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

Holding:

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”).  

Background:

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.

Takeaways

• 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 law.
• 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 succeeding.