Patent Trial Research Articles

Round-up of English patent litigation in 2022

... After the bumper year of 2021 in terms of the number of patent trials in the English courts, 2022 saw a slight easing off in the level of trial activity, at least in terms of determinations as to patent validity and infringement.1 2022 saw, at first instance, in inter partes proceedings in which patent infringement and/or validity was in issue, 16 final decisions in the Patents Court and one in the Intellectual Property Enterprise Court concerning in total 27 patents. The validity of all but two2 of these patents was challenged, successfully so in respect of 18 of them, but infringement was in issue in respect of only 15 patents, of which only five were held to be not infringed at all. Of the 18 patents held to be invalid, 15 were held to be obvious,3 one anticipated and one insufficient. The patentee prevailed, in whole or in part, in relation to seven patents, all of which survived challenges to validity and all of which were held to be infringed, at least in relation to some of the products or processes in issue, apart from four where infringement was admitted.

Immaculate Conception? Priority and Invention in the CRISPR Patent Dispute.

The U.S. Patent Trial and Appeal Board (PTAB), in an interference proceeding decided in February 2022, concluded that researchers at the Broad Institute (Cambridge, MA) were the first to "conceive" of using single-guide RNA CRISPR-Cas9 genome editing in eukaryotic cells in 2012. The PTAB reached this verdict even though competing researchers at the University of California, Berkeley, among other institutions, could document the idea 7 months earlier. Understanding the basis for the PTAB's decision turns on patent law's particular "conception" requirement. In this study, I explain that requirement, detail the PTAB's interference decision, and discuss the decision's practical effects on CRISPR technology and routine science.

US Supreme Court precludes judicial review of time-bar challenges of US Patent and Trademark Office Patent Trial and Appeal Board institution decisions

US Supreme Court precludes judicial review of time-bar challenges of US Patent and Trademark Office Patent Trial and Appeal Board institution decisions

Deconfounding and Sandboxing Patent Litigation with a Specialized Patent Trial Court

According to a recent study, patent litigation has been the target of multiple reform efforts over the past several decades, with mixed results that have left its fundamental dynamics—and problems—stubbornly intact. To make patent litigation more amenable to diagnosis and treatment, this Article proposes setting up a single, specialized Article III patent trial court that has exclusive original jurisdiction over patent cases and is empowered to promulgate its own rules of practice and procedure. Although the suggestion to set up a specialized patent trial court is not new, the existing rationales for doing so focus primarily on enhancing the quality of adjudication and eliminating forum shopping. But the literature has overlooked other potential benefits of such a court. Specifically, it can provide a controlled environment that could: (1) improve the ability of judges and policymakers to diagnose problems in patent litigation by removing certain variables, keeping other variables constant, or mitigating their variance (e.g., in the procedural rules, venue, trial judge experience), thereby decreasing the number and influence of potential confounders; and (2) allow for “sandboxing,” which can facilitate the adoption of reforms and expand the universe of solutions because the impact of a change that could materially alter the dynamics of patent litigation (and the risk of failure) may remain localized without affecting other parts of the federal court system or raise trans-substantivity concerns. More importantly, the controlled environment provided by a specialized trial court may make it easier to have an iterative diagnosis-treatment cycle, which is necessary for a complex system (like patent litigation) where the initial attempt at diagnosis or reform is unlikely to yield a definitive answer or a lasting solution. It is expected that the diagnostic- and reform-facilitating benefits of a specialized trial court—when aggregated with the other theorized benefits of specialized courts suggested in the literature—could outweigh the potential downsides, such as a lack of percolation, susceptibility to capture, and tunnel vision from the loss of the generalist perspective.

