Justia Patents Opinion Summaries

Azurity Pharmaceuticals, Inc. filed a lawsuit against Alkem Laboratories Ltd. under the Hatch-Waxman Act, alleging infringement of claims 5, 7, 8, and 9 of U.S. Patent No. 10,959,948. The patent pertains to non-sterile drinkable liquid formulations containing the antibiotic vancomycin. Alkem had submitted an Abbreviated New Drug Application (ANDA) for a product that Azurity claimed infringed on their patent.The United States District Court for the District of Delaware conducted a two-day bench trial and concluded that Alkem’s ANDA did not infringe any of the asserted claims of the ’948 patent. The court found that Azurity had disclaimed any presence of propylene glycol in the prosecution history of the ’948 patent. Since Alkem’s ANDA product contained propylene glycol, the court ruled in favor of Alkem. Azurity argued that a stipulation made during discovery should preclude Alkem’s disclaimer argument, but the district court found this interpretation unpersuasive.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The Federal Circuit agreed that Azurity had clearly and unmistakably disclaimed propylene glycol during the prosecution of the ’948 patent. The court also found that the stipulation regarding suitable flavoring agents did not preclude the application of the disclaimer. Consequently, the presence of propylene glycol in Alkem’s ANDA product established non-infringement of the ’948 patent claims. The Federal Circuit affirmed the district court’s judgment, holding that Alkem’s ANDA product did not infringe the asserted claims of the ’948 patent. View "AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. " on Justia Law

In 2008, the plaintiff, ams-OSRAM USA Inc. (formerly Texas Advanced Optoelectronic Solutions, Inc. or TAOS), sued Renesas Electronics America, Inc. (formerly Intersil Corporation) in the Eastern District of Texas. TAOS alleged patent infringement and state-law claims of trade secret misappropriation and breach of a confidentiality agreement related to ambient-light sensors. The patent claim is no longer at issue. TAOS claimed that Intersil used confidential information disclosed during merger discussions to develop competing products.The district court entered a judgment in 2015 based on a jury verdict, awarding TAOS damages for trade secret misappropriation but not for breach of contract, deeming the latter duplicative. In 2018, the Federal Circuit affirmed Intersil’s liability for trade secret misappropriation on a narrower basis, vacated the monetary award, and remanded for further proceedings. The court also vacated the judgment denying contract damages as duplicative.On remand, the district court held additional proceedings, including a new jury trial. The court awarded TAOS $8,546,000 in disgorged profits for trade secret misappropriation, $17,092,000 in exemplary damages, and reasonable royalties for breach of contract totaling $6,637,693. The court also awarded prejudgment interest and attorneys’ fees. Both parties appealed.The United States Court of Appeals for the Federal Circuit affirmed the district court’s findings on the trade secret and contract claims, including the disgorgement and exemplary damages awards. However, the court reversed the finding that the trade secret became properly accessible in January 2006, determining the correct date to be February 28, 2005. The court affirmed the 26-month head-start period and the inclusion of profits from sales to Apple for the iPod Touch in the disgorgement award. The court vacated the prejudgment interest awards and remanded for further consideration of the appropriate accrual dates for interest on sales occurring after the complaint was filed. View "AMS-OSRAM USA INC. v. RENESAS ELECTRONICS AMERICA, INC. " on Justia Law

Donald Forest submitted a patent application for an "Apparatus for Selecting from a Touch Screen" to the United States Patent and Trademark Office (USPTO) on December 27, 2016. The Patent Trial and Appeal Board (PTAB) affirmed in part the examiner’s rejection of certain claims under 35 U.S.C. § 103 and nonstatutory double patenting. Forest appealed this decision.The PTAB reviewed the case and upheld the examiner's rejection of certain claims in Forest's patent application. Forest did not dispute that his application was filed more than a year after the expiration date of any resulting patent, which would have been in 2015. The USPTO raised a jurisdictional issue, arguing that Forest had no personal stake in the appeal because he could not be granted enforceable rights by a patent with zero term. Forest argued that he would still acquire "provisional rights" under 35 U.S.C. § 154(d) if the USPTO issued him an expired patent.The United States Court of Appeals for the Federal Circuit reviewed the case and disagreed with Forest's interpretation of the statute. The court held that provisional rights are granted only when a patent would issue with exclusionary rights, meaning before its expiration date. Since Forest's patent would issue after its expiration date, he would not receive any enforceable rights. Consequently, the court dismissed the appeal. View "In Re FOREST " on Justia Law

The case involves an appeal by the named inventors of U.S. Patent Application No. 11/005,678, which is directed to logistics systems and methods for the transportation of goods. The application was rejected by an Examiner under pre-AIA 35 U.S.C. § 102(e) as anticipated by a published patent application (Lettich) and under 35 U.S.C. § 103 as obvious over Lettich in view of another reference (Rojek). The inventors appealed the rejection to the U.S. Patent Trial and Appeal Board (Board).The Board initially reversed the Examiner's rejections but later granted the Examiner's request for rehearing, determining that Lettich did qualify as prior art under pre-AIA § 102(e). The Board then sustained the Examiner's anticipation and obviousness rejections. The inventors appealed the Board's decision to the United States Court of Appeals for the Federal Circuit.The Federal Circuit reviewed the case and found that the Board conducted an incomplete analysis in determining whether Lettich qualifies as prior art under § 102(e). Specifically, the court held that it is not sufficient to show that a single claim in the prior art application is supported by the provisional application; the specific portions of the application relied on in the rejection must also be supported by the provisional application. The court vacated the Board's decision and remanded the case for further analysis to determine whether the Lettich Provisional Application provides written description support for the specific disclosures in Lettich that the Examiner identified and relied on in the prior art rejections. View "In Re RIGGS " on Justia Law

Wash World Inc. sought to reverse a final judgment that it infringed Belanger Inc.'s 8,602,041 patent. Wash World contended that the district court erred in not construing three claim terms and that Belanger could not prove infringement under the correct constructions. Wash World also disputed the jury's decision to award Belanger $9.8 million in lost profits damages and requested a remittitur of approximately $2.6 million. Belanger argued that Wash World forfeited these issues by not preserving them in the district court.The United States District Court for the Eastern District of Wisconsin ruled that no construction was needed for the disputed terms and denied Wash World's motion for summary judgment of noninfringement. The jury found that Wash World’s Razor EDGE car wash system infringed Belanger’s patent and awarded $9.8 million in lost profits and $260,000 in reasonable royalties. The district court denied Wash World’s post-trial motions for judgment as a matter of law, a new trial, or remittitur.The United States Court of Appeals for the Federal Circuit reviewed the case. It found that Wash World forfeited its arguments regarding the constructions of "outer cushioning sleeve" and "predefined wash area" by not presenting them adequately in the district court. However, the court agreed with the district court's construction of "dependingly mounted" and affirmed the judgment of infringement.On the issue of damages, the Federal Circuit concluded that the jury's award improperly included $2,577,848 for convoyed sales, which lacked sufficient evidence of a functional relationship with the patented product. The court vacated the damages portion of the judgment and remanded with instructions to remit the damages by $2,577,848, resulting in a total award of $7,482,152 in favor of Belanger. View "WASH WORLD INC. v. BELANGER 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

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

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

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