Transcript Adrian Bradley Recent Developments in the Patenting of Medical

Recent Developments in the
Patenting of Medical Technology at
the European Patent Office
Oxford Intellectual Property
Research Centre
7 March 2011
Adrian Bradley
Industry Trends
Enlarged Board Decisions
• Surgical methods (G2/08).
• Dosage regimes (G1/07).
Surgical Methods (G 1/07)
• Article 53 Exceptions to patentability
European patents shall not be granted in respect of:
…
(c) methods for 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.
The Claim
• A method for MRI imaging the pulmonary
and/or cardiac vasculature using dissolved –
phase polarized 129Xe comprising the steps
of…
delivering polarized 129Xe to a predetermined
region of the patient's body...
• 129Xe had no therapeutic effect.
• “Delivery” included injection into heart –
mentioned in specification, but not claims.
“Surgery”
• Is a claimed imaging method for a diagnostic
purpose…which comprises…a step consisting in
a physical intervention practised on the human or
animal body…to be excluded…if such step does
not per se aim at maintaining life or health?
• Defined by nature or purpose of intervention?
• Required involvement of a medical practitioner?
Divergent Board of Appeal
Decisions
• T182/90, T35/99
• Treatment not confined to curative
purpose – cosmetic treatments,
sterilisation, embryo implantation.
• “In their nature” methods for
treatment by surgery.
“Purpose” decisions
• T 383/03 – Hair removal using optical
radiation.
• Non-insignificant intentional physical
intervention.
• Not potentially suitable for maintaining
or restoring health.
• Merely cosmetic results.
• Patentable.
Enlarged Board
• Examined travaux préparatoires.
• Looked into rationale for exclusion.
• Criticised approach taken in T
383/03.
• 53(c) defines three separate
exclusions.
Indicative Features of Surgical
Methods

“A claimed...method, in which, when carried
out...maintaining the life and health of the subject
is important and which comprises or
encompasses an invasive step representing a
substantial physical intervention on the body
which requires professional medical expertise to
be carried out and which entails a substantial
health risk even when carried out with the
required professional care and expertise”
Advances in Technology
• Certain non-therapeutic invasive
techniques have routine character
not excluded from patentability.
• No reason in principle why medical
techniques of similar nature
excluded.
Further Questions
• Claim cannot encompass such a
surgical step.
• It is in principle possible to disclaim
methods having excluded surgical step.
• Possibility of omitting surgical step
depends on circumstances.
• Imaging method not excluded merely
because of use in surgery.
Putting it into Practice T266/07
Method for producing a magnetic resonance angiogram of selected vasculature in a subject, wherein a contrast agent
has previously been introduced into the selected vasculature so that the intensity of the NMR signal of the
vasculature dominates the intensity of NMR signals in other materials within an entire field of view, comprising the
steps:
a) operating the MRI system to perform a pulse sequence which includes:
i) producing an RF excitation pulse to excite spins in the entire field of view which includes the selected vasculature;
ii) applying a phase encoding gradient along a first axis;
iii) applying a radial gradient directed at an angle θ in a plane perpendicular to the first axis; and
iv) acquiring an NMR signal during the application of the radial gradient to sample an angular projection of the data in kspace having NR data points radially spaced along a projection;
b) repeating step a) with a set of different phase encoding gradient values for each of a plurality of different radial gradient
angles θ until k-space is sampled, wherein the plurality of different radial gradient angles θ is less than NR π/4 in
number so that a sparsely sampled three-dimensional k-space data set is acquired;
c) Fourier reconstructing along the first axis a three-dimensional volume image of the entire field of view from the sparsely
sampled k-space data set, whereby the spacial resolution of the resulting image is not affected by the sparse angular
sampling and the artifacts associated with the sparse angular sampling are acceptable being no more than a few
percent of the signal associated with the tissue surrounding the vasculature,
d) providing reduction of image artifacts generated by the sparse sampling by subtracting from the image reconstructed in
step c), a mask image of the selected vasculature that was acquired before the contrast agent was introduced into
the selected vasculature; and
e) displaying the reconstructed image produced in step d).
Application of Principles
• Examining division found claimed
method implicitly covered injection of
contrast agent => contravened 53(c).
