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

The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, establishes a scheme for adjudicating claims of patent infringement in the FDA's approval of “biological products.” To obtain FDA approval, the sponsor of a new biological product must demonstrate that it is “safe, pure, and potent.” For a “biosimilar” product based on an approved “reference” product, a party may submit an abbreviated “subsection (k)” application that “piggybacks” on the showing made for an approved reference product but must provide the reference product's sponsor with its subsection (k) application and information that describes the manufacturing process. The parties then collaborate to identify patents for immediate litigation. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the lists but not previously litigated. Hospira's subsection (k) application sought approval of a biosimilar of EPOGEN®, Amgen’s FDA-approved product, Although Amgen asserted that Hospira failed to disclose the composition of the cell-culture medium used during manufacturing, the parties began identifying patents. Amgen claimed that it could not assess the reasonableness of asserting infringement claims concerning other patents for culturing cells and moved to compel discovery on the composition of Hospira’s cell-culture medium in its suit on listed patents. The court denied Amgen’s motion, stating that the information had no relevance to the asserted patents. Amgen appealed that interlocutory order. The Federal Circuit dismissed, holding that it lacked jurisdiction under the collateral order doctrine and that Amgen failed to satisfy the prerequisites for mandamus. View "Amgen, Inc.. v. Hospira, Inc.." on Justia Law

NexLearn sued Allen in Kansas, alleging patent infringement and breach of contract. The companies had entered into a nondisclosure agreement to allow Allen to try NexLearn’s software, SimWriter®. Allen accessed SimWriter several times, then stated it was no longer interested in a deal with NexLearn, and developed its software, ZebraZapps. The agreement stated Kansas law governs the agreement. Allen, a Minnesota corporation with its principal place of business in Minnesota, argued it was not subject to Kansas jurisdiction, due to its limited contacts with the forum, which amounted to a single sale unrelated to ZebraZapps, and represented less than 1% of its five-year revenue. It argued the choice-of-law provision did not subject it to Kansas jurisdiction because NexLearn’s contract claim was supplemental to its patent claim, requiring NexLearn to establish personal jurisdiction over its infringement claim to bring its contract claim. NexLearn responded that Allen agreed to a License Agreement when it accessed SimWriter, specifying that “any dispute arising out of or related to this Agreement or the Product” must be brought in Kansas; that Allen “continually sent direct emails regarding ZebraZapps” to NexLearn employees; that Allen included Kansas in the dropdown menu on its ZebraZapps website; and summarized Allen’s activities with a trade association, which disseminated a magazine to Kansas residents that included Allen’s advertisement. The Federal Circuit affirmed dismissal for lack of jurisdiction. Allen’s website, plus its contacts with NexLearn create only an “attenuated affiliation” with Kansas, not a “substantial connection” as required for specific jurisdiction. View "NexLearn, LLC v. Allen Interactions, Inc." on Justia Law

Presumptive service connection exists for veterans who served in the Persian Gulf War and have chronic: undiagnosed illness; medically unexplained chronic multisymptom illness (MUCMI); or any diagnosed illness as determined by the Secretary, 38 U.S.C. 1117(a)(2). VA regulations define MUCMI as “a diagnosed illness without conclusive pathophysiology or etiology, that is characterized by overlapping symptoms and signs and has features such as fatigue, pain, disability out of proportion to physical findings, and inconsistent demonstration of laboratory abnormalities. Chronic multisymptom illnesses of partially understood etiology and pathophysiology, such as diabetes and multiple sclerosis, will not be considered medically unexplained.”. Both the statute and regulation identify sleep disturbances and signs or symptoms involving the respiratory system as possible MUCMI manifestations. The VA revised its M21-1 Manual, changing the definition of MUCMI to require “both an inconclusive pathology, and an inconclusive etiology.” Under the subsection “Signs and Symptoms of Undiagnosed Illnesses or MUCMIs,” the VA added, “Sleep apnea cannot be presumptively service-connected (SC) under the provisions of 38 C.F.R. 3.317 since it is a diagnosable condition.” The Federal Circuit dismissed a veterans’ group’s petition for review for lack of jurisdiction, reasoning that the revisions are not binding and not reviewable under 38 U.S.C. 502. View "Disabled American Veterans v. Secretary of Veterans Affairs" on Justia Law

