main aspects in procedures of patent acquiring with emphasis on pharmaceuticals tihomir dragun...

Main aspects in procedures of patent acquiring with emphasis on pharmaceuticals

Tihomir Dragun

Zagreb; February 20, 2007

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Topics of discussion

Search techniques

Claim drafting: 1. Introduction

2. Scope of the claim

3. Drafting strategy

Patentability in the chemical/pharmaceutical filed: 1. Introduction

2. Novelty

3. Inventiveness

4. Specific inventions

Search techniques

After inventor has recognized technical problem, and after he has anticipated technical solution of that particular problem.

Search should be repeated after invention has been done.

Every searchable databases enables search by key terms and/or by

International patent classification (IPC)

Search techniques

Before caring out the search searcher should compile list of the all possible search terms, following by list of the synonyms for the each key term.

When caring out the search logic operator OR is applied between

synonyms, and logic operator AND is applied between different key terms.

Before search execution it is advisable to make a table where in

columns synonyms are listed and in rows different key terms.

Classification is used only for improvement reliability, where number of the documents retrieved by search based on key terms combinations are to small.

Search techniques

Useful web sites:

http://ep.espacenet.com/advancedSearch?locale=en_EP

http://www.uspto.gov/patft/

http://chem2.sis.nih.gov/chemidplus/chemidlite.jsp

http://www.fda.gov/cder/ob/

Search techniques

CASE STUDY

EP 1 069 651

Search techniques

CONCEPT 1 CONCEPT 2 CONCEPT 3

Metal terminal Electrical circuit Resilient

Contact Printed wired board Deformable

Pin Substrate Elastic

Needle eye Printed circuit bord PCB

borne Printed wired board PWB

Serarch techniques

AND AND AND

CONCEPT 1 CONCEPT 2 CONCEPT 3

OR OR OR

OR OR OR

OR OR OR

Search techniques

Features D1=GB2245770 D2=US4676579

Claim 1 Metal terminal (10) Claim 16; fig. 3,3A Fig 2, 3A, 3B

Contact hole (H) of an el. Circuit substrate (P)

Fig 3 Fig3A, 3B

Stop member (13) Fig3, 3A ________________

Removal prevention portion (15)

Abstract; fig. 3,3A Fig 3A,3B

Resiliently deformable


Claim 2 Pair of laterally spaced resiliently deformable locking member (16)


Search techniques


Claim 3 opposite outer surface (16U) inclined

Fig 3, 3A, 4 Fig 3A,3B

Mutually taper Fig 3,4 Fig 3A,3B

Urge the terminal Fig. 3,4 Fig 3A,3B

Claim 4 Pair of laterally spaced resilently deformable contact member (14)

_______________ Fig 3A

Claim 5 Contact member connected to locking member

_______________ Fig 3A, 3B

Search techniques


Claim 6 El. Circuit substrate (P)

Fig 3, 3A Fig 3A, 3B

At least one contact hole (H)

Fig 3, 3A Fig 3A, 3B

Metal terminal (10) Fig 3, 3A Fig 3A, 3B

Claim 7 Bears resiliently on an outer surface of the substrate (P)

Fig 3 Fig 3B

Search techniques

Other types of searches

Patent family search

Freedom to operate search

Patent equivalent search

Claim drafting

Introduction

Scope of the claims

Types of claims

Drafting strategy

Parts of patent application

1. Title of the invention

2. Description of the invention

3. Claims

4. Abstract

5. Drawings

6. List of sequences

Parts of description of the invention

1. technical area

2. technical problem

3. technical solution

4. review of drawings

5. Disclosure of embodiments of the invention

6. Industrial applicability

Claims

In principle, claims consists of three parts:

1. a preamble

2. a transition term

3. a body

Preamble

An image processing device…

A printer…

A method of processing metal powders…

A cleaning fluid…

Tip: To minimize confusion as to the scope of a claim, avoid using limiting terms and phrases in the preamble. Do not assume that terms or phrases in the preamble will not be construed as claim limitations.

Transitional phrase

Open ended

Closed ended

…, said device comprising:…

…, said method comprising the steps of:…

…, which comprises:…

…, said apparatus including:…

…, said processor containing:…

…, said server characterized by…

…, said fluid consisting of:…

…, said process consisting of…

Body of a claims

The body of the claim sets forth what invention covers and should be a clear technical description of what others are excluded from practicing.

Usually the body recites a list of elements/steps in combination, with elements/steps separated with semi-colons (;).

Elements recited in the claim must be supported by the description of the

invention as originally filed including drawings and/or sequence listing.

Negative limitation is permissible and can be used to define what the

invention excludes. This may be done to provide novelty over prior art.

