PATENTS
PATENTS A. RATIONALES AND THE CONCEPT OF INVENTION Patents – a good idea? •
Patent registration provides a 20 monopoly for new products and processes
•
The monopoly protection has costs & benefits
•
Benefits: o
increased level of invention, innovation & spread of technical knowledge through the public disclosure patentee required to make
o
development of new and better products
o
potential stimulation of further development due to incentive for others in market to invent around patented invention to avoid infringing it
o
protection the patent system can provide for small firms against larger firms & benefits of royalty/licence fee income
Patents •
•
Costs o
the patent monopoly term can lead to monopoly pricing
o
monopoly pricing can lead to market power, which in turn can lead to anticompetitive behaviour and practices
o
whilst patents can offer protection for small firms, these smaller firms may be unable to afford to take on patent infringement proceedings against larger firms due to the high costs of patent litigation
No CL or unregistered patent rights o
all rights come through the registration system under the Patents Act 1990
Patents Registration Procedure - 4 Step Process 1. Request/Application o
Priority Date from specie s.43
o
Who can be granted a patent? S.15
2. Examination o
Patentable Invention?
3. Possible Opposition o
If survive opposition, then;
4. Registration
1. Application •
•
• • •
•
Section 29 o Provisional or complete o Specification required Filing date may be priority date o S.43 o Only if later complete specie is supported by disclosure in earlier filed provisional Priority date VERY important- first to file system Specification must be filed o S.29(3) & (4) Provisional specie o Must disclose invention clearly & completely enough to enable skilled person to make invention (enablement requirement) S.40(1) o Holds place in queue for 12 months only o If don’t follow up with complete, application lapses Complete specie o Must meet enablement requirement o Must disclose the best known way of making it o Must contain claims defining the scope of the invention o S.40(2) o Claims S.40(3-4)
2. Examination •
• • •
3. Possible Opposition • • •
After application accepted and docs OPI, application is open for opposition Any person can oppose rego of patent o S.59 Commissioner decides opposition o S.60 o Can appeal to FCA
4. Registration •
•
Term of Registration •
How long do registered patent rights last for?
•
20 monopoly term o
S.67
o
Use to be 16 years
•
Be careful if reading old cases/texts
Extension possible for pharma patents
On request, Commissioner of Patents will examine filed patent docs o S.45 If patent application accepted & published o S.49 Patent docs become OPI o S.55 OPI date VERY important o S.55 & S.57
If no opposition or if win opposition, patent granted o S.61 But registration no guarantee of validity o S.20
o
SS.70-79A
Patentability – Requirements of an invention and manner of manufacture (numbers 1 and 2) To be valid, a claim in a patent specie must, per S.18: 1. 2. 3. 4. 5. 6. 7.
Disclose an invention be a manner of manufacture be novel involve an inventive step be useful not have been secretly used satisfy S.40 formalities 8. not be for excluded subject matter
Topic 8 will cover 1,2 & 8
1. Invention •
2 aspects o Must meet definition of ‘invention’ o Inherent in this is requirement of newness ask if ‘new’ on face of specification? Definition of Invention •
S.3 & Sch 1 o
“any manner of new manufacture the subject of letters patent and grant of privilege within s.6 of the Statute of Monopolies, and includes an alleged invention”
•
The UK Statute of Monopolies of 1623 passed in order to ban monopolies, which were seen as undesirable
•
S.6 of the Statute of Monopolies o
carves out of the ban on monopolies an exception for manners of new manufacture, which could, according to s.6, be protected by letters patent and thereby have a valid monopoly
o
“any manner of new manufacture the subject of letters patent and grant of privilege within s.6 of the Statute of Monopolies, and includes an alleged invention”
• •
What is manner of new manufacture? Rogers v. Commissioner of Patents o a new and useful thing or (product) o a new and useful method or way of producing an old or known thing (process/method) Requirement of newness • Lockwood v Doric [2007] HCA 21 , para 106 o
o
•
“… a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification "on its face" shows the invention claimed is not a manner of new manufacture” “ it does not involve a separate ground of invalidity or a discrete "threshold" test”
requirement of newness or inventiveness will not be met if invention claimed would have been obvious, based on this prior known information disclosed on the face of the specification o
Eg, I apply to patent car with 3 wheels and in my patent specification filed with application I refer to existing cars with 4 wheels. Commissioner examining my application may decide development of 3 wheeled car was an obvious (& so not new) one in light of my disclosure in my specification of existing 4 wheeled cars
•
Does specification disclose lack of newness: o
Look at what is disclosed on the face of the specification and ask: is it so obviously lacking in newness or inventiveness that it fails to amount to an invention?
