Fresh from the Bench: Precedential Patent Cases from the Federal Circuit
By Peter E. Heuser
Rembrandt Vision v. Johnson & Johnson Vision – A divided panel rules that the district court abused its discretion in denying Rembrandt's Rule 60(b)(3) motion for a new trial based upon falsified expert witness testimony. Rembrandt alleged that Johnson & Johnson's Acuvue Advance® and Oasys® contact lenses infringed its patent. During the trial, JJVC's expert Dr. Bielawski described the testimony of Rembrandt's expert Dr. Beebe as being "misleading and tantamount to dishonesty." The district court apparently agreed, and struck the testimony. Since this testimony was the only evidence Rembrandt advanced in support of its position that JJVC's lenses met the "soft" limitation of the asserted claim, the district court granted JMOL that JJVC did not infringe.
JJVC presented testimony from Dr. Bielawski to support its position that its accused lenses did not meet the "surface layer" limitation of the claim. Following trial, Rembrandt received information indicating that Dr. Bielawski testified falsely regarding his background, experience and the testing he alleged that he conducted on the accused lenses. That evidence was not refuted by JJVC. Based on this, Rembrandt moved for a new trial pursuant to Rule 60(b)(2) and (3). The motion was denied because the district court concluded that JJVC's counsel was not complicit in the false testimony and because, in its opinion, Rembrandt was not prevented from fully and fairly presenting its case.
The majority of the panel notes that Dr. Bielawski testified on a central infringement issue at trial—whether JJVC's accused lenses met the "surface layer" claim limitation. Dr. Bielawski and JJVC's counsel seized several opportunities to impugn the credibility of Dr. Beebe, but the jury never heard that Dr. Bielawski had presented false testimony. The majority rules that under these circumstances, Rembrandt was prevented from fully and fairly presenting its infringement case. According to the majority, Rembrandt is not required to prove that the withheld testing documents were of such nature as to alter the result in the case. Instead, Rembrandt need only show that timely production of the documents would have made a difference in the way Rembrandt's counsel approached the case or prepared for trial.
The majority also rules that it need not determine whether JJVC's failure to obtain and produce contradictory test data was intentional or merely accidental, and whether JJVC or its counsel was complicit, since even an accidental omission qualifies as misconduct under Rule 60(b)(3). Because it is ruling in favor of reversal and remand as to the 60(b)(3) motion, the panel does not rule as to 60(b)(2).
Genetic Technologies v. Merial and Bristol-Myers Squibb – The Circuit affirms a dismissal under Rule 12(b)(6) for failure to state a claim because Genetic's patent is not directed to patentable subject matter. Genetic brought suit against Merial and Bristol-Myers Squibb for infringement of its patent directed to methods of detecting genetic variations. Merial had previously filed for inter partes review and the patent survived the challenge. However, IPR does not consider section 101 challenges, so that issue was being considered for the first time by the district court. The district court concluded that the claims at issue were directed to unpatentable subject matter and dismissed the case.
The panel considered Genetic's appeal of the dismissal and applies the two-step analysis of Alice and Mayo, concluding that the claimed invention is, like the claimed inventions in Mayo and Ariosa, directed to a law of nature. Applying the second step of Mayo, and again comparing the claimed invention to those in Mayo andAriosa, the panel rules that the claimed physical steps of DNA amplification and analysis of the amplified DNA to provide a user with the sequence of the non-coding region do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible.
Rembrandt Vision Technologies, L.P. v. Johnson & Johnson Vision Care, Inc.,
Fed. Cir. Case 2015-1079 (April 7, 2016)
Rembrandt sued JJVC, alleging that its Acuvue Advance® and Oasys® contact lenses infringed its patent. The parties disputed whether JJVC's accused lenses met the "surface layer" and "soft" limitations of the asserted claim. The jury returned a verdict of noninfringement and the court granted JMOL that Rembrandt failed to prove that the accused lenses were "soft."
Rembrandt relied on expert testimony from Dr. Beebe to prove that the accused lenses met both limitations. During his direct examination regarding the "soft" limitation, Dr. Beebe presented test results to show that the accused lenses met this limitation. During cross-examination, however, Dr. Beebe drastically changed his testimony regarding the testing methodology he used. Because his testimony on cross-examination significantly conflicted with both his testimony during his direct examination and his expert report, the court struck Dr. Beebe's testimony regarding this testing. After noting that Dr. Beebe's stricken testimony was the only evidence that Rembrandt advanced to prove the accused lenses were "soft" in opposing JJVC's motion, the district court granted JMOL that JJVC did not infringe.
