Contributors: Akin Gump
Strauss Hauer & Feld LLP
Admission in Specification Dooms Organ Transplant Patents Under § 101
by Daniel L. Moffett, Matthew George Hartman, Shawn Bastani (Law Clerk)
District Court, 35 U.S.C. § 101, District of Delaware
October 4, 2021
The United States District Court for the District of Delaware recently held that claims covering methods for evaluating organ transplant rejection are invalid under 35 U.S.C. § 101.
The patents at issue disclose methods to assess organ transplant rejection without the need for invasive biopsies. This is accomplished by detecting particular concentrations of donor cell-free DNA (cfDNA) in the blood of transplant recipients. The disclosed methods have four steps for detecting a donor’s cfDNA in a transplant recipient: “1. ‘obtaining’ or ‘providing’ a ‘sample’ from the recipient that contains cfDNA; 2. ‘genotyping’ the transplant donor and/or recipient to develop ‘polymorphism’ or ‘SNP’ ‘profiles’; 3. ‘sequencing’ the cfDNA from the sample using ‘multiplex’ or ‘high-throughput’ sequencing; or performing ‘digital PCR’; and 4. ‘determining’ or ‘quantifying’ the amount of donor cfDNA.”
In 2019, plaintiffs sued defendants for allegedly infringing the asserted patents by making and selling certain organ transplant tests. The defendants each filed a motion for summary judgment of invalidity of the asserted patents under § 101 and in December 2020 the court denied those motions. Later, the court sua sponte raised the § 101 validity issue under Fed. R. Civ. P. 56(f)(3). According to the court, it was uncontested that the claims were directed to detecting natural phenomena. The court determined, therefore, that the dispositive question under both steps of the Alice/Mayo framework for patent eligibility was whether the claimed methods used only standard/conventional detection techniques.
To answer this question, the court examined the specifications. Language in each specification stated that the “invention employs, unless otherwise indicated, conventional techniques . . . which are within the skill of the art.” (emphasis added). The court held that since the specifications never indicated “otherwise,” they conclusively established that standard/conventional detection methods were used. The court in reaching its decision rejected plaintiffs’ argument that, because this language “appears verbatim in myriad patents,” including patents not directed to DNA sequencing technology, it would be unfair to read this “widely repeated passage” as an admission that the claimed steps were conventional. In doing so, the court emphasized the fundamental principle that a “patentee is bound by the words it uses in its patent[.]” The court further explained that patent applicants often represent that techniques are conventional in order to meet § 112 requirements and, having done that here, plaintiffs “cannot now avoid the consequences that flow from its representation.”
The court rejected several other arguments by plaintiffs that these detection techniques were not conventional. Specifically, the plaintiffs pointed to disclosure in the patents as allegedly indicating that sequencing techniques used in the methods—including digital polymerase chain reaction (PCR) and “next generation sequencing”—were not conventional, routine or well-understood. The court found that plaintiffs’ alleged evidence “mischaracterized the written description” and that its assertions that these sequencing techniques are nonconventional was “simply false.” The court also determined that extrinsic evidence plaintiff relied on failed to establish that the detection techniques were nonconventional. According to the court, “[p]ermitting [plaintiffs] to now nullify with extrinsic evidence an unambiguous representation it made to the PTO to secure its patents and exclude competitors like Defendants from making or using the claimed invention would be fundamentally at odds with the basic principles underlying our patent system.” Having found no genuine disputes of material fact that the asserted patents claim patent-ineligible subject matter, the court entered summary judgment of invalidity for defendants.
Practice Tip: When considering whether to characterize any disclosed technique or method in a patent as “conventional” or “routine,” a patent applicant should carefully weigh any possible benefits of including such language (e.g., to meet § 112 requirements) against any potential risk that the statements could be used later in litigation to show that the claims are invalid under § 101.
CareDx, Inc. et al. v. Natera, Inc., No. CV 19-0567-CFC-CJB, 2021 WL 4439600 (D. Del. Sept. 28, 2021).
PTAB: Expert’s Factual Bases Fair Game for Additional Discovery, but Communications with Counsel Are Off Limits
by Karina J. Moy & Rubén H. Muñoz
Patent Trial and Appeal Board, Inter Partes Review
October 25, 2021
In an inter partes review (IPR) proceeding, the Patent Trial and Appeal Board (PTAB) granted the patent owner’s motion for additional discovery related to experiments conducted by the petitioner’s expert to characterize two prior art references, but denied the motion to the extent it sought protected communications between the petitioner’s counsel and expert.
Pursuant to the PTAB’s authorization and 37 C.F.R. § 42.51(b)(2), the patent owner requested four categories of additional discovery. Requests 1 and 4 sought the protocols and results of experiments conducted by the petitioner’s expert. Requests 2 and 3 sought “documents identifying, including, or referring to” instructions provided to the petitioner’s expert concerning the design and parameters of the experiments.
The patent owner argued that additional discovery into the experimental parameters, and possible instructions from counsel for selecting those parameters, would be useful for assessing the petitioner’s inherent anticipation argument. In its opposition, the petitioner indicated it would produce documents about the experimental parameters for characterizing the two prior art references at issue in the IPR, but argued that correspondence between the petitioner’s counsel and expert related to the design of the experiment were protected work product.
