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.

Machine learning-based prediction of drug approvals using molecular, physicochemical, clinical trial, and patent-related features.

BACKGROUND: Drug development productivity has been declining lately due to elevated costs and reduced discovery rates. Therefore, pharmaceutical companies have been seeking alternative ways to determine and evaluate drug candidates. RESEARCH DESIGN AND METHODS: In this work, we proposed a new computational approach to directly predict the regulatory approval of drug candidates, and implemented it as a method called 'DrugApp.' To accomplish this task, we employed multiple types of features including molecular and physicochemical properties of drug candidates, together with clinical trial and patent-related features, which are then processed by random forest classifiers to train our disease group-specific approval prediction models. RESULTS: Our evaluations indicated DrugApp has a high and robust prediction performance. Within a use-case study, we showed our method can predict phase IV trial drugs that are later withdrawn from the market due to severe side effects. Finally, we used DrugApp models to forecast the approval of drug candidates that are currently in phases I/II/III of clinical trials. CONCLUSIONS: We hope that our study will aid the research community in terms of evaluating and improving the process of drug development. The datasets, source code, results, and pre-trained models of DrugApp are freely available at https://github.com/HUBioDataLab/DrugApp.

Pharmaceutical patent term extension and patent prosecution in Brazil (1997-2018) / Extensão do prazo de vigência e tramitação de patentes farmacêuticas no Brasil (1997-2018) / Extensión de la vigencia y tramitación de patentes farmacéuticas en Brasil (1997-2018)

In Brazil, if patent prosecution takes more than 10 years, this extra period is added to the regular 20-year term. This paper analyses all pharmaceutical patents granted by the Brazilian National Institute of Industrial Property (INPI) with term extension and later discusses some intellectual property and health policy implications. On average, pharmaceutical patent applications wait seven years after substantive examination is requested before being examined, which takes only three and a half years. Furthermore, the role of the Brazilian Health Regulatory Agency (Anvisa) in providing prior consent has a marginal effect in prolonging the prosecution. Therefore, the extension of pharmaceutical patents' term is caused by the number of pending applications per examiner, which halts the prosecution for double the time it takes to examine the applications. Thus, proper solutions should focus on reducing the backlog per examiner at the INPI, which has caused the extension of 92% of the pharmaceutical patents in three and a half years, on average. We concluded that the Brazilian pharmaceutical patenting policy is biased towards the patentee. This imbalance will only be effectively corrected when the INPI is financially and administratively autonomous to reduce the ratio between the pharmaceutical patent application backlog and the number of examiners.

No Brasil, quando a tramitação de uma patente demora mais de 10 anos, esse tempo adicional é acrescentado à vigência regular de 20 anos. Este artigo analisa todas as patentes farmacêuticas concedidas pelo Instituto Nacional de Propriedade Industrial (INPI) com prorrogação de prazo, e em seguida discute algumas implicações para políticas de propriedade intelectual e de saúde. Em média, os pedidos de patente farmacêuticas esperam sete anos entre o requerimento do exame e o início da análise, que leva apenas três anos e meio. Além do mais, o papel da Agência Nacional de Vigilância Sanitária (Anvisa) na anuência prévia tem efeito marginal sobre o período de tramitação. Portanto, a extensão da vigência das patentes farmacêuticas é provocada pelo alto número de pedidos pendentes por examinador, o que atrasa em até duas vezes o tempo que leva para examinar os pedidos. Logo, soluções adequadas devem focar na redução do acúmulo de pedidos pendentes por examinador no INPI, que causou a extensão de 92% das patentes farmacêuticas em três anos, em média. Conclui-se que a política brasileira para patentes farmacêuticas apresenta um viés em favor do titular da patente. Esse desequilíbrio só será sanado efetivamente quando o INPI tiver autonomia financeira e administrativa para reduzir a razão entre o backlog de pedidos de patentes farmacêuticas e o número de examinadores.

En Brasil, si la tramitación de una patente tarda más de 10 años, este período extra se añade a la vigencia regular de 20 años. Este trabajo analiza todas las patentes farmacéuticas otorgadas por la Oficina de Patentes Brasileña (INPI) con extensión de su vigencia, y discute posteriormente algumas implicaciones para las políticas de propriedade intelectual y de salud. En promedio, las solicitudes de patentes farmacéuticas esperan siete años desde el requerimiento del examen antes de ser examinadas, lo que tarda solamente tres años y medio. Asimismo, el rol de la Agencia Nacional de Vigilancia Sanitaria (Anvisa) al dar su consentimiento previo tiene un efecto marginal para prolongar la tramitación. Por ello, la extensión de la vigencia de las patentes farmacéuticas está provocada por el número de solicitudes pendientes por examinador, lo que paraliza la tramitación por el doble de período de tiempo que cuesta examinar las solicitudes. Así pues, las soluciones apropiadas deberían centrarse en reducir el acúmulo de solicitudes pendientes por examinador en el INPI, que ha provocado la extensión de la patente en un 92% de las solicitudes farmacéuticas en tres años y meio, en promedio. Se concluye que la política de patentes farmacéuticas brasileña está sesgada hacia el titular de la patente. Este desequilibrio solo se corregirá efectivamente cuando el INPI tenga autonomía financeira y administrativa para reducir la razón entre el backlog de solicitudes de patentes farmacéuticas y el número de examinadores.

