Proving Inherent Anticipation – Make or Break Your Case With Expert Testimony
- Winter 2015 (snippets)
- Snippets
Anticipation is a basic concept in patent law. On its face the concept is simple—if a single prior art reference teaches every element of a claim in the proper context, then the claim is not patentable, i.e., it is anticipated by the prior art reference. Anticipation is easy enough to establish if the prior art expressly sets forth each of the elements of the claims. However, more interesting issues of proof arise when one or more elements of the claims are not expressly stated in the prior art, but following the prior art necessarily yields the missing elements of the claim.
The courts developed the concept of inherent anticipation to deal with the situation where an issued patent covers subject matter that already exists in the prior art but is not expressly taught or even appreciated.[1] Simply stated, inherent anticipation exists where although a limitation of a claim is not expressly taught in the prior art reference, the claim limitation necessarily and inevitably will be present when the teaching of the prior art is practiced. The idea being that if the subject matter already exists in the prior art, then it is not patentable. Interestingly, however, there does not have to be any conception of the invention in the prior art for there to be inherent anticipation. Specifically, it is not necessary that anyone previously understood the existence of the inherent subject matter.[2] The courts often express this by saying that a newly discovered feature of a known invention is not patentable. In other words, if the feature is always present when practicing the prior art, whether appreciated or not, a patent cannot later be granted on an invention directed to the feature once it is discovered. One example of this can be found in the In re Cruciferous Sprouts[3] case. In that case the inventors had discovered that eating certain cruciferous sprouts high in glucosinolates had significant health benefits. It was undisputed that the benefits of eating these plants was not previously understood or appreciated. Yet it was also clear from the record that the prior art taught eating the same sprouts later discovered to be high in glucosinolates. Thus, the court concluded that when following the prior art teaching to eat these sprouts, the eater would inherently experience the claimed benefit; thus the claims are inherently anticipated and not patentable.
To inherently anticipate, the prior art does not need to expressly teach each claim limitation, but it must enable one skilled in the art to practice the claimed invention, including the inherent limitations. The case law addresses the enablement issue by requiring that the inherent limitation must be the necessary and inevitable result of practicing the teaching of the prior art.[4] It is often quite difficult to establish that a claim limitation necessarily and inevitably exists in a prior art reference. The limitation must always be present when practicing the art. Inherent anticipation cannot be established by mere possibilities. It is not sufficient that sometimes the inherent feature results; it must always be there.
Discussed herein is how the courts have viewed expert witness testimony with respect to proving inherent anticipation and what pitfalls parties have encountered in efforts to use experts to establish or refute inherency.
The first issue is to determine whether to use an expert witness to help establish inherency. The answer should almost always be yes. When defenses of inherent anticipation have been successful, the courts have inevitably relied on expert testimony to resolve whether a claimed characteristic is inherent in the prior art. Indeed, when an argument of inherency has been put forth without the benefit of expert testimony, the courts have often found the evidence to be inadequate.[5] While there may be fact situations that would allow inherency to be established without the benefit of expert testimony, those circumstances will likely be relatively rare.
Expert testimony should be focused on directly establishing that the missing claim element is inherent in the prior art. Specifically, the testimony must establish by clear and convincing evidence that the claimed characteristic is always present when practicing the teaching of the prior art reference.[6] When an expert’s analysis is not directed specifically to the claimed limitation, the court may find that the burden of establishing inherency has not been carried.[7]
Often the best way to establish inherency is to have your expert replicate the prior art and test the results to demonstrate the presence of the missing claim element. This can, however, be a risky proposition. Inherency requires that the missing claim element be present every time the prior art teaching is practiced. Therefore, an unsuccessful or poorly run test could damage your ability to make the inherency argument. However, the failure to do appropriate testing can also weaken your case. An expert may be vulnerable to criticism if he had the ability to run tests to support his position but chose not to. An expert must have facts on which to base his opinion; simply reciting a party’s contentions in an expert report will generally not suffice.[8] One of the best places to get these facts is from testing. Of course there are potentially other sources, such as published articles in the relevant field, but very little is as relevant as replicating the prior art relied upon for anticipation.