Scope of the claims

First “Law” of Claim Scope

The claim scope encopasses all the technical subject matter covered by the claim and excludes everything else

Second “Law” of Claim Scope

The technical subject matter covered by a claim is determined by the claim wording

Scope of the claim

Excercise on claim scope

Claim scope

Claim 1: A geometrical device comprising three sides connected together at equal angles.

Claim 2: A geometrical device comprising three sides of equal length.

Claim 3: A geometrical device comprising three sides at least two of which are of equal length.

Claim 4: A geometrical device consisting of three sides at least two of which are of equal length.

Claim 5: A geometrical device consisting of three sides connected so that the sum of the angles between the adjacent pairs of sides is 180°.

Claim 6: A geometrical device comprising three sides of equal length connected at equal angles.

Claim 7: A geometrical device consisting of three sides of equal length connected at equal angles to one another.

Which of the following “geometrical devices” are included within the scope of claims 1 to 7? Answer “yes”, “no”, “?”

Claim 1 Yes Yes? No? No Yes

Claim 2 Yes Yes No No No

Claim 3 Yes Yes Yes No Yes

Claim 4 No No Yes No No

Claim 5 No No Yes Yes No

Claim 6 Yes No? No No No

Claim 7 No No No No No

Scope of the claim

Excercise: European patent application has been filed. Meantime, prior art B to F has been found. Answer which

claims are novel/lack of novelty

Scope of the claim

Prior art B: Compound A made by process P (P is not M) is known for the treatment of dogs with distemper.

Prior art C: Compound A mixed with another compound D is known as toothpaste wherein A is active ingredient to prevent gingivitis. Compound A is made by process M.

Prior art D: Compound A made by process P is known for immunostimulation of racing horses.

Prior art E: Compound A, made by method M, alone or mixed with usual herbicidal carriers, is known as weed killer.

Prior art F: Compound A produced by process P is known as a lipstick ingredient.

Scope of the claims

CLAIMS B C D E F

1. Compound A x x x x x

2. Compound A for its use in therapeutic treatment of the human or animal body x x x + +

3. Compound A for treatment of gingivitis x x x + +

4. Use of compound A for imunostimulation of pigs + + + + +

5. Use of compound A for the manufacture of a medicament for treatment of gingivitis

+ x + + +

6. Use of compound A for the manufacture of a medicament for immunostimulation of pigs

+ + + + +

7. Use of compound A as herbicide + + + x +

8. Compound A for its use as herbicide x x x x x

9. A herbicidal composition containing compound A as active ingredient + + + x +

10. Use of compound A for the cosmetic treatment of baldness + + + + +

11. A method M for producing compound A + x + x +

12. Compound A obtainable by method M x x x x x

13. A catalyst composed of compound A with 0-5% of another catalyst Z x x x x x

Types of claims

Claims could be divided by the subject matter for which protection is sought on:

1. 1. process claim,

2. 2. article claim (including article of manufacture, machines, compositions of matter), and

3. product by process claim

Claims are divided on:

1. Independent claims

2. Dependant claims

Exercise

Draft claims which cover a rugby goal post structure and a football goal post structure and then differentiate them one from another

Exercise

Objects of exercise:

Identify and develop technical features

Explore different terminology

Develop ways of making differentiations

Try wording (positive or negative limitations) to claim what is wanted and exclude or disclaim what is not wanted

Relate visual representations with claim wording (make drawings of what is covered by your claims)

Exercise

Technical features:

The structural components (uprights, cross-bar)

The number of components (2 uprights, 1 cross-bar)

Relationship of structure to environment (uprights perpendicular to field/ground; cross-bar horizontal and above the ground)

Relationship of structural parts to one another (cross-bar connects the uprights; cross-bar at the top of or mid-way/par-way along the upright)

Relative dimension of the parts (uprights longer than/shorter than the cross-bar; the uprights are of equal length)

Functional features: ball passage zone or ball throughput zone/area/opening or scoring zone

Rigidity; fixed connection; planarity

Shape (H shape or inverted U shape)

Exercise

Terminology

Goal post, ball passage structure, ball-game scoring structure,…

Uprights, post, vertical post,…

Cross-bar, horizontal bar, horizontal connector element,…

Ground, field, substantially horizontal supporting surface,…

Ball throughput zone, ball passage area, scoring passage, opening for the passage of objects

Exercise

Differentiation

Common features

Two spaced apart uprights

A horizontal cross-bar supported above the ground

Ball throughput zone (ball passage area) defined between the uprights and cross-bar

Exercise

Differentiation

Differentiation features:

Football Goal post

The cross bar is connected to the top of the uprights

The uprights are shorter than the cross-bar

The uprights do not protrude above the cross-bar

The ball throughput zone (ball pasage area) is entirely under cross-bar

Inverted U shape

Exercise

Differentiation

Differentiation features:

Rugby Goal post

The uprights protrude above cross-bar

There is a ball throughput zone above crossbar

The uprights are longer than the cross-bar

The upper part of the uprights is also longer than the cross-bar

The cross-bar is mid-way/just under the mid way up the uprights

H-shape

Exercise

Examples

Claim 1

A ball-passage structure comprising two spaced-apart uprights connected by a horizontal cross-bar, the uprights and the cross-bar defining there between a ball-passage area

Exercise

Notes on claim 1:

Claim 1 is generic claim covering a football post and a rugby post and various other ball passage structures. It can be used as the precharacterising part of subclaims for a football goalpost (claim 2) or a rugby goalpost (claim 3)

The word “comprising” opens the definition to include a structure with three or more uprights and two or more cross-bars. Because the manner of connection is not specified, the claim does not clearly exclude (therefore covers) a “temporary” structure like a cricket wicket.

The claim does not specify if the connection is rigid. Movable connection are covered, like high jump bar. It also covers door or window frame.

The claim’s open wording leaves it vulnerable to objections of this type.

Exercise

Examples

Claim 2

A ball passage structure comprising two spaced-apart uprights connected by a horizontal cross-bar, the uprights and the cross-bar defining there between a ball-passage area, characterised in that the two uprights are connected at their upper ends by the cross-bar

Exercise

Notes on claim 2:

Claim 2 covers a football goalpost.

It also covers door or window frame. The cricket wicket is still claimed.

The word horizontal combined with the definition of connection at the top ends implies that two uprights are of equal lenght, unless the field is inclined. (If equal length of the uprights is to be specified explicitly, this should go in the precharacterising part).

By positively claiming that the cross bar is connected to the upper ends of the uprights, this disclaims that the uprights can be extended above the cross bar. Claim 2 therefore excludes (disclaims) the rugby goalpost.

Exercise

Example

Claim 3

A ball passage structure comprising two-spaced-apart uprights connected by a horizontal cross-bar, the uprights and the cross-bar defining there between a ball-passage area, characterised in that the uprights extend above the cross-bar to define there between and above the cross-bar a ball passage area open at its top end.

Exercise

Notes on claim 3:

Claim 3 covers rugby post.

It also covers high jump bar.

By positively stating that the uprights extend above the crossbar, this disclaims that cross bar can be connected on top of the uprights. Therefore claim 3 exclude football goalpost as well as cricket wicket and most door frames.

The functional definition of the ball passage area is intended to disclaim embodiments in which the uprights only extend above the cross bar by a slight amount.

The open wording of claim 3 leaves it vulnerable.

Exercise

Example

Claim 4

A scoring post structure of a substantially horizontal game playing area, the structure consisting of two equal spaced apart uprights connected by a horizontal cross bar above horizontal playing area, the uprights and the cross bar defining there between a ball passage structure, characterised in that the two uprights are rigidly connected at their upper ends by the cross bar and wherein the uprights are shorter than the cross bar

Excercise

Notes on claim 4:

Claim 4 covers the football goalpost structure.

“A scoring post structure of a substantially horizontal game playing area” is intended to exclude door or window frames etc, but without limiting to football. The claim includes structures such for waterpolo and ice hockey.

Rigid connection differentiates over a cricket wicket or high-jump post and like structures. But the “rigid” connection is common with the known rugby post. Therefore “rigid” should be in the precharacterising part.

By saying that scoring post structure consists of two uprights and a horizontal bar, this rules out structures with three uprights and/or two cross-bars, but does not exclude fitting of accessories like net.

Real life example for importance of claim scope

Epilady

Improver corporation patented a depilatory device – Epilady – having a curved rotating helical spring.

Remington brought out a similar device where the helical spring was replaced by a grooved plastic cylinder in which the grooves did not go all the way around the circumference.

Patent infringement suits and requests for injuction were filed in several countries with different resuls, depending on whether the grooved cylinder was considered to be a technical equivalent with the claim scope, or whether the claim protection was limited to a helical spring.

At the point where litigation was settled, the patent was held to be infringed in Germany, but in the UK the patent was held not to be infringed.


