" Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration ," 49 The Journal of Law, Medicine and Ethics 456 (2021) (with Alexander C. Egilman, Amy Kapczynski, Margaret E. McCarthy, Anita T. Luxkaranayagam et al.)

"Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration," 49 *The Journal of Law, Medicine and Ethics* 456 (2021) (with Alexander C. Egilman, Amy Kapczynski, Margaret E. McCarthy, Anita T. Luxkaranayagam et al.)

Alexander C. Egilman et al., Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration, 49 J.L. Med. & Ethics 456 (2021)

Alexander C. Egilman
Amy Kapczynski
Margaret E. McCarthy
Christopher J. Morten
Anita T. Luxkaranayagam et al.

istorically, sponsors and regulatory agencies have kept confi dential much of the clinical data generated to support the approval and continued monitoring of small molecule and biologic drugs (i.e., regulatory data). Notable cases, such as rofecoxib (Vioxx) and gabapentin (Neurontin), revealed how treating data as confi dential can conceal important information about drug safety and efficacy, as well as improper research practices, including the selective publication and reporting of trial results. 1 Providing access to these data may not only help prevent unscrupulous research practices, but also advance our understanding of the safety and eff ectiveness of medical products. 2 Over the past two decades numerous initiatives have been launched to make regulatory data, including clinical study reports (CSRs) and individual patient-level data (IPD), publicly available. 3 For instance, there are data sharing initiatives organized by industry (e.g. ClinicalStudyDataRequest. com [CSDR]) and independent organizations (e.g. Yale University Open Data Access [YODA] Project). 4 While these eff orts have advanced transparency for many medical products, 5 they have not gained traction industry-wide and remain constrained by their lack of authority to require companies to make data publicly available. 6 In contrast, regulatory agencies, as gatekeepers of market authorization, are best positioned to disclose data, particularly clinical data submitted for regulatory review. Several laws and policies -some recent -authorize the European Medicines Agency (EMA) in Europe, Health Canada (HC) in Canada, and the Food and Drug Administration (FDA) in the United States Policy 0043 and Policy 0070 govern the EMA's approach to providing access to regulatory data for drugs and biologics (Table 1). Policy 0043, adopted in 2010, authorizes the EMA to release data reactively. 11 Policy 0070, adopted in 2014, authorizes the EMA to proactively publish data on an online data sharing portal. 12 The scope of policy 0043 is expansive, providing access to any document originated, received, or held by the EMA. The scope of Policy 0070 is narrower, applying only to data submitted under the central marketing authorization procedure after January 1, 2015. EMA plans to implement Policy 0070 in two phases. Phase 1 publishes clinical reports, which include clinical overviews, clinical summaries, CSRs, along with several appendices to the CSRs, including protocol and protocol amendments, sample case report forms (CRFs), and statistical analysis plans (SAPs). Phase 2 will publish IPD. However, in 2018 EMA temporarily suspended its proactive publication of data, citing the disruption and resource constraints caused by the United Kingdom's withdrawal from the European Union. 13 EMA's proactive and reactive disclosure policies take a similar position on CCI, generally considering information contained in clinical reports not as CCI, unless disclosure undermines the competitive position of the information's owner. This position faced several challenges in court but was recently validated by the European Court of Justice. The Court found that clinical reports were not covered by a general presumption of confidentiality and that market authorization holders must meet a high standard to qualify any data included in the reports as CCI, by establishing that disclosure poses the risk of concrete harm to their commercial interests. 14 Additional details regarding data accessibility and the timeline for data publication are available in Table 1. Provide a factual summary and critical analysis of the clinical data submitted in the dossier. These documents present the strengths and limitations of the development program, analyze the benefits and risks of the medicinal product in its intended use, and describe how the study results support critical parts of the prescribing information. • Provide insight into the quality and limitations of studies, issues encountered during product development and testing, and unusual prescribing information Comprehensively describes the methodology and results of a clinical trial. It contains more detail regarding trial design, conduct, and results than is contained in published versions of the same trial. It has several appendices, which include protocol and protocol amendments, sample case report forms, and statistical analysis plans. • Appraise a trial and synthesize evidence, including evaluation of product safety and effectiveness • Inform systematic reviews, meta-analyses, and risk of bias evaluations • Provide greater detail than journal publications, which are often subject to word-count restrictions, particularly on secondary effectiveness endpoints and safety • Determine improper research practices, such as datadredging, outcome switching, and selective reporting Describe the original objectives, design, methods, statistical considerations and organization of a clinical trial, and include any subsequent protocol modifications. Both the protocol and later modifications are reviewed by an ethics committee. • Assess study design and facilitate replication • Identify unscrupulous research practices, such as outcome switching and P-hacking Case report forms Questionnaires used by the sponsor of the clinical trial to record information about each trial participant. • Ensure the accuracy of individual patient-level data Provides a complete description of the planned methods for collection, analysis, interpretation, presentation, and organization of the data. • Assess statistical methodology, including clinical trial power calculations, endpoint definitions, and proposed and conducted analyses • Appraise and replicate statistical methods Provides detailed information related to a suspected adverse reaction to a medicinal product that occurs in a single patient at a specific point of time. • Identify an increase in the reporting of a known adverse event, a new serious adverse event not listed in a medicines label, or a new drug-drug interaction Individual data recorded for each participant in a clinical study, such as age, gender, race, efficacy and safety outcomes, laboratory results, etc. • Appraise a trial and synthesize evidence, including for evaluation of product safety and effectiveness and for use in systematic reviews and meta-analyses • Classify all adverse events when performing a meta-analysis focused on safety • Perform relevant subgroup analyses • Allow for longer follow-up compared to publications EMA Policy 0070 by proactively releasing data for not only approved, unapproved, and withdrawn drug and biologic submissions but also Class III and IV medical device applications (Table 1). 