Patentability of Biotechnological Inventions by INVESTIN

Patentability of Biotechnological Inventions The Polish Patent Office Approach

Ewa Waszkowska Examiner, Polish Patent Office BIOFORUM Łódź, 11-12.05.2011

Patentability of Biotechnological

Inventions The Polish Patent Office Approach Ewa Waszkowska, Ph.D., Examiner, Polish Patent Office BIOFORUM Łódź, 11-12.05.2011

Biotechnological inventions â&#x20AC;&#x201C; patentability criteria

Categories of biotechnological inventions

Practical aspects ď&#x201A;§3

Biotechnological inventions â&#x20AC;&#x201C; patentability criteria

Categories of biotechnological inventions Practical aspects

ď&#x201A;§4

Biotechnological inventions â&#x20AC;&#x201C; patentability criteria

Categories of biotechnological inventions Practical aspects

ď&#x201A;§5

Patentability criteria

Novelty (Art. 25 IP Law)

Invention (Art. 24, 28 IP Law)

Inventive step (Art. 26 IP Law)

Industrial applicability (Art. 27 IP Law)

Exclusions (Art. 29 IP Law)

Sufficiency of disclosure (Art. 33.1 IP Law)

Clarity of claims (Art. 33.3 IP Law)

Description support (Art. 33.3 IP Law)

6

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 7

What is a biotechnological invention?  biotechnological invention means the invention, concerning a product consisting of 

or containing biological material, or a process by means of which biological material



is produced, processed or used;

 biological material which is isolated from its natural environment or produced by means



of a technical process, even if it previously occurred in nature;

 biological material means any material containing genetic information and capable 

of reproducing itself or being reproduced in a biological system;

 elements isolated from the human body or otherwise produced by means of 

a technical process, including the sequence or partial sequence of a gene, even if



the structure of that element is identical to that of a natural element;

 plants or animals, if the technical feasibility of the invention is not confined to 

a particular plant or animal variety.

8

What is a biotechnological invention?  biotechnological invention means the invention, concerning a product consisting of 

or containing biological material, or a process by means of which biological material



is produced, processed or used;

 biological material which is isolated from its natural environment or produced by means



of a technical process, even if it previously occurred in nature;

 biological material means any material containing genetic information and capable 

of reproducing itself or being reproduced in a biological system;

 elements isolated from the human body or otherwise produced by means of 

a technical process, including the sequence or partial sequence of a gene, even if



the structure of that element is identical to that of a natural element;

 plants or animals, if the technical feasibility of the invention is not confined to 

a particular plant or animal variety.

9

What is a biotechnological invention?  biotechnological invention means the invention, concerning a product consisting of 

or containing biological material, or a process by means of which biological material



is produced, processed or used;

 biological material which is isolated from its natural environment or produced by means 

of a technical process, even if it previously occurred in nature;

 biological material means any material containing genetic information and capable 

of reproducing itself or being reproduced in a biological system;

 elements isolated from the human body or otherwise produced by means of



a technical process, including the sequence or partial sequence of a gene, even if



the structure of that element is identical to that of a natural element;

 plants or animals, if the technical feasibility of the invention is not confined to 

a particular plant or animal variety.

10

What is a biotechnological invention?  biotechnological invention means the invention, concerning a product consisting of 

or containing biological material, or a process by means of which biological material



is produced, processed or used;

 biological material which is isolated from its natural environment or produced by means 

of a technical process, even if it previously occurred in nature;

 biological material means any material containing genetic information and capable 

of reproducing itself or being reproduced in a biological system;

 elements isolated from the human body or otherwise produced by means of



a technical process, including the sequence or partial sequence of a gene, even if



the structure of that element is identical to that of a natural element;

 plants or animals, if the technical feasibility of the invention is not confined to 

a particular plant or animal variety.

11

What is a biotechnological invention?  biotechnological invention means the invention, concerning a product consisting of 

or containing biological material, or a process by means of which biological material



is produced, processed or used;

 biological material which is isolated from its natural environment or produced by means 

of a technical process, even if it previously occurred in nature;

 biological material means any material containing genetic information and capable



of reproducing itself or being reproduced in a biological system;

 elements isolated from the human body or otherwise produced by means of 

a technical process, including the sequence or partial sequence of a gene, even if



the structure of that element is identical to that of a natural element;

 plants or animals, if the technical feasibility of the invention is not confined to 

a particular plant or animal variety.

