Orange Book Research Articles

Impact of Trauma Verification Level on Management and Outcomes of Combined Traumatic Brain and Solid Organ Injuries: An NTDB Retrospective Review.

Level-I and level-II trauma centers are required to offer equivalent resources since "The Orange Book." This study evaluates differences between level-I and level-II management of solid organ injury (SOI) with traumatic brain injury (TBI). We conducted a retrospective review of the National Trauma Data Banks from 2013 to 2021 of adult (≥18years), blunt trauma patients with both TBI and SOI treated at level-I or level-II trauma centers. 48,479 TBI and SOI patients were identified, 32,611 (67.3%) at level-I centers. Unadjusted incidence of laparotomy was higher at level I (14.5% vs 11.7%, P < 0.001), and angiography rates were similar (3.3% vs 3.4%, P 0.717). Sub-group analysis of stable patients (SBP ≥100) showed an increase in nonoperative management at level II (87.3% vs 88.7%, P < 0.001) and decrease in laparotomy (9.9% vs 8.3%, P < 0.001). On logistic regression (LR), severe TBI, high-grade SOI, and level I trauma status were predictors of laparotomy. Logistic regression showed mild/moderate TBI with high-grade SOI and level II were associated with use of angiography. Unadjusted mortality rates were slightly different (14.8% vs 13.4%, P < 0.001), but there was no association with trauma level on LR. Nonoperative management was seen more at level-II centers with laparotomy at level I. Subgroup analysis showed no difference in mortality in trauma levels. Matched patients for level I and II showed no statistical difference in management. Patients were treated similarly at both levels with similar outcomes and mortality.

The application of chemical similarity measures in an unconventional modeling framework c-RASAR along with dimensionality reduction techniques to a representative hepatotoxicity dataset

With the exponential progress in the field of cheminformatics, the conventional modeling approaches have so far been to employ supervised and unsupervised machine learning (ML) and deep learning models, utilizing the standard molecular descriptors, which represent the structural, physicochemical, and electronic properties of a particular compound. Deviating from the conventional approach, in this investigation, we have employed the classification Read-Across Structure-Activity Relationship (c-RASAR), which involves the amalgamation of the concepts of classification-based quantitative structure-activity relationship (QSAR) and Read-Across to incorporate Read-Across-derived similarity and error-based descriptors into a statistical and machine learning modeling framework. ML models developed from these RASAR descriptors use similarity-based information from the close source neighbors of a particular query compound. We have employed different classification modeling algorithms on the selected QSAR and RASAR descriptors to develop predictive models for efficient prediction of query compounds’ hepatotoxicity. The predictivity of each of these models was evaluated on a large number of test set compounds. The best-performing model was also used to screen a true external data set. The concepts of explainable AI (XAI) coupled with Read-Across were used to interpret the contributions of the RASAR descriptors in the best c-RASAR model and to explain the chemical diversity in the dataset. The application of various unsupervised dimensionality reduction techniques like t-SNE and UMAP and the supervised ARKA framework showed the usefulness of the RASAR descriptors over the selected QSAR descriptors in their ability to group similar compounds, enhancing the modelability of the dataset and efficiently identifying activity cliffs. Furthermore, the activity cliffs were also identified from Read-Across by observing the nature of compounds constituting the nearest neighbors for a particular query compound. On comparing our simple linear c-RASAR model with the previously reported models developed using the same dataset derived from the US FDA Orange Book (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm), it was observed that our model is simple, reproducible, transferable, and highly predictive. The performance of the LDA c-RASAR model on the true external set supersedes that of the previously reported work. Therefore, the present simple LDA c-RASAR model can efficiently be used to predict the hepatotoxicity of query chemicals.

SEPs infringement and competition law defence in German case law

Within the debate on the role of competition law in standard essential patents (SEPs) litigation, German case law has taken centre stage because of the number of decisions handed down and its traditional patent-owner-friendly approach. As the framework handed down by the European Court of Justice (CJEU) in Huawei is usually interpreted as being opposed to the approach adopted by the German Federal Court in the Orange Book Standard decision, it is worth investigating how German courts have tackled the competition law defence in the post-Huawei scenario. The article maintains that the Federal Court’s rulings in Einwand have aligned German case law with the Huawei framework and that the attention devoted in German case law to the implementer’s obligations is consistent with the principles set out by the CJEU. Nonetheless, recent lower courts’ decisions confirm that the case-by-case detection of the licensee’s willingness is still a challenging issue.