Brief of Amici Curiae Professors of Patent and Administrative Law in Support of Respondent, Thryv, Inc. v. Click-To-Call Technologies, LP, No. 18–916 (Sup. Ct., Nov. 4, 2019)

This case implicates a significant balance in the patent system between the competing powers of the federal courts and the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“PTAB”) to review patent validity. Congress allocated those powers through several provisions of the America Invents Act, including the one-year time bar of 35 U.S.C. § 315(b). The Federal Circuit, starting with its en banc decision in Wi-Fi One, LLC v. Broadcom Corp., 878 F.3d 1364 (Fed. Cir. 2018), has been taking proper account of that balance of power by exercising judicial review over the PTAB’s application of the one-year bar. Judicial review of § 315(b) time-bar determinations is foundational to safeguarding the court-agency balance of patent powers, whose scope and impact extend well beyond the PTAB and into the courts. Accordingly, the Federal Circuit’s conclusion that such review is available correctly applies this Court’s guidance in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), and is strengthened even further by this Court’s subsequent decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018). Moreover, detailed empirical evidence reveals that litigants use the PTAB to a significant extent as a strategic substitute for courts in reevaluating patent validity. Strategic substitution is subject to important statutory constraints, especially the one-year bar of § 315(b). These constraints promote repose for litigants, conservation of both court and agency resources, and inter-branch respect for the judgments of competing tribunals. Accordingly, in evaluating the reviewability of the PTAB’s timeliness determinations under § 315(b), this Court should take careful account of the significant scope and impact that § 315(b) has beyond the inter partes review setting in preserving the balance of power that Congress has allocated to the PTAB and to the courts.

권리범위확인심판에서 확인대상발명의 특정에 관한 소고

권리범위확인심판에서 확인대상발명의 특정에 관한 소고

Attorney Fees after Octane Fitness and Highmark

A court may award attorney fees to a prevailing party in a patent trial under exceptional circumstances. Since 2005, courts had applied a rigid formula to determine whether a case was exceptional. In the summer of 2014, the Supreme Court rejected this rigid test. Instead, the Court held that an exceptional case is “simply one that stands out from others.” Finding a case exceptional, the Court said, was at the discretion of the district court and only reviewable on appeal for an abuse of discretion. A little over a year later, one interesting question is: how do district courts now determine what cases are exceptional in the absence of a more formulaic approach? The analysis of several recent cases reveal that district courts primarily analyze a party’s (1) litigation position and (2) litigation conduct to determine whether — in its discretion — to award attorney fees. To a lesser degree, district courts have also awarded attorney fees to deter infringement and unsavory litigation practices. However, the deterrence rationale has the potential to be problematic: its purpose is to deter litigation practices, but given the current legal climate it could be used to unfairly penalize litigants that might be classified as “patent trolls.” The existing literature on the award of attorney fees in patent cases sheds very little light on the problems district courts’ reliance on the deterrence rationale could present. This essay addresses these problems and offers practical insights as to when courts should rely on the deterrence rationale to award attorney fees. The essay points out that what makes a case exceptional should have little to do with the identity of the parties. In addition, this essay prescribes that district courts should not take into account the business model of the parties to justify deterrence as a rationale for awarding attorney fees.

IPR Protection and Antitrust Regulation of SEPs in China

This paper explores the practice of IPR protection and antitrust regulation of standard essential patents (SEPs) in China and discusses whether the licensing of SEPs should be regulated in a way different from other patent cases. With regard to IPR protection, the Chinese judiciary has actively taken a role in patent infringement trials. Differences are observed in SEP infringement lawsuits as compared to ordinary patent cases in terms of non-infringement defense, counter-injunction defense, and damages. In relation to antitrust regulation, the Chinese competition agencies and the courts have mainly focused on price-related abuses and SEP-related merger review, and paid particular attention to the possibility of SEP holders leveraging, tying SEPs with non-SEPs, and charging high royalty fees. Since SEPs have raised a different issue than other types of IPRs, a delicate balance between protecting the private interest of the SEP holders and the public interest of standardization will have to be re-struck.

