SUNNY WANG GLOBAL HEAD OF PATENT OPERATIONS 赛诺菲全球专利营运资深总监 SANOFI

Bio Patent Search in Assessment of FTO 确定自由使用权限中的生物专利检索查询

DISCLAIM

ER

Disclaimer

The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily his/her employer

(与我工作的单位无关）

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EXAMPLE

Pink Sheet

https://pink.pharmamedtechbi.com/PS118913/AbbVie-v-Amgen-Round-One-Humira-Biosimilar-Infringes-10-Patents-Suit-Claims

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安进的专利部门在开发这个Biosimilar之前做了什么？

https://pink.pharmamedtechbi.com/PS118913/AbbVie-v-Amgen-Round-One-Humira-Biosimilar-Infringes-10-Patents-Suit-Claimshttps://pink.pharmamedtechbi.com/PS118913/AbbVie-v-Amgen-Round-One-Humira-Biosimilar-Infringes-10-Patents-Suit-Claims

CO

NTEN

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Content Freedom To Operate (FTO) (自由使用权限）

Patent Search and Bio Patent Search （专利检索与生物专利检索）

Example of Bio Patent Search (举例）

Summary （总结）

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WHAT IS FTO

Freedom To Operate (FTO)

FTO Opinion or analysis: The ability to perform a particular commercial

activity without “infringing” 3rd party’s valid IP rights. （是否侵权）

FTO analysis tells the patent landscape in field (雷区布置） Patent search is first step （第一步)

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PATENT SEARCH （专利查询）

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PATEN

T SEARCH AND BIO SEARCH

Patent Search

A key step to solve any questions regarding patents （解决有关专利问题的第一步） It is not merely “searching patents” （不仅仅检索专利）

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PATEN

T SEARCH AND BIO SEARCH

Patent Search

Common Patent Search FTO/Clearance （自由实施法律分析） Patentability/Novelty (新颖性） Invalidation/Validation （使之无效/有效）

Other types: Patent Family Search （专利家族） Legal Status （法律状态） Ownership/Assignment （拥有人）

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PATEN

T SEARCH AND BIO SEARCH

Patent Search

FTO/Clearance search vs Patentability/Novelty search A four legged chair is invented: A five legged chair will be cited for a

patentability/novelty search because it discloses all features you have. A three legged chair will be cited for a

FTO/clearance search because you use all features other already claimed.

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BIO PATENT SEARCH （生物专利查询）

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BIO

LOG

ICS

Bio Patent Search -- Scope

Biologics include a wide range of macro molecules (生物大分子） Any process or platform or technologies related to biologics, such as phage display, adoptive cell transfer etc. （与生物大分子有关的方方面面）

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COVERAG

E

Bio Patent Search --Could be Any

Biologics Biology Biochemistry Biotechnology Bio-therapeutics Pharmacology ……

DNA: Oligonucleotide Nucleotide

RNA iRNA

Protein: Motif peptide Whole protein or

fragment

Antibody Specific CDR regions General IG

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DATABASES The BIOSCIENCE cluster consists of the following databases on STN:

ADISCTI ADISINSIGHT ADISNEWS AGRICOLA ANABSTR ANTE AQUALINE AQUASCI BIOENG BIOSIS BIOTECHABS BIOTECHDS BIOTECHNO CABA CAPLUS CEABA-VTB CIN CONFSCI CROPB CROPU DDFB DDFU DGENE DISSABS DRUGB DRUGMONOG DRUGMONOG2DRUGU EMBAL EMBASE ESBIOBASE FOMAD FOREGE FROSTI FSTA GENBANK HEALSAFE IFIPAT IMSDRUGNEWS IMSPRODUCT IMSRESEARCH OSMET LIFESCI MEDLINE NTIS NUTRACEUT OCEAN PASCAL PCTGEN PHAR PHARMAML PHIC PHIN PROMT PROUSDDR PS RDISCLOSURE SCISEARCH SYNTHLINE TOXCENTER USGENE USPAT2 USPATFULL USPATOLD VETB VETU WATER WPIDS WPIFV WPINDEX

EPfull PCTfull

Sequence databases:

CA Registry Dgene Genbank USgene PCTgen GenomeQuest

Bio Patent Search –Databases （数据库）

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Bio Vs Small Molecule Patent Search

Small molecules have distinct characterized chemical structures and low molecular weights

Biologics are large complex molecules with high molecular weight manufactured in a living system

Structure Search: 1. Background study 2. Structure search （结构检索） 3. Keyword search

Sequence Search: 1. Background study 2. Sequence search （序列检索） 3. Keyword search

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GEN

ERAL CON

SIDERATION

S

Bio Patent Search --General Considerations Searching biologics can be difficult and time-consuming

due to biologics’ complex structures and properties The patent owner of a biologic drug tends to file patent

applications aggressively to protect the drug. The patent family could be large containing hundreds of patent family members （一个专利家族上百个专利）

Not only are patents on composition of matter important, but patents on production methods or process of making are critical too （分子序列重要，但怎么提取也一样重要）

A patent owner continues to file new patents related to the drug product and technologies along the drug development process （不停地专利）

