Justia Patents Opinion Summaries

Apotex applied to the FDA, under the Biologics Price Competition and Innovation Act of 2009, for permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA-approved Neulasta®. Apotex and Amgen proceeded under the Act’s process for exchanging information and channeling litigation about patents relevant to the application. In this suit, Amgen alleged that Apotex’s proposed marketing would infringe an Amgen patent. On Amgen’s motion, the district court preliminarily enjoined Apotex from entering the market unless it has given Amgen notice after receiving the requested FDA license and then waited 180 days, pursuant to 42 U.S.C. 262(l)(8)(A). The Federal Circuit affirmed. The Act’s commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and an injunction was proper to enforce the provision against even a biosimilar product​ applicant that did engage in the statutory process for exchanging patent information and channeling patent litigation. View "Amgen Inc. v. Apotex Inc." on Justia Law

Plaintiffs filed suit alleging that defendant fraudulently obtained his federal trademark registration for the PUDGIE’S mark in connection with restaurants that principally serve pizza, pasta, and submarine sandwiches. The district court granted summary judgment to plaintiffs. In this case, the district court correctly concluded that no material issue of fact existed as to whether defendant knowingly made false, material representations in his application where the specimen he included with his application exhibited that the PUDGIE'S mark originally came from another source. The court concluded that no genuine issue of material fact exists as to whether defendant knew that other entities had rights to use the mark in the very manner in which he sought to use the mark, and whether he intended to mislead the PTO by attesting otherwise in his trademark application. Accordingly, the court affirmed the judgment. View "MPC Franchise, LLC v. Tarntino" on Justia Law

In January, 2000, Immersion filed an application (846 patent) with the U.S. Patent and Trademark Office, disclosing a mechanism for providing haptic feedback to electronic device users. Immersion filed an International Application that published as WO 109 in July, 2001. The two written descriptions are materially identical. The WO 109 publication invalidates claims to its disclosed subject matter unless those claims were entitled to an effective filing date before July 26, 2002, 35 U.S.C. 102(b). On August 6, 2002, the day the 846 patent issued, Immersion filed the application for the 875 patent, which shared its description. Immersion asserted a January 2000 effective filing date (846 patent’s application date), citing 35 U.S.C. 120, under which, “[a]n application for patent for an invention disclosed adequately … in an application previously filed ... shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application.” This timing benefit shrinks the universe of “prior” art for determining validity. The district court held that the 875 application was not “filed before the patenting” of the 846 application because they were filed on the same day, so that the 875 patent’s filing date was August 6, 2002, rendering the patent invalid because the WO 109 publication was published more than one year earlier. The Federal Circuit reversed: an application may be “filed before the patenting” of the earlier application when both legal acts, filing and patenting, occur on the same day. View "Immersion Corp. v. HTC Corp." on Justia Law

A third party may ask the Patent and Trademark Office (PTO) for inter partes review to reexamine claims in an issued patent and to cancel any claim found to be unpatentable in light of prior art; the decision “whether to institute an inter partes review . . . shall be final and non-appealable,” 35 U.S.C. 314(d). PTO is authorized to issue regulations governing inter partes review. One such regulation provides that, during inter partes review, a patent claim “shall be given its broadest reasonable construction in light of the specification of the patent in which it appears.” Garmin sought inter partes review of Cuozzo’s patent, asserting that claim 17 was obvious in light of prior patents. PTO reexamined claims 17, 10 and 14, finding those claims to be logically linked to the challenge; concluded that the claims were obvious in light of prior art; and canceled the claims. The Federal Circuit and Supreme Court affirmed. Section 314(d) bars a challenge to the decision to institute review. The “strong presumption” favoring judicial review is overcome by clear and convincing indications that Congress intended to bar review of the determination “to initiate an inter partes review under this section,” or where the challenge consists of questions closely tied to statutes related to that determination. Cuozzo’s claim does not implicate a constitutional question, nor present other questions beyond “this section.” The regulation requiring the broadest reasonable construction standard is a reasonable exercise of PTO's rulemaking authority, which is not limited to procedural regulations. The purpose of inter partes review is not only to resolve disputes among parties, but also to protect the public’s “paramount interest in seeing that patent monopolies . . . are kept within their legitimate scope.” Congress did not dictate what standard should apply in inter partes review. The broadest reasonable construction standard helps ensure precision in drafting claims and prevents a patent from tying up too much knowledge; PTO has used the standard for more than 100 years. View "Cuozzo Speed Techs., LLC v. Lee" on Justia Law

Allied’s patent, “Multiple Tool Attachment System,” is directed to heavy machinery construction and demolition tools, such as metal cutting shears, plate shears, concrete crushers, and grapples, that can be attached to a universal body. Traditionally, such tools were separate. The system has a “quick change feature” for easy conversion to each of several tools. Genesis sought inter partes reexamination, asserting the patent was unpatentable because it was anticipated and obvious over prior art. During reexamination, Allied amended claims and added new claims. A U.S. Patent and Trademark Office examiner allowed the amended claims and confirmed patentability. The Patent Trial and Appeals Board concluded that seven claims would have been obvious and allowed Allied to reopen prosecution. Allied submitted a second round of amendments. The examiner found the amendments did not overcome the PTAB’s ground of rejection. The PTAB affirmed, finding that prior art “teaches one of ordinary skill in the art the desirability of simplifying disassembly of jaws, and discloses a mechanism for doing so,” and that a person of ordinary skill in the art could have modified prior art to provide for a “wide range of angular movement.” The Federal Circuit affirmed, stating that substantial evidence supported a finding of motivation to combine prior art references. View "Allied Erecting & Dismantling Co., Inc. v. Genesis Attachments, LLC" on Justia Law