Snyder represented a veteran, Beck, under a 2001 fee agreement (38 U.S.C. 5904). Eight months later, Snyder requested the Board of Veterans’ Appeals to cancel his fee agreement. In 2003 the VA awarded past-due benefits based on a 100% disability rating effective 1992. Snyder sought attorney fees. A VA regional officer (RO) determined that Snyder was entitled to $41,920.47, deductible from the past-due benefits. Beck filed notice of disagreement. Beck died. His widow sought to recover the disputed fees as accrued benefits. The RO denied that request. The Board dismissed Beck’s dispute over attorney fees, citing 38 C.F.R. 20.1302, and remanded Mrs. Beck’s claim. The RO determined Mrs. Beck could not recover the disputed attorney fees because her husband’s claim ceased to exist upon his death. She appealed. The VA’s General Counsel published a precedential opinion stating: A claim, pending at the time of a veteran’s death, challenging an attorney’s entitlement to payment of attorney fees under section 5904 from the veteran’s retroactive periodic monetary benefits may provide a basis for an accrued benefits claim under section 5121, because such a claim concerns entitlement to periodic monetary benefits allegedly due and unpaid to the veteran at the time of death. The Federal Circuit dismissed Snyder’s appeal. That 38 C.F.R. 20.1302 requires dismissal of a veteran’s appeal upon his death has no bearing on a claimant’s separate entitlement to accrued benefits under section 5121. The attorney fee dispute remains pending. View "Snyder v. Secretary of Veterans Affairs" on Justia Law

The District Court for the Northern District of Texas dismissed, for lack of personal jurisdiction, New World’s declaratory judgment complaint against FGTL, a wholly owned subsidiary of the automaker Ford Motor Company. FGTL had previously filed an infringement suit against New World in the Eastern District of Michigan. The Federal Circuit affirmed the dismissal of the declaratory judgment action. Both FGTL and the Ford Motor Company are incorporated in Delaware and headquartered in Michigan. FGTL does no business in Texas and neither maintains an office nor has any employees in Texas. FGTL does not make or sell automobiles or automotive products; it owns, manages, and licenses intellectual property for Ford. FTGL’s pertinent contacts with Texas are limited to the cease and desist letters. While those letters may be sufficient to constitute minimum contacts with the forum, they are not sufficient to satisfy the fairness part of the test for specific personal jurisdiction. View "New World International, Inc. v. Ford Global Technologies, LLC" on Justia Law

Rothschild alleged that ADS’s home security system infringed its 090 patent. Rothschild has filed numerous lawsuits against others alleging infringement of the 090 patent. ADS filed an answer and counterclaims and sent Rothschild an email alleging that the patent covered patent-ineligible subject matter (35 U.S.C. 1011) and that prior art anticipated claim 1 (35 U.S.C. 102(a)(1)). ADS offered to settle if Rothschild paid ADS $43,330 for attorney fees and costs. Rothschild rejected ADS’s offer. ADS moved for judgment on the pleadings, sending Rothschild an FRCP 11(c)(2) Safe Harbor Notice, with copies of a proposed Rule 11(b) motion for sanctions and prior art that purportedly anticipated the claim. Rothschild voluntarily moved to dismiss. ADS opposed and filed a cross-motion for attorney fees, arguing that Rothschild’s suit was objectively unreasonable because Rothschild knew or should have known that claim 1 covers patent-ineligible subject matter and was anticipated. The Federal Circuit reversed the holding that Rothschild had not engaged in conduct sufficient to make the litigation “exceptional” for purposes of section 285 attorney fees. Whether a party avoids or engages in sanctionable conduct under Rule 11(b) is not the appropriate benchmark; a court may award fees in the rare case in which a party’s unreasonable conduct—while not necessarily independently sanctionable—is so exceptional as to justify an award. View "Rothschild Connected Devices Innovations, LLC v. Guardian Protection Services, Inc." on Justia Law

Plaintiffs sued Nagel in Massachusetts Superior Court alleging 15 state-law claims. Nagel answered the complaint and filed 11 counterclaims under the Declaratory Judgment Act seeking declarations of non-infringement of several patents held by plaintiff Electromagnetics Corporation. Nagel also removed the case to the District of Massachusetts under 28 U.S.C. 1441, the general removal statute, and 28 U.S.C. 1454, the patent removal statute. The federal court remanded to state court, finding that it lacked subject-matter jurisdiction because plaintiffs’ state-law claims did not arise under federal law and Nagel’s patent counterclaims did not present a justiciable case or controversy under Article III. The Federal Circuit dismissed an appeal; 28 U.S.C. 1447(d) bars review of the district court’s decision to remand. To the extent the America Invents Act prefers that closely related state-law claims and patent-law counterclaims be heard together, it does not follow that the circuit courts have jurisdiction to review remand decisions that require such claims to be pursued in separate forums. “Absent a clear statutory command to the contrary, it is assumed that Congress is aware of the universality of th[e] practice of denying appellate review of remand orders when Congress creates a new ground for removal.” View "Preston v. Nagel" on Justia Law