15 The clinical data made available is similar in scope to EMA Policy 0070, with HC publishing clinical reports. HC also intends to make clinical reports available upon request for medical products that had a final regulatory decision prior to March 2019, similar to Policy 0043. However, HC will not release IPD under the PRCI initiative. HC plans to phase in the proactive release of clinical reports over four years, beginning in 2019. HC construes CCI (known as "confidential business information" in Canada) narrowly, protecting only clinical information not used by the applicant to support the proposed conditions of use or clinical information that describes tests, methods, or assays used exclusively by the manufacturer, and then only with adequate justification. 16 Going forward, HC aims to publish data within 120 days after issuance of a final regulatory decision or after an information request is lodged. Unlike the EMA, data posted in response to information requests are made available on HC's online portal, requests are not limited to the citizens of the nation's regulator (i.e. Canadians), and registration is not required to access data. In January 2018, FDA launched a new pilot program to proactively publish CSRs of pivotal studies for nine recently-approved novel drugs, including trial protocols, protocol amendments, and SAPs (Table 1). 17 However, FDA announced in March 2020 that it was ending the pilot, with only a single CSR having been made available. 18 The Freedom of Information Act (FOIA), enacted in 1966, requires federal agencies, including the FDA, to disclose records upon request by the public, unless records fall under one of nine specific exemptions protecting interests such as CCI and personal privacy. 19 FOIA is the only mechanism to access certain types of regulatory data, such as CSRs, for medical products approved by the FDA. 20 The FDA has defined CCI as "valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs." 21 However, even if information meets the definition of CCI, FDA may have discretion to release it if there is a compelling public interest in disclosure. 22 To assess the EMA and HC's proactive publication of clinical data under Policy 0070 and the PRCI initiative, respectively, we systematically searched each agency's online data sharing portal, 23 documenting for each data release through April 2021: the type of medical product (drug, biologic, medical device, or vaccine); regulatory procedure (initial marketing authorization application (MAA) or post-authorization application); regulatory decision (approved, unapproved, or withdrawn); regulatory decision date; public release date; and time from regulatory decision to release. EMA and HC generally release the same categories of data across medical product types and regulatory procedures. Thus, to compare the data released across agencies, we randomly selected a single product for which both EMA and HC had made clinical data available, and then characterized the category of data released, number of pages, presence of redactions, reason for redactions provided (protected personal data (PPD) or CCI), and described the information redacted. To assess EMA, HC, and FDA's reactive data disclosure processes, we first reviewed the literature to identify studies on information requests submitted to EMA, HC, or FDA. To better understand the scope of data made available by EMA, HC, and FDA in response to information requests, we submitted a FOIA request to FDA in 2014 for a wide range of clinical data and regulatory records for Gilead's Hepatitis C drugs sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) (Appendix Box 1), as well as a parallel request to EMA in 2016 under Policy 0043 and to HC in 2020 under the PRCI initiative. Sovaldi and Harvoni were selected as illustrative test cases because of their novelty, the safety issues that were being evaluated at the time we initiated this work, their use in the treatment of Hepatitis C, a major global health problem, and high cost. 24 We documented the date of each request milestone (e.g. initial request filed, appeal filed) and the date of each document production. For each production, we then characterized the category of data and the number of pages made available. We then described the information that had been redacted and compared the number of pages and redactions in CSRs of phase 2 and 3 trials produced by EMA, HC, and FDA. Since HC releases information in response to requests on the same online data sharing portal as the information it proactively discloses, we followed the journal of law, medicine & ethics c. That has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors. 41 Valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs. 42 Not specified At the time of initial data collection (April 30, 2020), no data supporting the same MAA were proactively released by both EMA and HC. However, data supporting the same initial MAA for 4 medicines were made available proactively by EMA and reactively by HC. After reviewing HC's data releases and confirming the agency typically makes available equivalent categories of information proactively and reactively, we randomly selected daratumumab (Darzalex) among those 4 medicines to compare the information shared across EMA and HC. EMA and HC released 28 and 29 documents, respectively, for Darzalex, including all of the same categories of data: a clinical overview; summaries of biopharmaceutical and pharmacological studies, summaries of safety and efficacy, a biomarker technical report, and a population pharmacokinetic report; for each of its 5 clinical trials: a CSR (4 full, 1 synoptic), protocol and protocol amendments, sample CRFs, and SAPs for 3 of the trials (Table 3). There were no substantive discrepancies in the released data. However, EMA disclosed a more updated clinical overview, while HC posted an additional clinical overview addendum describing Canadian treatment approaches for multiple myeloma. The full CSRs, protocols, including those with amendments, CRFs, and SAPs had a median length of 1612, 108, 115, and 76 pages, respectively, for both EMA and HC. Redactions were comparable and minimal across EMA and HC: PPD and CCI were provided as the reasons for redactions in 3 and 15 documents, respectively. Names of report investigators or subject ID numbers were the most common redactions. We identified two studies on information requests to EMA under Policy 0043, no studies on information requests to HC under the PRCI initiative, one study on FOIA requests to FDA, and one study examining CSRs released in response to information requests to EMA and FDA, among other sources. One study determined that of the 457 information requests EMA received between 2010 and 2012, 66% were granted, 27% were denied, and 7% were pending. 25 Requests were processed in a median of 26 days. In a case series of 12 information requests filed between 2011 and 2015, the EMA released a wide variety of regulatory data, including CSRs, regulatory comments, meeting and decision records, periodic safety update reports, correspondence, and postmarket data and took a median of 301 days to process the requests. 26 A study examining 78 CSRs, including 11 obtained from information requests to EMA and FDA, found that key appendices of CSRs, such as protocols and case report forms were frequently omitted. 27 Based on a study of FOIA requests to FDA between 2008 and 2017, FDA fully or partially granted 72% of requests. 