In turn, JJVC relied on expert testimony from Dr. Christopher Bielawski to support its position that its accused lenses did not meet the "surface layer" limitation. Dr. Bielawski described Dr. Beebe's failure to correct allegedly incorrect data as "misleading and tantamount to dishonesty." During his closing argument, JJVC's counsel urged that "you should not trust Dr. Beebe, and you should throw out his testimony, not in part, but in whole. You should not trust Dr. Beebe."
After trial, Rembrandt received information through an open records request and state court litigation suggesting that Dr. Bielawski testified falsely at trial, which is not contested by JJVC. Specifically, Dr. Bielawski repeatedly testified that he personally conducted testing including time-of-flight secondary ion mass spectrometry ("TOF-SIMS") on JJVC's lenses when, in fact, the testing was conducted by his lab personnel. Moreover, Dr. Bielawski apparently overstated his qualifications and experience with these testing methodologies. Whereas Dr. Bielawski was presented to the jury as an expert in TOF-SIMS testing, he actually had no TOF-SIMS experience whatsoever. Dr. Bielawski thus testified falsely when he said that he personally performed tests, and about his qualifications as an expert in performing those tests. In addition to showing Dr. Bielawski's false testimony, Dr. Bielawski withheld test results and data analysis that would have undermined his opinions and trial testimony. JJVC claims that it was unaware that any data had been generated, but had these test results been produced to Rembrandt prior to trial, they would have shown that the infringing lenses do not have a surface coating of about 20 nanometers, undermining Dr. Bielawski's testimony at trial.
In light of this post-trial discovery, Rembrandt moved for a new trial under Rules 60(b)(2) and (3), which state:
On motion and just terms, the court may relieve a party. . . . from a final judgment . . . for the following reasons: . . . (2) newly discovered evidence, that with reasonable diligence, could not have been discovered in time to move to a new trial under Rule 59(b); [or] (3) fraud (whether previously called intrinsic or extrinsic), misrepresentation, or misconduct by an opposing party.
With little discussion, the district court dismissed Rembrandt's argument that the withheld documents prevented it from fully and fairly presenting its case. The court thus limited its analysis to Dr. Bielawski's false testimony, concluding that Rembrandt was not entitled to a new trial under Rule 60(b)(2) because Rembrandt had not satisfied the requirement in the Eleventh Circuit that a new trial would probably produce a new result. It concluded that Rembrandt was not entitled to a new trial under Rule 60(b)(3) because JJVC's counsel was not complicit in the false testimony and because Rembrandt was not prevented from fully and fairly presenting its case.
The District Court Abused Its Discretion in Denying the Motion for a New Trial
We first consider Rembrandt's motion for a new trial under Rule 60(b)(3), which permits a district court to grant a new trial in cases involving "fraud (whether previously called intrinsic or extrinsic), misrepresentation, or misconduct by an opposing party." To prevail on such a motion in the Eleventh Circuit, the movant must establish that: "(1) the adverse party engaged in fraud or other misconduct; and (2) this conduct prevented the moving party from fully and fairly presenting its case. Proof that the result of the case would have been different but for the fraud or misconduct is not required; instead, Rule 60(b)(3) is aimed at judgments which were unfairly obtained, not at those which are factually incorrect."
We start with the easier question of whether Rembrandt had a full and fair opportunity to present its case given Dr. Bielawski's false testimony and withholding of relevant documents. In denying Rembrandt's motion under Rule 60(b)(3), the court concluded that "even accounting for Dr. Bielawski's misconduct, Rembrandt was not prevented from making its case," and explained that this holds true "even without considering that JJVC was entitled to judgment as a matter of law because Rembrandt failed to present evidence on an essential element of its case." The court also summarily dismissed Rembrandt's argument that it was prevented from fully and fairly presenting its case due to the withheld documents as "murky at best." We conclude that the district court clearly erred in finding that Rembrandt had a full and fair opportunity to present its infringement case.
