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PATENTING MEDICAL INVENTIONS IN EUROPE, CHINA, JAPAN & US
PROBLEMS & PITFALLS6 OCTOBER 2015
High-Tech Patents and High-Caliber Training
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 2
Speaker: Pete Pollard
European & Dutch patent attorney European trademark & designs attorney Technical expertise:
– electron optics, optics, vacuum systems, mechatronics, medical systems & imaging
Career:– BEng Electrical & Electronic Engineering [University of Newcastle
upon Tyne, UK]– Developer and engineer at Philips, Leica and ASML– Involved in patents since 2002– Teaches European and PCT patent law to new attorneys
Contact: [email protected]
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 3
Protecting your IPCaffeine-dosage & -delivery system
Patents for technical aspects
Designs Trademarks
Domain names: www.senseo.nl
Copyright onembedded software
An assembly (1) for use in a coffee machine for preparing coffee, comprising a container (2) having a bowl-shaped inner space (6) bounded by a bottom (8) having at least one outlet opening (12) and a vertical sidewall (10) and, included in the inner space (6) of the container, a pill-shaped pouch (4) manufactured from filtering paper and filled with ground coffee …
Patents forembedded software
Photo source: http://www.newscenter.philips.com/nl_nl/standard/about/news/productnews/20080218.wpd
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 4
Patent = right to forbid in exchange for sharing knowledge
Officially-granted temporary right:– for technical innovation– that is new & non-obvious (examined)– for maximum 20 years (medicines longer)
to stop others using or selling your invention
Only for countries where protection was requested and granted– expected in 2017: protection for EU with a single patent
In exchange for publishing your invention 18 months after filing– = complete instructions how to practice your invention– others are free to use when the protection expires
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 5
“Product” = physical entity– substance, medicine, gene sequence – apparatus, device, system
“Method” = activity – procedure, process – specific use of a “product”
Choice determined by what is new and not-obvious: – physical entity, activity or both
But “product” preferred– it protects all ways to make or use “product”– infringement is easier to detect than “method”
Types of protection that can be claimed
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 6
Most countries refuse to allow certain patents ...
1) ... to discourage certain commercial exploitation– “immoral” inventions – those dangerous to life (human, animal, plant)
or to the environment
2) .... to ensure medical staff not prevented from using best available procedures– therapeutic method
=> treating or preventing a disease– diagnostic method
=> determining health or a health condition– surgical method
=> performing invasive procedures
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 7
... based on national criteria
Exclusion criteria vary per country:– nature of the actions when using invention– medical practitioner who would carry it out – nurse, surgeon etc.– purpose for which invention is used– actions that must be carried out when invention is used
.... and criteria are continuously developing to follow advances in technology– they may even change during grant procedure of your
patent application
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 8
Most countries allow patents for ....
Substances, medicines and medical devices, even if they are used in excluded therapeutic, diagnostic and surgical methods
Other types of medical procedures– not for treating a disease (cosmetic)
• China does not allow patenting of cosmetic methods
– performed on dead humans / animals– non-invasive procedures
Diagnostic procedures on in vitro samples or ex vivo samples not returned to the same body
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GROUP 1
DANGEROUS TO LIFE (HUMAN, ANIMAL, PLANT)
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Very generally, no patent for ...
