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Care required to draft pharma patents and prosecution of pharma patents. Ahmedabad, November 26, 2006 Kiyoshi Kuzuwa Patent Attorney KUZUWA & PARTNERS Tokyo, Japan. Care required to draft pharma patents and prosecution of pharma patents. I. Patentability on pharmaceutical/medical

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Care required to draft pharma patents and prosecution of pharma patents l.jpg

Care required to draft pharma patents and prosecution of pharma patents

Ahmedabad, November 26, 2006

Kiyoshi Kuzuwa

Patent Attorney

KUZUWA & PARTNERS

Tokyo, Japan

Nov. 26, 2006 Kuzuwa & Partners


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Care required to draft pharma patents and prosecution of pharma patents

I. Patentability on pharmaceutical/medical

inventions

II. Historical background of pharmaceutical/

medical patent practice in JPO, EPO and

USPTO

III. How to draft pharmaceutical/medical patent specification

  • Special attention to experimental data for

    pharmaceutical patent applications

Nov. 26, 2006 Kuzuwa & Partners


Patentability on pharmaceutical medical inventions l.jpg
Patentability on pharmaceutical/ pharma patentsmedical inventions

1. Categories of medical inventions

(1) Novel chemical compounds

(2) “Pharmaceutical” agent comprising chemical compounds

(3) “Anti-cancer” agent comprising chemical compounds

(4) Use of chemical compounds for manufacturing anti-cancer agent (Swiss-type)

(5) Therapeutic or diagnostic method

(6) Medical devices

Nov. 26, 2006 Kuzuwa & Partners


Patentability on pharmaceutical medical inventions4 l.jpg
Patentability on pharmaceutical/medical inventions pharma patents

2. Criterion on patentability of pharmaceutical/medical

inventions

(1) Novelty

(2) Inventiveness

(3) Industrial applicability

(4) Reproducibility/Enablement

Nov. 26, 2006 Kuzuwa & Partners


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Patentability on pharmaceutical/medical pharma patentsinventions

2. Criterion on patentability of pharmaceutical/

medical inventions

(1) Novelty

Novelty of chemical compounds, novelty of use, novelty of medical devices

Nov. 26, 2006 Kuzuwa & Partners


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Patentability on pharmaceutical/medical pharma patentsinventions

2. Criterion on patentability of pharmaceutical/medical

inventions

(2) Inventiveness

Unexpectedly remarkable effects : most critical

proven by experimental data

-in the original disclosure

-later submission

Nov. 26, 2006 Kuzuwa & Partners


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Patentability on pharmaceutical/medical inventions pharma patents

2. Criterion on patentability of pharmaceutical/medical

inventions

(3) Industrial applicability

depends on political, ethical, humanitarian reasons in

each country.

Nov. 26, 2006 Kuzuwa & Partners


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Patentability on pharmaceutical/medical inventions pharma patents

2. Criterion on patentability of pharmaceutical/medical

inventions

(4) Reproducibility/Enablement

Experimental data on

● chemical entity per se, i.e. identification data (m.p. IR etc.)

● medical use, i.e. pharmacological data (in vivo, in vitro)

-in the original disclosure

-later submission

Nov. 26, 2006 Kuzuwa & Partners


Ii historical background of pharmaceutical medical patent practice in jpo epo and uspto l.jpg
II. Historical background of pharmaceutical/ pharma patents medical patent practice in JPO, EPO and USPTO

1. JPO

(1) General principle on pharmaceutical/medical inventions

-Medical devices, pharmaceutical products per se: patentable since 1975, where substance patent was introduced

-Method for surgery, therapy or diagnosis: unpatentable

due to lack of industrial applicability

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

1960s Inventions having features involving human bodies

e.g. method for permanent wave to hairs:

unpatentable

1970s Only method for surgery, therapy or diagnosis out of

inventions having features involving human bodies:

unpatentable

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

1993 Method for surgery, therapy or diagnosis:

unpatentable irrespective of whether inventions have

features involving human bodies

Note inventions involving a process to return extracts to the

same human body (e.g. artificial dialysis): unpatentable

Nov. 26, 2006 Kuzuwa & Partners


Ii historical background of pharmaceutical medical patent practice in jpo epo and uspto12 l.jpg
II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

2003 •A part of regenerative medicine and/or gene therapy

related technology: patentable

-inventions involving a process to return extracts to the

same human body for therapeutic purpose (e.g. dialytic

treatment): unpatentable, but

-method for producing medical products by using

extracts, even if inventions involve a process to return

said extracts to the same human body for therapeutic

purpose (e.g. dialytic treatment): patentable

• Method for operating medical devices not involving the

process applying to the human body: patentable

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

2003 A part of regenerative medicine and gene

therapy related technology: patentable

Example (patentable)

“Process for producing a therapeutic cell for treating cancer characterized by introducing the gene by vector Z comprising DNA encoding protein X into tissue W extracted from a human body”

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

2003 A part of regenerative medicine and gene

therapy related technology: patentable

Example (patentable)

Extract

Tissue W

Vector Z

Gene:

DNA encoding

protein X

Therapeutic

cell

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

2005 -Broader protection on method for operating

medical devices, e.g.

driving and moving incision means,

transmitting and

detecting radiation etc.: patentable

unless the claim sets forth a work of medical doctor

directly applied to human bodies.

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

2005-Protection on method for generating a new

efficacy and/or new indication for producing

and/or selling medicaments, e.g.

“therapeutic agent forHepatitis C for treating patient

having α-type gene, characterized by administering

compound A in a dosage of 5.0 - 10.0 mg at the first

time and 0.3 – 0.5 mg every two days”

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

1. JPO

(2) History in patent practice (Examination Standard)

• 5.0-10.0 mg/

first time

• 0.3-0.5 mg/

every two days

administer

Compound

A

α-type gene

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. EPO

(1) General principle on pharmaceutical/medical inventions under current EPC

Article 52 (patentable inventions)

(1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

………….

(4) Methods for treatment of human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. EPO

(2) Current practice under EPC

-Method for surgery, therapy or diagnosis: unpatentable

due to lack of industrial applicability (Art. 52(4))

Exceptions, e.g.

Out of 3 steps, i.e. data collecting step, comparison step

and medical determination step, invention related to

only 1st and 2nd steps: patentable

-Medical devices, pharmaceutical products: patentable

-2nd medical use: patentable only in Swiss type claim

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. EPO

(3) EPC2000

will come into effect on December 13, 2007.

Article 53 (Exceptions to patentability) in place of Article 52

European patents shall not be granted in respect of:

………….

(c) methods for treatment of human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. EPO

(3) EPC2000

-Methods for treatment of human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body have been excluded from patentablity by the fiction of their lack of industrial applicability.

-This fiction is not appropriate, because those methods are excluded in the interests of public health rather than lack of industrial applicability.

                     ↓

Article 52 (industrial applicability)→Article 53 (Exceptions to patentability)

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. EPO

(4) Possible practice under EPC2000

2nd medical use:

-Swiss type claim no longer necessary

-Product claim patentable

“Use of compound A and/or its physiologically acceptable salts for manufacturing a therapeutic agent treating diabetes” (Swiss type claim)

 ↓

“A therapeutic agent treating diabetes comprising compound A and/or its physiologically acceptable salts” (product claim)

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. USPTO

(1) General principle on pharmaceutical/medical inventions

-Any inventions are patentable

-exceptions for infringements against practitioner’s performance of medical activity

Art. 287, Art. 271

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. USPTO

US patent law §287

…………

(c) (1) with respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

Nov. 26, 2006 Kuzuwa & Partners


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II. Historical background of pharmaceutical/medical patent pharma patents practice in JPO, EPO and USPTO

2. USPTO

(2) History of practice on pharmaceutical/medical inventions

- 1950 medical methods: unpatentable

1950 - medical methods: patentable

1993 Pallin vs Singer (both practitioners)

1996 current US patent law §287(c)

Nov. 26, 2006 Kuzuwa & Partners


Iii how to draft pharmaceutical medical patent specification l.jpg
III. How to draft pharmaceutical/ pharma patentsmedical patent specification

Novelty, Inventiveness, Industrial applicability,

Reproducibility (enablement) must be met.

How to draft

- Claims - Specification

How to amend specification

How and when to submit - Working examples, comparative examples

- Pharmacological data

Nov. 26, 2006 Kuzuwa & Partners


1 comparison on patentability of pharmaceutical medical inventions among jpo epo and uspto 1 l.jpg
1. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (1)

III. How to draft pharmaceutical/medical patent specification

EN:enablement NV:novelty IA:industrial applicability

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

2. Chemical compounds

“Chemical compounds of chemical formula X” (JP,EP,US patentable)

-Novelty and inventiveness are met,

when compounds are new and inventive.

-Industrial applicability are met,

when disclosed how to make, how to use (medical use)

in the original specification.

-Reproducibility (enablement) is met,

when data on identification of compounds, e.g., IR,

m.p., etc. are disclosed in the original specification

(at least for JP).

(pharmacological data not necessarily needed)

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

3. First medical use of novel (inventive) compounds

“ Pharmaceutical agent comprising novel chemical

compounds of chemical formula X” (JP,EP,US patentable)

Industrial applicability is met,

when identification data on at least one chemical compound.

Reproducibility is met,

when pharmacological data (in vivo or in vitro) on at least

one disease, e.g., diabetes,

are disclosed in the original specification (at least for JP).

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

4. First medical use of known compounds

“ Pharmaceutical agent comprising known chemical

compounds of chemical formula X“ (only EP patentable)

Industrial applicability are met in JP,EP,US.

Novelty are met in JP,EP, but not in US due to known

compounds.

Reproducibility is met,

when pharmacological data on at least one disease (e.g.

diabetes) in EP, but not in JP due to insufficient disclosure.

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

5. Second medical use of known compounds

For novelty/inventiveness and industrial applicability

Product: Anticancer agent comprising chemical compounds

of chemical formula X (JP, EPC2000)

Swiss type: Use of chemical compounds of chemical formula X

for producing therapeutic agents for treating

cancer (Swiss-type, current EPO)

Method: Therapeutic method for treating cancer using

chemical compounds of chemical formula X (US)

For reproducibility/enablement

At least one pharmacological data (in vivo or in vitro)

on the second indication, e.g., anticancer in the original

specification (at least for JP)

Nov. 26, 2006 Kuzuwa & Partners


6 comparison on patentability of pharmaceutical medical inventions among jpo epo and uspto 2 l.jpg

III. How to draft pharmaceutical/medical patent specification

6. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (2)

EN:enablement NV:novelty IA:industrial applicability, EX:exception to patentability

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

7. Therapeutic or diagnostic method using pharmaceutical products

JP: unpatentable, due to lack of industrial applicability

EP: unpatentable, due to lack of industrial applicability

EPC2000: unpatentable, due to unpatentable invention

US: patentable

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

8. Regenerative medical method

JP: patentable

if extracts used for producing medical products

EP: unpatentable, due to lack of industrial applicability

EPC2000: patentable?

US: patentable

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

9. Dosage form characterized by administering method

JP: patentable

EP: unpatentable, due to lack of industrial applicability

EPC2000: patentable?

US: unpatentable due to lack of novelty, but

patentable as administering method

Nov. 26, 2006 Kuzuwa & Partners


Iii how to draft pharmaceutical medical patent specification36 l.jpg
III. How to draft pharmaceutical/medical patent specification

10. Operating method for medical devices

JP: patentable, if not involving human body

EP(EPC2000): patentable, if not involving diagnostic

determination

→ depends on how to draft the claim

US: patentable

Nov. 26, 2006 Kuzuwa & Partners


Iii how to draft pharmaceutical medical patent specification37 l.jpg
III. How to draft pharmaceutical/medical patent specification

11. How to draft original specification and how to amend claims in the prosecution

-Practice on amendments, so strict …

so called new matter practice:

EP (§123)> JP (§ 17bis)> US (§ 132)

Nov. 26, 2006 Kuzuwa & Partners


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III. How to draft pharmaceutical/medical patent specification

11. How to draft original specification and how to amend claims in the prosecution

In the original specification,

- more working examples,

- more specific compounds listing,

- more stepwise numerical ranges,

e.g. “5-50°C, preferably 10-30°C, more preferably 15-20°C”,

- less negative expression,

e.g. “if higher than 50°C, adverse effect appears”

more possibilities for amending claims during prosecution

Nov. 26, 2006 Kuzuwa & Partners


How important identification data pharmacological data etc are l.jpg

IV. Special attention to experimental data for specification

pharmaceutical patent applications

How important Identification data, Pharmacological data etc. are?

  • Critical for fulfilling enablement requirements

  • Must be present in the original specification.

    • Late submission of data is not acceptable when none of data was given in the original specification (at least for Japan).

Nov. 26, 2006 Kuzuwa & Partners


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IV. Special attention to experimental data for specification pharmaceutical patent applications

Recent Court decisions (JP)

Nov. 26, 2006 Kuzuwa & Partners


Slide41 l.jpg

IV. Special attention to experimental data for specification pharmaceutical patent applications

How to cope with the strict practice (at least for Japan) on pharmaceutical/

medical patent application?

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 1 l.jpg

1. New chemical compounds represented by following formula I

A-R (A: novel chemical structure)

2. Anticancer agent comprising chemical compounds represented by formula I

IV. Special attention to experimental data for pharmaceutical patent applications

N

Hypothetical example 1

A-

A-

A-

H

A-

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 143 l.jpg

Substance invention I

No chance

Pharmaceutical invention

No chance

IV. Special attention to experimental data for pharmaceutical patent applications

Hypothetical example 1

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 2 l.jpg

1. New chemical compounds represented by following formula I

A-R (A: novel chemical structure)

2. Anticancer agent comprising chemical compounds represented by formula I

IV. Special attention to experimental data for pharmaceutical patent applications

N

Hypothetical example 2

A-

A-

H

A-

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 245 l.jpg

Substance invention I

A-H: Likely patentable

A-

A-

A-

Pharmaceutical invention

No chance

IV. Special attention to experimental data for pharmaceutical patent applications

N

Hypothetical example 2

Patentable if pharmacologically equivalent to A-H

H

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 3 l.jpg

1. New chemical compounds represented by following formula I

A-R (A: novel chemical structure)

2. Anticancer agent comprising chemical compounds represented by formula I

IV. Special attention to experimental data for pharmaceutical patent applications

N

Hypothetical example 3

A-

A-

H

A-

Nov. 26, 2006 Kuzuwa & Partners


Hypothetical example 347 l.jpg

Substance invention I

A-H: Likely patentable

A-

A-

A-

Pharmaceutical invention

A-H: Likely patentable

A-

A-

A-

IV. Special attention to experimental data for pharmaceutical patent applications

N

N

Hypothetical example 3

Patentable if pharmacologically equivalent to A-H

H

Patentable if pharmacologically equivalent to A-H

H

Nov. 26, 2006 Kuzuwa & Partners


Suggestion l.jpg

IV. Special attention to experimental data for I pharmaceutical patent applications

Suggestion

1. General

  • The more experimental data, the more chance.

  • Experimental data for at least one embodiment, which support the utility of said embodiment, are absolutely necessary for chemical/pharmaceutical inventions.

Nov. 26, 2006 Kuzuwa & Partners


Suggestion49 l.jpg

IV. Special attention to experimental data for I pharmaceutical patent applications

Suggestion

2.Substance invention

  • Identification data on at least one chemical compound selected from a reasonably categorized group should be given in the specification. Otherwise, almost no chance as a whole.

  • The reasonably categorized group has more chance to be granted, whereas the other groups are likely rejected.

  • Pharmacological data are not necessarily needed for enablement requirements for substance invention, but would be useful for asserting inventiveness.

Nov. 26, 2006 Kuzuwa & Partners


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IV. Special attention to experimental data for I pharmaceutical patent applications

Suggestion

3.Pharmaceutical (use) invention

  • Pharmacological data on at least one chemical compound selected from a reasonably categorized group should be given in the specification.

  • The reasonably categorized group may well be patentable.

  • The other groups falling within the claim are theoretically also patentable, only if

    -a reasonable explanation on why compounds falling within the other groups are pharmacologically equivalent to the above compound and

    -additional pharmacological data on the other group’s compounds

    are submitted.

Nov. 26, 2006 Kuzuwa & Partners


Thank you l.jpg

Thank you ! I

Nov. 26, 2006 Kuzuwa & Partners