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

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

Bullshine Distillery LLC applied to register the mark BULLSHINE FIREBULL for alcoholic beverages. Sazerac Brands, LLC opposed the registration, alleging a likelihood of confusion with its FIREBALL marks for liqueurs and whiskey. Bullshine counterclaimed, seeking cancellation of Sazerac’s registrations, arguing that "fireball" was a generic term for a type of alcoholic drink.The Trademark Trial and Appeal Board (Board) found that "fireball" was not generic at the time of registration or at the time of trial. The Board also determined that there was no likelihood of confusion between the FIREBALL marks and Bullshine’s BULLSHINE FIREBULL mark. Specifically, the Board found that while Sazerac’s FIREBALL mark was commercially strong, it was conceptually weak, the marks were dissimilar, the goods were purchased without great care, and Bullshine did not act in bad faith.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the Board’s decision, holding that the Board applied the correct legal standard in determining that "fireball" was not generic at the time of registration. The court found substantial evidence supporting the Board’s finding that "fireball" was not generic, including the lack of evidence that competitors used the term and the association of the term with specific products rather than a generic category.The court also affirmed the Board’s determination of no likelihood of confusion, finding that the Board’s analysis of the fame and conceptual strength of the FIREBALL mark, as well as the similarity of the marks, was supported by substantial evidence. The court concluded that the Board did not err in its findings and affirmed the decision in favor of Bullshine. View "Bullshine Distillery LLC v. Sazerac Brands, LLC" on Justia Law

Merck Patent GmbH owns U.S. Patent No. 10,647,861, which relates to α-alumina flakes used in various applications such as paints and cosmetics. CQV Co., Ltd. petitioned the Patent Trial and Appeal Board (PTAB) for post-grant review of claims 1-22 of the '861 patent, arguing that the claims were unpatentable due to obviousness based on prior art references, including a product known as Xirallic®. The PTAB concluded that CQV failed to show by a preponderance of the evidence that any of the challenged claims were unpatentable.The PTAB found that CQV did not adequately demonstrate that the Xirallic® lot used for Sample C qualified as prior art under the relevant critical dates. Consequently, the PTAB did not consider Xirallic® in its analysis and determined that CQV had not proven the claims were unpatentable. CQV appealed the PTAB's decision, arguing that the Board's decision was not supported by substantial evidence and that it failed to consider relevant evidence.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that the PTAB had not adequately considered the entirety of the evidence, particularly the unrebutted testimony regarding the availability of Sample C. The court noted that the PTAB must consider all relevant evidence and provide a satisfactory explanation for its decisions. The Federal Circuit vacated the PTAB's decision and remanded the case for further proceedings, instructing the PTAB to reassess whether Sample C was available as prior art by the critical dates and to provide a clear explanation of its findings. View "CQV CO., LTD. v. MERCK PATENT GMBH " on Justia Law

Sisvel S.p.A. owns U.S. Patent No. 7,869,396, which relates to a data transmission and retransmission method in a wireless communication system. The patent describes a method where data is packaged into protocol data units (PDUs) and assigned sequence numbers. The method includes a variation of the automatic repeat request (ARQ) method, where a receiver activates a timer when a PDU is detected as missing. If the missing PDU is not received before the timer expires, a reception failure is reported to the transmitter. If the missing PDU is received before the timer expires, the timer is stopped.The Patent Trial and Appeal Board (Board) held claims 1, 2, and 6–8 of the '396 patent to be unpatentable as anticipated by and obvious in view of International Patent Application Publication No. WO 02/091659 (Sachs). However, the Board held that claims 3–5, 9, and 10 were not shown to be unpatentable. Appellants Sierra Wireless, ULC; Honeywell International Inc.; and Telit Cinterion Deutschland GmbH appealed the Board’s decision regarding claims 3–5, 9, and 10. Sisvel cross-appealed the Board’s decision regarding claims 1, 2, and 6–8.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that the Board erred in its construction of the claim limitations and that its finding that Sachs disclosed certain limitations was not supported by substantial evidence. The court also determined that the Board abused its discretion by relying on testimony from Sisvel’s expert, Mr. Bates, without finding that he was qualified as an ordinarily skilled artisan.The Federal Circuit vacated the Board’s holdings that claims 1, 2, and 6–8 were unpatentable and remanded the case for further proceedings. The court did not reach the arguments regarding the patentability of claims 3–5, 9, and 10 due to the vacatur of the independent claims. View "SIERRA WIRELESS, ULC v. SISVEL S.P.A. " on Justia Law