cloned humans or animals cloning humans industrial or commercial uses of human embryos any product/substance obtained by the destruction of human
embryos at any time in the past Processes for modifying genetic identity of animals which are
likely to cause them suffering without any substantial medical benefit to man or animal, and the resulting animals
Isolated gene sequences without technical effect– US does not allow patenting of any isolated human gene
sequences
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GROUP 2
MEDICAL PROCEDURES (THERAPEUTIC, DIAGNOSTIC, SURGICAL)
3 May 202312
Example 1: improved blood flow rate measurement
• Method for determining blood flow rate in pulmonary or cardiac vasculature:
–positioning patient in MRI–injecting polarized 129Xe gas into region of body–providing RF excitation pulse, and–acquiring an MR image associated with
dissolved phase polarized gas–determining blood flow rate
• Invention: interaction between Xe & MRI, and providing RF excitation pulse to retain polarization
• Description describes 2 methods of delivery of gas:–injection into the heart region–inhalation
Patenting Medical Inventions in Europe, China, Japan & US
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 13
Example 1: objections in Europe
Therapeutic method: No objection– only provides information on blood flow – does not improve well-being
Diagnostic method: No objection– only provides information on blood flow– method does not include deductive medical decision phase
Surgical method: YES => may not be patented– injecting into the heart is “substantial physical intervention”
(& substantial health risk) requiring “professional medical expertise”
– but if delivery is limited to inhalation, then possibly NO surgical objection
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 14
Example 1: objections in China
Therapeutic method: No objection– only provides information on blood flow. – does not intercept, relieve or eliminate cause of disease
Diagnostic method: YES => may not be patented– practiced on a living human/animal– information on blood flow is a health condition
Surgical method: YES => may not be patented– injecting into the heart is “traumatic & invasive” on live
human– purpose is not therapeutic, so limiting delivery to inhalation
does not change surgical objection: YES => may not be patented
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 15
Example 1: objections in Japan
Therapeutic method: No objection– only provides information on blood flow. – does not cure, restrain or prevent disease
Diagnostic method: No objection– does not include steps of deducing disease or physical
health Surgical method: YES => may not be patented
– injecting into the heart requires the presence of a medical practitioner
– but if delivery is limited to inhalation, then possibly NO surgical objection
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 16
Example 1: objections in US
No objections - methods of surgery, diagnosis and therapeutic methods are patentable
but enforcement against doctors & medical facilities is prohibited for medical & surgical methods, and methods of treatment
Enforcement is still possible for medical devices and medicines
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Example 1: overview of objections
Basis of objection Europe China Japan US
Therapeutic method None None None None
Diagnostic method None YES None None
Surgical method YES YES YES None
Overall conclusion Not patentable
Not patentable
Not patentable
Patentable
Delivery by inhalation may be patentable
Delivery by inhalation may be patentable
But not enforceable against doctors & medical facilities
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 18
Conclusions
If the invention is a substance, medicine, device or part of a device, then it can be protected in most countries (even if used in an excluded method)
If the invention is in the use, then protection is difficult if:– any part of the device (e.g. probe or catheter) or substance
(e.g. medicine or contrast liquid) has to be inserted into a living human or animal body by a medical practitioner
– its purpose is to improve the well-being or health– its purpose is to deduce the medical condition
if possible, claim the product instead of the method
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 19
Possible to claim “product” for example 1?
MRI scanner RF coil 129Xe gas
From 3 different suppliers Showing indirect infringement is complex:
– must provide essential element of invention– knows that element are suitable for & intended for use in
invention
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 20
Example 2: endoscope
Product = endoscope– increased opening angle due to
displaceable cutting blades
Method of inspection– quicker inspection improved viewing strategy
Conclusion Patentable in Europe, China, Japan and US because it is a product
1
3
4
2
1b
Europe China Japan US
Objection Substantial physical intervention
Endoscopy diagnostic method
Using medical device inside body
None
Conclusion Not patentable Not patentable Not patentable Patentable
Patentable if inside ear, nose or mouth
But not enforceable
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 21
Example 3: image processing
Method of improving contrast (software)– obtaining CT scan– determining frequency of gray levels– applying non-linear gray level bins– displaying improved image
= “Computer-implemented invention”
Europe China Japan US
Objection None None None None
Conclusion Patentable due to technical effect
Patentable due to external technical data processing
Patentable due to processing based on biological properties
Patentable as it adds something extra to abstract idea
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 22
THANKS FOR YOUR ATTENTION
COME AND SEE USOR INVITE US TO VISIT YOU
INVITE US TO VISIT YOU: +31 (0)40 2938800 [email protected]
OR VISIT US AT: FELLENOORD 370, 5611 ZL EINDHOVEN
RIJNSBURGERWEG 10, 2333 AA LEIDEN
High-Tech Patents and High-Caliber Training
Contributors: • Nico Cordes• Sander van Rijnswou• Alex Hogeweg• Mehdi Khoshgoftar• Arjan van der Maarl• Jeroen Willekens
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 24
What sets us apart
A unique fusion of
– technological understanding
– industrial strategic experience
– legal knowledge
– candid and fully integrated IP approach
3 May 2023Patenting Medical Inventions in Europe, China, Japan & US 25
Keep up to date with our blogs
Recent changes in European patent proceduresep-patent-procedure.blogspot.nl
Local patent news (in Dutch & English)octrooi-actueel.blogspot.nl
Unitary Patent and the Unified Patent Courtunitary-patent.blogspot.nl
Most recent European patent case lawdp-patentlaw.blogspot.nl