Of course replicating the prior art is not always as easy as it may seem. Often the prior art omits details that the expert must fill in with his experience. For example, the prior art may teach a process but not specify certain process conditions, such as temperature, residence time, reaction equipment, or the like. In such a case, these omissions may require testing of multiple variables to fully establish inherency. Very often, choices must be made when attempting to replicate the prior art. This requires that the expert be involved in the planning of any experimentation, and the potential issues should be fully evaluated before the testing begins. If choices are made to limit the testing to a particular variation, then there must be a defensible justification for any choices made in this regard. Failure to be faithful to the prior art in the replication effort can destroy your expert’s credibility and render his testimony of no value to the court.[9]
It is also important to make sure the expert’s testimony is fully supported by the evidence.[10] If the expert stretches her testimony (i.e., is perceived as an advocate rather than simply as an expert) again it can destroy her credibility and reduce the chances of establishing inherency through her testimony. In other words, do not allow an expert to overreach. If the argument requires your expert to overreach, then there is an issue with the argument or the support for it. Those issues should be addressed well before the preparation of the expert report.[11]
Just as important as your expert testimony is the testimony of the opposing party’s expert. Generally when it comes to basic scientific principles, experts have a hard time disagreeing with each other. Few things are more convincing to the court than testimony of an opposing expert that supports your position. Therefore it is important to understand the positions that opposing experts are taking, the basis for their positions, and how to challenge those positions at deposition in advance of trial. The courts have considered agreement among the experts convincing with respect to inherency[12]. It can be very powerful evidence.
The defense of inherent anticipation carries with it a high standard of proof to reach the level of clear and convincing evidence.[13] Expert witness testimony is most often critical in determining whether this standard has been met. As can be seen from the courts’ treatment of expert testimony on this issue, it is important that the expert’s testimony be well thought out, consistent, and cognizant of the challenges to that testimony. Not every case is appropriate for an inherent anticipation argument. But when the facts support such an argument, properly prepared expert testimony is often a key factor in a successful outcome.
[1] See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (“a prior art reference may anticipate when the claim limitation or limitations not expressly found in that reference are nonetheless inherent in it”).
[2] See Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1378 (Fed. Cir. 2003) (“this court’s precedent does not require a skilled artisan to recognize the inherent characteristic in the prior art that anticipates the claimed invention”).
[3] In re Cruciferous Sprouts, 301 F.3d 1343 (Fed. Cir. 2002).
[4] See, e.g., Leggett & Platt, Inc. v. Vutek, Inc., 537 F.3d 1349, 1354 (Fed. Cir. 2008) (“Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claims limitations, it anticipates.”); Rexnord Indus., LLC v. Kappos, 705 F.3d 1347, 1355 (Fed. Cir. 2013) (“anticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.”).
[5] See TV Interactive Data Corp. v. Sony Corp., No. C 10-0475 PJH, 2012 WL 6020113 (N.D. Cal. Dec. 3, 2012). Defendant, Sony, moved for summary judgment arguing inherent anticipation based on a published Japanese patent application. The application did not expressly teach one claim limitation, but Sony argued it was inherent in the UNIX operating system utilized in the application. Sony apparently supported its argument with claim charts but no expert testimony. The Court held that Sony had not carried its burden as the claim charts were not evidence and without expert testimony the material cited by Sony was “incomprehensible to the court.” Id. at *22. But see Centricut, LLC v. Esab Group, Inc., 390 F.3d 1361, 1369 (Fed. Cir. 2004) (expert testimony not required when the technology is easily understood).
[6] See Haberman v. Gerber Prods. Co., 236 Fed. Appx. 592 (Fed. Cir. 2007). The Federal Circuit reversed a finding of inherent anticipation on a patent directed to the valve in a sippy cup, noting that no evidence was introduced as to the claimed quantum of pressure necessary to operate the prior art valve. The Federal Circuit concluded that at most the evidence established that applying some amount of suction “may” result in drawing liquid through the prior art valve. The court found this evidence insufficient to meet the clear and convincing standard that the prior art necessarily functions in a manner within the scope of the claim. Id.
