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

In this case, the United States Court of Appeals for the Federal Circuit considered whether the defendants' Abbreviated New Drug Applications (ANDAs) infringed two patents owned by the plaintiffs. The patents pertained to the use of the drug vortioxetine in the treatment of patients who had previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events, and for the treatment of cognitive impairment. The defendants were seeking approval to market vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults, a use not covered by the patents. The plaintiffs sought to block the defendants from marketing a generic version of the drug until after the expiration of the patents.The court held that the defendants' ANDA filings did not infringe the plaintiffs' patents. The court found that the defendants' intended use of the drug, for the treatment of MDD in adults, did not infringe the patents which pertained to other specific uses of the drug.Moreover, the court found no induced or contributory infringement. Regarding induced infringement, the court held that the defendants' proposed labels for the drug did not encourage, recommend, or promote an infringing use. Regarding contributory infringement, the court held that the defendants' sale of the drug would have substantial noninfringing uses, thus there would be no contributory infringement.Additionally, the court rejected Lupin's cross-appeal, which challenged the district court's determination that Lupin infringed a patent concerning a process for manufacturing vortioxetine. The court affirmed the district court's construction of the term "reacting" in the patent and its determination of infringement. View "H. LUNDBECK A/S v. LUPIN LTD. " on Justia Law

The case involves the classification of certain knit gloves with partial plastic coating under the Harmonized Tariff Schedule of the United States. The United States Court of Appeals for the Federal Circuit affirmed the decision of the United States Court of International Trade that the gloves are properly classified under heading 6116. The plaintiff, Magid Glove & Safety Manufacturing Co. LLC, imported the gloves from China and South Korea and argued that the gloves should have been classified under subheading 3926.20.10, a duty-free provision. However, the Court of International Trade and the Court of Appeals disagreed, stating that the gloves are not "of plastics" as required by heading 3926, but are "knitted" as described by heading 6116. The Court of Appeals also rejected the plaintiff's argument that Section XI Note 1(h) and the "completely embedded" test applied in a previous case excluded the gloves from classification under heading 6116. The court concluded that the term "completely embedded" does not appear in Section XI Note 1(h) or the two competing headings in this case and is not applicable to the classification of the gloves. View "MAGID GLOVE & SAFETY MANUFACTURING CO. LLC v. US" on Justia Law

In a case before the United States Court of Appeals for the Federal Circuit involving VLSI Technology LLC and Intel Corporation, the court examined claims of patent infringement and respective damages. VLSI alleged that Intel had infringed two of its patents, U.S. Patent No. 7,523,373 ("373 patent") and U.S. Patent No. 7,725,759 ("759 patent").The jury found that Intel had indeed infringed both patents and awarded separate damages for each. Intel appealed these decisions. The court affirmed the judgment of infringement of the 373 patent but reversed the judgment of infringement of the 759 patent. The court also vacated the award of damages for the 373 patent and remanded the case for a new trial limited to damages. The court further reversed the denial of Intel's motion for leave to amend to add a license defense.The court's decisions hinged on a number of factors, including the interpretation of the patents, the evidence presented by both parties, and the legal conclusions drawn by the district court. The court's decision underscores the complexity of patent infringement cases and the importance of accurately interpreting and applying patent law. View "VLSI TECHNOLOGY LLC v. INTEL CORPORATION " on Justia Law

