Medical Use Patents Enforcement

Second and further medical use patents:
enforcement perspective

Dr Duncan Curley
Director and Head of Patents, Innovate Legal
C5 Pharma & Biotech Patent Litigation Conference - 29 January 2014

© 2014 Innovate Legal Services Limited

Second and further medical use patents:
enforcement perspective

Outline of presentation
1.Proving

infringement
2.Regulatory position and skinny labelling
3.Some caselaw
4.Conclusions


Proving infringement

It is necessary for manufacturers of generic medicines to provide detailed
instructions on the use and dosage of their products.
….but including a patented indication on a product label may give rise to
liability for direct infringement.
Generic manufacturers will usually pick up on patented uses during their
freedom to operate searches, so they are generally alert to this issue.


Regulatory position

Directive 2001/83/EC (as amended) – Article 11
For authorisations under Article 10, those parts of the summary of product
characteristics (SmPC) of the reference medicinal product referring to
indications or dosage forms which were still covered by patent law at the time
when a generic medicine was marketed need not be included.
“Skinny labelling” (removing or ‘carving out’ the patented use from the label) is
therefore an option.


Regulatory position

2012 Guidance from CMDh (European Co-ordination Group for Mutual
Recognition and Decentralised Procedures – Human) – see:
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh-279-2012-Rev02012_10.pdf

.

‘Usage’ Patents claim novel ‘uses’ (indications, formulations, routes of
administration, dosage schedules, patient populations etc.) for known / already
patented active substances. To the extent that the ‘usage’ patent satisfies the
requirements for a valid patent, it confers an independent full period of patent
protection in relation to the claimed invention.


Regulatory position

Guidance from CMDh (ctd).
This can give rise to potential patent infringement in the event that a generic of
an innovator product for which the initial patent protection period has expired
but which is still protected by a ‘usage’ patent is authorised by a competent
authority which would normally require the generic authorisation to conform to
that of the innovator with respect to the summary of product characteristics and
package leaflet and labelling as appropriate.


Regulatory position
Guidance from CMDh (ctd).
Is it possible not only to delete the patented indication, but also to
change/delete further sentences in other sections directly connected to this
patented indication, e.g. in posology, contra-indications or warnings?
Answer: The Directive states only the exclusion of information referring to
indication and dosage forms. Any other deletion connected to the patented
indications or dosage forms must be properly justified and discussed with the
member state concerned.
Some care therefore needed when skinny labelling!


Contributory infringement - background

For example, section 60(2) of the UK Patents Act 1977 [simplified for present
purposes]:
A person also infringes a patent if he supplies or offers to supply a person…
with any of the means relating to an essential element of the invention for
putting the invention into effect when he knows, or it is obvious to a reasonable
person in the circumstances that those means are suitable for putting, and are
intended to put, the invention into effect….



Example: UK supply chain [for hospital products]:
Generic pharmaceutical company supplies wholesaler
wholesaler supplies hospitals
where products are used by doctors to treat patients



Pharmaceutical product labels and “contributory infringement” - caselaw:
“It is sufficient if it is shown that the invention [i.e. the patented use] will be put
into effect by some users [e.g. some doctors]”.
“ One would only disregard maverick or unlikely uses of the thing”
- per Jacob, L.J. in Grimme Maschinenfabrik GmbH v Scott (English Court of Appeal decision)


Grimme applied in KCI Licensing Inc. v Smith & Nephew plc (another English
Court of Appeal decision):
The question is what the supplier knows (or ought to know) about the intention
of the person who is in a position to put the invention into effect, i.e. the doctor.
•

It is enough to prove contributory infringement if the supplier knows (or it is
obvious to a reasonable person in the circumstances) that some ultimate users
will intend to “use” the product so as to infringe.
•

•

Thus, it is the intention of the ultimate user (i.e. the doctor) that “counts”.