Quantifying Challenges to Development of Generics and Biosimilars in Non-Hodgkin's Lymphoma Therapeutics: The Future of Low-Cost Alternatives from Monoclonal Antibodies to CAR-T

Background: There are numerous monotherapies and combination therapies available to treat Non-Hodgkin lymphoma's (NHL), however relatively few of these varied antineoplastics agents have commercially available, lower-cost generic forms in the United States. High cancer drug prices, in particular for socioeconomically vulnerable and underinsured patients, pose challenges to affordable cancer treatment in the United States. In 2017, FDA initiated the Drug Competition Action Plan (DCAP) that aimed to ensure timely market competition by enabling generic drug development, review, and approval, and streamlining regulatory complexities. This regulatory program was designed to limit so-called “gaming” recognized as a cause of delay to generic drug approvals, a phenomenon that has the further deleterious effect of extending brand monopolies beyond what Congress intended with Hatch-Waxman Amendments (1984) establishing modern generic drug regulatory processes. In 2018, FDA announced analogous Biosimilars Action Plan (BAP). However, to date the efficacy of these measures has not been comprehensively assessed in the NHL development landscape. Methods: A model was created by surveying the FDA Orange Book (drug approval database) and Purple Book (biologic product approval database) for initial approval of drugs/biologics with their initial generic/biosimilar approval. Approvals were classified by drug class and availability of generic/biosimilar for the innovator product with approval from 2002 to 2023 (Fig. 1) and t-test were used to determine significance. Results: Of small molecule drug NHL therapeutics approved in the last two decades, only 37% (19/52; Fig. 2) have available, lower-cost generics, with use in more than one indication and time on market both positively and significantly corresponding with availability of generics for the original innovator drug (P &amp;lt; 0.05). Notably, while generic drug approvals dropped during the 2020-2021 period (possibly due to impact of the COVID-19 pandemic), after 2017 implementation of DCAP more generics for common NHL antineoplastics were approved. Conversely, there are relatively few biologic drugs (total of 41 approvals; Fig. 2) with biosimilars, in part due to retained patents and exclusivity, and perhaps indicating a lack of efficacy in BAP among NHL antineoplastics therapies. For off-patent innovator monoclonal antibodies (mAbs), which make up the majority of these therapies, development of biosimilars is effectively blocked by secondary or “process-related” patents which effectively extend the period of non-competition for complex biologic therapies. It is expected that novel bispecific antibody (biAb) therapeutics and novel therapies, such as CD19 CAR-T will also have a delayed time to low-cost biosimilar availability following a similar trend. Conclusions: With drug price and ever-rising insurance and patient payments a critical area of public health, in particular in the United States, availability of lower cost generics and biosimilars is a critical issue for NHL patients. As we move into the maturation of gene therapies and CAR-T therapeutics, it merits consideration of that additional regulatory programs may be needed to incentivize the development of efficacious and lower cost biosimilars. However, it is critical that controlling competition be carefully balanced with investment in both biologic drug entity and process-related innovations among these relatively complex therapeutic entities.

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019.

Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)-e.g., a vial and pen-were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines-defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products-defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs.

The development of a novel simultaneous in vitro dissolution - in situ perfusion system as a potential tool for studying the absorption of solid oral formulation in rat

The aim of this work is to develop a novel simultaneous in vitro dissolution - in situ perfusion system (SDPS) as a potential tool to evaluate the in vivo performance of solid oral formulation in rat. The innovative nitrendipine (NTD) tablet of Bayotensin mite® made in Germany was used as reference listed drug (RLD), and five generic products from Chinese market were compared with RLD using the in vitro dissolution test method specified by the orange book and the SDPS method developed in this study. Four self-prepared NTD tablets with different proportions of microcrystalline cellulose/starch were employed to investigate the discriminatory ability of the SDPS for formulation. In addition, the predictivity of the SDPS in relation to data from in vivo pharmaceutics studies was evaluated. The 45-min dissolution test and multiple-pH dissolution profiles of generic product 1 and 2 have no difference compared with the RLD, but their dissolution profiles from the SDPS showed statistically significant differences. A biexponential formula successfully described the concentration profiles of self-prepared formulations in SDPS experiments. The kdis (0.08 ± 0.01 ∼ 0.2 ± 0.03 min−1) and ka (about 2.30 × 10−3 min−1) values calculated by the formulas of F1-F3 suggested that the used excipients had no effect on the intestinal absorption of NTD, and it might be the property of active pharmaceutical ingredient that led to the difference among the generics. Furthermore, the in vivo rat pharmacokinetics study results of F1-F3 showed a good correlation (R2 = 0.99) with the SDPS data. In summary, the SDPS is a promising tool to detect the unexpected quality changes of pharmaceutical products in weakly regulated markets, facilitate formulation screening, and potentially reduce animal testing for estimating the in vivo absorption behavior of solid oral formulations. The absorption performance of generic drugs in vivo should be further investigated.

