Lecture 4 Flashcards
What is the state of the art?
Section 2(2) PA (see also Article 54(2) EPC: The state of the art... shall be taken to comprise all matter... which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way.
What is the priority date?
The date at which the novelty is to be assessed is the ‘priority date’ of the invention.
The priority date is normally the date on which the application was filed… or earlier if the application was made during the previous 12 months in a Paris Convention country.
length of patent and prior art all calculated from this date.
Where does a Grace Period for disclosures exist?
Only the US - 1 year grace period within which to file a patent.
Not in the UK/EPO
What type of disclosures will not anticipate a patent application? (3)
Section 2(4)-(6) (see also Article 55 EPC) define specific types of disclosure which will not anticipate a patent application. These include:
1) information obtained unlawfully
2) information disclosed through a breach of confidence, and
3) disclosure at a recognised international exhibition
ONLY 6 months before filing date
In terms of novelty and prior art, what is meant by an enabling disclosure?
To form part of the state of the art a disclosure must be ‘enabling’
Synthon BV v SmithKlein Beecham: enabling disclosure consists of two separate requirements which need to be satisfied if an objection of lack of novelty is to succeed:
Prior Disclosure
Enablement
Asahi Kasei Kogyo: skilled person required not only formula of chemical compound but also the means by which the compound could be produced.
Bristol-Myers Squibb Co. v Baker Norton Pharmaceuticals: lecture given by patentee’s Director of R+D before the priority date on the use of the drug taxol to treat ovarian cancer amounted to enabling disclosure.
What is the relevance of the Windsurfing patent case?
Prior use of sailboard was successfully used by the defendant to invalidate the litigants patent for invalidity due to anticipation.
What is the relevance of the Merrel Dow v Norton case for novelty and (secret) use in terms of prior art?
- Merrel owned patent product claim to acid metabolite of a compound
- Sued generics for infringement as by offering for sale the compound which is then metabolised into the acid metabolite in the human body by consumers they were infringing.
- Merrel patent found to be invalid as the acid metabolite was a natural product of ingesting the original compound and thus was occuring before the priority date of the application
Wrt excluded subject-matters, under Article 53 EPC (c) patents shall not be granted in respect of (section 1(3), 4A and schedule A2 PA) of what?
(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 does shall not apply to products, in particular substances or compositions, for use in any of these methods.
What was the outcome of Merrell Dow Pharmaceuticals v Norton Healthcare [1996] RPC 76 (HL) with regard to novelty and (secret) use?
What was the outcome of Merrell Dow Pharmaceuticals v Norton Healthcare [1996] RPC 76 (HL) with regard to novelty and (secret) use?
Terfinadine patent granted 1972
Patentees applied for patent for class of compounds which included the metabolite of terfenadine.
BUT the manufacture of the metabolite in the human body was an inevitable result of carrying out the invention.
Patentees then tried to sue on grounds that, although not directly making and selling the metabolite, Norton was indirectly infringing by supplying the means to infringe to their customers (i.e. causing their customers to become ‘mini-factories’ of the metabolite).
It was claimed as a defence that there had been anticipation of the acid metabolite patent by use. The anticipation by use had taken place when the terfenadine was made available to, and used by, volunteers in clinical trials.
Acid metabolite had been produced in their livers and they had experienced its anti-histamine effects.
An invention is a piece of information. Making matter available to the public within the meaning of s 2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information (at 86).
So no anticipation by use.
But what did invalidate the metabolite patent?
A: Anticipation by disclosure
the composition of the acid metabolite had already been part of the disclosure of the earlier 1972 patent for terfenadine, even though it was not appreciated at the time the patent was granted.
If the specifications of the 1972 patent were followed then the production of acid metabolite was inevitable and therefore not novel.
The claim for the acid metabolite was therefore not new so the patent was invalid.
What is a first medical use exception to Article 54 EPC (4)?
Can get a patent for a compound known for use as a dye if the patent is for its use in treating a medical disease etc. IF the compound has not been known in the art in that field of use.
What is the second/subsequent medical use exception under Article 54 EPC (5)?
Can get a patent for use of a known compound known for treating acne if it has not previously been known to treat toothache etc.
What was the outcome regarding use of known substances for new purposes of Dosage Regimes/ABBOTT RESPIRATORY [2010]? (2)
1) Where it is already known to use a medicament to treat an illness, Art.54(5) EPC does not exclude that this medicament may be patented for use in a different treatment by therapy of the same illness.
2) Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.
What was the issue of the Mobil Friction Reducing Additive case?
Patent application for a friction reducing additive for motor engine lubrication oils.
Prior art was a US patent for use of the same compound as a rust inhibitor additive.
The problem was that the friction-reducing property was inherent in, but not explicitly described by, the prior patent claim. No new process or product, but merely a discovery of something new about an old process or product.
“However, in Decision G 2/88 it was emphasised in paragraph 10.1 that the question to be decided is what has been made available to the public, not what may have been inherent in what was made available to the public. Furthermore, as emphasised in paragraph 10, when considering how far the teaching in a written description also makes available to the public the inevitable result of carrying out such teaching, in each case “a line must be drawn between what is in fact made available and what remains hidden or otherwise has not been made available”. Thus, whether a previously undisclosed technical effect which in fact inevitably occurs when a previously disclosed technical teaching in a written description is carried out has been made available to the public by reason of the teaching in the written description is a question of fact which has to be decided in the context of each individual case.”
Claim upheld and patented.
What is the rationale behind ‘inventive step’?
Patents should only be granted to meritorious inventions.
Distinguishing inventions from mere ‘workshop improvements’.
The public should not be prevented from doing anything which was merely an obvious extension or workshop variation of what was already known at the priority date.
PLG Research v Ardon [1995] CA
How does Section 3A of the Patents Act (Article 56 EPC) define inventive step?
An invention shall involve an inventive step if it is not obvious to a person skilled in the art having regard to any matter which forms part of the state of the art.
