In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s decision holding claims directed to polymorphic form “β” of rifaximin invalid as obvious. 

Advice that may have served House of Pain in their 1992 hit song, “Jump Around,” to “bring a shotgun” to battle likely does not translate well to plaintiffs in federal litigation contemplating bringing a “shotgun” pleading to court. In this article we explore types of shotgun pleadings identified by courts and outline potential responses to a shotgun pleading.

On January 9, 2023, the U.S. Court of Appeals for the Federal Circuit in In re Stingray IP Solutions, LLC, No. 23-102 granted a writ of mandamus, vacating a decision of the Eastern District Court of Texas which had transferred a patent infringement suit filed against foreign defendants to the Central District of California based on defendants’ post-suit consent to jurisdiction there.

On December 19, 2022, U.S. Magistrate Judge Robert W. Lehrburger of the Southern District of New York recommended denying a motion to dismiss claims of willful infringement of eight patents asserted in a Second Amended Complaint (“SAC”). The recommendation finds (1) that pleading willful infringement does not require allegations of egregious infringing conduct and (2) that requisite knowledge of the asserted patents and alleged infringement could be satisfied by the filing of the Original Complaint along with plaintiff’s email (“pre-SAC email”) informing the defendants of additional alleged infringement of two patents prior to filing the SAC.

On October 5, 2022, U.S. Magistrate Judge Roy S. Payne of the Eastern District of Texas recommended denying-in-part a motion for summary judgment of no willful infringement, holding that requisite knowledge of the asserted patent and alleged infringement of that patent could be satisfied by notice of the lawsuit before the moving defendant was added as a party.

On July 12, 2022, U.S. District Judge Alan D. Albright of the Western District of Texas denied alleged infringer Lenovo’s motion to dismiss ACQIS’s willful and indirect infringement and enhanced damages claims, holding that patent owners need not allege egregious infringing behavior to assert a claim of willful infringement.

On March 16, 2022, U.S. District Judge William Alsup of the Northern District of California certified two of the hot button issues splitting district courts on the standard for pleading willful infringement, holding that:

• The complaint itself is insufficient to provide the requisite knowledge of the asserted patents and alleged infringement; and
• Patent owners need not otherwise allege egregious infringing behavior as part of a willful infringement claim.

Recognizing the split among district courts on these issues, the court certified its decision for interlocutory appeal to the Court of Appeals for the Federal Circuit under 28 U.S.C. § 1292(b). Thus, the Federal Circuit may soon have an opportunity to resolve this long-standing split among districts, which, according to Judge Alsup, has consumed a “vast amount of resources” in litigation around the country.

On January 26, 2022, in what appears to be a case of first impression, U.S. District Court Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant defendant’s motion to dismiss patent infringement claims brought in the second phase of the parties’ Biosimilar Price Competition and Innovation Act (“BPCIA”) litigation. In so doing, Judge Lee held that the reference product sponsor (“RPS”) plaintiff is not limited to only declaratory judgment actions in the second phase of litigation under the BPCIA.

On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an erroneous legal theory” in a suit alleging defendants’ proposed generic Abbreviated New Drug Application (“ANDA”) product would infringe Exela’s patents under the Hatch-Waxman Act. Judge Noreika’s decision in this case reinforces the Federal Circuit’s holding in Sunovion and serves as a reminder that ANDA product infringement is primarily assessed by comparing the asserted claims with the ANDA specification, rather than other ANDA submission materials further describing the ANDA product.