KSR Reigned In For A Preliminary Injunction

John Kong | January 18, 2012

Celsis in Vitro, Inc. v Cellzdirect, Inc. and Invitrogen Corp.

January 9, 2012

Panel:  Rader, Gajarsa, and Prost.  Opinion by Rader; Dissent by Gajarsa.

Summary:

While Rader’s majority opinion affirmed the district court’s grant of a preliminary injunction despite defendant’s obviousness challenge, Gajarsa’s dissenting opinion asserts that the majority’s decision disregards the Supreme Court’s KSR flexible guidelines regarding the finding of obviousness in the mere repetition of well-known techniques to achieve a desired result, and in the application of “obvious to try.”  Gajarsa’s dissent also notes that this is a preliminary injunction, and the standard is not whether defendant has shown obviousness by clear and convincing evidence, but rather, whether defendant has shown a “substantial question of invalidity” to defeat a preliminary injunction.  Perhaps, the strongest position for the majority opinion is its consideration of the showing of a “teaching away” in the record, as well as deference given to the district court’s determinations of credibility of the parties’ expert witnesses.

Details:

The Defendant appeals the district court’s grant of a preliminary injunction to Plaintiff for failure to show a likelihood of success on the merits regarding infringement and validity.  The claimed technology is directed to improving the preservation of hepatocytes (a type of liver cell) used for drug research.  Due to unpredictability in liver cell availability (from organ donors) and short lifespan, there has been a need in the industry for long-term preservation of hepatocytes in the laboratory.  Cryopreservation (freezing) was a well-known option which did not work well because freezing extensively damages hepatocytes (and once damaged, do not recover).

Plaintiff’s claimed invention was basically thawing frozen hepatocytes, using density gradient fractionation to separate viable and non-viable cells, refreezing the viable cells, and rethawing the viable hepatocytes a second time.  The claimed invention also called for greater than 70% viability of the hepatocytes preparation after the final thaw.  Both cryopreservation (freezing) and density gradient fractionation were well known at the time of the invention.

Gajarsa’s dissent noted that the only thing missing from the prior art was the refreezing and rethawing a second time.  Gajarsa characterized the claimed invention as simply using two known techniques (freezing and thawing), repeating them, and obtaining a 70 percent viability of hepatocytes.  Repeating known steps, with no change to their respective functions, to obtain a desired result of 70% viability is not inventive.

This is reminiscent of Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009) where the CAFC held that a claimed invention that merely involves repeating earlier steps was obvious in view of the common sense for doing so, citing KSR.  In Perfect Web, the claim was directed to managing bulk email, including the steps of (A) matching profiles, (B) transmitting bulk emails to the matched profiles, (C) calculating the quantity of the bulk emails successfully received by target recipients, and (D) if the calculated quantity does not exceed a threshold, repeating steps (A)-(C) until the threshold is exceeded.  The court held that it would have been common sense to the skilled artisan to repeat the first three steps to deliver a prescribed quantity of emails.

Gajarsa also criticizes the majority’s focus on the Defendant failing to point out any explicit teaching, suggestion, or motivation in the prior art to multi-cryopreserve hepatocytes, and recalls the guidance from KSR that “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”

Gajarsa also emphasizes KSR’s finding of obviousness “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp.”  Here, there was a need in the art to multi-cryopreserve hepatocytes, as reflected in the patent and in Plaintiff’s brief.  And, the basic approach to determining whether hepatocytes could be frozen multiple times and remain viable was simply to pursue it.  Instead of considering KSR’s “obvious to try” in view of design need/market pressure, the majority refers to Defendant’s “vague references” to market need as being probative of the non-obviousness consideration of a long felt need.

Perhaps, the most significant point in the majority opinion is that the prior art teaches away from multi-cryopreservation.  Besides the fact that there was no prior art reference to multi-cryopreservation in this crowded field, the prior art taught that a single round of freezing severely damages hepatocyte cells and results in lower cell viability.  There was a sufficient showing on the preliminary record that a person of ordinary skill in the art at the time of the invention would expect a second freezing on those damaged cells to kill even more cells and lower cell viability even more than the first freezing.  Though not explicitly addressed, this “teaching away” point also touches on the “obvious to try” requirement to show that one of ordinary skill in the art could have pursued the known finite options with a reasonable expectation of success (which the dissent does not address).  The dissent did suggest a contradiction in the majority simultaneously recognizing the unpredictability in this art, and the ability for a person of ordinary skill in the art to predict a low viability of hepatocytes that had been frozen and thawed.  If the art is unpredictable, how can one predict a low viability?  But, this appears to be the dissent’s play on the majority’s words, because the majority recognized the unpredictability in availability of hepatocytes, and the Plaintiff’s expert testimony on expectations is supported in the prior art documentation of low viability in frozen and thawed hepatocytes.

The majority also relied on the district court’s credibility assessments regarding each side’s expert testimony.  The Defendant’s two experts testified about how cells that survived the first freeze would be “more resistant” and therefore more likely to survive a second freeze, as well as how the same number of cells that survived the first freeze would survive the second freeze.  However, the district court did not find Defendant’s experts credible, and had this to say, “Instead of a more candid ‘Why didn’t I think of that,’ we get [Defendant arguing] ‘Anybody reasonably skilled in the art would have thought of that.’”  Giving deference to the district court’s determinations of credibility, as well as noting that no prior art document disclosed or suggested the use of multi-cryopreservation, the majority found no error in the district court’s finding that a person of ordinary skill in the art likely would not have found the invention obvious.

However, Gajarsa’s dissent also questioned whether the majority applied the correct standard of review.  At the preliminary injunction stage, the Defendant does not need to show obviousness by clear and convincing evidence.  Instead, the Defendant needed only to prove that the subject patent was vulnerable – whether it is more likely than not that the patent will be proven invalid at trial.  A preliminary injunction should not issue if Defendant raises a substantial question as to validity.  This, Gajarsa believes, the Defendant has shown.  From the patent and Plaintiff’s own expert, all the claim elements were already known in the prior art.  From there, based on the need for multi-cryopreserved hepatocytes, it is obvious to repeat well-known steps to obtain a desired result.  Such a showing in the preliminary record is sufficient to raise a substantial question as to validity to defeat a preliminary injunction.

PROSECUTION TIPS

This case reinforces the strength of “teaching away” in overcoming even KSR’s flexible approach in determining obviousness, including use of common sense and “obvious to try.”

LITIGATION TIPS

The majority characterized the Defendant’s experts’ testimony as including “vague references to ‘market need,’” which the majority associated with the non-obviousness consideration of a long felt, but unmet need.  This is one area where better preparation of the expert witness may have helped to clarify certain points to be made.  If the expert wanted to trigger the “obvious to try” point from KSR, involving design need or market pressure to try, use of like words during the testimony would have helped.

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