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Medical Use Claims in Europe
September 2015
Amanda Simons
asimons@jakemp.com
www.jakemp.com
Infringement of Medical Use Claims
• Types of claim: Swiss style claims and EPC 2000
medical use claims
– Background, why we have two claim types
– What protection is afforded by each type of claim?
• What constitutes an infringement of a medical
use claim?
EPO Enlarged Board Decision G5/83
• Swiss claims were allowed by the EPO in
Decision G5/83:
“Use of compound X for the manufacture of a
medicament for treating disease Y”
• Allowed in UK for new disease indication – John
Wyeth & Brother Ltd’s Application (1985)
• Also allowed in Germany – Hydropyridin and
Trigonellin
EPC 2000 (Effective from Dec 2007)
• New Article 54(5) EPC allows purpose limited
product claims:
“Compound X for use in method of the therapy Y” for
both first and second/further medical indications
• Compare to purpose limited process of Swiss
claim:
“Use of compound X for the manufacture of a
medicament for treating disease Y”
The End of “Swiss Style” Claims
• G5/83 – approved “Swiss style” claims only because the
Enlarged Board did not want to exclude from patent
protection second and subsequent medical uses for a known
drug, but EPC 1973 did not envisage a suitable claim format
• EPC 2000 provides a new statutory claim format for 2nd and
subsequent medical uses. “Swiss style” claims are no longer
needed, and are rejected in cases with a priority date of 29
January 2011 or later.
What This Means in Practice
• Both claim formats will persist for over 20 years…
 is there a difference between them?
G2/08:“It appears that the rights conferred by the claim
category under A.54(5) EPC are likely broader…”
“Swiss
style” claim
New 2nd medical
use format claim?
Examples of Scope of Medical Use Claims
• Hypothetical Examples:
– Prodrugs
– Manufacturing intermediates
• Warner Lambert vs Actavis:
– Skinny labelling of pregabalin
“Swiss Style” Narrower?
Example: Prodrugs
• Competitor develops a pro-drug Y which
degrades in vivo to form active agent X
Patient takes tablet
containing Y
Y metabolised into X
in patient’s stomach
Patient benefits from
anticancer activity of X
Is This Covered by 2nd Medical Use Claims
Covering X?
1. “Use of X in the manufacture of a medicament for use in
the treatment of cancer”
 Patient produces X for use in treating cancer, but does he
manufacture a medicament for use against cancer? Arguably
not
2. “X for use in the treatment of cancer”
 Patient makes X for use in the treatment of cancer – drug
supplier liable for providing patient with the means for
infringement? Arguably yes
“Swiss Style” Broader?
Example: Intermediates
• PEGylation of a drug prior to administration
Patient benefits from
anticancer activity of X
Compound X
(
O
)n
administration
PEGylation
Tablet containing XPEG
X-PEG
Process into
drug
Is This Covered by 2nd Medical Use Claims
Based on X?
1. “Use of X in the manufacture of a medicament for use in
the treatment of cancer”
 Arguably yes – compound X is being used, albeit as
intermediate, in the manufacture of a medicament
2. “X for use in the treatment of cancer”
 Arguably not, because X is converted into a different product
before being used to treat cancer
Potential Difference Between the Claims
Manufacturing
intermediate?
Swiss style claim
Prodrug?
Product for use
Infringement of Second Medical Use Claims
Swiss style claims in action: how can they be used
to enforce your rights?
Warner-Lambert (Pfizer) vs Actavis
• Warner-Lambert markets pregabalin as Lyrica
• Lyrica is authorised for three indications including neuropathic pain
• Patent protection for pregabalin per se expired October 2013, but
Warner-Lambert have a European patent with the following claims:
1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof
for the preparation of a pharmaceutical composition for treating
pain.
3. Use according to claim 1 wherein the pain is neuropathic pain
• Actavis sought (and obtained) authorisation to market pregabalin for
non-pain indications under a skinny label
The Problem for Warner-Lambert – How to
Enforce a Swiss Claim in the UK?
Balance between allowing generic companies to market pregabalin for
non-patented indications whilst preventing prescription of generic
pregabalin for pain.
However, in the UK this is difficult:
• Doctors often prescribe drugs with reference to the INN for the active
ingredient (i.e. pregabalin)
• Prescriptions do not specify the disease which is to be treated – so
pharmacists do not know whether they are dispensing generic
pregabalin for pain
• If the prescription refers to the INN, then in the UK pharmacists will
often supply the generic medicament, as they are incentivized to do so
Legal Framework
• Section 60(1)(c):
– A person infringes a patent for an invention if… where the
invention is a process, he disposes of, offers to dispose of, uses
or imports any product obtained directly by means of that
process or keeps any such product whether for disposal or
otherwise
• Use of [pregabalin] or a pharmaceutically acceptable
salt thereof for the preparation of a pharmaceutical
composition for treating pain.
Legal Timeline
Warner-Lambert 1 –
WL applied for
interim injunction
The word “for” imports a requirement of subjective intent on the behalf of
the manufacturer. Actavis attempted to avoid its product being prescribed
for pain, so relevant intent is not present and there is no infringement.
Warner-Lambert 2 – A
applied to strike out
infringement case
Warner-Lambert CA –
WL appealed interim
injunction decision
The request to strike-out the infringement action was denied.
“Subjective intent” is not required. Floyd LJ proposes a “foreseeability”
test, i.e. is it foreseeable that the drug will be used for the patented use?
Floyd LJ notes that the relief available must be considered carefully.
Warner-Lambert has an arguable case for infringement.
Warner-Lambert 3 –
An injunction against the NHS was granted, but a large cross-undertaking
WL applied for an
was put in place. The NHS must write to various organisations requiring that
injunction against the pregabalin is prescribed by the brand-name Lyrica for the treatment of
NHS
pain. This appears to have increased the amount of pregabalin prescribed
by the Lyrica brand-name.
Full trial was heard in July 2015
Warner-Lambert vs Actavis Full Trial at First
Instance (1)
Arnold J: Warner-Lambert’s patent was invalid on grounds of lack of
sufficiency, not infringed and that groundless threats had been made.
• interpreted CoA’s foreseeability test to include “subjective intent”:
“A manufacturer infringes when he knows or foresees that users will
intentionally administer pregabalin for the treatment of pain”
• Has any user intentionally administered generic Lecaent for pain?
 A doctor prescribing pregabalin generically does not intend Lecaent specifically to
be administered for pain
 The pharmacist does not know the indication for which the drug is being used
 The patient takes the drug the doctor has prescribed and does not necessarily
know what it was prescribed for or whether the drug is efficacious for that
condition
 Actavis took measures to avoid Lecaent being prescribed for pain
The Future of Second Medical Use Claims –
Heading
Are second medical use claims still valuable?
• the Warner-Lambert result does seem to have taken the bite out of second
medical use claims, but this may be overturned at the Court of Appeal
• Second medical use claims are clearly more valuable when they relate to
the only use of a drug
• Second medical use claims are more likely to be valuable where different
indications required different dosages or administration regimes
• EPC 2000 claims may be more useful than Swiss claims: indirect
infringement?
Any Questions?
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Name of Attorney
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www.jakemp.com