Justia Civil Procedure 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

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

The patent venue statute, 28 U.S.C. 1400(b), provides that “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” In its 1957 “Fourco” decision, the Supreme Court concluded that for purposes of section 1400(b) a domestic corporation “resides” only in its state of incorporation, rejecting the argument that section 1400(b) incorporates the broader definition of corporate “residence” contained in the general venue statute, 28 U.S.C. 1391(c). Congress has not amended section 1400(b) since Fourco. Kraft filed a patent infringement suit in the District of Delaware against TC, a competitor, organized under Indiana law and headquartered in Indiana. TC ships the allegedly infringing products into Delaware. Reversing the district court and Federal Circuit, the Supreme Court held that, ss applied to domestic corporations, “reside[nce]” in section 1400(b) refers only to the state of incorporation. Section 1400(b) was enacted as a "stand alone" statute. Amendments to section 1391 did not modify the meaning of 1400(b) as interpreted by Fourco. View "TC Heartland LLC v. Kraft Foods Group Brands LLC" on Justia Law

The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

In 2003, SCA notified First Quality that its adult incontinence products infringed an SCA patent. First Quality responded that its patent antedated SCA’s patent and made it invalid. In 2004, SCA sought reexamination of its patent. In 2007, the Patent and Trademark Office confirmed the SCA patent’s validity. SCA sued for patent infringement in 2010. The district court granted First Quality summary judgment, citing equitable estoppel and laches. While SCA’s appeal was pending, the Supreme Court held that laches could not preclude a claim for damages incurred within the Copyright Act’s 3-year limitations period. The Federal Circuit nevertheless affirmed, based on Circuit precedent, which permitted laches to be asserted against a claim incurred within the Patent Act’s 6-year limitations period, 35 U.S.C. 286. The Supreme Court vacated. Laches cannot be invoked as a defense against a claim for damages brought within the limitations period. A statute of limitations reflects a congressional decision that timeliness is better judged by a hard and fast rule instead of a case-specific judicial determination. Applying laches within a statutory limitations period would give judges a “legislation-overriding” role that exceeds the Judiciary’s power and would clash with the gap-filling purpose for which the laches defense developed in the equity courts. View "SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC" on Justia Law

Xilinx a Delaware corporation headquartered in California, develops and markets programmable logic devices for electronics systems. Papst, organized and having its principal place of business in Germany, is a nonpracticing entity that does not manufacture or sell products. Papst’s website describes “a global patent licensing and monetization firm specialized in enforcing infringed patents with the goal to conclude a license agreement with the infringer.” Papst has repeatedly filed patent infringement suits in California federal courts. Before acquiring the patents-in-suit, Papst investigated potential infringers and targets for licensing, including 28 companies based, or having significant presence, in California. Papst sent a patent-infringement notice letter and a follow-up letter to Xilinx. Papst’s managing director, its senior counsel, and its Texas-based outside counsel, traveled to California to meet with Xilinx. No agreement was reached. Xilinx sought a declaratory judgment, in the Northern District of California, that Xilinx’s products do not infringe the patents-in-suit and that the patents are invalid. Papst filed an infringement suit against Xilinx in the District of Delaware asserting the same patents. The California court dismissed the declaratory judgment action for lack of personal jurisdiction. The Federal Circuit reversed; the court has specific personal jurisdiction over Papst. Considering the totality of circumstances, the court found “sufficient minimum contacts” and that the exercise of jurisdiction would not be unreasonable. View "Xilinx, Inc. v. Papst Licensing GMBH & Co. KG" on Justia Law

The 856 patent generally relates to “huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates.” The claimed methods of treatment purport to combat a variety of cancers. ImmunoGen provided Genentech with a “worldwide exclusive license,” which Genentech uses to produce the drug Kadcyla®TM. Phigenix, “a for-profit discovery stage biotechnology, pharmaceutical, and biomedical research company” that focuses “on the use of novel molecular therapeutics” designed to fight cancer, sought inter partes review. The Patent Board found the asserted claims of the 856 patent nonobvious. The Federal Circuit dismissed an appeal for lack of standing, finding that Phigenix has not offered sufficient proof establishing that it has suffered an injury in fact. Phigenix does not contend that it faces risk of infringing the 856 patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent. Phigenix only claimed that it has suffered an actual economic injury because the 856 patent increases competition between itself and ImmunoGen; “‘[i]ncreased competition represents a cognizable Article III injury,’” View "Phigenix, Inc. v. Immunogen, Inc." on Justia Law