Minnesota Patent Litigation Wrap-Up: Q2 2023

Co-Authored by: Ryan Petty, Ph.D.

This blog post was written in collaboration with Summer Associate Evan Falk.

This post continues our summary of substantive orders in patent litigation in the District of Minnesota. It includes a judgment on the pleadings in Hatch-Waxman cases and a declaratory judgment of invalidity.

Bristol-Myers Squibb Co. v. Nanocopoeia, LLC, Case No. 22-cv-1283 (KMM/JFD), 2023 WL 2867945 (D. Minn. March 24, 2023)¹

Plaintiff Bristol-Myers Squibb manufactures Sprycel^®, a drug used to treat certain forms of leukemia, which contains dasatinib crystalline monohydrate as the active ingredient. Id. at *1. BMS has two patents—the ’725 and ’103 patent—that cover the crystalline monohydrate form of dasatinib. Id. Defendant Nanocopoeia filed a New Drug Application with the Food and Drug Administration under 21 U.S.C. § 355(b), and included a paragraph IV certification that the ’725 and ’103 patents were either invalid or would not be infringed by Nanocopoeia’s proposed drug product. Id. BMS then sued Nanocopoeia for infringement under 35 U.S.C. § 271(e).

Nanocopoeia moved for judgment on the pleadings, arguing that its proposed drug product would not infringe the ’725 and ’103 patents. BMS responded by asserting that Nanocopoeia’s motion should fail on procedural grounds. Id. at *3. First, BMS argued that it need not state a particular theory of infringement at the pleadings stage. Id. But Judge Menendez observed that the artificial infringement cause of action created by the Hatch-Waxman Act did not relieve BMS of its obligations under Federal Rule of Civil Procedure 12. Id. Indeed, she noted that the Federal Circuit had granted judgment on the pleadings of noninfringement in the Hatch-Waxman context. Id. Second, BMS argued that the court could not consider documents attached to the pleadings “for the truth of the matter asserted within.” Id. at *4. But Judge Menendez noted that the documents at issue were the patents and FDA application, and thus the parties did not and could not dispute their authenticity. Id.

Moving to the merits, while the precise arguments are redacted in the court’s order, the parties generally disputed whether Nanocopoeia’s NDA specification “directly answer[ed] the question of infringement.” Id. at *5. This is particularly important, as Judge Menendez observed, because “[w]here the specifications in the defendant’s NDA directly resolve the infringement question by defining a proposed drug in a manner that either meets the limitations of an asserted patent claim or is outside the scope of such a claim, then the district court's analysis begins and ends with the NDA.” Id. (Internal quotations and citations omitted.) If the NDA specifications do not completely answer the infringement question, then courts may consider other evidence, including testing of drug samples and expert testimony, which would be inappropriate for a Rule 12 motion. Id. 

Judge Menendez then noted that Nanocopoeia could not identify any case where judgment on the pleadings had been granted where, as here, the parties disputed whether the NDA specifications completely answer the question of infringement. Id. Instead, her own research identified three categories of cases where judgment on the pleadings had been granted in Hatch-Waxman cases. Id. In the first category, the plaintiff conceded that the NDA specifications directly resolved the infringement inquiry. Id. In the second category, the patents were directed to method of use claims and the NDA was directed to approval for a different use. Id. at *6. In the third category, the issues were purely legal, including the application of prosecution history estoppel and disclosure-dedication. Id. None of those scenarios, however, were present here. Id. at *5-6.

Judge Menendez then independently reviewed the NDA specifications, although her analysis was heavily redacted. Id. at *6-7. There appeared, however, to be at least a claim construction dispute, and district courts have “‘repeatedly held’ that if a court must engage in claim construction to ‘resolve a motion to dismiss or motion for judgment on the pleadings, the motion should be denied, because this type of analysis is inappropriate at the pleading stage.’” Id. (quoting Anglefix Tech, LLC v. NuVasive, Inc., No. 13-CV-983-BEN(RBB), 2014 WL 197736, at *2 (S.D. Cal. Jan. 14, 2014)). Her review concluded that there were “quintessential factual disputes . . . that are inappropriate for the Court to resolve on the pleadings.” Id. at *7. Accordingly, Judge Menendez denied Nanocopoeia’s motion for judgment on the pleadings. Id.

Condair Grp. AG v. Dri-Steem Corp., Case No. 21-cv-0863 (PJS/ECW), 2023 WL 3480240 (D. Minn. May 16, 2023)

Plaintiff Condair Group AG alleged that humidifiers manufactured by defendant Dri‐Steem Corporation infringed claim 17 of U.S. Patent No. 10,634,372. Id. at *1. The ’372 patent relates to dual‐stage vaporizing humidifiers that increase energy efficiency by using a secondary heat exchanger to warm replacement water fed into the humidifier using hot exhaust gases. Id. Dri‐Steem moved for summary judgment of invalidity, arguing claim 17 was invalid as obvious and indefinite. Id.

On obviousness, Dri‐Steem relied on Korean Patent No. 10‐1243698, which disclosed a boiler “having a structure that maximizes thermal efficiency by installing double [heat exchangers].” Id. This efficiency is accomplished by “selectively controlling when water from the tank . . . should be reheated using the hot exhaust gases by selectively running water from the tank . . . through the [heat‐exchanger] . . . and back into the tank.” Id. Judge Schiltz noted that whether an invention was obvious is ultimately a legal question for the court, but that determination is based on several factual findings. Id. at *2. He concluded that there were disputed issues of material fact, including whether boiler art (generally) and the Korean Patent (specifically) are relevant prior art and, if so, whether they teach using a secondary heat exchanger, and whether it was obvious to combine the heat exchanger with a controlled valve. Id. Because these disputes remained for the jury, Judge Schiltz denied summary judgment of obviousness. Id.

Judge Schiltz next considered indefiniteness. Dri-Steem argued that claim 17 was indefinite because it was an apparatus claim that also recited a method of using the apparatus. Id. at *3. Specifically, Dri‐Steem contended that “a secondary fill valve . . . which is pulsed to provide cool water” and “the water from a primary fill valve is fed directly into the water tank” described method steps. Id. Judge Schiltz noted that, while the Federal Circuit had held in IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005), that a single claim covering both an apparatus and method of using an apparatus is indefinite, subsequent cases from the Federal Circuit had “clarified that an apparatus claim is not indefinite simply because it uses functional language.” Id. (citing Microprocessor Enhancement Corp. v. Tex. Instruments Inc., 520 F.3d 1367, 1375 (Fed. Cir. 2008)). He further explained that a claim disclosing an apparatus that is “capable of performing [certain] functions” is not indefinite so long as the claim’s functional language is tied to the structure of the apparatus. Id. Judge Schiltz concluded that the verbal phrases on which Dri‐Steem focused (“is pulsed” and “is fed”) actually described the functions of structural elements of the claimed humidifier, not actions that must be performed by a user of the humidifier. Id. Since claim 17 did not describe any method steps, Judge Schiltz denied summary judgment of indefiniteness. Id.