NIH funding for patents that contribute to market exclusivity of drugs approved 2010-2019 and the public interest protections of Bayh-Dole.

Previous studies have shown that National Institutes of Health (NIH) funding contributed >$187 billion for basic or applied research related to the 356 drugs approved 2010-2019. This analysis asks how much of this funding led to patents cited as providing market exclusivity, patents that would be subject to the provisions of the Bayh-Dole Act that promote and protect the public interest. The method involves identifying published research in PubMed related to the approved drugs (applied research) or their targets (basic research). NIH-funded projects (grants) funding these publications and patents arising from these projects were both identified in RePORT. Patents cited as providing market exclusivity were identified in DrugPatentWatch (which incorporates FDA Orange Book). NIH funded basic or applied research related to all 313 FDA-approved drugs 2010-2019 with at least one patent in DrugPatentWatch. This research comprised 350 thousand publications (9% applied research; 91% basic research) supported by 341 thousand fiscal years (project years) of NIH funding and $164 billion in NIH project year costs (17% applied research; 83% basic research). These NIH projects also produced 22,360 patents, 119 of which were cited in DrugPatentWatch as protecting 34/313 drugs. These patents were associated with 769 project years of NIH funding (0.23% total) and project year costs of $0.95 billion (0.59% total). Overall, only 1.5% of total NIH funding for applied research and 0.38% of total NIH funding for basic research was associated with patents in DrugPatentWatch. This analysis shows that very little of the NIH funding for research that contributes to new drug approvals leads to patents that provide market exclusivity and are subject to the provisions of the Bayh-Dole Act that promote the public interest in practical applications of the research, reasonable use and pricing, and a return on this public sector investment. This suggests that the Bayh-Dole Act is limited in its ability to protect the public interest in the pharmaceutical innovations driven by NIH-funded research.

Chemical insights into the synthetic chemistry of five-membered saturated heterocycles-a transition metal-catalyzed approach.

Drug design and delivery is primarily based on the hunt for new potent drug candidates and novel synthetic techniques. Recently, saturated heterocycles have gained enormous attention in medicinal chemistry as evidenced by the medicinal drugs listed in the FDA Orange Book. Therefore, the demand for novel saturated heterocyclic syntheses has increased tremendously. Transition metal (TM)-catalyzed reactions have remained the prime priority in heterocyclic syntheses for the last threedecades. Nowadays, TM catalysis is well adorned by combining it with other techniques such as bio- and/or enzyme-catalyzed reactions, organocatalysis, or using two different metals in a single catalysis. This review highlights the recent developments of the transition metal-catalyzed synthesis of five-membered saturated heterocycles.

Recent Developments in the Listing of Patents in FDA's Orange Book

Recent Developments in the Listing of Patents in FDA's Orange Book

C'mon feel the Moys: a trip through the orange book

AbstractThis article is based on a course on how to use Moys classification scheme,1 delivered by Helen Garner and Felicity Staveley-Taylor on behalf of the British and Irish Association of Law Librarians (BIALL) in November 2022. The article, which is also written by Helen and Felicity, provides guidance on how to use Moys classification, explaining the features that enable the scheme to be expanded to accommodate new subject areas. The article also explains some of the features which ensure the scheme remains relevant to legal libraries today. Sections from the classification scheme, as published in the fifth edition, appear in the article text. In addition, any references to page numbers are to the fifth edition.

The NBER Orange Book Dataset: A user’s guide

This paper introduces a newly digitized, open-access version of the Food and Drug Administration’s “Orange Book”—a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book’s coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case—calculating legal exclusivity periods for drugs—to highlight the types of choices that researchers must make when using this resource.

Role of global public sector research in discovering new drugs and vaccines

Analysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers’ payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total.

