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BACKGROUND: Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers. OBJECTIVE: This article tries to explain the patentability issues related to epitope-based patent claims. METHODS: For this purpose, an overview is given on the respective legal provisions and court decisions. RESULTS: The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. CONCLUSIONS: Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.
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Epítopos , Patentes como Asunto , Receptores de Antígenos de Linfocitos T , Patentes como Asunto/legislación & jurisprudencia , Humanos , Epítopos/inmunología , Receptores de Antígenos de Linfocitos T/inmunología , Receptores de Antígenos de Linfocitos T/uso terapéutico , Anticuerpos/uso terapéutico , Anticuerpos/inmunologíaRESUMEN
CRISPR Cpf1/Cas12a has been discussed as a less conflict prone alternative, patent-wise, to Cas9. This article investigates whether or not this assumption is correct, and comes to the conclusion that the promise that CRISPR Cpf1/Cas12 would make things easier, and be less conflict-prone, is fragile.
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Sistemas CRISPR-Cas , Edición Génica , Sistemas CRISPR-Cas/genéticaRESUMEN
CRISPR Cas9 has turned out to be one of the most influential technologies in the life sciences. However, ferocious patent debates and an unclear licensing situation makes access to this technology difficult for Small and medium enterprises. This article gives an overview of the status quo 10 years after the seminal patents were filed.
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Disciplinas de las Ciencias Biológicas , Sistemas CRISPR-Cas , Sistemas CRISPR-Cas/genética , Concesión de Licencias , Edición GénicaRESUMEN
Since the authors are not responding to the editor's requests to fulfill the editorial requirement, therefore, the article has been withdrawn.Bentham Science apologizes to the readers of the journal for any inconvenience this may have caused.The Bentham Editorial Policy on Article Withdrawal can be found at https://benthamscience.com/editorial-policies-main.php. BENTHAM SCIENCE DISCLAIMER: It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting the article for publication the authors agree that the publishers have the legal right to take appropriate action against the authors, if plagiarism or fabricated information is discovered. By submitting a manuscript the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication.
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Introduction: NGOs and governments of some countries have demanded suspension of patents protection of COVID-19 vaccines and the underlying technology to enhance worldwide access. At the same time, companies actually developing and producing COVID-19 vaccines have to navigate the patent landscape and have to deal with 3rd party patents.Areas covered: This article discusses these different aspects regarding patent protection of COVID-19 vaccines. Patent searches have been carried out in Espacenet and the ORBIT database. Different search strings were used by the author, based on his own background knowledge.Expert opinion: SARS-CoV 2 was for the first time fully described on 10 January 2020, so it is so far not possible to determine if, and by whom, patent applications were filed for respective vaccines. On that background, allegations that patents would be responsible for insufficient access to the vaccine in particular in developing countries are baseless. Even the key players are facing contraints caused by third-party patents, and legal disputes are already ongoing. Anyway, the bigger obstacle for worldwide equitable vaccine distribution seems to reside in know how transfer and production capacities, as ramping up production requires considerable efforts.
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Vacunas contra la COVID-19/uso terapéutico , COVID-19/prevención & control , Patentes como Asunto , Humanos , ARN Viral/inmunologíaRESUMEN
Epitope-based antibody claims have emerged to become one of the most important claim species in antibody patents. At the same time, they are heavily disputed. This article strives to give an overview about the as is situation both in Europe and the United States.