Dr. Bielawski testified on a central infringement issue at trial—whether JJVC's accused lenses met the "surface layer" claim limitation. In doing so, he testified falsely about his personal involvement in the testing, as well as his experience with the relevant testing methodologies. He also withheld contradictory test results on third party lenses known to infringe and generated at the request of JJVC's counsel. Because these test results were not produced, Dr. Bielawski testified without contradiction about alleged differences between the accused lenses and the third-party lenses to show that the accused lenses did not have the claimed surface layer. JJVC's counsel emphasized these differences as proof of noninfringement in his closing argument. In addition, Dr. Bielawski and JJVC's counsel seized several opportunities to impugn the credibility of Dr. Beebe, but the jury never heard that Dr. Bielawski had presented false testimony. Under these circumstances, we cannot agree with the district court that this conduct did not prevent Rembrandt from fully and fairly presenting its infringement case. The verdict was irretrievably tainted by Dr. Bielawski's false testimony and Dr. Bielawski's and JJVC's withholding of relevant documents. While we do not know the exact impact the false testimony would have had on the jury, the jury may well have been impacted upon learning that Dr. Bielawski committed an act at least as egregious as Dr. Beebe's.
We agree with Rembrandt that it was prejudiced by the withholding of test results and by the false testimony. Rembrandt is not required to prove that the withheld documents were of such nature as to alter the result in the case. Instead, Rembrandt need only show that timely production of the documents would have made a difference in the way Rembrandt's counsel approached the case or prepared for trial. We cannot and will not speculate about the profound effects knowledge of the withheld documents and falsified testimony of JJVC's primary witness would have had on the proceedings and the JMOL. Suffice it to say that this raises a substantial question undermining the judgment of noninfringement.
Rule 60(b)(3) Does Not Require That JJVC or Its Counsel Be Complicit in the Misconduct
We next look to whether Rembrandt established that the adverse party engaged in fraud or other misconduct. We conclude that the district court abused its discretion in concluding otherwise. Specifically, the district court erred by summarily dismissing Rembrandt's allegations of misconduct and by requiring proof that JJVC or its counsel was complicit in Dr. Bielawski's false testimony. Rembrandt alleges fraud based on Dr. Bielawski's false testimony and misconduct based on Dr. Bielawski and JJVC's failure to produce the contradictory test results on third-party lenses. Each allegation forms an independent basis for a new trial under Rule 60(b)(3). JJVC does not dispute that Dr. Bielawski testified falsely and that it never produced the test results for the third party lenses. Instead, JJVC argues that Rule 60(b)(3) cannot provide relief because JJVC was not complicit in the fraud or the misconduct. Considering only Dr. Bielawski's false testimony, the district court held that Rembrandt was not entitled to a new trial under Rule 60(b)(3) because it had not shown that either JJVC or its counsel was complicit in any fraud or misconduct.
Turning first to Rembrandt's allegations of misconduct, we agree with Rembrandt that the district court erred by failing to fully address Rembrandt's allegations of misconduct and requiring proof of complicity. As used in Rule 60(b)(3), "misconduct" does not demand proof of nefarious intent or purpose as a prerequisite to redress. The term can cover even accidental omissions—elsewise it would be pleonastic, because "fraud" and "misrepresentation" would likely subsume it. The effect of misconduct was the same whether there was evil, innocent or careless, purpose.
JJVC admits that it provided samples of third-party lenses to Dr. Bielawski to conduct initial set up experiments on the lenses. The relevance of these tests to JJVC's noninfringement defense cannot be disputed—Dr. Bielawski testified about differences between JJVC's accused lenses and the third-party lenses that were known to infringe and JJVC's counsel emphasized these differences during his closing argument.
JJVC argues that a new trial is not warranted because it "was unaware of any testing of these lenses." But we need not determine whether JJVC's failure to obtain and produce this data was intentional or merely accidental; even an accidental omission qualifies as misconduct under Rule 60(b)(3).
Turning next to Rembrandt's allegations of fraud, the court concluded that Rule 60(b)(3) requires proof of JJVC's complicity in the false testimony. Rembrandt argues that the court misinterpreted Eleventh Circuit precedent by requiring proof of complicity to satisfy Rule 60(b)(3). We agree.
We have previously affirmed a grant of a new trial under Rule 60(b)(3) in view of an expert's perjured testimony, even when it was undisputed that the party was unaware of the perjury. Although JJVC may have been unaware of Dr. Bielawski's false testimony, JJVC should have known that additional tests were conducted and additional documents were generated. The court erred by concluding that the Eleventh Circuit would require proof that JJVC or its counsel was complicit in Dr. Bielawski's false testimony. We cannot agree that the Eleventh Circuit would require complicity in Dr. Bielawski's false testimony. The court erred in requiring complicity and summarily dismissing Rembrandt's allegation of misconduct. We thus conclude that the court abused its discretion in denying Rembrandt's motion for a new trial under Rule 60(b)(3).
