COOPERAÇÃO EMPRESA-UNIVERSIDADE E PROSPECÇÃO DE...

COOPERAÇÃO EMPRESA-UNIVERSIDADE E PROSPECÇÃO DE TECNOLOGIAS

UTILIZANDO PATENTES

Geciane Silveira PortoCristiano Gonçalves Pereira

São Paulo, Outubro de 2018

Adaptado de Etzkowitz e Leydesdorff (2000).

Exemplos de modelo avançado: Silicon Valley

✓ Investimento privado P&D

✓ Colaboração com P&D público

✓ Emprega e treina RH

✓ Capital de Risco

✓ Implementa inovação

✓ Investimento público C&T&I

✓ Formação de RH

✓ Colaboração P&D

✓ Spill-overs

✓ Fronteira do conhecimento

✓ Regulação

✓ Incentivo fiscal

✓ Financiamento inovação

✓ Formação de RH

✓ Investimento público P&D

Atores no Processo CEU & TT

FATORES MOTIVADORES DA CEU

▪ Universidade é percebida como um reservatório de conhecimento e tecnologia

▪ A cooperação permite o acesso à tecnologia de que a empresa não dispõe naquele momento, alavancando-a a um patamar tecnológico mais elevado

▪ Gerenciamento eficaz dos projetos cooperativos reduz dificuldades.

▪ Experiências bem sucedidas favorecem o surgimento de novos acordos cooperativos.

▪ Valorização da inovação associada à redução riscos intrínsecos a este processo

▪ A cooperação contribui para o reconhecimento do trabalhado das entidades envolvidas, tanto as empresas quanto as universidades, melhorando a imagem das mesmas e de seus profissionais.

▪ Contribuição para a formação de quadros (estudantes e funcionários), bem como ao acesso a RH qualificado.

▪ Acesso a mercados e oportunidades de desenvolvimento de novos produtos e serviços

▪ Disponibilidade de recursos financeiros voltados à cooperação e redução de custos.

BARREIRAS A CEU

▪ Processo de cooperação envolve questões operacionais suscetíveis a problemas

▪ Escassez de informação e diferenças no nível de conhecimento dos parceiros.

▪ Institucionais

▪ Gestão da cooperação frágil e pouco profissionalizada

▪ Aspectos culturais cristalizados que polarizam as percepções

REDES COMPLEXAS

EMPRESAS

ASS.

EMPRESARIAIS

ONG’SUNIVERSIDADES

AGÊNCIAS

FINANCIAMENTOCOOPERAÇÃO

INTERNACIONAL

Escritórios

Transf. Tecnologia

Rede de cooperaçãotecnologica das 50 maioresempreasinstadadas no Brasil

PATENTES COMO FONTE DE INFORMAÇÃO CIENTÍFICA E TECNOLÓGICA

Confere direitos exclusivos de uso e exploração

Recompensa o inventor estimulando o desenvolvimento de novas

invenções

Garante uma imagem positiva

Estimula a concorrência (soluções alternativas para mesmo problema)

Disponibiliza informação técnica bem antes do produto estar no

mercado

Permite o estabelecimento de uma forte posição no mercado

Permite maior rentabilidade do Capital Investido

Promove a difusão do conhecimento à sociedade

Facilita o monitoramento tecnológico e as atividades de

pesquisa dos concorrentes

Evita a duplicidade de pesquisa e desenolvimento


“Estima-se que 70% da informação

científica e tecnológica está

presente em documentos de

patentes” WIPO 2016

Patent Landscape

Oportunidades de CooperaçãoTendências

• Banco de dados de Patentes

• Extração e gerenciamento de dados

• Ferramenta de tratamento de dados

• Análise de Redes Sociais

• Rede de citações de patentes



• Evitar duplicação de esforços nas fases de P&D

• Definir o estado da técnica de determinada

tecnologia

• Conhecer potenciais alternativas técnicas

• Definir potenciais rotas para aperfeiçoamento

em produtos e processos existentes

• Efetuar levantamentos sobre tecnologias em

nível mundial

• Identificar os principais players no setor e a

origem das tecnologias

• Identificar tecnologias emergentes, tendências

de mercado e previsão de novos produtos

▪ 1 School of Economics, Business Administration and Accounting at Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil

▪ 2 Center for Cell-based Therapy CTC, Regional Blood Center of Ribeirão Preto, University of São Paulo. Ribeirão Preto-SP, Brazil.