Epilady – EP 101 656

Claim 1: An electrically powered depilatory device comprising:

a hand held portable housing (2);

motor means (4,4’) disposed in said houses; and

A helical spring (24) comprising a plurality of adjacent windings arranged to be driven by said motor means in rotational sliding motion relative to skin bearing hair to be removed,

Said helical spring (24) including an actuate hair engaging portion arranged to define a convex side whereat the windings are spread apart and concave side corresponding thereto whereat the windings are pressed together,

The rotational motion of the helical spring (24) producing continuous motion of the windings from a spread apart orientation at the convex side to a pressed together orientation on the concave side and for the engagement and plucking of hair from the skin of the subject, whereby the surface velocities of the windings relative to the skin greatly exceed the surface velocity of the housing relative thereto.


Remington EP 290 119

Claim 1: A depilatory device for removing body hair, comprising: a manually-grippable housing (2;102), and a flexible hair plucker body (4;104) of cylindrical contour mounted for rotation about its longitudinal axis to the housing (2;102); said hair plucker body (4;104) being supported with its longitudinal axis disposed arcuately and having an exposed section with a plurality of gaps (20;120) in its outer surface which during the rotation of the hair-plucker body (4;104) and its movement over a surface from which hair is to be removed, are open at the convex side of said section to receive the hairs in the gaps (20;120) and are closed at the concave side to catch, pluck out and then eject the hairs, characterised in that the hair plucker body (4;104) is a cylindrical member of plastic material having a smooth outer surface; and in that said gaps are defined by a plurality of slits penetrating only partially through, and extending circumferentially of, the hair plucker body (4;104).

Note how claim features have been redistributed to properly acknowledge Epilady in the preamble.

Specific types of claims

(1) Means-plus-function claim

(2) Swiss type of claim


Means-plus-function claim

Elements recited in means-plus function language are restricted to the structure disclosed in the description of the invention for performing the function under consideration and its equivalents that existed at the time of the invention.

Example:

…means for connecting said server to the network;…

…means for moving said arm from the first position to a second position;…

…means for mixing the combined materials;…



Although, means-plus-function type of claims was considered as broadest claim providing very broad scope of protection, in now days there are serious negative connotation:

This kind of claim may be objected to by an examiner or held invalid by a court as lacking proper support in a description which may identify only a specific means;

May allow an examiner or court to use any prior art element which could have performed the stated function to invalidate the claim;

May be subject to rejection as attempting "to define the invention by a result to be achieved - particularly if it amounts to claiming the underlying technical problem."



To avoid these disadvantages of means-plus-function, the following steps should be taken where appropriate:

include in the description a variety of alternatives for any element claimed in means-plus-function language

name the means with a generic yet not unduly limiting name (e.g., "a detector") as this may tend to limit the likelihood of an examiner or court going far for invalidating art.


Swiss type of claim

If protection is directed to the second medical indication for the known product, according to the decisions of Enlarged Board of Appeal G1/83, G5/83 and G6/83 wording of the claim has to be in special form. Claims drafted according to the cited decisions are known as "Swiss types of claims".

Example: Use of the substance X for the manufacture of the drug for treatment of disease Y

More about Swiss type of claim in the following slides

Drafting strategy

DISCLOSURE IN THE SPECIFICATION

General disclosure

Preferred embodiments (fall-back positions)

Specific examples

Purpose:

Enabling restrictions in various ways, thereby avoiding various limitations

Supporting broad claims by specification

Providing enabling disclosure

Creating prior art for other parties

Preventing selection inventions of other parties

Drafting strategy

CLAIMS AND SPECIFICATION

I. General strategy

1. General disclosure

general formula, general term or range as broad as possible

2. Preferred embodiments (fall-back positions)

preferred, more preferred embodiments

(residues of general formulae, general terms or ranges)

3. Specific examples in specification:

experimental details

Drafting strategy - example

R1

R2

claims description

Claim 1 R1=halogen R2=hydrocarbon General disclosure: R1=halogen; halogen=F, Cl, Br, J; R2=hydrocarbon; hydrocarbon=straight chain or branched chain C1-C10 alkyl, C2-C10 alkenyl, C2-C10

alkinyl

Subclaim 2: R1 and R2 in p-position R1 and R2 may be in o-, m-, p- position; preferred – R1 and R2 in p-position

Subclaim 3: R1=Cl, Br or J; R2=alkyl Preferred: R1=Cl, Br, J; R2=alkyl

Subclaim 4: R1=Cl or Br; R2=lower alkyl More preferred: R1=Cl or Br; R2=lower alkyl, lower alkyl is C1-C6 alkyl

Subclaim 5: R1=Cl; R2=C1-C3 alkyl Most preferred: R1=Cl; R2= C1-C3 alkyl;

specific example:

Drafting strategy - example

Specific terms in claims:

Broad terms, unknown terms or terms with various meanings:

- technical definition in specification

Physical parameters:

- measuring method or reference thereto in specification

Purpose: preventing clarity or novelty objections

Drafting strategy

Functional terms in claims:

Only allowable in case where a definition by technical terms is not possible or where it is only possible to use technical terms which unduly restrict the scope of the claims.

