Patentanwälte
Rechtsanwälte
München Basel Berlin
AIPPI Workshop Pharma I
The European Perspective:
First and Second Medical Uses
Treatment Regimes
Dr. Jürgen Meier
Medical uses?
2
Claims?
Claims
1. Beer, comprising at least 20% EtOH.
2. Pharmaceutical composition comprising beer as characterized in
claim 1.
3. Use of beer as characterized in claim 1 for the preparation of a
pharmaceutical composition for stress release, the treatment of
nervous disorders and/or myogelosis. [1973]
Beer as characterized in claim 1 [for use] in stress release, the
treatment of nervous disorders and/or myogelosis. [2000]
4. The pharmaceutical composition of claim 2 or the use of claim 3,
whereby the beer is to be administered after sunset.
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Claim categories of interest
• 1st medical use: composition claims;
• 2nd medical uses: use or “purpose-limited”
composition claims;
• specific treatment dosage regimen: claims
as for new 2nd medical uses with specific
details of how to administer.
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Legal Background
A53 EPC - Exceptions to Patentability
"European patents shall not be granted in respect of ...
(a) ...
(b) ...
(c) methods for the treatment of the 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."
 Claim format for medical use:
Not patentable:
"Method of medical treatment"
Patentable:
"Product for use in method of medical treatment"
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Legal Background
A54(4) and A54(5) EPC - Novelty
"§2 and 3 shall (also) not exclude the patentability
of any substance or composition comprised in the state of the art,
for (any specific) use in a method referred to in A53(c), provided that
its use for any such method / such use
is not comprised in the state of the art."
 Purpose limited product protection for 1st and 2nd medical use
Product:
"Substance X"
 novel over
1st medical use:
"Substance X for use in medicine"
 novel over
2nd medical use:
"Substance X for use in treating disease Y"
 novel over
Further medical use: "Substance X for use in treating disease Z"
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First Medical Use: Then and Now
The allowable claim format is the same under the old
and the new EPC!
Either:
Compound X for use as an active pharmaceutical substance.
(e.g. T 128/82, ”Pyrrolidine derivatives/HOFFMANN-LA
ROCHE”)
Or:
Pharmaceutical composition comprising compound X and,
optionally, a pharmaceutically acceptable carrier and/or
diluent.
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First Medical Use: Then and Now
When are such claims granted?
- when compound claims are submitted and the
pharmaceutical use is credible (T 604/04: grant of
claims for using the protein but not the antibodies);
- when specific applications are filed for a medical use:
it must be credible and supported (T 1045/98).
Note: There is no rejection of first medical use claims because
only a limited number of possible uses is identified in the
application.
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Claim Construction
2nd Medical Use under A54(5) EPC
"Substance / Composition X for use in treating disease Y"
 2nd medical use protection under to A54(5) EPC_2000;
 novel over use of X in treating a different disease Z
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Second and Further Medical Uses –
Dosage Regime (G 2/08)
Same compound, same disease but
-
different dosage or different chronological order of administration;
extension/shortening/interruption of administration pattern
Basic questions:
Is a dosage regime a feature that is part of typical activities and
duties of the doctor and therefore excluded from patentability?
Can it be taken into account for the assessment of
patentability?
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Claim Construction
Swiss Type Claim Format (G5/83)
"Use of compound X for the manufacture of a medicament for the
treatment of disease Y";
•
•
•
•
no provision for 2nd medical use under EPC1973;
adoption of practice applied by Swiss Federal IP Office for
protecting further medical indications;
to be interpreted as encompassing the industrial packaging of the
substance with the instructions for use ("augenfällige Herrichtung");
applicable only up to an effective date of the application of 28 January
2011 (G2/08)
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Claim Construction
Abolition of Swiss Type Claim Format (G2/08)
NOW:
"Compound X for use in the treatment of disease Y";
• with EPC2000 provision for 2nd medical use;
• purpose-limited product protection under Art 54(5) EPC2000 for
applications without decision of grant taken on 13 December
2007;
 Swiss type claim format of G5/83 redundant;
 Swiss type protection abolished within 3 months after publication
of G2/08 in the Official Journal = 28 October 2010 for applications
with effective date > 28 January 2011;
 after this date Swiss type claim to be construed as mere process of
manufacture without limitation by the therapeutic indication.
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Case Law
2nd Medical Use - Delimitation by Patient Group
T19/86 (BoA 3.3.1) Facts & Decision
"Use of... ...Aujeszky-virus for the manufacture of a vaccine for...