A jury found that Pulse directly infringed Halo’s patents with products that it shipped into the U.S. and induced others to infringe those patents with products delivered outside the U.S. that ultimately were imported into the U.S. in finished products; it was highly probable that Pulse’s infringement was willful; and the Halo patents were not invalid. The jury awarded Halo $1.5 million in royalty damages. The court held that Pulse had not willfully infringed and taxed costs. Halo did not seek interest. The Federal Circuit affirmed that Pulse’s infringement was not willful. In June 2015, in the district court, Halo sought an accounting for supplemental damages and awards of interest. The Supreme Court subsequently held that the enhanced damages test applied by the Federal Circuit was inconsistent with 35 U.S.C. 284. On remand, the Federal Circuit vacated the unenhanced damages award with respect to products delivered in the U.S. and remanded. In the meantime, the district court awarded Halo prejudgment and post-judgment interest and supplemental damages for direct infringement. In November 2016, the court entered a stipulation of satisfaction of judgment for the $1.5 million damages award, including costs, supplemental damages, and post-judgment interest, expressly excluding prejudgment interest, enhanced damages, and attorney fees. The Federal Circuit dismissed an appeal for lack of jurisdiction. There is no final decision because the district court has not specified the means for determining the amount of prejudgment interest. View "Halo Eelectronics, Inc. v. Pulse Electronics, Inc." on Justia Law

Trade Court abused its discretion in waiving the exhaustion requirement in appeal of antidumping order. The Department Commerce initiated an investigation into whether oil country tubular goods (OCTGs) from Saudi Arabia and other countries were sold for less than fair value in the U.S. Commerce selected Duferco as the mandatory respondent; preliminarily found dumping; determined to treat Duferco and three affiliates as a single entity; and determined that Duferco is affiliated with JESCO, the producer of the OCTGs. Duferco owns 10 percent of JESCO. JESCO participated as a voluntary respondent. Commerce published its final determination, concluding that Saudi OCTGs were being dumped and recalculating the duty margin at 2.69 percent. Following the final determination, JESCO identified an error in Commerce’s calculation of Constructed Value (CV) profit. Correcting this error lowered JESCO’s CV profit, reducing JESCO's dumping margin to 1.37 percent. Commerce issued an amended negative final determination, imposing no duties. U.S. companies appealed, arguing that JESCO’s sales to a Colombian distributor were intra-company transfers within the Duferco entity, not an appropriate basis to construct CV profit--an argument not made during the investigation. The Trade Court affirmed Commerce’s determination, declining to apply the exhaustion requirement because the parties did not know that Commerce was considering using the Colombian sales until the final determination. The Federal Circuit vacated. Commerce need not expressly notify interested parties when it intends to change its methodology between its preliminary and final determinations, given the inclusion of the relevant data in the record and the advancement of arguments related to that data. The parties had an opportunity to raise their single entity objection before Commerce. View "Boomerang Tube LLC v. United States" on Justia Law

Comments that the Court of Federal Claims made during a hearing, before the government’s corrective action materially altered the relationship between the parties, were not sufficient to qualify the contractor as a “prevailing party” under the Equal Access to Justice Act, 28 U.S.C. 2412(a), (d)(1)(A). The Federal Circuit remanded the case, which involved Dellew’s post-award bid protest, alleging that the Army improperly awarded TSI a contract because TSI did not accept a material term of the request for proposals when it refused to cap its proposed general and administrative rate, and the contract awarded varied materially from TSI’s proposal. During oral argument, the Claims Court provided “hint[s]” about its views favorable to Dellew on the merits, and repeatedly expressed its belief that corrective action would be appropriate. The Army subsequently terminated the TSI contract. The Claims Court dismissed Dellew’s action, determined that it retained jurisdiction despited mootness, and awarded Dellew $79,456.76 in fees and costs, stating that it made “numerous substantive comments during oral argument regarding the merits,” that “carried a sufficient judicial imprimatur to materially alter the relationship between [Dellew] and [the Government] such that [Dellew] qualifies as a prevailing party under the EAJA.” View "Dellew Corp. v. United States" on Justia Law