12

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 13

Exclusions from patentability (1) The following shall not be regarded as inventions: 

discoveries, scientific theories and mathematical methods



aesthetic creations



schemes, rules, and methods for performing mental acts, doing business or playing games



creations, which incapability of exploitation may be proved under the generally accepted and recognized principles of science



computer programs



information presentations 14

Exclusions from patentability (2) What is not technical ? Examples Methods proceeding only in silico (Art. 24 IP Law) Method of design a compound imitating 3-dimensional structure IGF-1, characterized that comprises following steps: a) defining 3-dimensional structure IGF-1; i b) designing a compound 3-dimensional structure surface of IGF-1. Invention concerning information presentations (Art. 28. 6 IP Law) Presentation of the 3-dimensional structure of a protein RGS using structural coordinates of the core protein RGS. The human body and the simple discovery of one of its elements, including the sequence or partial sequence of a gene (Art. 933 .1 IP Law) Organism containing nucleic acid coding the protein fusion comprising IL-15 and fragment FC. ď&#x201A;§15

Exclusions from patentability (3) Plant or animal varieties or essentially biological processes for the production of plants or animals (Art. 29. 1. 2 IP Law) e.g. new maize variety mv222, comprising recombinant DNA coding X protein Methods for treatment of the human or animal body by surgery, therapy, or diagnostic methods applied on human or animal bodies (Art. 29. 1.3 IP Law)

! this provision shall not apply to products, and in particular to substances or compositions applied in diagnostics or treatment

ď&#x201A;§16

Exclusions from patentability (4) The following, in particular, shall be considered as biotechnological inventions, whose exploitation would be contrary to public order or morality: (i) processes for cloning human beings, (ii) processes for modifying the germ line genetic identity of human beings, (iii) uses of human embryos for industrial or commercial purposes, e.g. inventions involving hESC (iv) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. ď&#x201A;§17

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 18

Novelty An invention shall be considered to be new if it does not form part of the state of the art (Art. 25 IP Law) written forms (e.g. publications,

monographies, posters)

many other

ways

STATE OF

THE ART

Filing date

by use

(e.g. internet)

oral forms (e.g. lectures)

19

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 20

Inventive step An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art (Art. 26 IP Law) Invention has an inventive step if fulfill at least one of these conditions: 

it is surprising for the person skilled in the art



it solves a problem which was undertaken without success by specialists



it satisfies a long standing social requirement



it leads to evident efficiency improvement



it breaks through existing technical prejudices



it permits obtaining a particular effect

21

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law)

Description support (Art. 33.3 IP law) 22

Industrial applicability An invention shall be considered as susceptible of industrial application, if by means of that invention a product may be produced or a process may be used, in a technical sense, in any kind of industry, including in agriculture (Art. 27 IP Law)

Industrial character excludes the possibility of granting some inventions used personally and privately, e.g.: contraception methods methods of treatment for humans and animals hair washing methods

ď&#x201A;§23

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law)

Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 24

Disclosure of invention Patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art Inventionâ&#x20AC;&#x2122;s examples method producing of biological material and its characteristic (biological functions) Disclosure of new genes gene sequence (list of sequences) its biological function (protein) commercial usefulness Deposit of biological material

! It is impossible to correct lack of disclosure of invention in the same application

ď&#x201A;§25

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law)

Description support (Art. 33.3 IP law) 26

Clarity of claims Patent claims – the most important part of a patent application  define the matter for which protection is sought  base for examination Requirements: 

unambiguous range of protection – without doubts



technical features – all essential for reproducing technical features



clarity and conciseness – for comparison with the state of the art 27

Patentability criteria Invention (Art. 24, 28 IP law) Exclusions (Art. 29 IP law)

Novelty (Art. 25 IP law) Inventive step (Art. 26 IP law) Industrial applicability (Art.27 IP law) Sufficiency of disclosure (Art. 33.1 IP

law) Clarity of claims (Art. 33.3 IP law) Description support (Art. 33.3 IP law) 28

Description support  The patent claims shall be entirely supported by the

description.

 Technical data proving the sought range of protection.

 Pharmacological and/or biological data that prove the

effectiveness of a drug.

29

Practical aspects

30

Categories of inventions (1)

Patents protect technical inventions An invention

PRODUCT

PROCESS

USE

APPARATUS

31

Categories of inventions (2) PRODUCT 

polynucleotides, gens, constructs, promoters,

 probs, vectors, plasmids  polypeptides, proteins, enzymes, antibodies  cells, microorganisms, plants, animals  pharmaceutical compositions, vaccines,  diagnostic kits

METHOD USE  medical  other purposes

   

producing screening diagnostic in vitro product by process

32

Patent Application Description

Claims

Sequence listing

Figures 33

Gens and DNA Nucleotide sequences Isolated nucleic acid containing nucleotide sequence encoding polypeptide that shows

the immunogenic activity and selected from the group of: a) a nucleotide sequence of SEQ ID NOS: 1, 3 or 9; b) nucleotide sequence having at least 80% sequence identity to SEQ ID NOS: 1, 3 or 9

wherein said nucleotide sequence encodes the polypeptide having immunogenic activity. Modifications–mutations

An isolated polynucleotide comprising a coding region of ABCG2 gene, containing Tyr581Ser mutation. Deposits A nucleotide sequence comprising the plant promoter sequence comprised in Deposit No.

NRRL B-50159.