Hemophilia

▪ Congenital disorder that affects blood clotting

▪ Hemophilia A, B and C

▪ Hemophilia A: Mutation F8 gene (Factor VIII)

▪ Patients may experience spontaneous or prolonged bleeding, especially in the muscles, joints, or internal organs, in addition to bleeding after injury or surgical procedures

F8

gene

Hemophilia

▪ What happens to the blood clotting when Factor VIII is missing?

Hemophilia - Treatment

▪ What happens to the blood clotting when Factor VIII is missing?

Hemophilia - Treatment

▪ Treatment of patients with Hemophilia A

▪ FVIII concentrates – plasma derived

▪ Recombinant FVIII *

Some challenges remains:

• Some patients develop inhibitory antibodies to the

exogenous protein

• rFVIII Short half-life (Multiple intravenous infusions)

Hemophilia - rFVIII

▪ Recombinant FVIII molecules targeting increased short half-life

they have proved to be only a moderate success to date

improvements in pharmacokinetic profile and efficacy of FVIII products, in addition to their safety and

convenience of administration, continue to be the focus of bioengineering in the development of new

products

Aims of the study

The main objectives of the study are

▪ mine patents related to rFVIII molecules used in hemophilia treatment,

▪ design a patent landscape of the sector,

▪ use Social Network Analysis (SNA) to map a cooperation network among patent assignees and to forecast emerging technologies based on patent citation network

Experimental approach and methods

• Keyword search - Patent database – Derwent Innovation (1997 – 2016)

• Text Clustering and text mining – Themescape

• Clean and normalize data with Open Refine

• Gephi software (network visualization, metrics, statistics)

• Main Path – Search Path Link Count (SPLC) Algorithm

• Discuss the technology trends based on results and individual analysis


• Keyword and IPC search - Patent database – Derwent Innovation

• Query: Priority Year: 1997 – 2016

• Keywords

• IPCs


• IPCs

Results – Patent Pub. Trend and coverage

3.424 Patents related to rFVIII

- Rising tendency line in patent publication in the last 20 years

- U.S. territories - more than a half of patents were first deposited

- EP office 9% and only 45 patents as PCT

Results – Tech areas and granted status

Main Technological areas by IPC

- C07K 14/755 - Factor VIII peptides

- A61K 38/00 – medicinal preparations containing peptides

- A61P 7/04 - medicinal preparations/drugs for disorders of the blood

- Recombinant DNA technology and gene therapy

Results – Top inventors and assignees

- First two main inventors are from the same company

- Baxter 70% of cooperation rate

- Novo Nordisk 31% of cooperation rate

- And Bayer 41% of cooperation rate

Results

- Two party network

- Red nodes – Patents

- Blue nodes – Assignee

- Node size according to node degree

- The patent node is responsible to

establish the link among companies

(co-assignee)

Results

Full cooperation network

- Some isolated clusters and a main

cluster

- We select the main cluster named

GIANT COMPONENT (most

interconnected group)

Results – Cooperation Network

Assignee Degree Weighted Degree Eigenvector Centrality Baxter 21 232 0.592877

Aventis Behring Gmbh 17 110 1

US Dept Health & Human Services 14 23 0.365792

INSERM 14 17 0.71615

American Nat Red Cross 13 22 0.315989

Bayer 12 63 0.354391

Novo Nordisk 11 111 0.343101

Univ North Carolina 10 21 0.326731

CNRS Cent Nat Rech Sci 10 12 0.617525

Nektar Therapeutics 9 19 0.266288

▪ Network metrics and meaning

1º

2º

3º

4º

Parceiros Consistência Influência

Results – text clustering

Text Clustering

- cluster similar terminology found in the titles, claims and abstracts

- used to discover meaningfully implicit subjects throughout all the patent documents

Themescape

- large-scale text and

data processing analysis

based on a visual map

Results – Text Mining

Red dots

-Patents published

last 5 years

XTEN rFVIII

Most of patents are

from Biogen

Results – Conjugates

Results – Technological Route

SPLC METHOD

Paten Citation network

- Node size according to in-degree

- Green community – most relevant patents (highly cited)