In this case, the United States Court of Appeals for the Federal Circuit was asked to review a decision by the United States Court of International Trade. The dispute arose from an anti-dumping investigation conducted by the Department of Commerce into the sale of certain welded carbon steel pipes from Thailand, specifically those sold by Saha Thai Steel Pipe Public Company Limited and Thai Premium Pipe Company Ltd.The Department of Commerce initially found that the costs of producing these pipes were distorted by a "particular market situation" (PMS) in Thailand that affected the cost of hot rolled steel coil, a crucial component in the production of these pipes. As a result, the Department made upward adjustments to the production costs of these companies when calculating the anti-dumping margins, which impacted the duty rates assigned to each company. This decision was challenged in the Court of International Trade, which found that the Department had overstepped its statutory authority.The Court of International Trade ruled, based on the precedent set in Hyundai Steel Co. v. United States, that the Department of Commerce was not allowed to make a PMS adjustment to the cost of production when determining anti-dumping margins. The court remanded the case to the Department to recalculate the dumping margins without the PMS adjustment.The case was subsequently appealed to the United States Court of Appeals for the Federal Circuit. The appellant, Wheatland Tube Company, argued that this case could be distinguished from Hyundai Steel because the Department had relied on a subsection of the statute to adjust the cost of production upward to account for a PMS by framing it as a constructed value calculation. The Court of Appeals disagreed, affirming the lower court's decision and holding that the statute does not authorize PMS adjustments to cost of production calculations, regardless of how the Department attempted to frame it. View "SAHA THAI STEEL PIPE PUBLIC COMPANY LIMITED v. US " on Justia Law

In 1882-1883, the Railway acquired property and constructed the now-abandoned railroad line. In 2008, the Railway filed a notice of exemption from formal abandonment proceedings with the Surface Transportation Board (STB). The Illinois Department of Natural Resources showed interest in railbanking and interim trail use under the 1983 National Trails System Act Amendments, 16 U.S.C. 1247(d). The STB issued a Notice of Interim Trail Use (NITU). The owners of property adjoining the railroad line sued, alleging takings by operation of the Trails Act with respect to 51 parcels; 22 parcels were conveyed by instruments including the words “right of way” (ROW Agreements); three were conveyed by instruments including the words “for railroad purposes” (Purpose Agreements); and three are those for which no instruments were produced.The Claims Court granted the government summary judgment, finding that the Railway held the ROW Agreement and Purpose Agreement parcels in fee simple and that the owners failed to show that they had cognizable property interests in the non-instrument parcels. The Federal Circuit reversed. The court rejected the government’s argument that using the term “right of way” in the ROW Agreements referred to the land conveyed, not a limitation on the interest conveyed. For the Purpose Agreements, the Claims Court mistakenly relied on cases discussing deeds that did not include an expression of purpose in the granting clause. Illinois law indicates that the Railway obtained, at most, an easement over the non-instrument parcels. View "Barlow v. United States" on Justia Law

Purdue sued Collegium for infringement of its patent, meant to deter the abuse of opioid analgesics by the inclusion of an aversive agent, Collegium petitioned the Patent Trial and Appeal Board for post-grant review (PGR) of claims 1– 17. The Board found the challenged claims eligible for PGR because the pre-America Invents Act (AIA) 2001 application to which Purdue claimed priority did not contain sufficient written description support for the claimed invention. Under 35 U.S.C. 326(a)(11), the Board had one year to issue a Final Written Decision subject to a six-month extension. In September 2019, Purdue filed a Notice of Bankruptcy. The PGR proceeding and court case were stayed. In October 2019, a six-month extension was approved: “Petitioner should seek any relief it deems appropriate from the Bankruptcy Court.” Neither party sought guidance or an order lifting the stay from the bankruptcy court. The April 2020, extended deadline passed. In July 2020, the bankruptcy court lifted the stay for both proceedings.Rejecting Purdue’s motion to terminate the PGR, the Board concluded that “the AIA’s silence as to a consequence for timely issuing a final written decision does not divest us of our authority” and found claims 1–17 unpatentable for lack of written description and anticipation. The Federal Circuit affirmed. Under Supreme Court precedent, the Board has the authority to issue a Final Written Decision after the deadline proscribed in the statute has passed absent any contrary indication in the language, structure, or legislative history of the statute. View "Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc." on Justia Law