Sufficient examples in specification.

Purpose: preventing clarity or novelty objection

Drafting strategy – exercise I

Draft claims to protect new product on the picture.

Patentability in the field of pharmaceutics

Introduction

Novelty issues

Inventive step issues

Specific types of invention

What kind of pharmaceutical invention can be protected by patents?

Patent protection

Novel productFirst use in the medical field for

a known product

Second medical indication for a known product

Novelty

Guidelines C-IV, 7.2

“A document takes away the novelty of any claimed subject-matter derivable directly and unambiguously from that document, including any features implicit to a person skilled in the art in what is expressly mentioned.”

Example:

Application claim: chemical product X

Prior art: Disclosure that enables person skilled in the art, using common general knowledge, to make or separate the product, without being explicitly mentioned

Claim not novel

Novel product

If the product per se is novel over the prior art than the product per se can be claimed.

This leads to broadest protection possible, including protection of all known and unknown applications of said product.

Specific chemical compounds/generic formulae

The disclosure of a specific examples takes away the novelty of a generic claim embracing that specific example, but

The disclosure of a generic term does not usually take away the novelty of a specific example.

Example:

1. Lower alkyl does not destroy the novelty of C2H5

2. A list of mentioned chemical compounds destroys novelty of every member of the list, provided it can be prepared and separated.

e.g. list contains the members: Ph-CH3, Ph-C2H5, Ph-

iC3H7, Ph-nC3H7 destroys novelty of Ph-C2H5

Novelty test

N

COOH

N

R1

R2

Is compound from the first box novel in view of prior art?

D1

R1= R2=

COOH Cl

NH2 SO3H

. .

. .

. .

Phenyl C3H7

D2

R1= R2=

COOH Cl

SO3H

.

.

.

C3H7

Novelty test

Choosing one single alternative from a list of alternatives disclosed for one substituent in the prior art document is not sufficient to confer novelty on a specific compound. The choice would be new if it were made from at least two lists of some length of alternatives disclosed for at least two different substituents.

Novelty – specific examples

Comprising/consisting of

Application: A tablet comprising aspirin, lactose and magnesium stearate.

Prior art: A tablet comprising aspirin, lactose, talc, cellulose and magnesium stearate

Application: A tablet consisting of aspirin, lactose, and magnesium stearate

Prior art: A tablet comprising aspirin, lactose, talc, cellulose and magnesium stearate


For/suitable for

Example:

Application: A composition comprising tamoxifen and lactose for nasal administration

Prior art D1: A lyophilized composition of tamoxifen and lactose for injection

Prior art D2: A coated tablet comprising tamoxifen and lactose


For/suitable for

Example:

Application: A composition comprising nifedipine for intravenous administration

Prior art D1: A topical solution comprising nifedipine

Prior art D2: A gargling solution comprising nifedipine

Prior art D3: A solution of nifedipine for subcutaneous administration


For/suitable for

Example:

Application: A topical cream comprising vitamin E, an oil and a surfactant

Prior art D1: A margarine omprising vitamin E, oils and surfactants


Example:

Application: A composition for treting inflammatory conditions comprising salicilic acid and ascorbic acid

Prior art D1: A composition for preservation of jam comprising ascorbic acid and salicilic acid

Prior art D2: A composition comprising salicilic acid and ascorbic acid for treating the pain


Implicit disclosure

Example:

Application: A sterile and apyrogenic parenteral composition comprising taxol and cremophor

Prior art D1: An injectable composition comprising taxol and cremophor. There is no mention of the sterility or the apyrogenicity


Example:

Application: A tablet comprising diltiazem, CMC sodium as disintegrating agent, HPC as binding agent, and talc as lubricant

Prior art D1: A tablet comprising diltiazem and a disintegrating agent, a binding agent and a lubricant

Generic/specific disclosure


Example:

Application: A tablet comprising diltiaze and disintegrating agent, a binding agent and a lubricant

Prior art D1: A tablet comprising diltiazem, CMC sodium, HPC, and talc

Generic/specific disclosure


Functional features

Example:

Application: A buccal tablet comprising Cox-2 inhibitor and lactose. The preferred compounds mentioned in the description are the “coxib” molecules: celecoxib, valdecoxib, rafecoxib

Prior art D1: A buccal tablet comprising nimesulide and lactose

Prior art D2: a buccal tablet comprising meloxicam and lactose

Prior art D3: A buccal tablet comprising diclofenac and lactose


Use, method and process claims

Example:

Application: Use of a copolymer of methacrylic acid and methacrylate (Eudragit L) as a disintegrating agent in tablets