34

Proteins Amino acid sequences, modifications 

A modified xylanase polypeptide, wherein the modification is at amino acid residue number 78 of the amino acid sequence depicted

by SEQ ID NO. 3, wherein said modified xylanase polypeptide is inactive yet retains its ability to bind to xylanase inhibitors.

Fusion proteins 

A fusion protein comprising



(a) a Caspase domain or a functionally active variant thereof and



(b) a ligand binding domain of a nuclear hormone receptor or a functionally active variant thereof.

35

ď&#x201A;§Antibodies Aminoacid sequences An isolated D2/B monoclonal antibody binding prostate specific membrane antigen (PSMA) characterized by comprising the nucleotide sequence of the variable regions VH and VL of SEQ ID NO: 1 and 2.

Deposits Monoclonal antibody 13D8 against hepatitis E virus, secreted by the hybridroma cell line deposited with the IDAC as accession number 29050701.

New, identified antigen recognized by this antibody An antibody which binds to the Apo-2DcR polypeptide comprising amino acid residues from 1 to 259 of Fig. 1A.

ď&#x201A;§36

Plants



A glyphosate tolerant plant having stably incorporated into its genome a DNA construct comprising at least one nucleotide

sequence selected from the group consisting of : SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6.

37

Uses / methods (1) A pharmaceutical composition for treatment of Parkinson's disease consisting of R(+)-N-propargyl-1-aminoindan and a pharmaceutically acceptable carrier. **************

An HCV vaccine comprising a polynucleotide that encodes the polypeptide sequences of the HCV proteins: core, ΝS3, NS4B and NS5B, for use in medicine. **************

A kit for the diagnosis of retinopathy comprising: a sterile container containing a recombinant gene delivery vector adapted for expression of a GDNF polypeptide in an eye of the subject.

38

Uses / methods (2) 

An in vitro method for the diagnosis of multiple sclerosis comprising the steps of: (a) providing a biological sample; (b) measuring the expression level of the human protein tyrosine phosphatase  gene (PAC-1) in the biological sample.  

**************

Use of IFN-β for the manufacture of a pharmaceutical combination preparation for use in a method of treating a disease caused by Herpes- viridae.

39

ď&#x201A;§Example 1. A polypeptide selected from the group consisting of SEQ ID NO : 1, SEQ ID NO : 2, SEQ ID NO: 3, SEQ ID NO: 4 and SEQ ID NO : 5. 2. A nucleic acid encoding a polypeptide according to claim 1. 3. A vector comprising the nucleic acid according to claim 2. 4. A host cell comprising the nucleic acid according to claim 2 or comprising the vector according to claim 3. 5. A method of producing the polypeptide according to claim 1 comprising the steps of (a) culturing the host cell according to claim 4; and (b) recovering the polypeptide from the host cell or culture medium. 6. A method of producing an antibody comprising the steps of: (a) immunizing a host with a polypeptide according to claim 1 or a host cell according to claim 4; and (b) recovering the antibody. 7. An antibody or an antigen-binding fragment thereof that specifically binds to a polypeptide according to claim 1. 8. A hybridoma cell line selected from the group consisting of: HB 7E11 (ATCC accession No. PTA-4587), HB 1H2 (ATCC accession No. PTA-4584).

ď&#x201A;§40

A scheme of gene therapy What can be protected by

patent(s)?

41

A scheme of gene therapy What can be protected by

patent(s)?



 

  

42

Gene Promoter Vector (virus) Use Method in vitro ? Kit

ď&#x201A;§Domestic bio-tech patent applications

in 2004 - 2009 100 90 80 70 60 50 40 30 20 10 0

66 44

2004 2005 2006 2007 2008 2009 ď&#x201A;§43

Industrial Property Law (IP Law)

Laws necessary for examining the biotechnological

inventions: 

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions



Polish Industrial Property Law (2000)



Inventor's Guides - Patent and utility model specifications rules and tips (2005-2006)  Budapest Treaty (1977)

44

Industrial Property Law (IP Law) Laws necessary for examining the biotechnological

inventions: 

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions



Polish Industrial Property Law (2000)



Inventor's Guides - Patent and utility model specifications rules and tips (2005-2006)  Budapest Treaty (1977)

45

Industrial Property Law (IP Law) Laws necessary for examining the biotechnological

inventions: 

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions



Polish Industrial Property Law (2000)



Inventor's Guides - Patent and utility model specifications rules and tips (2005-2006)



Budapest Treaty (1977) 46

Industrial Property Law (IP Law)

Laws necessary for examining the biotechnological

inventions: 

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions



Polish Industrial Property Law (2000)



Inventor's Guides - Patent and utility model specifications rules and tips (2005-2006)



Budapest Treaty (1977) 47

Thank you for your attention !

Ewa Waszkowska Ph.D. ewaszkowska@uprp.pl www.uprp.pl

48

INVESTIN Sp. z o.o. Ul. Koszykowa 59/8 00-660 Warszawa Tel. 22 835 77 33, Fax. 22 205 08 85