TRANSFERENCIA DE TECNOLOGÍA

Máster Universitario en Investigación Química y Química Industrial

susana.torrente@usc.es
CONTENIDOS

Introducción a la Transferencia de Tecnología. Marco legal

Propiedad Intelectual e industrial. El sistema de patentes

Criterios de Patentabilidad

Estrategias de protección

Búsquedas de patentes

Valorización de Resultados de Investigación

Contratos para la Transferencia de Tecnología

Bibliografía e Información
• Oficina Española de Patentes y Marcas www.oepm.es
• Oficina Europea de Patentes www.epo.org
• Ley 24/2015, de 24 de Julio, de Patentes
• Convenio de la Patente Europea https://www.epo.org/law-practice/legal-texts/epc.html
• Guidelines for Examination in the EPO https://www.epo.org/law-practice/legal-
texts/guidelines.html. En particular Part G y Part H.
• Búsquedas en bases de datos: http://worldwide.espacenet.com/;
http://consultas2.oepm.es/InvenesWeb/faces/busquedaInternet.jsp;
http://www.uspto.gov/patents-application-process/search-patents
• "Patents for chemicals, pharmaceuticals, and biotechnology : fundamentals of global law,
practice, and strategy”, Grubb, Philip W. Oxford ; New York : Oxford University Press, 2010.
• "Biopatent law: European vs. US patent law", Ulrich Storz, et al. Heidelberg: Springer, 2014.
• "The annotated European patent Convention", Derek Visser, 2015.
 INTRODUCCIÓN

Máster Universitario en Investigación Química

y Química Industrial

susana.torrente@usc.es
¿Qué es la transferencia de tecnología?
 Palobiofarma signs licensing agreement

Palobiofarma, which focuses on adenosine products and has locations in

Navarra and Barcelona, recently announced it has signed a licensing
agreement with Novartis for a possible drug for metastatic cancer.

Palobiofarma will receive an initial payout of $15 millions plus bonuses for
hitting short-term clinical goals, money to develop and market projects and
royalties in the double digits on net sales of PBF-509.

Moreover, Novartis will have access to several patents held by the

Spanish biotechnology firm associated with the role of adenosine in
immunotherapy.

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LG and Ericsson Sign Global Patent Cross-Licensing Agreement
Aug 6, 2018

LG and Ericsson have been one of the largest contributors to the 2G, 3G and 4G standards,
and are determined to even dominate the 5G domain. Lately, the 2 companies had been in
a patent licensing dispute which they finally decided to settle out of court. They’ve also
renewed their global licensing agreement along fair, reasonable and non-discriminatory
(FRAND) terms, covering both companies’ 2G 3G and 4G cellular standard essential
patents.

“It will allow us to focus on developing new technology for the global market and add to our
already industry-leading patent portfolio. The agreement confirms the value of our patent
portfolio and validates our ability to license it on FRAND terms and conditions,” he said.
Unha empresa galega capta 2,3 millóns para A inxección de capital permitirá a Origo Biopharma completar
o desenvolvemento preclínicoregulatorio do seu fármaco
investigar a fibrose e o cancro colorrectal para fibrose gastrointestinal e realizar os primeiros ensaios
Origo Biopharma desenvolve fármacos inhibidores de TGF-beta clínicos orientados ao desenvolvemento en pacientes con
fibrose asociada a enfermidade de Crohn, así como avanzar
e avanzará nestes proxectos co apoio de Sabadell Asabys, no desenvolvemento preclínico da súa molécula para o
XesGalicia e os socios promotores (07/07/2020) tratamento da fibrose pulmonar idiopática. Prevese iniciar os
primeiros estudos clínicos no 2021.
A empresa biotecnolóxica Origo Biopharma, con sede no Parque
Tecnolóxico de Galicia (Ourense) e socia da Agrupación industrial
Tecnolóxico Empresarial das Ciencias da Vida (Bioga) anunciou este
martes o peche dunha rolda de financiamento Series Seed de 2,3
millóns de euros achegados por Sabadell Asabys, XesGalicia e
os socios promotores. Con esta inxección de capital, a
biotecnolóxica “cobre as necesidades financeiras para completar o
desenvolvemento preclínico e iniciar os primeiros estudos clínicos co
seu medicamento para o tratamento de pacientes con fibrose
asociada á enfermidade de Crohn, así como avanzar os seus
programas en Fibrose Pulmonar Idiopática e en cancro colorrectal”,
expón Bioga nunha nota de prensa. A compañía foi fundada en 2017
por GalChimia(liderada pola súa CEO e fundadora, Carme Pampín)
e por Julio Castro, fundador e CEO de Palobiofarma. En 2019, a
compañía incorporou a Ramon Bosser como CEO e accionista.
Agilent Technologies Acquires ProZyme
Strengthens Agilent's customer value proposition in fast-growing biopharma market
06.29.18

