Functional Limitation, Claim Construction, and Obviousness: Bayer v. Mylan
| September 24, 2025
BAYER PHARMA AKTIENGESELLSCHAFT, v. MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA, INC., INVAGEN PHARMACEUTICALS INC.
Date of Decision: September 23, 2025
Before: MOORE, Chief Judge, CUNNINGHAM, Circuit Judge, and SCARSI, District Judge.
Summary
The Federal Circuit affirmed in part, vacated in part, and remanded the Patent Trial and Appeal Board’s decision invalidating claims of Bayer Pharma AG’s patent. The court upheld the invalidation of claims 1-4 but vacated and remanded with respect to claims 5-8.
Background
Bayer owns the ’310 patent (U.S. Patent No. 10,828,310), which claims methods for reducing the risk of cardiovascular events in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) through administration of rivaroxaban and aspirin.
Independent claim 1 recites administration of rivaroxaban and aspirin in clinically proven amounts. Independent claim 5 recites once-daily administration of a first product comprising rivaroxaban and aspirin and a second product comprising rivaroxaban. Claims 1 and 5 are listed below with emphasis added:
1. A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease, comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial dis-ease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily.
5. A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease, the method comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease, wherein the method comprises once daily administration of a first product comprising rivaroxaban and aspirin and a second product comprising rivaroxaban, and further wherein the first product comprises 2.5 mg rivaroxaban and 75-100 mg aspirin and the second product comprises 2.5 mg rivaroxaban.
Mylan, Teva, and InvaGen filed substantively identical IPR petitions, arguing that a 2016 journal article by Foley (summarizing a trial which includes its dosing regimen of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily without disclosing the trial results) and a 2014 journal article by Plosker (disclosing a dosing regimen of 2.5 mg rivaroxaban twice daily, co-administered with 75-100 mg aspirin) anticipated or rendered the claims obvious. The Board agreed and held all challenged claims unpatentable. Bayer appealed.
Discussion
The Federal Circuit addressed four disputes.
The first dispute is related to the phrase “clinically proven effective.” The Board had treated it as non-limiting or inherently anticipated. Bayer argued that the phrase should operate as a substantive limitation on the claims. According to Bayer, the language required that the claimed dosages of rivaroxaban and aspirin be supported by actual clinical trial evidence of efficacy, which in turn distinguished the claims from prior art references such as Foley. Bayer emphasized that Foley disclosed dosing regimens but did not provide trial results demonstrating that the regimens were effective and therefore could not anticipate or render the claimed methods obvious.
The Federal Circuit rejected this position, explaining that it did not decide whether the phrase “clinically proven effective” was a limiting element in claims 1-8. Even assuming it was limiting, the court reasoned that the phrase would not affect patentability because it merely described a characteristic of the treatment regimen rather than altering the steps of the claimed method. The court emphasized that the claims already specify the exact dosages of rivaroxaban and aspirin to be administered, and those dosages remain unchanged regardless of whether clinical trials later demonstrate efficacy. Accordingly, the limitation was deemed functionally unrelated to the claimed method and insufficient to distinguish the claims from the prior art.
The second dispute concerned the proper construction of the phrase “first product comprising rivaroxaban and aspirin” in claim 5. The Board had construed this language broadly to encompass circumstances where rivaroxaban and aspirin were provided in separate dosage forms and administered together, not limited to a single dosage form, and, if administered separately, the dosage forms could be administered simultaneously or sequentially.
The Federal Circuit disagreed with that interpretation. Relying on both the plain language of the claim and the description in the specification, the court concluded that “a first product comprising rivaroxaban and aspirin” required a single dosage form containing both ingredients. The court emphasized that the specification describes that “combination therapy may be administered using separate dosage forms for rivaroxaban and aspirin, or using a combination dosage form containing both rivaroxaban and aspirin.” The court agreed with Bayer that “first product comprising rivaroxaban and aspirin” corresponds to the latter, which narrows the term.
Therefore, the Federal Circuit remanded for further consideration so that the Board’s analysis of the obviousness arguments would be under the correct construction of the “first product” term.
The third dispute concerned whether the Board adequately explained a skilled artisan’s motivation to combine the prior art references with a reasonable expectation of success. The Federal Circuit agreed with the Board’s decision and found it supported by substantial evidence. The court noted that the Board identified both an overlap in the disclosed dosage ranges and the established practice of administering aspirin within that range. The court further found that Foley and Plosker described similar motivations for combining rivaroxaban with aspirin in patients with cardiovascular risk, which supported the Board’s conclusion that a skilled artisan would have had reason to combine the references with a reasonable expectation of success. Accordingly, the Federal Circuit affirmed the Board’s determination of obviousness as to dependent claims 3-4 and 6-7.
The fourth dispute concerned Bayer’s argument that its own clinical trial provided clinical proof of efficacy was an unexpected result. The Federal Circuit rejected this position, holding that there was no nexus between the asserted unexpected property and the claimed invention. The court explained that the asserted results were tied only to the “clinically proven effective” limitation, which it had already deemed functionally unrelated to the actual treatment method. Without that nexus, the secondary consideration of unexpected results could not support nonobviousness.
Takeaways
- Claim language that merely recites a property or result, without further defining the claimed steps or structure, may be deemed functionally unrelated and insufficient to establish distinction over the prior art.