Prior art D1: Eudragit L as an gastroprotective agent in tablets


Use, method and process claim

Example:

Application: Use of sildenafil citrate for the manufacture of a nasal powder for the treatment of erectile dysfunction by nasal administration

Prior art D1: A tablet of sildenafil citrate for treating erectile disfunction

Novelty - specific examples

Use, method and process claim

Example:

Application: Use of compound of formula (I) to stabilize a composition against light degradation

Prior art D1: A composition comprising the compound of formula (I). The use as stabilizer is not disclosed in D1, but the composition is said to be stable against the degradation by light

Amendments

Legal basis: A 123(2) EPC

A European patent application or a European patent may not be amended in such way that it contains subject-matter which extends beyond the content of the application as filed

Raison d’etre of Article 123(2) EPC

An applicant should not be allowed to improve his position during the examination procedure by adding subject matter not disclosed in the application as filed thus giving him an unwarranted advantage and posibly being detrimental to the legal security of third parties relying on the contents of the pplication as filed (G1/93).

Same principle when the amendment results in a limitation of the scope of the claims:

•By addition of a technical feature, or

•By deletion of originally disclosed meanings from the definition of symbols of a generic formula standing for a class of chemical compounds.

To which degree deletions from the list of meanings for various substitutents are admissible: depends on specific case

Amendments – T0615/95

N

R1

R2 R3

OR4

R5

R6

R7

R8

Original claim 1:

An acridinium ester of formula (I) wherein:

R4 and R8 independently represent hydrogen, alkyl, alkenyl, alkynyl, aralkyl or alkoxy;

R6 represents Q-R-Nu, Q-R(I)-Nu or Q-Nu

Amendments – T0615/95

Amended claim 1:

An acridium ester of formula (I) wherein:

R4 and R8 independently represent hydrogenhydrogen, alkyl, alkenyl, alkynyl, aralkyl or alkoxyl;

No basis in application as filed

R6 represents Q-R-Nu, Q-R(I)-Nu or Q-Nu provided that when R6 represents Q-Nu, Nu represents other than hydroxyl

Insertion of a disclaimer for R6

Amendments – T0615/95 and T0288/92

BoA found claims as amended permissible, because new claim did not generate another invention. Same general formula can be applied to the claim as originally filed and to the claim as amended. Amendments are maybe possible within the every particular meaning of the every particular radical group.

However, act as it is not permissible to amend generic formula defining a class of chemical compounds by restricting an originally disclosed generic definition of a substituent, to a specific (individual) one, which is arbitrarily derived from disassembling the structure of individual chemical entities, without some support for such restriction in general part of description.

Exercise I

Draft claims for protection of following compound:

OSO3

Compund was found to have good surfactant property

Inventive step

The question is, is the subject matter of an application obvious having regard to the state of the art?

This is quite subjective question…

Use the problem/solution approach for the following reasons:1. It is convenient and objective method for evaluating inventive step2. With it you are able to avoid retrospective consideration (ex post facto

reasoning)3. Only way of reasoning accepted by EPO

Inventive step - method

Choose the closest prior art

Identify the technical difference(s) between the claim(s) and the CPA

Identify the technical effect achieved by the difference

(Re)Formulate the technical problem according to the technical difference

Decide whether the invention is obvious, starting from the CPA and the (re)defined technical problem, by using the WOULD-COULD reasoning…

Inventive step - method

An application may be inventive:

If it provides “surprising effect” or an “unexpected effect”

If it fills a “long felt need”: the invention solves a problem that workers have been attempting to solve for a long time

If it overcomes a “technical prejudice”: esp. If the prior art teaches away a technical solution, or if the skilled person would not have considered this solution for technical reasons, like the impossibility to achieve it.

Inventive step – example 1

Application: an ampoule comprising lipoic acid and an inert gas as a stabilizing agent for lipoic acid

Prior art D1: an ampoule of lipoic acid and cysteine as a stabilising agent.

Prior art D2: any oxidation sensitive agent may be stabilised by inert gases, by reducing agent, or both together.

Inventive step – example 1

Closest prior art: D1

Difference: No use of inert gas

Technical effect achieved by the difference: None, stabilisation of lipoic acid in both cases

Technical problem: How to find an alternative solution to the solution of the application?

Solution: Found in D2

Inventive step - example 2

Application: a patch comprising a steroid in subsaturated concentration. The applicant proves that the skin flux is increased with roughly 20%, when the patch is in subsaturation.

