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

Maquet Cardiovascular LLC owns U.S. Patent No. 10,238,783, which relates to an intravascular blood pump system designed to improve the deployment of blood pumps within a patient's circulatory system. The patent aims to address the difficulties associated with guiding blood pumps to the appropriate position using supplemental guiding mechanisms. Instead, it employs integrated guide mechanisms located on the device itself. Maquet sued Abiomed Inc. and its affiliates for infringing claims of the '783 patent and U.S. Patent No. 9,789,238.The United States District Court for the District of Massachusetts construed certain claim terms of the '783 patent, including "guide mechanism comprising a lumen" and "guide wire" terms. The court included negative limitations in its constructions based on the prosecution history of related patents. The parties stipulated to non-infringement based on these constructions, leading the district court to enter a final judgment of non-infringement for both patents.The United States Court of Appeals for the Federal Circuit reviewed the district court's claim constructions. The Federal Circuit found that the district court erred in applying prosecution disclaimer to the "guide mechanism comprising a lumen" term in claim 1 of the '783 patent, as the prosecution history of the related '238 patent was not relevant due to differences in claim language. The court also found that the district court erred in construing the "guide wire" terms in claims 1 and 24 of the '783 patent, as Maquet did not make a clear and unmistakable disavowal of claim scope during the prosecution of the '728 patent.The Federal Circuit vacated the district court's judgment of non-infringement as to the '783 patent and remanded for further proceedings. The judgment of non-infringement as to the '238 patent was left undisturbed. View "MAQUET CARDIOVASCULAR LLC v. ABIOMED INC. " on Justia Law

Actavis Laboratories FL, Inc. ("Actavis") filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of branded drugs. The manufacturers of these branded drugs, who hold New Drug Applications (NDAs) and patents, sued Actavis for patent infringement under the Hatch-Waxman Act. This Act considers the submission of an ANDA with a Paragraph IV certification as an act of patent infringement if it seeks FDA approval before the expiration of the patents. Actavis incurred significant litigation expenses defending these suits and deducted these expenses as ordinary business expenses on its tax returns.The IRS disagreed, treating these expenses as capital expenditures related to the acquisition of an intangible asset (FDA approval) and issued Notices of Deficiency. Actavis paid the assessed taxes and sued in the Court of Federal Claims for a refund, arguing that the litigation expenses were deductible. The Court of Federal Claims ruled in favor of Actavis, holding that the litigation expenses were deductible as ordinary business expenses.The United States Court of Appeals for the Federal Circuit reviewed the case. The court considered whether the litigation expenses were ordinary business expenses or capital expenditures. Applying both the "origin of the claim" test and the IRS regulation under C.F.R. § 1.263, the court concluded that the expenses were deductible. The court found that the origin of the claim was the patent infringement suit, not the pursuit of FDA approval, and that the litigation did not facilitate the acquisition of the FDA-approved ANDA. Therefore, the court affirmed the decision of the Court of Federal Claims, allowing Actavis to deduct the litigation expenses as ordinary business expenses. View "ACTAVIS LABORATORIES FL, INC. v. US " on Justia Law

AMP Plus, Inc., doing business as ELCO Lighting, appealed a final written decision by the Patent Trial and Appeal Board (PTAB) which found that ELCO failed to show claim 22 of U.S. Patent No. 9,964,266 was unpatentable as obvious. The patent, owned by DMF, Inc., relates to a compact recessed lighting system that can be installed in a standard electrical junction box. The key issue on appeal was whether claim 22, which includes a limitation referred to as "Limitation M," was obvious.The PTAB initially found that claim 17 of the patent was anticipated by prior art, but did not explicitly address the patentability of claim 22. ELCO appealed, and the United States Court of Appeals for the Federal Circuit vacated and remanded the case for the PTAB to address the arguments concerning claim 22. On remand, the PTAB concluded that ELCO failed to show the unpatentability of claim 22, noting that ELCO's petition lacked sufficient analysis and evidence to establish that the marine recessed lighting system disclosed in the prior art could be installed in a building, as required by Limitation M.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the PTAB's decision. The court held that ELCO's petition did not adequately address the specific requirement of Limitation M and that the evidence cited did not support the installation of the marine lighting system in a building. The court also rejected ELCO's argument that claim 22 was anticipated by the same prior art that anticipated claim 17, as this argument was not raised in the original petition. The court concluded that the PTAB's determination was supported by substantial evidence and affirmed the decision. View "AMP PLUS, INC. v. DMF, INC. " on Justia Law

