RESUMO
BACKGROUND: The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. METHODS: We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. RESULTS: We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. INTERPRETATION: No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.
Assuntos
Custos de Medicamentos, Patentes como Assunto, Canadá, Estudos Retrospectivos, Humanos, Patentes como Assunto/legislação & jurisprudência, Custos de Medicamentos/legislação & jurisprudência, Estados Unidos, Comércio/legislação & jurisprudência, Comércio/economiaRESUMO
In this Policy Forum piece, Robin Feldman discusses how current legislation contributes to informational deficits around drug patents for biologic drugs in the United States.
Assuntos
Medicamentos Biossimilares, Propriedade Intelectual, Estados Unidos, Humanos, Produtos Biológicos, Patentes como Assunto/legislação & jurisprudência, Legislação de Medicamentos, United States Food and Drug Administration/legislação & jurisprudênciaAssuntos
Comércio, Indústria Farmacêutica, Farmacoeconomia, Política de Saúde, Preparações Farmacêuticas, Humanos, Comércio/economia, Comércio/legislação & jurisprudência, Custos de Medicamentos/legislação & jurisprudência, Indústria Farmacêutica/legislação & jurisprudência, Indústria Farmacêutica/economia, Farmacoeconomia/legislação & jurisprudência, Patentes como Assunto/legislação & jurisprudência, Preparações Farmacêuticas/economia, Estados Unidos, United States Food and Drug Administration/economia, United States Food and Drug Administration/legislação & jurisprudência, Política de Saúde/economia, Política de Saúde/legislação & jurisprudênciaRESUMO
The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.
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Bancos de Espécimes Biológicos, Propriedade Intelectual, Humanos, Bancos de Espécimes Biológicos/legislação & jurisprudência, Bancos de Espécimes Biológicos/ética, Patentes como Assunto/legislação & jurisprudência, Tecnologia Biomédica/legislação & jurisprudência, Tecnologia Biomédica/ética, Doadores de Tecidos/legislação & jurisprudência, Temas Bioéticos/legislação & jurisprudênciaRESUMO
This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition.
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Medicamentos Genéricos, Patentes como Assunto, Medicamentos sob Prescrição, Avaliação de Risco e Mitigação, Custos de Medicamentos, Indústria Farmacêutica, Medicamentos Genéricos/uso terapêutico, Competição Econômica, Avaliação de Risco e Mitigação/legislação & jurisprudência, Estados Unidos, Patentes como Assunto/legislação & jurisprudênciaRESUMO
This study examines the frequency of drug patent invalidations based on inequitable conduct.
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Patentes como Assunto, Preparações Farmacêuticas, Má Conduta Científica, United States Food and Drug Administration, Patentes como Assunto/ética, Patentes como Assunto/legislação & jurisprudência, Má Conduta Científica/ética, Má Conduta Científica/legislação & jurisprudência, Estados UnidosAssuntos
Inteligência Artificial, Invenções, Patentes como Assunto, Invenções/economia, Invenções/legislação & jurisprudência, Patentes como Assunto/legislação & jurisprudência, Inteligência Artificial/economia, Inteligência Artificial/legislação & jurisprudência, Descoberta de Drogas/economia, Descoberta de Drogas/legislação & jurisprudênciaRESUMO
Importance: Glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive. Objective: To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity. Evidence Review: The annual US Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity. Findings: On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval. Conclusions and Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.
Assuntos
Diabetes Mellitus Tipo 2, Aprovação de Drogas, Medicamentos Genéricos, Receptor do Peptídeo Semelhante ao Glucagon 1, Hipoglicemiantes, Patentes como Assunto, Humanos, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, Aprovação de Drogas/legislação & jurisprudência, Medicamentos Genéricos/economia, Medicamentos Genéricos/uso terapêutico, Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas, Preparações Farmacêuticas/economia, Hipoglicemiantes/economia, Hipoglicemiantes/uso terapêutico, Patentes como Assunto/legislação & jurisprudência, Estados Unidos, Equivalência Terapêutica, Comércio, Competição Econômica/economia, Competição Econômica/legislação & jurisprudência, Fatores de TempoRESUMO
This Viewpoint discusses a current Supreme Court lawsuit, Amgen v Sanofi, involving Amgen's broad patents on PCSK9 that could effectively prevent other manufacturers from producing similar or even clinically superior antibodies, with important negative consequences for patients.
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Patentes como Assunto, Decisões da Suprema Corte, Estados Unidos, Patentes como Assunto/legislação & jurisprudênciaAssuntos
Medicamentos Biossimilares, Indústria Farmacêutica, Medicamentos Genéricos, Competição Econômica, Patentes como Assunto, Humanos, Medicamentos Biossimilares/economia, Medicamentos Biossimilares/uso terapêutico, Custos de Medicamentos, Medicamentos Genéricos/economia, Medicamentos Genéricos/uso terapêutico, Indústria Farmacêutica/economia, Indústria Farmacêutica/legislação & jurisprudência, Patentes como Assunto/legislação & jurisprudência, Competição Econômica/economia, Competição Econômica/legislação & jurisprudênciaRESUMO
This Viewpoint discusses the CRISPR patent ruling, an ongoing patent dispute, and the implications for research and medical innovation.
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Sistemas CRISPR-Cas, Edição de Genes, Patentes como Assunto, Repetições Palindrômicas Curtas Agrupadas e Regularmente Espaçadas, Edição de Genes/legislação & jurisprudência, Patentes como Assunto/legislação & jurisprudência, Estados Unidos, Legislação MédicaRESUMO
This Viewpoint discusses 3 bills introduced recently in Congress that focus on patent eligibility, fraud, and quality and that have major implications for clinical medicine and pharmaceutical development.
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Reforma dos Serviços de Saúde, Legislação de Medicamentos, Patentes como Assunto, Medicamentos sob Prescrição, Reforma dos Serviços de Saúde/legislação & jurisprudência, Estados Unidos, Patentes como Assunto/legislação & jurisprudênciaRESUMO
This study quantifies the revenue earned on all brand-name inhalers approved by the US Food and Drug Administration from 2000 to 2021 and compared earnings before and after expiration of primary patents on these products.
Assuntos
Indústria Farmacêutica, Competição Econômica, Nebulizadores e Vaporizadores, Patentes como Assunto, Medicamentos Genéricos, Competição Econômica/economia, Nebulizadores e Vaporizadores/economia, Estados Unidos, Patentes como Assunto/legislação & jurisprudência, Indústria Farmacêutica/economia, Indústria Farmacêutica/legislação & jurisprudênciaRESUMO
This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriads various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but in some way only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)
Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que en cierto modo sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)