• BoA – presence of contrasting agent
obligatory for functioning of method;
BUT
• imaging method not functionally related
to actual administration of contrast
agent.
Relevant Paragraph
“Methods which are merely directed to the operating of a
device without themselves providing any functional
interaction with the effects produced by the device on
the body are teachings in which the performance of a
physical activity or action that constitutes a method
step for treatment of a human or animal body by
surgery or therapy is not required in order for the
teaching of the claimed invention to be complete.
Hence, even if in such a case the use of the device
itself requires the application of a surgical step to the
body or is for therapeutic treatment the same does not
apply to the claimed method for operating the device.”
Impact on Practice
• Diagnostic/imaging methods not involving
substantial physical interventions should be
patentable (e.g. methods involving routine blood
sampling).
• Some cosmetic/non-therapeutic techniques may
be excluded if they involve substantial
intervention.
• Consider use of terms such as “previously
obtained,” “previously injected,” or “preadminstered agent” to circumvent the exclusion.
Dosage Regimes (G2/08)
• Known medicament for treatment of known indication.
• Only novel feature “use in the treatment by oral administration
once per day prior to sleep”.
•
A 53 European patents shall not be granted in respect of.... (c)
methods for treatment of the human or animal body by surgery
or therapy and diagnostic methods practised on the human or
animal body.
• A 54(5) …shall not exclude the patentability of any substance or
composition…for any specific use in a method...provided that
such method is not comprised in the state of the art.
Position Under EPC 1973
• Only “First Medical Uses” mentioned in Article
54.
• Methods of medical treatment deemed to lack
industrial applicability.
• Subsequent uses protected by form of claim
approved in G5/83.
• “Use of substance X for the manufacture of a
medicament for the treatment of disease Y”
Divergent Case Law
• First line of cases •
Mere dosage regime incapable of imparting novelty.
•
Feature exclusively pertaining to skill of practitioner;
thwarts purpose of 53(c).
• Second line •
“Specific use” covered all therapeutic uses prohibited
by 53(c).
•
Legislator did not distinguish between new indication
and new dosage regime.
• As scope of claim under EPC 2000 & 1973 different,
important point to address.
Enlarged Board's Reasoning
• Article 54(5) does not define the nature of the
“further therapeutic use”.
• On the contrary, the provision provides that
“any specific use” not comprised in the state
of the art is eligible.
• Legislative history – contemplated doing
away with prohibition on methods of
treatment provided there was a technical
problem solved; no re-patenting of
substances.
The Decision
• “A seamless fit”
• Either • A method is prohibited by A 53(c), and so
may be protected by via a claim to a
composition for use in such a method; or
• Method is not prohibited by A 53(c), and
may be claimed as such.
• Whole jurisprudence relating to novelty and
inventive step applies.
Impact on Practice
• Useful protection available in Europe for
novel and inventive
• routes of administration;
• dosage formats/regimes;
• patient populations.
• Focus should be on unexpected results
compared with known therapies.
• “Swiss claim” no longer allowable.
Highlights of Other TBA
Decisions
• T 1002/09
• A liquid nutritional composition for use in
promoting gut health in an elderly patient
comprising a protein source, a source of
digestible carbohydrates and a source of
dietary fibre, characterised in that it has an
energy density of 1.3-1.8 kcal/ml and dietary
fibre in an amount of more than 2.5g/100ml.
• Composition was novel per se.
T1002/09
• Issue – could feature “for use in promoting
gut health in an elderly patient” be considered
a method for treatment of the human or animal
body by therapy?
T1002/09 - Decision
• In the board’s judgement, alleviation of pain and suffering
by promoting gut health in applying measures which
regulate gut flora and improve intestinal transit are
therefore therapeutic measures (at least in the sense of
prophylaxis) for preventing malfunctions or illness of the
human body.
• Limitation to elderly population group distanced claim from
prior art, which taught that high amounts of fibre where
undesirable in old people.
T 566/07 – Vital Dyes for
Vitreo-Retinal Surgery
“1. Use of at least one vital dye for the
manufacture of a composition for staining a
retinal membrane in an eye to visually
distinguish the retinal membrane from the
underlying retina in a method for
performing retinal membrane removal.”