28 FDA processed one-fifth of requests in 20 days but took more than 61 days to process two-thirds of requests. HC released data for 55 unique medical products in response to 70 processed requests between February 2019 and April 2021, including for 23 drugs, 6 biologics, 6 vaccines, and 20 medical devices. HC took a median of 132 (interquartile range 103-167) days to process requests and published the same categories of regulatory data reactively as it had proactively. In response to our parallel requests for information supporting approval of Sovaldi and Harvoni, FDA and HC released substantially more regulatory data than EMA, including clinical overviews, summaries and integrated summaries of safety and efficacy, clinical study protocols and amendments, and narratives of deaths and serious adverse events. Information only made available by FDA include individual safety case reports; records and correspondence related to product labeling, safety concerns, pediatric studies, expedited approval pathway designations, and postmarket study requirements and commitments; safety update reports; site initiation visit reports; and IPD, albeit heavily redacted (Appendix Table 2). Information only produced by HC include sample case report forms and statistical analysis plans (Appendix a Alternative formulations were combined, along with generics or biosimilars with original products. b For HC, initial marketing authorization includes new drug submission-new active substances (n=42), new drug submissions (n=15), Class III medical devices (n=1), Class IV medical devices (n=1), and 2 vaccines and 1 biologic authorized under Interim Order (n=3). For FDA, initial marketing authorization includes 1 new drug application. c For EMA, post-authorization includes extension of indications (n=45), line extensions (n=5), and workshare (n=2) procedure types. For HC, postauthorization includes supplemental new drug submissions (n=2) and supplemental new drug submissions containing confirmatory trials (n=11). d For EMA, dates of two post-authorization procedures were unavailable, and were excluded from processing time calculations. e EMA's temporary suspension of Policy 0070 remains in place, however, clinical data for these 5 medical products were published in line with EMA's exceptional measures to maximize the transparency of its regulatory activities on treatments and vaccines for Coronavirus Disease 2019 that are approved or are under evaluation. f One biologic and one medical device package proactively released by HC were identified as part of the agency's pilot program and thus were excluded from processing time calculations. Information only made available by EMA include periodic safety update reports and pharmacovigilance risk assessment committee reports (Appendix Table 4). All three agencies made available CSRs for phase 1, 2, and 3 trials. Comparing the productions of CSRs of phase 2 and 3 clinical trials, EMA released CSRs corresponding to more phase 2 and 3 trials than FDA and HC (25 vs. 18 vs. 24); however, of the 16 CSRs produced for the same clinical trials by all three regulators, 11 released by FDA and HC were longer, 4 were the same, and 1 released by EMA was longer (Appendix Table 5). Among the 16 CSRs, those produced by FDA had an average of 473 pages compared to 464 and 179 pages for those produced by HC and EMA, respectively. EMA, HC, and FDA redactions of the CSRs were minimal, most commonly redacting names and contact information of study investigators and administrators and subject ID numbers. EMA and FDA also commonly redacted information about the drug manufacturer and supplier, citing CCI, while HC redacted narratives of deaths and serious adverse events, citing PPD. Time from initial request to final data production was 918 and 968 days for FDA and EMA, respectively (Appendix Table 6). While HC processed the information request much faster, publicly posting the data packages for Harvoni and Sovaldi 155 and 351 days, respectively, after the initial request. The request to FDA required considerably more resources, including multiple appeals and court filings. Additionally, FDA waived processing fees; however, the agency normally charges fees unless it is shown disclosure of the requested information is in the public interest. 29 Last, HC organizes its data productions into categories, making the information much easier to navigate and process. Over the past decade, EMA and HC have greatly expanded the public availability of regulatory data, while FDA has lagged behind by not proactively publishing clinical reports. EMA and HC's routine publication of clinical reports, including clinical overviews and summaries, CSRs, protocols, sample CRFs, and SAPs, which just a decade ago had largely been treated by regulators as CCI, represents a paradigm shift in clinical trial transparency. HC's more recent PRCI initiative goes beyond EMA Policy 0070 in proactively posting clinical reports supporting medical device applications, not just drug and biologic MAAs. HC also offers the most efficient source of regulatory data, typically posting clinical reports about 5 months after a regulatory decision, nearly a year quicker than EMA, and processing most information requests in less than 5 months, about 150 days quicker than EMA takes to release requested regulatory data that are complex or voluminous. 30 EMA and FDA required nearly three years to process our request for comprehensive regulatory data supporting the approvals of Sovaldi and Harvoni, substantially longer than EMA had previously taken to process requests for CSRs. 31 While EMA and FDA processing times vary widely, 32 our findings suggest there may be an opportunity for EMA and FDA to increase their processing speed to align with HC. The CSRs released upon request by FDA and HC were more than double the length of those produced by EMA, suggesting FDA and HC may source more comprehensive CSRs. A similar request to FDA may require greater resources than to EMA and HC. Nonetheless, use of EMA or FDA's information request processes may be necessary to gain access to other types of regulatory data, such as sponsorregulator correspondence. Consistent with findings from other recent studies, redactions across the agencies were mostly minor (e.g., primarily researcher and participant identifying information) and generally did not impede interpretation of the evidence. 33 Two notable exceptions are FDA and HC's complete redaction of IPD and narratives of serious adverse events and deaths, respectively. Our study has several limitations. First, HC's start date, the date when HC initiates the process to prepare information for public release, was used to calculate HC's processing time for information requests, not the actual date information requests were submitted, which is not publicly available. HC may take several weeks, and in some cases months, to begin processing requests, particularly when a request requires clarification or where paper records need to be digitized. Therefore, HC may take moderately longer than a median of 132 days to process requests. However, it is unlikely to impact the study's finding that HC is the most efficient source of clinical reports, given EMA required a median of 301 days to process a series of comparable information requests and HC also completed our requests for information on Sovaldi and Harvoni in about one-third the time that EMA and FDA required. 