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Anticuerpos/fisiología , Anticuerpos/uso terapéutico , Epítopos/fisiología , Epítopos/uso terapéutico , Animales , Europa (Continente) , Humanos , Estados UnidosRESUMEN
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
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Adalimumab/economía , Antirreumáticos/economía , Artritis Reumatoide/tratamiento farmacológico , Biosimilares Farmacéuticos/economía , Disentimientos y Disputas/economía , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab/uso terapéutico , Anticuerpos Monoclonales/economía , Anticuerpos Monoclonales/uso terapéutico , Antirreumáticos/provisión & distribución , Antirreumáticos/uso terapéutico , Artritis Reumatoide/economía , Artritis Reumatoide/genética , Artritis Reumatoide/inmunología , Biosimilares Farmacéuticos/provisión & distribución , Biosimilares Farmacéuticos/uso terapéutico , Certolizumab Pegol/economía , Certolizumab Pegol/uso terapéutico , Disentimientos y Disputas/legislación & jurisprudencia , Esquema de Medicación , Cálculo de Dosificación de Drogas , Etanercept/economía , Etanercept/uso terapéutico , Regulación de la Expresión Génica , Humanos , Infliximab/economía , Infliximab/uso terapéutico , Patentes como Asunto , Factor de Necrosis Tumoral alfa/genética , Factor de Necrosis Tumoral alfa/inmunologíaRESUMEN
A new gene engineering technology has recently made it through the media, not only because of its technical advantages, but also because it is in the focus of an epic patent battle between two academic institutions. The technology bears the cryptic name "CRISPR Cas9", and allows the manipulation of genes (so called "gene editing") with so far unseen simplicity and efficacy. Dana Carroll of the University of Utah said for this reason that CRISPR Cas9 has brought about the "democratization of gene targeting". However, due to legal battles and conflicting patent estates, third parties may find it difficult to decide where to acquire licenses. This article gives an overview.
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Sistemas CRISPR-Cas , Concesión de Licencias , Patentes como AsuntoRESUMEN
As the $100B therapeutic monoclonal antibody (mAb) market continues to grow, developers of therapeutic mAbs increasingly face the need to strengthen patent protection of their products and enforce their patents in courts. In view of changes in the patent law landscape, patent applications are strategically using information on the precise binding sites of their mAbs, i.e., the epitopes, to support patent novelty, non-obviousness, subject matter, and a tightened written description requirement for broad genus antibody claims. Epitope data can also allow freedom-to-operate for second-generation mAbs by differentiation from patented first-generation mAbs. Numerous high profile court cases, including Amgen v. Sanofi over rival mAbs that block PCSK9 activity, have been centered on epitope mapping claims, highlighting the importance of epitopes in determining broad mAb patent rights. Based on these cases, epitope mapping claims must describe a sufficiently large number of mAbs that share an epitope, and each epitope must be described at amino acid resolution. Here, we review current best practices for the use of epitope information to overcome the increasing challenges of patenting mAbs, and how the quality, conformation, and resolution of epitope residue data can influence the breadth and strength of mAb patents.
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Anticuerpos Monoclonales , Mapeo Epitopo , Legislación de Medicamentos , Patentes como Asunto , Medicamentos bajo Prescripción , HumanosRESUMEN
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
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Adalimumab/economía , Antiinflamatorios/economía , Antirreumáticos/economía , Disentimientos y Disputas/legislación & jurisprudencia , Patentes como Asunto/legislación & jurisprudencia , Adalimumab/uso terapéutico , Antiinflamatorios/uso terapéutico , Antirreumáticos/uso terapéutico , Artritis Psoriásica/tratamiento farmacológico , Artritis Psoriásica/economía , Artritis Psoriásica/inmunología , Artritis Psoriásica/patología , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/economía , Artritis Reumatoide/inmunología , Artritis Reumatoide/patología , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/economía , Colitis Ulcerosa/inmunología , Colitis Ulcerosa/patología , Disentimientos y Disputas/historia , Aprobación de Drogas/legislación & jurisprudencia , Expresión Génica , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Propiedad Intelectual , Patentes como Asunto/ética , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Factor de Necrosis Tumoral alfa/genética , Factor de Necrosis Tumoral alfa/inmunologíaRESUMEN
Since 2006, some of the highest ranking European Courts have issued decisions related to the patent eligibility of human embryonic stem cells. The question of patent eligibility of human embryonic stem cells remains, however, still erratic, at least in some aspects. This article will give a short comprehensive overview of the case history, and discuss questions still unsolved.