Caselaw

Ribavirin - District Court of Düsseldorf, 2004
The patentee’s claim covered the use of ribavirin for the treatment of HCV infections.
1.The

use of ribavirin for the manufacture of a pharmaceutical composition for treating a patient
having chronic hepatitis C infection to eradicate detectable HCV-RNA
2.by a method comprising administering an effective amount of ribavirin in association with an
effective amount of interferon alpha
3.for a time period of 40-50 weeks
4.wherein the patient is one having failed to respond to a previous course of interferon alpha therapy,
characterised in that
5.the patient has a viral load of greater than 2 million copies per ml of serum as measured by HCVRNA quantitative PCR
6.of a HCV genotype type 1 infection.


Caselaw

Ribavirin - District Court of Düsseldorf, 2004
The package insert (SmPC) was presented as proof of direct infringement. This
specified ribavirin co-administered with alpha interferon, but the court found
that the main use intended was ribavirin monotherapy and furthermore there
was no specific reference in the SmPC to the patient group defined in the
claim.
Conclusion: no direct infringement, even though the court noted that “…it
cannot be excluded that…patients belonging to the special subgroup described
in the patent in suit are also treated [with the Defendant’s product]”.


Caselaw
Ribavirin – Schering v Teva, District Court of The Hague, 2010
The Dutch court considered Teva’s SmPC to their ribavirin product, but again in
the context of direct infringement.
Teva had skinny labelled and there was no reference to the claimed patient
group.
Conclusion: no direct infringement. Teva’s SmPC tracked the use of ribavirin in
the prior art. However, the Dutch court observed that the conclusion might
have been different if evidence had been provided that Teva’s ribavirin would
have been prescribed for the patient sub-group because of information given
elsewhere in the SmPC.

Caselaw

Clopidogrel
In 2008, the data exclusivity period for the Sanofi anti-coagulant product
Plavix® (containing the API clopidogrel) ended.
Although Sanofi had continuing patent protection for a specific salt form of
clopidogrel (the hydrogen sulphate), a number of generics subsequently sought
to enter the market with products based on alternative clopidogrel salts.
Sanofi had a further patent which claimed (inter alia) the use of clopidogrel in
combination with aspirin (European patent no. 0,881,901).


Caselaw
Clopidogrel
European patent (DE) no. 0,881,901 (Sanofi)
In Germany, Sanofi sued ratiopharm and Hexal in September 2009 for
infringement of European patent (DE) no. 0,881,901, based on information in
the generic companies’ Patient Information Leaflet (PIL) and SmPC suggesting
the combined use of clopidogrel with aspirin.
However, because serious doubts were raised about the validity of the patent
at the preliminary injunction hearing, no injunction was granted.


Caselaw
Losartan
4 main indications on the label of the originator product, Cozaar®.
European patent (UK) no. 0,253,310 (Merck). SPC expired on 1 September
2009; extended (after a struggle) to 1 March 2010 by paediatric extension.
Numerous other Merck patents to various uses of losartan ran on past 1 March
2010, including European patent nos. 0,533,840, 0,966,282 and 0,636,027.
Generic competitors launched with a variety of skinny labels, some bearing 1,
2, 3 and 4 indications…no action taken (despite the high value of the product).


Conclusions

Clinical research has advanced and so new medical uses now recognised and
explored earlier in product lifecycles.
Second and further medical use patents probably becoming increasingly
important in the research-based companies enforcement armoury.
Raises some challenging questions for research-based companies, both in
terms of defending validity and of obtaining adequate evidential proof of
infringement, but there is developing jurisprudence on contributory infringement
and skinny labelling – so watch this space.


Thank you for listening.

Dr Duncan Curley
Innovate Legal
107 Fleet Street
London
EC4A 2AB
Tel: +44(0)20 7936 9056
Fax: +44(0)20 7936 9111
Email: duncancurley@innovatelegal.co.uk
www.innovatelegal.co.uk


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