34 Second, parts of the study were based on analyses of case studies, including Sovaldi, Harvoni, and Darzalex, which represent just a few of the many medical products for which data has been made publicly available. Third, the length of CSRs was used to compare the scope of data made available reactively by each agency; specific differences in the content of CSRs were not examined. Last, the study was limited to transparency of regulatory data, which comprises just a portion of data generated in clinical trials. Given the progress government agencies have made toward https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press transparency of regulatory data, non-governmental led data sharing initiatives, such as the YODA Project, might consider shifting their focus and resources toward advancing data transparency of trials not submitted to regulators (e.g., academic trials). While clinical reports and other categories of regulatory data supporting MAAs of drugs, biologics, and medical devices have been made accessible, there are several ways regulators could enhance transparency over the next decade. First, EMA and FDA should mitigate or remove barriers to accessing clinical reports, including citizenship requirements and processing costs associated with information requests, particularly for those requesting information in the public interest. Second, to improve access to information, EMA and FDA should post requested clinical data on a public online portal and increase their processing speed to more closely align with HC. To reduce delays, regulators should consider hiring more personnel and devoting greater resources to responding to requests. Third, EMA and FDA should extend access to data supporting medical devices. Last, while EMA remains committed to make available IPD in Phase 2 of Policy 0070, FDA and HC also should implement policies to share IPD, which would provide the raw data necessary to conduct secondary analyses. While sharing IPD poses increased risks of patient reidentification, data sharing initiatives, such as the YODA Project and CSDR, have demonstrated that through use of a "trusted intermediary," regulatory agencies could share IPD with researchers to maximize the use and utility of the data while still protecting patient privacy. 35 The administrative and redaction costs incurred by industry and regulatory authorities represent a substantial obstacle to the future of clinical data sharing programs, exemplified by the ongoing, albeit temporary, suspension of Policy 0070 and the restriction of information requests to EMA to EU citizens and legal residents in 2018. To address this challenge, governments and institutions, such as the European Union, should give greater priority and funding to regulatory data sharing programs. Concurrently, efforts to improve the efficiency of data sharing initiatives should be considered. For instance, multiregional disclosure requirements with varying anonymization standards for CCI and PPD increase costs. Regional regulators may consider a harmonized approach for clinical report disclosure to help reduce inefficiencies. In fact, HC has already begun accepting clinical information previously published under Policy 0070 for its PRCI initiative. Also, FDA recently announced that sharing of CSRs in harmony with international regulators is a long-term goal. 36 However, an important benefit of a multiregional approach is that it encourages greater transparency by incentivizing sponsors to anonymize data in accordance with the standards least amenable to CCI claims. For example, we found that names of drug manufacturers and suppliers were often redacted by EMA and FDA, but HC did not consider this information as CCI, and thus pharmaceutical sponsors may be encouraged to not devote resources to redact such information in a multiregional approach, recognizing the data will become public under the PRCI initiative. Therefore, it is important that measures, such as enforcement of HC's narrower definition of CCI, are taken to prevent harmonization of disclosure standards toward less transparency. In summary, regulatory data pertinent to public health and clinical medicine that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make IPD available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is -for now -more available than ever before. In summary, regulatory data pertinent to public health and clinical medicine that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make IPD available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is -for now -more available than ever before. https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press malingering & health policy • fall 2021 The Journal of Law, Medicine & Ethics, 49 (2021): 456-485. © 2021 The Author(s) CSR=clinical study report; FDA=United States Food and Drug Administration; IPD=individual patient-level data. https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press PD=pharmacodynamic; PK=pharmacokinetic; SAE=serious adverse event. https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press CSR=clinical study report; PRAC=pharmacovigilance risk assessment committee; PSUR=periodic safety update report. https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press • Drugs, biologics, and medical devices • Approved, unapproved, or withdrawn • 2019: NDS-NAS, SNDS-c, and Rx-switch • 2020: All NDS, SNDS-c, and Rx-switch • 2021: All NDS, all SNDS, and Class IV medical devices • 2022: All NDS, SNDS, ANDS, SANDS, and Class III and IV medical devices • Upon request: NDS, SNDS, ANDS, SANDS, EUNDS, SEUNDS, Class III and Class IV medical device applications or application amendments (all must have a final regulatory decision prior to March 20, 2019) a. That is not publicly available b. In respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and ANDS=abbreviated new drug submission; CCI=confidential commercial Information; CHMP=Committee for Medicinal Products for Human Use CRF=clinical report form; CSR=clinical study report; EMA=European Medicines Agency; EPAR=European public assessment report; EUNDS=extraordinary use new drug submissions; FDA=United States Food and Drug Administration; HC=Health Canada; IPD=individual patient-level data; MAA=market authorization application; MAH=market authorization holder; NAS=new active substance; NDS=new drug submission; Rx-switch=submissions to switch an authorized medicinal ingredient to non-prescription status; SANDS=supplemental abbreviated new drug submissions; SAP=statistical analysis plan; SEUNDS=supplemental extraordinary use new drug submissions; SNDS-c=supplemental new drug submission containing confirmatory trials; SNDS=supplemental new drug submission. journal of law, medicine & ethics INDEPENDENT The Journal of Law, Medicine & Ethics, 49 (2021): 456-485. © 2021 The Author(s)same methodology (described above) for extracting information on HC's reactive disclosure as we did for the agency's proactive disclosure.Findings: https://doi.org/10.1017/jme.2021.67 Published online by Cambridge University Press 463 The Journal of Law, Medicine & Ethics, 49 (2021): 456-485. © 2021 The Author(s) journal of law, medicine & ethics INDEPENDENT The Journal of Law, Medicine & Ethics, 49 (2021): 456-485. © 2021 The Author(s)

Transparency Laws and Policies European Medicines Agency

Assessing Proactive Disclosure of Regulatory Data

Assessing Reactive Disclosure of Regulatory Data

Findings: Reactive Disclosure of Regulatory Data

Enhancing Regulatory Data Transparency in the 2020s

malingering & health policy • fall 2021


Tribute to Judge Pauline Newman

" Tribute to Judge Pauline Newman ," 74 N.Y.U. Ann. Surv. Am. L. 7 (2018)

"Tribute to Judge Pauline Newman," 74 *N.Y.U. Ann. Surv. Am. L.* 7 (2018)

Rochelle C. Dreyfuss, Tribute to Judge Pauline Newman, 74 N.Y.U. Ann. Surv. Am. L. 7 (2018)

a period of time but then returns to his work on the invention in time before the second inventor begins his work on the invention. 3 When you read this opinion, you will see a judge's stubborn commitment in carefully, scrupulously reviewing all the relevant precedent, of which there was much, and after announcing the court's en banc holding, Judge Newman went on to make the following observations: "This result furthers the basic purpose of the patent system. The exclusive right, constitutionally derived, was for the national purpose of advancing the useful arts-the process today called technological innovation."foot_0 Judge Newman then goes on to say, "The reason for the patent system is to encourage innovation and its fruits: new jobs and new industries, new consumer goods and trade benefits. We must keep this purpose in plain view as we consider the consequence of interpretations of patent law. . ."foot_3 Judge Newman wrote the Paulik decision thirty-two years ago in 1985, after only one year on the court. And I think it serves as a calling card for how she has been approaching cases during her decades on the court. All along, she has consistently been able to work through the sometimes convoluted legal frameworks and technologically difficult factual records to reach wise and just decisions that always help to remind us of the core principles underlying our laws. There's a persistence, a level of scholarship, and an eloquence in her writings that are second to none. Like so many students who have studied patent law in the last thirty years, I deeply admired her work on the court while I was at NYU. My next intersection with Judge Newman came after law school, when I joined the Patent and Trademark Office (PTO) as an associate solicitor. In that position, I had the opportunity to argue several cases at the Federal Circuit on behalf of the PTO. In these cases, the patent applicant or patent owner typically receives an adverse decision from the agency and is appealing that decision to the Federal Circuit. My office's role was to explain why the agency's decision was eminently reasonable and should be given considerable amounts of deference. Judge Newman, however, seemed to take a different view of the agency's work and she stood out as the most active and relentless questioner of PTO attorneys. In fact, after one particularly withering oral argument in front of Judge Newman in 2001 or 2002, I remember walking out of court, grumbling out loud, "My God, when is Newman going to retire?" Polly, I don't feel that way anymore and I hope we are on the court together for the next twenty years until I retire. What I came to appreciate eventually was that Judge Newman's persistent scrutiny was driven by a broader concern to ensure that the PTO, as a large bureaucracy, refrained from applying the patent laws in an overly rigid, mechanical way that would harm inventors and undermine the very purposes of the patent system. And Polly, I can tell you that the PTO lawyers would often go back and transmit your messages that you expressed during those oral arguments. Judge Newman had a profound impact, not only through her many opinions, for example, In re Sang Su Lee, 6 but also through her comments during oral arguments. Finally, I'm proud to be Judge Newman's colleague and friend, and it's been quite an adjustment for me to begin thinking of someone I looked up to for as long as I did as my coworker. But I have to say that she's been exceptionally warm and gracious in welcoming me and sharing her wisdom and experiences on the court. As the longest serving judge on our court, she is the embodiment of the Federal Circuit, and I also think of her as the conscience of the court. More than anyone else on our court, she is sensitive to ensuring that the rights of the pro se individual are upheld and protected whether that person is an inventor or a federal employee that is seeking to invoke his or her civil service protections. Of course, we often see patent cases in which hundreds of millions of dollars are on the line, but we have other cases as well, and Judge Newman is always there, commenting on the court's draft opinions where she sees an injustice that warrants deeper scrutiny. What I've also seen up close is the courage she has in following her convictions. There is no doubt Judge Newman is an independent thinker. I don't have any statistics with me, but I would bet that she dissents more than the average judge, and I have no problem with that. I think it's a healthy thing for a court to see and consider diverging views on an issue. Knowing when to dissent, however, is something I've had to feel my way through during my first couple years. Polly and I had a case with Judge Lourie recently called Amgen v. Sandoz. 7 This is a statutory interpretation case that's now pending at the Supreme Court dealing with a very complex, new statute known as the Biologics Price Competition and Innovation Act, 8 and when it comes to the intersection of life sciences and It's fabulous that the Annual Survey has dedicated a volume to Judge Newman, a very loyal alum, a great friend of the school, and a terrific and terrifically interesting judge. As Trevor said, I'm the Pauline Newman Professor of Law, so I especially wanted to say a few words about why I'm so happy to hold this chair. The first reason is this: I was appointed to the chair not all that long after I entered the academy, in a day when only very senior faculty were chaired. People were extremely impressed that I was honored so early in my career. Little did they know that Judge Newman had styled the chair in such a way that at the time, I was the only one at the entire university who met the criteria. So they had no choice, for which I thank her. And I've managed to fool a lot of people, including sometimes myself. The second reason it's so fun to have this chair is because the Judge and I are interested in many of the same things. We're often invited to the same conferences and what's more, find ourselves on the same panel. First the audience hears from Pauline Newman and then my PowerPoint slides come up and they say, "Pauline Newman Professor," and since we often disagree with one another, the contents of those slides are often diametrically opposed to what the Judge just said. We wind up in a great dialogue, a dialogue that can only happen because Judge Newman is so gracious about, and as we'll see may even relish, disagreements. So I'm truly lucky to have her chair. But the most important reason I love having this chair is that it's brought us close and given me a fantastic opportunity to learn from her. Like many academics, I tend to go spinning off into the world of doctrine and theory. The judge, in contrast, is eminently down to earth and practical. As you heard, she was a chemist before she became a lawyer, so she knows what it takes to work in the creative sector, to make progress at the lab bench, and to bring the products developed there to market. And as you heard, she never loses sight of the goals of intellectual property protection, which is to encourage and facilitate that kind of work. I know my students think I emphasize her cases because of our connection, but I teach them because they're in the casebook. And they're in the casebook because textbook authors recognize how often her approach is the right approach. Or I should say, the right approach normatively. And the right approach eventually, but not always the law of the moment. The first Justice Harlan is often called the great dissenter, but within the world of patents, that title unquestionably goes to Judge Newman. And I do have the statistics. In a recent empirical study, Daryl Lim reviewed her thirty years of work on the Federal Circuit. 