Telefex’s 116 patent. is directed to a method for using a guide extension catheter with a guide catheter. In 2019, Medtronic launched its own allegedly infringing guide extension catheter product, Telescope. Medtronic filed two petitions for inter partes review (IPR) of the 116 patent. The Federal Circuit affirmed the Patent and Trademark Office Patent Trial and Appeal Board in holding that Medtronic had not shown the challenged claims to be unpatentable. In finding that the claimed invention was conceived before the critical date of alleged prior art (Itou), the court determined that the claimed invention was actually reduced to practice before the critical date of Itou and the patent owner diligently pursued work on the invention until its constructive reduction to practice. “In vivo” testing was not required for actual reduction to practice because the claims at issue are method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” View "Medtronic, Inc. v. Teleflex Life Sciences Ltd.," on Justia Law

In 2018, Presidential Proclamation 9693 imposed duties on imports of solar panels, starting at 30% and scheduled to decrease each year to 25%, 20%, and in the final year, 15%. Importers of bifacial solar modules, consisting of cells that convert sunlight into electricity on both the front and back of the cells, petitioned the U.S. Trade Representative (USTR), asking that bifacial solar panels not be subjected to the duties. Ultimately, bifacial solar panels were excluded from the duties. In October 2020, Presidential Proclamation 10101, “modified” Proclamation 9693 to withdraw the exclusion of bifacial solar panels from the scheduled duties, and to increase the fourth-year duty rate to 18%. IImporters of bifacial solar panels sued, alleging that the statute authorizing the President to “modify” Proclamation 9693 only allowed him to make previously adopted safeguard measures more trade-liberalizing while eliminating the exclusion of bifacial panels and raising the fourth-year duty were trade-restrictive. They further argued that even if the President had the authority to “modify” safeguards in a trade-restrictive direction, he failed to follow appropriate procedures.The Trade Court agreed that the authority to “modify” a safeguard is limited to trade-liberalizing changes but rejected the procedural challenges under the Trade Act, 19 U.S.C. 2251. The Federal Circuit reversed. The President’s interpretation of the statute, which allows him to “modify” an existing safeguard in a trade-restricting direction, is not unreasonable. In adopting Proclamation 10101, the President committed no significant procedural violation. View "Solar Energy Industries Association v. United States" on Justia Law

Bell served on active duty from 1952-1954 in the Army, and from 1955-1957 in the Air Force. During service, Bell sustained a lower back injury. Years later Bell filed a VA claim for entitlement to service connection for a lumbar spine disability and received a 20% disability rating, effective March 2017. In a December 2019 internal memorandum, the agency requested an administrative review by the Director of Compensation Service on the issue of entitlement to an extra-schedular rating for Bell’s lumbar spine disability under 38 C.F.R. 3.321(b)(1); the agency recommended denying entitlement to an extra-schedular rating. The Director issued an advisory opinion denying entitlement, finding that the “lumbar spine disability picture does not demonstrate an unusual or exceptional disability pattern that would render application of the regular rating criteria impractical.” The regional office denied entitlement to an extra-schedular disability evaluation.The Board of Veterans’ Appeals the Veterans Court, and the Federal Circuit affirmed the decision. Bell “d[id] not present any argument, under any applicable authority,” why the denial should be reversed. The regulation authorizing the Director of Compensation Service to approve an extra-schedular rating does not prohibit the Director from considering recommendations from agency officials before making this decision. View "Bell v. McDonough" on Justia Law

Cloudbreak’s patent discloses compositions and methods for treating pterygium, an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea, by administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). The patent discloses that nintedanib in particular “may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization.”In inter partes review, the Patent Trial and Appeal Board held that the petitioner, Allgenesis, failed to prove two claims of the patent are unpatentable. The Federal Circuit dismissed an appeal. Allgenesis failed to establish an injury in fact sufficient to confer standing to appeal. Allgenesis identified no concrete plans to develop and bring to market a nintedanib treatment for pterygium and has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement. The court rejected an argument that Allgenesis suffered an injury in fact based on the Board’s priority determination that will have a preclusive effect on the scope of its pending patent application. Allgenesis has not established that the Board’s decision will have preclusive effect. View "Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC" on Justia Law