Saliency, Anchors & Frames: A Multicomponent Damages Experiment

Modern technology products contain thousands, sometimes hundreds of thousands, of different features. Nonetheless, when electronics manufacturers are sued for patent infringement, these suits typically accuse only one feature, or in more complex suits, a handful of features, of actual patent infringement. But damages verdicts often do not reflect the relatively small contribution an individual patent makes to an infringing product. One study observed that verdicts in these types of cases average 9.98% of the price of the entire product. While both courts and commentators have blamed the law of patent damages, the role cognitive biases play in these outsized damages awards has been understudied. Relying on decision-making concepts from other contexts, we hypothesize that two biases, namely, a saliency bias and anchoring, may be at work in a patent trial. Since the infringing feature is the most salient feature in a patent trial (i.e. the focus of the trial), jurors may tend to overvalue that feature. Moreover, a patentee’s irrationally high damages demand may “anchor” the juries to that number. We conducted an online 3x3x2 between-subjects experiment to test whether these biases exist and if so, whether particular debiasing techniques may reduce these biases. In eighteen different scenarios, mock jurors were asked to assess damages for different smartphone features. The three manipulations involved: 1) rotating three features so that they were either the feature underlying the plaintiffs’ claim (the “feature-in-suit”) or one of the other features defendant identified as contributing to the smartphone’s overall value; 2) changing the jury verdict form so that mock jurors had to evaluate both the feature-in-suit and other features together; and 3) having the defendant explicitly call out the plaintiff for anchoring the jury in an irrationally high number. The results suggest that some combination of the saliency bias and anchoring were at play when juries assessed damages for all three tested features. However, for the storage feature the results were only significant for the feature’s relative rank, but not its dollar valuation. That may be because mock jurors are familiar with the cost of the increased storage. Modifying the jury verdict form reduced, but did not eliminate, the primary effect of the saliency bias, while the defendant’s tactic of exposing the plaintiffs’ anchor did not significantly reduce damages. In addition, qualitative comments suggested that some mock jurors resisted the jury instructions designed to compensate plaintiffs for the missing feature and instead assessed damages to punish the defendant.

U.S. Patent Litigation Juries and a Solution for Improving Jury Comprehension

The right to a trial by jury is a basic and fundamental feature of American federal jurisprudence, protected by the Seventh Amendment. Over the past several decades, patent litigation has gone through several transformations in an effort to resolve disputes fairly and efficiently. The Apple-Samsung trial increased the publicity of high profile patent litigation cases and provoked skepticism from legal scholars on the validity of the current patent litigation system. Judge Richard Posner mistrusted judges’ and jurors’ abilities to decide complex patent cases effectively. Judge Posner, and others, argue that it’s time to end jury trials in patent cases. However, improvements can be made to the current patent litigation system without eliminating patent jury trials. This article focuses on the current U.S. patent litigation system, patent litigation systems in other countries, current revisions to improve U.S. patent litigation trials, and proposes a mixed jury solution to ensure jurors fully understand the complex and technical facts of a patent case.

Casting Aspersions in Patent Trials

Bad actors in patent litigation can face serious consequences. Infringers who are found to “willfully” infringe may be subject to trebled damages. Patentees who assert weak claims in bad faith can be ordered to pay the defendant’s attorneys’ fees. These remedies are of such importance to the patent system today that the Supreme Court reinvigorated both of the respective doctrines in back-to-back landmark decisions in 2014 (Octane Fitness) and 2016 (Halo Electronics). Those decisions have helped district courts more effectively punish and deter misconduct. But the Supreme Court neglected to address a critical part of these remedies—whether and to what extent they should be tried to a jury. Under current law, willfulness can be tried to a jury but bad-faith enforcement cannot. This means that plaintiffs alone can legitimately cast aspersions at defendants that profoundly color the case and the jury’s views of it.It has long been held that willfulness is an issue triable by jury, but courts have reached that conclusion without conducting the proper analysis, which requires delving into the historical treatment of the issue. This article performs that analysis, finding that the Seventh Amendment does not guarantee a right to try willfulness to a jury. Nor does the Seventh Amendment require that questions of bad-faith enforcement be tried to juries. Both issues lack clear historical antecedents or analogues that would suggest juries decided the issues when the Seventh Amendment was ratified. Whether such issues should be tried to juries likely comes out in the negative as well. Juries are ill-equipped to appreciate the proper significance and context of evidence touching on willfulness and bad-faith enforcement, which typically includes matters of claim construction, discovery, legal interpretation, or settlement discussions. And evidence about a party’s culpability can easily bleed into the threshold liability and damages determinations, resulting in unsupportable compromise verdicts on those issues.The best practice would be to try neither issue, but as it is, with willfulness being submitted to juries, a separate question is whether that alone justifies trying bad-faith enforcement to juries as well. This article demonstrates that basic fairness, as well as evidentiary practicalities for how such issues are proven, compels that both issues be tried together, and to the same jury, to ensure that juries hear both sides of the story before they assign moral blame.