Authorship and individualization in the digital public sphere

Authorship and individualization in the digital public sphere

Patenting Strategies on Inhaler Delivery Devices

Patients with asthma and COPD rely on inhalers to control symptoms. Yet, these products remain expensive, in part because brand-name manufacturers have obtained numerous patents on inhalers, including on their delivery devices. Recent antitrust litigation has raised questions about the boundaries of listing device patents with the US Food and Drug Administration (FDA), particularly when patents do not claim any active ingredients. How have manufacturers relied on device patents to preserve market exclusivity on brand-name inhalers? We identified patents on brand-name inhalers approved for asthma and COPD between 1986 and 2020 using the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). We extracted information about patents from LexisNexis TotalPatent One and Google Patents and searched device patents for mention of active ingredients or other prespecified features linking the patent to the relevant drug. For each inhaler, we determined the duration of protection added by device patents. The FDA approved 53 brand-name inhalers for asthma and COPD from 1986 through 2020, 39 of which had at least one device patent. One hundred thirty-seven distinct device patents were in the final cohort, representing 49%of all patents listed on inhalers. Seventy-seven percent of device patents made no mention of active ingredients or their molecular structures, and 72%made no mention of any relevant prespecified feature connecting the device patent to the drug product. For the 39 brand-name inhalers with one or more device patents listed in the Orange Book, device patents extended the duration of market protection by a median of 5.5 years (interquartile range, 0.0-10.5 years) beyond the last-to-expire nondevice patent. Patent and regulatory reform is needed to promote generic competition and to ensure that patients with asthma and COPD have access to affordable medications.

OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?

IntroductionWhile various criteria exist to define or categorize innovative medicines as new or repurposed, to our knowledge there are no standardized systems that sufficiently capture the range of pipeline products. The National Institute for Health and Care Research Innovation Observatory (NIHR IO) undertakes routine horizon scanning to support health technology assessment (HTA) in England and maintains a comprehensive Medicines Innovation Database (MInD). The aim of this project is to develop a ‘technology type’ (new versus repurposed) classification system for application within the MInD and to provide a high-level analysis of the emergent data.MethodsWe reviewed gray literature, regulatory websites, and drug repositories to identify existing ‘technology type’ classification criteria. Preliminary definitions and classifications for use on the MInD were discussed, refined, and agreed by consensus. Innovative medicines on the MInD were classified as either new or repurposed based on their regulatory approval status (Marketing Authorization) using data from the electronic medicines compendium. For repurposed medicines, further classification was undertaken using abbreviated new drug application (ANDA) data from the FDA Orange Book to identify generic medicines (patency and exclusivity status). We combined a range of semi-automated and manually derived data during this process.ResultsSix technology types were identified and applied to the MInD: (i) new technology; (ii) repurposed technology (on-patent/branded); (iii) repurposed drug (off-patent/generic); (iv) repurposed technology (never commercialized); (v) new and repurposed technology (combinations); and (vi) repurposed technology (combinations). Preliminary analysis of a subset of MInD records identified in July 2021 (n = 113) found mainly 52 percent new technologies, 27 percent new and repurposed technologies (combinations) and 14 percent repurposed technology (never commercialized). Further analysis of approximately 7000 MInD records are ongoing and will report temporal trends, regulatory status, and key challenges.ConclusionsOur novel evidence-based approach to developing classifications for technology types of innovative medicines resulted in six mutually exclusive states that can be applied to a larger dataset. We believe this offers HTA stakeholders a mechanism to gain valuable insights into the innovation trends, gaps, and areas of unmet need.

Medicare coverage and cost-sharing for abiraterone following generic entry.

13 Background: Generic competition lowers drug prices, but may not reduce out-of-pocket costs for patients. Abiraterone, first approved by the United States Food and Drug Administration in 2011, has two commonly used dosage units (250mg and 500mg) with multiple generic market entrants over the last 5 years. This makes it ideal to evaluate the association between generic competition and changes in product coverage and cost-sharing. Methods: We studied 4 abiraterone products (tablets): generic 250mg, generic 500mg, brand-name 250mg, and brand-name 500mg. We used the FDA’s Orange Book to identify market entry of generic products until May 2022. We used Part D formulary data from 2018 to 2022 to identify changes in product coverage and expected annual out-of-pocket costs for the average Part D beneficiary (daily dose of 1000mg). We also calculated “best-case” cost-sharing in 2022, using the Part D Plan Finder. Results: During 2018-2022, 12 generic 250mg and 4 generic 500mg abiraterone formulations came to market. The first 250mg generic came to market in October 2018, and 10 of the 12 formulations came to market by 2019. The first 500mg generic formulation came to market in December 2020. The proportion of Part D plans that covered generic products increased from 0% in 2018, to 100% for 250mg and 79% for 500mg in 2022. Expected annual out-of-pocket costs for a Part D beneficiary ranged from $7,491 to $10,148 across products and years. In 2022, the average out-of-pocket costs for generic 500mg tablets was $10,148, greater than that for brand-name 500mg tablets, which was $9,298. The same was true when using the Part D plan finder (generic, $11,093, brand-name, $9,476). For the 250mg product, however, out-of-pocket costs were much higher for the brand-name versus generic product (&gt; $150,000 versus $1,139). Conclusions: During 2018-2022, market entry of generic abiraterone products led to their preferential coverage over brand-name products on Part D formularies, but this was associated with only modest savings for beneficiaries. In fact, in 2022 for the 500mg product, average out-of-pocket costs were higher for generic, versus brand-name products. For the 250mg generic product, a patient able to price-shop could pay approximately $1,100, 1/7th of what the average beneficiary spent. These data indicate that Part D beneficiaries do not immediately benefit from price reductions associated with generic entry of specialty drugs. Part D beneficiaries’ out-of-pocket costs with generics can be higher despite lower list prices (vs. brand-name). Proposals to redesign Part D correct this fundamental flaw that makes high-cost generic drugs more expensive to patients than brands. Affordable medications should be available to all patients, not just the most resourced and able to price-shop. Limitations include that formulary files capture data from the prior 3 months, and expected out-of-pocket costs are averaged across beneficiaries and plans.