9 During that time, she wrote 202 dissents, the most of any Federal Circuit judge. She has dissented on substantive questions: patentability, infringement, inequitable conduct, remedies. She has dissented on procedural issues: reviewability, joinder of parties, evidentiary questions. And she's dissented on institutional matters, such as overreaching by the Federal Circuit into the discretionary authority of the district courts and most recently on the relationship between the Federal Circuit and the Patent Trial and Appeal Board, the PTAB. These dissents are of crucial importance. The Federal Circuit is almost unique in the federal judicial system because its jurisdiction is based on subject matter, not geography, and thus it has near plenary authority over patent law. That means there's no forum shopping at the appellate level on patent cases, which is a good thing, but it also causes a significant problem. There's no dialogue, no percolation among appellate courts, no opportunity for courts to debate open questions, distill the issues, experiment with different approaches. And there's no way to serve up a rich, detailed understanding of these issues to the Supreme Court for ultimate resolution. Instead of conflicts among the circuits, patent law relies on conflicts within the Federal Circuit. So for those of you sitting here within CA2, you should think of her as embodying the entirety of the Ninth Circuit. And she does that job brilliantly. As I said, her views tend to be the ones that ultimately prevail. Sometimes the Federal Circuit simply ignores the majority opinion and goes with her dissent in later cases. Sometimes her dissents signal the Supreme Court to intervene. That's happened nine times and in eight of those cases, the Supreme Court reversed or vacated the majority's opinion, and sided with Judge Newman. 10 The only one who comes even close to that is Judge Mayer, and his dissents were sustained on certiorari only three times. 11 But in the end, sometimes it takes an act of Congress to get where she wants to go, but she does tend to get there. So the best current example here lies in the recent set of Supreme Court cases stripping patent eligibility from a whole slew of technical advances. 12 At the Supreme Court, the effort began with a cry of anguish from Justice Breyer that sometimes patents can impede rather than promote the progress of science. Now he thought that for a specific reason. He thought that because the Federal Circuit had significantly compromised the ability of scientists to build on one another's work. 13 In a series of cases, it narrowed nearly to extinction the experimental use defenses in both common and statutory law. Judge Newman dissented every time she had the chance. She knew as a former scientist just how important experimentation is to pushing forward the frontiers of knowledge. Take, for example, Integra v. Merck, where the Federal Circuit majority narrowed the scope of the statutory experimental use defense. 14 Judge Newman dissented. "The purpose of the patent system," she said, "is not only to provide a financial incentive to create new knowledge and bring it to public benefit through new products; it also serves to add to the body of published scientific/technical knowledge. The requirement of disclosure of the details of patented inventions facilitates further knowledge and understanding of what was done by the patentee, and may lead to further technologic advance. The right to conduct research to achieve such knowledge, need not, and should not, await expiration of the patent." 15 Now she was right. The Federal Circuit's Integra decision was vacated and remanded nine-zip by the Supreme Court. 16 Unfortunately, that reversal failed to solve the larger problem of experimentation. The statutory exemption sustained by the Supreme Court in Integra applies only to research in the life sciences, and then only for work required to secure FDA approval of new drugs and medical devices. 17 To prevent patents from impeding, rather than promoting the progress of science elsewhere, what the Supreme Court has done is to categorize many important advances in genetics, biotechnology, and computer sciences as simply non-patentable. 18 Great, perhaps, for fundamental scientific advances, but not so good for firms that want to invest in bringing things like new diagnostics and computer technology to market. So Judge Newman has continued to dissent. In CLS Bank v. Alice on the patentability of computerized business methods, she opined as follows: "This [issue on patentable subject matter] appears to have its foundation in a misunderstanding of patent policy. For the debate about patent eligibility . . . swirls around concerns for the public's right to study the scientific and technological knowledge contained in patents. The premise of the debate is incorrect, for patented information is not barred from further study and experimentation in order to understand and build upon the knowledge disclosed in the patent." 19 She went on to suggest that the problem of destroying patentability along with incentives to innovate would fade away with clarification on experimental use. And you know what's happening? The patent industries can't live with the current state of affairs so they're lobbying Congress and their proposal is to couple reform of patentable subject matter to restoration of the experimental use defense. 20 Exactly Judge Newman's point. We've had a very patent-heavy discussion so far tonight, but the Federal Circuit also has jurisdiction over appeals from the Trademark Office, so I'll give as one last example a trademark case: In re Bayer, a case that nicely demonstrates the difference between a theoretical or purely doctrinal approach and the hardcore, practical common sense views of Judge Newman. 21 The issue there was whether Aspirina, a trademark for Bayer Aspirin in almost the entire world, is generic and therefore un-protectable here in the United States. The majority opinion by Judge Moore is a ton of fun. To see what the word means in the U.S., she Googled it. She then wrote an extremely learned opinion on what one can deduce from Google. Judge Moore was a professor before she went on the bench. She's an academic at heart and wrote the kind of opinion that, I have to confess, I aspire to write. In the end, she decided Aspirina was generic and could not be protected as a trademark. 22 Judge Newman's dissent, I'm paraphrasing, is basically this: everyone who has travelled anywhere in Europe or South America knows Aspirina is Bayer's trademark. The use by anybody but Bayer will be confusing. The goal of trademark law is to protect against consumer confusion. So why in the world would we want to let anyone but Bayer use the mark? 23 Now that was a dissent. Aspirina didn't get registered per Judge Moore's opinion on genericity. But, you know what? The notion that we should pay more attention to what words mean abroad is becoming the law. Bayer won its next case about the trademark for an analgesic based on knowledge of the mark in Mexico. 24 That case, decided by the Fourth Circuit, is now on appeal to the Supreme Court. 