Associated Energy Group, LLC (AEG) initiated multiple bid protests concerning contracts managed by the U.S. Department of Defense, Defense Logistics Agency Energy (DLA) to deliver fuel to a U.S. military base and nearby airfield in Djibouti. This appeal concerns whether AEG has standing to bring its second bid protest in the U.S. Court of Federal Claims, challenging a one-year sole-source bridge contract awarded to the incumbent contractor. AEG argued that officials within the Djiboutian Ministry of Energy and Natural Resources were preventing contract performance by threatening AEG’s contracted fuel delivery truck drivers and refusing to issue or renew petroleum activity licenses (PALs) to AEG and its contractors.The U.S. Court of Federal Claims dismissed AEG’s complaint for lack of subject matter jurisdiction, ruling that AEG lacked both Article III constitutional standing and Tucker Act statutory standing to challenge the sole-source bridge contract awarded to United Capital Investments Group, Inc. (UCIG). The Claims Court found that neither AEG nor its contractors possessed the required PAL, making AEG ineligible to bid on the contract.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Claims Court’s dismissal. The court held that AEG lacked Article III standing because it could not bid on or compete for the bridge contract due to the lack of a PAL. Additionally, the court found that AEG lacked statutory standing under the Tucker Act, as it did not have a substantial chance of winning the contract even if the alleged errors by DLA were corrected. The court concluded that an exception to mootness applied to the case, but AEG’s inability to secure the required PAL meant it had no concrete stake in the lawsuit. View "ASSOCIATED ENERGY GROUP, LLC v. US " on Justia Law

Larry Williams served in the U.S. Navy from August 1972 to March 1974 and filed a claim for compensation for schizophrenia in April 1978. The VA's Regional Office (RO) denied the claim in July 1978. Williams filed a Notice of Disagreement in January 1979, and the VA received additional evidence, including a hospital report diagnosing chronic schizophrenia. In June 1979, the RO confirmed the denial of service connection for schizophrenia but did not send this decision to Williams. Instead, the RO issued a Statement of the Case, which included the new evidence and confirmed the denial.Williams did not perfect his appeal to the Board of Veterans’ Appeals. In 2009, he submitted a claim to reopen his previously denied claim and was eventually granted a 100 percent disability rating effective June 4, 2009. Williams sought an earlier effective date, but the Board denied this request. The United States Court of Appeals for Veterans Claims affirmed the Board's decision, finding that the VA had complied with 38 C.F.R. § 3.156(b) in the 1979 Statement of the Case.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Veterans Court's decision. The Federal Circuit held that the VA met the requirements of 38 C.F.R. § 3.156(b) by issuing the 1979 Statement of the Case, which included the new evidence and confirmed the denial of service connection. The court found that the Statement of the Case provided sufficient indication that the VA considered the new evidence in connection with the pending claim, thus satisfying the regulatory requirements. View "WILLIAMS v. COLLINS " on Justia Law

Dollar Financial Group, Inc. (DFG) has operated loan financing and check cashing businesses under the name MONEY MART since the 1980s. In 2010, DFG began expanding its services to include pawn brokerage and pawn shop services, using the MONEY MART mark in commerce for these services starting in 2012. DFG registered two marks in 2013, which were officially registered in 2014. Brittex Financial, Inc. (Brittex) has operated pawn shops in Texas under the names MONEY MART PAWN and MONEY MART PAWN & JEWELRY since the 1990s and has common law rights in these marks.The Trademark Trial and Appeal Board (TTAB) initially denied Brittex’s petition to cancel DFG’s registrations, concluding that DFG had priority due to its earlier use of the MONEY MART mark for loan financing services. Brittex appealed, and the United States Court of Appeals for the Federal Circuit reversed the TTAB’s decision, finding that pawn services are not covered by loan financing services. On remand, the TTAB held that Brittex had priority for pawn services and that DFG could not rely on the zone of natural expansion doctrine to claim priority. The TTAB also found a likelihood of confusion between the marks and partially granted the petition for cancellation, requiring the deletion of "pawn brokerage and pawn shops" from DFG’s registrations.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the TTAB’s decision. The court held that the zone of natural expansion doctrine is purely defensive and cannot be used to establish priority offensively. The court also found that DFG’s tacking argument was forfeited as it was not raised before the TTAB. Additionally, the court concluded that substantial evidence supported the TTAB’s findings on the likelihood of confusion, including the similarity of the marks and the strength of Brittex’s mark. The court affirmed the TTAB’s partial cancellation of DFG’s trademark registrations. View "DOLLAR FINANCIAL GROUP, INC. v. BRITTEX FINANCIAL, INC. " on Justia Law

Realtek Semiconductor Corporation appealed a decision by the United States International Trade Commission (ITC) regarding a motion for sanctions against DivX, LLC. DivX had filed a complaint alleging a violation of 19 U.S.C. § 1337 by Realtek and others, which was later withdrawn. Realtek then sought sanctions against DivX for alleged misconduct occurring months prior. The Administrative Law Judge (ALJ) denied the motion on procedural grounds, and the ITC adopted this decision without comment.Realtek petitioned for the ITC to issue a show cause order sua sponte, which the ITC declined to do. Realtek argued that the ITC's failure to issue the order violated the Administrative Procedure Act (APA). The ITC and DivX contended that the appeal should be dismissed due to lack of standing, jurisdiction, and because the decision was unreviewable.The United States Court of Appeals for the Federal Circuit reviewed the case and determined that the ITC's decision not to issue a show cause order sua sponte was within its discretion and thus unreviewable under the APA. The court noted that such decisions are committed to agency discretion by law and are not subject to judicial review. Consequently, the court dismissed Realtek's appeal. View "REALTEK SEMICONDUCTOR CORPORATION v. ITC " on Justia Law