Lead Compound Approach: An Eternal Standard for Chemical and Pharmaceutical Obviousness at US PTAB?

It is all about reinforcing lead compound approach (LCA) for structural obviousness determination of new chemical compounds in chemical and pharmaceutical patents, which is trending at the United States Patent Trial and Appeal Board (US PTAB)! Synchronising with the United States Court of Appeals for Federal Circuit (US CAFC)’s eternal and time-tested standard of LCA framework, the PTAB issued an Inter Partes Review decision (IPR 2015-0340 dated August 18, 2017)) in Mylan Pharm. v. AstraZeneca AB, to uphold the validity of patent RE44,186 (a reissue of U.S. patent no. 6,395,767) covering claims directed to AstraZeneca’s Saxagliptin (drug originally developed by BMS, the active ingredient in Onglyza and Kombiglyze XR).

The Universality and Specificity of Patent Trial and Appeal: Focusing on IP5(Intellectual Property 5) Countries

The Universality and Specificity of Patent Trial and Appeal: Focusing on IP5(Intellectual Property 5) Countries

Inventive steps: the CRISPR patent dispute and scientific progress: The recent patent decisions about CRISPR tell us a lot about how advances in biology are actually made-and how they are not.

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene‐editing technology, CRISPR/Cas9, have shed light on the importance—and puzzles—of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. In February 2017, the US Patent Trial and Appeal Board (PTAB) found that the work of Feng Zhang, a researcher at the Broad Institute in Cambridge, MA, USA, constituted a “nonobvious” advance over the celebrated work of Jennifer Doudna of the University of California, Berkeley (USA) and Emmanuelle Charpentier, then at Umea University, Sweden [1]. As a consequence, the Broad Institute will be able to keep its US patents covering the technology irrespective of how Doudna and Charpentier's patent application proceeds. By contrast, the European Patent Office (EPO) announced that it had granted Doudna and Charpentier's European patent application covering broad uses of CRISPR/Cas9 in essentially any cell type, despite the US Patent Office's decision to the contrary [2]. Other parties—including the Broad Institute—will be able to challenge Doudna and Charpentier's European patent. But for now, the EPO's decision is an implicit recognition that Doudna and Charpentier's work was, itself, a major “inventive step” over the work that came before it. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions have put those differences on parade. The US decision in particular—and even the nature of the controversy between the two US research institutions—has been widely criticized by scientists. One prominent researcher, Michael Eisen from the University of California, Berkeley, has taken particular issue with the PTAB's articulation of the typical manner in which molecular biologists adapt discoveries to different cell systems. “[O]ne can believe that it was obvious that CRISPR would work in eukaryotic cells, …

Dispute the patent, short the stock: Empirical analysis of a new hedge fund strategy