[7] In Atofina v. Great Lakes Chemical Corp., 441 F.3d 991 (Fed. Cir. 2006), the Federal Circuit reversed a finding of anticipation based in part on inherency. The claims at issue were directed to a method for making difluoromethane. One of the limitations of the claim required a contact time with a catalyst of between 0.01 and 10 seconds. The prior art was silent with respect to contact time. The court concluded that Defendants evidence was insufficient to establish that the contact times were inherent. Specifically the defendants had presented evidence about the size of the reaction tube and the flow rates through the tubes (presumably in an effort to demonstrate how long the reactants were present in the reaction tube). The court, however, concluded that this evidence “do[es] not say anything about any contact times.” Id. at 1000. The court then concluded that the evidence was insufficient to establish that the missing limitation must necessarily be present in the teaching of the prior art.
[8] See Warner Chilcott Labs. Ireland Ltd. v. Impax Labs., Inc., Nos. 2:08–cv–06304 (WJM), 2:09–cv–02073 (WJM), 2:09–cv–01233 (WJM), 2012 WL 1551709 (D.N.J.). Defendants ran no experiments to support their position and cited to no scientific papers that supported the position. The only evidence that Defendants relied upon was the testimony of an expert, which the court gave no weight, characterizing it as “merely a recitation of Defendants’ theory” and unsupported by any extrinsic evidence. Id. at *47.
[9] See, e.g., Pfizer, Inc. v. Teva Pharms., 882 F. Supp. 2d 643 (D. Del. 2012). The Plaintiff’s expert and the Court read the prior art process to require the use of anhydrous ammonia (lacking water). The Defendant’s expert had used ammonia that included water in his replication, thus the Court discounted the evidence. Id. at 679. See also Valeant Int’l. (Barbados) v. Watson Pharms., Inc., No. 10-20526-CIV, 2011 WL 6792653 (S.D. Fla.) (because the expert did not follow the explicit disclosure of the art, “his experiment is simply not probative of the issue of inherent anticipation”).
[10] See Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 640 (Fed. Cir. 2011) (finding that defendant was attempting to “characterize one structure (chamfers) as a completely different structure (a bearing race) based on a hypothetical configuration of surrounding structures disclosed nowhere in the prior art (expressly or inherently) and suggested by nothing in the record.”); see also Harris Corp. v. Fed. Express Corp., No. 6:07-CV-1819-ORL-28KRS, 2010 WL 2639564 (M.D. Fla.) (holding that the inherency argument failed because it was “not supported by a single prior art reference and extrinsic evidence explaining inherent features.”).
[11] An expert should be given all the relevant information when developing his testimony on inherency. Failure to provide the expert with the information could render his testimony of little value. See In re Omeprazole Litigation, 483 F.3d 1364 (Fed. Cir. 2007), where the finding of inherency rested in part upon an admission about the nature of the prior art that plaintiff made during a related Korean litigation. Plaintiff’s expert testimony was discounted because he was not provided with the testing done in conjunction with the Korean litigation. Id. at 1372.
[12] See, SRAM Corp. v. AD-II Eng’g., Inc., 367 Fed. Appx. 150 (Fed. Cir. 2010). The Federal Circuit found there was no factual dispute with respect to the presence of the inherent feature (compensation for lost motion) in the prior art as both parties’ expert testified as to its presence in the art. Particularly important was the “admission” from Plaintiff’s expert that the while prior art “may have compensated for cumulative lost motion, they did so in a clumsy and imprecise way.”); see also Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312 (Fed. Cir. 2009) (finding that Plaintiff’s experts’ testimony supported a finding of inherent anticipation).
[13] See Par Pharm., Inc. v. TWI Pharms., Inc., No. 2014-1391, 2014 WL 6782649 at *5–8(Fed. Cir. Dec. 3, 2014) (Recent Federal Circuit discussion of the proofs necessary to establish inherency).
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