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Células Madre Embrionarias Humanas/citología , Patentes como Asunto/ética , Patentes como Asunto/legislación & jurisprudencia , Investigación con Células Madre/ética , Investigación con Células Madre/legislación & jurisprudencia , Unión Europea , Humanos , Propiedad IntelectualRESUMEN
Dosage patents are one way to extend the market exclusivity of an approved drug beyond the lifetime of the patent that protects the drug as such. Dosage patents may help to compensate the applicant for the long period where the active pharmaceutical ingredient as such is already under patent prosecution, but not on the market yet, due to lengthy development and approval procedures. This situation erodes part of the time the drug is marketed under patent protection. Dosage patents filed at a later date can provide remedy for this problem. Examples of successful and unsuccesful attempts, and the reasons for the respective outcomes, are provided in this article.
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Anticuerpos Monoclonales/uso terapéutico , Aprobación de Drogas/legislación & jurisprudencia , Aprobación de Drogas/métodos , Inmunoterapia/legislación & jurisprudencia , HumanosRESUMEN
Immune checkpoint inhibitors are drugs that interfere with tumor escape responses. Some members of this class are already approved, and expected to be blockbusters in the future. Many companies have developed patent activities in this field. This article focuses on the patent landscape, and discusses key players and cases related to immune checkpoint inhibitors.
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Antineoplásicos , Puntos de Control del Ciclo Celular , Inmunoterapia , Neoplasias , Patentes como Asunto , Animales , Humanos , Neoplasias/inmunología , Neoplasias/terapiaRESUMEN
Antibody-drug conjugates are highly complex entities that combine an antibody, a linker and a toxin. This complexity makes them demanding both technically and from a regulatory point of view, and difficult to deal with in their patent aspects. This article discusses different issues of patent protection and freedom to operate with regard to this promising new class of drugs.
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Anticuerpos Monoclonales/inmunología , Aprobación de Drogas , Inmunoconjugados/inmunología , Propiedad Intelectual , Ado-Trastuzumab Emtansina , Aminoglicósidos/inmunología , Aminoglicósidos/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados/inmunología , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/inmunología , Antineoplásicos/uso terapéutico , Brentuximab Vedotina , Gemtuzumab , Humanos , Inmunoconjugados/uso terapéutico , Maitansina/análogos & derivados , Maitansina/inmunología , Maitansina/uso terapéutico , Patentes como Asunto , Trastuzumab , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Because drug development is not a static process, a drug's market authorisation may change over time. In many cases, the number of indications for which a drug is approved increases. Because this facet of drug development also comes at significant costs, a corresponding patent filing strategy is required to protect these investments. The strategy as applied to rituximab, which is approved for a variety of indications, is discussed in this review.
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Anticuerpos Monoclonales de Origen Murino/historia , Anticuerpos Monoclonales de Origen Murino/uso terapéutico , Aprobación de Drogas/historia , Diseño de Fármacos , Factores Inmunológicos/historia , Factores Inmunológicos/uso terapéutico , Aprobación de Drogas/métodos , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Patentes como Asunto , RituximabRESUMEN
This article discusses the status quo of the Cabilly patents, their scope of protection and the role these patents play for the therapeutic antibody industry in Europe and the US.
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Anticuerpos/uso terapéutico , Industria Farmacéutica/legislación & jurisprudencia , Patentes como Asunto , Animales , Europa (Continente) , Humanos , Estados UnidosRESUMEN
Therapeutic antibodies need international patent protection as their markets expand to include industrialized and emerging countries. Because international intellectual property strategies are frequently complex and costly, applicants require sound information as a basis for decisions regarding the countries in which to pursue patents. While the most important factor is the size of a given market, other factors should also be considered.