Week 11 part 2 Flashcards
What is a patent?
- A bargain between the state and the inventor
2. The inventor has to supply full and complete disclosure of the invention
How long does it take to develop a drug?
10-12 years
What is a patent different from?
- Trade mark
2. Copy rights and design
For a trade mark what can you think of?
A logo
What are patents described to be?
Territorial
What is the price range of filing an initial patent?
- Not expensive
- Between £1,000 - £5,000
- When you file it around the world, the cost goes up
What happens when you file a patent in one country?
- Once it is published, it is public disclosure and no one else can buy it
Where does UK patent have no effect?
Outside the UK
What does a person have to apply for?
Patent protection in each country around the world
What is the process of filling and grant of a patent?
- Date of filing (priority date if no priority claimed)
- Preliminary examination - formal examination
- Search
- Publication (18 months from priority date)
- Substantive Examination - a conversation between examiner and applicant - back and forth - tenacity is to claim everything
- Grant
What are the basic requirement of a patent?
- Novelty i.e. the invention is new
- Inventive step i.e. the invention is not obvious
- Capable of industrial application
- Not excluded subject matter
What are examples of Novelty?
- Section 2, UK patent Act, Art. 54, PC, Art.27(1), TRIPS
- Article 54-
- Prior state of art
- New use of an old thing allowed
- New advantage of an old thing
Section 2, UK patent Act, Art. 54, PC, Art.27(1), TRIPS
- State of the art: what is known by someone who is familiar with it
- The knowledge of the product
- What knowledge is available to a person’s skills of art
What does the Article 54 state?
- An invention shall be considered to be new if it does not form part of the state of art
- The state of the art shall be held to comprise everything made available to the public by means of written or oral description, by use in any other way, before date of filling of European patent application
What is prior state of art?
- Everything made available to the public by means of written or oral description, by use or any other way before filling date of application
What is one way of extending the patent life of original idea?
If you patent a technique, and patent it for using one area, you can come and patent it in a new area because things have been discovered thats going to be useful in that area aswell
What are the following things that are patentable?
- New things (product)
- New processes
- New uses for old things
- New advantage of old things used in an old way
- Selection patent
What is the priority date?
The date on which the novelty of the invention is judged
What is prior art?
Something which existed in the state of art before the priority date of invention
What is anticipated?
Some piece of prior art exist which affects the novelty of the invention
What is the consequence of anticipating an invention?
It must be made available to the public
What are possible fetters?
- Non-disclosure agreement
2. Duty of confidence
What can you patent?
A novel use
- Unsuspected of a compound that is known as long as there is nothing in the public domain
Mobil Oil III (EPO, 1991)
“A claim to the use of a known compound for a particular (novel) purpose, which is based on a technical effect which is described in the patent, should be interpreted as including that technical effect as a functional technical feature, and is accordingly not open to objection under Article 54(1) EPC provided that such technical feature has not previously been made available to the public.”
What did Merrel Dow state?
Active substance openly used but effect not known about
e.g. Held chemical substance does not need to be identifiable - it was still available in public
What is a traditional example of an active substance?
Amazonian Indians who believed the effects of the cinchona bark on malaria was due to the ‘‘spirit of the bark’’
➢ Section 3, UK Patents Act 1977/Article 56, European Patent Convention - Inventive step
“An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. If the state of the art also includes documents within the meaning of Article 54, paragraph 3, these documents shall not be considered in deciding whether there has been an inventive step.”
What is the inventive step requirement intended to prevent?
Exclusive rights forming barriers to normal and routine development
How is the inventive step usually evaluated?
On the basis of the ‘‘problem-solution’’ approach
- Whether the solution presented to the problem in patent application is obvious or not to the person skilled in the art
What is a new test for the inventive step?
- The old ‘‘windsurfing’’ test
What are the steps of the windsurfing test?
- Identify the notional ‘‘person skilled in the art’’
- Identify the relevant common general knowledge of that person
- Identify the inventive concept of the claim in question
- Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;
5iewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention
Under the Excluded Subject Matter, what are are not regarded as inventions?