Because we reverse the district court's denial of Rembrandt's motion for a new trial under Rule 60(b)(3), we do not consider whether the district court abused its discretion in denying Rembrandt's Rule 60(b)(2) and discovery motions. We hold that the district court abused its discretion in denying Rembrandt's motion for a new trial under Rule 60(b)(3). We therefore reverse and remand for a new trial.
Judge Dyk's Dissent
This case presents two important questions about the interpretation of Rule 60(b)(3) in the context of false testimony by an expert witness. The first is whether a showing by a movant that it lacked a "full and fair" opportunity to present its case requires some showing that the result could have been affected by the false testimony. The second is whether false testimony by an expert witness can be attributed "to the opposing party" (as required by the rule) without a showing of knowledge or reason to know that the testimony was false. I respectfully suggest that the majority is wrong on both counts.
Genetic Technologies Ltd. v. Merial L.L.C, Fed. Cir. Case 2015-1202, -1203 (April 8, 2016)
GTG brought suit against Merial and Bristol-Myers Squibb ("appellees"). GTG alleged that appellees infringed its '179 patent, which relates to methods of detecting genetic variations. GTG discovered that certain DNA sequences in coding regions (exons) of certain genes are correlated with non-coding regions (introns) within the same gene, non-coding regions in different genes, or non-coding regions of the genome that are not part of any gene. Claim 1 of the '179 patent recites:
1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
b) analyzing the amplified DNA sequence to detect the allele.
The district court granted appellees' motion to dismiss under Rule 12(b)(6) for failure to state a claim, based on the patents being directed to ineligible subject matter under 35 U.S.C. § 101.
The Supreme Court's Two-Step Test for Patentable Subject Matter
Section 101 establishes that "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof" may be eligible for a patent, subject to the conditions and requirements of the Patent Act. But the Supreme Court has "long held that this provision contains an important implicit exception: Laws of nature, natural phenomena, and abstract ideas are not patentable." Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalk v. Benson, 409 U.S. 63 (1972). Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.
In the past several years, most notably in its Mayo and Alice decisions, the Supreme Court has articulated a now well-established two-step test for patent eligibility under § 101. The test "distinguishes patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Ina, 134 S. Ct. 2347 (2014).
First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. If so, we then ask, what else is there in the claims before us? We have described step two of this analysis as a search for an inventive concept—i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.
Claim 1 Is Directed to a Patent-ineligible Law of Nature
We begin at step one of the Mayo/Alice test and ask first whether claim 1 is directed to a patent ineligible concept—e.g., a law of nature, natural phenomenon, or abstract idea. We find that it is. Claim 1 is directed to the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences—a law of nature.
Claim 1 is quite similar to the claims invalidated in Mayo itself. In Mayo, the Supreme Court considered method claims that likewise required analysis of a biological sample (the blood of a patient being treated with a thiopurine drug) and in which the focus of the claimed advance over the prior art was allegedly newly discovered information about human biology: the likelihood that a patient could suffer toxic side effects from particular doses of the drug. "Claim 1, for example, states that if the levels of 6-TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8 x 108 red blood cells, then the administered dose is likely to produce toxic side effects." The Court concluded that the claims were necessarily directed to an underlying law of nature or natural phenomenon, even if implementation of the method involves substantial human labor and ingenuity. We agree with the district court that "just as the relationship at issue in Mayo was entirely a consequence of the body's natural processes for metabolizing thiopurine, so too is the correlation here (between variations in the non-coding regions and allele presence in the coding regions) a consequence of the naturally occurring linkages in the DNA sequence."
In our recent Ariosa decision, we considered genetic testing method claims remarkably similar to the claim here and found, at step one of the Mayo/Alice test, that they too were directed to unpatentable subject matter.Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The claims in Ariosa covered a method of detecting fetal DNA by amplifying and analyzing cell-free fetal DNA ("cffDNA") sampled from a pregnant woman's blood. The court found that "the claims are directed to matter that is naturally occurring" and that the inventors there did not purport to "create or alter any of the genetic information encoded in the cffDNA." The focus of the claimed advance over the prior art was allegedly newly discovered information about human biology: paternally inherited cffDNA is to be found in maternal blood (using established detection techniques). So too in the present case: the patent claim focuses on a newly discovered fact about human biology (the linkage of coding and non-coding regions of DNA), involves no creation or alteration of DNA sequences, and does not purport to identify novel detection techniques.