Pompe’s disease is a genetic condition associated with a deficiency or absence of the lysosomal enzyme acid α-glucosidase (GAA), which breaks down glycogen, a larger molecule, into glucose. In a person with Pompe’s disease, glycogen accumulates in the heart and muscles, causing progressive muscle weakness and respiratory symptoms, and, in early-onset cases, cardiac symptoms. Early efforts at enzyme replacement therapy failed because the injected enzyme was predominantly taken up by the patient’s liver. By 1997, research had progressed and the FDA approved Duke University’s application for Orphan Drug Designation for a new therapy, involving injection of a recombinant form of GAA. In 2013, Biomarin sought inter partes review of Genzyme’s patents, directed to treating Pompe’s disease with injections of GAA, asserting that claims were obvious, given the Duke press release and prior references. Genzyme argued that because all references described in vitro experiments, a person of ordinary skill would not find those experiments predictive of results in a human patient. The Federal Circuit affirmed the Patent Board’s conclusion that “a person of ordinary skill in the art would have had a reasonable expectation of success at the time the invention was made,” and “no more than routine processes were needed” to achieve the results recited in the disputed claims. View "Genzyme Therapeutic Prods., Ltd. P'ship v. Biomarin Pharma., Inc." on Justia Law

In Patent Act infringement cases, courts may increase the damages up to three times the amount assessed, 35 U.S.C. 284. Under the Federal Circuit’s “Seagate” test for section 284 damages, a patent-holder had to demonstrate by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent and that the risk of infringement “was either known or so obvious that it should have been known to the accused infringer.” The Federal Circuit reviewed objective recklessness de novo; subjective knowledge for substantial evidence; and the award of enhanced damages for abuse of discretion. The Supreme Court unanimously held that the Seagate test is inconsistent with section 284, which includes no precise rule for awarding damages. By requiring an objective recklessness finding, the test excluded from discretionary punishment many of the most culpable offenders, including the “wanton and malicious pirate” who intentionally infringes a patent, with no thoughts about its validity or defenses. A patent infringer’s subjective willfulness, whether intentional or knowing, may warrant enhanced damages, regardless of whether infringement was objectively reckless. Under Seagate, the ability of the infringer to muster a reasonable defense at trial was dispositive, even if he was not previously aware of the defense. Culpability is generally measured against the actor’s knowledge at the time of the challenged conduct. Seagate’s clear and convincing evidence requirement is also inconsistent with section 284, which imposes no specific evidentiary burden, much less such a high one. The Court also rejected the Federal Circuit’s tripartite appellate review framework. Section 284 commits the enhanced damages determination to the district court’s discretion; that decision should be reviewed for abuse of discretion. View "Halo Elecs., Inc. v. Pulse Elecs., Inc." on Justia Law

ComplementSoft’s patent, issued in 2006, is directed to an “Integrated Development Environment for generating and maintaining source code . . . in particular, programmed in data manipulation languages,” and characterizes a development environment as comprising a set of software tools allowing users to develop, edit, and debug software for a particular programming language or set of programming languages. The contemplated development environment utilizes a graphical user interface and is particularly designed for data manipulation languages, including SAS®, which is developed by SAS. On SAS's petition for inter partes review, the Patent Trial and Appeal Board found all of the instituted claims, except for claim 4, unpatentable in view of prior art. The Federal Circuit agreed on the challenged constructions and determined that the Board did not need to address claims it did not institute. The court vacated the determination that claim 4 was patentable and remanded for the parties to address a new construction that the Board adopted in its final decision after previously interpreting the claim differently. The court noted that it is uncertain whether SAS will be able to show unpatentability of claim 4 even under the construction of “graphical representations of data flows” that the Board adopted and that it agreed with. View "SAS Inst., Inc. v. ComplementSof, LLC." on Justia Law

Indacon’s patent is directed to a system and method for searching, indexing, perusing, and manipulating files in a database, particularly through the insertion of automatically generated hyperlinks. Following the district court’s claim construction order, Indacon stipulated to noninfringement. The court entered final judgment in favor of Facebook. The Federal Circuit affirmed, upholding the constructions of the claim terms “alias,” “custom link,” “custom linking relationship,” and “link term.” View "Indacon, Inc. v. Facebook, Inc." on Justia Law

Warsaw’s 973 patent claims oversized spinal implants; its 933 patent claims methods and devices for retracting tissue to create a working channel for minimally invasive spinal surgery. NuVasive’s patent relates to neuromonitoring during surgery. Warsaw sued NuVasive, alleging infringement; NuVasive counterclaimed, asserting infringement. A jury found that the asserted claims of the 973 patent were not invalid (infringement was not in dispute), that the asserted claims of the 933 patent were infringed under the doctrine of equivalents (validity was not in dispute), and that the asserted claims of the NuVasive patent were infringed (validity was not in dispute), and awarded damages for each. The Federal Circuit affirmed with respect to invalidity and infringement of all three patents, but remanded for a new trial on damages with respect to the 973 and 933 patents. The Supreme Court remanded for further consideration in light of its 2015 decision, Commil USA v. Cisco Systems, which reaffirmed that willful blindness can satisfy the knowledge requirement for active inducement under 35 U.S.C. 271(b). The First Circuit reaffirmed the district court’s judgment with respect to the NuVasive patent and otherwise reinstated its earlier judgment. There was substantial evidence from which a jury could reasonably have found knowledge or willful blindness to infringement. View "Warsaw Orthopedic, Inc. v. NuVasive, Inc." on Justia Law