Agilent Technologies has entered into a definitive agreement to acquire privately-held

ProZyme, a provider of glycan analysis reagents, kits and standards. This acquisition will
expand Agilent's portfolio of biopharma consumables in the fast-growing glycan market.

"Agilent is focused on being a complete workflow solutions provider," said Mark Doak,
president of Agilent's CrossLab Group. "We have a strong installed base of customers
worldwide, and expanding our consumables portfolio is key to our strategy of providing a
seamless customer experience and helping our customers reduce the cost and time
required to bring new therapeutics to market."

Founded in 1990, ProZyme is a developer and manufacturer of glycan reagents, kits and
standards, which are required for efficient sample prep in the analysis of free glycans.
Glycobiology, which is the study of the structure, function and biology of carbohydrates,
also called glycans, is a fast-growing and important field of study in life sciences. Glycans
play diverse roles in biotherapeutics, novel drug development, the study of bacterial
physiology, and proteomics research.
Tech Transfer Your Existing MAb Production
Process • The goal of technology transfer activities is to transfer product and process knowledge from development and GMP clinical
production to GMP commercial manufacturing location.

Technical transfer activities include:

• Analytical methods validation to test methods robustness prior to process scale up
• Small scale process validation to test process limits prior to scale up
• Process scale up to reach the expected production capacity
• Analytical methods and USP/DSP technical transfer activities including:
• Tech transfer protocol
• Associated tests and reports
• Detailed process description
• Process risk analysis and training plan for your production technicians and operators
• Commercial scale process validation for the production and release of DS validation batches at commercial scale in your
facility
• Make Your Process a Success, Anywhere in the World
• When the time comes to scale up your production process, transfer it to a local manufacturing partner for commercial
routine production, or move it and build your own facility, our experts will work with you to ease the process and make your
program a success.

Transfers need to be performed in an organized, methodical manner with appropriate documentation and within shortest
possible timeframe. With you, our local team of experts can develop and execute the process technical transfer plan, ensuring
that the overall project will stay within expected timing and lead to a successful outcome.

Our experience implementing and operating a full single use and hybrid GMP processes with our own technologies and
products platforms.
Ángela Ruiz Robles
(1895 – 1975)
Investigación y desarrollo
 HORIZON 2020 - Commission Decision C(2014)4995G.
Technology readiness levels (TRL). Where a topic description refers to a TRL, the following
definitions apply, unless otherwise specified:

 TRL 1 –basic principles observed

 TRL 2 –technology concept formulated
 TRL 3 –experimental proof of concept
 TRL4 –technology validated in lab
 TRL 5 –technology validated in relevant environment (industrially relevant environment in the
case of key enabling technologies)
 TRL 6 –technology demonstrated in relevant environment (industrially relevant environment in
the case of key enabling technologies)
 TRL 7 –system prototype demonstration in operational environment
 TRL 8 –system complete and qualified
 TRL 9 –actual system proven in operational environment (competitive manufacturing in the case
of key enabling technologies; or in space)
 Investigación y desarrollo

Autorización de Servicio
comercialización Post-venta
Fabricación o vigilancia

Marketing
Distribución
 Transferencia de Tecnología

Entorno industrial vs. Entorno centros de investigación

• https://www.hyaip.com/es/espacio/descubre-la-relacion-entre-los-
derechos-de-pi-y-el-rendimiento-de-las-empresas-en-la-ue/

• Cómo proteger el producto?