CDCDB: A large and continuously updated drug combination database

In recent years, due to the complementary action of drug combinations over mono-therapy, the multiple-drugs for multiple-targets paradigm has received increased attention to treat bacterial infections and complex diseases. Although new drug combinations screening has benefited from experimental tests like automated high throughput screening, it is limited due to the large number of possible drug combinations. The task of drug combination screening can be streamlined through computational methods and models. Such models require up-to-date databases; however, existing databases are static and consist of the data collected at the time of their creation. This paper introduces the Continuous Drug Combination Database (CDCDB), a continuously updated drug combination database. The CDCDB includes over 40,795 drug combinations, of which 17,107 are unique combinations consisting of more than 4,129 individual drugs, curated from ClinicalTrials.gov, the FDA Orange Book®, and patents. To create CDCDB, we use various methods, including natural language processing techniques, to improve the process of drug combination discovery, ensuring that our database can be used for drug synergy prediction. Website: https://icc.ise.bgu.ac.il/medical_ai/CDCDB/.

Phosphate moiety in FDA-approved pharmaceutical salts and prodrugs.

The salification and prodrug approaches modulate the physicochemical properties and absorption, distribution, metabolism, excretion, and toxicity parameters of drugs and lead candidates. The "phosphate" is one of the key counterions/promoiety used in the salt formation and prodrug synthesis. Salification with phosphoric acid enhances the aqueous solubility and thereby facilitates the administration of a drug by the parenteral route. Phosphate moiety in prodrug synthesis mainly improves permeability by lipophilic substitution. Histamine phosphate is the first phosphate salt, and hydrocortisone phosphate was the first prodrug approved by FDA in 1939 and 1952, respectively. The orange book enlists 12 phosphate salts and 17 phosphate prodrugs. Phosphate prodrugs, namely combretastatin A-4 diphosphate, combretastatin A-4 phosphate, lufotrelvir, TP-1287, pyridoxal phosphate, riboflavin phosphate, and psilocybin are clinical candidates. This review focuses on the FDA-approved phosphate salts and prodrugs from 1939 to 2021. The biopharmaceutical advantage of phosphate salts and prodrugs over the parent molecule is also deliberated.

Fixing The FDA's Orange Book.

The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This regime needs updating. The process that Hatch-Waxman established for listing patents and challenging patents on the Food and Drug Administration's Orange Book is one important area for reform.

High Assurance in the Twenty-First Century With Roger Schell

Bob Blakley: Welcome, everybody, to episode three of the IEEE Over the Rainbow podcast. I am your host Bob Blakley, and we’re here today with one of the founders of the field of information security, Roger Schell. Roger, back in the early 1980s, was one of the leaders of the production of a U.S. government standard called the Orange Book [formally titled the Trusted Computer System Evaluation Criteria, (TCSEC)], which essentially defined the model for a secure computer system. I have a copy of it here. Roger, you’ll be happy to see that I used it heavily enough that I had to take the staples out. I think it’s probably a good time to be having this conversation because this year is the 50th anniversary of the reference monitor model. Nineteen seventy-two saw the publication of the Anderson report, which introduced the concept, as far as I’m aware, in the public literature—and that’ll be 50 years ago this year. And—as I think you’re aware, Roger—the title of our podcast is a sort of multilayered pun, and one of the aspects of the pun is a reference to the Rainbow Series, which the Orange Book was the inaugural volume of. One of the sly suggestions we were hinting at in the title was that, in some sense, the computer security industry is over the Rainbow Series—over in the sense of sort of wanting to leave it in the past. But I think one of the things that we’re going to talk about today is that it’s not easy to leave the Orange Book in the past and also possibly not wise. So, with that introduction, Lorrie, I’ll hand it to you to start our questions.