- Secondary considerations require a demonstrated nexus between the evidence presented and the claimed invention as construed.
The Federal Circuit’s First AIA Derivation Case
| September 10, 2025
Global Health Solutions LLC v. Selner
Date of Decision: August 26, 2025
Before: Stoll, Stark, Circuit Judges. Goldberg, District Judge.
Summary:
The Federal Circuit addressed a derivation proceeding under the AIA for the first time. While derivation issues arose in pre-AIA interference proceedings, AIA derivation does not require a showing of who is first-to-conceive. Independent conception by an accused inventor overcomes the derivation accusation.
Procedural History:
Global Health Solutions (GHS) petitioned for an AIA derivation proceeding against Selner. The Patent Trial and Appeal Board (“Board”) granted the petition because GHS identified at least one claim in GHS’ application that is (i) the same or substantially the same as Selner’s claimed invention and is also (ii) the same or substantially the same as the invention disclosed to Selner. After the derivation proceedings, the Board ruled in Selner’s favor. GHS appealed to the Federal Circuit.
Background:
In 2013, Selner and Burnam worked together, although unsuccessfully, to make and sell a novel emulsifier-free wound treatment ointment. Burnam later left and formed GHS. GHS and Selner each filed a patent application on a wound treatment ointment and method for making it, resulting in permanently suspended nanodroplets without the use of an emulsifier that can irritate a patient’s skin. Selner is the first-filer, and GHS is the second-filer. An AIA derivation proceeding provides a limited opportunity for a first-inventor second-filer to obtain a patent despite another person filing an application first (first-filer) in the situation where the first filer derived the invention from the second-filer. During the derivation proceedings, the Board found that Burnam conceived the invention and communicated it to Selner, but the Board also found that Selner proved conception earlier the same day Burnam contacted him.
Decision:
Pre-AIA case law involving derivation often arose in the context of an interference to determine who was the first to invent under the previous first-to-invent law. However, when the AIA eliminated interferences and transformed 35 USC 135 from a law governing interferences to one governing derivation proceedings, Congress did not specify what a second-filer inventor must prove to show that the first-filer inventor derived the claimed invention from the second-filer inventor. However, the court concludes that “the required elements of a derivation claim have not changed other than to the extent necessary to reflect the transition from a first-to-invent to a first-to-file system of patent administration.”
Derivation in an AIA case requires the petitioner to “produce evidence sufficient to show (i) conception of the claimed invention, and (ii) communication of the conceived invention to the respondent prior to respondent’s filing of that patent application.” In a footnote, the Court sidestepped any decision regarding whether a party’s burden of proof in an AIA derivation proceeding is by a preponderance of evidence or by clear and convincing evidence (in pre-AIA interferences, proof of derivation was by clear and convincing evidence) since neither party raised this issue. But, a “respondent can overcome the petitioner’s showing by proving independent conception prior to having received the relevant communication from the petitioner.”
In particular, Selner need not prove that he was the first-to-conceive. Although the Board erred in focusing on whether Selner or Burnam was the first-to-invent or first-to-conceive, that was harmless error. “[A] first-to-file respondent like Selner need only prove that his conception was independent.” While the Board erroneously reached its decisions predicated on Selner being the first-to-conceive, the Board, in doing so, also indirectly determined that Selner independently conceived, and therefore, did not derive his invention from Burnam.
GHS argued that the Board erred by not requiring Selner to corroborate his inventorship with evidence independent of himself. The court found no such error. First, a “rule of reason test is used to determine whether an alleged inventor’s testimony is sufficiently corroborated.” Second, “the Board must consider ‘all pertinent evidence’ and then determine whether the ‘inventor’s story’ is credible.” More importantly, “[d]ocumentary or physical evidence that is made contemporaneously with the inventive process provides the most reliable proof that the inventor’s testimony has been corroborated.” Here, the corroboration was achieved through emails retrieved by Selner’s attorney’s law clerk from Selner’s AOL email account that were generated contemporaneously with the inventive process. And, such emails, whose authenticity was not challenged by GHS, do not require independent corroboration. In addition, the metadata generated by the web-based email server is independent of Selner’s own testimony and documents. Accordingly, the Board had substantial evidence for its findings of fact and there was no reversible error.
GHS argued that Selner did not show reduction to practice to prove conception. The court agreed with the Board that conception can occur without reducing the invention to practice. “Selner’s conception was complete at the point at which he was ‘able to define [the Invention] by its method of preparation’ or when he had formed ‘a definite and permanent idea of the complete and operative invention.’”
GHS argued that Burnam should be named as a co-inventor on Selner’s application. The court refused because GHS did not properly present this request to the Board and is thus forfeited. 37 CFR 42.22 requires a contested request for correction of inventorship in a patent application to be made in a separate motion, including a “statement of the precise relief requested” and a “full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent.” No such separate motion was made to the Board, nor was any detailed explanation supporting joint inventorship and material facts relating thereto provided.
Takeaways:
In this case, even though the second-filer showed conception and communication of the invention to the first-filer, the first-filer’s independent conception was a complete defense over the derivation accusation. Unfortunately for Burnam (because GHS did not file a separate motion for correcting inventorship in Selner’s application), the “independent” nature of Selner’s conception was never really challenged despite all the interactions between him and Selner.
This case also provided good reminders that reduction to practice is not required for showing conception, and that contemporaneously generated evidence can corroborate the inventor’s story.