Prior art D1: a patch with the same steroid at saturation, or in oversaturation

Prior art D2: a subsaturated patch of nicotine to solve the stability problem

Inventive step - example 2

Closest prior art: D1

Difference: subsaturation

Technical effect: Increasing skin flux

Technical problem: How to improve the skin flux of steroid patches

Solution: The present application, which offers an unexpected effect

Specific types of inventions and claims for them

• First medical use

• Second medical use

1. Second medical use claims directed to a “mode of action”

2. Second medical use claims directed to a “mode of administration”

3. Second medical use claims directed to a “regime”

4. Second medical use claims directed to specific “patients”

• Enantiomers

Specific types of inventions and claims for them

Selection inventions1. Selection at the level of the disease2. Selection of the specific chemical compound3. Selection of a generic chemical formula4. Selection of ranges

Wording of first medical use claims

Allowable first medical use claims

1. Product X/Composition comprising product X• For use as a medicament• For use as an antibacterial agent (or as an analgesic agent, etc.)• For use in the treatment of disease Y

2. Medicament comprising product X

More than one specific therapeutically use can be claimed separately in the same application

Unallowable second medical use claims

Method of treating disease Y by administering (a therapeutically effective amount of) a substance or composition X

Use of substance or composition X for the treatment of disease Y

Use of a substance or composition X as an antibacterial (cardiovascular, bronhiolitic, etc.) agent

Use of a substance or composition as a medicament for the treatment of disease Y

Allowable second medical use claims

Use of a product X• For the preparation of a medicament for the treatment of disease Y• For the manufacture of a medicament for the treatment of disease Y• For the preparation of a pharmaceutical composition for the treatment of

disease Y

Method for manufacturing a medicament intended for therapeutical application Z, characterised in that substance X is used

Interpretation: novelty is linked to the specific disease to be treated

Example: Sildenafil (Viagra)

EP0463756

A compound of formula (I) wherein the compound is selected from…5-[2-etoxy-5-(4-methylpiperazinylsulphonyl)phenil]pyrimidin-7-one.

A pharmaceutical composition comprising a compound of the formula (I),… together with a pharmaceutically acceptable diluent or carrier

The use of a compound of formula (I)…for the manufacture of a medicament, particularly for the treatment of hypertension, heart failure, atherosclerosis, stroke, peripheral vascular disease, conditions of reduced blood vessel potency, chronic asthma, bronchitis, allergic asthma, allergic rhinitis, glaucoma or diseases characterised by disorders of gut mobility.

Example-write a claim for the sildenafil

N

N

SO2

N

NH NN

CH3CH2O

O CH3

CH2CH2CH3

Example: Sildenafil (Viagra)

The use of 5-[2-etoxy-5-(4-methylpiperazinylsulphonyl)phenil]pyrimidin-7-one for the manufacture of a medicament for the curative or prophylactic treatment of erectile dysfunction in a male animal, including man.

EP patent revoked in UK by LILY ICOS for reasons of obviousness

Relevant prior art:

D1 New England J. Med. 362(2), 90, 1992, (Rajfer)

D2 Drug News ad Perspectives 6(3) 150-156, April 1993, (Murray)

D3 PhD dissertation, Dr. M. A. Bush

Second medical use claim directed to a “mode of action”

Examples:

Use of a compound X for the manufacture of a medicament for controlling the metabolism of tryptophan

Use of a compound X for the manufacture of a medicament having a 5-HT3 antagonistic activity

Use of a compound X for the manufacture of a medicament inhibiting the production interleukin-I in a human or animal body

Use of a compound X for the manufacture of a medicament for the treatment of disease affected by an increased production of interleukin-I

Current practice at the EPO

Second medical use claims should always directed to a specific therapeutic application, i.e. a well-known and defined disease.

Claims directed to a “new” mode of action, a mechanism or an effect are considered as a discovery under article 52(2)(a) EPC

“A newly discovered technical effect does not confer novelty on a claim directed to the use of a known substance for a known medical purpose if the newly discovered technical effect already underlines the known use of the known substance.”

Practical implementation

Example:

Claim:

Use of compound X for the manufacture of a medicament for the treatment diseases mediated by the 5-HT1a receptor

(Said receptor may mediate e.g. drug abuse, anxiety, compulsive disorder…)

Prior art:

Compound X for the treatment of anxiety

Medical use claims directed towards a “mode of administration

Claim:

Use of HCG for the manufacture of a non-depot medicament for subcutaneous administration…

Prior art:

1. Intramuscular or subcutaneous administration of depot HCG

2. Intramuscular administration of non-depot HCG (C.P.A.)

Difference between claim and prior art

Claim prior art

Subcutaneous injection intramuscular injection

Inventive: YES

Medical use claims directed towards a “regimen”

Claim:

Drugs A and B for treating disease X, administered within 5 minutes of each other (treatment schedule)