25 We'll see who it is the Supreme Court agrees with this time. I should add that Judge Newman is an independent thinker in real life as well as in her opinion writing. My husband and I once took her from NYU, from an NYU event, to her hotel, and on the way we passed Hogs and Heifers, a sleazy bar in what was, at that time, a sleazy meatpacking district. As we passed, she rolled down the window and called out, "Hogs! Heifers! Hogs! Heifers!" I said, "Judge Newman, do you know that's a biker bar?" She said, "Of course I know it's a biker bar. I was a biker." NYU has been amazingly lucky having Judge Newman as our grad. She has taken time to be in residence and taught classes. She has done fireside chats, often with Judge Dyk, whose opinions often provoke her dissents. She has given many of our students a leg up in the profession by hiring them as clerks. We'll have one of them speaking soon. And she's been involved in many alumni programs. It's hard to think of anyone more deserving of this award, so, congratulations. Thank you for the introduction and for having me here today. If you Google "Pauline Newman", you'll find the judge shares her name with a famous labor activist. And if you read some of the articles, you'll find that many of the attributes used to describe Pauline Newman the labor activist are also synonymous with Pauline Newman the judge. An educator, an organizer, an expert, a writer, a mentor: all words that aptly describe Judge Newman. Both women also achieved remarkable firsts as females, but also more broadly as leaders in their respective fields. And both women could undoubtedly be described, as Judge Newman's namesake once was, as capable of smoking a cigar with the best of them. Throughout her career, Judge Newman has found success both in science and law. But the thing that impresses me most, the thing that I'm going to attempt to talk to you about today, is who Judge Newman is as a person. Those who know Judge Newman well know her to be incredibly humble and modest. She's very quick to recognize the achievements of others, but much more reserved when it comes to her own accomplishments. Once a year, she gathers her clerks together for a reunion, and as part of the gathering we stand in a circle and talk about what's going on in our lives and our careers. But the judge has never touted a single one of her accomplishments at these events, including the one that was specifically intended to celebrate her thirty years on the bench. Instead, she typically ends the conversation by encouraging her clerks to be leaders and by reminding us, to borrow her words, of the enormous amount of work that remains to be done. Another thing you learn quickly as a clerk for Judge Newman is that she has a very good sense of humor and a quick wit. She also enjoys pranks. For most of my clerkship, we had two girls and two guys in chambers. And the two girls were "disorganized", not totally unlike Judge Newman. And the two guys were "particular" about their space. And so every once in a while, Christine, my co-clerk, and I would go over to the guys' desks when they were out of chambers and reorganize them for them just to play a prank. Judge Newman always got a great laugh out of this. And, like any good boss does, she would offer suggestions about which articles might look best upside down. Judge Newman also possesses a tremendous sense of adventure, and I'm not just saying that because she regularly orders the cheesesteak sandwich from the deli next to the court. I don't think it's an understatement to say she's lived five lives. She's built and driven fast cars, as well as the occasional tank. She's flown airplanes and jumped out of them. She's traveled extensively and met many world leaders, including the Queen of England, who once complimented her curtsy. She's even judged a science competition with Steve Jobs. And as a clerk, this leads to the occasional unexpected interaction. I remember driving with the judge to court one day and asking her what she'd done the night before. She responded that she was reading Wired magazine. She said, "Rachel, did you know all those new millionaires in Silicon Valley are buying Ferraris?" I said, "Yes, Judge, I think I heard that." To which she responded, "In my opinion, the Lamborghini and Maserati are far superior cars." I think she still laments not having a Maserati. This, of course, was not her first dissent, as you have heard tonight. The judge has, throughout her career, not shied from expressing her opinion, either in majority or dissent, and has always done so with the singular objective of promoting a strong patent system. But despite being steadfast in her convictions, and from time to time at odds with her colleagues, Judge Newman harbors no animosity and bears no grudges. Instead her opinions, like herself, are forward-looking, sincere, and always cognizant of the need to strive for excellence. The words "we must do better" are not uncommon in a Judge Newman opinion, but when used they are couched in a respect for both the judges with whom she works and the institution she represents. But the thing that might be most remarkable about Judge Newman is that, despite her many accomplishments, she's approachable and able to interact with all sorts of different types of people. To get a sense of this, you can look at her clerk family. No two are alike. Judge Newman's clerks come from every background, with varied experiences in law and life, and yet she runs a chambers in which everyone is equal. There is no favorite clerk or special treatment. Her only expectations of her clerks are that they work hard and think critically. And, although she would never say it, I suspect this is because the Judge can do most of the work herself. But the Judge has no ego. In fact, it's not uncommon for a clerk and the Judge to exchange up to twenty drafts of an opinion before it leaves chambers. The Judge editing the clerk, and the clerk editing the Judge, exchanging ideas openly and without criticism. Judge Newman has a patience and a respect for others that make her truly unique. In conclusion, I just want to say: con-gratulations, Judge Newman. I'm grateful for the opportunity you gave me as a clerk, and I thank you for being a role model, a mentor, and a friend. Thank you for the introduction. As the fourth speaker up here tonight, you've heard all the high notes about the remarkable person that is Judge Newman. I should say that when I initially was invited to speak, it was somewhat lost on me the magnanimity of this event until I saw who the previous years' dedicatees were and that I would be standing up here with Judge Chen, Professor Dreyfuss, Judge Worth, and Rachel. It is humbling to be up here alongside them, but an even greater honor is standing up here to pay tribute to Judge Newman, a person who in my opinion has made a bigger impact on our country than anyone I have personally ever met, and she could not be more deserving of this honor. The theme of my comments are Judge Newman the patriot, and I will get into how I came to that in a minute, but before I do, I would like to spend just a moment on the human being, the Judge. When I started clerking for Judge Newman, I had only a cursory understanding of the internal machinations of the judiciary, and I had virtually no opinions on how I thought judges should judge or courts should rule. I could, if asked, tell you what I thought should be the qualities of a good judge: integrity, fidelity, honesty, intellect. But these were just abstract ideas, disembodied from concepts and attributes that we hope apply to all our sacred institutions, not just our judges and courts and civil servants. Once I started clerking for Judge Newman, the view I quickly developed was that she defined my notion of the ideal judge. I'm quick to note, however, that with Judge Chen being in attendance, this is not intended as a comparison to him or any other judge at the Federal Circuit. Judge Chen truly is a remarkable jurist and an undeniable asset to the court. Judge Newman is