If It Isn’t The Same, It’s Different!
| December 4, 2025
MERCK SERONO S.A., Appellant v. HOPEWELL PHARMA VENTURES, INC., (Presidential)
Date of Decision: October 30, 2025
Panel: Before HUGHES, LINN, and CUNNINGHAM, Circuit Judges. LINN, Circuit Judge.
Summary:
Merck Serono S.A. (“Merck”) appeals the determinations by the Patent Trial and Appeal Board (“Board”) in two consolidated inter partes reviews (“IPR”). In this case, the Board held several claims of Merck’s U.S. Patent No. 7,713,947 (“’947 patent”) and U.S. Patent No. 8,377,903 (“’903 patent”) unpatentable as obvious over a combination of Bodor and Stelmasiak. The Patents in question related to oral formulations of cladribine to treat MS.
In 2002, Serono partnered with IVAX Corporation (“Ivax”) to develop oral cladribine to treat MS. Serono was acquired by Merck in 2006. Under their joint research agreement, Merck would “‘conduct clinical trials’ to determine ‘the dose, safety, and/or efficacy’” of cladribine oral tablets, and Ivax would “develop an oral dosage formulation of [cladribine] in tablet or capsule form suitable for use in clinical trials and commercial sale.” On March 26, 2004, Ivax employees Drs. Bodor and Dandiker filed the Bodor international patent application (the primary reference used by Hopewell here). The application was published less than one year before the effective filing date of the patents in-suit, which were each filed December 22, 2004. Both patents list as inventors: Drs. De Luca, Ythier, Munafo, and Lopez Bresnahan (collectively, “named inventors”). All four were employees of Serono and, in at least some way, were a part of the development team that developed the claimed oral cladribine regimen back in 2002 (as evidenced by meeting minutes).
Hopewell Pharma Ventures, Inc. (“Hopewell”) filed two IPRs, respectively challenging claims of the ’947 patent and the ’903 patent as obvious over Bodor and Stelmasiak. The Board held that all challenged claims were unpatentable as obvious thereover. In doing so, the Board rejected patentee’s legal argument that “a reference’s disclosure of the invention of a subset of inventors is disqualified as prior art against the invention of all the inventors.” Id. at 36 (emphasis in original). The rule of In re Land, 368 F.2d 866 (CCPA 1966), that any difference in the “inventive entity” between the reference disclosure and the challenged claims—whether adding or subtracting inventors—rendered the reference a disclosure “by another” and therefore available as prior art, was affirmed. The Board also found there was insufficient corroboration evidence that De Luca’s contribution provided an inventive contribution found in Bodor, as would be required to exclude the disclosure from the prior ar.
Ultimately the CAFC affirmed the Board’s determinations.
Under pre-AIA § 102(e), a patent is anticipated if “the invention was described in . . . a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent.” 35 U.S.C. 102(e) (emphasis added).
The question presented to the CAFC in this appeal is “whether and to what extent a disclosure invented by fewer than all the named inventors of a patent may be deemed a disclosure “by another” and thus included in the prior art, or whether the disclosure should properly be treated as “one’s own work” and therefore excluded from the prior art.”
Merck argued for the latter, but the CAFC found for the first.
Merck focuses on the following two sentences in Applied Materials, Inc. v. Gemini Res. Corp., 835 F.2d 279 (Fed. Cir. 1987):
However, the fact that an application has named a different inventive entity than a patent does not necessarily make that patent prior art.
Id. at 281 (citing In re Kaplan, 789 F.2d 1574, 1576 (Fed. Cir. 1986)); Appellant’s Opening Br. 30–31. And:
Even though an application and a patent have been conceived by different inventive entities, if they share one or more persons as joint inventors, the 35 U.S.C. § 102(e) exclusion for a patent granted to ‘another’ is not necessarily satisfied.
Applied Materials, 835 F.2d at 281 (emphasis added); Appellant’s Opening Br. 29.
Merck essentially argued that the Courts have rejected a bright-line rule requiring an identical inventive entity to exclude a reference as not “by another.”
The CAFC held that Merck overreads Applied Materials. The CAFC clarified that the decision did not rely on the fact that two of the three named inventors in the later patent were named in the earlier reference patent. Instead, the decision rested on the fact that the later patent and the earlier reference patent were descendants of the same application. The CAFC emphasized that it is erroneous to place too much reliance on the inventive entity “named” in the earlier reference patent: “[T]he fact that an application has named a different inventive entity than a patent does not necessarily make that patent prior art.” Id. (emphasis added). Instead, like in Land, the key question is whether the disclosure in the earlier reference evidenced knowledge by “another” before the patented invention.
The CAFC stated that:
Our case law—in particular, Land—precludes our adoption of the policy argument presented by Merck. As those cases make clear, for a reference not to be “by another,” and thus unavailable as prior art under pre-AIA § 102(e), the disclosure in the reference must reflect the work of the inventor of the patent in question. That is clear enough when a single inventor is involved. What should also be clear is that when the patented invention is the result of the work of joint inventors, the portions of the reference disclosure relied upon must reflect the collective work of the same inventive entity identified in the patent to be excluded as prior art. That showing may be made by fewer than all the inventors but nonetheless must evince the joint work of them all to avoid being considered a work “by another” under the statute. Any incongruity in the inventive entity between the inventors of a prior reference and the inventors of a patent claim renders the prior disclosure “by another,” regardless of whether inventors are subtracted from or added to the patent.
Here, ultimately, Merck failed to provide sufficient evidence that one of the inventors had made an inventive contribution to the relevant disclosure in Bodor, but even if Merck had shown such a contribution, the evidence did show that Bodor’s inventors had made significant contributions, so the reference would still qualify as “by another”.
Next, Merck next argued that it was “surprised by the Board’s application of the above-discussed rule requiring complete identity of inventive entity because the rule is contrary to several provisions of the Manual of Patent Examining Procedure (“MPEP”).”
Merck relies on the following MPEP sections. Appellant’s Opening Br. 34. MPEP § 2132.01:
An inventor’s or at least one joint inventor’s disclosure of his or her own work within the year before the application filing date cannot be used against the application as prior art.
And MPEP § 2136.05(b):
[E]ven if an inventor’s or at least one joint inventor’s work was publicly disclosed prior to the patent application, the inventor’s or at least one joint inventor’s own work may not be used against the application subject to preAIA 35 U.S.C. 102 unless there is a time bar.
Hopewell responded that Merck “did not lack notice of the rule because the MPEP expressly adopts the rule of Land in § 2136.04 (titled “Different Inventive Entity; Meaning of ‘By Another’”)”.
The CAFC agreed with Hopewell. Moreover, the CAFC noted that “To the extent the MPEP describes our case law differently, that interpretation does not control,” but nonetheless failed to agree that the MPEP was different.
Accordingly, the CAFC found that Bodor was proper prior art. Once confirmed, the Court went on to affirm the Board’s determination that the challenged claims were obvious in view of Bodor and Stelmasiak,
Comments:
- The phrase “by another” requires complete identity of the inventive entity to exclude a reference as prior art. In order to disqualify overlapping inventor references, corroborated evidence must be provided that all named inventors contributed to the inventive aspect of prior relevant disclosure. Thus, it is important for inventors working under joint research agreements to keep up-to-date lab and meeting notes that could aid in establishing such corroborated evidence.
- MPEP is not controlling over case law where interpretation is distinct.