2. Manner of manufacture • Not defined in Act
NRDC case •
•
•
2 elements to manner of manufacture: o Economic utility o Artificially created state of affairs 2 grounds on which patent claims rejected by Patent Office in this case: o Mere use of known substance o Not a vendible product Mere use of known substance o HCA referred to Microcell:
o
o
HCA:
Didn’t agree that claim for mere use of known substance the NRDC claim was for a new process for ridding crop areas of certain kinds of weeds the inventive element consisted in the discovery of previously unknown properties of the chemicals and that they were useful for selectively killing the weeds and not the crop ie discover something new AND suggest useful application Distinction between discovery & invention Why clearly an invention & not mere use of known substance
o o o
a claim for the use of a known material in the manufacture of known articles for the purpose of which it is suitable because of its known properties, is not a manner of manufacture within the meaning of the Statute of Monopolies and therefore the Patents Act, 1990
“by an application of scientific ingenuity, combining knowledge, thought and experimentation, not only in relation to the chemicals, but in relation also to the enzyme systems of certain weeds and plants, the [NRDC] has evolved a new and useful method of destroying weeds without harming” the crops amongst which the weeds were growing
Vendible product HCA: didn’t agree that ‘manufacture’ should be restricted to vendible products & processes for their production HCA: the terms ‘product’ and ‘vendible’ need to be understood in the widest possible sense, & the idea of a ‘product’ covers every end produced (artificially created state of affairs), & ‘vendible’ connotes a requirement of a useful end (economic utility) NRDC’s claims for a method of selectively killing weeds patentable per HCA b/c the method consisted in o an artificially created end state of affairs (selectively killing weeds),&
o
economic utility (in improving crop yields)
SUMMARY (invention and manufacture) INVENTION •
•
In order to be a manner of new manufacture it must be o a new and useful thing or (product), or o a new and useful method or way of producing an old or known thing (process/method) Rogers v Commissioner of Patents Claim to “invention” may be nullified by admission/information as to lack of newness or inventiveness on the face of the patent specification o Lockwood v Doric
MANNER OF MANUFACTURE •
there needs to be an artificially created state, in the sense of a change or end result other than the natural state; and
•
the end result must have utility in a practical or economic sense o
NRDC
Patentability of inventions in different areas of science •
Treatment of humans o
•
Ag & horticultural processes o
•
No exception, Apotex case
NRDC
Schemes, ideas, plans, etc o
Not per se manners of manufacture
o
may be patentable if suggest practical useful application
o
Rolls Royce
Eg, law of gravity not patentable (more in nature of discovery of law of nature) but if suggest new & useful application or way of using it, may be a manner of manufacture
Business systems
Grant v Commissioner of Patents – yes if meet requirements of Act
•
Computer software/programs o
•
No in this case, mere scheme
IBM v Commissioner of Patents
Living Organisms o
No specific exclusion in patents act (except s18(2))
o
Amercian Cyanamid v Berk
o
Diamond v Chakrabarty
Artificially created state of affairs
Not naturally occurring bacterium but produced by man’s technical intervention
Economic utility
Useful for breaking down oil spills
Patentability Requirement: Excluded subject matter (number 8) •
Human being exception o
S.18(2)
o
D’Arcy v Myriad Genetics & Anor [2014] FCAFC 115 Special leave granted
•
Patent Amendment (Human Genes and Biological Materials) Bill 2010
•
This bill did not proceed o
“The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.” Explan Memo
o
Proposed amendments included:
amend subsection 18(2) by adding, as another category of subject matter to be expressly excluded from patentability, “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”
insert after section 18(4) the definition of “biological materials” to mean “includes DNA, RNA, proteins, cells and fluids.”
PATENTS QUESTION GUIDE 1. Is there an invention that is patentable?
2. Work through section 18 elements •Invention •A manner of manufacture within the meaning of section 6 of Statute of Monopolies •Novelty •Inventive Step •Useful •Not secretly used •Don't forget - section 18(2) --> human being exception
3. Does the specification comply with section 40? •Sufficiently described? •Are the claims clear or are they ambiguous? •Are the claim fully supported?
