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On-Sale Bar: The “Critical Date” Is Critical – Patent

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In Sysmex Co. v. Beckman Coulter, Inc., 2022 U.S.
Dist. LEXIS 103757 (D. Del. June 9, 2022), Judge Bataillon granted
Sysmex’s request to uphold the validity of several claims of
two patents even in view of on-sale bar assertions by Beckman
Coulter (“BCI”).  


The patents at issue (U.S. Patent No. 10,401,350 and 10,401,351
(“the ‘350 patent” and “the ‘351
patent,” respectively) describe “sample analyzers
having a plurality of detectors for sensing blood samples or
body-fluid samples.”

Sysmex asserted that BCI infringed upon both patents, and BCI
asserted that the patents were invalid under the on-sale bar of 35
U.S.C. §102(b) based on two different products, the Advia 2120
and the Advia 120. Id. at *4. Both products are owned
by Siemens and are hematology analyzers designed for laboratories.
For the on-sale bar to apply, an accused infringer must demonstrate
both that the invention (1) was the subject of a commercial offer
for sale and (2) was ready for patenting. The ready for patenting
requirement may be satisfied either by “proof of reduction to
practice before the critical date or by proof that prior to the
critical date the inventor had prepared drawings or other
descriptions of the invention that were sufficiently specific to
enable a person skilled in the art to practice the
invention.” Id. at *5.

In this case, the critical date was January 31, 2007. BCI argued
that the Advia 2120 product met both prongs of the on-sale bar as
of the critical date and thus rendered both the ‘350 and the
‘351 patents invalid. The magistrate judge determined that
there was insufficient evidence to conclude that the Advia 2120
product anticipates or renders obvious the asserted claims of both
patents, even if the Advia 2120 was on sale in the United States
prior to the critical date. This was because the manual on which
BCI relied to show Advia 2120’s functionality was printed in
2008, i.e., after the critical date of January 31, 2007. The manual
could not adequately show Advia 2021’s functionality prior to
the critical date. Id. at *6.

BCI’s additional evidence from expert testimony was also
not enough; the expert “did not explain what [his] experience
was or how it supported his opinion and there no separate
corroborating evidence.” Id. at *7. The
magistrate judge concluded that the expert’s statements
equating the Advia 2120 and the Advia 120 products were
unsupported. Id.

District Court Decision:

The district court adopted the magistrate judge’s decision
and rejected all of BCI’s arguments. With regard to the Advia
manual, the Court determined there was no disputed factual issue
“requiring resolution at trial” because the guide
describes the Advia 2120 as of 2008 rather than
2007. Id. at *7.

BCI also argued that the Court should construe the evidence of
the Advia 120’s functionality in support of its argument
regarding the Advia 2120. But the Court determined that the
witness’s explanations were too vague to preclude summary
judgment because they were based on “personal
experience” without any supporting or corroborating
evidence. Id. at *8.  

A jury trial began June 27, 2022, in Wilmington, Delaware in
which Sysmex seeks royalties from BCI for infringement from
BCI’s sales of analyzers.


  • A motion for summary judgment could sway the outcome of a case
    if the movant shows there is no genuine dispute at to any material
    fact and the movant is entitled to judgment as a matter of

  • Where the on-sale bar is concerned, the “critical
    date” is just that − critical. Make sure the evidence
    submitted is in the correct date range to support your argument
    about a pre-critical date sale.

  • Conclusory, unsupported arguments are always vulnerable to
    attack for inadequateness. Issued claims are presumed valid, so a
    challenge to them must be supported by evidence to have a chance of

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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