Prior art:

Drugs A and B for treating disease X

Difference between claim and prior art:

Claim prior art

Time laps between A and B A + B

Industrial applicable: NO

Novelty: NO

Medical use claims directed towards a specific patients

Claim:

Use of a mixture of phospholipid vesicles and mammalian blood factor Xa for the manufacture of a medicament for controlling bleeding in non-hemophilic mammals

Prior art:

Use of the same mixture for the treatment of bleeding in haemophilics

Difference between claim and prior art:

Claim prior art

Non-haemophilc mammal haemophilic mammal

Medical use claims directed towards a specific patients

A specific (group of) patient(s) can confer novelty to the treatment of a known disease by a known compound

In present example if blood coagulation process is different than novelty and inventiveness will be acknowledged.

Selection inventions

Selection from a general (generically) known piece of prior art.

Based on a particular technical effect/technical difference

Purposive Arbitrary

Continous range Classes with individual members

Generically disclosed Specifically (explicitly) disclosed


Patentability:

Novelty

Select narrow range

Values should be far from disclosed points

The selection needs to have different technical effect than the prior art range that it is selected from

Inventive step

The technical effect of the selected range is also unexpected


Occur frequently in Chemistry and Pharmacy:

Selection at the level of disease

Selection of specific chemical compound

Selection of a specific chemical formula (particular technical effect?)

Selection of ranges (particular technical effect?)

Enantiomers - novelty

Disclosure of prior art Novelty of single enantiomers

Racemate only YES

Racemat and mention of (+) and (-)-enantiomer

NO

Racemat and only general mention of optically active forms

YES

Individual enantiomers (chemical name, or formula drawn)

NO

Information enabling the preparation or isolation of a single enantiomer

NO

Enantiomers – inventive step

For the assessment of inventive step of enantiomer inventions the same principles apply that are to be used in the assessment of inventive step of any other invention

Inventive step is assessed by the question of obviousness and the problem-solution approach.

There must be SPECIAL ASPECTS forwarded for an enantiomer invention to involve an inventive step.

Enantiomers – inventive step

If the invention relates to an enantiomer exhibiting the same pharmacological activity as already known for the racemic mixture, and no unexpected effect is demonstrated, the patent application lacks an inventive step.

Furthermore, enantiomer invention lacks of inventive step where it was known in the prior art that the other enantiomer was responsible for the side-effects of the racemic mixture.

Enantiomers – special aspects

Novel therapeutic use of one enantiomer

Selection from non-obvious diastereomers

Overcoming a disincentive

Overcoming unexpected reverse synergism

Exercise

Which of the following claims are allowable?

Exercise

1. X is new X

2. X is not new, prior art filed before, but published on or after priority date does not comprise its medical use

X

3. X is not new, prior art filed before, but published on or after priority date comprise its medical use

X

a. Compound X for use as a medicament YES YES NO

b. Compound X for use as an analgesic YES YES NO

c. Compound X for use in treating disease Y YES YES NO

d. Composition A containing X for use in treating disease Y YES YES NO

Exercise

1. X is new X


X


X

e. Medicament containing the product X YES YES* NO

f. Use of X in a composition for the treatment of disease Y NO NO NO

g. Use of X as a medicament for the treatment of disease Y NO NO NO

h. Use of X for the treatment of disease Y NO NO NO

Excercise

1. X is new X


X


X

i. Use of X for preparing a medicament YES YES* NO

j. Use of X for the manufacture of a medicament for treating disease Y

YES YES* YES

k. Process for the preparation of a medicament for treating disease Y using compound X as an active ingredient

YES YES YES

*The term "medicament" does not produce novelty as in the case in items (a) to (d). Therefore it is necessary to examine possible disclosures of X in a composition which,

at the same time, would be useful as a medicament, e.g. an aqueous solution.

Case study - repaglinide

Client whishes to know if it is allowable to come in Croatian market with antydiabetic drug with generic name Repaglinide. He knows that NovoNordisc sells repaglinide as Novonorm on Croatian market.

Your task is to provide the client with information weather is he free to proceed with marketing and selling repaglinide.

Case study - perindopril

You are pharmaceutical firm with exclusive rights of production and distribution of perindopril in Croatia and abroad.

Your competitor Les Laboratories Servier, from France has invented new cristallinic form of perindopril.

Your task is to stop your competitor in aquiring any market exclusivity.

Case study - perindopril

1. Step: novelty search

2. Patent family search

3. Try to invalidate patent/application in all relevant country

4. Cease-desist letter

5. Negotiation/court action

main aspects in procedures of patent acquiring with emphasis on pharmaceuticals tihomir dragun...

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