4. If registered, what are the patentee's exclusive rights? (section 13)
5. Have any of the exclusive rights been infringed? •Remember the basic principles - construe the patent to work out what is within the scope of the claims •You identify the essental and inessential integers - there is no infringement unless all the essential integers of an invention are taken •Infringement only occurs if the acts are done without authority , so consider whether there are any restrictions ont he use of the invention by purchasers or any implied licence to repair
6.What is the appropriate remedy? •Section 122 - injunction, damages, accounts of profits •Section 123 - discretion to refuse an award for damages or account of profits for innconent
7. What is the patent vulnerable to revocation? •If sue for patent infringement, def will likely counterclaim for revocation of patent: s121 •Grounds for revocation •s138(3)(b) - patent not a patentable invention (ie doesn’t comply with s18) •s138(3)(f) - patent specie doesn’t comply with s40(2) and (3) requirements
Patent registration provides a 20 monopoly for new products and processes
•
The monopoly protection has costs & benefits
•
Benefits: o
increased level of invention, innovation & spread of technical knowledge through the public disclosure patentee required to make
o
development of new and better products
o
potential stimulation of further development due to incentive for others in market to invent around patented invention to avoid infringing it
o
protection the patent system can provide for small firms against larger firms & benefits of royalty/licence fee income
Patents •
•
Costs o
the patent monopoly term can lead to monopoly pricing
o
monopoly pricing can lead to market power, which in turn can lead to anticompetitive behaviour and practices
o
whilst patents can offer protection for small firms, these smaller firms may be unable to afford to take on patent infringement proceedings against larger firms due to the high costs of patent litigation
No CL or unregistered patent rights o
all rights come through the registration system under the Patents Act 1990
Patents Registration Procedure - 4 Step Process 1. Request/Application o
Priority Date from specie s.43
o
Who can be granted a patent? S.15
2. Examination o
Patentable Invention?
3. Possible Opposition o
If survive opposition, then;
4. Registration
1. Application •
•
• • •
•
Section 29 o Provisional or complete o Specification required Filing date may be priority date o S.43 o Only if later complete specie is supported by disclosure in earlier filed provisional Priority date VERY important- first to file system Specification must be filed o S.29(3) & (4) Provisional specie o Must disclose invention clearly & completely enough to enable skilled person to make invention (enablement requirement) S.40(1) o Holds place in queue for 12 months only o If don’t follow up with complete, application lapses Complete specie o Must meet enablement requirement o Must disclose the best known way of making it o Must contain claims defining the scope of the invention o S.40(2) o Claims S.40(3-4)
2. Examination •
• • •
3. Possible Opposition • • •
After application accepted and docs OPI, application is open for opposition Any person can oppose rego of patent o S.59 Commissioner decides opposition o S.60 o Can appeal to FCA
4. Registration •
•
Term of Registration •
How long do registered patent rights last for?
•
20 monopoly term o
S.67
o
Use to be 16 years
•
Be careful if reading old cases/texts
Extension possible for pharma patents
On request, Commissioner of Patents will examine filed patent docs o S.45 If patent application accepted & published o S.49 Patent docs become OPI o S.55 OPI date VERY important o S.55 & S.57
If no opposition or if win opposition, patent granted o S.61 But registration no guarantee of validity o S.20
o
SS.70-79A
Patentability – Requirements of an invention and manner of manufacture (numbers 1 and 2) To be valid, a claim in a patent specie must, per S.18: 1. 2. 3. 4. 5. 6. 7.
Disclose an invention be a manner of manufacture be novel involve an inventive step be useful not have been secretly used satisfy S.40 formalities 8. not be for excluded subject matter
Topic 8 will cover 1,2 & 8
1. Invention •
2 aspects o Must meet definition of ‘invention’ o Inherent in this is requirement of newness ask if ‘new’ on face of specification? Definition of Invention •
S.3 & Sch 1 o
“any manner of new manufacture the subject of letters patent and grant of privilege within s.6 of the Statute of Monopolies, and includes an alleged invention”
•
The UK Statute of Monopolies of 1623 passed in order to ban monopolies, which were seen as undesirable
•
S.6 of the Statute of Monopolies o
carves out of the ban on monopolies an exception for manners of new manufacture, which could, according to s.6, be protected by letters patent and thereby have a valid monopoly
o
“any manner of new manufacture the subject of letters patent and grant of privilege within s.6 of the Statute of Monopolies, and includes an alleged invention”
• •
What is manner of new manufacture? Rogers v. Commissioner of Patents o a new and useful thing or (product) o a new and useful method or way of producing an old or known thing (process/method) Requirement of newness • Lockwood v Doric [2007] HCA 21 , para 106 o
o
•
“… a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification "on its face" shows the invention claimed is not a manner of new manufacture” “ it does not involve a separate ground of invalidity or a discrete "threshold" test”
requirement of newness or inventiveness will not be met if invention claimed would have been obvious, based on this prior known information disclosed on the face of the specification o
Eg, I apply to patent car with 3 wheels and in my patent specification filed with application I refer to existing cars with 4 wheels. Commissioner examining my application may decide development of 3 wheeled car was an obvious (& so not new) one in light of my disclosure in my specification of existing 4 wheeled cars
•
Does specification disclose lack of newness: o
Look at what is disclosed on the face of the specification and ask: is it so obviously lacking in newness or inventiveness that it fails to amount to an invention?