The similarity of claim 1 to the claims evaluated in Mayo and Ariosa requires the conclusion that claim 1 is directed to a law of nature. The sole function of the "primer pair defining a DNA sequence which is in genetic linkage with a multi-allelic genetic locus" is to amplify a sequence of non-coding DNA in linkage disequilibrium with a sequence of coding DNA of interest. "The method comprises amplifying genomic DNA with a primer pair that spans an intron sequence and defines a DNA sequence in genetic linkage with an allele to be detected." The claim is directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.
The Claim Does Not Contain an Inventive Concept Sufficient to Transform the Law of Nature into a Patent-Eligible Application
We thus proceed to step two of the Mayo/Alice analysis. At step two, after identifying a claim directed to unpatentable subject matter, "we must examine the elements of the claim to determine whether it contains an inventive concept sufficient to transform the claimed abstract idea [or law of nature] into a patent-eligible application." Alice. "The question . . . is whether the claims do significantly more than simply describe a natural relation." Mayo. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Aliceframework, a claim directed to a newly discovered law of nature (or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere "well-understood, routine, conventional activity." Mayo. "Simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable." Mayo. Claims directed to laws of nature are ineligible for patent protection when, "(apart from the natural laws themselves) they involve well understood, routine, conventional activity previously engaged in by researchers in the field." Mayo.
We look first at the physical steps by which claim 1 implements the natural law of linkage disequilibrium between coding and non-coding regions to determine whether they provide more than "well-understood, routine, conventional activity" already engaged in by those in the field. Claim 1 contains two implementation steps, "amplifying genomic DNA with a primer pair" and "analyzing the amplified DNA sequence to detect the allele." The first claimed step of "amplifying" genomic DNA with a primer pair was indisputably well known, routine, and conventional in the field of molecular biology as of 1989, when the first precursor application to the '179 patent was filed. In fact, GTG expressly argued during prosecution of the '179 patent that "amplification was a technique practiced at the time the application was filed."
The second physical implementation step, "analyzing" amplified DNA to provide a user with information about the amplified DNA, including its sequence, was also clearly well known, routine, and conventional at the time the '179 patent was filed. GTG concedes that "techniques to analyze amplified DNA were . . . admittedly known." Moreover, the Background section of the '179 patent acknowledges as prior art the claimed two-step combination of amplification of DNA and subsequent analysis of its sequence.
Thus the physical steps of DNA amplification and analysis of the amplified DNA to provide a user with the sequence of the non-coding region do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible. In this regard, claim 1 of the '179 patent is directly comparable to the claims invalidated in Ariosa.
The Panel Rejects GTG's Argument That Claim 1 Provides More
GTG argues that claim 1 provides more: once the noncoding DNA has been amplified and sequenced, an instruction to users to "analyze the amplified DNA sequence to detect the [coding region] allele." We disagree. The term "to detect the allele" is a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind. As we held in CyberSource, "methods which can be performed entirely in the human mind are unpatentable not because there is anything wrong with claiming mental method steps as part of a process containing non-mental steps, but rather because computational methods which can be performed entirely in the human mind are the types of methods that embody the 'basic tools of scientific and technological work' that are free to all men and reserved exclusively to none." CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011). Mayo itself also considered and rejected diagnostic and therapeutic method claims that combined routine and conventional physical implementation of a law of nature with a simple mental process step. Specifically, Mayo held that the "wherein" clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient. That is, "these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decision-making (rather like Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant)."
To be sure, it seems to be true, as GTG alleges, that at the time the '179 patent was filed, no one was "using the non-coding sequence as a surrogate marker for the coding region allele." Claim 1 was found by the patent examiner to be novel over the prior art and survived multiple rounds of reexamination. But the novelty of looking to non-coding DNA to detect a coding region allele of interest resides in the novelty of the newly discovered natural law of linkage disequilibrium between coding and non-coding regions and adds little more than a restatement of the natural law itself. We thus hold that the simple mental process step of "detecting the allele" in claim 1, either alone or in combination with the physical steps described above, does not supply sufficient inventive concept to make the claim patent-eligible under § 101.