A new US patent legislation, called the America Invents Act, became effective in 2011. The reform strived toward facilitating the patent system. But soon it was also blamed for facilitating immoral third party profits. Urges for revision of the America Invents Act became even louder since hedge fund manager Kyle Bass had publicly outlined his questionable investment strategy: he challenges the validity of important drug patents, while shorting the owner's shares in order to eventually cash out on negative stock movements.The following questions aroused public interest the most: Does the mere filing of a patent opposition already result in negative stock returns? And is it really possible to earn money following such a strategy? The paper on hand is the first to empirically answer these questions. Event study methodology using three years of data from the United States Patent Trial and Appeal Board was employed.Findings were that the mere filing of a patent opposition in fact produces statistically significant negative returns. The result is robust with the abnormal return being −30 base points. In addition, multiple linear regression results confirm the conjecture that the higher the importance of the disputed patent, the higher the negative abnormal return on the filing date will be. However, transaction cost simulations prove that this strategy is still highly speculative and cannot be considered a real threat to patent holders or the US intellectual property system. The only ones who should start worrying are the few patent owners who really rely on absolutely unjustified and tenuous patent protection.

Brief of Amici Curiae Professors of Patent and Administrative Law in Support of Neither Party, Wi-Fi One, LLC v. Broadcom Corporation, No. 1551944, -1945, -1946 (Fed. Cir., Feb. 23, 2017)

This case implicates a significant balance in the patent system between the competing powers of the federal courts and the U.S. Patent and Trademark Office to review patent validity. Although Congress already allocated these powers through various provisions of the America Invents Act, this Court’s decision in Achates Reference Publishing, Inc. v. Apple, Inc., 803 F.3d 652 (Fed. Cir. 2015), failed to take account of that balance of power and now threatens to obstruct this Court’s ability to safeguard the balance from further disruption. Intervening guidance from the Supreme Court in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), sheds new light on the court-agency balance of patent powers, whose scope and impact extend well beyond the USPTO Patent Trial and Appeal Board and into the courts. New empirical evidence reveals that litigants use the USPTO to a significant extent as a strategic substitute for courts in reevaluating patent validity. Strategic substitution is subject to important statutory constraints, especially the one-year bar of 35 U.S.C. § 315(b). These constraints promote repose for litigants, conservation of both court and agency resources, and inter-branch respect for the judgments of competing tribunals. Notably, these constraints appear to channel litigants into socially desirable collective action but may also foster undesirable harassment of patent owners and delay in adjudicating patent disputes. Accordingly, in deciding the judicial reviewability of USPTO determinations regarding timeliness under § 315(b), this Court should take careful account of the significant scope and impact that § 315(b) has beyond the inter partes review setting in preserving the balance of power that Congress has allocated to the USPTO and to the courts.

Who owns CRISPR?

“They have a patent on green tennis balls; we will have a patent on all tennis balls.” That is how Jennifer Doudna, professor of chemistry and of molecular and cell biology at the University of California, Berkeley, reacted to the U.S. Patent Trial and Appeal Board’s recent ruling that Broad Institute, a research center affiliated with Massachusetts Institute of Technology, gets to retain more than a dozen patents that had been granted for the use of the technique known as CRISPR ( see page 7). Short for “clustered regularly interspaced short palindromic repeats,” CRISPR is a way of editing DNA in the cells of humans, other animals, and plants. Doudna was credited as an inventor of the gene-editing technology for work she did with Emmanuelle Charpentier, who used to be based at the University of Vienna but is now director of the Max Planck Institute for Infection Biology. The pair,

Microsoft ruling clarifies guidance oninter partesreviews

The US Court of Appeals for the Federal Circuit provides guidance on practice before the US Patent Trial and Appeal Board in inter partes review proceedings (IPR) with respect to claim construction and motions to amend. Specifically, the Federal Circuit confirmed (i) that the Board had the discretion to apply the ‘broadest reasonable interpretation’ claim construction standard to IPRs, and (ii) that the Board had discretion to require a patentee to show that its proposed substitute claims are patentable over all prior art of record, even if certain prior art did not form the basis for institution of the proceedings with respect to the corresponding challenged claim.