...protecting maternally immune pigs against Aujeszky's disease."
 claimed group of sero-positive pigs does not overlap with the
known group of sero-negative pigs;
 treatment of Aujeszky's disease in sero-positive pigs novel over
same treatment in sero-negative pigs (Art 54 EPC);
 see also T893/90 (control bleeding in non-hemophilic vs.
hemophilic mammals);
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Case Law
2nd Medical Use - Delimitation by Patient Group
T233/96 (BoA 3.3.2) Facts & Decision
"Use of adenosine... ...in the preparation of a diagnostic agent for
detecting... ...vascular disease of coronary arteries by... ...administration
to a human who is unable to exercise adequately..."
 not-adequately exercising patients at best a sub-group of the known group
of coronary artery disease patients;
 no functional relationship between selected sub-group and pharmacological
effect of adenosine;
 sub-group arbitrarily selected;
 criteria for delimitation of selection inventions from prior art not fulfilled
(Art 54 EPC);
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Case Law
2nd Medical Use - Delimitation by Patient Group
Conclusion:
Difference in patient group distinctive over prior art provided that
• the claimed group does not overlap with the known group (T19/86),
i.e. patient group represents an alternative vis-à-vis the prior art
or
• the claimed (sub-)group does not represent an arbitrary choice
(T233/96),
i.e.
patient
group
represents
a
purposive
and
clearly
distinguishable selection from the already known entirety of
patients;
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Patentanwälte
Rechtsanwälte
München Basel Berlin
Patentability of a specific treatment regimen
Second and further medical uses
Dosage regime
Same compound, same disease but
– different dosage or different chronological order of
administration
– extension/shortening/interruption of administration pattern
Basic questions:
Is dosage regime a feature that is part of typical activities and duties
of doctor and therefore excluded from patentability?
Can it be taken into account for assessment of novelty?
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But then !
T1319/04:
„Nicotinic acid compositions for treating hyperlipidemia“ KOS
LIFE SCIENCE
• Dosage regime
...for use in a treatment by oral administration once per day prior
to sleep...
• Examining Division:
...feature reflected a medical activity excluded from patentability
under Art. 52(4) EPC...
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YES...he can! G2/08
!Dosage or Treatment Regimen Are Allowable!
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What Do We Learn From G2/08?
Certain liberalization on second medical uses:
-
It is not per se necessary for the treatment to be directed to a different
(novel) disease to confer novelty on a second medical use claim.
This applies also to second medical uses where the only novel feature is a
"dosage regimen"
HOWEVER: There must be a clear technical effect of the dosage regime!
(improvement, surprising effects or advantages)
"Swiss-type language" is now obsolete and will from now on (3 months after
publication of G 2/08; i.e. January 29, 2011) not be accepted by the EPO.
Applications filed from now on are required to use the new EPC2000 format:
"Substance X for use in a method of treating disease Y"
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But Was That Everything?
•
Scope of protection?:
there is probably a difference for off-label use
•
"Double patenting" in divisional applications?:
first med. use, sec. med. use old/new, regimen;
T 307/03
… the "national DE view" …
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Patentanwälte
Rechtsanwälte
München Basel Berlin
"Carvediol II" BGH X ZR 236/01
Carvedilol II
Main Request
1. Use of carvedilol for the manufacture of a medicament
for decreasing mortality resulting from congestive
heart failure in human patients in conjunction with an
angio-tensin-converting enzyme inhibitor, a diuretic
and a digi-talis glycoside, with said medicament being
administered at an initial dose containing either 3,125
mg or 6,25 mg carvedilol per day for a period of 7-28
days, followed by dose increases in bi-weekly intervals
up to a maximum dose of 2 x 25 mg carvedilol per
day.
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Carvedilol II
Second Auxiliary Request:
1. Use of carvedilol for the manufacture of a medicament
for decreasing mortality resulting from congestive heart
failure in human patients in conjunction with an
angiotensin-converting enzyme inhibitor, a diuretic and
a digitalis glycoside, with said medicament being
formulated for administration purposes at an initial
dose containing either 3,125 mg or 6,25 mg carvedilol
per day for a period of 7-28 days, followed by dose
increases in bi-weekly intervals up to a maximum dose
of 2 x 25 mg carvedilol per day.
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Carvedilol II
Headnotes of the Decision:
a) Administering a medication intended for the
treatment of a particular condition amounts to a
therapeutic procedure for the treatment of the
human body.
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Carvedilol II
51.1However, there are no reservations against the
admissibility of the patent claims according to
auxiliary request 2, which provides under both
patent claims that the medication containing
carvedilol is formulated in certain doses for
administration over certain periods.
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Carvedilol II
51.1Accordingly, protection is to be accorded to the
use of a chemical substance in the therapeutic
treatment of the human body, such substance
being formulated to suit such use – for instance
by means of suitable packaging for the tablet
sizes, an inscription on the package or package
inserts.
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Carvedilol II
YES, …he COULD… but:
claim language requests a “formulation”;
see reason 51.1
“…whereby said beer is formulated for
administration after sunset…”
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The Future
Carvedilol II comes from a time when EPC2000 did not exist.
Question: How is Germany going to deal with second medical use
claims granted under EPC2000?
Answer:
Limited accessibility because of Article 138 EPC1973/2000!
and:
The Patent Act has been adapted effective as of the same date!
Olanzapine BGH X ZR 89/07 and Escalitopram BGH Xa ZR 130/07
demonstrate a tendency for "Europeanization" (Finasteride, UK).
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Thank you …
… for your attention!!!!!!!!!!
… and Dr. Dieter Tzschoppe (EPO
Director Pure and Applied Organic
Chemistry) for some slides
Questions?
meier@vossiusandpartner.com
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