Main path of citation network

• WO2015120056A – Biogen: improved methods in the separation of recombinant

polypeptides with post-translational modifications from complex mixtures using a

cation exchange medium

• WO2016070152A1 – Biogen: describes the use of supplements for cell culture

medium to support the expression of the polypeptide of interest in a large-scale

cell culture

• US20110046061A1 – Amunix: compositions comprising coagulation factor VII

linked XTEN (which in fusion with proteins prolongs its half-life), for treatment of

coagulation factor-related diseases. The patent hereby proposes an improvement

in hemostatic efficacy and stability of rFVII molecules in order to optimize the

dosing to bypass the rFVIII need and to treat patients that has developed

antibodies to FVIII

• subsequent patents include inventions related to improving in vivo stability of

rFVIII (prolonged half life) as well as the development of less immunogenic

peptides


Pub. Number Title Assignee Pub. Year

WO2016070152A1 Hypotaurine, gaba, beta-alanine, and choline for control of waste byproduct accumulation in mammalian cell

culture process

Biogen 2016

WO2015120056A1 Use of cation-exchange chromatography in the flow-through mode to enrich post-translational modifications Biogen 2015

US20110046061A1 Coagulation factor VII compositions and methods of making and using same Amunix 2011

US20100189682A1 Biologically active proteins having increased In Vivo and/or In Vitro stability Amunix 2010

US20050042721A1 Compositions and methods for enhanced expression of recombinant polypeptides from a single vector using a

peptide cleavage site

Biosante Pharm Inc | Cell

Genesys Inc

2005

WO2003087161A1 Modified Factor VIII Merck 2003

WO1998052976A1 Method for the production of non-immunogenic proteins Merck | Biovation LTD 1998

WO1999053038A2 Mutant proteins having lower allergenic response in humans and methods for constructing, identifying and

producing such proteins

Genencor INT 1999

WO1998059244A1 Identification of MHC Binding Peptides Eclagen ltd 1998

WO1997003195A1 Novel factor VIII:c polypeptide analogs with altered protease sites Chiron Corp. 1997

WO2002096454A1 Recombinant molecules with reduced immunogenicity, methods and intermediates for obtaining them and their

use in pharmaceutical compositions and diagnostic tools

Collen Res Found VZW 2002

WO2001040281A2 Method for reducing the immunogenicity of heterologous proteins by elimination of t-cell epitopes Thromb-X N.V. 2001

EP426913A1 Pharmaceutical composition and method for the suppression of factor VIII inhibitor production Baxter | Int Inst Cellular

Molecul Path

1991

WO2000074688A1 Methods for preventing formation of inhibitory antibodies in the setting of gene therapy Philadelphia Children

Hospital

2000

US6093392A Methods and compositions for use in gene therapy for treatment of hemophilia Philadelphia Children

Hospital

2000

US6071883A Flavone analogues useful as anti-rejection agents Chen, H et al. 2000

US6093567A Gene therapy for cystic fibrosis Genzyme Corp 2000

US5952221A Adeno-associated virus vectors comprising a first and second nucleic acid sequence Avigen INC 1999

US5698443A Tissue specific viral vectors Calydon INC 1997

Conclusions

• there has been a noticeable increase in patent publication during the last 20 years

• Baxter is a giant player (287 patent families, many of them in cooperation with Baxalta)

• Novo Nordisk is also an important player in rFVIII production and recently launched a new FDA

approved rFVIII named Novoeight® with more stability and less immunogenicity properties.

• This study highlights the importance of establishing partnerships in order to develop better and

new technologies

• Some regional cluster (in the European community) was also observed, evidencing the

importance of geographic proximity in establishing cooperation

• The development of conjugates forms of rFVIII seems to be very promising for future therapies

• The emerging technologies identified in this study, showed patents related to inventions dealing

specifically with two limitations, as well as some improvements in recombinant protein

production, expression, and purification from mammalian cells.

• The study hereby provides a valuable information to company’s’ R&D managers who can better

understand how technological developments are advancing and changing in their priority fields,

and thus prepare themselves to better face competitions.

• Na fase de planejamento de um projeto de P&D é fundamental entender o estado da arte da

tecnologia.

• Patentes são uma importante fonte de informação científica e tecnológica, mas que ainda são

pouco utilizadas no ambiente acadêmico.

• Análise de patentes podem contribuir para a identificação das rotas tecnológicas e de

tecnologias emergentes para direcionar um futuro investimento em P&D.

• O estudo de cooperação tecnológica pode contribuir para a identificação de parceiros em um

determinado tema e que estejam dispostos a cooperar no desenvolvimento de novas

tecnologias.

• entendam o fenômeno de mudança tecnológica....

Considerações finais

Geciane Porto (geciane @usp.br)

Cristiano Pereira ([email protected])

mailto:[email protected]

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