2. Manner of manufacture • Not defined in Act
NRDC case •
•
•
2 elements to manner of manufacture: o Economic utility o Artificially created state of affairs 2 grounds on which patent claims rejected by Patent Office in this case: o Mere use of known substance o Not a vendible product Mere use of known substance o HCA referred to Microcell:
o
o
HCA:
Didn’t agree that claim for mere use of known substance the NRDC claim was for a new process for ridding crop areas of certain kinds of weeds the inventive element consisted in the discovery of previously unknown properties of the chemicals and that they were useful for selectively killing the weeds and not the crop ie discover something new AND suggest useful application Distinction between discovery & invention Why clearly an invention & not mere use of known substance
o o o
a claim for the use of a known material in the manufacture of known articles for the purpose of which it is suitable because of its known properties, is not a manner of manufacture within the meaning of the Statute of Monopolies and therefore the Patents Act, 1990
“by an application of scientific ingenuity, combining knowledge, thought and experimentation, not only in relation to the chemicals, but in relation also to the enzyme systems of certain weeds and plants, the [NRDC] has evolved a new and useful method of destroying weeds without harming” the crops amongst which the weeds were growing
Vendible product HCA: didn’t agree that ‘manufacture’ should be restricted to vendible products & processes for their production HCA: the terms ‘product’ and ‘vendible’ need to be understood in the widest possible sense, & the idea of a ‘product’ covers every end produced (artificially created state of affairs), & ‘vendible’ connotes a requirement of a useful end (economic utility) NRDC’s claims for a method of selectively killing weeds patentable per HCA b/c the method consisted in o an artificially created end state of affairs (selectively killing weeds),&
o
economic utility (in improving crop yields)
SUMMARY (invention and manufacture) INVENTION •
•
In order to be a manner of new manufacture it must be o a new and useful thing or (product), or o a new and useful method or way of producing an old or known thing (process/method) Rogers v Commissioner of Patents Claim to “invention” may be nullified by admission/information as to lack of newness or inventiveness on the face of the patent specification o Lockwood v Doric
MANNER OF MANUFACTURE •
there needs to be an artificially created state, in the sense of a change or end result other than the natural state; and
•
the end result must have utility in a practical or economic sense o
NRDC
Patentability of inventions in different areas of science •
Treatment of humans o
•
Ag & horticultural processes o
•
No exception, Apotex case
NRDC
Schemes, ideas, plans, etc o
Not per se manners of manufacture
o
may be patentable if suggest practical useful application
o
Rolls Royce
Eg, law of gravity not patentable (more in nature of discovery of law of nature) but if suggest new & useful application or way of using it, may be a manner of manufacture
Business systems
Grant v Commissioner of Patents – yes if meet requirements of Act
•
Computer software/programs o
•
No in this case, mere scheme
IBM v Commissioner of Patents
Living Organisms o
No specific exclusion in patents act (except s18(2))
o
Amercian Cyanamid v Berk
o
Diamond v Chakrabarty
Artificially created state of affairs
Not naturally occurring bacterium but produced by man’s technical intervention
Economic utility
Useful for breaking down oil spills
Patentability Requirement: Excluded subject matter (number 8) •
Human being exception o
S.18(2)
o
D’Arcy v Myriad Genetics & Anor [2014] FCAFC 115 Special leave granted
•
Patent Amendment (Human Genes and Biological Materials) Bill 2010
•
This bill did not proceed o
“The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.” Explan Memo
o
Proposed amendments included:
amend subsection 18(2) by adding, as another category of subject matter to be expressly excluded from patentability, “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”
insert after section 18(4) the definition of “biological materials” to mean “includes DNA, RNA, proteins, cells and fluids.”
PATENTS QUESTION GUIDE 1. Is there an invention that is patentable?
2. Work through section 18 elements •Invention •A manner of manufacture within the meaning of section 6 of Statute of Monopolies •Novelty •Inventive Step •Useful •Not secretly used •Don't forget - section 18(2) --> human being exception
3. Does the specification comply with section 40? •Sufficiently described? •Are the claims clear or are they ambiguous? •Are the claim fully supported?
4. If registered, what are the patentee's exclusive rights? (section 13)
5. Have any of the exclusive rights been infringed? •Remember the basic principles - construe the patent to work out what is within the scope of the claims •You identify the essental and inessential integers - there is no infringement unless all the essential integers of an invention are taken •Infringement only occurs if the acts are done without authority , so consider whether there are any restrictions ont he use of the invention by purchasers or any implied licence to repair
6.What is the appropriate remedy? •Section 122 - injunction, damages, accounts of profits •Section 123 - discretion to refuse an award for damages or account of profits for innconent
7. What is the patent vulnerable to revocation? •If sue for patent infringement, def will likely counterclaim for revocation of patent: s121 •Grounds for revocation •s138(3)(b) - patent not a patentable invention (ie doesn’t comply with s18) •s138(3)(f) - patent specie doesn’t comply with s40(2) and (3) requirements