To assess whether granting additional discovery would serve the interests of justice, the PTAB applied the Garmin factors. Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26 at 6–7 (PTAB Mar. 5, 2013) (precedential).
Under the first Garmin factor, the PTAB considered whether there was more than a mere possibility that additional discovery would yield useful information—namely, information “favorable in substantive value to a contention of the party moving for discovery,” and not merely relevant or admissible. The PTAB concluded that Requests 1 and 4 fell squarely within routine permissible discovery, as the requests inquired about the facts and prior art references that the petitioner’s expert considered in preparing his testimony. The PTAB observed, “it makes no sense to us to deny the document discovery requested here and then permit it in [the petitioner’s expert’s] deposition.”
In contrast, the PTAB found that the first Garmin factor did not support granting additional discovery as to Requests 2 and 3. The PTAB noted that the patent owner had provided no basis for its belief that opposing counsel had instructed petitioner’s expert to use particular parameters in his experiments. Furthermore, although the Federal Rules of Civil Procedure do not apply to IPR proceedings, the PTAB found that granting Requests 2 and 3 would be both impermissible under PTAB rules and inconsistent with Rule 26(b)(4)(C). Requests 2 and 3 sought not only documents that identify material discoverable under Rule 26(b)(4)(C)—namely, communications between a party’s attorney and expert related to the expert’s compensation or facts, data and assumptions considered by the expert—but also documents that merely include or refer to that discoverable material.
As to the second Garmin factor, the PTAB concluded that Requests 1 and 4 did not impermissibly seek petitioner’s litigation positions or the underlying bases for those positions. The PTAB found that Requests 1 and 4 were fair in that they sought information that the petitioner’s expert considered in testing reconstructions that formed part of petitioner’s case-in-chief. On the other hand, the PTAB found that the second factor weighed against granting Requests 2 and 3, and reiterated that these requests sought information outside the scope of the PTAB’s rules.
The PTAB found that the third and fourth Garmin factors weighed in favor of granting the motion for additional discovery, as none of the requested information could be generated by other means, and the additional discovery requests were easily understandable.
Finally, under the fifth Garmin factor, the PTAB considered whether the requests were overly burdensome, “given the expedited nature of inter partes review, including financial burden, burden on human resources, and burden on meeting the time schedule.” The PTAB concluded that Requests 1 and 4 were limited in scope and therefore not overly burdensome for the petitioner to answer. However, the PTAB found that attempting to answer Requests 2 and 3 without revealing protected attorney work product would be overly burdensome to the petitioner.
The PTAB noted that the petitioner did not specifically address factors 3, 4 and 5 in its opposition briefing.
In light of its analysis of the Garmin factors, the PTAB granted the patent owner’s motion for additional discovery as to Requests 1 and 4, but denied the motion as to Requests 2 and 3.
Practice Tip: A party seeking additional discovery in an IPR proceeding must show that granting the request is in the interests of justice under the Garmin framework. Requests for documents showing the factual bases of an expert’s testimony are typically permissible as providing useful information (factor 1) that is not merely the opposing party’s litigation positions (factor 2) and that cannot be generated by other means (factor 3). However, the party seeking discovery should carefully draft such requests to not run afoul of protections afforded to attorney work product. In addition, the party opposing discovery should expressly argue why each Garmin factor disfavors the requested discovery.
Tennant Co. v. Oxygenator Water Techs., Inc., IPR2021-00625, Paper 30 (PTAB Oct. 18, 2021)
Unavailability of Witness for Cross-Examination Dooms Reliance on Affidavit Testimony in PTAB Proceeding
by Matthew George Hartman, Rubén H. Muñoz, Megan Mahoney (Law Clerk)
Patent Trial and Appeal Board, Inter Partes Review
November 23, 2021
In a series of related inter partes review proceedings, the Patent Trial and Appeal Board recently granted a petitioner’s motion to strike the sworn affidavit of a witness who was unwilling to submit to cross-examination. In striking the affidavit, the PTAB explained that it would be improper to consider the affidavit because the patent owner had failed to comply with the PTAB’s applicable discovery rules by not making the witness available for cross-examination.
The petitioner challenged several patents, all related to methods and devices used to open and remove tissue from a patient’s eye. In support of its petitions, the petitioner submitted a 1984 article that discusses a surgical method for opening or tearing the trabecular meshwork of an eye.
After the PTAB instituted review, the patent owner submitted a sworn affidavit from the named author of the 1984 article to clarify what the article was meant to report. However, upon the petitioner’s request to cross-examine the witness, the patent owner was unable to produce him. The witness—an 85-year-old, retired Spanish citizen residing in Spain—was unwilling to travel to the United States for a deposition because of health concerns and the COVID-19 pandemic. The PTAB instructed the parties to further cooperate and depose the witness in Spain, but the witness eventually stated he did not wish to be involved in the dispute beyond his previous affidavit.