Riociguat in Combination With Endothelin Receptor Antagonists (ERAs) for the Treatment of Pulmonary Arterial Hypertension (PAH): A Subgroup Analysis of PATENT

SESSION TITLE: Pulmonary Arterial Hypertension Posters II SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM PURPOSE: The ACCP suggests that riociguat may be added to the treatment regimen of PAH patients who remain symptomatic despite stable regimens of an inhaled prostanoid or an ERA. PATENT-1 (the Pulmonary Arterial Hypertension Soluble Guanylate Cyclase-Stimulator Trial) allowed patients to enroll while on stable regimens of ERAs. Here, we report findings from analysis of the subgroup of patients from the PATENT trial who were on background ERA therapy (BERA). METHODS: Patients were assigned to placebo (N=126; n=54 on BERA), to individualized dosing of riociguat up to 2.5 mg TID (N=254; n=113 on BERA), or to an exploratory riociguat group capped at 1.5 mg TID (N=63; n=27 on BERA). Primary outcome was change from baseline (BL) in 6-minute walk distance (6MWD) at week 12. Secondary exploratory outcomes included change from BL in pulmonary vascular resistance (PVR), NT-proBNP, WHO functional class (WHO-FC), and clinical worsening. RESULTS: All apply to patients (riociguat and placebo) on BERA. For the placebo-corrected mean change from baseline to last visit, 6MWD in riociguat patients (1.0 to 2.5 mg TID) increased by 26 meters (95% CI: 5-46 meters). Mean change in PVR for riociguat patients was -174±202 dyn·s·cm-5, versus -46±266 dyn·s·cm-5 for placebo. Mean change in NT-proBNP was 90±2212 pg/mL for riociguat patients versus 172±759 pg/mL for placebo. By last visit, 26% of riociguat patients had improved one WHO-FC (71% maintained FC, while 4% worsened 1 FC) compared with 13% of placebo patients (76% maintained FC, and 9% and 2% worsened 1 and 2 FC, respectively). Among riociguat patients, only 1 (0.9%) had at least 1 clinical worsening event, compared with 3 (5.6%) among placebo patients, including 1 death. CONCLUSIONS: These data suggest that adding riociguat to stable regimens of ERAs in symptomatic PAH patients has favorable effects on 6MWD, PVR, WHO-FC, and perhaps clinical worsening. CLINICAL IMPLICATIONS: Adding riociguat to stable regimens of ERAs may be beneficial in symptomatic PAH patients but additional studies are needed to further explore this possibility. DISCLOSURE: Nicholas Hill: Consultant fee, speaker bureau, advisory committee, etc.: Bayer Healthcare Namita Sood: Consultant fee, speaker bureau, advisory committee, etc.: Actelion, Consultant fee, speaker bureau, advisory committee, etc.: Gilead, Consultant fee, speaker bureau, advisory committee, etc.: Bayer Healthcare No Product/Research Disclosure Information

Navigating the Sea Changes in Patent Law to Successfully Build Value

Major changes in U.S. patent law are having an impact on the value of patents. The Leahy-Smith America Invents Act (AIA) introduced numerous changes to U.S. patent law including the switch to a first to file patent system from a first to invent patent system. New proceedings at the U.S. Patent and Trademark Office to challenge the grant of issued patents have produced quick results and emerging trends. Recent U.S. Supreme Court decisions have changed the threshold determination of patentability under 35 U.S.C. § 101, altering the patentability standards for biotech/pharma inventions, as well as computer/business method inventions. In Europe, the framework for an emerging unitary patent system, expected to be implemented by mid-2016, will add complexity to strategic patent planning for that region. This article will review these changes, discuss trends and provide strategies to build a patent portfolio with valid and enforceable patent claims as a foundation to withstand patentability and validity challenges. Keywords: America Invents Act (AIA), Biotech/pharma, European unitary patent, Intellectual property (IP), Inventions, patents, Patent trial and appeal board (PTAB), Patentability.