Regeneron Pharmaceuticals, Inc. sought a preliminary injunction against Amgen Inc., alleging that Amgen's biosimilar product, ABP 938, infringed its U.S. Patent 11,084,865. The patent covers a pharmaceutical formulation containing a fusion protein known as aflibercept, used in Regeneron's EYLEA® product for treating angiogenic eye disorders. Regeneron argued that Amgen's product, which does not contain a separate buffer component, infringed its patent claims.The United States District Court for the Northern District of West Virginia denied Regeneron's motion for a preliminary injunction. The court found that Regeneron failed to establish a likelihood of success on the merits, as the claims of the '865 patent required the VEGF antagonist and buffer to be separate components. The court applied the precedent from Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, which states that when a claim lists elements separately, the clear implication is that those elements are distinct components. The court determined that the intrinsic evidence, including the claims and specification, supported the conclusion that the VEGF antagonist and buffer must be separate components.The United States Court of Appeals for the Federal Circuit reviewed the district court's decision. The Federal Circuit affirmed the lower court's ruling, agreeing that the claims and specification of the '865 patent required the VEGF antagonist and buffer to be distinct components. The court found that the intrinsic evidence was clear and unambiguous, and the extrinsic evidence did not overcome the presumption of separateness. Consequently, the Federal Circuit held that Regeneron had not demonstrated a likelihood of success on the merits, and the denial of the preliminary injunction was appropriate. View "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc." on Justia Law

Merck Sharp & Dohme B.V. and Merck Sharp & Dohme, LLC owned U.S. Patent No. 6,670,340 (the '340 patent), which was directed to a class of 6-mercapto-cyclodextrin derivatives, including sugammadex. After the '340 patent issued, Merck applied for FDA approval of sugammadex, which took nearly twelve years. During this period, Merck filed for a reissue of the '340 patent, resulting in U.S. Patent No. RE44,733 (the RE'733 patent), which retained the original claims and added narrower claims directed to sugammadex. Merck then sought a five-year patent term extension (PTE) for the RE'733 patent based on the '340 patent's issue date.The United States District Court for the District of New Jersey granted Merck's request for a five-year PTE for the RE'733 patent, using the '340 patent's original issue date. Aurobindo Pharma and other defendants, who had filed Abbreviated New Drug Applications (ANDAs) for generic versions of BRIDION®, argued that the PTE should be calculated from the RE'733 patent's issue date, which would result in a shorter extension. The district court disagreed, holding that the PTE should be based on the original patent's issue date to align with the purpose of the Hatch-Waxman Act.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court's decision. The court held that, in the context of reissued patents, the reference to "the patent" in 35 U.S.C. § 156(c) refers to the original patent. This interpretation ensures that the PTE compensates for the time lost during regulatory review, consistent with the purpose of the Hatch-Waxman Act. Therefore, the RE'733 patent was entitled to a five-year PTE based on the '340 patent's issue date. View "MERCK SHARP & DOHME B.V. v. AUROBINDO PHARMA USA, INC." on Justia Law

Xencor, Inc. appealed a decision by the Appeals Review Panel (ARP) of the Patent Trial and Appeal Board (Board) rejecting claims of its patent application for lack of written description. The application involved methods of treating patients with anti-C5 antibodies, specifically focusing on claims 8 and 9. Xencor argued that the Board and ARP erred in their interpretation of the preamble of the claims and the requirement for written description.The Board initially rejected the claims, finding that the preambles were limiting and that Xencor had not shown sufficient written description for the claimed methods. Xencor's petition for reconsideration was denied, and the case was remanded to the ARP, which upheld the Board's decision. The ARP found that the preamble of the Jepson claim (claim 8) required written description and that the specification did not provide adequate support for the broad genus of anti-C5 antibodies or the specific use of these antibodies in treating patients.The United States Court of Appeals for the Federal Circuit reviewed the case. The court held that the preamble of claim 9, which included "treating a patient," was limiting because it was necessary to give meaning to the claim and was not merely a statement of purpose. The court also agreed with the ARP that the specification did not provide sufficient written description for treating a patient with the claimed anti-C5 antibodies, as it lacked examples and detailed descriptions of treating specific diseases or conditions.Regarding claim 8, the court held that the preamble of a Jepson claim requires written description, as it defines the scope of the claimed invention. The court found that Xencor had not established that anti-C5 antibodies were well-known in the art and that the specification did not provide adequate written description for the claimed genus of antibodies.The Federal Circuit affirmed the ARP's decision, concluding that Xencor's patent application did not meet the written description requirement for the claims in question. View "In Re XENCOR, INC. " on Justia Law