- Discoveries. scientific theories, and mathematical models
- Aesthetic creations
- Schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers
- Presentations of information
- Discoveries that don’t have practical uses
Under Article 53, EPC - what are not patentable?
- Invention of commercial exploitation
- Plant or animal varieties or essentially biological processes
- Methods for treatment of human or animal body by surgery/therapy and diagnostic method practised on human/animal body
T 356/93 Plant cells/PLANT GENETIC SYSTEMS [1995] OJ EPO 545
- “It is generally accepted that the concept of ‘ordre public’ covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment.
- The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms that are deep routed in a particular culture
T 19/90 Oncomouse/HARVARD [1990] OJ EPO 476
a balancing test was introduced:
1. “A careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other.”
What patent is invalid in the UK?
Onco-Mouse
Article 6(2)(c), Directive 98/44/EC, on the protection of biotechnological inventions: Article 6
Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation
The following, in particular, shall be considered unpatentable
Uses of human embryos for industrial or commercial purposes
What can you use human embyro’s for?
- Scientific research
- The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable (for example to correct a malformation and improve the chances of life) but their use for purposes of scientific research is not patentable
What does a Patent Application contain?
- A request for the grant of a patent
- A description of the invention - important legally
- Any drawings
- An abstract
- Clear enough for someone to repeat the work
- State what it is your invention can do and make various claims for that
- It is the claim that when they go to the patent office - having a conversation with them come back and say actually you cannot claim that
What are essential elements of invention?
- Novel
2. Useful
What is duration of rights?
20 years from the date of filing
What is infringement of a patent?
❖ Where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise
❖ Where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent
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
What are construction of claims?
- scope of protection = construction of claims
- Protocol of Article 69, EPC
- Doctrine of equivalents
What are the European Patent Convention, Protocol?
- Article 1 - General Principles
2. Article 2 - Equivalents
Article 1 General principles
- the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims
- Neither should it be interpreted in the sense that the claims serve only as a guideline nor that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patentee has contemplated
- be interpreted as defining a position between these extremes, which combines a fair protection for the patentee with a reasonable degree of certainty for third parties
What is Article 2 - Equivalents?
For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims
What are exceptions and limitations of infringement of patent?
- Private and non-commercial use
- Experimental purposes
- Extemporaneous preparation on prescription
Private and non-commercial use
An act is not an infringement of the patent provided it is done privately and for purposes which are non-commercial
Experimental purposes
- Experiments undertaken solely to demonstrate to a third party that a product works or to provide information to a third party, which can include a regulatory authority, are not experimental use
Extemporaneous preparation on prescription
act which consists of the extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with medicines so prepared is not infringing
An act which consists of the use by a farmer of the product of his harvest for propagation or multiplication by him on his own holding,
where there has been a sale of plant propagating material to the farmer by the proprietor of the patent or with his consent for agricultural use does not infringe
Ownership and Employee Inventions
❖ Basic rule of entitlement - first to file and not first to invent
❖ Inventor is entitled to invention - unless contract etc.
❖ Employer owns inventions made by employee during the course of normal duties- employer
❖ Co-ownership
What gets patented in EU?
- New product
- New processes
- Further uses and new methods relating to existing products (‘‘old-drugs’’)
➢ Incremental variants including new forms of old chemicals
➢ Enantiomers (old patent covers both halves; second patent covers one half if there is a therapeutic advantage)
➢ Combinations & selection inventions
➢ Genes and biomarkers for use in/as diagnostics, prediction, personalised responses to specific drugs
➢ Further uses and new methods relating to existing products (“old drugs”)
➢ New indications
➢ Optimised or personalised dosage regimes (dosing same API, changing just dosage from 5 to 2 mg, for example)
➢ Patient subpopulations (use of same API for sub-population of existing patients - e.g. a sub-population with particular genetic variant which responds more efficiently to drug)