The Legislative Approach and System Improvement of China's Compulsory Licensing for Drug Patents.

Compulsory licensing for drug patents is of great significance to ensure the accessibility of drugs. Although the development of China's compulsory licensing system for drug patents has been gradually improved, there are still problems. For example, the scope of the object is not realistic, the setting of the initiating subject is unreasonable, the reasons for issuance are not clear, the duration and scope of the license are not refined, and the provisions on the exploitation fee are missing. Consequently, in order to improve China's compulsory licensing system for drug patents, it is necessary to expand reasonably the scope of the object, remove the restrictions on the initiating subject, adjust the initiating rights of different subjects, determine the duration and scope of the license and the applicability of the hearing on a case-by-case basis, and determine a reasonable exploitation fee by taking into account the national income, patent cost, market share and other factors, in consideration of the flexibly international norms and the actual situation in China.

Breaking Bad Patents: Learning from HIV/AIDS to make COVID-19 treatments accessible.

The COVID-19 pandemic has brought renewed attention to the topic of challenging drug patents in the interest of public health. Pharmaceutical companies have already begun to patent existing medicines for the treatment and prevention of SARS-CoV-2, affording them exclusive manufacturing rights over vital medicines. Advocates have raised concerns regarding the pricing of COVID-19 drugs, as well as patent monopolies on the manufacture of COVID-19 treatments. The HIV/AIDS pandemic provides a useful lens through which we can analyse existing pathways for challenging pharmaceutical patents in the context of global pandemic. In this article, we review three legal pathways for overriding and seizing patents on medicines by describing cases in which they were employed to make antiretroviral drugs more accessible to people living with HIV. Last, we highlight the weaknesses inherent in these pathways and offer advocacy and policy suggestions for how to strengthen these pathways to improve access to COVID-19 treatments as they become available in the United States and globally.

Ebola Therapeutic Study and Future Directions.

The constant Ebola epidemic outbreaks in Africa arisen in waves of panic worldwide. There is a high mortality rate (30-70%) among the Ebola-infected people in virus- stricken areas. Despite these horrors, the medical capabilities against this deadly viral disease were provided by limited therapeutic agents/options. As a result, several patented agents, biotherapies or prophylactic/therapeutic vaccines need to be reviving into the global markets-including patents of small molecular chemicals, short sequences or oligomers of DNA/RNA, linkages of chemicals with bio-molecules, herbal medicine and so on. In addition, the possible mechanisms of action of these therapeutic options are underway. To promote Ebola biomedical study, the multiple characters of Ebola infections-its origin, pathologic progress, genomic changes, therapeutic context and economic considerations are outlined in this review. Finally, a great difference can be expected after these types of efforts.

The Feasibility of the Connection between the Drug Patents Examination and the New Drug Registration / 中国药学杂志

OBJECTIVE: To improve the feasibility of the connection between the drug patents examination and the new drug registration and design the connecting pattern between them, which will enhance the appearance on the market for the patent drugs, eventually increase the drug choice for the public. METHODS: To find the connecting space between drug patents examination and the evaluation standards for drug registration by comparing the "novelty", "inventiveness", "practical applicability" standards for a patent with the "safety", "efficacy" and "quality" standards for drug registration. RESULTS AND CONCLUSION: A large connecting space between the practical applicability standard for a patent and the evaluation standards for drug registration is found in this paper. The practical applicability standard for a patent can be adjusted dynamically according to the evaluation standards for drug registration based on the development level of the pharmaceutical industry, interests of patent holders and the public, etc.

Especificidades do patenteamento no setor farmacêutico: modalidades e aspectos da proteção intelectual: [revisão] / Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property: [review]

As formas de proteção das invenções no setor farmacêutico apontam para estratégias de perpetuação da proteção patentária. Com base em uma revisão bibliográfica mostrou-se as especificidades do patenteamento no setor, perpassando por um breve histórico sobre a concessão de patentes farmacêuticas no Brasil, uma abordagem sobre invenções patenteáveis e não-patenteáveis, e pelas modalidades e aspectos da proteção patentária que visam à extensão do monopólio temporário conferido pela patente. Dentre essas estratégias estão as patentes direcionadas a polimorfos e isômeros ópticos de fármacos; combinações de fármacos e segundo uso médico, cada vez mais presentes nas reivindicações dos pedidos de privilégio de invenção das indústrias farmacêuticas. O objetivo do trabalho é mostrar algumas especificidades dos pedidos de patente farmacêuticas, de modo a contribuir para a formação de expertise na área e para a discussão sobre o impacto da ampliação dos escopos de proteção das patentes. Conclui-se que se por um lado a tendência de escopos de proteção mais permissivos pode desvelar oportunidades para os inventores nacionais, por outro, pode ser danosa para uma política de acesso a medicamentos.

Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines.