1. 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

2. 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

3. Patentability on pharmaceutical/ medical 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

4. Patentability on pharmaceutical/medical inventions
2. Criterion on patentability of pharmaceutical/medical
inventions
(1) Novelty
(2) Inventiveness
(3) Industrial applicability
(4) Reproducibility/Enablement
Nov. 26, 2006 Kuzuwa & Partners

5. Patentability on pharmaceutical/medical inventions
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

6. Patentability on pharmaceutical/medical inventions
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

7. Patentability on pharmaceutical/medical inventions
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

8. Patentability on pharmaceutical/medical inventions
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

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

10. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO
(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:
Nov. 26, 2006 Kuzuwa & Partners

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

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

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

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

15. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO
(2) History in patent practice (Examination Standard)
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

16. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO
(2) History in patent practice (Examination Standard)
Protection on method for generating a new
efficacy and/or new indication for producing
and/or selling medicaments, e.g.
“therapeutic agent for Hepatitis C for treating patient
having α-type gene, characterized by administering
compound A in a dosage of mg at the first
time and 0.3 – 0.5 mg every two days”
Nov. 26, 2006 Kuzuwa & Partners

17. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO
(2) History in patent practice (Examination Standard)
• mg/
first time
• mg/
every two days
administer
Compound A
α-type gene
Nov. 26, 2006 Kuzuwa & Partners

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

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

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

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

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

23. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and 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

24. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and 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

25. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO
(2) History of practice on pharmaceutical/medical inventions
medical methods: unpatentable
medical methods: patentable
Pallin vs Singer (both practitioners)
current US patent law §287(c)
Nov. 26, 2006 Kuzuwa & Partners

26. III. How to draft pharmaceutical/ medical 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

27. III. How to draft pharmaceutical/medical patent specification
1. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (1)
Category of invention
JPO
EPO
EPC2000
USPTO
Chemical entity
Yes
Pharmaceutical agent comprising novel compounds(1st use)
Pharmaceutical agent comprising known compounds(1st use)
No(EN)
No(NV)
Anticancer agent comprising known compounds(1st use)
Anticancer agent comprising known compounds(2nd use)
No(IA)
Swiss-type
No need
EN:enablement NV:novelty IA:industrial applicability
Nov. 26, 2006 Kuzuwa & Partners

28. 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

29. 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

30. 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

31. 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

32. III. How to draft pharmaceutical/medical patent specification
6. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (2)
JPO
EPO
EPC2000
USPTO
Therapeutic, diagnostic method
No(IA)
No(EX)
Yes
Regenerative medicine related method
Dosage form characterized by administering method
No(NV)
Medical devices
Operating method for medical devices
if not involving human body
If not involving diagnostic determination
EN:enablement NV:novelty IA:industrial applicability, EX:exception to patentability
Nov. 26, 2006 Kuzuwa & Partners

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. How important Identification data, Pharmacological data etc. are?
IV. Special attention to experimental data for
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

40. Recent Court decisions (JP)
IV. Special attention to experimental data for pharmaceutical patent applications
Recent Court decisions (JP)
Case A
Case B
Case C
Case D
Date of Decision
Oct. 2001
Oct. 2002
Dec. 2003
Aug. 2005
Plaintiff
Ausimont SPA
Pfizer Inc.
Univ. of Virginia
Astellas Pharma
Category of invention
Process for preparing
Medicine
Dietary supplement
How to use/make
Yes
Effects
Data No
Yes ?
Data late submission
Decision
Rejected
Corresponding EP, US
Granted
Nov. 26, 2006 Kuzuwa & Partners

41. medical patent application?
IV. Special attention to experimental data for pharmaceutical patent applications
How to cope with the strict practice (at least for Japan) on pharmaceutical/
medical patent application?
Nov. 26, 2006 Kuzuwa & Partners

42. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 1
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
A-R
Identification data
Pharmacological data
A-H
Late submission A- A- A- H N A-
Nov. 26, 2006 Kuzuwa & Partners

43. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 1
Substance invention
No chance
Pharmaceutical invention
No chance
Nov. 26, 2006 Kuzuwa & Partners

44. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 2
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
A-R
Identification data
Pharmacological data
A-H
Originally disclosed
Late submission A- A- H N A-
Nov. 26, 2006 Kuzuwa & Partners

45. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 2
Substance invention
A-H: Likely patentable A-
Patentable if pharmacologically equivalent to A-H H N
Pharmaceutical invention
No chance
Nov. 26, 2006 Kuzuwa & Partners

46. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 3
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
A-R
Identification data
Pharmacological data
A-H
Originally disclosed
Late submission A- A- H N A-
Nov. 26, 2006 Kuzuwa & Partners

47. IV. Special attention to experimental data for pharmaceutical patent applications
Hypothetical example 3
Substance invention
A-H: Likely patentable A-
Patentable if pharmacologically equivalent to A-H H N
Pharmaceutical invention
A-H: Likely patentable A-
Patentable if pharmacologically equivalent to A-H H N
Nov. 26, 2006 Kuzuwa & Partners

48. IV. Special attention to experimental data for 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

49. IV. Special attention to experimental data for 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

50. IV. Special attention to experimental data for 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

51. Thank you !
Nov. 26, 2006 Kuzuwa & Partners