Multiple companies work on similar biologic molecule and file patents. As a result, multiple licenses from other patent owners likely are needed for developing and marketing a biologic drug （很多公司都发同一生物分子的专利）

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GEN

ERAL CON

SIDERATION

S

FTO on drug target: both DNA, protein, screen method and agonists and antagonists from the screening may all be considered （一个生物药，与它有关的什么都要查） FTO on DNA or Protein as drug: what is the cut off for

homology/similarity? 75%, 80% or 90%? Species? （序列可能不是百分百相同） For antibody as drug: very complicated structure and many variable domains; General antibody claim vs specific Design claim （抗体更复杂） Case by case only

Bio Patent Search –More Considerations

ENBREL AS EXAM

PLE

Bio Patent Search –Example （例子）

Enbrel, a trade name of etanercept is an FDA-approved drug to treat rheumatoid arthritis,

psoriasis, ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis. Enbrel is a fusion protein produced through expression of recombinant DNA that treats autoimmune diseases by interfering with the TNF receptor (a part of the immune system) by acting as a TNF inhibitor

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恩利

ENBREL AS EXAM

PLE

FTO Search on Enbrel –Background Study

Google (background study) NCBI Site (free to start with) Entrez Genebank OMIM

Other Good Free Sites, iHOP (information hyperlinked over protein)

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免费开始

http://www.ihop-net.org/UniPub/iHOP/

ENBREL

FTO Search on Enbrel –iHOP Info

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ENBREL AS EXAM

PLE

FTO Search on Enbrel –Search Strategy

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ENBREL

FTO Search on Enbrel --Keyword Search Keyword searching can find exact matches from text (either title, abstract, bibliographic information, specification or claims). The main considerations for keyword searching are:

Synonyms for a biologic including brand name and generic name For

example, tumor necrosis factor alpha-induced protein 1 (TNFAIP1) has the following synonyms: B12, B61, BTB/POZ domain-containing protein TNFAIP1, EDP1, MGC2317, protein B12 [18], etc. （关键词）

However, not all synonym names need to be searched for biosimilar searching. It requires a good understanding of bioscience and subject to decide what synonym should be included and what should not. A discussion with scientists in the field and patent attorney in charge of the project can be helpful. （不是所有的关键词都有用）

Spelling variations and truncated forms （不同的拼法）

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SEQU

ENCE SEARCH

FTO Search on Enbrel --Sequence Search

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SEQU

ENCE SEARCH

FTO Search on Enbrel --Sequence Search (2)

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SEQU

ENCE SEARCH

FTO Search on Enbrel -- Sequence Search (3)

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SEMAN

TIC SEARCH

FTO Search on Enbrel -- Semantic Search Semantic searching （ 语义检索） According to Wikipedia, ‘‘semantic search is a process

used to improve online searching by using data from semantic networks to disambiguate queries and web text in order to generate more relevant results”

It is broader than a keyword search but false hits are much higher For example, Enbrel semantic search on LexisNexis TotalPatent generates over 2000 hits. It not only includes Etanercept or human TNF receptor, etc. in the search but also includes other similar TNF drugs, such as Remicade/Infliximab, Lenercept, Humira, etc. in the search terms, which are not the fusion protein.

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OTHER CO

NSIDERATIO

NS

FTO Search on Enbrel --Post Search Processing All search results from different databases

should be combined for a full analysis before being reported to clients. Although the report should be structured to clients’ demands and focuses, the report for a biosimilar FTO should contain the following information （后处理很重要！）: Patents claiming composition. Patents claiming process of making, including vector

and cell lines. Patents claiming formulation. Patents claiming particular use (which clients are

interested in)

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Patent Search --Keep in Mind

FTO Search is not legal analysis （检索查询不是法律分析） Don’t Interpret for Attorneys （检索查询专家不是律师） If a search result is not complete, attorney can’t do a good job (精诚合作）

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http://www.sciencedirect.com/science/article/pii/S0172219010000414

http://www.sciencedirect.com/science/article/pii/S0172219010000414

Summary FTO patent search is an essential step to

understand “infringing” 3rd party’s valid IP rights or not. （自由使用专利检索查询很重要） Bio patent searching can be difficult and time-consuming due to biologics’ complex structures and properties （生物专利检索查询很复杂） Sequence searching combined with keyword

searching is a mainstream approach （序列与关键词是基本步） Post searching process is important to provide a

meaning search report （后期阅读筛选迈向优异） 29 Sunny Wang

THANK YO

U AND Q

UESTIO

NS

Thank you very much for your attention

Any questions?

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Sunny Wang��Global Head Of Patent Operations �赛诺菲全球专利营运资深总监� �SanofiDisclaimerExampleContentWhat is ftoPatent Search （专利查询）Patent search and bio searchPatent search and bio searchPatent search and bio searchBio Patent search （生物专利查询） BiologicscoverageDatabasesComparisons General considerations General considerationsEnbrel as exampleEnbrel as example Enbrel Enbrel as example Enbrel Sequence Search Sequence searchSequence searchSemantic searchOther considerations Slide Number 27Slide Number 28Slide Number 29Thank You and questions