechnology, pharmaceutical, and biomedical research company” that focuses “on the use of novel molecular therapeutics” designed to fight cancer, sought inter partes review. The Patent Board found the asserted claims of the 856 patent nonobvious. The Federal Circuit dismissed an appeal for lack of standing, finding that Phigenix has not offered sufficient proof establishing that it has suffered an injury in fact. Phigenix does not contend that it faces risk of infringing the 856 patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent. Phigenix only claimed that it has suffered an actual economic injury because the 856 patent increases competition between itself and ImmunoGen; “‘[i]ncreased competition represents a cognizable Article III injury,’” View "Phigenix, Inc. v. Immunogen, Inc." on Justia Law
In re: Ethicon, Inc.
Ethicon’s 844 patent relates to intraluminal medical devices for the local delivery of drugs, e.g., drug-eluting stents, and methods for maintaining drugs on those devices. Angioplasty can be used to alleviate blockages of blood vessels, but expansion of the balloon catheter during angioplasty can result in injury to the smooth muscle cells within the vessel wall, which can lead to restenosis, the gradual re-closure of the vessel. The 844 patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing restenosis. Following inter partes reexamination, the Patent Trial and Appeal Board affirmed the examiner’s rejection of several claims as obvious. The Federal Circuit affirmed. Substantial evidence supports the Board’s factual findings that the claimed invention is merely the simple substitution of a coating known to be useful in in vivo applications, including stents, in a weight ratio known to provide a good balance between strength and elasticity, for that coating. View "In re: Ethicon, Inc." on Justia Law
Medgraph, Inc. v. Medtronic, Inc.
Medgraph’s patents are directed to a method for improving and facilitating diagnosis and treatment of patients: data relating to “medically important variable[s],” such as blood sugar levels, measured from a patient’s body, are uploaded and transmitted to a central storage device, from which they can be accessed remotely by medical professionals. Medtronic manufactures and markets integrated diabetes management solutions, allowing patients to upload data relating to their diabetes, including blood glucose readings, to Medtronic’s server; patients can keep an online record and share the information remotely with a healthcare provider. Medgraph sued, alleging infringement. A year later, the Federal Circuit issued the first of its “Akamai” holdings, which culminated with a remand by the Supreme Court in 2014. The district court subsequently entered summary judgment of no infringement in favor of Medtronic, applying the law on direct infringement liability as it then stood, stating that “more than one person, i.e., the patient or doctor, neither of whom is an agent of or under contractual obligation to Medtronic, is required to perform all of the steps of the method claims.” The Federal Circuit then issued Akamai V, an en banc holding that attribution is proper “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.” The Federal Circuit affirmed, finding the decision unaffected by Akamai V. View "Medgraph, Inc. v. Medtronic, Inc." on Justia Law
In re: Nuvasive, Inc.
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
Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp.
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
In re: NuVasive, Inc..
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
In re: Efthymiopoulos
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
Mass. Inst. of Tech. v. Shire Pharma., Inc.
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
Yeda Research & Dev. Co., Ltd. v. Abbott GMBH & Co. KG
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 Health v. Lifecell Corp.
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