unwavering in her sense and pursuit of justice through her judicial opinions. She's impervious to grandstanding and rhetoric, and her integrity is beyond question. Her commitment to the judicial process is evident in all of her opinions and particularly so in her dissents, which give the Bar and the Supreme Court a window into the different interpretations on a particular issue. But quote Judge Newman's dissents to her at oral argument, and she will quickly tell you that her dissents are not the law. Now, Judge Newman the patriot. I thought this theme might capture just some of the essence of Judge Newman, a lens through which I think we can view a lot of aspects of her life. For it is a deeprooted sense of patriotism and civic commitment that I think informs Judge Newman's journey to the bench, her judgeship, and her jurisprudence. To hear her speak or read her opinions, one is likely to see Judge Newman refer to the nation, the important role innovators and patents have in it, and the impact courts have on civil society when they interpret the law. It was not out of a sense of aggrandizement, self-aggrandizement, or simple corporate protectionism that Judge Newman in the early '80's testified before Congress in support of a bill that would create the Federal Circuit, to which she would be the court's first direct appointee just a few years later. 26 Although if that had been the case, a better example of manifest destiny I've never seen. Asking Congress to create a new court for you and then appoint you to it is not a realistic life goal for anyone. Rather, her testimony to Congress was on the heels of her work on the advisory committee of President Carter's domestic policy review, which was tasked with finding ways to pull the country out of its deep economic recession. 27 Unpredictability in the application of patent law was seen as frustrating the recovery by encumbering innovation and investment, and it was the committee's proposal to create a uniform appellate court to administer these laws. 28 So it was with her understanding of how patents can help a nation thrive that Judge Newman joined the bench in 1984. Judge Newman believes strongly in the founding principle that the framers memorialized in our Constitution that an industrial nation depends on the system of protecting its dreamers' intellectual property. 29 But it is not, I think, simply because the framers provided for a patent system in the Constitution that Judge Newman holds this view. Rather, it is because of the essential role innovation plays in our society. When we interpret the law, when we apply the law to a new set of facts, we should be mindful of where these laws stand in relation to the nation that they serve. This, I believe, is Judge Newman's judicial philosophy. Judge Newman's civic commitment extends far beyond her support for a robust patent system. Her thoughtful judicial writings in cases involving veterans' benefits and government employees are a hallmark of her judgeship. Re-gardless of the outcome on the merits, Judge Newman's writing is mindful and sensitive to the sacrifices veterans and government workers make for their country. I think it is with this devotion to the country that Judge Newman has served tirelessly on the bench for over 30 years. Why, when I served as her clerk, she took my calls late on the weekend to discuss a case, and why it was not uncommon to receive emails from her at three in the morning. Why, just two years ago, Judge Newman embarked on a new endeavor to create an organization that would teach science to judges, with the view that it would help them across the entire spectrum of their dockets, from forensic issues in criminal cases to technical product warranty disputes. In short, Judge Newman has not devoted the latter part of her life to the improvement of the law and judiciary as an ends in and of itself, although, if she had, it would be a more noble endeavor than most. Rather, Judge Newman has devoted herself to the betterment of the nation through improvements to the judiciary, our nation's capacity to lift up explorers and inventors, and our system of governing rules we call laws. She's a constant inspiration to me, and I thank her from the bottom of my heart for letting me serve as her law clerk. Congratulations. Good evening Dean Morrison, Judge Newman, Judge Chen, Professor Dreyfuss, assembled guests. This is a really nice occasion. I'm honored to be a part of it. It's great to be back here at NYU. NYU is really lucky to have Judge Newman and to call her one of its own. I know the Judge has made great contributions to the nation. She has also made great contributions to this institution, the NYU School of Law. NYU can certainly be very proud to have her on their rolls of this institution and to call her an alumna. Judge Newman has had a great impact, not only on patent law, but on the wide-ranging jurisdiction of the Federal Circuit on takings law, tax law, trade law and international trade, trademark law, contract law, federal labor law, and veterans' law. Plus, Judge Newman has shown us that to be a good patent attorney you have to be conversant with a wide-ranging interconnecting range of discipline. Judge Newman is a great writer. We've heard some of her own writing tonight. Her opinions are polished and many read like the spoken word. It's in a style all of her own. I can tell you that Judge Newman has had a tremendous impact, not only on the court system, not only on patent law and the other areas of the court's jurisdiction. I can tell you that Judge Newman has had a tremendous impact on me. Pretty much every day I ask myself, what would Judge Newman do? Although I can tell you the answer to that question is not always obvious. This isn't about legal analysis either. One occasion had a profound impact on me, and I remember it well. There was a pro se litigant, a woman who requested oral argument but became choked up, was crying, and couldn't get a word out. Judge Newman reached out her hand from the bench with a glass of water and just asked her if she would like to have some water. Now at the court, the parties have their own water, not just the judges. But here, Judge Newman leaned over the bench and offered her some of hers. That gesture by the Judge won't be in an opinion, but, as they say, it speaks volumes. Judge Newman also has incredibly high ethical standards. I remember one day it was raining, and I had more than one umbrella to choose from. Judge Newman suggested that I use one without a logo, just in case some day the entity on that logo might become a party. That's just one example of how Judge Newman takes her work seriously and applies it to her own life. I can tell you that as her former clerk, research had to be thorough. What did Jefferson say? What did Blackstone say? What did the Supreme Court say over the last 200 years? What did the English courts say at common law? My wife says that Judge Newman lit the fire of curiosity in me to get to the bottom of the issue. Judge Newman was a great boss. Sure, we worked hard. Sometimes we worked late. But Judge Newman frowned on working on weekends, if you can imagine. Except one time she gave me an assignment, one weekend in April. Homework, if you will. I was ordered to visit the cherry blossoms in the D.C. area, and you know you have to comply with the Judge's orders. Judge Newman works incredibly hard, you may have gathered. She was a pioneer in the law, and that might have been enough for some, but she continues to work hard day in and day out. She definitely has a vision for the law and she works to carry it out. NYU ANNUAL SURVEY OF AMERICAN LAW[Vol. 74:3 Paulik, 760 F.2d at 1273. NYU ANNUAL SURVEY OF AMERICAN LAW[Vol. 74:7 NYU ANNUAL SURVEY OF AMERICAN LAW[Vol. 74:12

TRIBUTE TO JUDGE PAULINE NEWMAN JAMES A. WORTH

Paulik, 760 F.2d at 1273.