The petitioner then moved to strike the affidavit, arguing that its inability to cross-examine the witness would cause extreme prejudice, as the affidavit attempted to contradict and rewrite portions of the 1984 article. In response, the patent owner argued that the affidavit is not dispositive to the issues in dispute, and therefore something less than a live deposition would be a suitable alternative for the petitioner. The patent owner further advocated that, rather than strike the evidence, the PTAB should simply accord the appropriate weight to the affidavit in light of having no cross-examination.
The PTAB ultimately agreed with the petitioner, determining that it would be improper to consider the affidavit without the patent owner making the witness available for cross-examination. The PTAB explained that routine discovery requires that parties make their witnesses available for cross-examination if they want to proffer testimony by affidavit. See 37 C.F.R. §§ 42.51–42.53. The PTAB’s Consolidated Trial Practice Guide further clarifies that “[d]iscovery is a tool to develop a fair record and to aid [the PTAB] in assessing the credibility of a witness,” and therefore a party seeking to present testimony by affidavit must make the witness available for cross-examination. Because allowing the affidavit to remain in evidence without cross-examination would not provide a fair record and would prevent the PTAB from assessing the witness’s credibility, the PTAB granted the petitioner’s motion to strike the affidavit from each of the proceedings.
Practice Tip: To introduce and rely on sworn affidavits as evidence in an inter partes review proceeding, parties should be prepared to make those witnesses available for cross-examination. Failure to do so may have profound consequences on the merits of the proceeding, such as the PTAB striking evidence from the record and according no weight to briefing that relies on such evidence. While extenuating circumstances may elicit some flexibility from the PTAB, it does not relieve a party of its duty to produce a witness for cross-examination.
New World Medical, Inc. v. Microsurgical Tech., Inc., IPR2020-01573, Paper 49 (PTAB Nov. 5, 2021).
U.S. Patent Office Director Kicks Back IPR Decision to PTAB Panel in Light of Federal Circuit Decision in Related IPR
by Karina J. Moy & Rubén H. Muñoz
Patent Trial and Appeal Board, Inter Partes Review, Federal Circuit
November 30, 2021
In a rare move, the interim Director of the U.S. Patent Office granted review of a final written decision in an review proceeding. In its request for Director review, the patent owner argued that the Patent Trial and Appeal Board’s failure to give weight to objective evidence of nonobviousness in one IPR was legal error for the same reasons cited by the Federal Circuit on appeal of the PTAB’s decision in a related IPR.
U.S. Patent No. 9,403,626 (the ’626 Patent) claims a container intended for use in fracking, and U.S. Patent No. 9,440,785 (the ’785 Patent) claims methods of delivering, storing, unloading, and using the container. In two separate IPRs, the PTAB concluded that all challenged claims of both patents were unpatentable as obvious. In particular, the PTAB found that the patent owner had presented evidence of nexus between its commercialized container product and the claims of the ’626 Patent and ’785 Patent. However, the PTAB ultimately credited the patent challenger’s evidence purportedly showing that the patent owner’s commercial success and industry praise were the result of additional, unclaimed features, thereby rebutting the patent owner’s presumption of nexus.
The patent owner appealed the final decisions in both IPRs. On appeal of the IPR of the ’626 Patent, the Federal Circuit reversed and remanded the PTAB’s obviousness finding as to a subset of challenged claims. The appellate court faulted the PTAB for failing to weigh the patent owner’s evidence showing that the container had generated significant revenue and was specifically praised by customers and a market analyst as an effective and industry-disrupting technology. Because a patented invention need not be solely responsible for commercial success in order for such indicia of nonobviousness to be given weight, the Federal Circuit concluded that the PTAB had legally erred by ignoring the patent owner’s evidence.
After this Federal Circuit decision issued but while the appeal of the second IPR was pending, the patent owner requested Director review of the final written decision in the second IPR. The patent owner used the Director review process implemented by the PTAB in view of United States v. Arthrex, 141 S. Ct. 1970 (2021). The patent owner argued that the PTAB’s treatment of evidence of nonobviousness in the IPR of the ’785 Patent was nearly identical to its approach in the IPR of the ’626 Patent, which the Federal Circuit had found legally erroneous. The patent owner therefore requested that the Director either review the evidence of nonobviousness de novo or remand the proceeding for reconsideration in light of the Federal Circuit decision as to the ’626 Patent. The Director agreed that the PTAB’s analysis of the patent owner’s evidence was “substantially similar” in the two cases, and thus vacated the final written decision in the IPR of the ’785 Patent and remanded for the PTAB to address the patent owner’s objective evidence of nonobviousness.
Practice Tip: Although the impact of Arthrex has been modest thus far, Director review appears to be a viable option in some unique circumstances. The grant of review in this case—where the Federal Circuit had already decided the same legal question on appeal of an IPR involving the same parties, the same technology, similar evidence, and similar approach to that evidence by the PTAB—makes clear that Director review is not a dead end. Parties should thus consider carefully, and set forth explicitly in their requests, any unique circumstances that may support Director review.
Proppant Express Invs., LLC v. Oren Techs., LLC, IPR2018-00733, Paper 95 (PTAB Nov. 18, 2021).