AliveCor, Inc. appealed from three final written decisions of the Patent Trial and Appeal Board (Board) in related inter partes reviews (IPRs) that found all claims of its three patents unpatentable over certain prior art. The patents in question relate to systems and methods for measuring and analyzing physiological data to detect cardiac arrhythmias. The Board found the claims unpatentable based on obviousness and AliveCor's forfeiture of its discovery challenge.The Board's decisions were based on the combination of prior art references, including Hu 1997 and Li 2012, which teach the use of machine learning to assess ECG data, and Shmueli, which describes a system for detecting irregular heart conditions using PPG and ECG data. The Board found that a person of ordinary skill in the art would have been motivated to use machine learning in the context of PPG and ECG data to detect cardiac arrhythmias, and that Shmueli teaches the step of confirming arrhythmias using ECG measurements after detecting a potential arrhythmia using PPG.AliveCor argued that the Board erred in its obviousness findings and that Apple violated its discovery obligations by not producing secondary consideration evidence from a parallel ITC proceeding. However, the United States Court of Appeals for the Federal Circuit found that the Board's findings were supported by substantial evidence, including expert testimony, and that AliveCor forfeited its discovery argument by failing to raise it with the Board.The Federal Circuit affirmed the Board's decisions, concluding that the machine learning claims were obvious over the prior art and that the Board's interpretation of Shmueli was reasonable. The court also held that AliveCor's failure to present its discovery concerns to the Board precluded it from raising the issue on appeal. View "ALIVECOR, INC. v. APPLE INC. " on Justia Law

IQRIS Technologies LLC sued Point Blank Enterprises, Inc. and National Molding, LLC in the United States District Court for the Southern District of Florida for patent infringement. The patents in question relate to quick release systems on tactical vests. The defendants moved for summary judgment of noninfringement, arguing that their products did not include a "pull cord" as required by the patent claims. The district court agreed, granting summary judgment on the basis that the accused products did not infringe either literally or under the doctrine of equivalents.The district court construed the term "pull cord" to mean a cord that can be directly pulled by a user to disengage a releasable fastener or hook. Based on this construction, the court found that the accused products did not have a pull cord as defined, since their release mechanisms involved triggers and internal Bowden cables, which are not directly pulled by the user. The court also held that the accused products did not infringe under the doctrine of equivalents because the use of a trigger mechanism was not equivalent to a pull cord.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the district court's claim construction de novo. The Federal Circuit found that the district court erred in its construction of "pull cord" by improperly limiting it to cords that are directly pulled by a user and excluding cords with handles. The appellate court held that the claim language and specification did not support such a narrow interpretation. Consequently, the Federal Circuit vacated the district court's summary judgment of noninfringement and remanded the case for further proceedings consistent with the correct claim construction. View "IQRIS TECHNOLOGIES LLC v. POINT BLANK ENTERPRISES, INC. " on Justia Law

ImmunoGen, Inc. sought a patent for a dosing regimen for administering IMGN853, a drug used to treat ovarian and peritoneal cancers. The patent application claimed a specific dosing method using adjusted ideal body weight (AIBW). The U.S. Patent and Trademark Office (USPTO) rejected the claims, and the Patent Trial and Appeal Board affirmed the rejection. ImmunoGen then filed a civil action under 35 U.S.C. § 145 in the U.S. District Court for the Eastern District of Virginia, seeking a judgment that it was entitled to the patent.The district court initially granted summary judgment in favor of the government, finding the claims indefinite and obvious, and unpatentable under the doctrine of obviousness-type double patenting. The Federal Circuit vacated this decision and remanded the case for further proceedings. On remand, the district court held a bench trial and again ruled in favor of the government, determining that the claims were fatally indefinite and obvious, and thus unpatentable.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the district court's judgment on the grounds of obviousness, finding that a person of ordinary skill in the art would have been motivated to use AIBW dosing to address known toxicities associated with the drug and would have had a reasonable expectation of success. The court noted that the prior art disclosed similar dosing regimens and that the claimed dosing method was within the knowledge of a skilled artisan. The Federal Circuit did not address the issue of indefiniteness, as the obviousness determination was sufficient to affirm the judgment. View "IMMUNOGEN, INC. v. STEWART " on Justia Law

Odyssey Logistics & Technology Corp. filed a patent application for a web service interface for transit time calculation in 2007. The application was rejected by a patent examiner in 2015, and the Patent Trial and Appeal Board (PTAB) affirmed the rejection in 2018. Odyssey appealed to the United States Court of Appeals for the Federal Circuit, which affirmed the PTAB's decision in 2020. Odyssey did not raise an Appointments Clause challenge during this appeal.After the Supreme Court's decision in United States v. Arthrex, Inc. in 2021, which held that PTAB administrative judges' unreviewable authority violated the Appointments Clause, Odyssey requested Director review of the PTAB's 2018 decision. The United States Patent and Trademark Office (PTO) denied this request, stating that it did not accept requests for Director review of ex parte appeal decisions. Odyssey then filed a complaint in the United States District Court for the Eastern District of Virginia, seeking to compel the Director to consider its request. The district court dismissed the case for lack of subject matter jurisdiction.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court's dismissal, but on different grounds. The Federal Circuit concluded that the PTO did not abuse its discretion in denying Odyssey's request for Director review, noting that Odyssey had forfeited its Appointments Clause challenge by not raising it during the initial appeal. The court held that the PTO's decision to deny the request for review was reasonable given the significant delay and lack of justification for Odyssey's failure to raise the issue earlier. The Federal Circuit affirmed the district court's decision for failure to state a claim for relief under Rule 12(b)(6). View "ODYSSEY LOGISTICS & TECHNOLOGY CORP. v. STEWART" on Justia Law