• https://gurung.es/
•
• http://www.bioincubatech.com/portfolio-item/neoxenica/
•
• https://www.fabrx.co.uk/
 Merck ends development of obesity drug taranabant

NEW YORK, Oct 2 (Reuters) - Merck & Co (MRK.N) has stopped development

of its experimental obesity drug taranabant after data in a late-stage clinical study

found more side effects at higher doses, the drug maker said on Thursday.

Though a potential blockbuster, taranabant had been considered a risky project….

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 Isolation and characterization of the product
EP 0309477 B1 (01/06/1987)

ANTI-CANCER DRUG

Clinical improvement for the Treatment for patients with

treatment of cáncer in combination advanced soft-tissue sarcoma
with dexamethasone
EMEA 17/09/2007
EP 1702618 B1 (15/05/2000)
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 Riesgo

 Interés del mercado

 Valorización de Resultados

Tecnología

Prueba de
Captación de Concepto
financiación

Plan de
Licencia
Comunicación Comercialización
Negociación
EBT
de Resultados Protección

Estudio de
Promoción
Mercado

Roadmap Formación en
Empredimiento
Valoración
 Proceso de Transferencia de Tecnología
Captación de financiación para I+D
Financiación europea Fondos privados para prueba de concepto
Contratos I+D, consorcios Retos y otros Fondos públicos para prueba de concepto
Colaboraciones con empresas Personal
Valorización
Tecnología
Acuerdo de
Captación de Prueba de
Concepto
Licencia
financiación

Comunicación Negociación Plan de

Financiación Investigación Comercialización
de Resultados Protección
Estudio de
Promoción
Mercado
Roadmap
Formación en
Empredimiento
EBT

GESTIÓN DE PROPIEDAD INDUSTRIAL

 Salida profesional

Solicitante
Examinador
Química vs Derecho

Agente
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 Salida profesional

Empresas – Dpto. propiedad industrial

Funciones:
- Búsqueda de patentes y publicaciones en bases de datos
- Realización de informes de patentabilidad
- Realización de informes de riesgos de infracción
- Detección de oportunidades de negocio en nuevos proyectos
- Vigilancia tecnológica en los proyectos en curso
- Coordinación de acciones contra terceros
- Coordinación de redacción de patentes y tramitación

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 Salida profesional

Empresas – Dpto. propiedad industrial

- Trabajo estratégico con Dpto. comercial

- Trabajo con Dpto. I+D

- Trabajo con agencias de patentes

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 Salida profesional

Agencia de patentes

- Alto nivel científico

- No estar interesado en la carrera investigadora
- Interés en patentes
- Normalmente forman al personal, internamente y en curso externos
- Idiomas
- Buen trato al cliente

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 Salida profesional

Agencia de patentes

Elzaburu

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 Salida profesional

Agente español de propiedad industrial

1º Examen preguntas a desarrollar

2º Examen de traducción
3º Examen práctico patentes y marcas

Temas divididos en 4 bloques, exámenes eliminatorios,

sin carácter técnico. Se convocan cada 2 años

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 Salida profesional

European Patent Attorney

European Qualifying Examination (EQE) Chemistry

Electricity/Mechanics

Pre-Examination
Paper A: Redacción (3 h)
Paper B: Contestación a acción oficial (3 ½ h)
Paper C: Oposición (5 h)
Paper D: Aspectos jurídicos (5 h)

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